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])

On September 9, 2026 Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, reported that more than 35 abstracts featuring data from its multiple myeloma portfolio will be presented at the 2026 International Myeloma Society (IMS) Annual Meeting in Glasgow, Scotland from September 23 to 26. The presentations span approved and pipeline therapies across multiple stages of disease. They feature long-term follow-up and Phase 3 analyses evaluating outcomes in earlier treatment settings, highlighting advances that contribute to deeper and more durable responses and support the company’s ambition toward potential cures.

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Leadership comments on redefining what’s possible for patients with multiple myeloma

"Multiple myeloma treatment has advanced significantly, but our ambition is to keep pushing beyond disease control toward patient outcomes that were once difficult to imagine," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "The breadth of new data at IMS reflect our focus on bringing highly effective therapies into earlier treatment settings, generating long-term follow-up that deepens our understanding of durable responses, and building the scientific understanding needed to further progress potential cures."

Key presentations include:

New ≥ 5-year follow-up from the Phase 2 CARTITUDE-2 Cohort A study evaluating CARVYKTI (ciltacabtagene autoleucel; cilta-cel) as a single infusion in patients with relapsed or refractory multiple myeloma treated as early as second line (1-3 prior lines) (Abstract #PA-288)
New analyses from the Phase 3 MajesTEC-3 study further evaluates overall survival, progression and non-relapse mortality with TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in patients with relapsed or refractory multiple myeloma treated as early as second line (1-3 prior lines), with mixture cure modeling (MCM) estimating >85% statistical cure fractions and suggesting the potential to redefine long-term survival expectations for a substantial proportion of patients (Abstract #OA-49 and Abstract #OA-58)
Results from the Phase 3 MonumenTAL-3 study evaluating TALVEY (talquetamab-tgvs) in combination with DARZALEX FASPRO, with or without pomalidomide, versus DARZALEX FASPRO, pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma [Encore of EHA (Free EHA Whitepaper) 2026], as well as results from the Phase 2 MajesTEC-5 TALVEY induction arm evaluating TALVEY plus DARZALEX FASPRO and lenalidomide as induction therapy in transplant-eligible patients with newly diagnosed multiple myeloma. (Abstract #PA-350 and Abstract #OA-51)
Long-term outcomes from the Phase 3 PERSEUS study evaluating DARZALEX FASPRO in a Dara-VRd regimen vs. VRd (bortezomib, lenalidomide and dexamethasone) in transplant-eligible patients with newly diagnosed multiple myeloma (Abstract #LBA-07)
Updated safety and efficacy data for ramantamig (JNJ-5322), an investigational BCMA and GPRC5D trispecific antibody, at the recommended Phase 2 dose, with new data demonstrating feasibility of outpatient dosing in patients with relapsed or refractory multiple myeloma (Abstract #OA-70)
A complete list of Johnson & Johnson–sponsored abstracts is available on JNJ.com.

About Multiple Myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.1 In multiple myeloma, these clonal plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.2 Multiple myeloma is the second most common blood cancer worldwide.3 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.4 People living with multiple myeloma have a 5-year survival rate of 59.8%.5 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.6,7 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.

(Press release, Johnson & Johnson, SEP 9, 2026, View Source [SID1234670668])