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, Agenus Inc. ("Agenus") reported to have entered into a Promissory Note Agreement (the "Note") with Zydus Pharmaceuticals (USA) Inc. ("Zydus"), a wholly owned subsidiary of Zydus Lifesciences Limited, for up to $10,000,000 (the "Principal Amount") (Filing, 8-K, Agenus, OCT 8, 2025, View Source [SID1234656531]). The Note bears interest at 3.81% per annum and matures upon the closing of the Asset Purchase Agreement and Securities Purchase Agreement signed by Agenus and Zydus on June 3, 2025 (together, the "APA/SPA"), or, if such closings will not occur, within 10 days after notification that the APA/SPA closings will not be consummated. The Note contains terms and conditions, including representations and warranties, governing its issuance.

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Use of Proceeds; Forgiveness Feature. Proceeds from the Note will (i) fund the operational expenses of the Emeryville and Berkeley facilities for the fourth quarter of 2025—which amount, pursuant to the Note, will be forgiven and not repaid if the APA/SPA close—and (ii) to make certain payments owed in respect of assets subject to the APA between the parties.

Collateral. As collateral for the Note, Agenus pledged 822,910 shares of common stock of MiNK Therapeutics, Inc. (NASDAQ: INKT) that are owned by Agenus. Agenus also executed a control agreement related to these shares, which control agreement provides certain rights to Zydus in the event that there is an event of default under the Note. Upon satisfaction of the obligations under the Note (including repayment or forgiveness in connection with an APA/SPA closing), the pledge is expected to be released in accordance with the Note and related agreements.

The foregoing summary of the Note, the related pledge agreement and the control agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such agreements, copies of which will be filed, with confidential terms redacted as applicable, as exhibits to Agenus’s Quarterly Report on Form 10 Q for the quarter ended September 30, 2025

On October 8, 2025 Aarvik Therapeutics, an innovative, ADC-focused biotechnology company dedicated to engineering precision medicines for cancer therapy, reported an investment by Laurus Labs, India in Aarvik’s recently-concluded Series Seed 2 financing round (Press release, Aarvik Therapeutics, OCT 8, 2025, View Source [SID1234656527]).

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Since launching in 2021, Aarvik has developed its proprietary MUTTA (MUlti-epitope Targeting Tetravalent Antibody) plaform with a focus on developing next generation antibody drug conjugates (ADCs) that can expand the success of ADCs beyond a limited number of targets. Aarvik’s comprehensive approach facilitiates the lowering of the minimum effective dose (MED) while maintaining or improving the maximum tolerated dose (MTD) thereby significantly improving the therapeutic window. The Series Seed 2 round, which had investments from multiple investors including Laurus, is an acknowledgement of the substantial progress made by Aarvik on the MUTTA platform and will allow Aarvik to further advance its exciting pipeline of ADC assets.

"As part of our global support of innovation and progress in healthcare, we are delighted to invest in Aarvik’s efforts to pursue breakthroughs in oncology therapies," said Dr. Satyanarayana Chava, Founder & CEO of Laurus Labs. "We look forward to a highly productive collaboration that results in tangible benefits for patients across the globe."

"Aarvik is delighted to welcome Laurus Labs as an investor and a partner in our efforts to pursue improved therapies for hard-to-treat indications in cancer," said Jagath Reddy Junutula, PhD, Co-founder, President and CEO of Aarvik Therapeutics. "Our mission to provide transformational benefits for cancer patients is greatly strengthened by our ability to work with outstanding companies like Laurus Labs."

On October 8, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported 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, View Source [SID1234656526]). 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.

On October 8, 2025 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to VT3989, the company’s first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor (Press release, Vivace Therapeutics, OCT 8, 2025, View Source [SID1234656525]). The designation pertains to VT3989’s use as a treatment for patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.

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FDA’s Fast Track Designation is granted to drug candidates that are being developed for the treatment of serious or life-threatening conditions and have the potential to fill unmet medical needs. The program is designed to ensure that these important new treatments can reach patients as quickly as possible. A company that receives Fast Track Designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate’s clinical development plan, including possible eligibility for accelerated approval and priority review.

"We are pleased to receive Fast Track Designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options. This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy," said Sofie Qiao, Ph.D., president and chief executive officer of Vivace Therapeutics.

VT3989 is a novel investigational small molecule cancer therapeutic that is designed to target the Hippo pathway by inhibiting palmitoylation of members of the TEAD protein family. The compound has been evaluated in more than 200 patients to date in an ongoing, open-label Phase 1 clinical study and, to the company’s knowledge, is the first and only member of the TEAD autopalmitoylation inhibitor class for which compelling clinical efficacy data have been publicly reported. In addition to the promising data to date, VT3989 has demonstrated a positive safety profile in the Phase 1 trial, which supports its best-in-class potential.

About Phase 1 study of VT3989
The Phase 1 study of VT3989 (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma.