On December 16, 2025 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs targeting oncological and inflammatory diseases, reported an update on its clinical development activities and financial status.

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Namodenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available. An interim analysis from the Phase III study is expected to be in approximately Q4 2026. Subject to positive interim results, the Company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In parallel, Can-Fite is enrolling patients in a Phase IIb clinical study of Namodenoson for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This study follows positive results from a completed Phase IIa trial, which demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.

In addition, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the Company expects to report data during the second quarter of 2026.

Piclidenoson drug candidate: Can-Fite is currently enrolling patients in a pivotal Phase III clinical study for the treatment of psoriasis. In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician’s Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies. Based on the Company’s current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The Company also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026.

Cash and cash equivalents: As of June 30, 2025, Can-Fite had cash and cash equivalents and short term deposits of $6.45 million. On July 28, 2025, Can-Fite completed a public offering for aggregate gross proceeds of $5 million. In November 2025 Can-Fite Raised $2.2M through its ATM facility.

"Our advancing clinical programs reflect Can-Fite’s focused strategy of addressing significant unmet medical needs with orally administered, well-characterized drug candidates," said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma. "With pivotal Phase III studies ongoing in liver cancer and psoriasis, alongside progressing mid-stage programs in MASH and pancreatic cancer, we believe we are well positioned to generate meaningful clinical data over the coming quarters while maintaining disciplined execution."

(Press release, Can-Fite BioPharma, DEC 16, 2025, View Source [SID1234661453])

On December 16, 2025 Biostar Pharma, Inc., the U.S. wholly-owned subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (Stock Code: 2563.HK), reported that the first patient has been dosed for one of its key oversea clinical studies: the U.S. pivotal clinical study (NCT06764940) of Utidelone Injection(UTD1) combined with capecitabine for the treatment of HER2-negative breast cancer brain metastases (BCBM).

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The study adopts a two-stage design and plans to enroll approximately 120 subjects. The primary endpoint is the central nervous system objective response rate (CNS-ORR). Nearly 20 top tier clinical institutes across the United States are participating in the trial, including MD Anderson Cancer Center, John Hopkins Sidney Kimmel Comprehensive Cancer Center, City of Hope-Duarte, Robert H. Lurie Comprehensive Cancer Center at Northwestern University, University of Colorado Hospital, Augusta University, and University of California Los Angeles.

Utidelone’s unique physicochemical properties and insensitivity to P-glycoprotein-mediated efflux enable it to cross the blood-brain barrier (BBB) and prevent or treat brain metastases of solid tumors, setting it apart from taxanes, which are also microtubule stabilizers. A Phase II clinical study of utidelone combined with bevacizumab and chemotherapy for HER2-negative BCBM, which enrolled 34 subjects, was presented orally at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting [1]. The results showed a CNS-ORR of 67.6%, a central nervous system clinical benefit rate (CNS-CBR) of 88.2%, and a median central nervous system progression-free survival (CNS-PFS) of 15 months. The results of another Phase II clinical study of utidelone combined with bevacizumab for HER2-negative BCBM were published in JAMA Oncology in 2025 [2]. 47 subjects were recruited in the study, with a CNS-ORR of 42.6%, a median CNS-PFS of 10.6 months, and a median overall survival of 15.1 months. In both studies, most treatment-related adverse events (TRAEs) were Grade 1-2, controllable, and reversible. The U.S. FDA has also granted Utidelone orphan drug designation for the treatment of breast cancer brain metastases.

Approximately 20-50% of advanced breast cancer patients develop brain metastases [3]. Due to the presence of the BBB, many breast cancer treatments were unable to achieve effective concentrations intracranially, leading to generally poor prognoses for BCBM patients, particularly those with HER2-negative BCBM, whose median progression-free survival is only 2-6 months. However, there is currently no clearly effective drug therapy for HER2-negative BCBM, and no drugs worldwide have been approved for this indication, highlighting a significant and urgent unmet medical need. Utidelone has the potential to change this landscape, offering a new treatment option and hope for survival to these patients.

(Press release, Beijing Biostar Technologies, DEC 16, 2025, View Source [SID1234661469])

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])