On February 13, 2025 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into an additional clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead’s Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion non-small cell lung cancer (NSCLC) (Press release, Ideaya Biosciences, FEB 13, 2025, View Source [SID1234650271]).

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"We are pleased to broaden the ongoing evaluation of the potential first-in-class clinical combination of IDE397 and Trodelvy to now include patients with MTAP-deletion NSCLC in our ongoing Phase 1 trial currently evaluating the combination in MTAP-deletion urothelial cancer. We are excited to continue to explore this potential first-in-class combination in MTAP-deletion solid tumors and look forward to providing clinical program updates in 2025," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with MTAP-deletion. The prevalence of MTAP-deletion is estimated to be approximately 26% in urothelial cancer (UC) and approximately 15% in NSCLC, representing approximately 48,000 cases in the U.S. annually.

Trodelvy is currently approved in in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

In addition to the Phase 1/2 trial evaluating IDE397 in combination with Trodelvy in UC and NSCLC, IDEAYA is actively enrolling patients into a monotherapy expansion in MTAP-deletion NSCLC and urothelial cancer and is expecting to initiate a wholly-owned clinical combination trial of IDE397 and IDE892, IDEAYA’s potential best-in-class, MTA-cooperative PRMT5 inhibitor in the second half of 2025.

Pursuant to the clinical study collaboration and supply agreement, IDEAYA and Gilead retain the commercial rights to their respective compounds, including with respect to use as a monotherapy or combination agent. IDEAYA is the study sponsor and Gilead will provide the supply of Trodelvy to IDEAYA.

IDE397 monotherapy or in combination with Trodelvy has not been approved by any regulatory agency and the efficacy and safety of this combination has not been established.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

On February 13, 2025 Novita Pharmaceuticals, Inc., a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, reported that the Company will present additional data from the Phase 2 trial of its novel fascin inhibitor, NP-G2-044, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Immuno-Oncology Conference 2025 (AACR IO), being held February 23-26, 2025 in Los Angeles, California (Press release, Novita Pharmaceuticals, FEB 13, 2025, View Source [SID1234650270]).

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Details of the poster presentation are below.

Title: Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy
Session: Poster Session B
Date and Time: Tuesday, February 25, 2025 at 1:45-4:00 p.m. PT
Presenting Author: Anup Kasi, M.D., M.P.H., University of Kansas Medical Center

The poster will be available on Novita’s website following the presentation. For more details about the AACR (Free AACR Whitepaper) IO Annual Meeting, please visit their website here.

On February 13, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that it has concluded dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical trial (Press release, TC Biopharm, FEB 13, 2025, View Source [SID1234650269]).

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The available data show a favorable safety and efficacy response in Cohort A patients, patients with relapse or refractory AML. No patients have experienced any drug-related adverse event, and preliminary efficacy data demonstrate a number of patients attaining stable disease following multiple infusions of TCB008.

"We’re thrilled to be sharing these preliminary results," stated Alison Bracchi, EVP of Clinical Operations. "These early data points pave the way for future clinical studies, as we consider how the therapeutic effect of TCB008 can be prolonged or enhanced to reverse the disease state in these incredibly sick patient populations. We have additional data review to complete, which will further define our next steps with TCB008, including as a potential bridge to transplant or other combination efforts."

The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB008. This trial is focused on assessing the treatment’s effectiveness and tolerability in patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML). Cohort A targeted patients who were ineligible for, or had exhausted all, available therapies, as they were unable to achieve remission or had subsequently relapsed following remission.

Cohort A recruitment was re-initiated in July 2024 using higher doses of TCB008 that contained a cumulative dose of up to a billion Gamma Delta T-Cells. Investigator and patient interest in the ACHIEVE trial has allowed the Company to expedite recruitment; as such, enrolment into Cohort A has concluded. Recruitment into Cohort B continues.

"This early safety and efficacy data, obtained in patients with significant unmet clinical need, reiterates our confidence in our lead candidate, TCB008," said Bryan Kobel, CEO of TC BioPharm. "We’re seeing the expedited delivery of data, six months after study re-initiation, signalling a positive safety and efficacy profile for TCB008. This data will shape our approach to clinical development as we continue to investigate how stable disease can be sustained, both to prevent relapse and to progress patients to additional treatment options in conjunction wth TCB008."

On February 13, 2025 GenomOncology, a precision medicine software company, and Pillar Biosciences, a leader in Decision Medicine, reported a co-marketing partnership aimed at advancing precision oncology care (Press release, GenomOncology, FEB 13, 2025, View Source [SID1234650268]). The collaboration will integrate GenomOncology’s cutting-edge clinical decision support platform with Pillar’s research-use-only (RUO) targeted Next Generation Sequencing (NGS) panels to enable healthcare providers with comprehensive workflows to advance personalized cancer insights.

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This collaboration aims to provide personalized and effective cancer treatment guidance by integrating genomic data through GenomOncology’s Pathology Workbench reporting, enabling a seamless workflow from the NGS sequencer to the report. Together, the companies will leverage genomic data, enabling healthcare providers to advance informed decisions based on the unique genomic profiles of individual patients. By combining their expertise, GenomOncology and Pillar Biosciences are committed to optimizing and accelerating the use of genomic data to support precision medicine in oncology, while streamlining the implementation of their respective and now integrated solutions.

"Partnering with Pillar Biosciences will allow us to enhance our offering and provide clinicians with an integrated, data-driven sample to answer approach to precision cancer management," said Garreth Hippe, Chief Commercial Officer of GenomOncology. "This collaboration enables us to provide more comprehensive, actionable insights for cancer care, empowering healthcare providers to make better, more informed decisions."

"We are excited to collaborate with GenomOncology to further expand our portfolio and provide complete solutions to researchers and treating clinicians," said Dan Harma, Chief Commercial Officer of Pillar Biosciences. "By combining our next-generation sequencing capabilities with their decision support platform, we can help deliver more rapid personalized cancer data that may help improve oncology patient management."

On February 13, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing the tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed AML, reported it has entered into a common share purchase agreement and registration rights agreement with an institutional investor (Press release, Aptose Biosciences, FEB 13, 2025, View Source [SID1234650266]).

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The Committed Equity Facility agreement provides Aptose the right, in its sole option and discretion without obligation, to sell and issue up to $25 million of its common shares (the "Common Shares") over the course of 24 months to the Investor, subject to certain conditions being met, and subject to certain limitations and conditions imposed by the Nasdaq Capital Market ("Nasdaq"), the U.S. Securities and Exchange Commission (the "SEC") and other regulators. The securities offered have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. No Common Shares will be sold on the Toronto Stock Exchange ("TSX") or other trading market in Canada under the common share purchase agreement. The TSX has conditionally approved the committed equity facility based on the exemption set forth in Section 602.1 of the TSX Company Manual.

Aptose also announced it has entered into a sales agreement to issue and sell Common Shares through "at-the-market" (ATM) distributions on the Nasdaq. Aptose will decide the timing, price, and number of shares sold. Prospectus supplements (the "Prospectus Supplements") have been filed with the SEC qualifying the offer and sale of Common Shares (i) to the Investor with an aggregate offering price of up to US $25 million and (ii) pursuant to the sales agreement with an aggregate offering price of up to US $1 million. The Prospectus Supplements and accompanying prospectus are available on EDGAR at www.sec.gov and can also be accessed on the SEC’s website at View Source Investors should review the Prospectus Supplements and other filed documents for comprehensive information about the issuer and the offering before making any investments.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, and shall not constitute an offer, solicitation, or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.