Genocea Biosciences Inc. (NASDAQ: GNCA) shares skyrocketed 101% before the opening bell Monday, after the biopharmaceutical firm announced positive results from its ongoing Phase 1/2 clinical trial for GEN-009 – its lead neoantigen drug candidate.
GEN-009 is a personalized cancer vaccine that uses neoantigens (antigens corresponding to tumor mutations that the immune system of a patient sees as foreign to the body) to enable the immune system to trace and kill tumors.
In five patients for whom immune response results are currently available, the vaccine elicited T-cell responses to 91 percent of the vaccine neoantigens given to the patients, Genocea said.
Genocea is running an early-stage trial to evaluate the efficacy and safety of the vaccine. According to the company, immune-response data is available for five patients and the therapy induced T-cell responses to 91 percent of the vaccine neoantigens administered.
“I believe these data could represent a breakthrough in the development of neoantigen vaccines,” said Roger B. Cohen the principal investigator in Genocea’s ongoing GEN-009 clinical trial. “The Genocea data indicate that using the patients’ own T cells and antigen-presenting cells to select vaccine neoantigens results in higher immunogenicity than previously reported results using in silico methods.”
Genocea also said that 47 percent of the neoantigens elicited ex vivo CD8+ T-cell responses. Shares of the Cambridge, Massachusetts-based company have risen more than 300% since the beginning of the year. The stock was up more than 61.68% to $9.07 as of 11:20 a.m. ET on Monday.
Genocea Biosciences CEO Comments
“These data clearly differentiate ATLAS, our neoantigen discovery platform, from first-generation, machine-based approaches. As we continue to say, “targets matter,” and these data highlight the necessity of selecting the right neoantigens to drive immune responses in cancer patients,” commented Chip Clark, Genocea’s President & Chief Executive Officer.
“We believe that ATLAS holds the potential to benefit the clinical efficacy of both GEN-009 and GEN-011, our neoantigen-specific T cell therapy program, and to enable additional immunotherapy modalities.”
Genocea Biosciences Inc Profile
Genocea Biosciences Inc is a US-based biopharmaceutical company which is engaged in developing novel vaccines and immunotherapies to address diseases with significant unmet needs.
Its product candidate includes GEN-003 which is an immunotherapy for the treatment of genital herpes as well as it owns pre-clinical immuno-oncology program focused on personalized cancer vaccines.
The company focuses on developing vaccines and immunotherapies for unmet needs through its AnTigen Lead Acquisition System, which is used to design vaccines and immunotherapies. Genocea operates its business through the single segment being Developing and Commercializing vaccines.