On March 10, 2022 Genocea Biosciences, Inc. (Nasdaq: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the fourth quarter ended December 31, 2021 (Press release, Genocea Biosciences, MAR 10, 2022, View Source [SID1234609865]).
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GEN-011 TiTAN trial update
Genocea is conducting the Phase I/2a TiTAN clinical trial for its lead program GEN-011, a neoantigen-targeted peripheral T cell (NPT) therapy candidate. GEN-011 is comprised only of CD8+ and CD4+ T cells, extracted from the patient’s peripheral blood and specific for ATLAS-prioritized neoantigens. Patients receive either GEN-011 in multiple fractional doses without lymphodepletion and with intermediate doses of IL-2, or as a single dose after lymphodepletion and with intermediate or high doses of IL-2.
Genocea will present clinical, preclinical, and manufacturing data at next month’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 to be held from April 8-13 in New Orleans. In addition, the company will host an investor call which will span the late-breaking clinical data from the TiTAN clinical trial, results demonstrating success with GEN-011’s PLANET manufacturing process, and new preclinical data on Inhibigens, antigens of pro-tumor immune responses uniquely identifiable by Genocea’s ATLAS platform.
"We are excited to present initial data on the first five patients in our TiTAN clinical trial for GEN-011," said Chip Clark, Genocea’s President and Chief Executive Officer. "We believe these data will begin to solidify the potential for GEN-011 to represent a differentiated autologous T cell therapy for solid tumors through the neoantigen selection capabilities of our ATLAS platform and the reliable expansion of T cells specific to ATLAS-validated neoantigens taken from peripheral blood by the PLANET manufacturing process."
ATLAS performance
As of March 3, 2022, Genocea has completed screening 23 patient samples with ATLAS in the TiTAN trial. On average in these samples, ATLAS has prioritized 12 neoantigens (range 0-43) and identified 16 Inhibigens (range 1-82) per patient. T cells specific for the prioritized neoantigens (and therefore not the Inhibigens) are expanded in the PLANET process.
PLANET performance
These T cells are grown in PLANET, Genocea’s robust and rapidly scalable cell expansion process. Of the 17 patient samples entering the PLANET manufacturing process, 100% have either successfully yielded a released drug product (14) or are continuing in process (3).
Of the 14 manufactured GEN-011 drug products, six have been administered to patients across both the multidose and single dose cohorts, with the remaining eight available for dosing upon patient need.
Operational updates
Strengthened Board of Directors
John Lunger was appointed to the Company’s Board of Directors, effective March 3, 2022. Mr. Lunger is Chief Patient Supply Officer at Adaptimmune, leading the teams responsible for producing and delivering products to patients, accelerating supply execution and optimizing the supply chain to be ready for commercialization. He is a seasoned biopharmaceutical leader with significant manufacturing and supply chain expertise.
Janssen Collaboration and Option Agreement
The Company entered into an R&D collaboration and option agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to explore the immunogenicity of neoantigens and the role and impact of Inhibigens in the context of vaccine therapies for cancer. The agreement was facilitated by Johnson & Johnson Innovation.
Under the collaboration, Genocea will use its clinically validated ATLAS platform to characterize Janssen-identified antigens as well as assess approaches that could mitigate the impact of Inhibigens. Genocea received an upfront technology access fee and will receive full R&D funding for its work under the collaboration. The agreement includes an option for Janssen to negotiate a future strategic partnership to develop non-personalized vaccine products using Genocea’s ATLAS platform and expertise on Inhibigens.
Upcoming presentations
American Association for Cancer Research’s (AACR) (Free AACR Whitepaper) 2022 Annual Meeting April 8-13, 2022
AACR POSTER SESSION CATEGORY: Phase 1 Adult Clinical Trials
Poster #CT153
Title: TiTAN: a phase 1 study of GEN-011, a neoantigen-targeted peripheral blood-derived T cell therapy with broad neoantigen targeting
Presenter: Maura Gillison, MD, PhD, MD Anderson Cancer Center
Date: Monday, April 11, 2022
Time: 1:30 p.m. – 5:00 p.m. CT
AACR POSTER SESSION CATEGORY: Inflammation, Immunity, and Cancer
Poster #2088
Title: The PLANET manufacturing process reproducibly generates high-quality neoantigen-targeted peripheral T cells (NPTs) for adoptive T cell therapy in the TiTAN clinical trial
Presenter: Harshal Zope, PhD, Genocea Biosciences
Date: Monday, April 11, 2022
Time: 1:30 p.m. – 5:00 p.m. CT
AACR POSTER SESSION CATEGORY: Clinical Research Excluding Trials
Poster #2745
Title: ATLAS-identified Inhibigen-specific responses accelerate tumor growth in mouse melanoma and pancreatic cancer
Presenter: Jessica Flechtner, PhD, Genocea Biosciences
Date: Tuesday, April 12, 2022
Time: 9:00 a.m. – 12:30 p.m. CT
Genocea sponsored investor call
Initial GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial data to be presented
Presenter: Melissa L Johnson, MD, Sarah Cannon Research Institute
Date/Time: TBA
Needham & Company 21st Annual Healthcare Conference
Title: Corporate Overview
Presenter: Chip Clark, President and CEO, Genocea Biosciences
Date: Tuesday, April 12, 2022
Time: 2:15 p.m. ET
More information can be found for each of these presentations on our Events and Presentations page on our website genocea.com.
Financial updates
Fourth quarter 2021 financial results
•Cash position: As of December 31, 2021, cash and cash equivalents were $37.1 million compared to $79.8 million as of December 31, 2020.
•Net loss: Net loss was $13.3 million or $0.19 diluted net loss per share for the quarter ended December 31, 2021, compared to $15.0 million or $0.18 per share for the same period in 2020. Net loss was $33.2 million or $0.48 diluted net loss per share for the year ended December 31, 2021, compared to $43.7 million or $1.11 per share for the same period in 2020.
•Research and Development ("R&D") expenses: R&D expenses were $10.3 million for the quarter ended December 31, 2021, compared to $7.8 million for the same period in 2020. R&D expenses were $39.0 million for the year ended December 31, 2021, compared to $34.0 million for the same period in 2020.
The increase in R&D expenses for the quarter ended December 31, 2021 is mainly due to GEN-011 manufacturing and clinical costs partially offset by a non-recurring payroll tax credit. The increase in R&D expenses for the year ended December 31, 2021 is mainly due to GEN-011 manufacturing and clinical costs as well as headcount related costs partially offset by facility related costs.
•General and Administrative ("G&A") expenses: G&A expenses were $3.1 million for the quarter ended December 31, 2021, compared to $3.9 million for the same period in 2020. G&A expenses were $14.7 million for the year ended December 31, 2021, compared to $14.4 million for the same period in 2020.
The decrease in G&A expenses for the quarter ended December 31, 2021 is mainly due to a decrease in professional services. The increase in G&A expenses for the year ended December 31, 2021 is mainly due to growth in our internal G&A team, partially offset by decreased facility related costs.
•Other income: Other income was $0.1 million for the quarter ended December 31, 2021, compared to expense of $3.3 million for the same period in 2020. Other income was $18.9 million for the year ended December 31, 2021, compared to income of $3.3 million for the same period in 2020.
The increase in other income for the quarter ended December 31, 2021 is mainly due to the non-cash impact of the fair-value adjustment for the liability-classified warrants issued in connection with the Company’s 2018 public offering, partially offset by net interest expense. The increase in other income for the year ended December 31, 2021 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 the Company’s July 2020 private placement (the "2020 Warrants"). In July 2021, the 2020 Warrants were remeasured to their fair value of $36.0 million and subsequently reclassified to equity.
Guidance
•Genocea’s existing cash is sufficient to support our current operations into Q3 2022, however we have strategic plans to extend our operations into 2023.
Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. ET Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 1066689. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source 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 90 days.