Product Development PortfolioLast update: Apr. 19, 2016

Therapeutic Area
Partner
Managed By
Compound/
Generic name
Trade name
Indication
Phase
123f
Expected Filing

1. Oncology

1. Oncology
RG6016
hematological and solid tumors
4. Phase 1

Description/Summary:

RG6016 is a potent, small molecule, irreversible inhibitor of lysine specific demethylase-1 (LSD1), an enzyme involved in the epigenetic regulation of gene expression by demethylating specific histone lysine residues on chromatin. LSD1 is overexpressed in acute leukemias and solid tumors. Inhibition of LSD1 is expected to be efficacious by down regulating tumor promoting gene expression and inducing anti-tumor growth effects, such as tumor cell differentiation.

Managed by:
2. Pharma Research and Early Development
Partner:
Oryzon Genomics, SA
1. Oncology
RG6047
metastatic estrogen receptor-positive, HER2-negative breast cancer
4. Phase 1

Description/Summary:

RG6047 (GDC-0927, ARN-927) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.

Managed by:
3. Genentech Research and Early Development
Partner:
Seragon acquisition
1. Oncology
RG6061
solid tumors
4. Phase 1

Description/Summary:

RG6061 is a locked nucleic acid (LNA) oligonucleotide that uses third-generation antisense oligonucleotide technology to specifically down-modulate hypoxia-inducible factor 1 alpha (HIF-1α) messenger ribonucleic acid (mRNA) and consequently protein. HIF-1 plays a critical role in angiogenesis during embryonic development and disease pathogenesis.

Managed by:
2. Pharma Research and Early Development
Partner:
Santaris origin
1. Oncology
RG6078
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. RG6078 (GDC-0919, NLG919) is a small-molecule investigational immunotherapy designed to inhibit IDO (indoleamine 2,3dioxygenase), a protein often overproduced by many cancer cells.

Managed by:
3. Genentech Research and Early Development
Partner:
NewLink Genetics
1. Oncology
RG6078 + atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. RG6078 (GDC-0919, NLG919) is a small-molecule investigational immunotherapy designed to inhibit IDO (indoleamine 2,3dioxygenase), a protein often overproduced by many cancer cells. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating RG6078 and atezolizumab in solid tumors is planned to start in Q3 2015.

Managed by:
3. Genentech Research and Early Development
Partner:
NewLink Genetics
1. Oncology
RG6146
oncology
4. Phase 1

Description/Summary:

RG6146 is a small-molecule inhibitor of BET (bromodomain and extraterminal family) proteins (BRD2/3/4/T), interfering with the protein-chromatin interaction. By preventing binding to acetylated histones, RG6146 inhibits pTEFb-dependent transcription from enhancer and super-enhancer regions, leading to down-regulation of genes regulating growth and survival of cancer cells (e.g., MYC).

Managed by:
2. Pharma Research and Early Development
Partner:
Tensha acquisition
1. Oncology
RG7155 emactuzumab
solid tumors
4. Phase 1

Description/Summary:

RG7155 is a humanized monoclonal antibody targeting colony stimulating factor-1 receptor (CSF-1R) designed to inhibit the CSF-1 mediated survival of tumor-promoting ‘M2’ macrophages without affecting tumor-killing ‘M1’ macrophages.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7155+RG7446 emactuzumab + atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Emactuzumab (RG7155) is a humanized monoclonal antibody targeting colony stimulating factor-1 receptor (CSF-1R) designed to inhibit the CSF-1 mediated survival of tumor-promoting ‘M2’ macrophages without affecting tumor-killing ‘M1’ macrophages. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating combined emactuzumab and atezolizumab in solid tumors is ongoing.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7159 obinutuzumab
Gazyva
hematological indications, multiple combination regimens
4. Phase 1

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
Biogen Idec
1. Oncology
RG7304
solid tumors
4. Phase 1

Description/Summary:

RG7304 is a small molecule MEK inhibitor with a novel structure based on a coumarin skeleton. It selectively inhibited Raf1 (C-Raf), B-Raf, mutant B-Raf (V600E), and MEK1 in in vitro studies and showed a strong and broad spectrum of antitumor activities both in vitro in various tumor cell lines and in vivo in mouse xenograft models.

Managed by:
2. Pharma Research and Early Development
Partner:
Chugai
1. Oncology
RG7386
solid tumours
4. Phase 1

Description/Summary:

RG7386 (FAP-DR5) is a novel bispecific antibody designed to induce tumour site-specific cell apoptosis (programmed cell death). One component targets fibroblast-activating protein (FAP)-positive cancer-associated fibroblasts, while the other is a potent death receptor 5 (DR5) agonist. The resulting avidity-driven binding of RG7386 mediates hyper-clustering of DR5, triggering tumour-cell death.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7446 atezolizumab
HER2-positive breast cancer
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase Ib trial evaluating atezolizumab in combination with Kadcyla (trastuzumab emtansine) or with Herceptin (trastuzumab) and Perjeta (pertuzumab), with or without chemotherapy, as appropriate, in patients with HER2-positive breast cancer is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab for solid tumours is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + Gazyva atezolizumab + obinutuzumab
lymphoma
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Gazyva in relapsed/refractory follicular lymphoma and diffuse large B cell lymphoma is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + Tarceva or Alecensa atezolizumab + erlotinib or alectinib
non-small cell lung cancer, EGFR mutation-positive or ALK-positive
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Tarceva (erlotinib) or Alecensa (alectinib) in patients with non-small cell lung cancer is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + ipilimumab or IFN alpha-2b atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I clinical trial evaluating anti-PDL1 in combination with ipilimumab or interferon alpha-2b in locally advanced or metastatic solid tumours is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 +/─ lenalidomide atezolizumab
multiple myeloma
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab alone and in combination with lenalidomide in multiple myeloma is planned to start in Q3 2015.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+Avastin atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Avastin (bevacizumab) and chemotherapy for solid tumours is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+Cotellic atezolizumab+cobimetinib
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I clinical trial evaluating atezolizumab in combination with cobimetinib in locally advanced or metastatic solid tumours is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+Zelboraf +/- Cotellic atezolizumab + vemurafenib +/- cobimetinib
metastatic melanoma
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase I trial evaluating atezolizumab in combination with Zelboraf (vemurafenib), with or without Cotellic (cobimetinib), for metastatic melanoma is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7461
solid tumours
4. Phase 1

Description/Summary:

RG7461 is a targeted immunocytokine combining an engineered interleukin-2 variant (IL2v) with an antibody against fibroblast activation protein (FAP), a protein expressed in several cancers. A phase I clinical trial evaluating RG7461 in solid tumours is ongoing.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7601 venetoclax
Venclexta
relapsed or refractory chronic lymphocytic leukemia
4. Phase 1

Description/Summary:

Venetoclax is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed by:
1. Roche Group
Partner:
Abbott, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax+obinutuzumab
Venclexta + Gazyva
chronic lymphocytic leukemia
4. Phase 1

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. Gazyva, (obinutuzumab), is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
AbbVie, WEHI
1. Oncology
RG7601 + Cotellic or idasanutlin venetoclax
Venclexta
relapsed or refractory AML not eligible for cytotoxic therapy
4. Phase 1

Description/Summary:

Venclexta (venetoclax, RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase I clinical trial is investigating Venclexta in combination with Cotellic (cobimetinib, RG7421, selective MEK inhibitor) or with idasanutlin (RG7388, selective MDM2 antagonist) for the treatment of relapsed or refractory acute myelogenous leukemia that is not eligible for cytotoxic therapy.

Managed by:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute (Venclexta); Exelixis (Cotellic)
1. Oncology
RG7741
solid tumors or lymphoma
4. Phase 1

Description/Summary:

Checkpoint kinase 1 (ChK1) is a protein kinase that regulates tumor cells' response to DNA damage, often caused by treatment with chemotherapy. In response to DNA damage, ChK1 blocks cell cycle progression in order to allow for repair of damaged DNA. Inhibiting ChK1 in combination with chemotherapy may enhance tumor cell death by preventing these cells from recovering from DNA damage. RG7741 (GDC-0575) is a small molecule ChK1 selective inhibitor designed to prevent tumor cells from recovering from DNA damage.

Managed by:
3. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7775
acute myeloid leukemia
4. Phase 1

Description/Summary:

RG7775 is a prodrug version of a selective, small molecule MDM2 antagonist that inhibits binding of MDM2 to p53. Blocking the MDM2-p53 interaction stabilizes p53 and activates p53-mediated cell death and inhibition of cell growth.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7802
solid tumors
4. Phase 1

Description/Summary:

RG7802 is a bispecific antibody designed to simultaneously target carcinoembryonic antigen (CEA) expressed on tumor cells and the CD3 receptor present on T cells, triggering T cell activation, migration and tumor killing. RG7802 is currently being investigated as a potential treatment for CEA-expressing solid tumors, as a single agent and in combination with atezolizumab.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7813
solid tumors
4. Phase 1

Description/Summary:

RG7813 is a targeted immunocytokine combining an engineered cytokine (IL2v) with an antibody against carcinoembryonic antigen (CEA), a protein expressed in several cancers. A phase I clinical trial evaluating RG7813 in solid tumors is ongoing.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7813 + RG7446
Solid tumors
4. Phase 1

Description/Summary:

RG7813 is a targeted immunocytokine combining an engineered cytokine (IL2v) with an antibody against carcinoembryonic antigen (CEA), a protein expressed in several cancers. RG7813 is being developed in combination with other immunotherapies, and it is currently being tested in combination with anti-PD-L1 RG7446.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7828
hematologic tumours
4. Phase 1

Description/Summary:

Anti-CD20/CD3 TDB (BTCT4465A, RG7828) is a humanised full-length T cell–dependent bispecific antibody designed to target both CD20 on B cells and CD3 on T cells. This dual-targeting antibody is designed to redirect T cells to attack cancer cells.

Managed by:
3. Genentech Research and Early Development
Roche Only
1. Oncology
RG7841
solid tumors
4. Phase 1

Description/Summary:

A phase I clinical trial evaluating the anti-Ly6E antibody–drug conjugate RG7841 in solid tumours is ongoing.

Managed by:
3. Genentech Research and Early Development
Roche Only
1. Oncology
RG7842
solid tumors
4. Phase 1

Description/Summary:

RG7842 (GDC-0994) is a selective inhibitor of ERK1/2, also known as extracellular-signal-regulated kinases. ERK is a key component of the RAS/RAF/MEK/ERK signalling pathway, which is frequently activated in human tumours. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. Phase I clinical trials evaluating RG7842 as a single agent or in combination with Cotellic (cobimetinib) in solid tumors are ongoing.

Managed by:
3. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7876 + atezolizumab
solid tumors
4. Phase 1

Description/Summary:

RG7876 is a fully human (IgG2) agonistic antibody against CD40. The antibody induces T cell-driven tumor killing by activation of CD40 on antigen-presenting cells which in turn prime T cells to attack the tumor. The antibody is being developed in combination with other immunotherapies and is currently being tested in combination with atezolizumab (anti-PD-L1, RG7446).

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7876 + vanucizumab
solid tumours
4. Phase 1

Description/Summary:

RG7876 is a fully human (IgG2) agonistic antibody against CD40. The antibody induces T cell-driven tumor killing by activation of CD40 on antigen-presenting cells which in turn prime T cells to attack the tumor. The antibody is being developed in combination with other immunotherapies and is also being tested in combination with vanucizumab (Ang2-VEGF biMAb, RG7221).

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7882
ovarian cancer, pancreatic cancer
4. Phase 1

Description/Summary:

A phase I clinical trial evaluating the antibody drug conjugate RG7882 in platinum-resistant ovarian cancer or unresectable pancreatic cancer is ongoing.

Managed by:
3. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG7888
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. RG7888 (anti-OX40, MOXR0916), a humanized monoclonal antibody, is designed to target OX40, a costimulatory receptor that is selectively expressed on the surface of antigen-experienced T cells. Anti-OX40 functions as an agonist antibody, which results in activation rather than blockade of the OX40 signaling pathway upon receptor binding.

Managed by:
3. Genentech Research and Early Development
Roche Only
1. Oncology
RG7888 + atezolizumab
solid tumors
4. Phase 1

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. RG7888 (anti-OX40, MOXR0916), a humanized monoclonal antibody, is designed to target OX40, a costimulatory receptor that is selectively expressed on the surface of antigen-experienced T cells. Anti-OX40 functions as an agonist antibody, which results in activation rather than blockade of the OX40 signaling pathway upon receptor binding. A phase I trial investigating RG7888 in combination with atezolizumab (anti-PD-L1, RG7446) in solid tumours is ongoing.

Managed by:
3. Genentech Research and Early Development
Roche Only
1. Oncology
RG7986
relapsed or refractory B cell non-Hodgkin's lymphoma
4. Phase 1

Description/Summary:

ADC

Managed by:
3. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG3502 trastuzumab emtansine
Kadcyla
HER2-positive advanced non-small cell lung cancer
3. Phase 2
2018+

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG6046
metastatic estrogen receptor-positive, HER2-negative breast cancer
3. Phase 2
2018+

Description/Summary:

RG6046 (GDC-0810, ARN-810) is a selective estrogen receptor degrader (SERD) that is designed to bind to the estrogen receptor to limit its function. In addition, when SERDs bind to the estrogen receptor, they may be able to change the shape of the receptor in such a way that the cell eliminates it by degradation.

Managed by:
3. Genentech Research and Early Development
Partner:
Seragon acquisition
1. Oncology
RG7221 vanucizumab
colorectal cancer
3. Phase 2
2018+

Description/Summary:

Vanucizumab (RG7221) is a bi-specific monoclonal antibody comprised of two different heavy chains and two different light chains. One arm of the antibody binds Angiopoietin-2 (Ang2) and the other is based on bevacizumab (Avastin), binding Vascular Endothelial Growth Factor A (VEGF-A). The antibody is designed to inhibit both VEGF-A and Ang2 simultaneously to offer superior clinical benefit compared to VEGF-A inhibition alone.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7421 cobimetinib
Cotellic
1st line metastatic triple negative breast cancer
3. Phase 2
2018+

Description/Summary:

Cotellic (cobimetinib, RG7421), a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), is a key component of the RAS/RAF/MEK/ERK pathway, which is frequently activated in human tumors. Inappropriate activation of the MEK/ERK pathway promotes cell growth in the absence of exogenous growth factors. A phase II trial of Cotellic in combination with paclitaxel in patients with triple-negative breast cancer is ongoing.

Managed by:
1. Roche Group
Partner:
Exelixis
1. Oncology
RG7440 ipatasertib
solid tumors
3. Phase 2
2018+

Description/Summary:

RG7440 is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.

Managed by:
3. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7596 polatuzumab vedotin
hematological malignancies
3. Phase 2
2018+

Description/Summary:

Anti-CD79b is an antibody drug conjugate (ADC) that consists of a monoclonal antibody, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells.

Managed by:
3. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta
front-line diffuse large B cell lymphoma
3. Phase 2
2018+

Description/Summary:

Venetoclax (RG7601) is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance.

Managed by:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax+rituximab
Venclexta + MabThera / Rituxan
relapsed/refractory follicular lymphoma
3. Phase 2
2018+

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase II clinical trial evaluating the combination of RG7601 and MabThera/Rituxan (rituximab) in relapsed or refractory follicular lymphoma is ongoing.

Managed by:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7604 taselisib
HER2-negative, hormone receptor-positive metastatic breast cancer, neoadjuvant treatment
3. Phase 2
2018+

Description/Summary:

PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Taselisib is being investigated as a potential treatment for PIK3CA mutation-positive, hormone receptor-positive metastatic breast cancer, PIK3CA mutation-positive squamous non-small cell lung cancer, and other solid tumours.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7604 taselisib
squamous non-small cell lung cancer, second-line
3. Phase 2
2018+

Description/Summary:

PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Taselisib is being investigated as a potential treatment for PIK3CA mutation-positive, hormone receptor-positive metastatic breast cancer, PIK3CA mutation-positive squamous non-small cell lung cancer, and other solid tumours.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7686 codrituzumab
metastatic liver cancer
3. Phase 2
2018+

Description/Summary:

RG7686 is a first in class monoclonal humanized anti-glypican 3 antibody being developed as single agent and in combination against metastatic hepatocellular carcinoma. Its therapeutic activity in pre-clinical models was shown to take place via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Managed by:
2. Pharma Research and Early Development
Partner:
Chugai
1. Oncology
RG1273 pertuzumab
Perjeta
2nd line HER2-positive breast cancer
2. Phase 3
2016

Description/Summary:

Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG1273 pertuzumab
Perjeta
advanced HER2-positive gastric cancer
2. Phase 3
2017

Description/Summary:

Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG1273 pertuzumab
Perjeta
early HER2-positive breast cancer
2. Phase 3
2016

Description/Summary:

Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with Herceptin and chemotherapy is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG3502 trastuzumab emtansine + pertuzumab
Kadcyla + Perjeta
early HER2-positive breast cancer, adjuvant treatment
2. Phase 3
2018+

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors. Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with T-DM1 is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed by:
1. Roche Group
Partner:
Immunogen
1. Oncology
RG3502 trastuzumab emtansine + pertuzumab
Kadcyla + Perjeta
early HER2-positive breast cancer, neoadjuvant treatment
2. Phase 3
2016

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors. Pertuzumab is a humanized monoclonal antibody designed to prevent HER2 dimerisation, a process that is believed to play an important role in the growth and formation of several different cancer types. The mechanism of action of pertuzumab is thought to be complementary to Herceptin, as both bind to the HER2 receptor but on different regions. The goal of combining pertuzumab with T-DM1 is to determine if the combination may provide a more comprehensive blockade of HER signalling pathways.

Managed by:
1. Roche Group
Partner:
Immunogen
1. Oncology
RG3502 trastuzumab-DM1
Kadcyla
early HER2-positive breast cancer adj
2. Phase 3
2018+

Description/Summary:

Trastuzumab emtansine (T–DM1) is a novel antibody–drug conjugate that combines the therapeutic effect of trastuzumab (the active substance of Herceptin) with intracellular delivery of DM1, a highly potent chemotherapy agent, to specifically target HER2-positive tumors.

Managed by:
1. Roche Group
Partner:
ImmunoGen
1. Oncology
RG435 bevacizumab
Avastin
relapsed ovarian cancer, platinum-sensitive
2. Phase 3
2016 US

Description/Summary:

Avastin is a monoclonal antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7159 obinutuzumab
Gazyva
diffuse large B-cell lymphoma
2. Phase 3
2016

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
Biogen Idec
1. Oncology
RG7159 obinutuzumab
Gazyva
front-line indolent non-Hodgkin's lymphoma
2. Phase 3
2017

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
Biogen Idec
1. Oncology
RG7204 vemurafenib
Zelboraf
adjuvant melanoma, BRAF mutation positive
2. Phase 3
2017

Description/Summary:

Zelboraf is an oral, small molecule, BRAF kinase inhibitor. The BRAF protein is a key component of the RAS-RAF pathway involved in normal cell growth and survival. Mutations that keep the BRAF protein in an active state may cause excessive pathway signalling, leading to uncontrolled cell growth and survival.

Managed by:
1. Roche Group
Partner:
Plexxikon Inc., member of Daiichi Sankyo Group
1. Oncology
RG7388 idasanutlin
acute myeloid leukemia
2. Phase 3
2018+

Description/Summary:

Idasanutlin is an oral, selective, small molecule MDM2 antagonist that inhibits binding of MDM2 to p53. Blocking the MDM2-p53 interaction stabilizes p53 and activates p53-mediated cell death and inhibition of cell growth.

Managed by:
2. Pharma Research and Early Development
Roche Only
1. Oncology
RG7446 atezolizumab
2nd line non-small cell lung cancer
2. Phase 3
2016

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
first-line non-squamous non-small cell lung cancer, PDL1-selected patients
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment for patients with non-squamous non-small cell lung cancer whose tumours express PDL1.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
first-line squamous non-small cell lung cancer, PDL1-selected patients
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment for patients with squamous non-small cell lung cancer whose tumours express PDL1.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
metastatic triple-negative breast cancer, first-line treatment
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with nab-paclitaxel (Abraxane®), for metastatic triple-negative breast cancer.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
muscle-invasive bladder cancer, adjuvant treatment
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III clinical trial evaluating atezolizumab as a potential adjuvant treatment (after surgery) for muscle-invasive bladder cancer is expected to start in Q3 2015.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
non-small cell lung cancer, adjuvant treatment, PDL1-selected patients
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being evaluated in a phase III clinical trial as a potential adjuvant treatment, following surgery and adjuvant cisplatin-based chemotherapy, for patients with non-small cell lung cancer whose tumours express PDL1.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + chemo +/─ Avastin atezolizumab
first-line non-squamous non-small cell lung cancer
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment in combination with chemotherapy, with or without Avastin (bevacizumab), for non-squamous non-small cell lung cancer.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + chemotherapy atezolizumab
first-line non-squamous non-small cell lung cancer
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy, for non-squamous non-small cell lung cancer.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + chemotherapy atezolizumab
first-line squamous non-small cell lung cancer
2. Phase 3
2018+

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy, for squamous non-small cell lung cancer.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 + chemotherapy + pemetrexed atezolizumab
first-line non-squamous non-small cell lung cancer
2. Phase 3
2018

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Atezolizumab is being tested in a phase III clinical trial as a potential first-line treatment, in combination with chemotherapy and pemetrexed, for non-squamous non-small cell lung cancer.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+Avastin atezolizumab
renal cell cancer
2. Phase 3
2017

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. A phase III trial evaluating atezolizumab in combination with Avastin (bevacizumab) for renal cell cancer is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7601 venetoclax+obinutuzumab
Venclexta + Gazyva
Frontline chronic lymphocytic leukemia
2. Phase 3
2018+

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. Gazyva, (obinutuzumab), is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax+rituximab
Venclexta + MabThera / Rituxan
relapsed/refractory chronic lymphocytic leukemia
2. Phase 3
2017

Description/Summary:

RG7601 is a novel small molecule Bcl-2 selective inhibitor designed to restore apoptosis, also known as programmed cell death, by blocking the function of a pro-survival Bcl-2 family protein. The Bcl-2 family proteins, which are expressed at high levels in many tumors, play a central role in regulating apoptosis and, consequently, are thought to impact tumor formation, tumor growth and resistance. A phase III clinical trial evaluating the combination of RG7601 and MabThera/Rituxan (rituximab) in relapsed or refractory chronic lymphocytic leukemia is ongoing.

Managed by:
1. Roche Group
Partner:
AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7604 taselisib
HER2-negative, hormone receptor-positive metastatic breast cancer
2. Phase 3
2018+

Description/Summary:

PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival. Taselisib is being investigated as a potential treatment for PIK3CA mutation-positive, hormone receptor-positive metastatic breast cancer, PIK3CA mutation-positive squamous non-small cell lung cancer, and other solid tumours.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7853 alectinib
Alecensa
ALK-positive non-small cell lung cancer, first-line treatment
2. Phase 3
2017

Description/Summary:

Alectinib (RG7853) is a small molecule designed to selectively target ALK (anaplastic lymphoma kinase) and to penetrate and stay in the central nervous system. Alectinib binds ALK, inhibiting downstream malignant pathways that contribute to tumorigenesis and disease progression. Alectinib was approved in Japan in July 2014 and is available under the brand name Alecensa.

Managed by:
1. Roche Group
Partner:
Chugai
1. Oncology
RG105 rituximab
MabThera / Rituxan
chronic lymphocytic leukemia subcutaneous formulation
1. Filed
2014

Description/Summary:

Rituxan is a monoclonal antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. Rituxan works with the body's own immune system to eliminate CD20-positive B-cells. Stem cells (B-cell progenitors that give rise to B-cells) in bone marrow do not have the CD20 protein allowing B-cells to repopulate after Rituxan treatment.

Managed by:
1. Roche Group
Partner:
Halozyme
1. Oncology
RG435 bevacizumab
Avastin
1st line glioblastoma multiforme
1. Filed
2013 EU

Description/Summary:

Avastin is a monoclonal antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG435+RG1415 bevacizumab+erlotinib
Avastin + Tarceva
EGFR mutation-positive non-small cell lung cancer
1. Filed
2015

Description/Summary:

Avastin is a monoclonal antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis – a fundamental process required for a tumour to grow and to spread (metastasise) to other parts of the body. Tarceva is a small-molecule, oral, non-chemotherapy medicine for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers.

Managed by:
1. Roche Group
Partner:
Tarceva in collaboration with Astellas Group
1. Oncology
RG7159 obinutuzumab
Gazyva
rituximab-refractory indolent non-Hodgkin's lymphoma
1. Filed
2017+

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on malignant B-cells and to bind with high affinity to the cell surface in a type II configuration.

Managed by:
1. Roche Group
Partner:
Biogen Idec
1. Oncology
RG7446 atezolizumab
metastatic non-small cell lung cancer, 2nd/3rd-line treatment
1. Filed
2016

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446 atezolizumab
2nd-line metastatic urothelial bladder cancer
1. Filed
2016

Description/Summary:

Cancer immunotherapy is the use of the immune system to fight cancer. Atezolizumab (anti-PDL1, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion.

Managed by:
1. Roche Group
Roche Only

2. Immunology

2. Immunology
RG3616 vismodegib
Erivedge
idiopathic pulmonary fibrosis
4. Phase 1

Description/Summary:

Erivedge (vismodegib, RG3616) is small molecule inhibitor of SMO, a receptor critical for sonic hedgehog (SHh) signalling, a key regulator of epithelial/mesenchymal interactions. The hedgehog pathway is active in the lungs of patients with idiopathic pulmonary fibrosis (IPF), and SHh appears to be a strong inducer of fibrogenic responses in vitro and tissue fibrosis in vivo. Biomarkers of SHh activity are elevated in the blood of IPF patients. A phase Ib study is investigating vismodegib in combination with Esbriet (pirfenidone), in patients with IPF.

Managed by:
1. Roche Group
Partner:
Curis
2. Immunology
RG3616 vismodegib + ruxolitinib
Erivedge
intermediate or high-risk myelofibrosis
4. Phase 1

Description/Summary:

Erivedge (vismodegib, RG3616) is small molecule inhibitor of SMO, a receptor critical for sonic hedgehog (SHh) signalling, a key regulator of epithelial/mesenchymal interactions. SHh appears to be a strong inducer of fibrogenic responses in vitro and tissue fibrosis in vivo. A phase Ib study (MYLIE) is investigating Erivedge in combination with ruxolitinib (an oral inhibitor of JAK 1 and JAK 2 tyrosine kinases), in patients with intermediate or high-risk myelofibrosis.

Managed by:
1. Roche Group
Partner:
Curis
2. Immunology
RG6069
fibrosis
4. Phase 1

Description/Summary:

Managed by:
3. Genentech Research and Early Development
Roche Only
2. Immunology
RG6125
rheumatoid arthritis
4. Phase 1

Description/Summary:

RG6125, a monoclonal antibody targeting cadherin-11, is believed to disrupt inflammatory tissue cell interactions in a non-immunosuppressive manner.

Managed by:
2. Pharma Research and Early Development
Partner:
Adheron acquisition
2. Immunology
RG6149
asthma
4. Phase 1

Description/Summary:

ST2 MAb

Managed by:
3. Genentech Research and Early Development
Partner:
Amgen
2. Immunology
RG7159 obinutuzumab
hypersensitised adults with end-stage renal disease awaiting transplantation
4. Phase 1

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanised anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration. A phase Ib trial is investigating obinutuzumab in hypersensitised patients awaiting renal transplant.

Managed by:
1. Roche Group
Partner:
Biogen Idec
2. Immunology
RG7625
autoimmune diseases
4. Phase 1

Description/Summary:

Managed by:
2. Pharma Research and Early Development
Roche Only
2. Immunology
RG7845
autoimmune diseases
4. Phase 1

Description/Summary:

RG7845 (GDC-0853) is a novel Bruton’s tyrosine kinase (BTK) inhibitor that helps block B cell proliferation and the resulting excessive immune response seen in autoimmune disorders. RG7845 binds to BTK in a novel way that is believed to increase its effectiveness. RG7845 is being investigated as a potential therapeutic option in difficult-to-treat autoimmune diseases.

Managed by:
3. Genentech Research and Early Development
Roche Only
2. Immunology
RG7880
inflammatory diseases
4. Phase 1

Description/Summary:

Managed by:
3. Genentech Research and Early Development
Roche Only
2. Immunology
CHU nemolizumab
pruritus in dialysis patients
3. Phase 2

Description/Summary:

Nemolizumab (CIM331) is a humanised monoclonal antibody directed against the interleukin-31 receptor. It is currently being investigated in a phase II study as a therapy for pruritis in dialysis patients.

Managed by:
4. Chugai
Roche Only
2. Immunology
CHU nemolizumab
atopic dermatitis
3. Phase 2

Description/Summary:

Nemolizumab (CIM331) is a humanised monoclonal antibody directed against the interleukin-31 receptor. It is currently being investigated as a therapy for atopic dermatitis.

Managed by:
4. Chugai
Partner:
Roche participation
2. Immunology
RG3637 lebrikizumab
atopic dermatitis
3. Phase 2
2018+

Description/Summary:

Lebrikizumab is a novel humanised monoclonal antibody designed to specifically block the action of the cytokine interleukin-13 (IL-13), a signalling protein that is thought to play a role in the inflammatory processes seen in atopic dermatitis.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG3637 lebrikizumab
chronic obstructive pulmonary disease
3. Phase 2
2018+

Description/Summary:

Lebrikizumab is a novel humanised monoclonal antibody designed to specifically block the action of the cytokine interleukin-13 (IL-13). A phase II trial is investigating lebrikizumab in patients with moderate to very severe chronic obstructive pulmonary disease.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG3637 lebrikizumab
idiopathic pulmonary fibrosis
3. Phase 2
2018+

Description/Summary:

Lebrikizumab is a novel humanised monoclonal antibody designed to specifically block the action of the cytokine interleukin-13 (IL-13). A phase II trial is investigating lebrikizumab, both as a single agent and in combination with Esbriet® (pirfenidone), in patients with idiopathic pulmonary fibrosis.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG7195 obinutuzumab
lupus nephritis
3. Phase 2

Description/Summary:

Obinutuzumab, GA101, is the first glycoengineered, type II, humanised anti-CD20 monoclonal antibody. It has a distinct mode of action compared with other anti-CD20s, including MabThera/Rituxan, and was specifically designed to selectively target the CD20 protein on B cells and to bind with high affinity to the cell surface in a type II configuration. A phase II trial is investigating obinutuzumab in patients with lupus nephritis.

Managed by:
1. Roche Group
Partner:
Biogen Idec
2. Immunology
CHU tocilizumab
Actemra
large-vessel vasculitis
2. Phase 3

Description/Summary:

Actemra (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6. Elevated tissue and serum levels of IL-6 have been implicated in large-vessel vasculitis. Inhibition of IL-6 therefore represents a new and novel approach for the treatment of large-vessel vasculitis.

Managed by:
4. Chugai
Partner:
Roche participation
2. Immunology
CHU
neuromyelitis optica
2. Phase 3

Description/Summary:

A humanized monoclonal antibody to the interleukin-6 receptor.

Managed by:
4. Chugai
Partner:
Roche participation
2. Immunology
RG105 rituximab
MabThera / Rituxan
pemphigus vulgaris
2. Phase 3
2018+

Description/Summary:

MabThera/Rituxan is a monoclonal antibody that binds specifically to a protein called CD20 located on the surface of B cells. MabThera works with the body's immune system to eliminate CD20-positive B cells. Stem cells (B cell progenitors that give rise to B cells) in bone marrow do not have the CD20 protein, allowing B-cells to repopulate after MabThera treatment. MabThera has been approved for the treatment of specific autoimmune diseases where B cells are thought to be involved: rheumatoid arthritis and two rare forms of vasculitis. MabThera is also being studied in a global phase III trial in a serious skin condition called pemphigus vulgaris (an autoimmune blistering disease), where preliminary data suggest the medicine may be effective.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG1569 tocilizumab
Actemra / RoActemra
giant cell arteritis
2. Phase 3
2016

Description/Summary:

Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6. Elevated tissue and serum levels of IL-6 have been implicated in giant cell arteritis (GCA). Inhibition of IL-6 therefore represents a new and novel approach for the treatment of GCA.



Managed by:
1. Roche Group
Partner:
Chugai
2. Immunology
RG1569 tocilizumab
Actemra / RoActemra
systemic sclerosis
2. Phase 3
2018+

Description/Summary:

Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 , a protein that plays a major role in the systemic sclerosis inflammation process.

Managed by:
1. Roche Group
Partner:
Chugai
2. Immunology
RG3637 lebrikizumab
severe asthma
2. Phase 3
2016

Description/Summary:

Lebrikizumab is a novel humanized monoclonal antibody designed to specifically block the action of the interleukin-13 cytokine (a signalling protein that serves as a messenger between cells that is increased in some patients with asthma) and so reduce airway inflammation, a key feature of asthma.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG7413 etrolizumab
Crohn's disease
2. Phase 3

Description/Summary:

Etrolizumab is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrin receptors, alpha4beta7 and alphaEbeta7. These receptors are required for trafficking and retention in lymphocytes in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases.

Managed by:
1. Roche Group
Roche Only
2. Immunology
RG7413 etrolizumab
ulcerative colitis
2. Phase 3
2018+

Description/Summary:

Etrolizumab is a humanized IgG1 MAb targeting the beta 7 integrin subunit. It binds to two integrin receptors, alpha4beta7 and alphaEbeta7. These receptors are required for trafficking and retention in lymphocytes in the gastrointestinal tract and appear to play a role in inflammatory bowel diseases.

Managed by:
1. Roche Group
Roche Only

3. Ophthalmology

3. Ophthalmology
RG4929
primary open-angle glaucoma or ocular hypertension
4. Phase 1

Description/Summary:

Managed by:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG3645 ranibizumab
AMD port delivery device (ranibizumab port delivery system)
3. Phase 2

Description/Summary:

Ranibizumab, the active ingredient of Lucentis, is a monoclonal antibody fragment. It is designed to bind to and inhibit VEGF (vascular endothelial growth factor), a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. A randomised comparative phase II trial is evaluating the the safety and efficacy of ranibizumab delivered via the ranibizumab port delivery system implant in patients with subfoveal neovascular age-related macular degeneration. The primary outcome measure of the trial is the time until a patient first requires a refill of the implant.

Managed by:
1. Roche Group
Partner:
Novartis, ForSight VISION4
3. Ophthalmology
RG7716
wet age-related macular degeneration
3. Phase 2
2018+

Description/Summary:

RG7716 is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm. A randomised, active comparator-controlled phase II study is currently investigating the safety and efficacy of RG7716 in patients with choroidal neovascularisation secondary to age-related macular degeneration

Managed by:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG7417 lampalizumab
geographic atrophy associated with AMD
2. Phase 3
2018+

Description/Summary:

Lampalizumab (anti-Factor D Fab) is a humanized monoclonal antibody fragment targeting complement factor D. It is designed to inhibit complement activation and chronic inflammation in tissues. Complement Factor D is a member of the trypsin family of peptidases and is a component of the alternative complement pathway.

Managed by:
1. Roche Group
Roche Only

4. Infectious Diseases

4. Virology
RG6024
influenza B
4. Phase 1

Description/Summary:

RG6024 (anti-influenza B, MHAB5553A) is a human monoclonal antibody that binds to a conserved epitope on the influenza B hemagglutinin protein. It is designed to neutralise the influenza B virus across a broad range of different strains. A Phase I clinical trial evaluating RG6024 in healthy volunteers in ongoing.

Managed by:
3. Genentech Research and Early Development
Roche Only
4. Virology
RG6080
bacterial infections
4. Phase 1

Description/Summary:

RG6080 (OP0595, FPI-1459) is a diazabicyclooctane beta-lactamase inhibitor (BLI). Beta-lactamases are enzymes produced by some bacteria that make them resistant to beta-lactam antibiotics. BLIs restore and/or potentiate the activity of beta-lactam antibiotics. The combination of RG6080 with a beta-lactam antibiotic targets severe infections caused by Enterobacteriaceae, including multi-drug-resistant strains.

Managed by:
2. Pharma Research and Early Development
Partner:
Meiji and Fedora
4. Virology
RG7834
chronic hepatitis B
4. Phase 1

Description/Summary:

Managed by:
2. Pharma Research and Early Development
Roche Only
4. Virology
RG7861
infectious diseases
4. Phase 1

Description/Summary:

Managed by:
3. Genentech Research and Early Development
Roche Only
4. Virology
RG7944
hepatitis B
4. Phase 1

Description/Summary:

The HBV therapeutic vaccine RG7944 (INO-1800) is an immunisation approach targeting multiple antigens of the hepatitis B virus, particularly those for surface and core proteins, which may drive immunological control of infection resulting in functional cure.

Managed by:
2. Pharma Research and Early Development
Partner:
Inovio
4. Virology
RG6152
influenza
3. Phase 2
2019+

Description/Summary:

RG6152 is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. RG6152 is being evaluated as a single-dose treatment in a Japanese phase II clinical trial.

Managed by:
2. Pharma Research and Early Development
Partner:
Shionogi
4. Virology
RG7227 danoprevir
hepatitis C
3. Phase 2
2018+

Description/Summary:

Danoprevir is a macrocyclic peptidomimetic small molecule compound that competitively inhibits the HCV NS3/4A protease.

Managed by:
2. Pharma Research and Early Development
Roche Only
4. Virology
RG7745
influenza A
3. Phase 2
2018+

Description/Summary:

RG7745 (anti-influenza A, MHAA4549A) is a human monoclonal antibody that binds to a highly conserved epitope on the influenza A hemagglutinin stalk region. It is designed to neutralise the influenza A virus across a broad range of different strains. A Phase IIb clinical trial evaluating RG7745 in hospitalised influenza patients is ongoing.

Managed by:
3. Genentech Research and Early Development
Roche Only
4. Virology
RG7795
hepatitis B
3. Phase 2
2018+

Description/Summary:

RG7795 is an investigational oral small-molecule compound that acts via the Toll-like receptor 7 (TLR7) pathway in hepatitis. TLR7 agonists cause the production of antiviral cytokines and the activation/maturation of immune cells with the potential to enhance immune response.

Managed by:
2. Pharma Research and Early Development
Roche Only

5. CardioMetabolism

5. CardioMetabolism
CHU
hyperphosphatemia
4. Phase 1

Description/Summary:

NME

Managed by:
4. Chugai
Roche Only
5. CardioMetabolism
CHU
hypoparathyroidism
4. Phase 1

Description/Summary:

PCO371 is an orally available small molecule parathyroid hormone (PTH1) receptor agonist for hypoparathyroidism. The compound is expected to stabilize blood calcium levels without causing hypercalciuria, a major concern in conventional treatment with oral activated vitamin D and calcium.

Managed by:
4. Chugai
Roche Only
5. CardioMetabolism
RG7992
metabolic diseases
4. Phase 1

Description/Summary:

RG7992 (anti-FGFR1/KLB, BFKB8488A) is a bispecific antibody designed to mimic the metabolic hormone FGF21. It is currently being investigated as a therapy for type 2 diabetes.

Managed by:
3. Genentech Research and Early Development
Roche Only
5. CardioMetabolism
CHU
gout
3. Phase 2

Description/Summary:

URC102 is a small molecule inhibitor of the urate transporter protein URAT1. The target indication of URC102 is gout. The compound is expected to reduce the level of serum uric acid by promoting its excretion through inhibition of URAT1. A phase I clinical trial with healthy volunteers is ongoing. URC102 is under co-development by Chugai and JW Pharmaceutical.

Managed by:
4. Chugai
Partner:
Roche participation

6. Neuroscience

6. Neuroscience
RG6029
pain
4. Phase 1

Description/Summary:

RG6029 (GDC-0310) is a selective, reversible, orally bioavailable small-molecule sodium channel blocker that is selective for Nav1.7, which is expressed primarily on peripheral nociceptor C-fiber neurons and is required for pain sensing in humans.

Managed by:
3. Genentech Research and Early Development
Partner:
Xenon Pharmaceuticals
6. Neuroscience
RG7203
schizophrenia
4. Phase 1

Description/Summary:

RG7203 is a highly potent and selective small molecule inhibitor of phosphodiesterase 10A (PDE10A). RG7203 has demonstrated efficacy in preclinical behavioral paradigms relevant to schizophrenia.

Managed by:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7800
spinal muscular atrophy
4. Phase 1

Description/Summary:

A phase I clinical trial evaluating RG7800, a novel small molecule SMN2 splicing modifier, is ongoing.

Managed by:
2. Pharma Research and Early Development
Partner:
PTC Therapeutics/ SMA Foundation
6. Neuroscience
RG7893
pain
4. Phase 1

Description/Summary:

RG7893 (GDC-0276) is a selective, reversible, orally bioavailable small-molecule sodium channel blocker that is selective for Nav1.7, which is expressed primarily on peripheral nociceptor C-fiber neurons and is required for pain sensing in humans.

Managed by:
3. Genentech Research and Early Development
Partner:
Xenon Pharmaceuticals
6. Neuroscience
RG7906
psychiatric disorders
4. Phase 1

Description/Summary:

Managed by:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7916
spinal muscular atrophy
4. Phase 1

Description/Summary:

RG7916 is an investigational oral SMN2 splicing modifier being studied in the treatment of spinal muscular atrophy.

Managed by:
2. Pharma Research and Early Development
Partner:
PTC Therapeutics, SMA Foundation
6. Neuroscience
RG7935
Parkinson's disease
4. Phase 1

Description/Summary:

RG7935 is a monoclonal antibody targeting alpha-synuclein, a protein that may misfold and be involved in the pathogenesis of Parkinson's disease. It has been tested in preclinical models of synuclein-related disease and has shown a reduction of neurodegeneration.

Managed by:
2. Pharma Research and Early Development
Partner:
Prothena
6. Neuroscience
RG1662 basmisanil
Down syndrome
3. Phase 2
2018+

Description/Summary:

Basmisanil (RG1662) is a small molecule negative allosteric modulator that acts on a specific subset of receptors called gamma-aminobutyric acid (GABA) A receptors alpha 5, GABRA5. They are present in discrete brain regions associated with cognitive processing. A relative increase in GABAergic tone is believed to be present in people with Down syndrome and responsible for cognitive disability.

Managed by:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG6083 olesoxime
spinal muscular atrophy
3. Phase 2

Description/Summary:

Olesoxime (RG6083) is an investigational medicine being tested for its potential ability to preserve healthy motor nerve cells. Olesoxime is a cholesterol-like compound that binds to proteins in cells and designed to reduce the release of cell death factors and promote the survival of motor cells. Olesoxime is believed to work by preserving the function of mitochondria, the powerhouse of cells.

Managed by:
1. Roche Group
Partner:
Trophos acquisition
6. Neuroscience
RG7314
autism
3. Phase 2
2018+

Description/Summary:

RG7314 is a potent and specific small molecule antagonist of the V1A vasopressin receptor, which is implicated in modulating emotional processing and key social deficits exhibited in patients with Autism spectrum disorders.

Managed by:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG1450 gantenerumab
Alzheimer's disease
2. Phase 3
2018+

Description/Summary:

Gantenerumab is a fully human monoclonal antibody that binds and neutralises disease-relevant aggregated forms of amyloid-beta: those that accumulate as plaques in the brain and those which interfere with brain-cell functioning.

Managed by:
1. Roche Group
Partner:
Morphosys
6. Neuroscience
RG1594 ocrelizumab
primary progressive multiple sclerosis
2. Phase 3
2016

Description/Summary:

Ocrelizumab is a humanized monoclonal antibody that selectively targets the CD20-positive B-cells implicated in the inflammatory and neurodegenerative processes of multiple sclerosis (MS), to effectively impact disease progression while maintaining immunosurveillance.

Managed by:
1. Roche Group
Roche Only
6. Neuroscience
RG1594 ocrelizumab
relapsing multiple sclerosis
2. Phase 3
2016

Description/Summary:

Ocrelizumab is a humanized monoclonal antibody that selectively targets the CD20-positive B-cells implicated in the inflammatory and neurodegenerative processes of multiple sclerosis (MS), to effectively impact disease progression while maintaining immunosurveillance.

Managed by:
1. Roche Group
Roche Only
6. Neuroscience
RG7412 crenezumab
Alzheimer's disease
2. Phase 3
2018+

Description/Summary:

Crenezumab is a humanized monoclonal antibody, which binds to amyloid beta (Abeta). Abeta is the main constituent of amyloid plaque in the brains of patients with Alzheimer's disease and is proposed to be causative in the development of the disease.

Managed by:
1. Roche Group
Partner:
AC Immune

7. Other

7. Other
RG6013 emicizumab
hemophilia A
2. Phase 3
2017

Description/Summary:

Emicizumab (RG6013, ACE910) is a bispecific antibody that mimics coagulation factor VIII, an essential blood clotting protein. It is currently investigated as a therapy for people with hemophilia A, a congenital bleeding disorder that is caused by deficiency or dysfunction of coagulation factor VIII.

Managed by:
1. Roche Group
Partner:
Chugai

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Phase 1
Phase 2
Phase 3
Filed
Approved
00

New / Advanced

 
 

RG6146

oncology

oncology

 
 

RG7601 + Cotellic or idasanutlin

Venclexta

acute myelogenous leukemia

relapsed or refractory AML not eligible for cytotoxic therapy

 
 

RG7876 + vanucizumab

solid tumours

solid tumours

 
 

RG7446 + chemotherapy + pemetrexed

first-line non-squamous NSCLC

first-line non-squamous non-small cell lung cancer

 
 

RG7446

metastatic NSCLC, 2nd/3rd-line treatment

metastatic non-small cell lung cancer, 2nd/3rd-line treatment

 
 

RG7601

Venclexta

rel/refract chronic lymphocytic leukemia, 17p del

relapsed/refractory chronic lymphocytic leukemia, 17p deletion

 
 

RG3616

Erivedge

myelofibrosis

intermediate or high-risk myelofibrosis

 
 

RG7203

schizophrenia

schizophrenia

 
 

RG7906

psychiatric disorders

psychiatric disorders

 
 

RG7412

Alzheimer's disease

Alzheimer's disease

00

Inlicensed / Partnered

 
 

RG6149

asthma

asthma

 
 

RG6152

influenza

influenza

00

Removed

 
 

RG7116

solid tumors

solid tumors

 
 

RG7597+cobimetinib

KRAS mut-pos tumors

KRAS mutation-positive tumors

 
 

RG7090

TRD

treatment-resistant depression

 
CardioMetabolism
 
Immunology
 
Neuroscience
 
Oncology
 
Ophthalmology
 
Virology
 
Other
Area
Product name
Description
Market

Instruments/devices planned for 2015

Laboratories
cobas c 513
dedicated HbA1C analyzer
EU
cobas t 411
core laboratory coagulation analyzer
EU
cobas 8100 V2
integrated pre- and post-analytical solution
WW
cobas 6800/8800
medium- to high-volume automated real-time PCR
US
VENTANA HE 600
automated H&E staining platform
WW
Diabetes Care
Accu-Chek Active no-code
next generation blood glucose meter, no coding of test strips
WW
Accu-Chek Connect
blood glucose meter with connectivity to smartphones, mobile applications and cloud
US
Point of care
CoaguChek Pro II
professional system for PT and aPTT testing
EU

Tests/Assays planned for 2015

Blood Screening
MPX test
multiplex blood screening test for cobas 6800/8800 systems
US
Infectious Diseases
Influenza A/B + RSV test
point-of-care detection on cobas LIAT
US
HTLV test
human T-lymphotropic virus test
EU
Virology
HIV-1 test
Quantitative HBV viral load test for cobas® 4800 System
EU
HBV test
Quantitative HBV viral load test for cobas® 6800/8800 Systems
EU
HCV test
Quantitative HBV viral load test for cobas® 6800/8800 Systems
EU
HCV test
Quantitative HBV viral load test for cobas® 4800 System
EU
HCV GT test
Qualitative HCV genotyping test for cobas® 4800 System
EU
CMV
Quantitative CMV viral load test for COBAS® AmpliPrep/COBAS® TaqMan® System
EU/US
Genomics & Oncology
EGFR test V2
detection of EGFR-mutations in plasma
EU
Cardiology
cobas h 232 Troponin T test
point-of-care test version of Elecsys cTNT-hs
EU

Title

Description...

Area
Market

WW - Worldwide.
PT - prothrombin time.
aPTT - activated partial thomboplastin time.