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Imugene Doses First Patient in BTK Inhibitor Combination Cohort of azer-cel Phase 1b Study

On May 28, 2026 Imugene Limited (ASX: IMU) a clinical-stage immunooncology company, reported the enrolment of first patient into the BTK inhibitor combination cohort of its ongoing Phase 1b basket study of azer-cel. Azer-cel is an offthe-shelf, allogeneic CAR T cell therapy being evaluated across multiple advanced blood cancers with significant unmet medical need.

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Patients in this third cohort will be treated with azer-cel in combination with a BTKi with the objective of evaluating safety and preliminary efficacy. These patients have previously failed BTKi therapy, an established standard of care therapy across multiple B-cell malignancies. including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Enrolment is ongoing across ten US and five Australian sites.

Despite their efficacy as front-line and subsequent treatments, many patients ultimately develop resistance or intolerance to BTKi therapy, representing a significant area of unmet medical need. The combination of azer-cel with a BTKi aims to explore whether concurrent dosing may enhance the activity of azer-cel and BTKi in this setting.

The addition of the BTKi combination cohort expands the clinical scope of the azer-cel program and may support further partnering and collaboration opportunities. By broadening the range of eligible B-cell malignancies in the Phase 1b study, the Company is better positioned to prioritise indications where azer-cel demonstrates the strongest clinical potential, supporting a disciplined and capital-efficient development strategy. The global BTKi market was valued at approximately US$12.0 billion in 2025.

Chief Executive Officer Leslie Chong said "The enrolment of first patients into the BTKi combination cohort is a meaningful step in expanding the clinical scope of the azer-cel program. BTKi-relapsed patients represent a significant population with limited options, and we believe the concurrent combination approach has the potential to address this unmet need.

We look forward to reporting safety and preliminary efficacy data as patients become evaluable, and to continuing to build the evidence base for azer-cel across B-cell malignancies."

Further updates will be provided as patients become evaluable and data matures.

About the Phase 1b azer-cel trial

The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients and CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including follicular lymphoma (FL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), and mantle cell lymphoma (MCL). The trial has recently expanded into a BTKi combination cohort, for patients with a range of B-cell malignancies who have previously failed BTKi therapy. Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated.

(Press release, Imugene, MAY 28, 2026, View Source [SID1234666111])

Systemic immune activation with eftilagimod alfa associated with statistically significant increased overall survival in late-stage cancer patients

On May 28, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company targeting cancer and autoimmune diseases, reported results from a systematic evaluation of 5 clinical trials of eftilagimod alfa ("efti") an antigen-presenting cell (APC) activator in combination with standard-of-care (SOC) therapies in late-stage cancer patients.

In these trials, treatment with 30 mg subcutaneous (SC) efti plus SOC resulted in a significant increase in circulating absolute lymphocyte count (ALC), a blood-based measure of immune activity, compared to SOC alone where this effect was not seen. More importantly, increased ALC was significantly associated with improved clinical outcomes in the E+SOC group. A clinically meaningful and significant median overall survival (OS) improvement (median +7.7 months; p=0.00171) was seen in ALC responders compared to ALC non-responders in the efti + SOC group (figure on the left). No corresponding association between ALC response and OS was observed in the SOC alone group (figure on the right).

The analysis included 5922 patients across five independent clinical studies (TACTI-mel, TACTI-002, TACTI-003, AIPAC, AIPAC-003) spanning four cancer indications (NSCLC, HNSCC, MBC, melanoma), correlating the pharmacological effects of efti in combination with SOC treatments with clinical efficacy.

Overall survival of late-stage cancer patients treated with SOC + efti (left) and SOC alone (right), ALC responders vs ALC non-responders.

Effects were observed across the different tumor types and were independent of the combination partner i.e., chemotherapy or immunotherapy such as PD-1 antagonists.

"These findings link the immune-activating effect of efti measured in patients´ blood with meaningful and significant survival improvements observed in previous clinical trials. Importantly, this highlights a key connection between efti´s mechanism of action and clinical efficacy," said Frederic Triebel, Chief Scientific Officer of Immutep.

In addition, treatment with efti plus SOC was associated with a rapid and significant increase in circulating TH1-related biomarkers, which correlated with clinical response. Gene expression profiling further demonstrated enhanced T-cell function scores in responding patients.

Collectively, these data suggest that efti induced broad immune activation, including circulating immune cells, cytokine responses and gene expression, and that this activation was associated with improved clinical benefit in late-stage cancer patients across multiple tumor types.

The data will be presented in a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

ASCO 2026 Poster Presentation Details
Title: Eftilagimod alfa, an APC activator via MHC class II, induced lymphocyte activation linked to improved survival in metastatic cancer patients
Poster Session: Developmental Therapeutics—Immunotherapy
Date and Time: 30 May 2026, 1:30 PM-4:30 PM CDT
Poster Board: 359
Abstract #: 2569

The poster will be available on the Posters & Publications section of Immutep’s website following the presentation.

TACTI Program Context
Efti has been tested in multiple clinical trials, including the TACTI program (TACTI-mel, TACTI-002, TACTI-003 and TACTI-004).

In March 2026, following a planned interim futility analysis, Immutep discontinued the TACTI-004 Phase III trial in first-line non-small cell lung cancer based on a recommendation from the Independent Data Monitoring Committee, and Immutep continues to review available data to understand factors behind the futility outcome and to evaluate implications for the broader eftilagimod alfa development program.

The data presented in this explorative analysis does not include data from the TACTI-004 study, as immune data collection for that trial had not been completed at the time of the analysis. All data presented were generated from earlier clinical trials.

(Press release, Immutep, MAY 28, 2026, View Source [SID1234666106])

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.

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])

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).

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.

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])