On December 14, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies reported that it held its first R&D day for investors and analysts today (Press release, Genocea Biosciences, DEC 14, 2016, View Source [SID1234517075]). The company highlighted its lead program, GEN-003, a T cell-directed immunotherapy for the treatment of genital herpes infections for which six-month Phase 2b placebo-controlled clinical efficacy is expected in January 2017. The Company also introduced its immuno-oncology strategy, including its plans to file an IND for a neoantigen cancer vaccine in 2017 and announced new research collaborations with Checkmate Pharmaceuticals, Inc. (Checkmate) and US Oncology Research.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Genocea is a leader in the development of innovative therapies at the forefront of the T cell revolution with GEN-003 for genital herpes and our emerging work in immuno-oncology," said Chip Clark, president and chief executive officer of Genocea. "We believe that ATLASTM, our T cell antigen discovery platform, that is the basis of our clinical success to date in infectious diseases, is ideally suited to advance the understanding of the role T cells play in killing cancer. Our confidence in our immuno-oncology programs is strengthened by the collaborations we announced today, which reflect broad interest in our unique ability to comprehensively profile a person’s actual T cell responses to cancer."
GEN-003 Program Highlights
Today, Genocea highlighted the significant body of clinical data it has generated over the course of three clinical trials for what may be the first new therapy for genital herpes in more than 20 years. GEN-003 is a first-in-class T cell-directed immunotherapy designed to elicit both a T cell and B cell immune response to antigens prioritized using the ATLAS platform. Genocea’s ATLAS platform profiled the comprehensive spectrum of actual T cell responses mounted by humans in response to their genital herpes disease to identify the antigen targets that drove protective T cell responses.
Based on clinical data to date, as well as market research showing the significant dissatisfaction among patients with current treatment options for genital herpes, GEN-003 may offer patients an important new treatment option with the promise of improved ‘real-world’ clinical outcomes and sustained reductions in viral shedding with the convenience of annual maintenance dosing. The Company expects to report six-month clinical efficacy data from its ongoing Phase 2b placebo-controlled trial in January 2017.
Guest speaker Nicholas Van Wagoner, M.D., Ph.D., Assistant Professor, Division of Infectious Diseases at the University of Alabama, Birmingham , School of Medicine provided an overview of the disease and reviewed the current treatment approach for genital herpes and affirmed his belief that a product with the profile of GEN-003 could create a much-needed additional treatment option for patients and physicians.
Genocea also today for the first time presented the results of extensive new market research based on GEN-003’s demonstrated clinical profile, suggesting that patients, physicians and payers all view GEN-003 favorably. Mr. Clark presented data demonstrating the Company’s belief that GEN-003 could have upwards of $2 billion global revenue potential if successfully developed worldwide.
Immuno-Oncology Program Highlights
Guest speaker Charles G. Drake, M.D., Ph.D., Director of GU Medical Oncology, Co-Director: Immunotherapy Program, Associate Director for Clinical Research, and Professor of Oncology and Immunology at the Herbert Irving Cancer Center at Columbia University, provided an overview of immunotherapy in cancer. His presentation reviewed the progress made in treating cancer with checkpoint inhibitors and the opportunity to further improve clinical outcomes, including through a better understanding of which patients will benefit from existing therapies and combining checkpoint inhibitors with cancer vaccines.
A Genocea presentation followed, introducing its immuno-oncology strategy and highlighting the unique ability of its ATLAS platform to comprehensively elucidate the T cell responses that patients make to cancers.
This capability is currently being applied to profiling T cell responses of patients who are treated with checkpoint inhibitors and other immune modulators, with the goal of finding signatures of T cell response that associate with positive and negative outcomes. Genocea plans to use these insights to help prospectively define, in a commercial or clinical setting, patients who could benefit from these therapies.
Genocea is also advancing a personalized neoantigen cancer vaccine program toward the filing of an Investigational New Drug (IND) application in 2017. This program leverages Genocea’s deep vaccinology experience along with ATLAS’s differentiated ability to select vaccine antigens based on an individual’s comprehensive T cell responses to the mutations in their own cancer. The company believes that ATLAS overcomes the weaknesses of conventional algorithm approaches to cancer antigen selection, which have significant false positive prediction rates.
The company also updated progress on the development of a vaccine for cancers associated with Epstein Barr Virus (EBV). ATLAS screening has already identified novel T cell antigens, including those which appear to be associated with natural immunity against EBV infection and antigen selection and prioritization is ongoing.
Collaboration with Checkmate Pharmaceuticals, Inc.
This morning, the Company announced a research collaboration with Checkmate to characterize patterns of T cell responses to tumor-associated antigens in advanced melanoma. The goal of the collaboration is to identify the specificity and characteristics of T cells associated with protective T cell responses to potentially optimize clinical development and ultimately, clinical practice with CMP-001. ATLAS will be used to profile the T cell responses of approximately 20 patients enrolled in Checkmate’s ongoing Phase 1b clinical trial of CMP-001 in combination with the checkpoint inhibitor pembrolizumab to a library of tumor-associated antigens common to patients with advanced melanoma. The T cell response signatures of those patients who respond to CMP-001 / pembrolizumab combination therapy will be compared to the signatures of those who do not respond, thereby potentially identifying antigens associated with positive or negative patient outcomes.
Collaboration with US Oncology Research
Genocea also announced this morning a new collaboration with US Oncology Research, one of the USA’s largest research programs specializing in oncology clinical trials, to screen the T cell responses of cancer patients with solid tumors who will be treated with checkpoint inhibitors against the complete repertoire of patient-specific putative cancer neoantigens. The objective of the collaboration is to use ATLAS to further Genocea’s expertise in identifying signatures of T cell responses in cancer patients and to discover new T cell cancer vaccine antigens.
R&D Day Replay
A replay of the R&D day can be accessed at: View Source
About ATLAS
ATLAS is a first of its kind proprietary rapid antigen identification screening system designed to find targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or cancer in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.