On May 05, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported corporate highlights and financial results for the first quarter ended March 31, 2016 (Press release, Genocea Biosciences, MAY 5, 2016, View Source [SID:1234511999]).
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"Our positive GEN-003 Phase 2 12-month efficacy data suggests that annual treatment with GEN-003 may offer genital herpes patients similar benefits to a full year of daily administration of oral antivirals. These data give us confidence in the potential of GEN-003 to become the cornerstone therapy for patients suffering from genital herpes," said Chip Clark, president and chief executive officer of Genocea. "For our recently initiated Phase 2b efficacy trial, we anticipate reporting virologic efficacy data in the third quarter of 2016, which we anticipate will confirm the efficacy of GEN-003 manufactured using improved processes at an increased scale. We expect clinical efficacy data versus placebo against potential Phase 3 endpoints at six months post dosing around the end of 2016 and we expect to conduct our end-of-Phase 2 meeting with the FDA in the first quarter of 2017. We also continue to advance our academic collaborations in the immuno-oncology field and expect to provide further updates in the coming months on our potential path to the clinic in 2017 for a neoantigen-based cancer vaccine."
Recent Business Highlights and Anticipated Milestones
GEN-003 – Immunotherapy for treatment of genital herpes in Phase 2 development. Greater than $1 billion potential revenue opportunity in U.S. alone
• Reported positive 12-month efficacy data from Phase 2 dose optimization trial
• Full data to be presented at an upcoming scientific meeting
In March 2016, Genocea announced positive 12-month efficacy data from its Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. GEN-003 demonstrated statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing as well as sustained efficacy across secondary clinical endpoints, in each case across multiple dose groups. GEN-003 was safe and well tolerated by patients, with no serious adverse events reported related to the vaccine in the trial.
Multiple anticipated 2016 clinical milestones for GEN-003
• Phase 2b virologic efficacy data expected in third quarter of 2016
• Phase 2b 6-month clinical efficacy data expected in late 2016
• End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in Q1 2017
In the third quarter of 2016, Genocea expects to report virologic efficacy data from a Phase 2b trial to confirm the efficacy of GEN-003 manufactured with Phase 3 processes at increased scale. Around the end of 2016, Genocea expects to report 6-month clinical efficacy versus placebo against the potential Phase 3 endpoint of the percentage of patients that are lesion free at 6-months after dosing. Positive data would provide an important step toward the end-of-Phase 2 meeting with the FDA, which is expected to occur in the first quarter of 2017.
This ongoing trial has enrolled approximately 135 subjects across the U.S. who have a history of recurrent genital herpes. Subjects will be randomized to one of three dose groups – placebo, 60µg per protein / 50µg of adjuvant, and 60µg per protein / 75µg of adjuvant – and will be monitored for 12 months.
Genocea also expects to commence a planned Phase 2b antiviral combination study in the second half of 2016. Clinical efficacy data from this trial is expected in the first half of 2017. If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, this would further strengthen GEN-003’s value proposition to patients and physicians.
First Quarter 2016 Financial Results
Cash Position: Cash, cash equivalents and investments as of March 31, 2016 were $95.7 million compared to $106.4 million as of December 31, 2015. Genocea expects that these funds will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of 2017.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2016 decreased $1.2 million, to $7.3 million, from the same period in 2015. The decrease was driven by lower clinical costs due to the completion of the GEN-004 Phase 2a trial, which was ongoing in the first quarter of 2015, and the conduct of a smaller Phase 2 trial for GEN-003 in the first quarter of 2016 compared to the same period in 2015. GEN-003 manufacturing costs also decreased due to the timing of activities in support of clinical trial supply. These lower costs were partially offset by higher personnel and lab-related costs to advance Genocea’s pre-clinical product candidates and develop the ATLAS platform for immuno-oncology.
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2016 were $3.9 million, compared to $3.4 million for the same period in 2015. The increase reflects higher personnel costs, consulting and professional fees, and depreciation expense, all of which support Genocea’s expanding R&D operations.
Refund of Research and Development Expense: A gain of $1.6 million for the quarter ended March 31, 2016 resulted from cash received pursuant to contractual obligations under a collaboration agreement with Isconova AB ("Isconova") (since acquired by Novavax, Inc.) to refund R&D expenses paid by Genocea to Isconova between 2009 and 2011 relating to the development of the Matrix-M2TM adjuvant technology.
Net Loss: Net loss was $9.8 million for the quarter ended March 31, 2016, compared to a net loss of $12.1 million for the same period in 2015.