Novavax Inc. – Genocea Up on Positive GEN-003 Data for Genital Herpes – Analyst Blog

Genocea shares shoot up on promising genital herpes data. In June 2016, Ron Cooper joined the company’s board of directors. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at http://ir.genocea.com. The strengthened balance sheet provides greater flexibility in capital strategy in advance of important clinical milestones and a strong foundation for ongoing business development activities. Over 3.7 billion people under 50 have genital HSV-1 infection, shows WHO report. Needless to say, these data are very encouraging and point to a possible annual treatment regimen for GEN-003, which may offer patients with genital herpes clinical benefits similar to a full year of daily administration of oral antivirus.

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. ATLAS™ profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, enabling the identification of antigen targets which drive protective T cell responses with which to design new vaccines and immunotherapies. Cooper is currently president and chief executive officer of Albireo Ltd. Genocea will be hosting a conference call and webcast today, November 6, 2014, at 9:00 a.m. You can get herpes through direct skin contact with an infected area or from secretions infected with herpes: saliva, vaginal secretions, or semen (including on shared utensils or toothbrushes). Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs.


Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. In his new role at Genocea, Dr. I will begin today’s call be reviewing the recent positive results from our ongoing Phase 2 dose optimization trial for GEN-003, our treatment for genital herpes. Schematic of K1p(−650 to +76) and LBS-deleted K1p(−350 to +76), generated by digesting pGL3BK1p with SmaI to remove the LBS region followed by religation of the remaining vector. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy.

If GEN-003 is additive to the effect of chronic suppressive oral anti-viral therapy, the Company believes this would further strengthen GEN-003’s value proposition to patients and physicians. Seth Hetherington, CMO is also with us today for the Q&A. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. When measured by the presence of pneumococcal DNA, the reductions ranged between 18 and 36 percent. Chlamydia can also cause genitourinary and rectal conditions in men.

GEN-004 showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but neither of the endpoints achieved statistical significance. Subjects were randomized into one of six groups of dosing Either 30 micrograms or 60 micrograms per antigen paired with one of three adjuvant doses (25 micrograms, 50 micrograms, or 75 micrograms). The stock did reach pre market lows of $4.05 meaning that it moved back up $1.25 at the open, or equivalent to 31%. This ongoing trial has enrolled approximately 135 subjects across the U.S. About Genocea Biosciences, Inc. Genocea was hit with a serious setback last fall, when GEN-004, its vaccine for pneumococcal infection, flopped in a mid-stage study.

Jacobs’ live, gD-2-deleted vaccine, the latest publication for that vaccine has shown amazing results in mice. Use this medication at the first signs of a cold sore (such as tingling, burning, redness, or a bump). (Nasdaq:NVAX), a clinical-stage biopharmaceutical company creating novel recombinant nanoparticle vaccines and vaccine adjuvants, today reported that its partner, Genocea Biosciences Inc., announced positive, interim topline data from a Phase 1/2A clinical trial of its lead candidate, GEN-003, a first-in-class investigational protein subunit vaccine for patients with moderate-to-severe herpes simplex virus type 2 (HSV-2) infection.