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 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported that its therapeutic research arm, Caris Discovery, has entered into a multi-year collaboration and license agreement with Genentech, a member of the Roche Group. In this collaboration, Caris will work to identify and validate novel oncology targets in solid tumor tissue.

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Under the terms of the agreement, Caris is eligible to receive upfront and near-term payments of $25 million and is also eligible for up to $1.1 billion of potential research, development, commercial and net sales milestone payments, as well as potential tiered royalties on net sales of collaboration therapies.

"At Caris, we are committed to making precision medicine a reality for all patients. This innovative collaboration with Genentech is specifically designed to identify and validate novel targets in solid tumors. By combining Caris’ unparalleled multimodal data and tissue-based discovery engine with Genentech’s deep expertise in therapeutics development, we hope to enable the development of first-in-class medicines for cancer patients," said Milan Radovich, PhD, Senior Vice President and Chief Scientific Officer at Caris.

"Roche and Genentech are driven by a profound vision – a future where cancer can be cured," said Boris L. Zaïtra, Head of Roche Corporate Business Development. "We have successfully led many fundamental scientific advances in oncology. As we continue to bring forth transformative medicines, collaborations with partners such as Caris allow us to pursue future innovation for patients with unmet needs."

Caris is able to leverage insights from its extensive repository of nearly 500,000 solid tumor samples, along with matched comprehensive molecular and clinical data, to offer sophisticated and flexible target discovery capabilities leveraging both tissue-based and data-centric techniques to biopharma partners. Caris Discovery scientists use an integrated bioinformatics and wet-lab workflow, which combines interrogation of solid tissue and cell-based systems with multimodal data to validate prioritized targets and help advance the development of next generation therapies.

(Press release, Caris Life Sciences, DEC 16, 2025, View Source [SID1234661467])

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 METiS TechBio ("METiS") reported that two of its oncology pipeline candidates, MTS-105 and MTS-107, have been published in leading international peer-reviewed journals, Nature Communications and the Journal for ImmunoTherapy of Cancer (JITC), representing two major breakthroughs in mRNA-based cancer therapeutics.

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Both studies leverage METiS’s proprietary AI-powered NanoForge platform, which introduces a precision-guided rocket-and-payload delivery analogy. By combining liver- and spleen-targeted lipid nanoparticle (LNP) delivery systems with programmable mRNA engineering, METiS has developed a new generation of immunotherapy strategies capable of efficiently activating antitumor immunity in specific organs in vivo.

MTS-105 is a first-in-class mRNA-encoded T cell engager (TCE) therapy candidate for hepatocellular carcinoma (HCC), delivered via METiS’s proprietary liver-targeted LNP system. Study results demonstrate that, once delivered to and taken up within the liver, the mRNA is translated in situ and secreted locally as high level of bispecific antibodies, which rapidly penetrate HCC tissues. Employing this "Trojan Horse" strategy, MTS-105 efficiently activates T cells within the tumor to induce tumor cell killing, achieving complete tumor clearance and long-term T cell immune memory in mouse models.

MTS-105 provides a breakthrough solution to the long-standing limitations of protein-based TCEs in solid tumors, positioned as the world’s first mRNA-encoded TCE therapy for solid tumors. The program has now entered clinical development.

MTS-107 is an innovative mRNA therapeutic vaccine targeting HPV16/18-positive cervical and head and neck cancers, with potential to achieve breakthrough treatment for HPV-associated cancers. Using spleen-targeted LNPs, METiS’s team designed a construct combining dual E6/E7 antigens with a novel immune-activating adjuvant. In mouse models, MTS-107 demonstrated synergistic antitumor activity with PD-1 checkpoint inhibitors, resulting in robust expansion of HPV-specific CD8⁺T cells. MTS-107 will continue into original clinical exploration.

Chris LAI, Co-founder and CEO, said:

"This is an important milestone demonstrating the power of METiS’s AI-driven NanoForge platform in therapeutic development. In conventional cancer therapy, most ‘soldiers’ remain outside the tumor, unable to infiltrate solid tumors for precise, effective killing. Our ‘rocket-and-satellite’ precision delivery paradigm has been strongly validated in these studies. We look forward to advancing global clinical development with our partners, bringing targeted therapies to patients and offering hope for survival or even cure."

Dr. Wei XU, Chief Scientific Officer and corresponding author of two studies, added:

"mRNA therapeutics have long been constrained by delivery challenges, and innovation in LNP technology is essential for unlocking their full potential. MTS-105 is the first to show that an Fc-free bispecific T cell engager can activate T cells without driving exhaustion, while MTS-107 introduces a new antigen design and built-in adjuvant that markedly enhance antitumor immunity.

A recent Nature study reported that patients treated with PD-1 inhibitors nearly doubled their three-year survival if they had also received an mRNA COVID-19 vaccine—a finding that strongly aligns with our observations for MTS-107. These results highlight how mRNA platforms can synergize with PD-1 blockade and signal a new chapter for immuno-oncology"

Dr. Andong LIU, Vice President and Head of Platform Technologies, and co-corresponding author of the Nature Communications study, stated:

"Our NanoForge engine significantly accelerates LNP and mRNA design cycles, boosting delivery efficiency and safety for liver- and spleen-targeted therapeutics. LNP nanodelivery is critical for precise tissue targeting and effective antitumor therapy. These studies open broad new avenues for innovative mRNA therapeutics."

MTS-105: Preclinical Breakthrough in Nature Communications

On December 15, Nature Communications (IF 15.7, 2024) published METiS’s preclinical study titled:
"Organ-Specific Delivery of an mRNA-Encoded Bispecific T Cell Engager Targeting Glypican-3 in Hepatocellular Carcinoma."

Key highlights:

Organ-Specific Delivery: MTS-105 achieves highly efficient liver-targeted delivery with minimal systemic exposure. Studies in mice, rats, and cynomolgus monkeys show superior hepatic enrichment compared to antibody-based TCEs.

Controlled Release and Safety: Reduced C max and systemic exposure lower toxicity risks. In cynomolgus monkeys, linear pharmacokinetics were observed with excellent tolerability, supporting potential weekly dosing.

Potent Antitumor Efficacy: Data from mouse models showed a marked increase in intratumoral exposure, enabling 100% complete responses—with full tumor clearance—at doses as low as 0.15 μg. In contrast, the protein-based TCE control achieved only ~50% tumor growth inhibition even at 1 mg/kg (approximately 20 μg).

Durable T Cell Memory: Cured mice remained tumor-free upon rechallenge, indicating long-term immune memory and prevention of recurrence.
MTS-105 sets a new paradigm for translating TCE therapy into solid tumors, paving the way for first-in-class mRNA-encoded TCE therapy.

MTS-107: Breakthrough HPV Vaccine Published in JITC

On September 17, JITC published: "mRNA-encoded mutant HPV16/18 vaccines promote specific T-cell responses and synergize with anti-PD-1 checkpoint blockade in mediating therapeutic tumor regression in mice."

Key findings:

Complete Tumor Regression: In advanced HPV18⁺MC38 tumor models, MTS-107 combined with PD-1 blockade achieved 100% complete response (CR).

Spleen-Targeted LNP Delivery: Enhances antigen presentation and T cell activation.

Dual-Subtype Antigen Design: Encodes mutated HPV16/18 E6/E7 antigens; optimized mRNA sequences improve translation and stability.

Built-in Adjuvant: Co-expresses GM-CSF to promote dendritic cell maturation and HPV-specific CD8⁺T cell activation.

Synergy with PD-1 Blockade: While monotherapy expands tumor-infiltrating HPV-specific T cells; combination with PD-1 blockade relieves immune suppression for complete tumor regression.
This work demonstrates the transformative potential of AI-powered mRNA vaccines in HPV-associated cancers and establishes METiS’s innovation at the intersection of AI-driven nanodelivery and tumor immunotherapy, providing a strong foundation for clinical translation.

(Press release, METiS Pharma, DEC 16, 2025, View Source [SID1234661468])

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])