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 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 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported the completion of cohort 2a in the clinical Phase I trial evaluating the drug candidate 177Lu-AKIR001. Cohort 2a investigated a higher activity dose than the run-in cohort. The results aligned with earlier findings, demonstrating continued favorable safety and encouraging tumor uptake.

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The trial is conducted at Karolinska University Hospital, which also serves as the study sponsor. The purpose of the study is to assess safety, tolerability, and pharmacokinetics in patients with advanced, difficult-to-treat solid tumors.

Akiram’s drug candidate 177Lu-AKIR001 is a targeted radiopharmaceutical combining a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. This mechanism enables selective and precise delivery of radiation to tumor cells while limiting exposure to healthy tissue.

All patients planned for cohort 2a have now been enrolled, and no dose-limiting toxicities or other safety concerns have been observed. Following review of the cohort 2a data, the Safety Review Committee has approved initiation of cohort 2b. In this next step of the dose-escalation stage, the protein dose will be increased while maintaining the same activity level used in cohort 2a. Cohort 2b aims to identify the most favorable protein dose for the remaining cohorts in the Phase I trial and for further clinical development of AKIR001.

"Completing cohort 2a marks solid and steady progress in our dose-escalation strategy," says Marika Nestor, CEO of Akiram Therapeutics. "The consistency of the safety profile together with encouraging tumor uptake provides confidence as the study advances into the next step of the dose-escalation stage and confirms that development remains on track. Protein-dose optimization is central to preparing for subsequent stages of evaluation."

"Following a thorough safety assessment, we are pleased to now proceed to cohort 2b," says Dr. Luigi De Petris, Principal Investigator at Karolinska University Hospital.

The trial enrolls patients with anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma, and non-small cell lung cancer.

The project is the result of a successful national collaboration between leading clinical and academic institutions in the field of precision oncology and has been supported by the Swedish Cancer Society, the Sjöberg Foundation, the Erling-Persson Foundation, the Swedish Research Council, and Vinnova, Sweden’s Innovation Agency.

The trial is registered at ClinicalTrials.gov: NCT06639191.

About Akiram’s drug candidate AKIR001
Developed through antibody phage display and affinity maturation targeting the cancer marker CD44v6, 177Lu-AKIR001 combines a CD44v6-directed antibody with the therapeutic radioisotope lutetium-177. Preclinical studies have demonstrated high tumor specificity, favorable dosimetry, and antitumor activity in CD44v6-expressing xenograft models.

(Press release, Akiram Therapeutics, DEC 16, 2025, View Source [SID1234661452])

On December 16, 2025 FivepHusion, an advanced clinical-stage biotechnology company, reported that Dr Marion Mateos, Co-Principal Investigator of the phase 1/2 Deflexifol at Relapse Trial (DART) proudly supported by the Kids with Cancer Foundation, recently presented a poster of the phase 1 (Part A) trial results at the Society of Neuro-Oncology (SNO) 2025 Annual Meeting in Honolulu, Hawaii, USA, which was held from the 19th – 23rd November.
The poster can be found on the FivepHusion website here.

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Key outcomes of the phase 1 trial are:

Nine participants (aged 4-14 years) with ependymoma (n=6), diffuse midline glioma (DMG) (n-2) and embryonal tumour with multilayered rosettes (n=1) were enrolled
Deflexifol is well tolerated in children, with a side effect profile consistent with adults
Deflexifol pharmacokinetic properties are similar to those reported previously in adults, and for 5-FU in children
The Deflexifol paediatric maximum tolerated dose (MTD) was defined as 525mg/m2 bolus (of delivered 5-FU) followed by a 3000mg/m2 infusion. These results reflect:
~25% greater than typical 5-FU clinical dosing in adults
~9x the previously reported 5-FU MTD in children
The Recommended Phase 2 Dose for future paediatric studies was declared as the MTD
The DART phase 2 expansion cohort (DART Part B) evaluating the activity of Deflexifol in children with ependymoma will commence soon
The phase 1/2 DART study is an Australian investigator-initiated trial, led by Principal Investigators Professor David Ziegler and Dr Marion Mateos and sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in collaboration with FivepHusion. The trial is designed to investigate Deflexifol monotherapy as a treatment for paediatric ependymoma and other childhood brain cancers. All major paediatric oncology centres in Australia are participating in the trial, and major trial funding has been provided by the Kids with Cancer Foundation, through Sydney Children’s Hospitals Foundation, and the Robert Connor Dawes Foundation.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, "Presentation of the DART Phase 1 results at SNO 2025 was an excellent opportunity to raise international awareness of Deflexifol and its potential use in the treatment of paediatric ependymoma and other brain cancers. Congratulations and thanks to Dr Mateos for presenting the DART study results at such a prestigious international congress."

Deflexifol is an advanced clinical-stage, next-generation co-formulation of 5-FU and leucovorin (LV), a drug that significantly enhances 5-FU activity. Deflexifol has been previously evaluated in two successfully completed clinical trials in adults with a variety of solid tumours; the DART study is the first clinical evaluation of Deflexifol in paediatric patients. FivepHusion is harnessing the proven cytotoxic activity of 5-FU together with the unique, optimised attributes of the Deflexifol co-formulation to pursue Deflexifol development in a range of strategic solid tumour indications presenting with significant unmet medical needs, including paediatric ependymoma.

Ependymomas are rare central nervous system tumours (annual incidence of ~4 patients per million) that are more common in young children 0-4 years of age. The current standard treatment for ependymoma is surgery and radiotherapy, though relapse occurs in one third of all paediatric patients and is associated with a poor prognosis. Currently, there are no therapeutic drugs approved for the treatment of ependymoma, presenting a significant unmet medical need for the development of safe and efficacious new treatments for this disease.

Previously, 5-FU has been reported as a promising drug candidate for the treatment of paediatric ependymoma by independent research groups1,2, and in a clinical trial conducted at the St Jude Children’s Research Hospital (Memphis, Tennessee, USA)3. Recently, independent studies have gained further insights into understanding the susceptibility of paediatric ependymoma to 5-FU4. Research by FivepHusion collaborators indicates that Deflexifol, as an optimised co-formulation of 5-FU and LV, may be efficacious against paediatric ependymoma and other brain cancers. Due to its improved safety, tolerability, and potentially superior anti-tumour efficacy, Deflexifol offers the exciting opportunity of addressing the limitations of current 5-FU formulations to enable development as potentially the first approved drug for ependymoma and possibly other brain tumours.

(Press release, FivepHusion, DEC 16, 2025, View Source [SID1234661451])

On December 16, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported strong operational progress in the TACTI-004 (KEYNOTE-F91) Phase III trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for advanced/metastatic non-small cell lung cancer.

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The registrational TACTI-004 trial has enrolled 289 patients (over 38% of the trial’s targeted enrolment of 756 patients), and enrolment continues at a robust pace. Additionally, the number of activated clinical sites now exceeds 120 and 27 countries have received full regulatory approvals.

This includes the United States where the first of multiple clinical sites has received full regulatory clearance following the recent completion of the FDA’s Project Optimus initiative and subsequent receipt of local and central Institutional Review Board (IRB) approvals.

As announced on 9 October 2025, TACTI-004 had enrolled the necessary 170 patients to conduct the futility analysis that remains on track for the first quarter of CY2026. Furthermore, Immutep expects to complete patient enrolment in the third quarter of CY2026.

Immutep Chief Executive Officer, Marc Voigt, said, "We are very pleased with the strong operational progress of TACTI-004 globally and the robust pace of recruitment. Growing interest in this pivotal trial has been enhanced by the recent licensing deal for efti in emerging markets with Dr Reddy’s. The Immutep team is excited about further delivering on key milestones ahead, including the futility analysis and completion of patient enrolment."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About TACTI-004
TACTI-004 (Two ACTive Immunotherapies) is a randomised, double-blind, controlled Phase III study evaluating eftilagimod alfa (efti), a first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and chemotherapy as first line therapy for patients with advanced or metastatic non-small cell lung cancer with no EGFR, ALK or ROS1 genomic tumour aberrations. The global trial will enrol approximately 756 patients regardless of PD-L1 expression and with non-squamous or squamous tumours at over 150 clinical sites in over 25 countries. Patients will be randomised 1:1 to receive either efti in combination with pembrolizumab and chemotherapy in the treatment arm or pembrolizumab in combination with chemotherapy and placebo in the control arm. The study’s dual primary endpoints are progression-free survival and overall survival.

About Eftilagimod Alfa (Efti)
Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, DEC 16, 2025, https://www.immutep.com/immutep-announces-strong-operational-progress-in-global-tacti-004-keynote-f91-phase-iii-and-enrolment-continues-at-robust-pace/ [SID1234661432])