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])

On December 16, 2025 Allink Biotherapeutics, Inc. (AllinkBio), a clinical-stage biotechnology company focusing on developing advanced antibody-drug conjugates (ADCs) and multi-specific antibody therapeutics for oncology and immunology, reported successful completion of its extension rounds of Series A, raising 47 million US dollars. The extension rounds were led by existing supporter Legend Capital and new investor Meituan Long-Z Investment, followed by other prominent returning and new investors including Lanchi Ventures, Yuanbio Venture Capital, 5Y Capital, Lapam Capital, Runzhang Venture Capital, etc.

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Advancing Global Clinical Development for Two Leading Assets

The Series A extension rounds will help advance global clinical development for the company’s two leading programs with distinct competitive advantages. ALK201, a potential first- and best-in-class FGFR2b-targeted ADC, has demonstrated encouraging efficacy signals across multiple tumor types with a favorable safety profile, supporting its development as a backbone therapy for FGFR2b-overexpressing solid tumors. In parallel, early clinical data for ALK202 have provided preliminary support of the EGFR/cMET bispecific ADC’s potential as a cornerstone therapy in non-small cell lung cancer. Furthermore, the program is being expanded into clinical evaluation of a broader range of biomarker-defined tumor types and patient populations.

AllinkBio has started developing both lead clinical assets through a biomarker-guided strategy designed to demonstrate efficacy in a broad spectrum of solid tumors. In the near term, the company plans to initiate combination therapy studies to further explore the two assets’ therapeutic potential in broader front-line patient populations. These initiatives will accelerate ALK201 and ALK202 toward pivotal trial readiness while establishing a differentiated profile in their respective target indications.

Augmenting Novel Technology Platform Capabilities

Expanding beyond its ADC technology, AllinkBio is establishing a proprietary masked T-cell engager (TCE) platform to evolve the application of TCEs for solid tumors. In the immunology space, the company is advancing a portfolio of first-in-class bi- and multi-specific antibody drug candidates. Anchored in rational biology design, these programs aim to deliver next-generation solutions for patient populations underserved by current standards of care.

"We sincerely appreciate the decisive and continued support from our investors within such a short timeframe," said Hui Feng, Ph.D., Founder and Chief Executive Officer of AllinkBio. "With this support, we are moving forward with a clear clinical roadmap to accelerate our lead programs. Beyond the two leading programs, our discovery engine is fully activated, poised to deliver new wave of innovative drug candidates that will unlock further value in the foreseeable future ."

"Our continued support is rooted in our confidence in the AllinkBio team’s efficient execution and their robust development strategy," said Tan Hong, Managing Director at Legend Capital. "The rapid clinical advancement of their two competitive lead assets is already serving as a strong validation of the company’s ADC platform and presenting significant value. We look forward to the near-term clinical readouts and seeing more innovative programs emerge from their discovery platforms."

"The AllinkBio team pairs an international mindset with best-in-class execution, setting a remarkable pace in the ADC space," said Xuejing Guo, Managing Director and Head of Healthcare at Meituan Long-Z Investment. "We are deeply impressed by the potential of their technology platform and are excited to help the team translate these original innovations into global impact, ultimately delivering life-changing therapies to patients worldwide."

(Press release, Shanghai Allink Biotherapeutics, DEC 16, 2025, View Source [SID1234661466])

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])