On November 3, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, reported financial results for the third quarter ended September 30, 2021 and reviewed business highlights (Press release, Gritstone Oncology, NOV 3, 2021, View Source [SID1234594219]).
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"We are pleased with our strengthened cash position and the significant clinical progress achieved during this third quarter," said Andrew Allen, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Gritstone. "Our leadership in neoantigen-derived immunotherapy and vaccination strategies for cancer and infectious diseases has been validated by several key partnerships and was further supported by a $55 million dollar PIPE financing led by Frazier Life Sciences Public Fund, enabling the rapid clinical development of our second-generation mRNA and integrated vaccine manufacturing capabilities. The data generated to date using both heterologous and homologous prime-boost approaches with our two vectors further validate the vast potential of our platform to deliver broad and durable immune responses across infectious diseases and common, solid cancers. We look forward to upcoming CORAL milestones, including imminent non-human primate viral challenge data from our collaboration with NIAID and Phase 1 data from our company-sponsored trial evaluating CORAL as a boost and immunogenicity enhancer for first-generation COVID-19 vaccines in older adults early in the first quarter of 2022."
Corporate Highlights
Entered into a funding agreement of up to $20.6 million with the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the clinical development of Gritstone’s CORAL second generation mRNA COVID-19 vaccine program, including a clinical trial in South Africa and manufacturing optimization (CEPI Press Release, August 2021)
Received gross proceeds of $55.0 million from a private investment in public equity (PIPE) financing led by Frazier Life Sciences Public Fund, with additional participation from Redmile Group and Gilead Sciences (PIPE Press Release, September 2021)
Clinical Highlights and Updates
Tumor-Specific Neoantigen (TSNA) Oncology Programs
GRANITE – Individualized, TSNA-directed immunotherapy using an adenoviral priming vector and self-amplifying mRNA boost vector
Updated Phase 1/2 results evaluating the safety, immunogenicity and clinical activity of GRANITE individualized neoantigen immunotherapy in combination with PD-1 checkpoint inhibitor nivolumab and subcutaneous anti-CTLA-4 antibody ipilimumab in advanced solid tumors presented at ESMO (Free ESMO Whitepaper) 2021 (GRANITE Press Release, September 2021)
GRANITE immunotherapy demonstrated a 44% molecular response rate (4/9) as measured by >50% reduction in circulating tumor DNA (ctDNA) with associated median overall survival >17 months in patients with end-stage microsatellite-stable colorectal cancer (MSS-CRC) for whom median overall survival is typically 6-7 months (as observed in the 5/9 patients without molecular response)
A Phase 2/3 randomized, controlled trial of maintenance GRANITE immunotherapy in newly diagnosed metastatic, MSS-CRC patients is expected to initiate in the first quarter of 2022
This Phase 2/3 trial has registrational intent and has been discussed with the FDA
A Phase 2 randomized trial of adjuvant GRANITE immunotherapy in MSS-CRC patients with stage II/III disease who are ctDNA+ after definitive surgery is expected to initiate in the second quarter of 2022
SLATE – "Off-the-shelf" shared neoantigen-directed immunotherapy using an adenoviral priming vector and self-amplifying mRNA boost vector
Presented Phase 1/2 data demonstrating SLATE v1 + nivolumab + ipilimumab in 26 patients with metastatic solid tumors
Observed multiple molecular responses and an unconfirmed RECIST radiologic response were observed in patients with metastatic NSCLC, all of whom had progressed on prior (chemo)immunotherapy (SLATE Press Release, September 2021)
SLATE v2, a mutant KRAS-focused version optimized for increased immune response, is currently being evaluated in a Phase 2 trial in patients with NSCLC and MSS-CRC. Initial clinical data are anticipated by mid-2022.
Infectious Disease Programs
CORAL – second-generation SARS-CoV-2 vaccine program delivering both spike and highly conserved non-spike T cell epitopes within either a self-amplifying mRNA vector or an optimized chimpanzee adenoviral vector (ChAdV). This approach offers potential for more durable clinical protection and broader immunity against SARS-CoV-2 variants than 1st generation products by inducing potent CD8+ T cells in addition to neutralizing antibody responses
Dosed first volunteer in a company-sponsored Phase 1 trial evaluating GRT-R910, a self-amplifying mRNA (SAM) second generation SARS-CoV-2 vaccine designed to boost and expand the immunogenicity of first-generation COVID-19 vaccines in subjects 60 years of age or older. (GRT-R910 Press Release, September 2021)
Initial Phase 1 data from this study are expected early in the first quarter 2022
Our collaboration with the National Institute of Allergy and Infectious Disease (NIAID) to evaluate the safety, tolerability and immunogenicity of investigational ChAdV and SAM SARS-CoV-2 vaccines continues:
Non-human primate viral challenge data are expected in November 2021
Preliminary results from a Phase 1 trial are now expected in the first half of 2022 due to protocol amendments necessitated by the changing landscape of vaccine use in the United States
Third Quarter 2021 Financial Results
Cash, cash equivalents. marketable securities and restricted cash were $216.4 million as of September 30, 2021 compared to $172.1 million as of December 31, 2020.
Research and development expenses were $24.4 million for the three months ended September 30, 2021, compared to $22.1 million for the three months ended September 30, 2020. The increase was primarily due to increases of $1.7 million in personnel-related expenses and $2.4 million in outside services, offset by $1.8 million decreases in laboratory supplies.
General and administrative expenses were $6.4 million for the three months ended September 30, 2021, compared to $5.0 million for the three months ended September 30, 2020. The increase was primarily attributable to increases in personnel-related expenses and outside services.
Collaboration revenue was $2.4 million for the three months ended September 30, 2021, compared to $0.8 million for the three months ended September 30, 2020. The increase was due to the collaboration revenue associated with the collaboration agreement with Gilead from January 2021.