On December 16, 2025 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported a multi-year supply agreement with Ionetix Corporation, a leading cyclotron technology innovator and full-service radioisotope manufacturer, for two critical alpha-emitting radioisotopes: Actinium-225 (Ac-225) and Astatine-211 (At-211).

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Under the agreement, Ionetix will provide Cellectar with a reliable, clinical and commercial-scale supply of cGMP-grade Ac-225 and At-211 to support its drug development programs through clinical trials and into potential commercial launches of targeted alpha therapy (TAT) candidates.

"As we prepare for the future expansion of Cellectar’s radiotherapeutic pipeline beyond our beta and Auger emitter clinical programs and work to advance CLR-225 into clinical trials as a potential treatment for challenging solid tumor cancers such as pancreatic cancer, establishing a dependable and fully scalable supply of high-quality alpha-emitting isotopes is essential for the development of our targeted PRC pipeline," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "This collaboration with Ionetix ensures sufficient supply of these isotopes moving forward."

Cellectar’s proprietary phospholipid ether platform technology has demonstrated robust delivery of a wide variety of isotopes directly to tumor cells for a broad range of cancers. This unique capability allows Cellectar to identify the optimal isotope for the targeted tumor type. When paired with the platform, Ac-225 and At-211 are ideal alpha-emitting radioisotopes designed to deposit highly localized, high-energy radiation, that can destroy tumors while sparing surrounding healthy tissue.

"We are excited to collaborate with Cellectar to support their mission to deliver life-extending therapies for cancer patients," said David Eve, vice president of medical affairs at Ionetix. "We are currently installing a second cyclotron at our Michigan facility, which will now house two cyclotrons on-site—one dedicated to commercial-scale Ac-225 production and the other dedicated for At-211 production. Our cyclotron-based platform is designed to meet the growing demand for Ac-225 and the rapidly emerging need for At-211—both essential to advancing Cellectar’s next-generation TATs."

(Press release, Cellectar Biosciences, DEC 16, 2025, View Source [SID1234661454])

(Press release, Cellectar Biosciences, DEC 16, 2025, View Source [SID1234661454])

On December 16, 2025 Affibody AB ("Affibody") reported that the Trial Review Committee (TRC) has recommended to advance the Phase I clinical study with the Radioligand Therapy (RLT) candidate ABY-271 in HER2-positive metastatic breast cancer to its second part, where higher radioactivity levels will be evaluated.

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The TRC has based its positive recommendation on safety, tolerability, dosimetry and biodistribution data from the first enrolled cohort of patients, demonstrating tumor targeting and a favorable safety profile with low uptake in kidneys and other critical organs.

"The initial data from the ABY-271 study are very promising. We observed a favorable safety profile and encouraging biodistribution data, supporting progression of the study to the next stage," said assistant professor Oscar Wiklander at the Karolinska University Hospital, coordinating investigator in the study. "These results offer important insight into how the therapy behaves in patients, and we are eager to advance the study to deepen our understanding of its clinical potential."

"I am thrilled that these early clinical results with ABY-271 mirror the preclinical findings and dosimetry predictions remarkably well. I am especially excited about the low kidney uptake," said David Bejker, CEO of Affibody. "The positive outcome not only marks an important milestone for this program but also for the Affibody platform as a powerful technology for developing next-generation targeted radiotherapeutics."

ABY-271 is an Affibody molecule that targets HER2-expressing tumors and is labeled with the radioisotope lutetium-177, which emits cytotoxic beta radiation exerting irreversible damage to the tumor cells. Affibody is evaluating ABY-271 in a first-in-human, open-label, two-stage, randomized Phase 1 clinical study to assess the safety, tolerability, and biodistribution of ABY-271 in tumors and critical organs in subjects with HER2-positive metastatic breast cancer. The study is conducted at sites specialized in breast cancer and nuclear medicine in Sweden and Germany.

The TRC, including principal investigators, medical monitor, dosimetry and nuclear medicine specialists, has reviewed safety, tolerability, dosimetry and biodistribution data from a pre-specified number of enrolled patients. The TRC confirmed favorable safety and biodistribution, with low uptake in kidneys and other critical organs. The TRC recommends advancing the study to part B, which will evaluate higher radioactivity levels and additional protein mass doses. In line with this recommendation, Affibody will submit a protocol amendment to the European Medicines Agency (EMA) to accelerate the transition to the second part, which is expected to start in H1 2026 with the first results anticipated in H2 2026.

About the Phase 1 clinical study

The clinical study is a Phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of ABY-271 in tumors and critical organs in subjects with HER2-positive metastatic breast cancer.

The trial consists of two parts, part A in which the uptake of ABY-271 in tumors and critical organs will be evaluated in up to six sequentially enrolled patients, and part B in which higher radioactivity levels and additional protein mass doses for subsequent clinical trials will be evaluated in a total of 15 randomized patients. Patients will receive a single intravenous infusion of ABY-271 in both part A and part B. Dr Oscar Wiklander at Karolinska University Hospital is the coordinating investigator in Sweden. More information about the study can be found on clinicaltrials.gov under NCT07081555.

(Press release, Affibody, DEC 16, 2025, View Source [SID1234661470])

On December 16, 2025 CytoAgents, Inc. a clinical-stage biotechnology company developing CTO1681, a novel, steroid-sparing inhibitor of prostaglandin-mediated inflammation, reported the appointment of Dr. Johannes Wolff, MD, PhD, as Chief Medical Officer (CMO) and Michael D. Howell, PhD, as Chief Scientific Officer (CSO).

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Dr. Johannes Wolff, MD, PhD, Chief Medical Officer

Dr. Wolff brings over three decades of distinguished leadership in academic medicine and the pharmaceutical industry, with deep expertise in clinical trial strategy, drug development, and medical affairs. Originally trained as a pediatric hematologist-oncologist, Dr. Wolff has held senior roles in both academic and industry settings, including Vice President of Clinical Development at Replimune, Senior Medical Director at AbbVie and Novartis, and department chair positions at leading institutions such as Cleveland Clinic and Tufts Medical Center. He has led successful Investigational New Drug applications, pivotal trials, and regulatory approvals across a broad spectrum of hematologic and solid tumor indications. Dr. Wolff is also a scholar, with more than 200 peer-reviewed publications, multiple books, and extensive experience mentoring the next-generation of clinical researchers.

Michael D. Howell, PhD, Chief Scientific Officer

Howell joins CytoAgents with more than 25 years of experience in research and drug development, spanning immunology, dermatology, oncology, and translational science. He has served as Chief Scientific Officer at Zura Bio and DermTech, and held senior scientific leadership roles at Incyte, AstraZeneca/MedImmune, and the Immune Tolerance Network. Howell is recognized as a scientific innovator and inventor on multiple patents, including monoclonal antibodies and biomarker strategies, and has played a pivotal role in securing significant funding and advancing precision medicine initiatives. His expertise in translational biomarker development and strategic leadership in both early and late-stage clinical programs will be instrumental as CytoAgents advances its pipeline.

"Johannes and Michael’s combined expertise in clinical development, translational science, and strategic leadership will be invaluable as we accelerate our mission to deliver transformative therapies for immune-mediated diseases," said Teresa Whalen, CEO of CytoAgents. "To truly expand CAR T access for patients, we must find better ways to manage toxicities, and broaden awareness within the medical community."

(Press release, CytoAgents, DEC 16, 2025, View Source [SID1234661455])

On December 16, 2025 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that European Urology Oncology published results of a clinical study demonstrating the implications of implementing Bladder EpiCheck in conjunction with standard-of-care (SoC) white light cystoscopy (WLC) for non-muscle invasive bladder cancer (NMIBC) surveillance in high-grade recurrence. The article was published online in European Urology Oncology.

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The results demonstrated superior Bladder EpiCheck sensitivity in detecting high-grade recurrences, specifically in patients with stage 0is (cases with carcinoma in situ [CIS] without papillary tumors [Tis]), versus current SoC WLC. Bladder EpiCheck outperformed WLC across all measures of sensitivity. The analysis included 231 high-grade NMIBC patients followed up for a median of 16 months with 316 surveillance visits of both WLC and Bladder EpiCheck. Two events of progression to muscle invasive bladder cancer (MIBC), 28 high-grade NMIBC recurrences and seven low-grade NMIBC recurrences occurred within 6 months of a surveillance visit. Bladder EpiCheck detected 92% of these events, including 90% of high-grade NMIBC/MIBC cases and 100% of low-grade NMIBC cases versus 62%, 63%, and 57%, respectively, detected by WLC. Importantly, Bladder EpiCheck detected 92% of Tis cases, where WLC detected 38%. These results underscore the ability of Bladder EpiCheck to detect high-grade recurrences that were missed by WLC by identifying NMIBC patients with a negative surveillance cystoscopy who should undergo biopsy.

"CIS is one of the more aggressive forms of bladder cancer, with up to a 60% risk of progressing to muscle-invasive disease (stage II) if left untreated," said Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian), who led this project and is a member of the European NMIBC and MIBC Guidelines Committees. "If CIS recurrence at stage 0 (Tis) is missed and the tumor is detected only after it has progressed to stage I or stage II, removal of the bladder by cystectomy is usually the recommended treatment and patients’ five-year survival rates might significantly decrease. The findings from this study are significant because they demonstrated that Bladder EpiCheck can open a vital window of tumor detection at an earlier disease stage allowing for earlier intervention, potentially avoiding bladder removal, and better outcomes."

"We are excited to see the results from this impressive study and believe that Bladder EpiCheck is poised to significantly improve care management for NMIBC patients," said Chris Hibberd, Chief Executive Officer of Nucleix.

Earlier data from this study was presented at the 46th Annual European Association of Urology (EAU) Congress and the American Urological Association’s (AUA) 2025 Annual Meeting.

About Bladder EpiCheck

Bladder EpiCheck provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The PCR test analyzes subtle disease-specific changes in DNA methylation markers, with high sensitivity and specificity. Bladder EpiCheck is intended for use as a non-invasive method for detection of NMIBC recurrence in conjunction with standard of care methods. Bladder EpiCheck is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. It is commercially available in Europe and in the United States.

(Press release, Nucleix, DEC 16, 2025, View Source [SID1234661471])

On December 16, 2025 Eli Lilly and Company (NYSE: LLY) reported it will participate in the 44th Annual J.P. Morgan Healthcare Conference, Jan. 12-15, 2025. David A. Ricks, Lilly chair and CEO, will take part in a fireside chat on Tuesday Jan. 13 at 5:15 p.m., Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

(Press release, Eli Lilly, DEC 16, 2025, View Source [SID1234661456])