After 12 months, GEN-003 shows durable reduction in genital lesions
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies against serious infectious diseases, announced today the presentation of final data from the Phase 1/2a study of GEN-003, the company's immunotherapy candidate for treatment of genital herpes. The oral presentation, titled "Therapeutic HSV-2 Vaccine (GEN-003) Results in Durable Reduction in Genital Lesions at 1 Year ", will be given on Saturday, Oct. 11 at IDWeek 2014™ in Philadelphia.
The Phase 1/2a clinical trial was a double-blind, placebo-controlled, dose-escalation study to evaluate the safety and immunogenicity of GEN-003. In addition, the study was designed to demonstrate proof-of-concept that GEN-003 can reduce HSV-2 viral shedding, a measure of viral activity, and the genital lesion rate, the percentage of days during which the subjects experienced visible herpes outbreaks or lesions. Current HSV-2 therapies only partially control clinical symptoms and viral shedding, which drives disease transmission.
During a 28 day observation period 6 months after GEN-003 dosing, subjects who received 30 microgram doses of GEN-003 had a 65% reduction in genital lesion rates compared to baseline (p < 0.001). In addition, during that same period, those subjects experienced a 40% reduction in viral shedding compared to baseline (p < 0.001). Twelve months after the final dose, the mean reduction in the genital lesion rate was 42 percent below baseline for this dose group. Immune responses to the treatment, including T cell, IgG, and neutralizing antibody, remained significantly above baseline at the end of the 12 month follow up.
Study findings also demonstrated that GEN-003 was safe in all three cohorts. The most common side effects were fatigue, muscle aches, tenderness and pain, with the majority being mild or moderate in intensity. There were no serious adverse events related to the vaccine.
The study enrolled 143 subjects with a history of moderate-to-severe recurrent HSV-2 infection at seven clinics in the United States. Patients were sequentially enrolled into one of three dose cohorts (10, 30 or 100 micrograms of each vaccine antigen combined with 50 micrograms of Matrix M adjuvant) and randomized within cohorts to receive either GEN-003, vaccine antigens without adjuvant or placebo. Patients were given three injections of the assigned treatment into an arm muscle at 21 day intervals. Safety, antibody, and T cell responses to GEN-003 were followed and measured for 12 months after the last dose.
Genocea initiated a Phase 2 study to confirm the efficacy of the 30 microgram dose and to test additional dose combinations of GEN-003 in July 2014.
Data will be presented at IDWeek 2014™ on Saturday, October 11, 2014 at 11:00 a.m. EDT in The Pennsylvania Convention Center, room 109-AB. Anna Wald, MD, MPH from the University of Washington, the principal investigator for the clinical trial, will present the findings.
GEN-003 is a first-in-class T cell-directed immunotherapy intended to reduce the transmission risk and clinical symptoms of genital herpes. GEN-003 was designed with insights from Genocea's ATLAS™ platform. 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.
For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-hsv-2/.
About Genital Herpes
Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide. In the United States roughly 16 percent of the adult population, or 40 million people, are infected. HSV-2 causes recurrent, painful genital lesions and can be transmitted to sexual partners, even when the disease is asymptomatic. HSV-2 infection can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth.
Current HSV-2 therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Many patients continue to experience frequent outbreaks of genital lesions and there is neither a cure nor a vaccine for this disease.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea's pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for HSV-2 therapy, GEN-004 to prevent infections caused by pneumococcus, and earlier-stage programs in chlamydia, HSV-2 prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company's website at www.genocea.com.
About IDWeek 2014™
IDWeek 2014™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). With the theme "Advancing Science, Improving Care," IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2014 takes place October 8-12 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The full name of the meeting is IDWeek 2014™. For more information, visit www.idweek.org.
Forward Looking Statements
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. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea's ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Genocea's ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under "Risk Factors" in Genocea's Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and other filings with the Securities and Exchange Commission (the "SEC"). Further information on the factors and risks that could affect Genocea's business, financial conditions and results of operations is contained in Genocea's filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.
Source: Genocea Biosciences, Inc.