Trogenix doses first patient in Phase I/II clinical trial of TGX-007 gene therapy for glioblastoma

On May 28, 2026 Trogenix Ltd ("Trogenix" or the "Company"), a clinical-stage oncology company engineering programmable immunotherapies, reported that the first patient has been dosed in its Phase I/II clinical trial evaluating TGX-007, a dual-payload adeno-associated virus (AAV)-based gene therapy. It will treat patients with newly diagnosed or recurrent glioblastoma (GBM), one of the most common and aggressive forms of brain cancer.

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The trial, named ADePT, is being conducted at two leading clinical sites: NHS Lothian, UK, and Ohio State University Hospital, USA. The seamless trial design will identify the optimal biological dose of TGX-007 and evaluate its safety and efficacy in newly diagnosed and recurrent GBM patients. It will generate clear and early insights into biological activity, tumour selectivity, safety, target engagement, immune activation and overall survival in GBM patients. The initial clinical data will immediately drive the Company’s broader vision, enabling testing of a potentially transformational treatment approach across many different solid tumours.

Ken Macnamara, Chief Executive Officer of Trogenix, commented:

"We’re excited to advance the ADePT clinical trial and bring a potentially transformative "one time" treatment to patients with significant unmet need. With precisely controlled therapeutic delivery, a strong safety profile, and support from US and UK regulators, we are positioned to treat newly diagnosed and recurrent glioblastoma patients ahead of standard-of-care. The trial will provide meaningful clinical endpoints for high-grade gliomas and inform development across our broader solid tumour pipeline. We are grateful to the patients, investigators and clinical teams for making this possible and look forward to reporting data from the trial in due course."

TGX-007 harnesses Trogenix’s proprietary Synthetic Super-Enhancer (SSE) technology to exploit the core cancer cell identity. In doing so, the programmable immunotherapy can switch on combination payloads to precisely kill tumour cells and activate the immune response. The dual mechanism of action, delivered via a single vector, creates synergistic effects that act as an in-situ vaccination to provide long lasting protection from a "one time" treatment.

Faye Robertson, Chief Investigator, Consultant Clinical Oncologist and Honorary Clinical Senior Lecturer University of Edinburgh, added:

"Despite decades of research, outcomes for patients with glioblastoma remain extremely poor, underscoring the urgent need for innovative therapeutic approaches. The start of the Phase I/II ADePT trial is a critical moment for patients facing this challenging and devastating disease. It is the culmination of more than a decade of research in pursuit of a therapy that delivers dual therapeutic payloads with exceptional precision directly to glioblastoma cells, while sparing surrounding healthy tissue. We are delighted to have treated the first patient in Edinburgh and look forward to progressing ADePT to determine whether this approach translates into meaningful clinical benefit for patients."

The first patient dosing in the ADePT trial follows the publication in Nature in April 2026 of a breakthrough pre-clinical study led by Professor Steve Pollard, Chief Scientific Officer of Trogenix, demonstrating that a single dose of SSE-based therapy achieved complete tumour eradication in 83% of treated cases in an aggressive brain cancer model that closely mimics human GBM, with no toxicity over 11 months and no tumour recurrence. The ADePT trial will establish the clinical proof-of-concept that will guide the Company’s broader pipeline development across colorectal, liver, and lung cancers.

Further details of the ADePT trial can be found here: NCT07346144

(Press release, Trogenix, MAY 28, 2026, View Source;utm_medium=rss&utm_campaign=trogenix-doses-first-patient-in-phase-i-ii-clinical-trial-of-tgx-007-gene-therapy-for-glioblastoma [SID1234666105])

Asahi Kasei Life Science Acquires License for Novel Antibody-Drug Conjugate Technology from The Noguchi Institute – A Major Milestone for More Efficient and Safer Cancer Treatments

On May 27, 2026 Asahi Kasei Life Science reported the company has acquired the license rights for a novel antibody-drug conjugate (ADC) technology from The Noguchi Institute. This modality enables precise control over the drug-to-antibody ratio and attachment site of single- and dual-payload ADCs, representing a major breakthrough toward more effective and safer use in a broad range of therapies.

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ADCs are an advanced form of targeted biologics treatment that combines the precision of an antibody with the potency of a cell-killing payload. Compared to conventional treatments, bioconjugation with ADCs more selectively targets cancer cells while minimizing damage to surrounding cells. Drawing from its long-standing research into carbohydrates and glycans, The Noguchi Institute has developed a novel ADC technology with a superior molecular structure conformity. This is expected to improve the predictability of drug efficacy and safety, enabling stable therapeutic effects.

Asahi Kasei Life Science continually explores opportunities for collaboration with external partners, seeking technologies that will lead to future drug development. The Noguchi Institute’s ADC modality not only improves precision but can also combine dual payloads onto a single antibody. These characteristics offer the ability to add different payloads for targeting more diseases with better specificity and potentially less toxicity.

Under this agreement, the two partners will advance initiatives to commercialize ADC drug platforms, including possible future sub-licensing to biopharma companies and Contract Development and Manufacturing Organizations (CDMOs) such as Bionova Scientific, an Asahi Kasei company. In addition, both parties will engage in joint research to further refine the technology to solve medical challenges.

(Press release, Asahi Kasei Pharma, MAY 27, 2026, View Source [SID1234671077])

NorthStar and QSA Global Announce Multi-Year Strategic Partnership to Strengthen Actinium-225 Supply Chain for Targeted Alpha Therapies

On May 28, 2026 QSA Global, Inc., a global leader in specialized radioactive source manufacturing and medical radiochemical services, and NorthStar Medical Radioisotopes, LLC (NorthStar), a leading radiopharmaceutical company, reported the execution of a multi-year strategic services agreement. This partnership is designed to solidify the supply chain for radium-226 (Ra-226) targets, the starting material for Actinium-225 (Ac-225) production, and further supports NorthStar’s commercial-scale production of no carrier added (n.c.a.) Ac-225 used in next-generation Targeted Alpha Therapies (TAT).

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The partnership combines QSA Global’s decades of specialized experience in high-activity source handling, industrial regulatory compliance, and logistics with NorthStar’s innovative approach to commercial-scale radiopharmaceutical production. It features a multi-year purification campaign where QSA Global will process legacy Ra-226 on behalf of NorthStar, transforming the material into high-purity precursors that will directly feed continuous target capsule manufacturing. Following irradiation and processing by NorthStar to produce n.c.a. Ac-225, the recovered radium will be returned to QSA Global for recycling into new targets – establishing a highly efficient, closed-loop supply chain.

"This multi-year agreement with QSA Global strengthens our supply chain with a reliable, high-quality supply of Ra-226 targets critical to our n.c.a. Ac-225 production capabilities," said Dr. Frank Scholz, President & CEO of NorthStar. "By ensuring consistent access to these vital starting materials, we can confidently meet growing demand within the industry."

"By managing the complex, highly regulated lifecycle of radium-226, QSA Global enables partners like NorthStar to focus their resources entirely on commercial Actinium-225 production," said Joe Lapinskas, Innovation Director at QSA Global, Inc. "NorthStar was a foundational partner as we developed our specialized radium services. We are proud to leverage our decades of high-activity radioactive materials expertise to help secure this critical supply chain and support NorthStar’s mission of delivering life-saving TATs to patients."

About Ac-225
NorthStar has been successfully producing n.c.a. Ac-225 using an indirect manufacturing approach that combines electron-accelerator irradiation of a Ra-226 target, followed by purified Ra-225 sources that constantly in-grow n.c.a. Ac-225. Ac-225 is an alpha-emitter, which belongs to a powerful class of radioisotopes that deliver high-energy, highly localized radiation directly to diseased cells. Ac-225 can be attached to a variety of targeting molecules, including antibodies, peptides, and small molecules, enabling precise delivery to cancer cells. This versatility makes isotopes like Ac-225 particularly valuable in supporting the development of next-generation radiopharmaceutical therapies that are highly effective and selective.

(Press release, NorthStar Medical Radiostopes, MAY 27, 2026, View Source [SID1234666185])

TD2 Oncology and Panome Bio Partner to Advance Translational Oncology Through Integrated Multi-Omics Capabilities

On May 27, 2026 Panome Bio, a leading multi-omics contract research organization (CRO) and CLIA-certified laboratory, and TD2 Oncology, a globally recognized oncology-focused CRO specializing in preclinical and clinical drug development, reported an expansion of their strategic partnership. The collaboration establishes a coordinated framework that gives researchers access to translational oncology expertise, clinical development, and comprehensive multi-omics analysis under a connected program.

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The partnership pairs TD2’s deep expertise in translational and clinical oncology with Panome Bio’s capabilities in metabolomics, proteomics, transcriptomics and exposomics. By aligning these strengths, the two organizations provide researchers with a more connected approach to studying cancer biology and therapeutic response, from research models through clinical trials.

TD2 is a widely recognized leader in translational oncology research and clinical development, with platforms designed to evaluate therapeutic candidates in clinically relevant settings. By integrating Panome Bio’s multi-omics technologies into this ecosystem, researchers can now connect therapeutic outcomes with broad molecular measurements spanning metabolism, protein signaling, gene expression, and environmental exposures. This combined approach supports biomarker discovery, mechanisms associated with sensitivity or resistance to treatment and a more detailed understanding of cancer biology during drug development.

"Modern oncology research generates enormous amounts of biological data spanning model development through clinical trials, but translating those findings into a deeper molecular understanding remains a major challenge," said Edward Weinstein, CEO of Panome Bio. "Working with TD2 allows us to pair their expertise across translational and clinical oncology with comprehensive multi-omics profiling. This will help to better characterize therapeutic response and connect biology across every stage of development."

"Our focus has always been optimizing oncology programs in moving efficiently from translational development into the clinic," said Stephen Gately, CEO of TD2 Oncology. "No other oncology CRO can offer this combination of translational and clinical expertise alongside this depth of molecular profiling. This partnership gives drug developers a direct connection between therapeutic outcomes and the molecular data needed to understand them".

The partnership is particularly well-suited to biomarker discovery, mechanism-of-action studies, evaluation of drug resistance and characterization of biological variability in therapeutic response. By integrating molecular data across multiple molecular and biological layers, researchers can identify signatures associated with treatment sensitivity, resistance, toxicity, and patient stratification that may not be apparent through single-modality analysis alone. These capabilities can support clinical development efforts by improving patient selection strategies, informing biomarker-driven trial design, and helping sponsors better understand variability in clinical outcomes. The partnership is available immediately to researchers seeking coordinated multi-omics support spanning translational research through clinical development.

(Press release, TD2, MAY 27, 2026, View Source [SID1234666138])

Ernexa Therapeutics Successfully Completes Key Manufacturing and IND Preparation Milestones for ERNA-101 Toward First-in-Human Clinical Development

On May 27, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported significant progress in the development of ERNA-101, the company’s lead therapeutic candidate, achieving multiple critical milestones that position the program for a planned Investigational New Drug (IND) submission in the third quarter of 2026 and the anticipated initiation of its first-in-human clinical study.

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The company has successfully completed process development activities for the ERNA-101 manufacturing process and has now transitioned into Good Manufacturing Practice (GMP) manufacturing in preparation for clinical development. In parallel, technology transfer activities for ERNA-101 are actively underway, representing another major operational milestone supporting the planned IND submission timeline.

"These achievements represent a defining moment for Ernexa Therapeutics," said Sanjeev Luther, CEO of Ernexa Therapeutics. "Completing process development and advancing into GMP manufacturing are critical steps toward IND clearance and the launch of our first-in-human clinical study for ERNA-101. We are executing against our development strategy with urgency and discipline and remain firmly on track for our planned IND filing in the third quarter of 2026, Most importantly, we believe ERNA-101 has the potential to bring new hope to patients and families in need of better therapeutic options."

The advancement of ERNA-101 reflects continued momentum across the company’s development and manufacturing operations and marks an important evolution in Ernexa’s corporate trajectory toward becoming a clinical-stage biotechnology company.

"With technology transfer now in progress and manufacturing activities advancing as planned, we believe Ernexa is entering a transformational phase," added CEO, Sanjeev Luther. "These milestones will significantly strengthen our operational readiness and reinforce our confidence in the path toward clinical evaluation of ERNA-101."

ERNA-101 is being advanced as part of Ernexa Therapeutics’ broader mission to develop innovative therapies designed to address significant unmet medical needs.

Key Highlights

IND submission for ERNA-101 targeted for Q3 2026
Technology transfer activities currently in progress
Process development for ERNA-101 manufacturing successfully completed
Transition to GMP manufacturing underway in preparation for clinical studies
Company advancing toward anticipated transformation into a clinical-stage biotechnology company
Progress supports planned first-in-human clinical study following IND clearance

(Press release, Ernexa Therapeutics, MAY 27, 2026, View Source [SID1234666137])