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 Bayer and Kumquat Biosciences Inc., a clinical-stage biotech company founded by pioneers of targeting the KRAS pathway, reported the initiation of a Phase I clinical trial with KQB548 (BAY 3771249), an investigational inhibitor designed to treat KRAS G12D-mutated tumors, such as pancreatic, colorectal and lung cancer (Press release, Kumquat Biosciences, OCT 8, 2025, View Source [SID1234656511]). The first-in-human, dose-escalation study (NCT07207707) will evaluate the safety and preliminary efficacy of KQB548 (BAY 3771249) as a monotherapy in patients with KRAS G12D mutated tumors. KRAS mutations occur in nearly 25 percent of human cancers, yet the most prevalent and oncogenic KRAS variant (G12D) still lacks effective treatment options.

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"Initiating clinical development of investigational KRAS G12D inhibitor KQB548 (BAY 3771249) marks an important milestone in our commitment to develop new medicines targeting highly relevant signaling pathways that promote tumor growth and survival," said Dominik Ruettinger, M.D., Ph.D., Global Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "Targeting KRAS has been considered quite challenging. We aim to deliver treatment options for patients with cancers driven by the KRAS G12D mutation. Through continued research innovation we can unlock the potential of precision oncology and improve the lives of people living with cancer."

KRAS G12D mutations are found most frequently in approximately 37 percent of pancreatic ductal adenocarcinoma (PDAC), 13 percent of colorectal cancer and 4 percent of non-small cell lung cancers. These mutations are often recognized as important targets for cancer treatment, and their detection paves the way for the creation of tailored therapies.

Despite recent scientific advancements, there are currently no effective treatments available that provide durable therapeutic benefits for most patients with KRAS-G12D-mutated cancers. Introducing the KRAS G12D inhibitor into clinical trials aims to address the long-standing unmet need.

"We are excited to initiate the clinical trial of our KRAS G12D inhibitor KQB548, which holds the prospect of transforming the KRAS G12D treatments for the deadly malignancies such as pancreatic, lung and colorectal cancers," said Dr. Nicolas Acquavella, Senior Vice President of Clinical Development and Corporate Alliance Management of Kumquat. "The speedy enrollment highlights our team’s execution capabilities and Kumquat’s long-standing commitment to delivering potentially life-changing medicines to cancer patients."

About KRAS G12D inhibitor (KQB548 – BAY 3771249)
KQB548 (BAY 3771249) is an investigational KRAS G12D inhibitor being developed to treat KRAS-mutated tumors, such as pancreatic, colorectal and lung cancer. KQB548 (BAY 3771249) is the lead program from the Bayer and Kumquat global exclusive license and collaboration in precision oncology. Kumquat received U.S. Food and Drug Administration (FDA) clearance of the investigational new drug (IND) for its KRAS G12D inhibitor in July 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 NUCLIDIUM AG a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, reported positive clinical data from the ongoing Phase I/II trial (NCT06455358) evaluating its novel copper-radiolabeled PET tracer, 61Cu-TraceNetTM ([61Cu]Cu-NODAGA-LM3) in patients with SSTR-positive gastroenteropancreatic and bronchopulmonary neuroendocrine tumors (GEP & BP-NETS) (Press release, NUCLIDIUM, OCT 8, 2025, https://nuclidium.com/nuclidium-presents-positive-phase-1-2-results-for-first-copper-based-pet-diagostic-in-neuroendocrine-tumors-at-eanm-congress-2025/ [SID1234656513]). Principal investigator Dr. Guillaume Nicolas, Deputy Head of Nuclear Medicine at the Department of Theragnostics at University Hospital Basel, Switzerland, presented the results in an oral session during the European Association of Nuclear Medicine (EANM) Congress in Barcelona, Spain.

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The first-in-human, open-label, randomized, reader-blinded, Phase I/II study compared the safety, biodistribution, tumor uptake, and image quality of NUCLIDIUM’s copper-61-radiolabeled somatostatin receptor subtype 2 (SSTR2) antagonist, 61Cu-TraceNetTM with the standard of care gallium-68-labelled SSTR2 agonist, [68Ga]Ga-DOTA-TOC. In the first 22 patients with well-differentiated GEP and BP-NETs evaluated at the University Hospital Basel, 61Cu-TraceNET was well tolerated with no clinically significant adverse events reported. 61Cu-TraceNET showed a higher tumor uptake and tumor-to-background ratio and detected additional lesions in the liver and lungs. In a blinded analysis, independent readers rated the 61Cu-TraceNET image quality as superior compared to 68Ga-DOTATOC at both 1- and 3-hour imaging post-injection, supported by its 5.6-hour half-life, which enables broader distribution and delayed imaging. The image quality of 61Cu-TraceNET at 1- and 3-hours post-injection was assessed as equally good.

"Next-generation radiopharmaceuticals have the potential to transform the diagnosis and management of difficult-to-treat cancers. The first-in-human data with NUCLIDIUM’s novel copper-based diagnostic, 61Cu-TraceNETTM, show its excellent tumor specificity, improved image quality, and its ability to detect additional metastases," said Guillaume Nicolas, MD, PhD, Principal Investigator of the trial. "I am also encouraged by the safety, pharmacokinetic data, and the strong potential for 61Cu-TraceNETTM to support clinicians in the diagnosis in a range of SSTR2-positive tumors, including metastatic breast cancer, where better diagnostic approaches are urgently needed to improve treatment strategies."

Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM added "This rapidly generated first clinical data with 61Cu-TraceNETTM validates the potential of our copper-based platform and our ability to radiolabel an SSTR2 antagonist with high yield at room temperature for convenient patient diagnosis. With high specificity, low toxicity, and the potential to detect even the smallest primary and metastatic tumors early, 61Cu-TraceNET is well positioned to become a best-in-class diagnostic. We remain committed to rapidly advancing our copper-based theranostic pipeline to improve outcomes for patients across multiple cancer types with a focus on women’s health."

61Cu-TraceNETTM is the diagnostic component of NUCLIDIUM’s TraceNETTM program, targeting NETs and other SSTR-positive tumors such as metastatic breast cancer. A clinical trial of the corresponding therapeutic, 67Cu-TraceNET, is expected to start enrolling patients in 2026.

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