{"id":758173,"date":"2023-05-11T17:39:48","date_gmt":"2023-05-11T21:39:48","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/gritstone-bio-reports-first-quarter-2023-financial-results-and-provides-corporate-updates\/"},"modified":"2023-05-11T17:39:48","modified_gmt":"2023-05-11T21:39:48","slug":"gritstone-bio-reports-first-quarter-2023-financial-results-and-provides-corporate-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/gritstone-bio-reports-first-quarter-2023-financial-results-and-provides-corporate-updates\/","title":{"rendered":"Gritstone bio Reports First Quarter 2023 Financial Results and Provides Corporate Updates"},"content":{"rendered":"
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\n — Robust enrollment in Phase 2 portion of randomized Phase 2\/3 study of GRANITE (personalized vaccine in first-line metastatic microsatellite-stable colorectal cancer [MSS-CRC]) to date; 71 of 80 patients (initial target) enrolled as of May 10, 2023 —<\/em>
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\n — Gritstone prioritizing GRANITE; expanding Phase 2 from 80 to 100 patients, enrollment completion expected in 3Q2023, preliminary data on approximately 50 patients expected in 1Q2024 — <\/em>\n <\/p>\n

\n — Cash, cash equivalents, marketable securities, and restricted cash of $153.2 million as of March 31, 2023 —<\/em>\n <\/p>\n

\n — Gritstone to host conference call today at 4:30pm ET —<\/em>\n <\/p>\n

EMERYVILLE, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world\u2019s most potent vaccines, today reported financial results for the first quarter ended March 31, 2023 and provided recent corporate and clinical updates.<\/p>\n

\u201cStrategically prioritizing GRANITE underscores our conviction in the program and focuses our near-term resources on the immense opportunity that lies directly ahead of us: potentially being the first to demonstrate efficacy of a neoantigen-based personalized cancer vaccine in a randomized, controlled trial for MSS-CRC,\u201d said Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio. \u201cGRANITE is a potentially transformative therapy that has already shown significant promise in our published Phase 1\/2 study in patients with metastatic MSS-CRC, who had received two prior lines of chemotherapy. The high demand seen to date for our ongoing Phase 2 is a testament to its potential. Expanding the study from 80 to 100 patients not only increases the statistical power of the study but also generates more time-to-event data to help inform the Phase 3. We are thrilled to have the momentum and capital to expand this study and take this important step forward for patients with newly diagnosed metastatic CRC, as well as those being treated for CRC in the adjuvant setting and other cold tumors. We look forward to sharing preliminary Phase 2 efficacy data from approximately half of the 100 total patients in the first quarter of 2024.\u201d<\/p>\n

Dr. Allen continued, \u201cAlong with the significant progress in GRANITE, the data flowing from our CORAL program is highly encouraging and provides early signals of the potential advantages of self-amplifying mRNA (samRNA) over first-generation mRNA against infectious disease. We recently observed durable neutralizing antibody titers at 6 months following samRNA vaccination in over 100 vaccine-na\u00efve subjects treated within our CORAL-CEPI trial, where interim results were presented at ECCMID 2023. Self-amplifying mRNA has several distinct characteristics including prolonged and elevated antigen expression that suggest it could play a key role in the induction of long-term, variant-proof immune protection. We look forward to continuing to work with our collaborators to demonstrate the full potential of our samRNA platform against SARS-CoV-2 and other important viruses.\u201d<\/p>\n

\n Corporate Updates<\/strong>\n <\/p>\n

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\n GRANITE (individualized neoantigen vaccine against cold tumors): <\/em>
\n <\/strong>Gritstone is focusing its resources to expand the ongoing Phase 2 portion of the Phase 2\/3 study, which is evaluating GRANITE as a maintenance therapy in first-line metastatic microsatellite-stable colorectal cancer (MSS-CRC). As of May 10, 2023, the company had randomized 71 of the initially planned 80 total patients. The company plans to expand the study to randomize 100 patients in total. Enrollment of all 100 patients is expected to complete in third quarter of 2023 and preliminary data on approximately 50 of the 100 patients from the Phase 2 portion of the study (circulating tumor DNA [ctDNA] and progression-free survival data [evaluated by both RECIST and iRECIST criteria] on patients completing at least 4 months of treatment) is expected in the first quarter of 2024.<\/p>\n

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\n SLATE (\u201coff-the-shelf\u201d neoantigen vaccine program):<\/em>
\n <\/strong> Given the strategic decision to focus on GRANITE, the company is deferring the initiation of a randomized Phase 2 clinical trial with SLATE until 2024. Previously, a KRAS-dedicated version of SLATE demonstrated strong T cell responses and an observed survival advantage among molecular responders in Phase 1\/2 studies of patients with MSS-CRC and non-small cell lung cancer (NSCLC, press release announcing ESMO 2022 data available here<\/a>). The company believes success in GRANITE has the potential to further validate the company\u2019s neoantigen-based approach, which SLATE and GRANITE share, and that SLATE is ready for application across solid tumor indications and shared tumor neoantigen classes.<\/p>\n

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\n Infectious Disease: <\/em>
\n <\/strong>The company will continue its ongoing clinical and preclinical infectious disease efforts as planned, with the vast majority of these efforts being funded via external collaborators. The Bill & Melinda Gates Foundation, the Coalition for Epidemic Preparedness Innovations (CEPI) and the National Institute of Allergy and Infectious Diseases (NIAID) support the company\u2019s CORAL program. Gilead Sciences, Inc. (Gilead) is conducting a Phase 1 study as part of a collaboration with Gritstone to research and develop a therapeutic vaccine against HIV.<\/p>\n

\n Clinical Program Updates <\/strong>
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\n Tumor-Specific Neoantigen Oncology Programs (GRANITE and SLATE)<\/strong>\n <\/p>\n