Kura Oncology to Host Virtual Investor Event on December 9, 2024

On December 2, 2024 Kura Oncology, Inc. (NASDAQ: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will be hosting a virtual investor event at 8:00 a.m. ET / 5:00 a.m. PT on Monday, December 9, 2024, to discuss the KOMET-007 combination trial of the Company’s oral and selective menin inhibitor, ziftomenib, following the presentation of updated clinical data at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego (Press release, Kura Oncology, DEC 2, 2024, View Source [SID1234648719]).

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The virtual event will feature members of the management team along with investigators from the KOMET-007 trial. The live call may be accessed by dialing (800) 715-9871 for domestic callers and (646) 307-1963 for international callers and entering the conference ID: 4326549. A live webcast will be available here and in the Investors section of Kura’s website, with an archived replay available shortly after the event.

IDEAYA Biosciences Announces Participation in Upcoming December 2024 Investor Relations Events

On December 2, 2024 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported its participation in upcoming investor relations events (Press release, Ideaya Biosciences, DEC 2, 2024, View Source [SID1234648735]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Citi’s 2024 Global Healthcare Conference
Tuesday, December 3rd, 2024 at 8:00 AM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Yigal D. Nochomovitz, Ph.D., Director, SMid Cap Biotech Analyst
7th Annual Evercore HealthCONx Conference
Wednesday, December 4th, 2024 at 1:20 PM ET

Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Jonathan Miller, Managing Director, Biotech and Pharma Equity Research
A live audio webcast of the conference event, 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 the webcast will be accessible for 30 days following the live event.

BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer

On December 2, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) combination regimen ( NCT06072612 ) (Press release, BriaCell Therapeutics, DEC 2, 2024, View Source [SID1234649126]). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

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"We are pleased with the DSMB’s recommendation for the continuation of BriaCell’s Phase 3 study without any protocol modification as a significant milestone towards clinical advancement of our novel immunotherapy as a safe and effective treatment option for metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President & CEO.

"We strongly believe in the potential of our novel immunotherapy to transform cancer care for metastatic breast cancer patients, and the positive DSMB review reinforces our confidence in the potential use of the combination regimen in metastatic breast cancer patients," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.

Amendment to Development Collaboration Agreement

On December 2, 2024 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have amended a Development Collaboration Agreement (the "Collaboration Agreement") with the Netherlands Cancer Institute, Amsterdam (NKI), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations (Filing, 8-K, Lixte Biotechnology, DEC 2, 2024, View Source [SID1234648720]).

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On November 29, 2024, the parties signed an amendment ("Amendment 3") to the Collaboration Agreement. This Amendment provides for a pause in the ongoing study activities and any payments thereunder until the initiation of a Phase 1b clinical trial combining LB-100 with a WEE1 inhibitor in metastatic colorectal cancer patients. The collaboration will resume upon dosing of the first patient in this clinical trial (the "Effective Date"), with the termination date revised to be one (1) year from the dosing date of the first patient.

Under Amendment 3, the parties will seek to study translational data derived from patient samples in clinical trials at NKI. Amendment 3 provides for a reduced annual budget of €100,000, invoiced quarterly, for one year from the Effective Date as compered to the initial budget of €250,000. The foregoing description of Amendment 3 does not purport to be complete and is subject to and qualified in its entirety by the full text of Amendment 3, a copy of which is filed hereto as Exhibit 10.1.

Ajax Therapeutics to Present Overview of Phase 1 Clinical Trial Evaluating AJ1‑11095, a First-in-Class Type II JAK2 inhibitor, for the Treatment of Myelofibrosis at the American Society of Hematology Annual Meeting

On December 2, 2024 Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), reported that an overview of the company’s ongoing first-in-human study with its next generation Type II JAK2 inhibitor, AJ1-11095, has been selected for presentation in a poster session on December 8, 2024 at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego (Press release, Ajax Therapeutics, DEC 2, 2024, View Source [SID1234648737]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The poster, entitled "A Multicenter, Open-Label, Phase 1 Clinical Trial of AJ1-11095 Administered As Oral Monotherapy in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed By a Type I JAK2 Inhibitor (JAK2i)," will be presented by John Mascarenhas, MD, Professor of Medicine, Icahn School of Medicine at Mt. Sinai and Director, Center of Excellence in Blood Cancers and Myeloid Disorders at Tisch Cancer Institute and principal investigator of the Phase 1 Study. Further details about the study can be found at www.clinicaltrials.gov under the NCT identifier: NCT06343805.

Details of the poster session are as follows:

Session Name: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II
Session Date and Time: Sunday, December 8, 2024, 6:00 – 8:00 p.m. PT
Location: San Diego Convention Center, Halls G-H
Publication Number: 3147.1

About AJ1-11095

AJ1-11095 was designed by Ajax Therapeutics, through an exclusive collaboration with Schrödinger, using structure-based drug design and computational methods at scale to selectively bind the Type II conformation of the JAK2 kinase in order to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the Type I conformation of JAK2. AJ1-11095 has been shown in preclinical studies to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic Type I JAK2 inhibition.

About Myelofibrosis

Myelofibrosis (MF) is a rare blood cancer that affects approximately 20,000 patients in the United States. The disease is characterized by spleen enlargement, scarring (fibrosis) in the bone marrow, progressive anemia, and debilitating symptoms, such as fatigue, night sweats, itching, and abdominal discomfort, which can impair a patient’s quality of life. The most widely used treatment for MF patients are Type I JAK2 inhibitors which can reduce spleen size and provide symptomatic improvement but have little effect on the underlying cause of disease. Over time, most MF patients stop Type I JAK2 inhibitor therapy. The most common causes for treatment discontinuation include a lack of benefit or loss of response, adverse events, and disease progression, leaving significant unmet treatment needs for these patients.