On December 3, 2025 Akiram Therapeutics, a Swedish biotech company specializing in targeted radiotherapy, reported that data on its CD44v6-targeted radiotherapeutic candidate AKIR001 have been published in The Journal of Nuclear Medicine, one of the leading journals in nuclear medicine. The publication summarizes key studies underpinning the ongoing first-in-human Phase 1 trial at Karolinska University Hospital. It reports high tumor selectivity, favorable safety and dosimetry findings, and antitumor effects in multiple preclinical models.

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The article, titled "Preclinical Validation of [177Lu]Lu-AKIR001, a CD44v6-Targeted Radiotherapeutic Entering First-in-Human Trials," presents foundational data supporting the clinical development of AKIR001. The study shows that the candidate exhibits a favorable tumor-to-organ profile, with sustained retention in tumors and low uptake in normal tissue — key characteristics of radiopharmaceuticals. The combined findings from biodistribution, dosimetry and specificity analyses confirm that 177Lu-AKIR001 demonstrates clear and selective targeting of CD44v6-expressing tumors.

The efficacy and safety results further strengthen the rationale for clinical evaluation, with clear dose-dependent antitumor activity and low uptake in normal tissues across several preclinical systems. These findings provide important scientific validation for Akiram’s CD44v6-targeted approach and support the ongoing first-in-human trial in patients with tumors that express CD44v6.

"These results bring together years of systematic development around our CD44v6 platform—spanning antibody engineering, dosimetry, in vivo studies and safety assessments. Having the work peer-reviewed adds an extra layer of confidence as the drug is now being evaluated in patients at Karolinska University Hospital. For us, it reaffirms that we are advancing on a solid and well-supported scientific foundation," says Marika Nestor, CEO of Akiram Therapeutics.

About the Phase 1 clinical trial
The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.
The trial is registered at ClinicalTrials.gov: View Source

(Press release, Akiram Therapeutics, DEC 3, 2025, View Source [SID1234661093])

On December 3, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following global update on FLAMINGO-01.

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Flamingo-01 Progress to Date

The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01, continuing its screening rate of approximately 150 patients per quarter or the equivalent of 600 patients per year in approximately 40 US sites and 100 EU sites for a total of 140 active sites. The Company is considering a strategy to continue enrolling in both the HLA-A*02 and non-HLA-A*02 arms until interim analyses are conducted and the appropriate size of each arm can be further assessed.

CEO Snehal Patel commented, "Reaching 1,000 screened patients confirms that the interest from doctors and patients is high. The clinical site start-up activities in Europe in 2025 have further increased the momentum in the study. We are also receiving interest from other countries to join FLAMINGO-01, driven by patient interest. The high screening rate will give the Company many options, including the opportunity to continue enrollment through multiple interim analyses, the potential to realize higher enrollment rates and event rates, and the potential to maximize indications by analyzing efficacy across multiple HLA types in larger patient populations."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, DEC 3, 2025, View Source [SID1234661092])

On December 2, 2025 Kytopen and TQ Therapeutics GmbH (TQx), a pioneer in modular, target-cell–specific gene modification for the generation and direct delivery of in vivo cell therapies, reported a joint agreement granting TQx access to Kytopen’s Flowfect cellular engineering technology through the company’s Technology Access Program (TAP). This latest TAP partnership marks another significant milestone in Kytopen’s expanding presence across Europe.

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A key driver of TQ Therapeutics’ decision to join the TAP program was the opportunity to evaluate a next-generation, non-viral cellular engineering technology that can be uniquely integrated into its proprietary EXiVO approach—an extracorporeal genetherapy process that precisely modifies T cells directly from patients’ unprocessed whole blood using the company’s FABfinity cell-selection technology. As part of the collaboration, the Flowfect technology will be incorporated exclusively as a core module of TQx’s CELLfinity platform, enabling highly efficient delivery of genetic material into defined target cell populations. By combining TQx’s in vivo therapeutic approach with Kytopen’s continuous flow transfection technology—which applies mechanical, electrical, and chemical forces to rapidly engineer hundreds of billions of healthy cells in minutes—the companies aim to advance a new generation of autologous mRNA T-cell therapies designed to revolutionize treatment across multiple disease areas.

Through TAP, TQ Therapeutics will receive comprehensive proof-of-concept and process-development support with Flowfect technology. Kytopen will install the Flowfect Tx system on-site and provide dedicated guidance from its Field Applications Team. In addition, TQ Therapeutics will gain access to the Flowfect Discover 96-well optimization platform, accelerating the progression from early feasibility testing through process optimization and into clinical and commercial manufacturing scale.

"Our partnership with TQ Therapeutics represents a shared vision to transform the landscape of engineered cell therapies," said Kevin Gutshall, Chief Commercial Officer at Kytopen. "By integrating Flowfect technology with TQx’s groundbreaking in vivo CELLfinity platform, we are not just advancing technology—we are opening the door to entirely new therapeutic possibilities that have the potential to redefine patient care."

We are delighted to partner with Kytopen and to integrate the Flowfect technology into our TQx platform," said Christian Stemberger, Chief Scientific Officer at TQ Therapeutics. "The seamless compatibility of the Flowfect Tx system with our extracorporeal in vivo cell therapy approach enhances our ability to efficiently engineer cells with high precision and safety. Access to the Flowfect Discover platform further accelerates our development pathway—from rapid optimization through to clinical readiness—strengthening our mission to deliver transformative therapies to patients.

(Press release, TQ Therapeutics, DEC 2, 2025, View Source [SID1234662194])

On December 2, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported it will be presenting positive Phase 2 survival, and Phase 3 biomarker data across three clinical posters at the 2025 San Antonio Breast Cancer Symposium (SABCS ) taking place December 9-12, 2025 at Henry B. Gonzalez Convention Center, 900 E. Market Street, San Antonio, Texas.

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"Our survival and biomarker data at SABCS is very encouraging because it underscores the potential of our novel immunotherapy and precision medicine to treat cancer patients," stated William V. Williams, MD, BriaCell’s President & CEO. "We remain committed to improve survival and clinical outcomes in cancer patients whose medical needs remain unmet."

"We are extremely pleased with biomarker and patient subgroup data suggesting their use for identifying patients who are most likely to benefit from our treatment," stated Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.

The details of the poster presentations are listed below.

Late-Breaking Abstract Number: 3688
Presentation Number: PS1-13-22
Presentation Title: Impact of Prior Therapy, Genotype Matching, and Biomarkers in the Bria-ABC Phase 3 Trial
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM

A pooled interim analysis of 116 patients with available MHC subtyping in the ongoing pivotal phase III study demonstrated an excellent safety profile, improved progression-free-survival (PFS) n HR+/HER-2 and HER2- low subtypes and potential use of Neutrophil to Lymphocyte Ratio (NLR) as a biomarker of clinical benefit,

Late-Breaking Abstract Number: 3713
Presentation Number: PS1-13-23
Presentation Title: Survival Results of Phase II Bria-IMT Allogenic Whole Cell-Based Cancer Vaccine
Poster Presentation Date/Time: Wednesday, December 10, 2025, 12:30 PM – 2:00 PM

Maturing data analysis of the of the Phase 1/2 study evaluating the Bria-IMT regimen in combination with an anti–PD-1 checkpoint inhibitor (CPI) in 54 metastatic breast cancer demonstrated continued overall survival benefit with potential use of delayed type hypersensitivity (DTH) as a biomarker predictive of clinical benefit.

Abstract Number: 1614
Presentation Number: PS2-09-03
Presentation Title: Th1-biased cytokine signatures as biomarkers of clinical benefit following SV-BR-1-GM cancer vaccination in breast cancer.
Poster Presentation Date/Time: Wednesday, December 10, 2025, 5:00 PM – 6:30 PM

Analysis of 35 different blood cytokines/chemokines from 30 patients enrolled in the Phase 1/2 studies of Bria-IMT alone or in combination with an immune checkpoint inhibitor (CPI) suggests that Th1 biased cytokines and chemokines may serve as potential predictive biomarkers of clinical responses to the Bria-IMT regimen in metastatic breast cancer

Copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, DEC 2, 2025, View Source [SID1234661340])

On December 2, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported new data from the AIPAC-003 trial will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, from December 9-12, 2025.

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The Phase II study randomised female participants (N=66) with HR+ and HER2-negative/HER2-low metastatic breast cancer (MBC) resistant to endocrine-based therapy (ET) including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors or metastatic triple-negative breast cancer (mTNBC) not eligible for PD-(L)1-based therapy. Patients were randomised 1:1 to receive either 30 or 90 mg eftilagimod alfa (efti) in combination with paclitaxel to determine the optimal biological dose (OBD) consistent with the FDA’s Project Optimus initiative.

Both efti dosing levels on top of weekly paclitaxel in heavily pretreated metastatic breast cancer patients, who received a median of three prior lines of systemic therapy, led to strong objective response rates (ORR) and disease control rates (DCR) of 41.9% and 87.1% (30 mg efti) and 48.5% and 78.8% (90 mg efti), respectively, in the evaluable population (N=64). Time to onset of response (TTR) was comparable at 2.0 months (30 mg) versus 1.9 months (90 mg).

Additionally, both dosing levels elicited the desired pharmacodynamic (PD) response in line with efti’s mechanism of action with substantial increases in immune activation biomarkers including absolute-lymphocyte count (ALC) and interferon-gamma (IFN-γ). Data cut-off date for efficacy results was 15 September 2025.

Dr. Nuhad Ibrahim, Professor, Department of Breast Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center noted, "Evaluating two biologically active doses allowed us to integrate clinical response data with meaningful pharmacodynamic readouts. In keeping with Project Optimus principles, the study generated rigorous comparative data in heavily pretreated metastatic breast cancer patients showing consistent efficacy measures and immune-activation signals across both arms, reinforcing efti’s novel mechanism of action and the clinical potential of this immunotherapy-chemo combination."

Tolerability at 90 mg was suboptimal including dose-limiting toxicities (DLT) and a higher proportion of local injection site reactions (LISR). In line with FDA guidance/advice and as previously reported on 13 October 2025, 30 mg of efti administered subcutaneously has been defined as the OBD.

(Press release, Immutep, DEC 2, 2025, View Source [SID1234661102])