On December 2, 2022 Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, and Gadeta B.V., an innovative clinical-stage biopharmaceutical company pioneering the development of gamma delta (γδ) TCR-based immunotherapies for solid tumors, reported that they will collaborate on the first γδ ImmTAC for solid tumors, including colorectal cancer (Press release, Immunocore, DEC 2, 2022, View Source [SID1234624740]).

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"Immunocore pioneered TCR therapy with the launch of KIMMTRAK and we continue to push the edge of TCR science, including researching non-HLA restricted TCR therapies, both internally and through collaborations that complement our platform," said David Berman, Head of Research and Development of Immunocore. "We are very pleased to collaborate with Gadeta to combine their expertise in gamma delta TCRs with our scientific, development, and commercialization capabilities to deliver new TCR therapies."

"Gadeta is excited to work with Immunocore on bringing these novel, soluble γδ-TCRs to patients with solid tumors," said Marcel Zwaal, Chief Executive Officer of Gadeta. "This agreement shows the potential of Gadeta’s new tumor targeting mechanism and it provides us with an opportunity for maximizing the impact of our suite of technologies for T cell related therapies, including the NOVA γδ-TCR discovery platform."

Gamma delta T cells are an important subset of immune cells that sit on the boundary of the innate and adaptive immune systems. They patrol the body using their T cell receptors to scan for cellular alarm signals, some of which are not HLA restricted, such as modified cell surface proteins or protein clusters caused by cancer or pathogens. Gadeta has identified a portfolio of novel, first-in-class, γδ-TCRs. One of those, referred to as ‘201, specifically recognizes a non-HLA restricted alarm signal on the surface of cancer cells. Gadeta is developing ‘201 TCR in its proprietary TEG (T Cells Engineered to Express a Defined Gamma Delta TCR) cell therapy platform as GDT201. Pre-clinical data for GDT201 show promising results across a wide range of colorectal cancer cell lines and the product will be evaluated in a Phase 1 trial for a range of solid tumor indications, slated to start in H2 2023. GDT201 remains fully owned by Gadeta.

Under the terms of the agreement, Immunocore and Gadeta will collaborate on ‘201 γδ-TCR target discovery, and Immunocore will have the option to develop ImmTAC therapies derived from the ‘201 TCR as part of the research collaboration. Immunocore has an option for an exclusive license to further research, develop and commercialize an ImmTAC candidate from the collaboration. Gadeta is eligible to receive upfront, near-term option fee and research milestone payments. If Immunocore exercises its option for an exclusive license, Gadeta is eligible to receive development milestone and commercial milestone payments and is also entitled to receive royalties on sales of the product.

On December 2, 2022 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its Executive Vice President, General Counsel and Chief Strategy Officer, Catherine Vaczy, will be providing an overview of the Company’s gene therapies for cancer and diabetes at the following investor conference in December 2022 (Press release, Genprex, DEC 2, 2022, View Source [SID1234624736]).

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Event: RHK 2022 Disruptive Growth Conference

Conference Dates: Dec. 5-6, 2022

Presentation Date: Tuesday, Dec. 6, 2022

Presentation Time: 2:40 p.m. ET

Location: Offices of Reed Smith in New York City

Presenter: Catherine Vaczy, Genprex’s Executive Vice President, General Counsel & Chief Strategy Officer

Ms. Vaczy will be available for Q&A following the presentation and for in-person one-on-one meetings with investors at the RHK Disruptive Growth Conference.

On December 2, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported that GSK’s RUBY/ENGOT-EN6/GOG3031/NSGO Phase 3 trial of JEMPERLI (dostarlimab) plus standard of care chemotherapy compared to chemotherapy plus placebo in patients with primary advanced or recurrent endometrial cancer, met its primary endpoint of investigator-assessed progression-free survival (PFS) (Press release, AnaptysBio, DEC 2, 2022, View Source [SID1234624735]). The JEMPERLI regimen showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroup.

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While the overall survival (OS) data were immature at the time of this analysis, a favorable trend was observed in the overall population, including both the dMMR/MSI-H and MMRp/MSS subgroups.

The safety and tolerability profile of dostarlimab plus chemotherapy was consistent with clinical trials of similar regimens.

Regulatory submissions based on the trial results are anticipated in the first half of 2023. GSK expects to publish full results from the RUBY trial in a medical journal and present at an upcoming scientific meeting.

JEMPERLI was discovered by AnaptysBio and licensed to TESARO, Inc., now a part of the GSK group of companies, under a Collaboration and Exclusive License Agreement signed in March 2014. GSK is responsible for the ongoing development and commercialization of JEMPERLI. AnaptysBio is entitled to receive milestones and tiered royalties of 8% for net sales of JEMPERLI below $1 billion and 12% up to 25% of net sales above $1 billion. In 2021, AnaptysBio monetized with Sagard Healthcare Royalty Partners certain commercial milestones and royalties for net sales of JEMPERLI below $1 billion up to a certain amount of receivables before such receivables revert back to AnaptysBio.

"We are encouraged to see AnaptysBio-discovered molecules continue to deliver differentiated outcomes for patients in indications with substantial unmet need. We are grateful to our partners at GSK for enabling broad development of JEMPERLI and to the patients in the RUBY and other JEMPERLI trials for their participation," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We believe that potential first-in-class approvals for JEMPERLI in endometrial cancer and other indications could over time materially contribute to our strong capital position as we focus on the R&D of our immune cell modulator pipeline. This includes our two checkpoint agonists in clinical-stage development, rosnilimab, a PD-1 agonist, and ANB032, a BTLA agonist, which act directly on cell types mediating disease pathology and have the potential to treat a broad range of autoimmune and inflammatory disorders."

About RUBY

RUBY is a two-part global, randomised, double-blind, multicentre study of patients with primary advanced or recurrent endometrial cancer. Part 1 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab versus placebo plus carboplatin-paclitaxel followed by placebo. Part 2 is evaluating dostarlimab plus carboplatin-paclitaxel followed by dostarlimab plus niraparib versus placebo plus carboplatin-paclitaxel followed by placebo. The primary endpoints are progression-free survival (PFS), per RECIST v1.1 by investigator assessment, and overall survival in Part 1, and PFS in Part 2. Secondary endpoints include PFS per blinded independent central review (BICR), overall response rate, duration of response, disease control rate, patient-reported outcomes, and safety and tolerability. RUBY is part of an international collaboration of European Network of Gynaecological Oncological Trial groups (ENGOT) and the GOG Foundation.

About JEMPERLI (dostarlimab-gxly)

JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. JEMPERLI is being investigated in registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.

JEMPERLI is indicated in the US for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. JEMPERLI is also indicated in the US for dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. These indications are approved in the US under accelerated approval based on tumour response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In the EU, JEMPERLI received conditional approval for adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum-containing regimen.

On December 2, 2022 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported that its abstract has been accepted for poster presentation at the British Society for Immunology Congress 2022 being held December 5-8, 2022 in Liverpool, UK (Press release, AIM ImmunoTech, DEC 2, 2022, View Source [SID1234624734]).

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Details for the presentation are as follows:

Poster No: P-220
Title: Safety, tolerability and biological activity of repeated intranasal administration of TLR3 agonist Ampligen (Poly I:Poly C12U) in healthy subjects
Presenter: Lisanne C.A. Smidt – Centre for Human Drug Research, Leiden, the Netherlands
Session: Poster Session 2
Date & Time: Wednesday December 7, 2022 from 5:30-7:00 PM GMT

For more information, please visit the Congress website, here.

On December 2, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that based on the results of an interim analysis on overall survival, the registrational Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO)1 in patients with second or third line non-squamous non-small cell lung cancer (NSQ-NSCLC) who have acquired resistance to prior therapy with chemotherapy and immune checkpoint inhibitor therapy (SAPPHIRE) will continue to the study’s final analysis (Press release, Mirati, DEC 2, 2022, View Source [SID1234624731]). The final analysis is expected to be reached in mid-2023.

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"We remain committed to developing our portfolio of oncology candidates and advancing our lung cancer strategy to positively impact the lives of patients with cancer. We look forward to providing an update based on the full analysis of the SAPPHIRE study in mid-2023," said Charles Baum, M.D., Ph.D., president, founder and head of research and development, Mirati Therapeutics, Inc.