GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial continues
GEN-009 neoantigen vaccine candidate shows promising long-term clinical results
Conference call today at
“I am pleased with the GEN-011 program progress. We continue to believe that GEN-011 has the potential to represent a major advancement in solid tumor T cell therapies based on the use of optimal T cells and targets. These T cells are derived from easily accessible peripheral blood as opposed to the tumor itself and are activated to pursue the surface-presented neoantigens of anti-tumor CD8+ and CD4+ T cell responses, prioritized by our proprietary ex vivo discovery platform, ATLAS™,” said
Clinical updates
GEN-011 (investigational neoantigen-targeted peripheral T cell therapy – or NPT)
- Genocea previously announced dosing of the first patient in its GEN-011 TiTAN™ clinical trial. GEN-011 is a next-generation solid tumor therapy comprised of neoantigen-targeted peripheral T cells (“NPTs”) selectively expanded on neoantigens of anti-tumor CD8+ and CD4+ T cell responses identified by ATLAS. The TiTAN trial is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. Preliminary clinical response data from an initial subset of patients is expected in late Q4 2021 or Q1 2022.
GEN-009 (investigational neoantigen vaccine)
- At the
American Society of Clinical Oncology (“ASCO”) 2021 Annual Meeting in June, the Company presented long-term follow-up clinical and immunogenicity data from its ongoing Phase 1/2a clinical study demonstrating that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part B of the clinical trial, of the nine CPI-sensitive patients, the data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses (“PRs”) and one complete response (“CR”). This is an increase from the two PRs and one CR previously reported at theSociety for Immunotherapy of Cancer’s (“SITC”) 2020 Annual Meeting. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. Expanded immunogenicity data revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response.
Research updates
Marcela Maus , M.D., Ph.D. joined the Company’sScientific Advisory Board .Dr. Maus , the Director of the Cellular Immunotherapy Program atMass General Cancer Center and an Associate Professor of Medicine atHarvard Medical School , is internationally known for her work as a translational physician-scientist in the field of immunology, particularly T cell immunotherapies and cellular therapies in the treatment of cancer.
Upcoming presentations
Bioprocessing Summit - Event Details
- Presentation Title: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-Targeted Peripheral T Cells (NPTs)
Date/Time:
Financial and other updates
Second quarter 2021 financial results
- Cash position: As of
June 30, 2021 , cash and cash equivalents were$60.4 million compared to$79.8 million as ofDecember 31, 2020 .
- Net loss: Net loss was
$4.3 million or$0.20 diluted net loss per share for the quarter endedJune 30, 2021 , compared to$11.3 million or$0.39 per share for the same period in 2020. Net loss was$16.3 million or$0.37 diluted net loss per share for the six months endedJune 30, 2021 , compared to$24.2 million or$0.84 per share for the same period in 2020.
- Research and Development (“R&D”) expenses: R&D expenses were
$10.5 million for the quarter endedJune 30, 2021 , compared to$8.6 million for the same period in 2020. R&D expenses were$19.3 million for the six months endedJune 30, 2021 , compared to$18.6 million for the same period in 2020.
The increase in R&D expenses for the three months endedJune 30, 2021 is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.
The increase in R&D expenses for the six months endedJune 30, 2021 is mainly due to growth in our internal research and manufacturing teams, partially offset by the timing of GEN-011 engineering and clinical manufacturing costs.
- General and Administrative (“G&A”) expenses: G&A expenses were
$4.0 million for the quarter endedJune 30, 2021 , compared to$3.5 million for the same period in 2020. G&A expenses were$7.7 million for the six months endedJune 30, 2021 , compared to$6.9 million for the same period in 2020.
The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
- Other income (expense): Other income (expense) was income of
$10.2 million for the quarter endedJune 30, 2021 , compared to expense of$0.2 million for the same period in 2020. Other income (expense) was income of$10.7 million for the six months endedJune 30, 2021 , compared to income of$0.4 million for the same period in 2020.
The increase in other income (expense) for both periods is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with ourJuly 2020 private placement.
Guidance
- Genocea’s operating plan extends its cash runway to the end of 2022.
Conference Call
Genocea will host a conference call and webcast today at
About
Genocea’s mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.
Forward-Looking Statements
This press release includes forward-looking statements related to GEN-011, GEN-009 and research updates within the meaning of the Private Securities Litigation Reform Act, including statements related to the anticipated timing of top-line results from Genocea’s Phase 1/2a clinical trial of GEN-011. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. These factors include, but are not limited to, risks related to the potential failure of our active product candidates which are in an early stage of clinical development; our ability to obtain regulatory approval for our current and future product candidates; potential delays in enrolling patients in our clinical trials; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under “Risk Factors” in our annual report on Form 10-K for the year ended
(Tables to follow)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(In thousands)
Cash and cash equivalents | $ | 60,399 | $ | 79,769 | ||||
Property and equipment, net | 5,214 | 5,123 | ||||||
Right of use assets | 8,371 | 9,308 | ||||||
Other assets | 3,399 | 4,293 | ||||||
Total assets | $ | 77,383 | $ | 98,493 | ||||
Accounts payable and accrued expenses | $ | 7,690 | $ | 7,878 | ||||
Deferred revenue | 1,641 | 1,641 | ||||||
Debt, current and long-term | 9,777 | 13,862 | ||||||
Warrant liabilities | 44,747 | 56,118 | ||||||
Lease liabilities | 9,473 | 10,012 | ||||||
Total liabilities | 73,328 | 89,511 | ||||||
Stockholders’ equity | 4,055 | 8,982 | ||||||
Total liabilities and stockholders’ equity | $ | 77,383 | $ | 98,493 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(In thousands, except per share data)
Three Months Ended | Six Months Ended | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
License revenue | $ | — | $ | 906 | $ | — | $ | 906 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 10,513 | 8,587 | 19,264 | 18,574 | |||||||||||
General and administrative | 4,033 | 3,480 | 7,704 | 6,868 | |||||||||||
Total operating expenses | 14,546 | 12,067 | 26,968 | 25,442 | |||||||||||
Loss from operations | (14,546 | ) | (11,161 | ) | (26,968 | ) | (24,536 | ) | |||||||
Other income (expense) | 10,235 | (160 | ) | 10,674 | 362 | ||||||||||
Net loss | $ | (4,311 | ) | $ | (11,321 | ) | $ | (16,294 | ) | $ | (24,174 | ) | |||
Net loss per share: | |||||||||||||||
Basic | $ | (0.06 | ) | $ | (0.39 | ) | $ | (0.24 | ) | $ | (0.84 | ) | |||
Diluted | $ | (0.20 | ) | $ | (0.39 | ) | $ | (0.37 | ) | $ | (0.84 | ) | |||
Weighted-average number of shares used in computing net loss per share: | |||||||||||||||
Basic | 67,970 | 29,142 | 67,074 | 28,642 | |||||||||||
Diluted | 70,202 | 29,142 | 72,467 | 28,642 |
Investor Contact:
daniel@lifesciadvisors.com
Media Contact:
Sarah O’Connell
soconnell@vergescientific.com
Source:
2021 GlobeNewswire, Inc., source