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Pipeline

Genentech's Research and Early Development pipeline has 30 new molecular entities in clinical development.

Our R&D activities are focused on applying excellent science to discover and develop potential new medicines with the goal of becoming first-in-class or best-in-class therapeutics.

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MAb = monoclonal antibody
DAF = dual action antibody
Fab = monoclonal antibody fragment

Anti-CD22 Antibody Drug Conjugate

Phase I
  • Hematologic malignancies

Description


Anti-CD22 (DCDT2980S, RG7593) is an antibody drug conjugate (ADC) that consists of a humanized IgG1 anti-CD22 monoclonal antibody, conjugated to a anti-mitotic agent, monomethyl auristatin E (MMAE). Anti-CD22 is designed to selectively bind to CD22 while minimizing cytotoxic effects on hematologic cells that do not express CD22.


Development Status


A Phase I clinical trial evaluating anti-CD22 ADC in combination Rituxan® (Rituximab) for hematologic malignancies is ongoing.

This molecule is being developed utilizing Seattle Genetics's ADC technology.

For Rituxan full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit http://www.rituxan.com or call 1-800-821-8590.


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Anti-EGFL7 MAb

Phase II
  • Metastatic colorectal cancer
  • Non-small cell lung cancer
Phase I
  • Solid tumors

Description


Anti-EGFL7 (MEGF0444A, RG7414) is a humanized antibody against EGFL7 (Epidermal Growth Factor Domain-Like 7). EGFL7 is a vascular-restricted secreted protein present in the tracks that surround tumor blood vessels, supporting their survival. Anti-EGFL7 antibody reduces tumor vascular function and is designed to inhibit tumor growth.


Development Status


Clinical trials are ongoing evaluating anti-EGFL7 in combination with Avastin®(bevacizumab) for first-line metastatic colorectal cancer, first-line metastatic non-squamous non-small cell lung cancer, and solid tumors.

For Avastin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.avastin.com.


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Anti-PD-L1 MAb

Phase I
  • Solid tumors

Description


Anti-PD-L1 (MPDL3280A, RG7446) is a monoclonal antibody that targets ligand PD-L1 (programmed cell death–1 ligand 1).


Development Status


A Phase I clinical trial evaluating anti-PD-L1 for solid tumors is ongoing.




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Anti-HER3/EGFR DAF MAb

Phase II
  • Head and neck cancer
Phase I
  • Metastatic epithelial tumors

Description


Anti-HER3/EGFR (MEHD7945A, RG7597), a dual action antibody, is a phage-derived, humanized IgG1 monoclonal antibody that is designed to target human epidermal growth factor receptor 3 (HER3) and epidermal growth factor receptor (EGFR).


Development Status


Clinical trials are ongoing evaluating anti-HER3/EGFR for metastatic epithelial tumors and metastatic squamous cell carcinoma of the head and neck cancer.


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PI3 Kinase Inhibitor (GDC-0032)

Phase I
  • Solid tumors

Description


GDC-0032 (RG7604) is a small molecule PI3 kinase inhibitor.
PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival.


Development Status


A Phase I clinical trial evaluating GDC-0032 for solid tumors is ongoing.


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Akt Inhibitor (GDC-0068)

Phase I
  • Prostate cancer
  • Solid tumors

Description


GDC-0068 (RG7440) is a small molecule pan-Akt inhibitor. The PI3K/Akt/mTOR pathway regulates cell growth and survival.


Development Status


A Phase I/II clinical trial evaluating both GDC-0068 and GDC-0980 for castration-resistant prostate cancer, a Phase Ib clinical trial in combination with GDC-0973, a MEK Inhibitor, for solid tumors, and Phase I clinical trials for solid tumors are ongoing.

This molecule was discovered in collaboration with Array BioPharma Inc.

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Bcl-2 Inhibitor (GDC-0199)

Phase I
  • Chronic lymphocytic leukemia and non-Hodgkin's lymphoma

Description


GDC-0199 (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.


Development Status


A Phase I trial evaluating GDC-0199 for chronic lymphocytic leukemia and non-Hodgkin's lymphoma is ongoing.

This molecule is being developed in collaboration with Abbott.


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ChK1 Inhibitor (GDC-0425)

Phase I
  • Solid tumors or lymphoma

Description


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. GDC-0425 (RG7602) is a small molecule ChK1 selective inhibitor designed to prevent tumor cells from recovering from DNA damage.


Development Status


A Phase I trial evaluating GDC-0425 for solid tumors or lymphoma is ongoing.

This molecule is being developed by Genentech as part of an oncology agreement with Array BioPharma.


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MEK Inhibitor (GDC-0623)

Phase I
  • Solid tumors

Description


GDC-0623 (RG7420), 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.


Development Status


A Phase I clinical trial evaluating GDC-0623 for solid tumors is ongoing.


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PI3 Kinase Inhibitor (GDC-0941)

Phase II
  • ER+ metastatic breast cancer
  • Metastatic non-small cell lung cancer
Phase I
  • HER2- metastatic breast cancer
  • HER2+ metastatic breast cancer
  • Metastatic non-small cell lung cancer
  • Solid tumor and non-Hodgkin's Lymphoma

Description


GDC-0941 (RG7321) is a novel, oral, specific Class I PI3 kinase inhibitor. PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival.


Development Status


A Phase II clinical trial evaluating both GDC-0941 and GDC-0980 for hormone receptor-positive metastatic breast cancer, and a Phase II trial evaluating GDC-0941 in combination with Avastin® (bevacizumab) for metastatic non-small cell lung cancer are ongoing.

Phase Ib clinical trials for metastatic breast cancer and metastatic non-small cell lung cancer are ongoing evaluating GDC-0941 in combination with targeted medicines, such as Avastin, Herceptin® (trastuzumab), and Tarceva® (erlotinib); and in combination with an investigational targeted agent, trastuzumab emtansine (T-DM1). Phase I clinical trials evaluating GDC-0941 as a single agent in solid tumor and non- Hodgkin’s lymphoma are ongoing.

This molecule was discovered by Piramed Ltd., which was acquired by F. Hoffmann-La Roche.

For Avastin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.avastin.com.

For Herceptin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.herceptin.com.

For Tarceva full prescribing information, including additional important safety information, please visit http://www.tarceva.com or call 1-877-TARCEVA.


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MEK Inhibitor (GDC-0973)

Phase I
  • Solid tumors
  • Metastatic melanoma

Description


GDC-0973 (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.


Development Status


A Phase Ib clinical trial in combination with Zelboraf® (vemurafenib) for metastatic melanoma; a Phase Ib clinical trial in combination with GDC-0068, an Akt Inhibitor, for solid tumors; and a Phase Ib clinical trial in combination with GDC-0941, a PI3 Kinase Inhibitor, for solid tumors are ongoing. A Phase I clinical trial evaluating GDC-0973 as a single agent in solid tumor is ongoing.

GDC-0973 is being developed in collaboration with Exelixis, Inc. and Zelboraf is being developed in collaboration with Plexxikon, Inc. co-developed under a 2006 license and collaboration agreement between Roche/Genentech and Plexxikon, a member of the Daiichi Sankyo Group.

For Zelboraf full prescribing information, including important safety information, please visit http://www.zelboraf.com.


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PI3 Kinase/mTOR Dual Inhibitor (GDC-0980)

Phase II
  • Endometrial carcinoma
  • ER+ metastatic breast cancer
  • Renal cell carcinoma
Phase I
  • Metastatic breast cancer
  • Prostate cancer
  • Solid tumors

Description


GDC-0980 (RG7422) is novel, oral, dual inhibitor of both mTOR complexes (TORC1 and TORC2) as well as a Class I PI3 Kinase inhibitor. PI3 Kinase is an oncogene that is commonly mutated in cancer. The PI3K/Akt/mTOR pathway regulates cell growth and survival.


Development Status


A Phase II clinical trial evaluating both GDC-0941 and GDC-0980 for hormone receptor-positive metastatic breast cancer, and Phase II clinical trials evaluating GDC-0980 for endometrial carcinoma and renal cell carcinoma are ongoing.

A Phase I/II clinical trial evaluating both GDC-0980 and GDC-0068 for castration-resistant prostate cancer is ongoing. Phase Ib clinical trials for metastatic breast cancer and solid tumors are ongoing evaluating GDC-0980 in combination with targeted medicines, Avastin® (bevacizumab), Herceptin® (trastuzumab), and Xeloda® (capecitabine) are ongoing or planned.

This molecule was discovered jointly by Genentech and Piramed Ltd. under a collaboration agreement. Piramed Ltd. was acquired by F. Hoffmann-La Roche.

For Avastin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.avastin.com .

For Herceptin full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.herceptin.com .

For Xeloda full prescribing information, including Boxed WARNINGS and additional important safety information, please visit http://www.xeloda.com.


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Anti-Factor D Fab

Phase II
  • Geographic atrophy associated with age-related macular degeneration

Description


Anti-Factor D Fab (FCFD4514S, RG7417) 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.


Development Status


A Phase I/II clinical trial evaluating anti-Factor D for geographic atrophy associated with dry age-related macular degeneration is ongoing.


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Anti-IL17 MAb

Phase I
  • Autoimmune disease

Description


Anti-IL17 (MCAF5352A, RG7624) is a fully human monoclonal antibody designed to specifically and selectively bind to the human interleukin-17 family of cytokines.

Development Status


A Phase I clinical trial evaluating anti-IL17 for autoimmune disease is ongoing.

This molecule is being developed in collaboration with NovImmune.

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Anti-LT alpha MAb

Phase II
  • Rheumatoid arthritis

Description


Anti-lymphotoxin alpha (LTa) (MLTA3698A, RG7416) is a humanized monoclonal antibody that binds to and is designed to neutralize the activities of secreted homotrimeric LTa3 and membrane bound heterotrimer LTa1/β2. Anti-LTa can also deplete pathogenic T cells that are implicated in autoimmune diseases.


Development Status


A Phase II clinical trial evaluating Anti-LT alpha for rheumatoid arthritis is ongoing.


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Anti-M1 prime MAb

Phase II
  • Asthma

Description


Anti-M1 prime (MEMP1972A, RG7449) is a humanized monoclonal antibody, targeting the IgE pathway, that binds to the M1 prime segment of membrane IgE. Anti-M1 prime is designed to eliminate the B cells that would develop into plasma cells and produce IgE, rather than binding to and neutralizing existing IgE.


Development Status


Phase II clinical trials evaluating Anti-M1 prime for asthma are ongoing.


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Etrolizumab (rhuMAb Beta7)

Phase II
  • Ulcerative colitis

Description


Etrolizumab (rhuMAb Beta7, 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.


Development Status


A Phase II clinical trial evaluating etrolizumab for ulcerative colitis is ongoing.


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Rontalizumab (Anti-IFN alpha)

Phase II
  • Systemic lupus erythematosus

Description


Rontalizumab (RG7415) is a recombinant humanized monoclonal antibody to interferon alpha, which recognizes and neutralizes IFN alpha subtypes.


Development Status


A Phase II clinical trial evaluating rontalizumab for systemic lupus erythematosus is ongoing.


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Crenezumab (Anti-Abeta)

Phase II
  • Alzheimer's Disease

Description


Crenezumab (Anti-Abeta, MABT5102A, 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.


Development Status


Phase II clinical trials evaluating crenezumab for Alzheimer's Disease are ongoing.

Genentech, the Banner Alzheimer's Institute, and the National Institutes of Health are collaborating on a trial in cognitively healthy individuals who are likely to develop Alzheimer’s disease due to their genetic history. We expect to initiate the trial in early 2013.

This molecule is being developed in collaboration with AC Immune SA.


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Anti-oxLDL

Phase II
  • Secondary prevention of cardiovascular events

Description


Anti-oxLDL (MLDL1278A, RG7418) is a novel full length human IgG1 antibody that is designed to selectively target a specific atherogenic epitope on oxidized LDL (oxLDL). Preclinical studies suggest that there is a strong link between oxLDL and the inflammatory processes that leads to unstable plaque formation in vessel walls.


Development Status


A Phase II clinical trial evaluating anti-oxLDL for secondary prevention of cardiovascular events in patients with acute coronary syndrome is ongoing.

This molecule is being developed in collaboration with BioInvent.


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