EMERYVILLE, CA, USA & NEW YORK, NY, USA I July 19, 2018 I Bristol-Myers Squibb Company (NYSE: BMY) and Gritstone Oncology today announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-based vector (prime) and a self-replicating RNA-based vector (boost), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
The two-part Phase 1 dose escalation trial, which is anticipated to be initiated before the end of 2018, will evaluate the combination of GRANITE-001 with systemic Opdivo, and a localized subcutaneous injection of Yervoy. Subcutaneous administration of Yervoy is intended to maximize delivery of drug to the immunotherapy-draining lymph node.
“The emergence of immunotherapies in the last decade has transformed the way we think about treating cancer, yet there remains a need for new therapies, which can initiate immune system recognition of tumors,” said Andrew Allen, Ph.D., president and chief executive officer, Gritstone Oncology. “We have developed our programs using insights from our proprietary tumor antigen discovery platform, EDGE™, together with an immunotherapy platform which has demonstrated the ability to elicit an enhanced antigen-directed T-cell response in preclinical primate models. We are excited to work closely with the experienced Bristol-Myers Squibb team to advance this novel combination approach into clinical trials.”
“Our innovative approach to translational medicine capabilities is fueled by the exploration of novel combinations of new assets with our oncology portfolio,” said Fouad Namouni, M.D., head of development, oncology, Bristol-Myers Squibb. “We look forward to working with the experienced Gritstone team and their neoantigen immunotherapy to gain a deeper understanding of the role of neoantigens as part of immunotherapy as we look to improve outcomes for patients with advanced cancer.”
Gritstone Oncology is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
About GRANITE-001
GRANITE-001 is Gritstone Oncology’s lead, personalized tumor-specific immunotherapy product candidate. It is engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T-cells) against mutation-derived tumor-specific neoantigens, or TSNA, identified for each patient through the company’s proprietary EDGE™ machine learning-based platform. GRANITE-001 consists of two components, first a priming adenoviral vector followed by monthly boosting with an RNA vector, each containing the same 20 patient-specific TSNA. GRANITE-001 will first be evaluated in combination with immune checkpoint blockade, for the treatment of patients with common solid tumors, including metastatic non-small cell lung cancer and gastroesophageal, bladder and colorectal cancers. Gritstone plans to initiate the Phase 1 trial before the end of 2018.
U.S. FDA-APPROVED INDICATIONS FOR OPDIVO
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor-risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Gritstone Oncology
Gritstone Oncology is developing tumor-specific cancer immunotherapies to fight multiple cancer types. The company has built its approach on two key pillars—a proprietary machine learning-based platform, Gritstone EDGE™, which provides the powerful ability to predict tumor-specific neoantigens, or TSNA, that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing a patient’s unique TSNA to drive the immune system to attack and destroy tumors. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing from Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments and Bay City Capital. More information can be found at www.gritstoneoncology.com or @gritstoneonc.
SOURCE: Gritstone Oncology
Post Views: 36
EMERYVILLE, CA, USA & NEW YORK, NY, USA I July 19, 2018 I Bristol-Myers Squibb Company (NYSE: BMY) and Gritstone Oncology today announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-based vector (prime) and a self-replicating RNA-based vector (boost), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
The two-part Phase 1 dose escalation trial, which is anticipated to be initiated before the end of 2018, will evaluate the combination of GRANITE-001 with systemic Opdivo, and a localized subcutaneous injection of Yervoy. Subcutaneous administration of Yervoy is intended to maximize delivery of drug to the immunotherapy-draining lymph node.
“The emergence of immunotherapies in the last decade has transformed the way we think about treating cancer, yet there remains a need for new therapies, which can initiate immune system recognition of tumors,” said Andrew Allen, Ph.D., president and chief executive officer, Gritstone Oncology. “We have developed our programs using insights from our proprietary tumor antigen discovery platform, EDGE™, together with an immunotherapy platform which has demonstrated the ability to elicit an enhanced antigen-directed T-cell response in preclinical primate models. We are excited to work closely with the experienced Bristol-Myers Squibb team to advance this novel combination approach into clinical trials.”
“Our innovative approach to translational medicine capabilities is fueled by the exploration of novel combinations of new assets with our oncology portfolio,” said Fouad Namouni, M.D., head of development, oncology, Bristol-Myers Squibb. “We look forward to working with the experienced Gritstone team and their neoantigen immunotherapy to gain a deeper understanding of the role of neoantigens as part of immunotherapy as we look to improve outcomes for patients with advanced cancer.”
Gritstone Oncology is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.
About Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
About Yervoy
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.
About GRANITE-001
GRANITE-001 is Gritstone Oncology’s lead, personalized tumor-specific immunotherapy product candidate. It is engineered to elicit a significant T-cell response (particularly CD8+ cytotoxic T-cells) against mutation-derived tumor-specific neoantigens, or TSNA, identified for each patient through the company’s proprietary EDGE™ machine learning-based platform. GRANITE-001 consists of two components, first a priming adenoviral vector followed by monthly boosting with an RNA vector, each containing the same 20 patient-specific TSNA. GRANITE-001 will first be evaluated in combination with immune checkpoint blockade, for the treatment of patients with common solid tumors, including metastatic non-small cell lung cancer and gastroesophageal, bladder and colorectal cancers. Gritstone plans to initiate the Phase 1 trial before the end of 2018.
U.S. FDA-APPROVED INDICATIONS FOR OPDIVO
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor-risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
About Gritstone Oncology
Gritstone Oncology is developing tumor-specific cancer immunotherapies to fight multiple cancer types. The company has built its approach on two key pillars—a proprietary machine learning-based platform, Gritstone EDGE™, which provides the powerful ability to predict tumor-specific neoantigens, or TSNA, that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing a patient’s unique TSNA to drive the immune system to attack and destroy tumors. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing from Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, RedMile, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments and Bay City Capital. More information can be found at www.gritstoneoncology.com or @gritstoneonc.
SOURCE: Gritstone Oncology
Post Views: 36
