On May 29, 2024 Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. (NASDAQ: PMVP; "PMV Pharma") reported a partnership to develop Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, as a companion diagnostic for PMV Pharma’s rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation (Press release, Foundation Medicine, MAY 29, 2024, View Source [SID1234643833]).

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Across all human cancers, TP53 is the most frequently altered gene, with mutations occurring in approximately 50% of cancer cases.1 Historically, TP53 mutations have been considered undruggable despite its prevalence across cancers.2 TP53 Y220C mutation is one of the most frequently observed TP53 mutations, occurring in approximately 1% of all solid tumors.3 PMV Pharma is developing rezatapopt, a small molecule, to reactivate the p53 function in an advanced cancer patient population harboring a TP53 Y220C mutation.

"The innovative science driven by PMV Pharma’s efforts specific to TP53 Y220C has the potential to offer a new therapeutic option for patients in this area of high unmet medical need," said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. "We’re proud to provide our high-quality tissue-based genomic test, along with real-world data from our Flatiron Health-Foundation Medicine Clinico-Genomic Database, to support PMV Pharma as they develop this exciting new treatment option."

Rezatapopt (PC14586) is an investigational, first-in-class, selective p53 reactivator designed to stabilize p53 Y220C proteins. The TP53 Y220C mutation creates a small pocket in the p53 protein, making it thermally unstable and unable to effectively interact with DNA. Rezatapopt is an orally available small molecule designed to selectively bind to a pocket in the p53 Y220C protein, leading to the restoration of the wild-type p53 tumor suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation, and is the subject of the ongoing registrational, tumor-agnostic PYNNACLE Phase 2 clinical trial. For more information about the Phase 2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

Foundation Medicine’s portfolio of FDA-approved comprehensive genomic profiling tests offers physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. If the CDx and separately the therapy are approved, FoundationOne CDx would be the first companion diagnostic to identify patients with TP53 Y220C mutations who may be eligible for rezatapopt.

On May 29, 2024 GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported that it will host a key opinion leader event on Tuesday, June 4, 2024, at 8:30am ET to provide a comprehensive overview of data from the company’s pivotal Phase 3 study of uproleselan in relapsed/refractory (R/R) acute myeloid leukemia (AML) (Press release, GlycoMimetics, MAY 29, 2024, View Source [SID1234643784]).

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The event will feature the study’s principal investigator Daniel DeAngelo, M.D., Ph.D., Professor of Medicine, Harvard Medical School, and Chief of the Division of Leukemia, Dana-Farber Cancer Institute, who will discuss results from the pivotal Phase 3 study of uproleselan, along with the current AML treatment landscape and unmet patient need.

To access the event by phone, please go to this registration link to obtain the dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On May 29, 2024 StarkAge Therapeutics, a French biotechnology company, reported a €1.2 million fundraising round conducted with biotech focused business angels and BPI (Press release, StarkAge Therapeutics, MAY 29, 2024, View Source [SID1234643800]). The company, founded in 2018, specializes in the targeting of cellular senescence in the onctext of age-related pathologies, especially cancer.

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Currently, cancers are mainly treated with radiotherapy, chemotherapy and/or targeted therapy. These therapies can lead to the emergence of senescent cells within the tumor and in adjacent normal tissues. Senescent cancer cells are implicated in treatment resistance, metastasis, and numerous side-effects including fibrosis. StarkAge Therapeutics’ mission is to identify specific targets expressed at the plasma membrane of senescent cells to develop targeted therapies and thus improve patients’ response to conventional therapies.

This funding round will enable the company to finalize in vivo testing of its first lead candidate, STX-1, an Antibody-Drug Conjugated (ADC) directed against the transmembrane protein DPP4 (CD26), highly overexpressed by senescent cells. The preliminary in vitro and in vivo results already obtained, particularly in liver and prostate cancer models, are extremely promising and applicable to a wide variety of other types of cancer expressing DPP4.

« We would like to thank all our partners for their support and confidence. Our ambition is to develop a highly innovative therapeutic approach based on the elimination of senescent cells in patients with refractory cancers, to increase their chances of recovery while limiting functional side effects. With this fundraising, we will finalize the in vivo experiments and initiate our second research program, STX-2. We hope to initiate a new round of financing in September 2024 to complete the preclinical studies for STX-1, prepare our entry into the clinic and continue the preclinical development of our STX-2 program, » explains Dr Thierry Mathieu, Founder and CEO of StarkAge Therapeutics.

The company is also focusing on research program, notably through a partnership with Professor Myriam Gorospe at the National Institute of Health (NIH), a world-renowned specialist in the field of cellular senescence. This collaboration will enable us to better understand the involvement of the DPP4 protein in age-related diseases, and to extend the STX-1 program to other therapeutic indications.

StarkAge Therapeutics’ research associated to an increasing number of scientific publications, demonstrate that the accumulation of senescent cells during disease progression is often extremely deleterious for patients. Many age-related diseases, such as pulmonary fibrosis, neurodegenerative and cardiovascular diseases, metabolic dysfunctions, liver fibrosis and cancer, are directly related to senescent cells and their accumulation in the human body. Targeting them opens the way to numerous innovative targeted therapies.

On May 29, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in the upcoming investor relations events (Press release, Ideaya Biosciences, MAY 29, 2024, View Source [SID1234643817]).

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2024 Jefferies Global Healthcare Conference
Wednesday, June 5th, 2024 at 9:00 AM ET

Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Maury Raycroft, Ph.D. Equity Research Analyst, Biotechnology
Goldman Sachs 45th Annual Global Healthcare Conference
Monday, June 10th, 2024 at 8:00 AM ET

Fireside chat with Yujiro S. Hata, Chief Executive Officer, hosted by Corinne (Jenkins) Johnson, Vice President, Equity Research, Biotechnology
A live audio webcast of the conference events, as permitted by the conference host, will be available at the "Investors/Events" section of the IDEAYA website at View Source and/or through the conference host. A replay of available webcasts will be accessible for 30 days following the live event.

On May 29, 2024 Grey Wolf Therapeutics, a clinical-stage biotechnology company leveraging first-of-its-kind antigen modulation therapies to address the source of immune dysfunction in oncology and autoimmunity, reported that the first clinical data for the company’s lead immuno-oncology candidate, GRWD5769, will be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Grey Wolf Therapeutics, MAY 29, 2024, View Source [SID1234643786]). The presented findings will consist of initial data from the company’s ongoing Phase 1/2 clinical trial of the first-in-class ERAP1 inhibitor in a range of solid tumour types. The 2024 ASCO (Free ASCO Whitepaper) Annual Meeting is being held May 31 – June 4, 2024, in Chicago, IL.

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Details of the company’s presentation at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Abstract Number: 2589

Title: EMITT-1: Proof-of-mechanism immunopeptidome (ImPD) effects at target PK exposure, in a Phase 1 study of GRWD5769 (a first-in-class inhibitor of Endoplasmic Reticulum Aminopeptidase 1 [ERAP1]) in patients with solid malignancies
Presenting Author: Thomas Lillie, M.D., Ph.D., Chief Medical Officer of Grey Wolf Therapeutics
Poster Session: Development Therapeutics – Immunotherapy
Date/Time: Saturday, June 1, 2024, 9:00 a.m. Central Time
Location: Poster Hall – Hall A

Grey Wolf has developed and is advancing a unique immune-oncology therapeutic strategy utilizing a proprietary antigen modulation strategy to reveal novel and potent cancer antigens on the surface of tumour cells. This is achieved through oral delivery of a targeted inhibitor of the endoplasmic reticulum aminopeptidases (ERAP1 or ERAP2), key proteins in the antigen presentation pathway. The targeted inhibition of ERAP is designed to elicit a de novo T cell response against tumours and to avoid T-cell exhaustion, thereby overcoming two key resistance mechanisms to current immuno-oncology therapy. The company is conducting an ongoing adaptive Phase 1/2 clinical trial of GRWD5769, which is evaluating the safety, tolerability, and efficacy of GRWD5769, including a planned combination with the PD-1 inhibitor Libtayo (cemiplimab), in a range of solid tumour types.

The company recently reported that it is expanding the scope of the Phase 1/2 trial, allowing for the enrolment of patients with additional tumour types. Additionally, the company has also recently initiated dosing in the study’s first combination treatment cohort.