On September 16, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), reported it has been selected for a poster and an oral presentation at the upcoming AACR (Free AACR Whitepaper) Special Conference in Cancer Research: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity, taking place September 24 to 27, 2025, in Montreal, Canada (Press release, CytoDyn, SEP 16, 2025, View Source [SID1234655996]).

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Richard Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn, will deliver a podium presentation on the effects of leronlimab on metastatic triple-negative breast cancer.

"We are encouraged by these findings, which suggest that leronlimab may convert ‘cold’ tumors into ‘hot’ ones, making them more responsive to checkpoint inhibitors in diseases like metastatic triple-negative breast cancer, an aggressive disease with substantial unmet need," said Dr. Pestell, "The results of this research will also help to shed light on an underlying mechanism of action for leronlimab with potential broad applicability for solid tumors with limited treatment options."

Details of the oral and poster presentations are as follows:

Abstract Title:
CCR5 inhibition with leronlimab is associated with enhanced PD-L1 expression, ICI response, and long‑term survival in metastatic TNBC

Presenter:
Richard Pestell, M.D., Ph.D., FRCP AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn

Poster presentation:
September 26, 2025, 6:30 p.m. – 8:30 p.m. EDT

Podium/speaking presentation:
September 27, 2025, 10:25 a.m. – 10:40 a.m. EDT

On September 16, 2025 Tasca Therapeutics, ("Tasca" or the "Company") a clinical-stage biotechnology company focused on developing targeted therapies for genetically defined cancers, reported that the first patient has been dosed in Phase 1/2 clinical trial of its lead drug candidate CP-383 (Press release, Tasca Therapeutics, SEP 16, 2025, View Source [SID1234656013]).

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CP-383 is a first-in-class (FIC) small molecule designed to modulate a critical oncogenic signaling pathway. Preclinical studies have demonstrated robust anti-tumor activity across a range of tumor models, including those with limited response to existing therapies. Tasca developed CP-383 using its proprietary drug discovery auto-palmitoylation platform that integrates pathway biology, structure-based design, and precision oncology strategies to unlock previously intractable targets.

"The dosing of the first patient with CP-383 is a major milestone for Tasca and a testament to the innovation and dedication of our team," said Milenko Cicmil, Ph.D., Co-Founder and Chief Executive Officer of Tasca Therapeutics. "CP-383 is a highly differentiated small molecule that targets a key pathway implicated in multiple difficult-to-treat cancers. We are looking forward to rapidly enrolling this study and beginning to define the clinical profile of this novel, targeted oncology candidate."

The Phase 1/2 trial is a multi-center, open-label study evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CP-383 in patients with advanced or metastatic solid tumors. Future study stages will incorporate biomarker-enriched cohorts based on emerging clinical and translational data.

Tasca also reported a second closing of its $67 million Series A financing round driven by strong investor demand and with new participation from 8VC, a leading technology and life sciences venture firm. 8VC’s support provides deep domain expertise in biotech innovation and a track record of partnering with companies at the forefront of transformative science. As previously announced by the Company, the Series A financing was co-led by Regeneron Ventures and Cure Ventures, with participation by Invus Group.

"We are thrilled to support Tasca’s clinical development of CP-383," said Seth Lieblich, Principal at 8VC. "The discovery of a druggable auto-palmitoylation pocket represents a breakthrough in targeting previously intractable cancer drivers. We believe Tasca’s team, platform, and mechanistic insight into oncogenic signaling have the potential to reshape the treatment landscape for genetically defined cancers. We’re excited to join backing their vision to dramatically improve the lives of cancer patients."

On September 16, 2025 Crossbow Therapeutics, Inc., a biotechnology company focused on advancing T-Bolt therapies, a novel class of antibody therapeutics, reported dosing of the first participant in its CROSSCHECK-001 Phase 1 clinical trial of CBX-250, a first-in-class, potent, and specific T-cell engager (TCE) for the treatment of myeloid malignancies (Press release, Crossbow Therapeutics, SEP 16, 2025, View Source [SID1234656014]).

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"Patients with relapsed or refractory myeloid malignancies urgently need new treatment options, and CBX-250 offers a novel approach," said Briggs Morrison, M.D., Chief Executive Officer of Crossbow. "The preclinical profile of CBX-250 and its novel targeting strategy bolster our confidence as we begin to bring the expansive potential of our T-Bolt platform to patients."

CBX-250 is the first candidate developed through Crossbow’s T-Bolt platform, a portfolio of novel TCE molecules that uniquely target peptide-loaded human leukocyte antigen (pHLA) complexes on tumor cells, using antibodies that mimic T-cell receptors (TCR-mimetics). Specifically, CBX-250 targets a cathepsin G pHLA complex, abundantly expressed on leukemic cells, but not normal cells. The Phase 1, open-label, dose-escalation CROSSCHECK-001 study is the first clinical trial for Crossbow and the T-Bolt platform. The study is evaluating the safety, tolerability, and preliminary clinical activity of CBX-250 in patients aged 12 years and older with relapsed or refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (HR-MDS), and chronic myelomonocytic leukemia (CMML).

AML, one of the most common myeloid malignancies, is primarily a disease of older adults, with an average patient age of 68 years. In the United States, the estimated incidence of AML exceeds 22,000 new cases each year, and the five-year survival rate is approximately 33%.1 In AML patients, relapse is common within the first year of achieving complete remission, occurring in more than 50% of patients after induction chemotherapy, the current standard of care.2 Those with relapsed or refractory AML have an especially poor prognosis, underscoring the urgent need for potent therapies directed against novel tumor-selective therapeutic targets.

CBX-250 was developed through an ongoing strategic collaboration between Crossbow and The University of Texas MD Anderson Cancer Center. Crossbow designed and is conducting the CROSSCHECK‑001 clinical study, which is investigating CBX-250 on a fixed step-up dosing schedule. The company expects initial clinical data from CROSSCHECK-001 in 2026.

For additional trial details, visit the CROSSCHECK-001 study page on ClinicalTrials.gov.

On September 16, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the first of two analyst/investor events focused on its farnesyl transferase inhibitor (FTI) program (Press release, Kura Oncology, SEP 16, 2025, View Source [SID1234655998]). The session features compelling preclinical data illustrating the potential of FTIs to address a common resistance pathway, thereby enhancing the anti-tumor activity of PI3Kα inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors (TKIs) across a range of diverse tumor types. These findings, drawn from Kura’s pioneering research on FTI mechanisms, offer important context to interpret the preliminary clinical data to be presented next month at the ESMO (Free ESMO Whitepaper) Congress 2025.

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"Innovation in cancer therapy demands not just new drugs, but smarter combinations to confront resistance head-on," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Today’s preclinical presentations underscore the transformative potential of KO-2806 – also known as darlifarnib – as a versatile combination therapy to major classes of precision medicines, paving the way for our upcoming presentations of its first, preliminary clinical data at ESMO (Free ESMO Whitepaper) 2025 next month."

Topics discussed during today’s event include:

Overcoming Resistance: Innate and adaptive resistance mechanisms can significantly limit the long-term efficacy of monotherapy with PI3Kα inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors (TKIs), underscoring the need for combination therapies.

Pioneering FTI Innovation: Kura has pioneered the discovery and development of farnesyl transferase inhibition and the targeting of mTOR – a clinically validated target – to overcome drug resistance and amplify the impact of targeted oncology therapeutics when paired with an FTI.

KO-2806, A Next-Generation FTI: Also known as darlifarnib, KO-2806 is Kura’s optimized, next-generation FTI, which was designed to provide superior potency, pharmacokinetics and physicochemical properties compared to first-generation candidates. Preclinical studies support the use of KO-2806 in combination with other agents to target pathways of resistance across a range of large indications.

Robust Preclinical Activity: In a broad panel of genetically-defined, in vivo tumor models, FTIs potently suppress mTOR signaling, driving enhanced anti-tumor activity when combined with antiangiogenic TKIs, PI3Kα inhibitors and KRAS inhibitors.

Class-Wide Applicability: Preclinical results with multiple agents from each targeted therapy class indicate broad mechanistic overlap, suggesting KO-2806’s potential extends across these classes.

Re-Sensitization in Relapsed Models: In preclinical non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models, KO-2806 re-sensitizes tumors to both mutant-selective or pan-KRAS inhibitors, restoring responsiveness in these models of relapsed settings.

Upcoming Clinical Milestones: In advance of its three presentations of FTI clinical data at the ESMO (Free ESMO Whitepaper) 2025 Congress, Kura reviewed the rationale, design and objectives of its ongoing FTI Phase 1 trials.

Expansive Patient Opportunity: KO-2806 combinations with standard-of-care agents could reach a substantial patient population. Combining with cabozantinib or other TKIs positions KO-2806 to address critical gaps in the treatment of renal cell carcinoma (RCC) and neuroendocrine tumors (NET). Extending to KRAS- and PI3Kα-mutant cancers in NSCLC, CRC, breast cancer and beyond, KO-2806 has the potential to impact more than 200,000 incident patients in the U.S. annually.
Today’s event will be held at 1:30 p.m. PT / 4:30 p.m. ET.

Kura plans to host a second event on October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET to review clinical data from Kura’s three scheduled presentations at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

A live webcast and archived replay of each event will be available on the Events page in the Investors section of Kura’s website.

On September 16, 2025 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported that the company’s abstract featuring first clinical data from its ongoing Phase I/II trial has been selected for an oral presentation at the European Association of Nuclear Medicine (EANM) congress, taking place from October 4 – 8, 2025 in Barcelona, Spain (Press release, NUCLIDIUM, SEP 16, 2025, View Source [SID1234655999]). The Phase I/II trial is evaluating the company’s PET tracer, 61Cu-TraceNetTM [61Cu]Cu-NODAGA-LM3 for the detection of SSTR-positive gastroenteropancreatic & bronchopulmonary neuroendocrine tumors (GEP & BP-NETS). Dr. Guillaume Nicolas, Deputy Head of Nuclear Medicine at the Department of Theragnostics, University Hospital Basel, Switzerland, and principal investigator of the study, will present the data.

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Oral Presentation Details
Session Title: Clinical Oncology Track – Top Rated Oral Presentation – Oncology & Theranostics Committee: NET Imaging
Abstract Title: "A phase I/II study of [61Cu]Cu -NODAGA-LM3 for the detection of neuroendocrine tumours: Preliminary results of the COPPER PET in NET Trial"
Date and Time: Monday, October 6, 2025, at 9:45 AM CEST
Location: Barcelona International Convention Centre Room 117