On September 9, 2026 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment, reported that it has entered into a research collaboration and license agreement with RayzeBio, Inc., a clinical-stage radiopharmaceutical company with a mission to transform the lives of people with cancer, to advance a novel radiopharmaceutical program focused on two undisclosed targets.

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Under the terms of the agreement, Ratio will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments, as well as royalties on net sales. The companies will apply their respective discovery, translational and radiopharmaceutical expertise to design, evaluate and optimize a next-generation clinical development candidate. RayzeBio has an exclusive worldwide license to candidates and products developed under the program and, following completion of specified research, translational and candidate-assessment activities led by Ratio, will assume responsibility for further development, manufacturing and commercialization worldwide. "The team at Ratio is proud to partner with RayzeBio to advance a next-generation novel radiopharmaceutical approach," said Jack Hoppin, Ph.D., Chief Executive Officer of Ratio. "By bringing together the complementary scientific expertise, technologies, and capabilities of both organizations, we believe this collaboration creates an opportunity to develop a differentiated therapeutic candidate. Together, Ratio’s discovery and translational capabilities and RayzeBio’s complementary radiopharmaceutical expertise position us to explore innovative approaches aimed at improving tumor targeting, retention, and therapeutic efficacy, with the goal of delivering meaningful benefits for patients with cancer."

"The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer," said Ben Hickey, President of RayzeBio. "The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated therapeutic candidate. We believe this approach has the potential to support more precise tumor targeting and expand future therapeutic options for patients with cancer."

(Press release, Ratio Therapeutics, SEP 9, 2026, View Source [SID1234670674])

On September 9, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported plans to commence a world-first Phase 1b first-in-human (FIH) study of PRP in February 2027.

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The multicenter, open-label study will enroll up to 50 patients with advanced solid tumors, including pancreatic, ovarian, and refractory prostate cancers, at trial centers across Australia. The two-part design, dose escalation (Part A) followed by dose expansion (Part B), is intended to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of PRP.

Several workstreams are advancing in parallel to support study start:

Manufacturing: GMP manufacture of finished drug product is underway. A small-scale technology transfer run has been completed. Two scale-up runs are scheduled this month, with an engineering run planned for late October. Raw drug substance supply for the PRP formulation is secured after recent audit and vendor qualification processes were successfully completed.
Bio-analytics: PK method validation has commenced. Development of an anti-drug antibody assay is underway, and in-use stability testing of the finished PRP formulation is scheduled.
Regulatory and ethics: Supporting documentation for Human Research Ethics Committee (HREC) submission is in preparation, including the Investigator’s Brochure (IB), a briefing document drawn from the IB, and the clinical trial protocol. Documents will be provided to investigators at Australian trial sites for feasibility assessment ahead of the planned HREC submission in November 2026.
PRP will be administered as a weekly intravenous infusion on Days 1, 8, 15, and 22 of each 28-day cycle. Treatment may continue until a withdrawal criterion is met.

Part A will use a Bayesian Optimal Interval (BOIN) design with backfill (BF-BOIN) and a predefined target dose-limiting toxicity (DLT) probability to identify the maximum tolerated dose (MTD), if reached, and/or up to two recommended doses for optimization and expansion (RDO). Up to five dose levels are planned. Following selection of the RDO(s) in Part A, Part B will further evaluate safety, tolerability, and preliminary antitumor activity in one or more tumor-specific expansion cohorts.

"We are making meaningful progress toward a pivotal milestone for Propanc as we prepare to advance PRP into the clinic," said James Nathanielsz, Chief Executive Officer of Propanc. "Our team is diligently executing planned manufacturing, analytical, and regulatory work required to initiate a world-first Phase 1b first-in-human study of PRP. Our objective is a therapy that can extend survival and improve quality of life for patients with limited remaining options — without the severe toxicities often associated with standard regimens. After years of research, that clinical milestone is now coming into view."

(Press release, Propanc, SEP 9, 2026, View Source [SID1234670673])

On September 9, 2026 Nerviano Medical Sciences S.r.l. ("NMS"), a global oncology-focused biopharmaceutical company, and HiDiamond Biotechnology Co., Ltd. ("HiDiamond"), a specialist in innovative NCEs therapeutics, reported a collaboration and license agreement for NMS-173.

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NMS-173 is a highly potent, second-generation dual inhibitor of mutant Isocitrate Dehydrogenase 1 and 2 (mIDH1/2). Unlike first-generation reversible inhibitors, NMS-173 utilizes a covalent mechanism of action designed to achieve sustained target inhibition and potentially address resistance mechanisms associated with existing reversible inhibitors.

Strategic Alliance Structure

Under the agreement, HiDiamond is responsible for advancing and funding the clinical development of NMS-173, including related regulatory activities, while NMS and HiDiamond jointly define the development strategy through an equally represented Joint Development Committee (JDC). This framework is structured for value creation, combining NMS’s scientific and development expertise with HiDiamond’s clinical development capabilities to accelerate the asset through Phase 1/2 and into proofof-concept studies.

The companies have established a stage-based proceeds-sharing framework to align long-term interests. Upon the future out-licensing of NMS-173 to a third-party global partner, NMS and HiDiamond will share the resulting proceeds — including upfront, milestone and royalty payments — pursuant to this agreed framework.

"NMS-173 is a highly differentiated molecule with the potential to advance the IDH inhibitor class through its covalent dual IDH1/2 mechanism," said Hugues Dolgos, Pharm.D., CEO of NMS. "This collaboration allows us to jointly advance and de-risk the asset ahead of a future global partnering opportunity."

"We are honored to work with the NMS team in Milan to bring this sophisticated molecule into broader clinical application," said Ying Shao, Ph.D., CEO of HiDiamond Biotechnology. "This proceeds-sharing model aligns our interests around generating compelling clinical data and demonstrating NMS-173’s differentiated profile, ensuring both teams are focused on a single objective: advancing a highly differentiated therapy that is attractive to global pharmaceutical partners."

About NMS-173

NMS-173 is an orally available, small molecule dual inhibitor of mIDH1 and mIDH2. It is currently ready to enter First-in-Human clinical development. By targeting the mutations directly through a covalent bond, NMS-173 is designed to suppress production of the oncometabolite 2-hydroxyglutarate (2-HG). Its dual inhibition mechanism is intended to address both IDH1- and IDH2-mutant tumors, including IDH-mutant cholangiocarcinoma, an area of high unmet medical need, with the overall indication strategy to be defined through the Development Plan.

(Press release, Nerviano Medical Sciences, SEP 9, 2026, View Source [SID1234670671])

On September 9, 2026 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that Company management will participate in a fireside chat at the following investment conference:

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H.C. Wainwright 28th Annual Global Investment Conference
Date: Tuesday, September 15, 2026
Time: 12:00 pm EDT / 6:00 pm CEST
Location: New York, NY
Presenters: Laurent Lévy, Chief Executive Officer of Nanobiotix, and Bart Van Rhijn, Chief Financial and Business Officer

(Press release, Nanobiotix, SEP 9, 2026, View Source [SID1234670670])

On September 9, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy approaches for cancer and autoimmune diseases, reported the completion of enrollment in the monotherapy cohorts of STARt-001, its Phase 1/2 clinical trial evaluating invikafusp alfa in patients with PD1–resistant, antigen-rich solid tumors. Enrollment continues in standard of care combination cohorts. In addition, updated results from the study have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress, taking place October 23– 27 in Madrid, Spain.

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The company also announced the appointments of Amy Otto as Senior Vice President, Program Leadership, and Zhenming Shun, Ph.D., as Senior Vice President, Data Science. Together, they will strengthen Marengo’s integrated development, execution and data capabilities as the company prepares invikafusp alfa for its next stage of clinical development.

"Completing enrollment in the STARt-001 monotherapy cohorts represents an important step in establishing invikafusp alfa’s single-agent activity across eight distinct PD-1–resistant tumor types, including MSS colorectal cancer, PD-L1–negative non-small cell lung cancer and triplenegative breast cancer," said Zhen Su, M.D., MBA, President and Chief Executive Officer of Marengo Therapeutics. "The signals observed across these diverse tumor types highlight invikafusp’s long-term potential as a pan-tumor immuno-oncology backbone. Our near-term priority is a focused development path in lead indications selected from these monotherapy cohorts, in areas of high unmet need for patients whose tumors are unresponsive to PD-1– directed therapies, which we expect to announce alongside the updated data at ESMO (Free ESMO Whitepaper)."

Following the ESMO (Free ESMO Whitepaper) presentation, the company expects to complete planned interactions with the U.S. Food and Drug Administration (FDA) to align on the development plan for invikafusp alfa, with the next stage of development expected to begin in 2027.

Appointment of Amy Otto, Senior Vice President, Program Leadership

Amy joins Marengo as Senior Vice President, Program Leadership. In this role, she will lead integrated development strategy and cross-functional execution for invikafusp alfa, partnering closely with Marengo’s leadership and functional teams to advance the program’s clinical, regulatory and operational priorities. Amy brings more than 20 years of oncology development leadership experience across Amgen, Seagen and Gilead, with deep expertise guiding programs from early development through regulatory approval, global launch and lifecycle expansion. Most recently, she served as Vice President and Head of Oncology Program Strategy Leadership at Gilead, where she grew the oncology program strategy function and shaped portfolio and program decisions across the pipeline of oncology investigational assets, including TRODELVY. Previously, Amy served as Product Team Leader for PADCEV at Seagen, leading the program through late-stage development, FDA approval, global launch and lifecycle expansion.

"Invikafusp alfa has generated compelling clinical momentum and has the potential to become an important new immuno-oncology backbone," said Amy. "I am excited to join Marengo at this important stage and work with its highly experienced team to integrate the evidence, strategy and execution required to realize the program’s full potential for patients."

Appointment of Zhenming Shun, Ph.D., to Senior Vice President, Data Science

Zhenming has been appointed Senior Vice President, Data Science, to lead biostatistics and data management across Marengo’s clinical portfolio, which will play a central role in shaping trial design, statistical strategy and evidence generation.

Zhenming brings more than 30 years of experience across the pharmaceutical industry and academia. Before joining Marengo, he served as Vice President, Global Head of Biostatistics and Data Management at Daiichi Sankyo and previously as Global Head of Biostatistics in Oncology at Sanofi. Across these roles, Zhenming led global teams responsible for clinical trial design, statistical analysis and regulatory submissions and contributed to multiple successful drug approvals in oncology and cardiovascular medicine.

"The breadth and maturity of the emerging invikafusp dataset create an important opportunity to apply rigorous statistical and data science approaches to its next stage of development," said Zhenming. "I look forward to working with our clinical, regulatory and program teams to translate these findings into an efficient, evidence-driven late-stage development strategy."

"As invikafusp advances toward its next critical inflection point, Amy’s extensive experience guiding oncology programs from early development through approval and commercialization and Zhenming’s deep statistical and data science expertise significantly strengthen our ability to translate emerging clinical evidence into a focused, integrated late-stage development strategy," said Dr. Su.

(Press release, Marengo Therapeutics, SEP 9, 2026, View Source [SID1234670669])