Gritstone Oncology (GRTS) Announces Updated Overall Survival Results from the Phase 1/2 GRANITE Study

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Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology firm working to develop the world’s most potent vaccines, at this time introduced up to date total survival (OS) outcomes from its Part 1/2 examine evaluating GRANITE, an individualized immunotherapy based mostly on on a vaccine, for the therapy of superior stable tumors. These outcomes, together with the outcomes of a clinicopathologic evaluation of metastatic sufferers with CCR-MSS with and and not using a molecular response, will likely be offered through a poster on the thirty seventh Annual Assembly of the Society for Immunotherapy of Most cancers (SITC).

“Observe-up knowledge from our Part 1/2 examine in sufferers with MSS-CRC who acquired a minimum of two prior strains of therapy proceed to show an affiliation between molecular response and total survival,” stated Andrew Allen. , MD, Ph.D., co-founder, president and CEO of Gritstone. “The median total survival (MOS) in sufferers with MSS-CRC who had a molecular response has nonetheless not been reached and can now exceed 22 months; 4 further months since our final replace in Could 2022. This can be a notable distinction from the 6-7 month MOS sometimes seen in third-line MSS-CRC and seven.8 month MOS in sufferers with no molecular response in our examine. Clinicopathologic evaluation exhibits that sufferers with MSS-CRC who obtain molecular response shouldn’t have elevated tumor mutation load, PD-L1 expression, or elevated IFNg-related gene expression. We’re additionally seeing molecular responses in sufferers with liver metastases, a subset that sometimes receives little profit from immunotherapy. The latest publication of GRANITE Part 1/2 ends in Nature Medication particulars this system’s novel method, and the information to this point demonstrates its promise in difficult-to-treat and end-of-line settings. The section 2/3 GRANITE randomized examine in front-line CRC, the place sufferers usually have extra time to develop an immune response, is ongoing and preliminary knowledge is predicted in 4Q2023. »

The Part 1/2 examine is evaluating the protection, immunogenicity and medical exercise of GRANITE together with the PD-1 checkpoint inhibitor nivolumab and ipilimumab, a subcutaneous anti -CTLA-4, in superior stable tumors. This examine recruited and handled 29 sufferers with beforehand handled metastatic stable tumors, together with sufferers with colorectal most cancers, gastroesophageal adenocarcinoma, and non-small cell lung most cancers. Of 13 sufferers with MSS-CRC, 6 achieved a molecular response outlined as ≥30% discount in circulating tumor DNA (ctDNA) and proceed to have an total survival benefit in comparison with sufferers with no molecular response .

GRANITE Part 1/2 OS Information Replace:

  • 6 of the 13 sufferers handled with MSS-CRC had a molecular response and the median total survival noticed on this group will now exceed 22 months (median OS not but reached versus 7.8 months in these with out molecular response). This compares to a median total survival not but achieved and higher than 18 months as reported in Could 2022.

Clinicopathologic traits of GRANITE Part 1/2:

  • 4 of 6 sufferers with a molecular response had liver metastases.
  • All sufferers had PD-L1 expression
  • The median tumor mutation load was 2.9 and three.6 mutations/MB in these with and with out molecular response, respectively.

The main points of the presentation of the SITC are as follows:Summary 660: Clinicopathologic Traits of Metastatic Colorectal Most cancers Sufferers with Molecular Responses Following Therapy with an Individualized Neoantigen Vaccine Routine & Parc des Expositions: Corridor C

About GRANITEGritstone’s neoantigen-based immunotherapies are designed to elicit a big T-cell (significantly CD8+ cytotoxic T-cell) response towards mutation-derived tumor-specific neoantigens (TSNA). Gritstone identifies these ASSWs utilizing its proprietary synthetic intelligence platform, EDGE™. GRANITE is an individualized neoantigen-based immunotherapy program that makes use of adenoviral (“prime”) and self-amplified (“enhance”) mRNA vectors to ship personalised immunotherapy containing the related neoantigens. GRANITE has acquired Quick Monitor designation from america Meals and Drug Administration for the therapy of MSS-CRC.

About Natural GritstoneGritstone works to create probably the most highly effective vaccines on this planet. We leverage our revolutionary vectors and payloads to coach a number of arms of the immune system to assault important illness targets and have applications in viral ailments and stable tumors. Independently and with our companions, we’re growing a pipeline of product candidates with the aim of enhancing affected person outcomes and eliminating illness.

Gritstone Ahead-Wanting StatementsThis press launch accommodates forward-looking statements, together with, however not restricted to, statements associated to the potential of Gritstone’s therapeutic applications; the progress of Gritstone’s ongoing medical trials; the timing of information bulletins associated to ongoing medical trials and the initiation of future medical trials. These forward-looking statements contain substantial dangers and uncertainties that might trigger Gritstone’s analysis and medical growth applications, future outcomes, efficiency or achievements to vary materially from these expressed or implied by the forward-looking statements. These dangers and uncertainties embrace, amongst others, uncertainties inherent within the drug growth course of, together with the stage of medical growth of Gritstone’s applications, the method for designing and conducting preclinical and medical trials, the approval processes regulatory filings, the challenges related to pharmaceutical manufacturing, Gritstone’s capacity to efficiently set up, defend and defend its mental property and different issues that might have an effect on the sufficiency of current liquidity to fund operations. Gritstone assumes no obligation to replace or revise any forward-looking statements. For a extra detailed description of the dangers and uncertainties that might trigger precise outcomes to vary from these expressed in these forward-looking statements, in addition to dangers regarding the corporate’s enterprise usually, see Gritstone’s newest annual report on the Kind 10-Okay filed March 10, 2022, in addition to Gritstone’s quarterly stories on Kind 10-Q filed Could 5, 2022 and August 4, 2022 and all present and periodic stories filed with the Securities and Trade Fee.

Grindstone ContactsTraders: George E. MacDougallDirector, Investor Relations and Company CommunicationsGritstone bio, Inc.[email protected]

Media: Dan Budwick1AB(973) 271-6085[email protected]

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Supply: Natural Gritstone

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