On January 9, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported it has been notified by the U.S. Food and Drug Administration (FDA) that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic (epNET) will no longer be the subject of discussion at an Oncologic Drugs Advisory Committee meeting (Press release, Exelixis, JAN 9, 2025, View Source [SID1234649539]). The sNDA remains under consideration by FDA with a Prescription Drug User Fee Act action date of April 3, 2025.

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On January 9, 2025 CatalYm reported the appointment of Scott Clarke as Chief Executive Officer. Mr. Clarke brings over two decades of executive leadership experience in driving company growth, developing products, and shaping and executing transactions in the biopharmaceutical industry (Press release, Catalym, JAN 9, 2025, View Source [SID1234649538]). He takes the helm as CatalYm enters a new stage of corporate and clinical development, including the initiation of a broad Phase 2b program for its lead candidate, visugromab, in non-squamous non-small-cell lung cancer and additional tumor indications. Based in the US, he will oversee both EU and US operations.

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"Scott Clarke is a fantastic addition to CatalYm’s leadership team. The company is in a strong position following its oversubscribed $150 million Series D financing and its recent publication in Nature of positive visugromab data. These events provide significant momentum for Scott’s start as CEO," said Jon Edwards, Interim Chair of CatalYm’s Board of Directors. "We are confident that his experience in oncology and partnering will be a substantial asset as we initiate CatalYm’s broad Phase 2b program with visugromab in hard-to-treat, metastatic solid tumor indications."

"I am impressed by CatalYm’s compelling clinical data demonstrating that visugromab is uniquely positioned as a novel cancer treatment capable of reversing key resistance mechanisms and reinstating an efficient anti-tumor response," said Scott Clarke, Chief Executive Officer at CatalYm. "I am very excited to join the CatalYm team at such a pivotal stage. I am committed to realizing visugromab’s potential to deliver unprecedented cancer remission depth and durability for patients with very limited therapeutic options."

Scott Clarke joins CatalYm from Ambagon Therapeutics, where he oversaw the company’s $85 million Series A financing and the evolution of its discovery pipeline of molecular glues. Previously, he served as CEO at Tizona Therapeutics, overseeing significant transactions and the development of its first-in-class anti-CD39 antibody for advanced cancers. Earlier in his career, he led oncology partnering at Roche, and was responsible for product development at BioMarin, contributing to multiple approved medicines. Mr. Clarke earned a Bachelor of Science in Chemical Engineering at the University of California, Berkeley, a Master of Science in Biotechnology at Northwestern University, and an MBA at London Business School.

On January 9, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate at the 43rd Annual J.P. Morgan Healthcare Conference in a podium presentation on Tuesday, Jan. 14, at 5:15 p.m. PT, followed by a question-and-answer breakout session at 5:35 p.m. PT (Press release, Bicycle Therapeutics, JAN 9, 2025, View Source [SID1234649537]).

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A live webcast of the presentation will be accessible from the Investor section of the company’s website at www.bicycletherapeutics.com. A replay of the webcast will be archived and available following the event.

On January 9, 2025 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company, reported dosing the first set of patients in the TUSCANY Phase 1/2 study with tuspetinib (TUS) in combination with venetoclax (VEN) and azacitidine (AZA) as a frontline triple drug combination (triplet) therapy for patients newly diagnosed with acute myeloid leukemia, or AML (Press release, Aptose Biosciences, JAN 9, 2025, View Source [SID1234649536]).

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Tuspetinib based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 trial with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Responses to TUS were also observed in those with prior-VEN and prior-FLT3 inhibitor (FLT3i) therapies, those with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes. Tuspetinib is a convenient once daily oral agent, and the TUS+VEN+AZA triplet has the potential to treat the larger AML population in a mutation agnostic manner, not just narrow subpopulations.

"We’re excited that our first several patients on the TUSCANY trial have received TUS+VEN+AZA," said Rafael Bejar, MD, PhD, Aptose’s Chief Medical Officer. "TUS+VEN+AZA triplet therapy holds the promise of delivering high response rates and longer survival to newly diagnosed AML patients, while avoiding toxicities seen with other agents, thereby broadening the application of triplet therapy to more AML patients, including those with adverse disease features."

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The TUSCANY triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard dosing of azacitidine and venetoclax for patients with AML who are ineligible to receive induction chemotherapy. TUS will be administered in 28-day cycles, beginning at 40mg once daily, with dose escalations planned after a safety review of each dose level. Multiple U.S. sites are enrolling in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov.

On January 9, 2024 Alessa Therapeutics, Inc., a privately held drug development company developing an innovative and proprietary localized drug delivery technology for the treatment of prostate disease, reported the enrollment of the first patient in the company’s Enolen clinical study at the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, Alessa Therapeutics, JAN 9, 2025, View Source [SID1234649535]).

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The Phase I Study (View Source) is a first-in-man study evaluating the safety, tolerability, and preliminary efficacy of Enolen for localized sustained delivery of enzalutamide into the prostate. The Enolen study will treat up to 20 patients in the US. Enrollment for the NCI study is through the NIH Clinical Center in Bethesda, Maryland.

"We are excited to complete the first patient enrollment with our partners at the NCI. As a medical oncologist and Phase I drug developer, it has been a long-held dream to be able to administer an effective anti-cancer agent without its side effects. Our prostate selective therapy spares men from the disabling side effects of unnecessarily blocking testosterone in the rest of the body and the brain." said Dr. Pamela Munster, Professor of Medicine at UCSF and founder and CSO of Alessa Therapeutics.

Prostate cancer is the second most prevalent cancer among men in the United States. According to the American Cancer Society, there were about 299,010 men in the U.S. in 2024, and 3.3 million men live with prostate cancer. (View Source)

While some men with low-risk tumors choose to monitor their disease, most prostate cancer patients are treated by completely removing or radiating their prostate. Both surgery and radiation treatment have expected complications, including urinary incontinence and erectile dysfunction. Systemic anti-androgen and testosterone-lowering drugs are approved for high-risk localized or metastatic disease but associated with side effects, including muscle mass loss, cognitive issues, sexual dysfunction, metabolic syndrome and cardiovascular events. Alessa’s Enolen implant is designed to deliver an anti-androgen drug directly to the target tissue in the prostate, eliminating significant side effects and improving the quality of life for men living with prostate cancer while avoiding surgery or radiation therapy.

Dr. Peter Pinto, Head of the Prostate Cancer Section at the National Cancer Institute, and Principal Investigator on the study noted, "There is a clear unmet therapeutic need for effective treatment options for men with localized prostate cancer that avoids definitive surgery or radiation or androgen ablating systemic therapy."

To learn more about this study, please visit View Source