TSNA

Gritstone Reports Third Quarter 2022 Financial Results and Provides Business Update

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Thursday, November 3, 2022
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EMERYVILLE, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today reported financial results for the third quarter ended September 30, 2022 and reviewed business highlights.

Key Points: 
  • These results are consistent with prior results from GRANITE in advanced colorectal cancer patients.
  • In August 2022, interim results from the Phase 1/2 trial of GRANITE were published in Nature Medicine ( here ).
  • In September 2022, Gritstone presented positive data from a Phase 1/2 study evaluating KRAS-directed SLATE at ESMO.
  • In October 2022, Gritstone shared interim positive results from the ongoing Phase 1 CORAL-BOOST (NCT05148962) and CORAL-CEPI (NCT05435027) trials at a company-sponsored webinar .

Gritstone Presents Positive Initial Phase 2 Data in Late-Line Solid Tumor Patients Treated With KRAS-Directed Immunotherapy (SLATE) at ESMO 2022

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Monday, September 12, 2022
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EMERYVILLE, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, presented positive safety, immunogenicity, and early efficacy data from its SLATE program, an “off-the-shelf” vaccine program targeting shared neoantigens, in combination with immune checkpoint blockade, for patients with advanced solid tumors at the 2022 European Society for Medical Oncology (ESMO) Congress. The presentation included initial data with SLATE-KRAS, a shared mutant KRAS-specific neoantigen vaccine candidate, in addition to updated data using the first version of the vaccine candidate (SLATE v1), which contains both KRAS and non-KRAS neoantigens. The data were presented by Chrisann Kyi, MD of Memorial Sloan Kettering Cancer Center during a mini-oral presentation on Saturday, September 10th.

Key Points: 
  • Gritstone developed the KRAS-optimized candidate (SLATE-KRAS) after initial testing of SLATE v1 suggested non-KRAS neoantigens (including TP53) might exhibit immunodominance over KRASmut, thus attenuating efficacy.
  • A total of 38 patients with advanced solid tumors have been enrolled in the study across cohorts using SLATE v1 (n=26) or SLATE-KRAS (n=12).
  • The majority of patients enrolled (31/38) had either advanced non-small cell lung cancer (NSCLC; n=18) or microsatellite stable colorectal cancer (MSS-CRC; n=13).
  • The OS analysis included patients with no detectable ctDNA or no data at baseline (n=7) in the no molecular response group.

Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of GRANITE, Individualized Neoantigen Vaccine for Solid Tumors

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Monday, August 15, 2022
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EMERYVILLE, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published today in Nature Medicine. The paper, “Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results,” details results demonstrating that GRANITE generated strong, persistent, and functional tumor-specific CD4+ and CD8+ T cell responses that have potential broad applicability across a range of disease settings. The published data were originally presented at the European Society for Medical Oncology (ESMO) Congress 2021, and acted as the basis for launching two randomized, controlled studies of GRANITE, including a Phase 2/3 trial that has registrational intent (GRANITE-CRC-1L).

Key Points: 
  • The paper, Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results, details results demonstrating that GRANITE generated strong, persistent, and functional tumor-specific CD4+ and CD8+ T cell responses that have potential broad applicability across a range of disease settings.
  • In a tough tumor type such as metastatic colorectal cancer, these data are sufficiently striking to merit publication in Nature Medicine.
  • The first patient was treated in this study in July 2022, and initial results from this study are expected in the second half of 2023.
  • 2) GRANITE-ADJUVANT (NCT05456165), a phase 2 study in patients with high-risk stage II/III colon cancer who are ctDNA+ after definitive surgery.

Gritstone Presentations at AACR Further Support Expertise in Neoantigen Vaccine Design and Delivery

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Tuesday, April 12, 2022
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EMERYVILLE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, delivered three presentations (one oral and two posters) further supporting the potential of its novel vaccine development capabilities and delivery platforms to develop transformational therapeutic cancer vaccines at the 2022 American Association for Cancer Research (AACR) Annual Meeting.

Key Points: 
  • The collective data we presented at AACR reinforce our expertise in designing and delivering potent vaccines, and support the optimization of antigen cassette design, dose and vaccine regimen as key tools to induce differentiated immune response, said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone.
  • Oral Presentation: Optimization of shared neoantigen vaccine design to increase vaccine potency: From bench to bedside and back
    SLATE v1* was well-tolerated and demonstrated a favorable safety profile in all subjects dosed (n=26).
  • Gritstone subsequently developed a second, optimized product candidate (SLATE-KRAS) that exclusively includes epitopes from mutated KRAS.
  • The forward-looking statements in this press release are based on information available to Gritstone as of the date hereof.

Benefits of Synthetic Nicotine versus Tobacco Derived Nicotine

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Wednesday, January 19, 2022
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While alternatives, made from food-grade ingredients instead of tobacco leaf, simulate the taste and feel of tobacco, some are also infused with nicotine in order to assist users to fully transition from tobacco.

Key Points: 
  • While alternatives, made from food-grade ingredients instead of tobacco leaf, simulate the taste and feel of tobacco, some are also infused with nicotine in order to assist users to fully transition from tobacco.
  • There is tobacco derived nicotine (TDN), derived from the tobacco plant, and there is synthetic (tobacco-free) nicotine which is synthesized in a lab.
  • TSNAs, or tobacco specific nitrosamines, are the main carcinogen found in tobacco and can be found in small amounts in TDN.
  • ( https://blog.dana-farber.org/insight/2018/07/nicotine-cause-cancer/ )
    Synthetic nicotine is a synthesized form of nicotine produced in FDA approved facilities with absolutely no tobacco constituents.

Zanoprima Launches Commercial Production of Its High Purity Tobacco-Free Synthetic (S) Nicotine Using Revolutionary Patented New Process

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Monday, October 11, 2021
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Zanoprima Lifesciences ( www.zanoprima.com ) ( https://www.linkedin.com/company/zanoprima/ ) a UK based company, announced commercial production of its high purity synthetic (S)-Nicotine (SyNic) using a revolutionary patented process that does not involve the use of tobacco or any synthetic racemic mixture.

Key Points: 
  • Zanoprima Lifesciences ( www.zanoprima.com ) ( https://www.linkedin.com/company/zanoprima/ ) a UK based company, announced commercial production of its high purity synthetic (S)-Nicotine (SyNic) using a revolutionary patented process that does not involve the use of tobacco or any synthetic racemic mixture.
  • Zanoprima has developed and patented the process to manufacture high purity (typically 99.9%), synthetic (S)-Nicotine (SyNic) for commercial use that is free of TSNA (tobacco-specific Nitrosamines), toxins, carcinogens, odour, and harsh taste.
  • Green Chemistry principles compliant production process minimizes the environmental impacts of nicotine production.
  • As a responsible synthetic nicotine (SyNic) manufacturer Zanoprima will distribute SyNic in strict compliance with regulations in each of its markets, globally.

Gritstone Announces Positive Clinical Data with GRANITE (Individualized Neoantigen Immunotherapy Program) during ESMO 2021 and Launch of Randomized Clinical Trial Program in Colorectal Cancer with Registrational Intent

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Friday, September 17, 2021
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EMERYVILLE, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced updated results from the Phase 1/2 study evaluating the safety, immunogenicity, and clinical activity of GRANITE individualized neoantigen immunotherapy (heterologous prime-boost in combination with PD-1 checkpoint inhibitor Opdivo® [nivolumab] and subcutaneous anti-CTLA-4 antibody Yervoy® [ipilimumab]) in advanced solid tumors. The data were presented during a mini-oral presentation by investigator and Associate Professor of Medicine at the University of Chicago, Dan Catenacci, MD, as part of the European Society of Medical Oncology (ESMO) Annual Meeting.

Key Points: 
  • These radiological observations were associated with prolonged time on study and decrease in biomarkers such as ctDNA.
  • I am excited to see how well GRANITE can perform in healthier, earlier-stage patients where we expect to see fewer patients progress rapidly before active immunotherapy.
  • Additional information about the trial can be found at www.clinicaltrials.gov, NCT03639714
    Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.
  • The companys lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an off-the-shelf shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies.

Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial

Retrieved on: 
Friday, September 17, 2021
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The data from SLATE v1 will be reviewed during the companys previously announced investor event taking place today at 1:30pm ET.

Key Points: 
  • The data from SLATE v1 will be reviewed during the companys previously announced investor event taking place today at 1:30pm ET.
  • SLATE v1 demonstrated the greatest activity in 6 NSCLC patients with the KRASmut G12C presented by the HLA protein A*02:01.
  • SLATE is being evaluated in combination with immune checkpoint blockade in the Phase 2 portion of its clinical study( NCT03953235 ).
  • The companys lead oncology programs include an individualized neoantigen-based immunotherapy, GRANITE, and an off-the-shelf shared neoantigen-based immunotherapy, SLATE, which are being evaluated in clinical studies.