Product Development PortfolioLast update: July 23, 2015

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
2018+

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
RG7116 lumretuzumab
solid tumors
4. Phase 1

Description/Summary:

Lumretuzumab is a glyco-engineered humanised monoclonal antibody that is designed to inhibit the activation and signalling of HER3, a member of the Human Epidermal Growth Factor Receptor (HER) family which amplifies cell survival and proliferation signals when associated with HER2 or HER1. Through glyco-engineering, HER3 MAb is designed to engage the immune system when bound to tumour cells and elicit enhanced antibody-dependent cellular cytotoxicity (ADCC).

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

Description/Summary:

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. 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 emactuzumab and atezolizumab in solid tumors is ongoing.

Managed by:
2. Pharma Research and Early Development
Roche Only
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
RG7388 idasanutlin
solid and hematological tumors
4. Phase 1

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
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
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
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 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
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+Gazyva
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
non-small cell lung cancer EGFRmut-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) for non-small cell lung cancer with EGFR-activating mutations is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+Zelboraf +/─ 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 cobimetinib, for metastatic melanoma is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446+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
RG7450
prostate cancer
4. Phase 1

Description/Summary:

RG7450 (Anti-STEAP1, DSTP3086S) is an antibody drug conjugate (ADC) that consists of a humanized monoclonal antibody directed against STEAP1, a six-transmembrane epithelial antigen of the prostate 1, conjugated to an anti-mitotic agent, monomethyl auristatin E (MMAE). STEAP1 is a membrane protein that is overexpressed in prostate cancer.

Managed by:
3. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG7597+cobimetinib duligotuzumab + cobimetinib
KRAS mutation-positive tumors
4. Phase 1

Description/Summary:

Duligotuzumab (RG7597), is a dual-action, phage-derived human IgG1 monoclonal antibody that is designed to target human epidermal growth factor receptor 3 (HER3) and epidermal growth factor receptor (EGFR). 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.

Managed by:
3. Genentech Research and Early Development
Partner:
cobimetinib in collaboration with Exelixis
1. Oncology
RG7601 venetoclax
relapsed or refractory chronic lymphocytic leukaemia
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, WEHI
1. Oncology
RG7601+Gazyva venetoclax+obinutuzumab
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
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
Roche Only
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.

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
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. A phase I clinical trial evaluating RG7842 in solid tumors is ongoing.

Managed by:
3. Genentech Research and Early Development
Partner:
Array BioPharma
1. Oncology
RG7876+RG7446
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 anti-PD-L1 (RG7446).

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
2018+

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
RG3502 trastuzumab emtansine
Kadcyla
HER2-positive advanced non-small cell lung cancer
3. Phase 2
2017+

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
2017+

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
RG7155 emactuzumab
solid tumors & pigmented villonodular synovitis
3. Phase 2
2017+

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
RG7221 vanucizumab
colorectal cancer
3. Phase 2
2017+

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
1st line metastatic triple negative breast cancer
3. Phase 2
2017+

Description/Summary:

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.

Managed by:
1. Roche Group
Partner:
Exelixis
1. Oncology
RG7440 ipatasertib
solid tumors
3. Phase 2
2017+

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
RG7446
metastatic urothelial bladder cancer
3. Phase 2
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. A phase II trial evaluating anti-PDL1 for locally advanced or metastatic urothelial bladder cancer is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446
metastatic non-small cell lung cancer
3. Phase 2
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
RG7596 polatuzumab vedotin
hematological malignancies
3. Phase 2
2017+

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
RG7599 lifastuzumab vedotin
platinum-resistant ovarian cancer
3. Phase 2
2017+

Description/Summary:

RG7599 (Anti-NaPi2b, DNIB0600A) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody directed against NaPi2b, sodium-dependent phosphate transport protein 2b, linked to the small molecule, cytotoxic, microtubule-disrupting agent, monomethyl auristatin E (MMAE). NaPi2b can be overexpressed in certain types of cancer.

Managed by:
3. Genentech Research and Early Development
Partner:
Seattle Genetics
1. Oncology
RG7601 venetoclax
front-line diffuse large B cell lymphoma
3. Phase 2
2017+

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/WEHI
1. Oncology
RG7601 venetoclax
relapsed/refractory chronic lymphocytic leukemia 17p deletion
3. Phase 2
2016

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:
Abbott, WEHI
1. Oncology
RG7601+MabThera/Rituxan venetoclax+rituximab
relapsed/refractory follicular lymphoma
3. Phase 2
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 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, WEHI
1. Oncology
RG7604 taselisib
squamous non-small cell lung cancer
3. Phase 2

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
metastatic liver cancer
3. Phase 2
2017+

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
RG7853 alectinib
ALK-positive non-small cell lung cancer, second-line treatment
3. Phase 2

Description/Summary:

Alectinib 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
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
2017+

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
2017+

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
advanced HER2-positive gastric cancer
2. Phase 3
2015

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
RG3502 trastuzumab-DM1
Kadcyla
early HER2-positive breast cancer adj
2. Phase 3
2017+

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
1st line metastatic ovarian cancer
2. Phase 3
2014 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
RG435 bevacizumab
Avastin
relapsed ovarian cancer, platinum-sensitive
2. Phase 3
2014 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
RG7159 obinutuzumab
Gazyva
rituximab-refractory 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
RG7446
2nd line urothelial bladder 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. A phase III trial evaluating atezolizumab for locally advanced or metastatic urothelial bladder cancer is ongoing.

Managed by:
1. Roche Group
Roche Only
1. Oncology
RG7446
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
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
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
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
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
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 + chemo +/─ Avastin
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
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
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+Avastin
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+Gazyva venetoclax+obinutuzumab
Frontline 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. 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+MabThera/Rituxan venetoclax+rituximab
relapsed/refractory chronic lymphocytic leukemia
2. Phase 3
2016

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, WEHI
1. Oncology
RG7604 taselisib
HER2-negative, hormone receptor-positive metastatic breast cancer
2. Phase 3
2017+

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:
3. Genentech Research and Early Development
Roche Only
1. Oncology
RG7853 alectinib
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
RG7421+RG7204 cobimetinib combo
metastatic melanoma BRAF mutation positive
1. Filed
2014

Description/Summary:

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. Combination study with the oral, small molecule, BRAF kinase inhibitor Zelboraf.

Managed by:
1. Roche Group
Partner:
Exelixis

2. Immunology

2. Immunology
RG6069
fibrosis
4. Phase 1
2018+

Description/Summary:

Managed by:
3. Genentech Research and Early Development
Roche Only
2. Immunology
RG7625
autoimmune diseases
4. Phase 1

Description/Summary:

Managed by:
2. Pharma 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
atopic dermatitis
3. Phase 2

Description/Summary:

CIM331 is a humanized monoclonal antibody. It is currently investigated as a therapy for atopic dermatitis.

Managed by:
4. Chugai
Partner:
Roche participation
2. Immunology
RG1569 tocilizumab
Actemra / RoActemra
systemic sclerosis
3. Phase 2
2017+

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
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
idiopathic pulmonary fibrosis
3. Phase 2
2017+

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
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
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
2017+

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
RG3645 ranibizumab
Lucentis
sustained delivery age-related macular degeneration/retinal vein occlusion/diabetic macular edema
4. Phase 1

Description/Summary:

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. In DME, damaged blood vessels leak fluid into the central portion of the retina, called the macula, causing it to swell. The macula is the part of the eye responsible for sharp central vision.

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

Description/Summary:

A phase I clinical trial evaluating RG7716 in wet age-related macular degeneration is ongoing.

Managed by:
2. Pharma Research and Early Development
Roche Only
3. Ophthalmology
RG7417 lampalizumab
geographic atrophy associated with AMD
2. Phase 3
2017+

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:
3. Genentech Research and Early Development
Roche Only

4. Infectious Diseases

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
RG7689
infectious diseases
4. Phase 1

Description/Summary:

Managed by:
2. Pharma Research and Early Development
Roche Only
4. Virology
RG7944
hepatitis B
4. Phase 1
2018+

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
RG7227 danoprevir
hepatitis C
3. Phase 2
2017+

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
2017+

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, which is designed to neutralize the influenza A virus across a broad range of different strains. A Phase IIa clinical trial evaluating RG7745 in an influenza challenge model in 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
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
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
RG7345
Alzheimer's disease
4. Phase 1

Description/Summary:

RG7345 is a humanized monoclonal antibody targeting pathological Tau in the brain. The two pathological hallmarks of Alzheimer’s disease are amyloid plaques and neurofibrillary tangles (NFT). NFTs consist of aggregated forms of the protein Tau which, like amyloid beta, are assumed to be causally implicated in Alzheimer’s.

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 an orally administered selective Nav1.7 inhibitor. Nav1.7 is a voltage gated sodium channel that is expressed in peripheral pain sensing neurons and may drive pain signaling.

Managed by:
3. Genentech Research and Early Development
Partner:
Xenon Pharmaceuticals
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
Roche Only
6. Neuroscience
RG1577
Alzheimer's disease
3. Phase 2
2017+

Description/Summary:

RG1577 is a potent small molecule inhibitor of monoamine oxidase-B (MAO-B) which reduces the formation of toxic reactive oxygen species in the brain of Alzheimer’s disease patients where overexpression of MAO-B is postulated to contribute to neuronal damage.

Managed by:
2. Pharma Research and Early Development
Partner:
Evotec
6. Neuroscience
RG1662
Down syndrome
3. Phase 2
2017+

Description/Summary:

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
RG1678 bitopertin
obsessive compulsive disorder
3. Phase 2
2017+

Description/Summary:

Bitopertin is an oral, small molecule first-in-class glycine reuptake inhibitor (GRI). Bitopertin enhances N-methyl-D-aspartate (NMDA) receptor activity, thereby targeting an important pathway in the treatment of psychiatric disorders, especially schizophrenia.

Managed by:
1. Roche Group
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
RG7090 basimglurant
treatment-resistant depression
3. Phase 2
2017+

Description/Summary:

RG7090 is a small molecule negative modulator of metabotropic glutamate receptor 5 (mGluR5), a receptor in the central nervous system regulating neurotransmitter release, signal transduction, mood and memory formation. Preclinical data has suggested that modulation of mGluR5 functioning is expected to play an important therapeutic role in depression and Fragile X syndrome.

Managed by:
2. Pharma Research and Early Development
Roche Only
6. Neuroscience
RG7314
autism
3. Phase 2
2017+

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
RG7412 crenezumab
Alzheimer's disease
3. Phase 2
2017+

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:
3. Genentech Research and Early Development
Partner:
AC Immune
6. Neuroscience
RG1450 gantenerumab
Alzheimer's disease
2. Phase 3
2017+

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
2015

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

7. Other

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

Description/Summary:

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

 
 

RG6078 + atezolizumab

solid tumors

solid tumors

 
 

RG7446 +/─ lenalidomide

multiple myeloma

multiple myeloma

 
 

RG7888 + atezolizumab

solid tumors

solid tumors

 
 

RG7446

NSCLC, adjuvant treatment, PDL1-selected patients

non-small cell lung cancer, adjuvant treatment, PDL1-selected patients

 
 

RG7446

metastatic triple-negative breast cancer, first-line treatment

metastatic triple-negative breast cancer, first-line treatment

 
 

RG7446

muscle-invasive bladder cancer, adjuvant treatment

muscle-invasive bladder cancer, adjuvant treatment

 
 

RG7446+Avastin

renal cell cancer

renal cell cancer

 
 

RG435+RG1415

Avastin + Tarceva

EGFR mut-pos. NSCLC

EGFR mutation-positive non-small cell lung cancer

 
 

RG6069

fibrosis

fibrosis

 
 

RG3637

atopic dermatitis

atopic dermatitis

 
 

RG105

MabThera / Rituxan

pemphigus vulgaris

pemphigus vulgaris

 
 

RG7944

hepatitis B

hepatitis B

 
 

RG7795

hepatitis B

hepatitis B

 
 

CHU

hypoparathyroidism

hypoparathyroidism

00

Removed

 
 

RG7787

solid tumors

solid tumors

 
 

RG3502

Kadcyla + Perjeta

1st line HER2-pos mBC

1st line HER2-positive metastatic breast cancer

 
 

RG6062

Esbriet

SSc-related ILD

interstitial lung disease related to systemic sclerosis

 
 

RG7929

antibiotic

antibiotic

 
 

RG7641

kidney disease

kidney disease

 
 

RG7697

type 2 diabetes

type 2 diabetes

 
 

RG7203

schizophrenia

schizophrenia

 
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
HBV test
quantitative HBV viral load test for cobas 6800/8800
EU
HIV-1 test
quantitative HIV-1 viral load test cobas 4800
EU
HCV test
quantitative HCV viral load test
EU
HBV test
quantitative HCV viral load test
EU
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.