RG6115
HCC
Hepatocellular carcinoma
Product Development PortfolioLast update: Jul. 23, 2020
Therapeutic Area
Partner
Managed By
Compound/
Generic name
Generic name
Trade name
Indication
Phase
123f
123f
Expected Filing
1. Oncology
1. Oncology
CHU
solid tumors
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. ERY974 is a bispecific antibody designed to elicit T cell activation and T cell-dependent cellular cytotoxicity by simultaneously binding to glypican-3, a protein expressed in certain cancers, and CD3 on the surface of T cells. A phase I clinical trial is evaluating ERY974 for the treatment of solid tumors.
- Managed By:
- 3. Chugai
- Partner:
- Chugai
1. Oncology
RG6026
relapsed or refractory non-Hodgkin's lymphoma
4. Phase 1
Description/Summary:
RG6026 (anti-CD20 CD3 TCB) is a 2:1 format T cell-engaging bispecific antibody, designed to engage both CD20 on B cells and CD3 on T cells. By engaging both targets simultaneously, the antibody activates the T cells to attack and eliminate the B cells, allowing treatment of B cell cancers such as non-Hodgkin’s lymphoma. A phase I clinical trial is evaluating RG6026 for the treatment of relapsed or refractory non-Hodgkin's lymphoma.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6058 tiragolumab
solid tumors in combination with Tecentriq
4. Phase 1
Description/Summary:
tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor. A phase I clinical trial is evaluating tiragolumab in combination with Tecentriq for the treatment of solid tumors.
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG6058 tiragolumab
Heme and solid tumors combinations
4. Phase 1
Description/Summary:
tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor. A phase I clinical trial is evaluating tiragolumab in combination with Tecentriq for the treatment of solid tumors.
- Managed By:
- 1. Roche Group
1. Oncology
RG6076 CD19-4-1BBL
heme tumours
4. Phase 1
Description/Summary:
CD19-4-1BBL(RG6076) is a fusion protein targeting the 4-1BB ligand to cells bearing CD19 acting as an NK- and T-cell co-stimulator.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6115 TLR7 agonist (4)
Hepatocellular carcinoma
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6139 Anti-PD1 x LAG3
solid tumors
4. Phase 1
Description/Summary:
The bispecific monoclonal antibody PD1 x LAG3 (RG6139) binds to the PD-1 and LAG-3 inhibitory checkpoint receptors on the surface of T-cells. PD1 x LAG3 MAb enable preferential targeting of dysfunctional effector T-cells over regulatory T-cells mediating immunosuppressive effects while restoring anti-tumor immune response. RG6139 is currently in phase I clinical study for solid tumors.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6160
relapsed or refractory multiple myeloma
4. Phase 1
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG6171
ER-positive and HER2-negative metastatic breast cancer
4. Phase 1
Description/Summary:
RG6171 (GDC-9545) 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. A phase I clinical trial is evaluating RG6171 for the treatment of ER-positive and HER2-negative metastatic breast cancer.
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG6180 Individualised Neoantigen-Specific Therapy
solid tumors
4. Phase 1
2023+
Description/Summary:
Individualized Neoantigen-Specific Therapy, iNeST (RG6180) is a messenger RNA (mRNA)-based, individually tailored, personalized cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumor, which is expected to elicit an effective immune response against that patient’s tumor. A phase I clinical trial is evaluating iNeST for the treatment of solid tumors.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- BioNTech AG
1. Oncology
RG6185
solid tumors
4. Phase 1
Description/Summary:
RG6185 (GDC-5573, HM95573) is a selective small-molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway, which is frequently activated in human tumors and drives tumor growth. A phase I clinical trial is evaluating RG6185 for the treatment of solid tumors.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- Hanmi Pharmaceutical
1. Oncology
RG6194
metastatic HER2-positive cancers
4. Phase 1
Description/Summary:
RG6194 is a bispecific antibody designed to target both the HER2-positive cells and CD3 on T cells. This dual-targeting antibody is designed to induce a polyclonal T-cell response against HER2-positive tumors. A phase I clinical trial is evaluating RG6194 for the treatment of metastatic HER2-positive cancers.
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG6279 PD1-IL2v
Solid tumours
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6290 MAGE-A4 ImmTAC
solid tumors
4. Phase 1
Description/Summary:
The trial (NCT03973333) is designed to study the safety and preliminary activity of MAGE-A4 ImmTAC as a monotherapy and in combination with atezolizumab (Tecentriq) in patients with MAGE-A4-expressing cancers.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- Immunocore
1. Oncology
RG6292 Anti-CD25
solid tumors
4. Phase 1
Description/Summary:
RG6292 is a monoclonal antibody that targets CD25 (IL-2Rα). The antibody mediates the depletion of regulatory T-cells (Tregs), a major suppressor of the anti-cancer immune response. RG6292 does not interfere with IL-2 signaling of other immune cells which are acting against the tumor. A phase I clinical trial is evaluating RG6292 in solid tumors (NCT 04158583).
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6296 BCMA x CD16a
relapsed/refractory multiple myeloma
4. Phase 1
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG6323 IL15/IL15Ra-Fc
solid tumours
4. Phase 1
Description/Summary:
IL15/IL15Ra-Fc alone, and in combination with Tecentriq
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG7421 cobimetinib
Cotellic
second and third line metastatic colorectal cancer in combination with Tecentriq plus Avastin
4. Phase 1
Description/Summary:
Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that 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 is evaluating Cotellic in combination with Tecentriq (atezolizumab, anti-PDL1) and Avastin as a second or third line treatment in patients with advanced or metastatic colorectal cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Exelixis
1. Oncology
RG7440 ipatasertib
triple-negative breast cancer in combination with Tecentriq
4. Phase 1
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase I trial is evaluating ipatasertib in combination with Tecentriq and Taxane as a treatment in patients with TNBC.
- Managed By:
- 1. Roche Group
1. Oncology
RG7440 ipatasertib
metastatic castration-resistant prostate cancer and solid tumors in combination with rucaparib
4. Phase 1
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase I clinical trial is evaluating ipatasertib with rucaparib (a small-molecule PARP inhibitor) for the treatment of metastatic castration-resistant prostate cancer and solid tumors.
- Managed By:
- 1. Roche Group
- Partner:
- Array BioPharma (ipatasertib), Clovis Oncology (rucaparib)
1. Oncology
RG7446 atezolizumab
Tecentriq
locally advanced or metastatic solid tumors
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) 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 Tecentriq for the treatment of locally advanced or metastatic solid tumors is ongoing.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
pancreatic, gastric, non-small cell lung and HER2-positive breast cancer (MORPHEUS platform)
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) is a monoclonal antibody that targets PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. MORPHEUS pancreatic cancer study is testing a number of cancer immunotherapy combinations to inform future development. MORPHEUS is a phase Ib/II adaptive development platform established by Roche to assess the efficacy and safety of combination cancer immunotherapies.
- Managed By:
- 1. Roche Group
- Partner:
- Cotellic in collaboration with Exelixis, BL-8040 in collaboration with BioLineRX, PEGPH20 in collaboration with Halozyme
1. Oncology
RG7446 atezolizumab
Tecentriq
advanced gynecologic cancers, ovarian cancer
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq in combination with rucaparib (a small-molecule PARP inhibitor) in advanced gynecologic cancers, with a focus on ovarian cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Rucaparib in collaboration with Clovis
1. Oncology
RG7446 atezolizumab
Tecentriq
metastatic melanoma in combination with Zelboraf, with or without Cotellic
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) 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 Tecentriq in combination with Zelboraf (vemurafenib), with or without Cotellic (cobimetinib), for the treatment of metastatic melanoma is ongoing.
- Managed By:
- 1. Roche Group
- Partner:
- Exelixis (Cotellic), Plexxikon (Zelboraf)
1. Oncology
RG7446 atezolizumab
Tecentriq
HER2-positive breast cancer
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (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 is evaluating Tecentriq 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.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
relapsed or refractory acute myeloid leukemia
4. Phase 1
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq in combination with anti-CD47 MAb in relapsed or refractory AML.
- Managed By:
- 1. Roche Group
1. Oncology
RG7461
solid tumors
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 tumors is ongoing.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory myelodysplastic syndromes in combination with azacitidine
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 evaluating Venclexta as a single agent and in combination with the hypomethylating agent azacitidine in patients with relapsed or refractory myelodysplastic syndromes.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory acute myeloid leukemia in combination with gilteritinib
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 evaluating Venclexta in combination with the gilteritinib for the treatment of patients with relapsed or refractory acute myeloid leukemia.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory acute myeloid leukemia, combination with AMG176
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 AMG176 (Amgen) for the treatment of relapsed or refractory acute myeloid leukemia.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute (Venclexta), Amgen
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
chronic lymphocytic leukemia in combination with Gazyva
4. Phase 1
Description/Summary:
Venclexta (venetoclax, RG7601) is a 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. Gazyva, (obinutuzumab), is the first glycoengineered, type II, humanized anti-CD20 monoclonal antibody 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. a phase I clinical trial is evaluating Venclexta in combination with Gazyva for the treatment of chronic lymphocytic leukemia.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory chronic lymphocytic leukemia
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 evaluating Venclexta for the treatment of relapsed or refractory chronic lymphocytic leukemia.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7769
solid tumors
4. Phase 1
Description/Summary:
RG7769 ( PD1-TIM3) is a bispecific antibody that binds to two co-inhibitory checkpoint receptors, PD-1 and TIM-3, to reinvigorate dysfunctional T-cells enabling them to attack the tumor. A phase I clinical trial is evaluating RG7769 for the treatment of solid tumors.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG7802 cibisatamab
solid tumors
4. Phase 1
Description/Summary:
cibisatamab (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. A phase I clinical trial is evaluating cibisatamab for the treatment of CEA-expressing solid tumors, as a single agent and in combination with atezolizumab.
- Managed By:
- 1. Roche Group
1. Oncology
RG7827
solid tumors
4. Phase 1
Description/Summary:
RG7827 (FAP 4-1BBL FP) is an agonistic immune modulator and targeted T-cell co-stimulator, which inhibits tumor growth by activating tumor-specific T-cells. RG7827 has an antibody-like structure, with one arm binding to FAP, which is a protein found in the stroma of many solid tumor types, and the other arm carrying the signaling molecule, 4-1BBL. A phase I clinical trial is evaluating RG7827 for the treatment of solid tumors.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG7828 mosunetuzumab
hematologic tumors
4. Phase 1
Description/Summary:
mosunetuzumab (Anti-CD20/CD3 TDB, RG7828) is a humanized 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. A phase I clinical trial is evaluating mosunetuzumab for the treatment of hematologic tumors.
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG7876 selicrelumab
solid tumors, combination with vanucizumab or Avastin
4. Phase 1
Description/Summary:
Selicrelumab (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. A phase I clinical trial is evaluating selicrelumab in combination with vanucizumab or Avastin for the treatment of solid tumors.
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
SQZ PBMC Vaccine
solid tumours
4. Phase 1
Description/Summary:
SQZ-PBMC-HPV as Monotherapy and in Combination With Atezolizumab
- Managed By:
- 2. Pharma Research and Early Development
1. Oncology
RG6058 tiragolumab
cervical cancer in combination with tecentriq
3. Phase 2
Description/Summary:
Randomised Phase II (SKYSCRAPER-04) in metastatic and/or recurrent PD-L1+ cervical cancer in combination with Tecentriq. tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.
- Managed By:
- 1. Roche Group
1. Oncology
RG6180 Individualised Neoantigen-Specific Therapy
first line melanoma
3. Phase 2
2023+
Description/Summary:
Individualised Neoantigen-Specific Therapy, iNeST (RG6180) is a messenger RNA (mRNA)-based, individually tailored, personalized cancer vaccine. Each vaccine will be made using unique neoantigen signatures from an individual patient’s tumor, which is expected to elicit an effective immune response against that patient’s tumor. A phase II clinical trial is evaluating iNeST for the treatment of first line melanoma.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- BioNTech AG
1. Oncology
RG6356 microdystrophin (SRP-9001)
Duchenne muscular dystrophy
3. Phase 2
2023+
Description/Summary:
Phase II gene therapy in Duchenne muscular dystrophy (DMD)
- Managed By:
- 1. Roche Group
1. Oncology
RG7421 cobimetinib
Cotellic
first line metastatic triple-negative breast cancer
3. Phase 2
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 clinical trial is evaluating Cotellic in combination with paclitaxel, with paclitaxel and atezolizumab, or with nab-paclitaxel and atezolizumab in patients with triple-negative breast cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Exelixis
1. Oncology
RG7446 atezolizumab SC
Tecentriq
locally advanced or metastatic non-small cell lung cancer
3. Phase 2
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death-ligand 1) aiming to prevent cancer immune evasion. A phase II is evaluating atezolizumab subcutaneous (SC) followed by atezolizumab IV for the treatment of locally advanced or metastatic non-small cell lung cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7596 polatuzumab vedotin
Polivy
relapsed or refractory follicular lymphoma
3. Phase 2
2023+
Description/Summary:
Polivy (Polatuzumab vedotin) is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody anti-CD79b, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells. A phase II clinical trial is evaluating Polivy for the treatment of relapsed or refractory follicular lymphoma.
- Managed By:
- 1. Roche Group
- Partner:
- Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
first line myelodysplastic syndrome in combination with azacitidine
3. Phase 2
2023+
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 II clinical trial is evaluating Venclexta in combination with the hypomethylating agent azacitidine for the treatment of patients with previously untreated myelodysplastic syndromes.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
second line or later HR-positive breast cancer
3. Phase 2
2023+
Description/Summary:
Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) 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 is evaluating ipatasertib for the treatment of second line or later HR-positive breast cancer.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory multiple myeloma
3. Phase 2
2023+
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. A phase II clinical trial is evaluating Venclexta in combination with the carfilzomib and dexamethasone for the treatment of patients with relapsed or refractory acute myeloid leukemia.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG6058 tiragolumab
1L non-small cell lung cancer (NSCLC) in combination with Tecentriq
2. Phase 3
2023+
Description/Summary:
Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L non-small cell lung cancer (NSCLC) patients whose tumours express PD-L1 (TPS>50%). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.
- Managed By:
- 1. Roche Group
1. Oncology
RG6058 tiragolumab
1L small cell lung cancer (SCLC) in combination with Tecentriq
2. Phase 3
2022
Description/Summary:
Randomised Phase III (SKYSCRAPER-02) of tiragolumab plus Tecentriq in 1L small cell lung cancer (SCLC). tiragolumab (anti-TIGIT, RG6058) is a fully human monoclonal antibody designed to bind to TIGIT and prevent its interaction with poliovirus receptor (PVR). T cell immunoglobulin and ITIM domain protein (TIGIT), a member of the immunoglobulin superfamily, is a novel immune inhibitory receptor.
- Managed By:
- 1. Roche Group
1. Oncology
RG6114 mPI3K alpha inh
metastatic ER-positive and HER2-negative breast cancer
2. Phase 3
2023+
Description/Summary:
RG6114 (GDC-0077) is a small molecule PI3 kinase (PI3K) inhibitor. Dysregulation of PI3K signaling is implicated in a broad range of human cancers, and activating mutations in the PI3K alpha-isoform gene (PIK3CA) are common oncogenic drivers. The PI3K/Akt/mTOR pathway regulates cell growth and survival.
- Managed By:
- 4. Genentech Research and Early Development
1. Oncology
RG7440 ipatasertib
first line castration-resistant prostate cancer
2. Phase 3
2020
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase III clinical trial is evaluating ipatasertib for the treatment of first line castration-resistant prostate cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Array BioPharma
1. Oncology
RG7440 ipatasertib
first line triple-negative and HR-positive breast cancer
2. Phase 3
2020
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase III clinical trial is evaluating ipatasertib for the treatment of first line triple-negative and HR-positive breast cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Array BioPharma
1. Oncology
RG7440 ipatasertib
first line HR-positive metastatic breast cancer in combination with palbociclib and fulvestrant
2. Phase 3
2023+
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase III clinical trial is evaluating ipatasertib in combination with palbociclib and fulvestrant for the treatment of HR-positive metastatic breast cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Array BioPharma
1. Oncology
RG7440 ipatasertib
triple-negative breast cancer in combination with Tecentriq + taxane
2. Phase 3
Description/Summary:
Ipatasertib (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival. A phase III clinical trial is evaluating ipatasertib in combination with Tecentriq and paclitaxel for the treatment of first line triple-negative breast cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Array BioPharma
1. Oncology
RG7446 atezolizumab
Tecentriq
first line non-squamous non-small cell lung cancer diagnostic positive via a blood-based tumor mutational burden assay
2. Phase 3
2021
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase II/III clinical trial for non-squamous non-small cell lung cancer patients who are positive via blood based tumor mutational burden(TMB) assay.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
neoadjuvant triple-negative breast cancer
2. Phase 3
2020
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (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 is investigating Tecentriq in combination with nab-paclitaxel (Abraxane) as a potential neoadjuvant (before surgery) treatment for triple-negative breast cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
front line ovarian cancer
2. Phase 3
2020
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq in combination with chemotherapy and Avastin in women with newly diagnosed stage III or IV ovarian, fallopian tube or primary peritoneal cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
first line metastatic urothelial carcinoma
2. Phase 3
2020
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq in combination with chemotherapy or as monotherapy in patients with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant triple-negative breast cancer in combination with paclitaxel
2. Phase 3
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, Atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential adjuvant treatment, in combination with paclitaxel, for triple-negative breast cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant renal cell carcinoma
2. Phase 3
2022
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq for the treatment of adjuvant renal cell carcinoma.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
neoadjuvant HER2-positive breast cancer
2. Phase 3
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (atezolizumab, RG7446) 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 is evaluating ddAC Trastuzumab/Pertuzumab + chemotherapy + Tecentriq followed by surgery and chemotherapy +Tecentriq in the treatment of neoadjuvant HER2+ breast cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant squamous cell carcinoma of the head and neck
2. Phase 3
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq, (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 is evaluating Tecentriq in patients with adjuvant squamous cell carcinoma of the head and neck (SCCHN).
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
first line metastatic triple-negative breast cancer in combination with paclitaxel
2. Phase 3
2020
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (Atezolizumab, RG7446, MPDL3280A) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death-ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with paclitaxel, for metastatic triple-negative breast cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant hepatocellular carcinoma in combination with Avastin
2. Phase 3
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (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 is evaluating Tecentriq in combination with Avastin in adjuvant Hepatocellular carcinoma (HCC)
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
adjuvant non-small cell lung cancer
2. Phase 3
2022
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, Atezolizumab ) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq 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 tumors express PDL1.
- Managed By:
- 1. Roche Group
1. Oncology
RG7446 atezolizumab
Tecentriq
first line metastatic triple-negative breast cancer in combination with capecitabine or carboplatin/gemcitabine
2. Phase 3
2023+
Description/Summary:
Cancer immunotherapy is the use of the immune system to fight cancer. Tecentriq (anti-PDL1, RG7446, atezolizumab) is an engineered monoclonal antibody that targets the ligand PD-L1 (programmed death ligand 1) aiming to prevent cancer immune evasion. Tecentriq is being evaluated in a phase III clinical trial as a potential first-line treatment, in combination with capecitabine or carboplatin/gemcitabine, for metastatic triple-negative breast cancer.
- Managed By:
- 1. Roche Group
1. Oncology
RG7596 polatuzumab vedotin
Polivy
first line diffuse large B-cell lymphoma
2. Phase 3
2021
Description/Summary:
Polivy (Polatuzumab vedotin) is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody anti-CD79b, conjugated to a potent anti-cancer agent that is selectively delivered to tumor cells. A phase III clinical trial is evaluating Polivy for the treatment of first line diffuse large B-cell lymphoma.
- Managed By:
- 1. Roche Group
- Partner:
- Seattle Genetics
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
relapsed or refractory t(11;14)-positive multiple myeloma
2. Phase 3
2023+
Description/Summary:
Venclexta (venetoclax, RG7601, GDC-0199, ABT-199) 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 is evaluating Venclexta for the treatment of relapsed or refractory t(11;14)-positive multiple myeloma.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7853 alectinib
Alecensa
adjuvant ALK-positive non-small cell lung cancer
2. Phase 3
2023+
Description/Summary:
Alecensa (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. A phase III clinical trial is evaluating Alecensa for the treatment of adjuvant ALK-positive non-small cell lung cancer.
- Managed By:
- 1. Roche Group
- Partner:
- Chugai
1. Oncology
RG6268 entrectinib
Rozlytrek
solid tumors positive for NTRK1 activating rearrangements
1. Filed
2019
Description/Summary:
Rozlytrek (entrectinib, RG6268) is a potent, selective CNS active tyrosine kinase inhibitor being developed for NTRK or ROS1 tumors. Activating rearrangements in NTRK have been identified across >30 different solid tumor types, including head and neck, thyroid, sarcoma, and brain. A phase II clinical trial is evaluating Rozlytrek for the treatment of solid tumors positive for NTRK1 activating rearrangements.
- Managed By:
- 1. Roche Group
1. Oncology
RG6268 entrectinib
Rozlytrek
non-small cell lung cancer positive for activating ROS1 rearrangements
1. Filed
2019
Description/Summary:
Rozlytrek (entrectinib, RG6268) is a potent, selective CNS active tyrosine kinase inhibitor being developed for NTRK or ROS1 tumors. Activating ROS1 rearrangements are concentrated in NSCLC, accounting for 1-2% of NSCLC. rain. A phase II clinical trial is evaluating Rozlytrek for the treatment of non-small cell lung cancer positive for activating ROS1 rearrangements.
- Managed By:
- 1. Roche Group
1. Oncology
RG7421 cobimetinib
Cotellic
first line BRAFv600 mutation-positive advanced melanoma in combination with Tecentriq plus Zelboraf
1. Filed
2020
Description/Summary:
Cotellic (cobimetinib, RG7421) is a selective inhibitor of MEK, also known as mitogen activated protein kinase kinase (MAPKK), a key component of the RAS/RAF/MEK/ERK pathway that 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 III clinical trial is evaluating Cotellic in combination with Tecentriq and Zelboraf as a first-line treatment in patients with BRAF-mutated advanced melanoma.
- Managed By:
- 1. Roche Group
- Partner:
- Exelixis (Cotellic), Plexxikon/Daiichi Sankyo (Zelboraf)
1. Oncology
RG7601 venetoclax
Venclexta/Venclyxto
first line acute myeloid leukemia in combination with azacitidine
1. Filed
2020
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 III clinical trial is evaluating Venclexta in combination with the hypomethylating agent azacitidine for the treatment of patients with previously untreated acute myeloid leukemia who are not eligible for standard induction therapy.
- Managed By:
- 1. Roche Group
- Partner:
- AbbVie, Walter and Eliza Hall Institute
1. Oncology
RG7853 alectinib
Alecensa
first line ALK-positive non-small cell lung cancer
1. Filed
2020
Description/Summary:
Alecensa (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. A phase II/III clinical trial is evaluating Alecensa for the treatment of non-squamous non-small cell lung cancer patients who are ALK+.
- Managed By:
- 1. Roche Group
- Partner:
- Chugai
2. Immunology
2. Immunology
RG6107 crovalimab
paroxysmal nocturnal hemoglobinuria
4. Phase 1
Description/Summary:
Crovalimab (RG6107) is a humanised complement inhibitor C5 monoclonal antibody discovered by Chugai using recycling antibody technology. By blocking the cleavage of C5 to C5a and C5b, it is expected to inhibit complement activation, which is the cause of a number of diseases. As the complement system is a key innate immune defense mechanism, we plan to study the potential of this antibody in a broader range of complement-mediated diseases. A phase I/II clinical trial is evaluating crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria.
- Managed By:
- 1. Roche Group
- Partner:
- Chugai
2. Immunology
RG6151
asthma
4. Phase 1
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG6244
asthma
4. Phase 1
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG6287
Inflammatory bowel disease
4. Phase 1
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG7835
autoimmune diseases
4. Phase 1
Description/Summary:
RG7835 is a conjugate of human IL-2 and IgG (fused IL-2 mutein). IgG–IL2 preferentially stimulates and expands T regulatory cells but not T effector cells. A phase I clinical trial is evaluating RG7835 for the treatment of autoimmune diseases.
- Managed By:
- 2. Pharma Research and Early Development
2. Immunology
RG6149
asthma
3. Phase 2
2023+
Description/Summary:
RG6149 (anti-ST2, AMG 282) is a fully human monoclonal antibody designed to inhibit binding of interleukin-33 (IL-33) to the ST2 receptor. A phase II clinical trial is evaluating RG6149 for the treatment of asthma.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- Amgen
2. Immunology
RG6149
COVID-19 pneumonia
3. Phase 2
Description/Summary:
RG6149 (anti-ST2, AMG 282) is a fully human monoclonal antibody designed to inhibit binding of interleukin-33 (IL-33) to the ST2 receptor.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- Amgen
2. Immunology
RG6173
asthma
3. Phase 2
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG6354 pentraxin-2
Idiopathic pulmonary fibrosis
3. Phase 2
2023+
Description/Summary:
Phase II study of pentraxin-2 (PRM-151) in idiopathic pulmonary fibrosis
- Managed By:
- 1. Roche Group
2. Immunology
RG6354 pentraxin-2
myelofibrosis
3. Phase 2
2023+
Description/Summary:
Phase II study of pentraxin-2 (PRM-151) in myelofibrosis
- Managed By:
- 1. Roche Group
2. Immunology
RG7159 obinutuzumab
Gazyva/Gazyvaro
lupus nephritis
3. Phase 2
2023+
Description/Summary:
Obinutuzumab (RG7159, 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 evaluating obinutuzumab for the treatment of patients with lupus nephritis.
- Managed By:
- 1. Roche Group
- Partner:
- Biogen Idec
2. Immunology
RG7845 fenebrutinib
autoimmune diseases
3. Phase 2
2023+
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. A phase II clinical trial is evaluating RG7845 as a potential therapeutic option in difficult-to-treat autoimmune diseases.
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG7880 IL22-Fc
inflammatory diseases
3. Phase 2
Description/Summary:
RG7880 (IL22-Fc, UTTR1147A) is a recombinant human protein with potential application across multiple inflammatory and metabolic diseases. A phase II clinical trial is evaluating RG7880 for the treatment of inflammatory diseases.
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG7880 IL22-Fc
COVID-19 pneumonia
3. Phase 2
Description/Summary:
RG7880 (IL22-Fc, UTTR1147A) is a recombinant human protein with potential application across multiple inflammatory and metabolic diseases.
- Managed By:
- 4. Genentech Research and Early Development
2. Immunology
RG1569 tocilizumab
Actemra/RoACTEMRA
Covid-19 pneumonia
2. Phase 3
2020
Description/Summary:
Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 and is being investigated in the treatment of Covid-19 pneumonia.
- Managed By:
- 1. Roche Group
2. Immunology
RG1569 tocilizumab
Actemra/RoACTEMRA
Covid-19 pneumonia in combination with remdesivir
2. Phase 3
2020
Description/Summary:
Actemra/RoACTEMRA (tocilizumab) is a humanised monoclonal antibody to the interleukin-6 receptor, inhibiting the activity of interleukin-6 and is being investigated in the treatment of Covid-19 pneumonia in combination with remdesivir.
- Managed By:
- 1. Roche Group
2. Immunology
RG3648 omalizumab
Xolair
Food allergy
2. Phase 3
2021
Description/Summary:
Xolair (omalizumab, RG3648) is a monoclonal antibody that specifically targets the antibody IgE (immunoglobulin E). In nasal polyps (NP) IgE is increased in mucosal tissue and frequently in serum.
- Managed By:
- 1. Roche Group
- Partner:
- Novartis
2. Immunology
RG7413 etrolizumab
Crohn's disease
2. Phase 3
2022
Description/Summary:
Etrolizumab (RG7413) 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. Phase III clinical trials are evaluating etrolizumab for the treatment of Crohn's disease.
- Managed By:
- 1. Roche Group
2. Immunology
RG7413 etrolizumab
ulcerative colitis
2. Phase 3
2020
Description/Summary:
Etrolizumab (RG7413) 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. Phase III clinical trials are evaluating etrolizumab for the treatment of ulcerative colitis.
- Managed By:
- 1. Roche Group
2. Immunology
RG3648 omalizumab
Xolair
chronic rhinosinusitis with nasal polyps
1. Filed
2019
Description/Summary:
Xolair (omalizumab, RG3648) is a monoclonal antibody that specifically targets the antibody IgE (immunoglobulin E). In nasal polyps (NP) IgE is increased in mucosal tissue and frequently in serum. Two phase III clinical trial are evaluating Xolair for the treatment of chronic rhinosinusitis with nasal polyps.
- Managed By:
- 1. Roche Group
- Partner:
- Novartis
3. Ophthalmology
3. Ophthalmology
RG6179
diabetic macular edema
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
3. Ophthalmology
RG6247 4D-R110
choroideremia
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
3. Ophthalmology
RG7921
neovascular age related macular degeneration
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
3. Ophthalmology
IONIS ASO factor B
geographic atrophy
3. Phase 2
Description/Summary:
ASO factor B (IONIS) is an antisense oligonucleotide that inhibits complement factor B gene expression by binding with factor B mRNA. ASO factor B is being studied for the treatment of geographic atrophy. A phase II clinical trial is evaluating ASO factor B for the treatment of geographic atrophy.
- Managed By:
- 0. -
- Partner:
- Ionis
3. Ophthalmology
IONIS ASO factor B
IgA-nephropathy
3. Phase 2
Description/Summary:
ASO factor B (IONIS) is an antisense oligonucleotide that inhibits complement factor B gene expression by binding with factor B mRNA. ASO factor B is being studied for the treatment of IgA-nephropathy. A phase II clinical trial is evaluating ASO factor B for the treatment of IgA-nephropathy.
- Managed By:
- 0. -
- Partner:
- Ionis
3. Ophthalmology
RG6147
geographic atrophy
3. Phase 2
Description/Summary:
- Managed By:
- 4. Genentech Research and Early Development
3. Ophthalmology
RG7774 NME
retinal disease
3. Phase 2
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
3. Ophthalmology
RG6321 ranibizumab
diabetic macular edema port delivery system with ranibizumab
2. Phase 3
2022
Description/Summary:
Ranibizumab (RG6321), 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 phase III clinical trial is evaluating ranibizumab delivered via the port delivery system implant for the treatment of patients with diabetic macular edema (DME).
- Managed By:
- 1. Roche Group
- Partner:
- ForSight VISION4
3. Ophthalmology
RG6321 ranibizumab
age-related macular degeneration port delivery system with ranibizumab
2. Phase 3
2020
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 phase III clinical trial is evaluating ranibizumab delivered via the ranibizumab port delivery system implant for the treatment of 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:
- ForSight VISION4
3. Ophthalmology
RG7716 faricimab
diabetic macular edema
2. Phase 3
2021
Description/Summary:
Faricimab (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. Two phase III clinical trials are evaluating faricimab for the treatment of diabetic macular edema.
- Managed By:
- 1. Roche Group
3. Ophthalmology
RG7716 faricimab
neovascular age related macular degeneration
2. Phase 3
2021
Description/Summary:
Faricimab (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. Two phase III clinical trials are evaluating faricimab for the treatment of neovascular age related macular degeneration.
- Managed By:
- 1. Roche Group
4. Infectious Diseases
4. Infectious Diseases
RG6084
chronic hepatitis B infection
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
4. Infectious Diseases
RG6346 HBV siRNA
Hepatitis B virus
4. Phase 1
Description/Summary:
RG6346 (DCR-HBVS) is a liver-targeted siRNA that employs RNA interference (RNAi) for selective knock-down of Hepatitis B virus gene expression in infected hepatocytes, inhibiting the production of viral factors required for viral replication. RG6346 leverages Dicerna Pharmaceuticals, Inc.’s proprietary GalXC™ RNAi technology. RG6346 is in a phase I clinical trial for the treatment of non-cirrhotic chronic HBV infection.
- Managed By:
- 2. Pharma Research and Early Development
4. Infectious Diseases
RG7854
chronic hepatitis B infection
4. Phase 1
Description/Summary:
TLR7 agonist (RG7854) is an oral, small molecule immuno-modulator activating the TLR (toll-like receptor) 7 and to a weaker extent TLR8. It is developed as best-in-disease for finite chronic hepatitis B combination therapy. A phase I clinical trial is evaluating RG7854 for the treatment of chronic hepatitis B infection.
- Managed By:
- 2. Pharma Research and Early Development
4. Infectious Diseases
RG7861
infections caused by Staphylococcus aureus
4. Phase 1
Description/Summary:
RG7861 (anti-S. aureus TAC, DSTA4637S) is a THIOMAB™ antibiotic conjugate (TAC) that consists of a human monoclonal antibody directed against Staphylococcus aureus, conjugated to an antiobiotic agent. Anti-S. aureus TAC is designed to bind to the surface of Staphylococcus aureus bacteria. A phase I clinical trial is evaluating RG7861 for the treatment of infections caused by Staphylococcus aureus.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- Seattle Genetics, Symphogen
4. Infectious Diseases
RG7907
chronic hepatitis B infection
4. Phase 1
Description/Summary:
CpAM (RG7907) is an orally administered small molecule, class I hepatitis B virus (HBV) core protein allosteric modulator, that disrupts HBV nucleocapsids assembly and induces the depletion of functional core proteins, thereby effectively inhibiting HBV replication. A phase I clinical trial is evaluating RG7907 for the treatment of chronic hepatitis B infection.
- Managed By:
- 2. Pharma Research and Early Development
4. Infectious Diseases
RG7854
chronic hepatitis B infection
3. Phase 2
Description/Summary:
TLR7 agonist (RG7854) in combination with RG7907 CpAM (2)
- Managed By:
- 2. Pharma Research and Early Development
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, pediatric patients (0-1yr)
2. Phase 3
2021
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of pediatric patients with the flu.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, direct transmission
2. Phase 3
2021
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, hospitalized patients
2. Phase 3
2021
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of patients hospitalized with the flu.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, post exposure prophylaxis
1. Filed
2020
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial of post exposure prophylaxis.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza high risk
1. Filed
2019
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being investigated in a Phase III clinical trial in people with the flu who are at high risk of complications
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, otherwise healthy
1. Filed
2018
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of people with flu but otherwise healthy.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
4. Infectious Diseases
RG6152 baloxavir marboxil
Xofluza
influenza, pediatric patients (1-12yr)
1. Filed
2020
Description/Summary:
Xofluza (baloxavir marboxil, RG6152) is an oral cap-dependent endonuclease inhibitor with broad and potent antiviral activity against seasonal influenza A and B viruses. Xofluza is being evaluated in a phase III clinical trial for the treatment of pediatric patients with the flu.
- Managed By:
- 1. Roche Group
- Partner:
- Shionogi
6. Neuroscience
6. Neuroscience
RG6000
amyotrophic lateral sclerosis
4. Phase 1
Description/Summary:
RG6000 (GDC-0134) is an investigational small molecule dual leucine zipper kinase (DLK) inhibitor being evaluated for the potential treatment of amyotrophic lateral sclerosis. DLK is a neuronally-enriched kinase that is designed to mediate stress-induced cell death. DLK inhibition may exhibit neuroprotective potential. A phase I clinical trial is evaluating RG6000 for the treatment of amyotrophic lateral sclerosis.
- Managed By:
- 4. Genentech Research and Early Development
6. Neuroscience
RG6102 Brain shuttle gantenerumab
Alzheimer's
4. Phase 1
Description/Summary:
Brain shuttle technology to transfer gantenerumab across the blood brain barrier and increase antibody concentrations in the brain
- Managed By:
- 2. Pharma Research and Early Development
6. Neuroscience
RG6237
neuromuscular disorders
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
6. Neuroscience
RG7637 NME
neurodevelopmental disorders
4. Phase 1
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
6. Neuroscience
RG7816 GABA-Aa5 PAM
autism spectrum disorder
4. Phase 1
Description/Summary:
RG7816 is a small molecule highly selective positive allosteric modulator of the GABAA α5 receptor, which is expressed in key brain regions for autism spectrum disorder. Two phase I clinical trial is evaluating RG7816 for the treatment of patients with autism spectrum disorder.
- Managed By:
- 2. Pharma Research and Early Development
6. Neuroscience
RG6100
Alzheimer's disease
3. Phase 2
2023+
Description/Summary:
RG6100 (Anti Tau) is an investigational medicine being evaluated as a potential treatment for Alzheimer’s disease. A phase II clinical trial is evaluating RG6100 for the treatment of patients with Alzheimer's disease.
- Managed By:
- 4. Genentech Research and Early Development
- Partner:
- AC Immune
6. Neuroscience
RG7412 crenezumab
Alzheimer's disease
3. Phase 2
2023+
Description/Summary:
Crenezumab (RG7412) 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. A phase II clinical trial is evaluating crenezumab in healthy individuals with a history of familial Alzheimer’s disease.
- Managed By:
- 1. Roche Group
- Partner:
- AC Immune
6. Neuroscience
RG7906
psychiatric disorders
3. Phase 2
Description/Summary:
- Managed By:
- 2. Pharma Research and Early Development
6. Neuroscience
RG7935 prasinezumab
Parkinson's disease
3. Phase 2
2023+
Description/Summary:
Prasinezumab (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. A phase II clinical trial is evaluating prasinezumab for the treatment of patients with Parkinson's disease.
- Managed By:
- 2. Pharma Research and Early Development
- Partner:
- Prothena
6. Neuroscience
RG1450 gantenerumab
Alzheimer's disease
2. Phase 3
2022
Description/Summary:
Gantenerumab (RG1450) 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. A phase III clinical trial is evaluating gantenerumab for the treatment of Alzheimer's disease.
- Managed By:
- 1. Roche Group
- Partner:
- Morphosys
6. Neuroscience
RG6042 ASO-HTT
Huntington's Disease
2. Phase 3
2022
Description/Summary:
ASO-HTT (RG6042) is an antisense drug in development for the treatment of Huntington's Disease. ASO-HTT is designed to reduce the production of all forms of the huntingtin (HTT) protein, which in its mutated variant (mHTT) is responsible for Huntington's Disease. Multiple clinical trials are evaluating ASO-HTT for the treatment of patients with Huntington's Disease.
- Managed By:
- 1. Roche Group
- Partner:
- Ionis
6. Neuroscience
RG6168 satralizumab
neuromyelitis optica spectrum disorder
1. Filed
2019
Description/Summary:
Satralizumab (RG6168) is a humanized monoclonal antibody to the interleukin-6 receptor. A phase III clinical trial is evaluating satralizumab as monotherapy or as an add-on therapy for the treatment of patients with neuromyelitis optica spectrum disorder.
- Managed By:
- 1. Roche Group
- Partner:
- Chugai
6. Neuroscience
RG7916 risdiplam
spinal muscular atrophy
1. Filed
2019
Description/Summary:
Risdiplam (RG7916) is an investigational oral SMN2 splicing modifier being studied in the treatment of spinal muscular atrophy. Multiple phase II and phase II/III are evaluating risdiplan for the treatment of patients with spinal muscular atrophy.
- Managed By:
- 1. Roche Group
- Partner:
- PTC Therapeutics, SMA Foundation
7. Other
7. Other
CHU
endometriosis
4. Phase 1
Description/Summary:
- Managed By:
- 3. Chugai
- Partner:
- Chugai
7. Other
CHU anti-FIXa/FX
hemophilia A
4. Phase 1
Description/Summary:
NXT007 is an optimized anti-FIXa/FX bispecific monoclonal antibody. NXT007 has an enhanced hemostatic activity and improved pharmacokinetics by antibody engineering technologies. The bispecific antibody is in phase I/II clinical study for healthy volunteers and hemophilia A.
- Managed By:
- 3. Chugai
7. Other
RG6357 SPK-8011
hemophilia A
3. Phase 2
Description/Summary:
- Managed By:
- 0. -
7. Other
RG6358 SPK-8016
hemophilia A with inhibitors to factor VIII
3. Phase 2
Description/Summary:
- Managed By:
- 0. -
7. Other
RG6367 spk-7001
choroideremia
3. Phase 2
Description/Summary:
- Managed By:
- 0. -
7. Other
RG6013 emicizumab
Mild to moderate hemophilia A, patients without FVIII inhibitors
2. Phase 3
2022
Description/Summary:
Emicizumab (RG6013, ACE910) is a bispecific antibody that mimics coagulation factor VIII, an essential blood clotting protein. It is being investigated as a therapy for people with mild ot moderate 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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Area
Product name
Description
Market
Instruments/devices planned for 2020
Workflow
cobas prime
Next generation pre-analytical platform to support cobas® 6800/8800 Systems
CE
Diabetes Care
Accu-Chek Solo Diabetes Manager
Integration of the Accu-Chek Guide test strip technology into the Accu-Chek Solo Diabetes Manager (remote control)
CE
Infectious Diseases
cobas® EBV EBNA IgG
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® EBV VCA IgG
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® EBV IgM
EBV panel offering 3 different assays (EBV IgM, EBV VCA IgG, and EBV EBNA IgG) for the qualitative detection of antibodies to Epstein-Barr Virus (EBV)
CE
cobas® HIV-1&2 Qual
Qualitative detection and confirmation of HIV-1 & HIV-2
US
cobas® EBV
Monitoring tests for transplant patients to aid in the management of EBV and BKV infections
US
cobas® BKV
Monitoring tests for transplant patients to aid in the management of EBV and BKV infections
US
Cervical Cancer
cobas® HPV (6800/8800)
The world’s leading cobas® HPV assay for use on the fully automated cobas® 6800/8800 Systems
US
CINtec PLUS Cytology
Next generation “Pap” test which leverages p16/Ki-67 dual-stain biomarker technology on cervical cytology samples
US
Tissue Dx
VENTANA HER2 Dual ISH
Fully automated, brightfield ISH assay to determine eligibility for HER2 targeted therapy
US
Algorithm - HER2 (4B5)
Whole slide image analysis algorithm for HER2 (4B5)
CE
Software planned for 2020
Sequencing
NAVIFY Mutation Profiler
Software as a medical device for annotating, variant classification, clinical interpretation and reporting from comprehensive genomic profile testing
US
Diabetes Care
RocheDiabetes InsulinStart
A messaging service designed for people with type 2 diabetes to ease the transition from oral antidiabetics to a complimentary insulin therapy
CE
mySugr app
Enabling control of the Accu-Chek Insight insulin pump from the mySugr app
WW
RocheDiabetes Care Platform
New releases with improved features focusing on device connectivity, integration of 3rd parties, and healthcare professionals’ workflow optimisation
WW
WW - Worldwide.
EU - European Union.
US - United States.
* - Achieve commercial readiness, dependent on Pharma label and approval.