Form 8-K GENOCEA BIOSCIENCES, For: Oct 07
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): October 7, 2015
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 October 7, 2015, Genocea Biosciences, Inc. (the “Company”) issued a press release announcing durability data from the Company’s planned interim analysis of data collected six months after dosing in its ongoing Phase 2 dose optimization trial evaluating the immunotherapy GEN-003 for the treatment of genital herpes. A copy of the press release, dated October 7, 2015, is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
The information contained in this Item 7.01 of this Current Report on Form 8-K, including the exhibit 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 8.01 Other Events.
On October 7, 2015, the Company gave a presentation to certain investors regarding the durability data from the six-month analysis of the Company’s Phase 2 dose optimization trial evaluating the immunotherapy 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.
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: October 7, 2015
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EXHIBIT INDEX
Exhibit No. | Description | |
99.1 99.2 | Press Release issued by Genocea Biosciences, Inc. on October 7, 2015 Investor Presentation dated October 7, 2015 | |
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Exhibit 99.1
Genocea Announces Positive Durability Data from 6-Month Analysis of Phase 2
Clinical Trial of Genital Herpes Immunotherapy GEN-003
- Sustained viral shedding rate reduction of 58 percent from baseline at best dose improves upon established attractive product profile -
- Efficacy seen consistently across several potential Phase 3 clinical endpoints -
- End of Phase 2 meeting with FDA expected in late 2016 -
- Company to host conference call at 9 a.m. ET today; data to be presented at IDWeek 2015 -
CAMBRIDGE, MA, October 7, 2015 --(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive results from a planned interim analysis of data collected six months after dosing from its ongoing Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. At its best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study.
In a planned secondary analysis to assess the impact on genital lesion rates, a patient-reported measurement of clinical disease, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. In addition, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies. A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups. The Phase 2 trial continues to show that GEN-003 is safe and well tolerated by patients, with no serious adverse events related to the vaccine.
“These data confirm the durable virological and clinical effect of GEN-003 to at least six months post dosing and further improve upon the results in our prior Phase 1/2a trial,” said Chip Clark, president and chief executive officer of Genocea. “These data support the potential of GEN-003 to serve as a cornerstone therapy for genital herpes infections with convenient, long term viral shedding and symptom control. Given the excellent results at six months, which reinforce GEN-003’s existing strong profile, upside exists from potential efficacy at twelve months. We look forward to this data in the first quarter of 2016 and to advancing GEN-003 towards an end-of-Phase 2 meeting with the FDA in late 2016.”
"The majority of people with genital herpes treat their disease episodically, but episodic treatment is not effective at either reducing the frequency of painful lesion outbreaks or periods of asymptomatic shedding, when the majority of disease transmission occurs,” said Nicholas Van Wagoner, M.D. Ph.D., Assistant Professor of Medicine, Division of Infectious Diseases, at the University of Alabama at Birmingham. “These six month data demonstrate the potential for a therapeutic vaccine to advance the treatment of this serious disease, providing durable efficacy, similar to chronic suppressive treatment with oral antivirals, with increased convenience and the potential for better compliance by patients."
Data will be presented in poster number 898 at IDWeek 2015TM on Friday, October 9, 2015 between 12:30 p.m. and 2:00 p.m. PST in the San Diego Convention Center Poster Hall. Nicholas Van Wagoner, M.D. Ph.D., will present the findings.
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About the GEN-003 Phase 2 Clinical Trial
In May 2015, Genocea reported initial positive top-line data from this Phase 2 dose optimization trial, which showed that during the 28-day observation period immediately after completion of dosing, the best dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a highly statistically significant (p < 0.0001) 55 percent reduction from baseline in the viral shedding rate. All dose combinations tested demonstrated a statistically significant viral shedding rate reduction versus baseline and only the lowest dose combination did not demonstrate a statistically significant reduction versus placebo. A planned secondary analysis to assess impact on patient-reported genital lesion rates demonstrated a statistically significant reduction from baseline in all groups, including the placebo group.
This Phase 2 study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and at six and, in time, twelve months following dosing. No booster doses will be given. After the 28-day observation period immediately after dosing, patients in the placebo arm were rolled over to 1 of the 6 active combinations of GEN-003 and Matrix-M2TM.
For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.
Conference Call
Genocea management will host a conference call and webcast today at 9 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 55798395). 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 HSV-2 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, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licensed from Novavax, Inc.
For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/.
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.
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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 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 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. For more information, please visit the company's website at www.genocea.com.
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; 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, 2014 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: | |
Amanda Johnson | Jonathan Poole | |
Spectrum Science Communications | Genocea Biosciences | |
O: 202-587-2520 | O: 617-876-8191 | |
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Positive 6 Month Durability Results GEN-003 Immunotherapy for Genital Herpes Phase 2 Dose Optimization Study 7 October 2015 Exhibit 99.2
Safe Harbor Statement 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
Highlights 3 • Improved impact on viral activity • Durable clinical efficacy demonstrated across potential Phase 3 endpoints • Potential for GEN-003 to serve as cornerstone treatment for genital herpes reinforced • Clear path to FDA end of Phase 2 meeting in Q4 2016 • Data will be presented at IDWeek 2015TM in San Diego this Friday 9 October
Agenda for Today’s Call • Disease pathology of genital herpes • Current treatment paradigms • Ongoing Phase 2 dose optimization trial – Study goals – Positive 6-month durability data • GEN-003 value proposition • Upcoming GEN-003 milestones • Conclusions • Q&A 4
Viral Shedding Underpins Pathology of Genital Herpes • A serious chronic infection caused by herpes simplex viruses (HSV) • Periodic disease reactivation causes viral shedding at rates specific to individual patients • Shedding necessary for genital lesions, disease transmission 5 Virus moves from nerve cell to skin and mucosa Nerve cell Skin cells Viral Shedding Genital mucosa Virus lays dormant in nerve ganglia
Current Genital Herpes Treatment Paradigms • Approximately two thirds (~4.5m) of treated U.S. patients use oral antivirals episodically – No impact on asymptomatic viral shedding/transmission risk – No impact on frequency of lesion outbreaks – Modest impact on duration of lesion outbreaks • Remaining one third (~2.5m) treat with chronic oral therapy – More durable reduction in viral shedding, visible lesions – Few options if outbreaks persist – Heavy compliance burden 6
Phase 2 Dose Optimization Trial Goals and Objectives • Goal: Select dose for late stage clinical trials • Primary endpoint: Reduction in viral shedding vs. baseline* • Secondary objectives: – Impact on clinical disease • Lesion rates* • Proportion recurrence free at 6* and 12 months • Time to next recurrence* – Safety and tolerability* – Immunogenicity 7 * Data discussed today
-100% -50% 0% Baseline Post dose 3 6 Months Chang e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Sustained Reduction in Viral Shedding Rate at 6 Months 8 • Sustained viral shedding reductions across several doses • Stronger response at 6 months than in Ph 1/2 – 58% vs. 40% • Upside potential for durable effect to 12 months Viral Shedding Rate Reduction vs. Baseline *** * Poisson model analysis vs. baseline *** p<0.0001, * p<0.05 Protein dose / adjuvant dose *** *** *** *** *** *** *** ***
-100% -50% 0% Baseline Post dose 3 6 Months Chang e v s. b a se lin e 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Genital Lesion Rate Reduction Sustained at 6 Months 9 • Sustained reductions at 6 months • Lesion rates results broadly parallel viral shedding rate reductions Genital Lesion Rate Reduction vs. Baseline * Poisson model analysis vs. baseline *** p<0.0001, * p<0.05 Protein dose / adjuvant dose *** *** *** *** *** *** *** *** *** ***
0% 20% 40% 60% 80% % Lesion Free at Six Months 30/25 µg 30/50 µg 30/75 µg 60/25 µg 60/50 µg 60/75 µg Consistent Efficacy on % Lesion Free at 6 Months Post Dosing 10 • Multiple doses similar to suppressive oral anti-viral therapy and superior to placebo from previous trials • Small sample size – ~45 per group vs. 269 for Valtrex % Lesion Free at Six Months* Protein dose / adjuvant dose Placebo** Famvir Valtrex * GEN-003 data displayed as mean result by dose group bounded by 95% confidence intervals ** n=134, Valtrex Phase 3 trial
Time to First Recurrence Results Consistent Across Dose Groups • Same data as % lesion free, analyzed slightly differently • Consistent time to first recurrence across groups – Range of 152 to >180 days • Efficacy similar to expected performance of orals, superior to placebo 11 Dose Group (protein dose / adjuvant dose) Time to First Recurrence 30 µg / 25 µg 159 30 µg / 50 µg 152 30 µg / 75 µg 160 60 µg / 25 µg >180 60 µg / 50 µg 164 60 µg / 75 µg 161
6 Months Durability Confirms GEN-003 Value Proposition • Convenient, durable efficacy may improve upon dominant treatment paradigm (episodic anti-viral therapy) – Reduce outbreaks – Reduce shedding to reduce transmission risk • Potential benefits vs. chronic suppressive therapy – Durable efficacy via novel mechanism – Orals reserved as rescue therapy during outbreaks – Improved compliance & convenience • GEN-003 profile supports revenue opportunity of >$1bn in US alone 12
Two Further Significant GEN-003 Catalysts in Coming Quarters; FDA End of Phase 2 Meeting on Track for Q4 2016 13 TODAY Ph 2 – 6 Month Data Q2 2016 Ph 2b – Bridging Q1 2016 Ph 2 – 12 Month Data • Confirmed 6 month durability of effect • Encouraging and consistent first read on 2o clinical endpoints • Better efficacy than Ph1/2 • Upside if efficacy durable to 12 months • Read on booster timing • Read on 2o clinical endpoints • Potential to strengthen EoP2 package with confirmation of Phase 3 material
Conclusions 14 • Improved impact on viral activity • Durable clinical efficacy demonstrated across potential Phase 3 endpoints • Potential for GEN-003 to serve as cornerstone treatment for genital herpes reinforced • Clear path to FDA end of Phase 2 meeting in Q4 2016 • Data will be presented at IDWeek 2015TM in San Diego this Friday 9 October
Questions & Answers 15
Jonathan Poole Chief Financial Officer Phone: +1 617-876-8191 [email protected] Megan Lustig Spectrum Science Communications Phone: +1 202-955-6222 [email protected] Investor inquiries: Media inquiries: