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])

On December 2, 2025 CorriXR Therapeutics, an oncology-focused biotherapeutics company pioneering a ground-breaking gene editing platform technology, InhaTarget Therapeutics, a company dedicated to the early development and clinical validation of innovative treatments of pulmonary diseases by inhalation, and Merxin Ltd, a designer and supplier of inhaler devices, reported to have entered a strategic collaboration to develop a pioneering inhaled genetic therapy targeting lung cancer.

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The partnership draws upon CorriXR’s proprietary CRISPR-based gene editing platform targeting NRF2, InhaTarget’s proprietary formulation platform and strong experience in pulmonary drug development, and Merxin Ltd’s advanced inhalation device technology. Through their combined expertise, they aim to create a patient-friendly inhaled therapy that delivers targeted treatment directly to lung tumors, maximizing efficacy, minimizing systemic side effects, and offering new hope for patients facing one of the world’s deadliest cancers.

Innovative Therapeutic Approach

CorriXR’s patented non-viral gene editing platform disables the transcription factor NRF2, a master regulator of cellular stress responses and known driver of tumor treatment resistance. As reported in a recent paper published in Molecular Therapy Oncology, preclinical data in lung cancer models have demonstrated that disabling NRF2 can meaningfully resensitize tumor response to chemotherapy with minimal off-target effects.

The collaboration seeks to demonstrate effective delivery of the CorriXR compound via InhaTarget’s proprietary lipid-nanoparticle (LNP) formulation platform, which enables encapsulation of active ingredients for inhalation delivery. Merxin Ltd will contribute their customized and patented inhaler device technology for drug delivery to the lungs. Initial studies will be conducted in cell culture and in a lung carcinoma mouse model, with results expected in mid-2026.

Addressing Unmet Medical Needs

Lung cancer continues to be one of the leading causes of cancer-related deaths globally. The study will focus on treatment of squamous cell lung carcinoma (LUSC), a common and aggressive form of non-small cell lung cancer (NSCLC) that comprises 25 – 30% of worldwide cases. With over 380,000 new cases of LUSC diagnosed globally each year and a five-year survival rate below 15%, the need for new therapies is urgent. Chemotherapy plus immunotherapy (IO) or IO alone is the current standard for first-line treatment of LUSC but still typically results in progression after 8 months or less. Many patients develop treatment resistance, leaving limited options beyond dose escalation, which increases toxicity and intolerance and typically worsens quality of life.

Leadership Perspectives

Dr. Eric B. Kmiec, founder and CEO of CorriXR Therapeutics, stated, "This partnership represents a significant step forward in our mission to harness the power of CRISPR-based gene editing for the benefit of patients with cancer by slowing the growth of solid tumors and improving effectiveness of existing treatments. We are excited by the potential of this collaboration to target lung cancer using a non-invasive inhaled delivery approach, which would greatly improve the quality of life for patients."

Dr. Frédéric De Coninck, co-founder and CEO of InhaTarget Therapeutics, commented, "Combining our pulmonary drug delivery LNP platform with CorriXR’s groundbreaking science and Merxin’s device technology has the potential to reshape the landscape of lung cancer treatment. We are eager to advance work on this novel combination."

Dr. Philippe Rogueda, CBO and founder of Merxin Ltd., remarked, "Our advanced inhaler technology is designed to ensure non-invasive, precise, consistent delivery of novel therapeutics. We are excited to contribute to this vital effort and help bring innovative solutions to patients with lung cancer."

(Press release, CorriXR Therapeutics, DEC 2, 2025, View Source [SID1234661073])

On December 2, 2025 CatalYm reported that the first patient has been dosed in the randomized Phase 2b GDFATHER‑NSCLC‑02 (GDF‑15 Antibody‑MediaTed‑Human‑Effector‑T‑Cell Relocation) trial (NCT07246863). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab as a second-line treatment in patients with metastatic non-squamous non-small cell lung cancer (nsq NSCLC) who have progressed following initial systemic treatment including an approved immune checkpoint inhibitor.

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The trial will assess multiple treatment strategies combining visugromab with an anti-PD-1 antibody and the chemotherapy docetaxel, including a chemo-free regimen. Standard-of-care chemotherapy alone will serve as the control arm. The trial consists of a safety run-in followed by a randomized phase evaluating visugromab in the different combination regimen settings.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and resistance to anti-PD-(L)1 therapies. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory NSCLC patients, demonstrating deep and durable responses, with a median duration of response of 32.2 months and a favorable safety profile. In addition to its ability to restore immune activation, visugromab also showed potential to alleviate cancer cachexia, a severe condition limiting treatment tolerability and responsible for 20-40% of cancer deaths.1

"The decision to evaluate visugromab in second-line nsq NSCLC, in addition to the first-line setting, was driven by the strength of our Phase 1/2a data in heavily pretreated patients, where we observed deep and durable responses well beyond those typically seen with other therapies in this setting," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "By neutralizing GDF-15, a key driver of immune suppression, visugromab may overcome resistance, restore responsiveness to immunotherapy and extend the benefit of anti-PD-1 agents. Its additional potential to mitigate cancer cachexia and support tolerance to chemotherapies and other anti-cancer regimens offers a distinct advantage in this difficult-to-treat population."

"We are expanding visugromab’s development into key settings where immune resistance severely limits treatment options," said Scott Clarke, Chief Executive Officer at CatalYm. "Second-line nsq NSCLC is a particularly challenging indication with limited benefit from current standard-of-care. This trial builds on the compelling rationale for GDF-15 neutralization and is part of our late-stage development program to deliver visugromab’s potential to patients in urgent need of better solutions."

The randomized, multi-arm Phase 2b GDFATHER-NSCLC-02 trial will enroll approximately 131 patients across multiple sites in the US, EU and Switzerland. Following the safety run-in, patients will be randomized into one of four treatment arms:

Visugromab + anti-PD-1 inhibitor + chemotherapy
Visugromab + anti-PD-1 inhibitor (chemo-free)
Visugromab (at lower dose) + anti-PD-1 inhibitor + chemotherapy
Chemotherapy alone (control)
The primary endpoint of the study is objective response rate (ORR) defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), overall survival (OS), participant weight course over time and safety-related measures.

About NSCLC

Lung cancers remain the leading cause of cancer-related mortality globally and non-small cell lung cancers (NSCLCs) account for approximately 87% of the 210,000 annual lung cancer diagnoses in the US2. Five-year survival rates in the US for non-squamous NSCLC are low: 12.8% for adenocarcinoma and 5.1% for large-cell carcinoma3. 70-85% of NSCLC patients either exhibit primary resistance to PD-1 blockade or develop acquired resistance to immunotherapy4, emphasizing the need for innovative approaches to overcome immunotherapy resistance.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, DEC 2, 2025, View Source [SID1234661072])