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 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 Cebiotex reported that CEB-01, its lead product for local post-surgical cancer treatment, has been granted Orphan Drug Designation (ODD) status by the EMA for the treatment of pancreatic cancer (PC), a disease with one of the lowest survival rates and few effective treatment options (Press release, Cebiotex, SEP 16, 2025, View Source [SID1234655995]). In this context, CEB-01 implant offers the possibility for localized drug delivery to improve postoperative local control. While CEB-01 is not intended to replace existing treatment methods, its development aims to serve as a complementary therapy within the current standard of care.

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"Our goal is to integrate CEB-01 alongside surgery and adjuvant chemotherapy, enhancing the local control of residual disease at the surgical site, where recurrence often begins, and ultimately improving survival outcomes.", explains Toni Pérez, Chief Medical Officer of Cebiotex.

Receiving ODD from the EMA is a critical milestone in Cebiotex mission to address an unmet medical need for this rare and life-threatening condition by offering new alternatives to patients facing PC.

Anna Huguet, Regulatory Manager at Cebiotex, commented: "The granted ODD acknowledges the therapeutic potential of CEB-01 to address an existing unmet medical need in PC. It will facilitate CEB-01 development through scientific and regulatory support from EMA including fee reductions and drug development incentives that will support the path towards CEB-01 authorization. Importantly, it also means that CEB-01 is eligible for up to 10 years of market exclusivity in the EU upon authorization, further enhancing its attractiveness for long-term investment and development."

On September 16, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in the Bernstein Insights: Healthcare Leaders and Disruptors – 2nd Annual Healthcare Forum on Tuesday, September 23, 2025 (Press release, Bristol-Myers Squibb, SEP 16, 2025, View Source;2nd-Annual-Healthcare-Forum/default.aspx [SID1234655994]).

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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 company will take part in a fireside chat beginning at 9:40 a.m. ET.

Investors and the general public are invited to listen to the session by visiting View Source An archived edition of the session will be available following its conclusion.

On September 16, 2025 Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, reported that it continues to expand its patent portfolio for iadademstat and vafidemstat, Oryzon’s clinical-stage LSD1 inhibitors for oncology and central nervous system (CNS) disorders, following new Decisions to Grant from the Australian and European patent offices (Press release, Oryzon, SEP 16, 2025, View Source;utm_medium=email&utm_campaign=NdP.27+2025-09-16+IP+additional+decision+grant+ENG778 [SID1234655986]).

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The Australian Patent Office has issued a Decision to Grant for Oryzon’s patent application AU2020249493, titled "Combinations of iadademstat for cancer therapy". The allowed claims cover combinations of iadademstat with PD1 or PD-L1 inhibitors for the treatment of cancer, including small cell lung cancer (SCLC). A Decision to Grant is an official communication from a national patent office indicating that a patent application has met all requirements for issuance as a patent. Once formally granted, this Australian patent will remain in force until at least 2040, not including any potential patent term extensions. A corresponding patent has also been granted in Russia, and applications are pending in Europe, the United States, Japan, China, and other countries.

Iadademstat is currently being evaluated in combination with PD-L1 inhibitors (atezolizumab or durvalumab) in first line SCLC patients with extensive disease in a Phase I/II trial conducted and sponsored by the U.S. National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) with Oryzon. More than 30 sites accross the U.S. participate in the trial, including leading institutions such as Memorial Sloan Kettering Cancer Center, Johns Hopkins, City of Hope, Yale University and the University of Chicago, among others.

Oryzon has also received a Decision to Grant from the European Patent Office for its patent application EP24205125.8, titled "Vafidemstat for treating behavior alterations". The allowed claims cover the use of vafidemstat for the treatment of aggressiveness and social withdrawal associated with CNS diseases. Among the allowed claims, there are claims specifically aimed at the treatment of aggressiveness associated with Borderline Personality Disorder (BPD), Autism Spectrum Disorder (ASD), Alzheimer’s disease and other conditions, as well as claims directed to treating social withdrawal associated with diseases such as schizophrenia or ASD. Once formally granted, this European patent will remain in force until at least 2038, not including any potential patent term extensions. Additional patents in this family have already been granted or allowed in Europe, Australia, Canada, Hong Kong, Israel, South Korea, Malaysia, the Philippines, and Russia, with applications pending in other countries.

Vafidemstat is in advanced clinical development for the treatment of aggression in psychiatric disorders, with an upcoming Phase III trial in aggression in BPD (protocol submitted), and a Phase II trial in aggression in ASD patients under preparation. In addition, a Phase II trial is ongoing in schizophrenia, with a focus on negative symptoms. One of the most prominent negative symptoms of schizophrenia is social withdrawal.

"These new patent grants strengthen Oryzon’s global IP position by protecting key therapeutic indications under clinical development for iadademstat and vafidemstat, thereby extending the commercial life for both compounds", said Neus Virgili, Oryzon’s Chief IP Officer.