Genocea Biosciences
GENOCEA BIOSCIENCES, INC. (Form: 8-K, Received: 07/24/2017 07:05:35)



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): July 24, 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (230.405 of this chapter) or Rule 12b-2of the Securities Exchange Act of 1934 (§ 240 12b-2 of this chapter).

Emerging Growth Company x

If an emerging growth company, indicate by a check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x











Item 7.01. Regulation FD Disclosure.

On July 24, 2017, Genocea Biosciences, Inc. (the “Company”) issued a press release announcing positive clinical results from the Company’s planned analysis of data collected twelve months after dosing in its placebo-controlled Phase 2b trial of GEN-003 for the treatment of genital herpes. A copy of the press release, dated July 24, 2017, is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

On July 24, 2017, the Company will give a presentation to investors regarding the positive clinical results for the twelve-month analysis of the Company’s Phase 2b trial 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.








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: July 24, 2017






EXHIBIT INDEX
Exhibit No.
 
Description
 
 
 
99.1
 
Press Release issued by Genocea Biosciences, Inc. on July 24, 2017
99.2
 
Investor Presentation dated July 24, 2017



EXHIBIT 99.1

GNCALOGOA04.JPG

Genocea Reports Positive Top-Line 12-Month Phase 2b Data for
GEN-003 in Genital Herpes

- Statistically significant result on expected Phase 3 primary endpoint with Phase 3 dose -
- Positive results on multiple secondary clinical endpoints -
- Potentially the first new treatment in more than 20 years for the millions infected with genital herpes -
- Conference call today at 8 a.m. ET -

CAMBRIDGE, Mass., July 24, 2017 - Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing novel vaccines and immunotherapies targeting T cell antigens, announced today positive 12-month top-line data from the Phase 2b clinical trial for GEN-003, its immunotherapy candidate for patients with genital herpes.

In this 131-subject Phase 2b clinical trial, GEN-003 reduced the median genital lesion rate (or percent days with genital lesions) versus placebo by 49 percent (p=0.01) over the 12 months’ post dosing at the 60 µg per antigen / 50 µg of adjuvant dose. Importantly, these results were achieved at the Phase 3 dose and expected Phase 3 primary endpoint. Other clinical endpoints for this dose improved or were consistent with previously reported positive data. No changes were observed to the previously established safety profile of GEN-003.

Chip Clark, President and CEO of Genocea, commented: “We believe these data further solidify the strong clinical profile for GEN-003, which could provide durable, convenient efficacy to a large and, we believe, highly dissatisfied patient population and serve as a cornerstone treatment of this burdensome disease.”

“These data and the continued progress of GEN-003 show the potential of this immunotherapy to change the treatment paradigm for patients with genital herpes infections,” said Jonathan Temte, M.D., Ph.D., M.S., former chair of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). “The benefits of using a periodic immunization to achieve fewer and shorter genital herpes outbreaks without the compliance challenges of a daily pill burden would represent an extremely important alternative for patients with genital herpes. I believe the potential individual and societal benefits of a treatment such as GEN-003 to address the uncontrolled growth in genital herpes infections resonates with the goals of bodies such as the ACIP.”

Conference Call
Genocea management will host a conference call and webcast today at 8 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 60267894). 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 the GEN-003 Phase 2b Clinical Trial
The Phase 2b trial (GEN-003-003) was a randomized, double-blind, placebo-controlled study evaluating potential Phase 3 endpoints with a formulation of GEN-003 manufactured with commercially-scalable processes and expected to be used in future Phase 3 trials. The trial enrolled 131 subjects from 9 institutions in the United States. Subjects were 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 received three injections at 21-day intervals. Subjects were followed for 12 months after the last dose was administered.

In September 2016, Genocea reported that the trial achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction in the rate of viral shedding in the 60 µg per antigen / 50 µg of adjuvant dose group compared to both baseline and placebo. In January 2017, the company reported that the 60 µg per antigen / 50 µg of adjuvant dose of GEN-003 significantly reduced the median genital lesion rate during the six months following dosing compared to placebo. Safety in the trial is continuously reviewed by an independent Drug Monitoring

1


Committee. Throughout the trial, there have been no drug-related serious adverse events or grade 4 reactogenicity and discontinuations due to adverse events have been low and similarly distributed across active dose groups and placebo. A 12-month extension of this study (GEN-003-005) is currently underway to examine the safety, efficacy and durability of a single maintenance dose administered at 12 months after initial dosing.

Summary of Reported 12 Month Data

Endpoint
60/50
(n=43)
60/75
(n=44)
Placebo
(n=44)
Number of subjects contributing clinical data
43
44
44
Median genital lesion rate (percent of days with lesions over 12 months)
2.3%
2.8%
4.5%
  Percent reduction versus placebo
-49%
-37%
NA
  p-value versus placebo (1)
0.01
NS
NA
Median number of recurrences over 12 months
1.5
2.0
4.0
  Percent reduction versus placebo
-63%
-50%
NA
  p-value versus placebo (1)
0.01
NS
NA
Median duration of recurrences (days)
2.7
4.0
3.6
  Percent reduction versus placebo
-25%
11%
NA
  p-value versus placebo (1)
0.02
NS
NA
Kaplan-Meier estimate of percent recurrence free after first dose
20%
16%
7%
  p-value versus placebo (2)
0.04
NS
NA
Kaplan-Meier estimate of percent recurrence free after last dose
20%
17%
8%
  p-value versus placebo (2)
NS
0.05
NA
Number of subjects contributing shedding data
30
32
31
Viral shedding rate reduction from baseline
-42%
-39%
-52%
  p-value versus baseline (3)
0.02
NS
0.03
  p-value versus placebo (3)
NS
NS
NA

Statistical tests pre-specified in Phase 2b trial protocol as follows:
(1) Wilcoxon Rank Sum test
(2) Log rank test
(3) Poisson mixed effect model with empirical variance
NS = p>0.05

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 investigational 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™ adjuvant (licensed from Novavax, Inc. (NASDAQ:NVAX)). For more information about GEN-003, please visit the GEN-003 section of the Genocea 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.


2


About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has successfully developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea used ATLAS to identify the antigens in its lead clinical candidate, GEN-003, an investigational immunotherapy to treat genital herpes, and is currently using ATLAS in immuno-oncology applications to develop neoantigen cancer vaccines (with an IND filing expected by the end of 2017), general cancer vaccines and a vaccine targeting cancers caused by Epstein-Barr Virus. For more information, please visit 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 that 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; anticipated timing for initiation of new clinical trials; 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 to continue its clinical programs 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, 2016 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:
Jennifer LaVin
 
Jonathan Poole
O: 207-360-0473
 
O: 617-876-8191
jennifer.lavin@genocea.com
 
jonathan.poole@genocea.com



3
GEN-003 Positive Phase 2b Clinical Efficacy Results Immunotherapy Candidate for Genital Herpes 12-Month Top-line Results 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, clinical trials and pre-clinical studies, regulatory approval of our product candidates, liquidity position and capital needs, financing plans, 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, the timing of results of our ongoing and planned clinical trials, our estimates regarding the amount of funds we require to complete our clinical trials for GEN-003, our plans to commercialize GEN-003, the timing of, and ability to, obtain and maintain regulatory approval for GEN-003 and 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 Disclaimer


 
• Statistically significant 49% reduction versus placebo in median genital lesion rate over 12 months for selected Phase 3 dose – Expected Phase 3 primary endpoint – Commercial-ready formulation • Positive results from other secondary clinical endpoints • No changes observed to the previously established safety profile 3 12-Month Top-Line Clinical Data Highlights


 
• Randomized, double-blind, placebo-controlled trial • 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) • Key elements consistent with prior GEN-003 trials – Inclusion / exclusion criteria, demographics, sites, dose regimen – Planned Phase 3 program shares key design elements • Clinical events collected through daily electronic patient reporting 4 Trial Design Recap


 
Wilcoxon Rank Sum test vs. placebo -49% p=0.01 -37%% reduction vs. placebo Notes: (1) Days with visible lesions divided by total days • 60/50 dose significant impact on genital lesion rate: – Reduction vs. placebo consistent with 52% reduction 6 months post dosing – Reductions vs. baseline consistent with those from prior Phase 2 5 Phase 3 Dose Significantly Reduces Genital Lesion Rate vs. Placebo over 12 Months - Expected Phase 3 Primary Endpoint Median Genital Lesion Rates(1) Post Treatment Over 12 Months After Last Dose Phase 3 Dose


 
6 Consistent, Positive Data From Secondary Clinical Endpoints at 60/50 Dose NS = p>0,05; (1) Wilcoxon Rank Sum test vs. placebo; (2) Log Rank Test; (3) Poisson mixed effect model with empirical variance


 
Phase 2 extension 24 month • Demonstrated 2-year durability of effect 7 GEN-003 Phase 3 on Track to Start by End of 2017* 2017 12 month Phase 2b Phase 3 Program FDA EoP2 Regulatory Phase 2b maintenance dosing Antiviral combination • Demonstrated clinical, virologic efficacy • Confirmed dose & commercial formulation • Phase 2b extension ongoing • Safety and benefits of GEN-003 in combination with daily antivirals • Safety and efficacy versus placebo * Subject to obtaining capital


 
• Significant efficacy at expected Phase 3 primary endpoint at Phase 3 dose, using Phase 3 formulation – ~50% fewer days with genital lesions; fewer and shorter genital lesion outbreaks; • GEN-003 Phase 3 program on track to commence in 2017* • Potential new cornerstone treatment for patients with genital herpes – Profile of durable effect on disease with convenient dosing regimen resonates with large, highly dissatisfied patient population – Potential to be first new treatment option in more than 20 years 8 GEN-003 Strongly Positioned Ahead of Phase 3 * Subject to obtaining capital


 
Q&A 9


 
Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 jonathan.poole@genocea.com Jennifer LaVin Media Relations/Corporate Communications Phone: +1 207-360-0473 jennifer.lavin@genocea.com Investor inquiries: Media inquiries: