On October 8, 2025 Sanofi reported positive results from the ALPHAMEDIX-02 phase 2 study (clinical study identifier: NCT05153772) showed AlphaMedixTM (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR)-Targeted Alpha Therapy using the lead-212 isotope, met all primary efficacy endpoints and showed clinically meaningful overall response rates (ORR) and prolonged clinical benefits in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients with unresectable or metastatic SSTR positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Benefits in key secondary endpoints, including progression-free survival (PFS) and overall survival (OS), were also observed across both cohorts. AlphaMedix had a manageable safety profile that was similar across both cohorts.

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"The positive results from the ALPHAMEDIX-02 study represent a pivotal movement for the Orano Med 212Pb-based platform and underscore the profound potential of lead-212-based radiopharmaceuticals in addressing critical unmet needs for patients with GEP-NETs. We are very encouraged by AlphaMedix’s consistent and clinically meaningful activity across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients," said Volker Wagner, MD, PhD, Chief Medical Officer at Orano Med. "These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment option for people living with GEP-NETs."

Alpha-emitters are being studied to determine their relative potency and targeted tumor activity compared to current approved therapies. It is believed they could potentially reduce exposure of surrounding healthy tissue due to the short range of alpha particles. In February 2024, AlphaMedix was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for treatment of PRRT-naïve patients with unresectable or metastatic, progressive SSTR-expressing GEP-NETs, recognizing the potential clinical benefits and potential of this lead-212–based therapy.

"The promising ALPHAMEDIX-02 results represent a significant step forward, reinforcing the potential of targeted alpha therapy to deliver precise treatment for GEP-NETs," said Christopher Corsico, MD, Global Head of Development at Sanofi. "These data, demonstrating clinically meaningful activity and a manageable safety profile, underscore our unrelenting commitment to developing innovative therapies for patients with difficult-to-treat cancers. We look forward to advancing AlphaMedix and working with Orano Med and regulators to bring this important treatment to the GEP-NET community as soon as possible."

The study is ongoing, and the full results will be presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The results will also form the basis of discussions with health authorities. AlphaMedix has not been approved by any regulatory authority.

About the ALPHAMEDIX-02 study

ALPHAMEDIX-02 is a phase 2, open-label, multicenter study evaluating the efficacy and safety of AlphaMedix (212Pb-DOTAMTATE) in patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least one site of measurable disease. The study included two cohorts evaluating PRRT-naïve (n=35) and PRRT-exposed (n=26) patients. PRRT-exposed patients had progressive disease after receiving up to four doses of 177Lu-DOTATATE and received their last dose at least six months prior to Day 1. In both cohorts, AlphaMedix was administered at 67.6 µCi/kg every eight weeks for up to four cycles (6 mCi maximum per cycle). Primary endpoints included ORR per RECIST1.1 and safety. Secondary endpoints included PFS and OS.

About NETs

NETs are a heterogeneous group of cancers that originate from neuroendocrine cells. These cancers occur mostly in the gastrointestinal tract and pancreas but can also occur in other tissues including the thymus, lung, and other uncommon sites such as the ovaries, heart, and prostate. Most NETs strongly express somatostatin receptors. Despite the global prevalence of NETs increasing each year, it is considered a rare cancer that is estimated to affect approximately 35/100,000 individuals worldwide. In the United States, around 12,000 patients annually are expected to be diagnosed with neuroendocrine tumors, with an average five-year survival rate of 60% at a metastatic stage.

(Press release, Sanofi, OCT 8, 2025, View Source [SID1234656678])

On October 8, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ) ("TransCode or the "Company") reported that it entered into a definitive agreement to acquire Polynoma LLC, a privately-held biotechnology immuno-oncology company (Press release, TransCode Therapeutics, OCT 8, 2025, View Source [SID1234656516]). Polynoma is developing a late-stage candidate, seviprotimut-L, a novel polyvalent shed antigen vaccine for the adjuvant treatment of stage IIB and IIC melanoma.

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Concurrent with the Polynoma acquisition, TransCode announced a $25 million investment from CK Life Sciences Int’l., (Holdings) Inc. ("CK Life Sciences") to be used primarily to advance clinical development of TransCode’s lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial.

Philippe Calais, PharmD, PhD, has been appointed as TransCode’s Chief Executive Officer and remains Chairman of the Board of Directors, but has stepped down from his positions on the Board’s Audit Committee and Compensation Committee. Tom Fitzgerald steps down as Interim Chief Executive Officer but remains Chief Financial Officer and a member of the Board Directors. There are no other changes to the executive team. TransCode expects to retain several finance, development and manufacturing professionals from Polynoma. Elizabeth Czerepak, MBA, has been selected as a new independent board member and becomes Chairperson of the Audit Committee, effective as of the closing of the transaction.

Dr. Philippe Calais stated that "I am very honored to deepen my commitment and lead TransCode’s transformation into a one-of-a-kind leading oncology company at this critical time. We are grateful for CK Life Sciences’ investment and their support of our miRNA candidate, TTX-MC138, as we now have the funding in place to fully execute our upcoming TTX-MC138 Phase 2. This acquisition allows us to create a unique and broader pipeline with Phase 3 ready seviprotimut-L, and potentially realize synergies between both technologies, for the ultimate benefit of patients suffering from cancer and metastases. Between the two programs, we see a unique potential to augment seviprotimut-L’s focus with our microRNA lead program, TTX-MC138, by addressing the micrometastases in stage IIB and IIC melanoma patients."

"Finally, I express my gratitude to Tom Fitzgerald for his remarkable dedication and commitment as he steps down from the Interim Chief Executive Officer position to revert to his previous role as Chief Financial Officer. I extend a warm welcome to all our new colleagues transitioning from Polynoma and to Elizabeth Czerepak, our new Independent Board member. All the ingredients are now in place to fully execute on our ambitious plan and deliver value to our shareholders" said Dr. Calais.

TransCode’s Proprietary Expanded Pipeline:

Clinical stage Programs:

· TTX-MC138 targets microRNA-10b, believed to be a master regulator of metastatic cancer across multiple indications
· Seviprotimut-L is a novel polyvalent shed antigen vaccine aimed at melanoma patients that have limited options in stage IIB and IIC

Pre-clinical Programs:

· R&D exploration of combining TTX-MC138 and seviprotimut-L technologies
· TTX-siPDL1, siRNA-based modulator of PD-L1
· TTX-RIGA, RNA-based agonist of RIG-I
· TTX-siMYC, RNA-based inhibitor of c-MYC

About the Acquisition and Financing

Pursuant to the definitive agreement, the sole stockholder of Polynoma, an indirect wholly-owned subsidiary of CK Life Sciences, will receive an aggregate of 83,285 shares of common stock and 1,152.9568 shares of non-voting Series A convertible preferred stock (with a 1:10,000 conversion ratio of preferred to common) (the "Series A Preferred Stock"). Concurrent with the acquisition, TransCode entered into an investment agreement with a subsidiary of CK Life Sciences in which that entity has purchased in a private placement an aggregate of 223.7337 shares of non-voting Series B convertible preferred stock (with a 1:10,000 conversion ratio of preferred to common) (the "Series B Preferred Stock, and together with the Series A Preferred Stock," the "Preferred Stock") for an aggregate consideration of $25 million, consisting of $20 million in cash and a promissory note with an aggregate principal amount of $5 million. Both transactions are expected to close on October 8, 2025. This represents, on a fully diluted basis, approximately 91% for CK Life Sciences and approximately 9% for the pre-acquisition stockholders of TransCode (including transaction fees) and a combined fully diluted equity value of approximately $165 million. Additional conditional payments totaling $95 million may be payable to the CK Life Sciences subsidiary upon the achievement of clinical, regulatory and commercial milestones for seviprotimut-L. The issuance of shares of common stock upon conversion of the Preferred Stock issued in the acquisition and the financing shall be subject to stockholder approval in compliance with the rules of the Nasdaq Stock Market where applicable. A non-transferrable CVR will be distributed to TransCode stockholders of record as of October 20, 2025 to receive certain proceeds received by TransCode, if any, related to future upfront, development or regulatory milestone payments resulting from a corporate partnering transaction of TTX-MC138.

Tungsten Advisors served as the exclusive financial advisor and sole placement agent to TransCode. Orrick, Herrington & Sutcliffe, LLP is serving as legal counsel to TransCode. Freshfields US LLP served as legal counsel to CK Life Sciences and its subsidiaries.

On October 8, 2025 Xspray Pharma reported to have received a CRL from the U.S. Food and Drug Administration (FDA) concerning the Company’s New Drug Application (NDA) for Dasynoc (dasatinib) for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) (Press release, Xspray, OCT 8, 2025, https://xspraypharma.com/modular_finance_pressmeddelande/xspray-pharma-provides-update-on-the-fda-process-for-dasynoc-observations-at-contract-manufacturer-delay-approval/ [SID1234656517]).

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The FDA’s decision is based on GMP (Good Manufacturing Practice) observations at the Company’s contract manufacturer. No observations were directed at the production line used for Dasynoc, but the FDA is pausing approvals of new products at the facility while corrective actions are being implemented. The manufacturer has confirmed that a remediation plan is already in place and that a meeting with the FDA is scheduled for December.

"It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date," said Per Andersson, CEO of Xspray Pharma. "We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed."

The FDA has also requested information demonstrating that the discussed product information is appropriate and data confirming the outcome of previously implemented corrective actions at the production line.

Other programs
Xspray’s other development programs are progressing according to plan. The review of the NDA for XS003 (nilotinib) is expected to be initiated by the FDA shortly, with an anticipated PDUFA date in June 2026.

On October 8, 2025 Sapu Nano reported the presentation of its poster, "Sapu-003: Novel Intravenous Deciparticle Everolimus Entering Phase 1 Study in Australia," at the 8th Australian Translational Breast Cancer Research Symposium (ATBCR 2025) (Press release, Sapu Bioscience, OCT 8, 2025, View Source [SID1234656520]). Sapu Nano is part of the Sapu family of companies, formed through GMP Biotechnology Limited, a joint venture between Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and Dragon Overseas Capital Limited.

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Sapu-003 is the first intravenous (IV) Deciparticle formulation of everolimus, an mTOR inhibitor widely used in oncology. While oral everolimus (Afinitor) has demonstrated efficacy in breast cancer, renal cell carcinoma, and neuroendocrine tumors, its broader use has been constrained by low bioavailability, variable systemic exposure, and gastrointestinal toxicities.

Global Development Partnership
The trial is being conducted in collaboration with SOCRU, a leading Phase 1 clinical unit in Australia; Ingenū, a clinical research organization with deep early-phase expertise; and Medicilon, Sapu Nano’s strategic partner for preclinical drug development. Together, these partnerships ensure robust clinical execution, regulatory alignment, and high-quality product supply for the study.

Call to Patients and Physicians
The trial (ACTRN12625001083482) is now open for enrollment at leading oncology centers across Australia. Eligible participants include adults with advanced HR+/HER2- breast cancer or other mTOR-sensitive tumors who have exhausted standard therapies. Physicians are encouraged to refer patients who may benefit from participation.

"Sapu-003 represents a significant advance in the delivery of mTOR-targeted therapies," said Vuong Trieu, PhD, Chief Executive Officer of Sapu Nano. "Through the combined expertise of SOCRU, Ingenū, and Medicilon, we are positioned to accelerate development and bring this next-generation treatment option to patients with advanced cancers."

On October 8, 2025 Oncoinvent reported new data highlight continued potential of Radspherin to prevent disease progression Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, announced positive final 24-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis (Press release, Oncoinvent, OCT 8, 2025, https://www.oncoinvent.com/press-release/oncoinvent-reports-positive-final-data-from-phase-1-trial-of-radspherin-to-treat-ovarian-cancer/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234656487]). Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

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In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq). The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point[1],[2],[3].

"These highly encouraging results conclude our Phase 1 program for Radspherin and fuel our determination to advance Radspherin as an innovative treatment for patients with peritoneal metastases as quickly as possible," said Oystein Soug, CEO of Oncoinvent. "We are profoundly grateful to the patients, investigators, and the team for their invaluable contributions and look forward to interim results from our Phase 2 study next year."

"Peritoneal metastases remain a defining challenge in ovarian cancer, often driving recurrence," said Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "These final results are truly encouraging, suggesting that Radspherin could help delay disease progression and offer patients hope for longer, healthier lives. It is particularly promising to see that the new recurrences were limited to lymph nodes, which are typically associated with longer survival compared to peritoneal relapses.

About RAD-18-001

RAD-18-001 was an open label Phase 1 trial conducted in patients with peritoneal metastases in platinum-sensitive recurrent ovarian cancer. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection. A total of 21 patients were enrolled across sites in Norway, Belgium and Spain.