Neogap receives approval to administer full dose in clinical trial – streamlining development of its personalised cell therapy

On May 28, 2025 Neogap Therapeutics AB, a Swedish clinical-stage biotechnology company developing personalised immunotherapy for cancer treatment, reported to have received approval from the Swedish Medical Products Agency to administer the full dose to all patients in its ongoing phase I/II clinical trial (Press release, Neogap Therapeutics, MAY 28, 2025, View Source;streamlining-development-of-its,c4156253 [SID1234653443]). The decision introduces a more flexible study design and contributes to a faster and more efficient development of the company’s cell therapy.

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According to the revised study protocol, the company is now authorised to treat each patient with the full dose, instead of starting with a low dose and gradually increasing it for subsequent patients. The amendment aligns with recently published data from other cell therapy studies and enables earlier analysis of treatment response.

"Being able to give the full dose from the outset is an important step in the development of our personalised cell therapy. It allows us to collect data earlier that may contribute to the evaluation of both the treatment’s safety and efficacy, while supporting a more efficient and flexible study design – to the benefit of both patients and our continued development efforts," says Samuel Svensson, CEO of Neogap Therapeutics.

The company has also received approval to extend the shelf life of both the starting material from the patient’s lymph nodes and the final frozen product. This provides greater flexibility in clinical operations, particularly when treatment needs to be scheduled around standard chemotherapy or temporary infections.

The treatment under evaluation is pTTL (personalised Tumour Trained Lymphocytes), Neogap’s personalised, cell-based immunotherapy designed to strengthen the patient’s own T cells to target solid tumours. It is based on Neogap’s patented technologies PIOR and EpiTCer, and is currently being investigated in a phase I/II clinical trial for advanced colorectal cancer. Patient recruitment is ongoing at several hospitals in Sweden.

AKTIS ONCOLOGY INITIATES PHASE 1B CLINICAL TRIAL OF ITS NECTIN-4-TARGETING RADIOPHARMACEUTICAL PRODUCT CANDIDATE, AKY-1189, ACROSS MULTIPLE TUMOR TYPES

On May 28, 2025 Aktis Oncology, Inc., an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, reported that it has initiated clinical development of AKY-1189 in its Phase 1b clinical trial for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC) and potentially other Nectin-4 expressing tumors (Press release, Aktis Oncology, MAY 28, 2025, View Source [SID1234653460]).

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Nectin-4 is a cell-surface protein highly expressed in several solid tumors with limited expression in normal tissues, making it an attractive target for precision oncology therapies. NECTINIUM-2 is a Phase 1b clinical trial that will enroll mUC patients during dose escalation, followed by dedicated expansion cohorts in mUC, TNBC and other Nectin-4 expressing tumors, including but not limited to lung, colorectal and cervical cancers. The trial is expected to enroll approximately 150 patients and patients will receive up to six doses of [225Ac]Ac-AKY-1189. The multi-center study is being conducted in the U.S.

"Advancing the first product candidate from our proprietary miniprotein radioconjugate platform into Phase 1b clinical development in the U.S. is an important milestone for Aktis," said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. "Data presented to date demonstrates AKY-1189’s substantial tumor uptake in patients with various Nectin-4-expressing tumor types with limited exposure to normal tissue, suggesting potential for a wide therapeutic window in addressing high unmet need patient populations."

Data presented in an oral plenary session at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrated that AKY-1189 has a promising biodistribution profile with significant tumor uptake in patients with mUC, metastatic breast cancer, non-small cell lung cancer carcinoma, colorectal cancer and cervical cancer. These data marked the first report of a Nectin-4 targeted radiopharmaceutical candidate to demonstrate significant tumor uptake in patients and support the progression of AKY-1189 into therapeutic clinical studies, potentially offering a new treatment option for patients with these challenging solid tumor types.

"Radiopharmaceutical therapy targeting Nectin-4 is a highly attractive strategy, enabling the targeted delivery of radiation directly to tumor cells. Building on the success of Nectin-4-directed antibody-drug conjugates, this approach combines imaging with therapeutic innovation to potentially personalize treatment for advanced urothelial cancer and other solid tumors. The NECTINIUM-2 trial, evaluating the safety and efficacy of the Nectin-4 radiopharmaceutical, [225Ac]Ac-AKY-1189, is a key step forward in advancing this concept," said Matthew Galsky, M.D., co-director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai Hospital in New York.

Theralase® to Present Groundbreaking Research at ASTRO 2025

On May 28, 2025 Theralase Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses reported promising new preclinical results (Press release, Theralase, MAY 28, 2025, View Source [SID1234653882]). The Company’s latest research demonstrates that radiation-activated Rutherrin is up to 100 times more effective at destroying cancer cells than radiation therapy alone in comparable models.

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This data will be showcased at the 2025 American Society for Radiation Oncology ("ASTRO") 67th Annual Meeting, the world’s largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase abstract titled, "Rutherrin Activated by Radiation Therapy Induces Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models", for presentation in a scientific poster session.

The study highlights the potent anti-cancer effects of Rutherrin—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ("RDT"), Rutherrin initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ("ROS") for immediate cytotoxicity, followed by Immunogenic Cell Death ("ICD") to stimulate a durable immune response.

Key Findings from the Preclinical Research:

Selective Tumor Targeting: Rutherrin preferentially accumulates in tumor tissues, sparing healthy cells.
Blood-Brain Barrier Penetration: Demonstrated 10x higher concentrations in Glio Blastoma Multiforme ("GBM") tumors than in healthy brain tissue.
Synergistic Mechanism: Combines direct tumor cell destruction with robust immune activation.
Improved Survival Rates: Statistically significant survival benefits compared to radiation therapy alone.
Resistance Overcoming: Effectively inhibits mechanisms associated with multidrug and radiation resistance.
Adaptive Immune Activation: Induces long-term immunity, as evidenced by resistance to tumor rechallenge.
Mark Roufaiel, Ph.D., research scientist at Theralase commented, "These results are highly encouraging. Rutherrin not only enhances the effectiveness of radiation therapy, but also activates a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase, added, "Our focus is to bring this innovative platform to clinical application. Rutherrin represents a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research provides a strong foundation for integrating Rutherrin with existing cancer therapies to deliver more effective, long-lasting solutions."

Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase, stated, "Based on this compelling data, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We’re excited to continue advancing Rutherrin toward commercialization and transforming cancer care."

About ASTRO

Founded in 1958, ASTRO’s mission is to advance the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research, disseminating research results and representing radiation oncology in a rapidly evolving health care environment.

The ASTRO Annual Meeting is the premier event in radiation oncology, bringing together leading scientists, clinicians and industry partners to share groundbreaking research and technological innovations. The 2025 meeting in San Francisco will showcase cutting-edge advances in radiation biology, translational medicine and cancer therapeutics.

About Rutherrin

Rutherrin is a patented formulation of Theralase’s lead ruthenium-based small molecule (Ruvidar) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma.

Alpha Tau to Present at Jefferies Global Healthcare Conference

On May 28, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that CFO Raphi Levy will present at the Jefferies Global Healthcare Conference on June 5, 2025 (Press release, Alpha Tau Medical, MAY 28, 2025, View Source [SID1234653428]).

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Event: Jefferies Global Healthcare Conference
Format: Presentation
Date: June 5, 2025
Time: 1:25 – 1:55PM ET
Location: New York, NY

Mr. Levy will be available for 1×1 investor meetings. Please reach out to your Jefferies representative to schedule.

ykode Therapeutics reports Q1 2025 Financial Results

On May 28, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported its unaudited financial results for the first quarter of 2025 (Press release, Nykode Therapeutics, MAY 28, 2025, View Source [SID1234653445]).

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The financial report can be accessed in the Investors section of the company’s website: View Source

The company will host a webcast presentation at 10 a.m. CET / 4 a.m. ET. A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website and on the following link: View Source;tp_key=4e61cabec4