Genocea Biosciences
GENOCEA BIOSCIENCES, INC. (Form: 8-K, Received: 01/05/2017 06:37:25)


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 5, 2017

GENOCEA BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)

Delaware
 

001-36289
 

51-0596811
(State or other jurisdiction of
incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)

Cambridge Discovery Park
100 Acorn Park Drive, 5th Floor
 
 
Cambridge, MA
 
02140
(Address of principal executive offices)
 
(Zip Code)
(Registrant’s telephone number, including area code): (617) 876-8191

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))





Item 7.01. Regulation FD Disclosure.

On January 5, 2017, Genocea Biosciences, Inc. (the “Company”) issued a press release announcing positive clinical results from the Company’s planned interim analysis of its ongoing placebo-controlled Phase 2b trial evaluating a new Phase-3 ready formulation of GEN-003 for the treatment of genital herpes. A copy of the press release, dated January 5, 2017, is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

On January 5, 2017, the Company will give a presentation to certain investors regarding the positive clinical results for the six-month post-dosing period of the Company’s Phase 2b trial evaluating a new Phase-3 ready formulation of GEN-003 for the treatment of genital herpes.  A copy of the presentation is attached to this Current Report on Form 8-K as Exhibit 99.2 and is incorporated herein by reference.  The presentation is also available on the Company’s website, www.genocea.com, however the Company’s website and any information contained on the website are not incorporated herein.

The information contained in this Item 7.01 of this Current Report on Form 8-K, including the exhibits attached hereto, is being furnished and shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.

Item 9.01 Financial Statements and Exhibits.

See Exhibit Index attached hereto.


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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 

GENOCEA BIOSCIENCES, INC.
 
 
 
 
By:
/s/ Jonathan Poole
 
 
Jonathan Poole
Chief Financial Officer
Date: January 5, 2017



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EXHIBIT INDEX
Exhibit No.
 
Description
 
 
 
99.1
 
Press Release issued by Genocea Biosciences, Inc. on January 5, 2017
99.2
 
Investor Presentation dated January 5, 2017


4
Exhibit 99.1


GNCALOGOA04.JPG

Genocea Announces Positive 6-Month Results from GEN-003
Phase 2b Clinical Trial

- Trial meets statistical significance vs. placebo for multiple clinical endpoints through six months -

- End of Phase 2 meeting with FDA expected in Q1 2017 -
 
- Phase 3 launch expected in Q4 2017 -

- GEN-003 has potential to be first new treatment for genital herpes infections in more than 20 years -

- Company to host conference call at 9 a.m. ET today -

CAMBRIDGE, Mass., January 5, 2017 --(GLOBE NEWSWIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive clinical results from a planned interim analysis of its ongoing placebo-controlled Phase 2b trial evaluating GEN-003 for the treatment of genital herpes infections. Even in a trial this small, at six months after dosing, GEN-003 demonstrated statistically significant improvements versus placebo across multiple clinical endpoints.
The 60 µg per antigen / 50 µg of adjuvant dose of GEN-003 significantly reduced the rate of genital lesions during the six months following dosing compared to placebo (4.5 percent of days vs. 7.9 percent, respectively; 41% reduction vs. placebo, p<0.05). The genital lesion rate is an important overall measure of disease that captures both the frequency and duration of recurrences, both of which are important to both patients and their caregivers. In the trial, GEN-003 also consistently demonstrated significant benefits versus placebo across several other clinical endpoints across the dose groups (see data summary below).
In aggregate, the data from the GEN-003 Phase 2 clinical trials continue to support the selection of the 60 µg per antigen / 50 µg of adjuvant dose for the planned Phase 3 program. GEN-003 also continues to demonstrate a safety profile appropriate for its therapeutic setting in the judgment of the trial’s independent Drug Monitoring Committee.
“We are very pleased to have demonstrated such a powerful impact on genital herpes clinical disease in this trial, supporting the groundbreaking potential of GEN-003 to be the first-ever therapeutic vaccine for a chronic infection and the first advance in the treatment of genital herpes in more than 20 years,” said Chip Clark, president and chief executive officer of Genocea. “We look forward to meeting with the FDA in the first quarter of 2017 and to commencing our GEN-003 Phase 3 program in the fourth quarter of 2017. It’s an exciting time for Genocea as we also continue to extend the potential of our ATLAS platform to harness the power of T cells in immuno-oncology.”
“In my experience, genital herpes is unique among sexually transmitted diseases, in terms of its physical and emotional impact on patients, who experience significant fear upon receiving the diagnosis, as well as isolation during their lifelong struggle with the disease,” said Nicholas Van Wagoner, M.D., Ph.D., Assistant Professor of Medicine, Division of Infectious Diseases, at the University of Alabama at Birmingham. “Today’s results, showing that GEN-003 significantly reduces the number of days with genital lesions, indicates that GEN-003 has the potential to be a much needed additional treatment option that could address compliance challenges and help me take better care of my patients.”





Summary of Reported Clinical Endpoint Data
Secondary clinical endpoint
Placebo
(n=44)
60/50
(n=43)
60/75
(n=44)
Mean genital lesion rate (percent of days with lesions over 6 months)
7.9%
4.5%
4.6%
  p-value versus placebo (1)
NA
0.03
0.03
Mean duration of recurrences (days)
4.8
3.3
4.3
  p-value versus placebo (1)
NA
0.01
0.64
Mean number of recurrences over 6 months
2.7
2.1
1.9
  p-value versus placebo (1)
NA
0.08
0.02
Kaplan-Meier estimate of percent recurrence free after first dose
10%
29%
31%
  p-value versus placebo (2)
NA
0.03
0.03
Kaplan-Meier estimate of percent recurrence free after last dose
13%
22%
36%
  p-value versus placebo (2)
NA
0.17
0.02

Statistical tests pre-specified in Phase 2b trial protocol as follows:
(1) Wilcoxon Rank Sum test
(2) Log rank test

About the GEN-003 Phase 2b Clinical Trial
This Phase 2b trial is the first study testing potential Phase 3 endpoints with the improved formulation of GEN-003 - manufactured with commercially-scalable processes - that will be used in future Phase 3 trials. The trial enrolled 131 subjects from 9 institutions in the United States. Subjects have been randomized to one of three dose groups - placebo, 60 µg per antigen / 50 µg of adjuvant and 60 µg per antigen / 75 µg of adjuvant - and have received three injections at 21-day intervals. All subjects will be followed for 12 months after the last dose.

In September 2016, Genocea reported that the trial achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction of 40 percent in the rate of viral shedding in the 60 µg per antigen/ 50 µg of adjuvant dose group compared to both baseline and placebo. Safety in the trial is continuously reviewed by an independent Drug Monitoring Committee. There has been no grade 4 reactogenicity or related serious adverse events in this trial and discontinuations due to adverse events have been low and similarly distributed across active dose groups and placebo. 12-month clinical data from the trial is expected in the middle of 2017.

For more information about this GEN-003 clinical study, visit www.clinicaltrials.gov .

Conference Call
Genocea management will host a conference call and webcast today at 9 a.m. ET to review these data. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 44780200). 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 . A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

About GEN-003
Inducing a T cell response against genital herpes is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T cell-directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea's ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease and identifies antigen targets that drive effective T cell responses. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M TM  adjuvant (licensed from Novavax, Inc. (NASDAQ:NVAX)). For more information about GEN-003, please visit the GEN-003 section of our website .

About Genital Herpes
Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. 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. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.

About Genocea
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 immunity. Using ATLAS TM , its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline includes GEN-003, a novel T cell-enabled immunotherapy for genital herpes currently in Phase 2 clinical development, and earlier-stage investments in immuno-oncology. For more information, please visit the company's website at www.genocea.com .

About Matrix-M
Matrix-M™ is a next-generation, patented saponin-based adjuvant comprised of purified saponin fractions mixed with synthetic cholesterol and a phospholipid to form stable particles than can be readily formulated with a variety of vaccine antigens. Saponin-based adjuvants act in part by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the local lymph nodes. Thus, Matrix-M™ induces both a cell-mediated and antibody mediated immune response. Matrix-M is manufactured by Novavax, Inc (NASDAQ:NVAX), in Uppsala Sweden.

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 ability of ATLAS to identify promising oncology vaccine and immunotherapy product candidates; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and 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; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea's 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; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea's 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, 2015 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.

For media:
 
For investors:
Liz Bryan
 
Jonathan Poole
Spectrum Science Communications
 
Genocea Biosciences
O: 202-955-6222
 
O: 617-876-8191
lbryan@spectrumscience.com
 
jonathan.poole@genocea.com





Positive 6 Month Clinical Efficacy Results GEN-003 Immunotherapy Candidate for Genital Herpes Phase 2b Study 5 January 2017 Exhibit 99.2


 
This presentation contains “forward-looking” statements that are within the meaning of federal securities laws and are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward- looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that may materially affect our results of operations include, among other things, those listed in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission (“SEC”). Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. You may get copies of our Annual Report on Form 10-K, Quarterly Report on Form 10-Q and our other SEC filings for free by visiting EDGAR on the SEC website at http://www.sec.gov. 2 Safe Harbor Statement


 
Successful Phase 2b Clinical Results – Advancing Potential Blockbuster to Phase 3 • Statistically significant improvements in clinical disease versus placebo across multiple endpoints 6 months post-dosing • Compelling profile cemented across three clinical studies – Durable impact on clinical disease – Significant reduction in viral shedding – At most once-yearly maintenance dosing – Safety profile appropriate for therapeutic setting • Important critical path milestones imminent – End-of-phase 2 meeting with the FDA: Q1 – Phase 3 start: Q4 • If approved, would be the first new treatment for genital herpes infections in more than 20 years • Large unmet patient need in a disease of epidemic proportions – Potential ~$2 billion global revenue opportunity* 3 *Source: Genocea market research


 
4 Millions Infected with Genital Herpes Need a New Treatment Option •Most patients do not persist – Loathe “daily reminder” – Incomplete efficacy • Little benefit – No impact on recurrence frequency – Small reduction in duration 2.6 5.2 4.4 Suppressive (Daily antiviral use) Episodic (Use antivirals upon recurrences) •No benefits GEN-003 Target Profile • No pill burden • Similar disease control • Potential additive effect as combo • Reduce clinical disease: • Total lesion days • Recurrence number • Recurrence duration • Reduce viral shedding • Minimize treatment burden * Millions of US patients Diagnosed, untreated Benefits from Antivirals Today Source: Genocea market research Treatment Distribution*


 
6 Month Clinical Readout GEN-003 Phase 2b Trial 5


 
• Overall goal – Evaluate Phase 3-ready formulation of GEN-003 and define dose for Phase 3 trials • Primary objective (completed successfully in September 2016(1)) – Compare efficacy of two dose levels of GEN-003 and placebo by impact on viral shedding • Secondary objectives – Evaluate impact on clinical disease vs. placebo at 6 and 12 months – Evaluate impact on viral shedding vs. placebo at 6 and 12 months – Immunogenicity – Safety and tolerability 6 Goals & Objectives Note (1) Press release - http://ir.genocea.com/releasedetail.cfm?ReleaseID=991389


 
• Randomized, double-blind, placebo-controlled • 131 subjects with a history of recurrent genital herpes • 3 dose groups – Placebo (n=44) – 60 µg per antigen / 50 µg of Matrix-M adjuvant (n=43) – 60 µg per antigen / 75 µg of Matrix-M adjuvant (n=44) • Most other design elements consistent with prior GEN-003 trials – Inclusion / exclusion criteria, demographics, sites, dose regimen, viral shedding swabbing compliance 7 Study Design


 
• Phase 2b – more comprehensive – Lesion data collected daily throughout trial – Data recorded via smartphone- based app with reminders • Previous GEN-003 studies – Lesion data only during 28-day observation periods • Pre-treatment • Immediately post-treatment • 6 & 12 months post-treatment – Data recorded via paper diary based on recall 8 Improved Lesion Data Collection Strengthens GEN-003 Clinical Endpoints Assessment • Capture data on additional clinical endpoints: – Number of recurrences – Duration of recurrences • Enables Phase 3-like analysis across doses after treatment, rather than versus baseline Analytical Enhancements


 
Wilcoxon Rank Sum test vs. placebo * p<0.05 605 354 374 41% 38% Total days with lesions(2) % reduction vs. placebo * * Notes (1) Days with lesions divided by total days (2) For dose group as a whole during 6 month period • Significant efficacy vs. placebo • Endpoint captures durable impact on clinical disease 9 GEN-003 Significantly Reduces Genital Lesion Rate vs. Placebo Mean Genital Lesion Rates(1) Post Treatment Over 6 Months After Last Dose * *


 
10 GEN-003 Significantly Reduces both the Number and Duration of Recurrences Versus Placebo Mean Number of Recurrences Over 6 Months Following Last Dose Mean Duration of Recurrences Over 6 Months Following Last Dose • Reducing the frequency and duration of recurrences is important to both patients and their caregivers Wilcoxon Rank Sum test vs. placebo * p<0.05 * *


 
11 GEN-003 Drives Significant Improvement in Number of Subjects Recurrence Free at 6 Months Kaplan-Meier Estimate of % Subjects Recurrence Free at 6 Months • GEN-003 patients 2-3 times more likely to be completely recurrence- free than placebo at 6 months • GEN-003 efficacy consistent with Phase 2 clinical trial Log rank test vs. placebo * p<0.05 * * *


 
• Statistically significant improvements in clinical disease versus placebo across multiple endpoints 6 months post-dosing • Significant reductions in viral shedding • Prioritizing 60 µg per antigen / 50 µg adjuvant based on clinical & virologic efficacy and tolerability • Finalizing Phase 3 program preparations with FDA in Q1 12 Positive GEN-003 Phase 2b Results Provide Strong Foundation for Phase 3


 
13 Phase 2b Clinical Efficacy Data Maintains Momentum to Phase 3 Start 2017 12 month FDA EoP2 Phase 2b Phase 3 Program Regulatory Phase 2b maintenance dosing Phase 2 extension 24 month Antiviral combination • Could GEN-003 be dosed every 2 years? • Introduced improved process material • Demonstrated clinical, virologic efficacy • Safety and efficacy of maintenance dosing • Pending Ph 2 extension • Safety and benefits of GEN-003 with daily antivirals 6 month


 
• Large unmet patient need in a disease of epidemic proportions – Potential ~$2 billion global revenue opportunity* • 3 successful clinical trials to date – Clinical efficacy demonstrated against multiple endpoints reflecting patient unmet need – Durable for at least 1 year; annual maintenance dose possible – Comprehensive dose exploration; consistent efficacy at selected dose – Safety profile appropriate for therapeutic setting • Multiple planned upcoming milestones – Q1: End of Phase 2 meeting – H2: 24-month Phase 2 data & 12-month Phase 2b data & combination study – Q4: Start Phase 3 trials • Exploring global development and commercialization partner(s) 14 GEN-003: Phase 3-Ready Program with Blockbuster Potential *Source: Genocea market research


 
Q&A 15


 
Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 jonathan.poole@genocea.com Liz Bryan Spectrum Science Communications Phone: +1 202-587-2526 lbryan@spectrumscience.com Investor inquiries: Media inquiries: