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Imvax Announces Additional Data from Phase 2b Clinical Trial of IGV-001 in Newly Diagnosed GBM and Provides Update on Planned Clinical Development

On September 15, 2026 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported that an abstract reporting results from the Company’s randomized, multicenter, double-blind, placebo-controlled Phase 2b trial of IGV-001 in 99 patients with newly diagnosed glioblastoma (ndGBM) has been accepted for poster and rapid oral presentation at the 31st Annual Meeting of the Society for Neuro-Oncology (SNO), taking place November 12-15, 2026 in Philadelphia. The Company also provided an update on its planned Phase 3 development of IGV-001 in ndGBM patients whose tumors had an unmethylated O6-methylguanine-DNA methyltransferase promoter (uMGMT). Patients with uMGMT ndGBM account for an estimated 55% to 60% of all ndGBM patients and they represent a biologically high-risk cohort with limited therapeutic options and poor expected outcomes with current standard-of-care approaches.

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In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm (HR 0.60, P=0.0808). Additionally, patients in the IGV-001 arm experienced delayed deterioration of Karnofsky Performance Status (KPS) score, favorable quality-of-life measures, lower rates of severe toxicities, and reduced burden of serious adverse events as compared to the placebo arm.

"Patients with uMGMT ndGBM have an urgent need for more effective treatment options. The magnitude and consistency of the treatment effect observed across survival, functional, and patient-reported outcome measures support continued investigation of IGV-001 in the uMGMT patient population," said J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center and the highest enrolling investigator in the Phase 2b trial.

Future Clinical Development of IGV-001

The Company met with the U.S. Food and Drug Administration (FDA) earlier this year to discuss the Phase 2b data and the regulatory pathway for IGV-001. Following this, the Company met with FDA in July to align on the key elements of a proposed randomized, open-label Phase 3 study of IGV-001 in approximately 375 uMGMT ndGBM patients in the United States. The planned primary endpoint of this study is overall survival (OS), and the study would include an interim analysis after a specified number of patient deaths. Imvax has incorporated the feedback from FDA into the proposed final protocol for the study, which it plans to submit to FDA in the coming months.

"With the FDA’s recent feedback, we will be finalizing the protocol for a Phase 3 study focused on patients with uMGMT ndGBM, a population that has lacked meaningful treatment innovation in decades and where we saw a clinically meaningful benefit in the Phase 2b study," said John P. Furey, Executive Chair of the Imvax Board of Directors. "We are also actively pursuing financing to support the initiation of this planned Phase 3 trial in 2027."

SNO 2026 presentation details

• Abstract title: "Initial efficacy and safety results of a randomized, double-blind, Phase 2b study to evaluate IGV-001, an autologous cell immunotherapy, plus standard of care (SOC) versus placebo (PBO) plus SOC in adult patients with newly diagnosed glioblastoma (ndGBM)"
• Presenting author: J. Bradley Elder, M.D., Director, Neurosurgical Oncology, Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center
• Presentation type: Rapid oral and poster
• Abstract number: CTIM-05
• Location: Pennsylvania Convention Center, Philadelphia

About IGV-001 and Glioblastoma

IGV-001 is an investigational, autologous biologic-device combination product candidate derived from Imvax’s proprietary Goldspire immuno-oncology platform. The platform is designed to induce a patient-specific immune response against a broad range of tumor antigens. FDA has granted IGV-001 Fast Track designation and Orphan Drug Designation for the treatment of ndGBM. IGV-001 has not been approved by FDA or any other regulatory authority.

Glioblastoma is the most common aggressive malignant primary brain cancer in adults and has resisted meaningful treatment advances for decades. Approximately 14,000 people are diagnosed with glioblastoma each year in the United States. Current treatment generally consists of maximal safe resection followed by radiotherapy and temozolomide, with subsequent maintenance temozolomide. MGMT promoter methylation is a biomarker associated with benefit from temozolomide. Patients whose tumors have an unmethylated MGMT promoter generally derive limited benefit from temozolomide, experience shorter overall survival than patients with methylated tumors, and currently have no approved treatment specifically for uMGMT disease.

About the Phase 2b Trial

The Phase 2b trial (NCT04485949) was a randomized, multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of IGV-001 in 99 patients with ndGBM at 19 U.S. sites. Participants were randomized 2:1 to IGV-001 or placebo. The trial assessed progression-free survival, overall survival and safety. In the trial, patients in the IGV-001 arm had a median overall survival (mOS) of 20.3 months, a difference of 6.3 months, or 45%, compared to a mOS of 14.0 months in the placebo arm. The median follow-up time for all patients in the study was 22 months. In a prespecified subgroup analysis of patients in the Phase 2b trial with uMGMT tumors (n=48), patients in the IGV-001 arm had a median overall survival (mOS) of 14.8 months, a difference of 4.2 months, or 40%, compared to a mOS of 10.6 months in the placebo arm. There were no drug-related serious adverse events in the treatment arm, and the safety profile seen in the Phase 2b trial is favorable, consistent with that observed in a previous Phase 1b study (n=33).

(Press release, Imvax, SEP 15, 2026, View Source [SID1234670863])

GSK to acquire potential best-in-class T cell-engager (TCE) for multiple myeloma from Chimagen Biosciences

On September 15, 2026 GSK plc (LSE/NYSE: GSK) reported it has entered an agreement to acquire a potential best-in-class trispecific T cell-engager (TCE) from Chimagen Biosciences (Chimagen), a privately held biotechnology company. GSK plans to develop and commercialise the asset for multiple myeloma, with the programme expected to enter phase I trials in 2027.

TCEs have shown transformational efficacy in multiple myeloma but have been associated with difficult tolerability profiles. The Chimagen trispecific asset is designed to address this by binding to T cells while simultaneously targeting two strategically selected and validated tumour-associated antigens. This targeted approach aims to achieve a deeper and more durable response compared to existing TCEs, along with an improved tolerability profile. This could enable broader adoption and earlier use in multiple myeloma treatment, providing an important advancement for patients who may require multiple options depending on their treatment needs. The US TCE market for multiple myeloma is expected to exceed $10 billion by 2032.1

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "Today’s deal secures a promising T cell engager and advances GSK’s leadership goals in blood cancer. The agreement complements our existing portfolio in multiple myeloma, adding a new potential option to address the different needs of patients facing this complex disease."

Zhenhao Zhou, Chief Executive Officer, Chimagen Biosciences, said: "Our mission has always been to translate cutting-edge innovation into life-changing medicines. Working with GSK combines our precision T-cell engager programme with their global development and commercial capabilities to redefine care for multiple myeloma patients. This agreement also marks another major milestone for our platforms as we continue to build an industry-leading pipeline of multi-specific antibody candidates."

Multiple myeloma is the third most common blood cancer globally, with approximately 180,000 new cases diagnosed globally each year.2,3 While generally considered treatable, it is not currently curable, and research into new therapies is vital as the disease commonly becomes refractory to available treatments.4

The agreement builds on GSK’s existing relationship with Chimagen, following a previous agreement to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted TCE currently in phase I trials for B-cell malignancies and B-cell dependent autoimmune disorders.

Financial considerations
Under the terms of the agreement, GSK will pay an upfront fee to acquire full global rights to the TCE programme. Chimagen will also be eligible to receive success-based development and commercial milestone payments. The agreement has a total potential value of up to $750 million.

This agreement is subject to customary closing conditions.

(Press release, GlaxoSmithKline, SEP 15, 2026, View Source [SID1234670861])

A2 Biotherapeutics Announces Findings from DENALI-1 Study of A2B395 Precision CAR T-Cell Therapy for Patients with Solid Tumors Expressing EGFR

On September 15, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported early safety and efficacy data from the ongoing DENALI-1 clinical study (NCT06682793). The study evaluates A2B395, an allogeneic, logic-gated chimeric antigen receptor T-cell (CAR T-cell) therapy targeting EGFR, developed based on the company’s proprietary TmodTM platform. The findings include the first reported complete response (CR) in a patient with metastatic anal cancer, and a partial response with disease control for six months in a patient with refractory head and neck squamous cell cancer (HNSCC) following treatment with A2B395. This data is being presented in a poster presentation during the 2026 Cell Coast Conference taking place October 9 – 11, 2026, in Tampa, Florida.

DENALI-1 is a first-in-human, open-label, Phase 1/2 study evaluating the safety and recommended Phase 2 dose of A2B395 in adults with previously treated EGFR-positive advanced solid tumors. DENALI-1 is currently enrolling patients with recurrent unresectable, locally advanced, or metastatic solid tumors associated with EGFR expression.

Few treatment advancements have been made for anal cancer. Standard EGFR-targeted therapies can cause severe toxicities,1 and surgical treatments can impact a patient’s quality of life.

Head and neck cancers are the seventh most common cancer worldwide, and high rates of morbidity and mortality are associated with this disease.2 According to the latest GLOBOCAN estimates (2020), HNSCC accounts for an estimated 890,000 new cases, or approximately 4.5% of all cancer diagnoses around the world, and 450,000 deaths per year, or approximately 4.6% of global cancer deaths.3

Complete responses have rarely been observed in studies of CAR T-cell therapies for the treatment of solid tumors, and to date none has been reported in patients with anal cancer.4

"We are deeply encouraged by the DENALI-1 study data being presented during the Cell Coast Conference, notably the first reported complete response in a patient with anal squamous cell carcinoma treated at our institution. This patient had previously undergone multiple lines of chemotherapy, retifanlimab, and radiation, before receiving A2B395, an allogeneic CAR T-cell therapy built on the Tmod platform, and experienced minimal toxicity. These early findings support the potential for A2B395 to treat patients with solid tumors expressing EGFR," said Kedar Kirtane, M.D., Medical Director for Solid Tumor Cellular Therapy at Moffitt Cancer Center and the principal investigator who oversaw the treatment of the patient.

"Our head and neck cancer patient had previously received several lines of therapy for a painful, softball-size tumor in their neck and had no response to any of those other treatments. After receiving A2B395, pain from the tumor resolved and the tumor shrank enough to allow them to return to work, and it is the first time since diagnosis to not be receiving regular chemotherapy doses. The partial response and minimal toxicity from the treatment resulted in a profound improvement of the patient’s quality of life," said Matthew Ulrickson, M.D., Chief, Section of Hematology, Banner MD Anderson Cancer Center.

"Recent results from our DENALI-1 and EVEREST-2 (NCT06051695) clinical trials provide exciting early evidence of safety and efficacy. Following a single dose of A2B395, we saw heavily pre-treated patients with refractory anal cancer and head and neck cancer respectively achieve a complete response and a partial response. Importantly, both patients experienced no serious adverse events. We previously reported similar outcomes with the MSLN-targeted autologous CAR T-cell therapy, A2B694, including a complete response by central review in a patient with refractory lung cancer. Together, these results provide encouraging early proof-of-concept that our Tmod logic-gated CAR T platform – both autologous and allogeneic approaches – can safely treat difficult solid tumors," said John Welch, M.D., Ph.D., Chief Medical Officer, A2 Bio.

Summary of DENALI-1 Study Findings

As of August 1, 2026, 10 patients received A2B395 for advanced solid tumors: anal (n=1); head and neck squamous cell (HNSCC; n=1); non-small cell lung (n=2); colorectal (n=3); and breast (n=3). The median patient age is 56 (range 33-70) years, and 80 percent enrolled are women. Dose levels (DLs) were 2×108 (n=3), 4×108 (n=4), and 8×108 (n=3) cells.

Safety: Lymphodepletion was well-tolerated with anticipated, transient cytopenias. No graft-versus-host disease, immune effector cell-associated neurotoxicity syndrome (ICANS), dose-limiting toxicities (DLTs), immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, or fatal adverse events were reported. Two patients had grade 1/2 cytokine release syndrome that fully resolved.
Efficacy: Nine patients were evaluable for efficacy. The patient with unresectable anal cancer, after five different chemotherapy regimens and two rounds of radiation treatment, received A2B395 (DL3) and achieved a complete response (CR) on Day 28, with complete resolution of all target and non-target lesions and no serious adverse events.
The patient with HNSCC (DL2) achieved a confirmed partial response (PR) on Day 180, after a 37% reduction in 3 target lesions, the largest which was 7.7 cm prior to receiving A2B395.
Remaining best responses were stable disease (n=5) and progressive disease (n=2), resulting in a 78% disease control rate.
Translational: A2B395 was detectable in blood and biopsies across all dose levels.
About DENALI-1

DENALI-1 (NCT06682793) is a phase 1/2, multicenter, open-label, nonrandomized study evaluating the safety and efficacy of A2B395, an allogeneic logic-gated Tmod CAR T-cell therapy, in adults. Patients are enrolled through BASECAMP-1 (NCT04981119), a master prescreening study that identifies patients with HLA LOH at any time in the course of their disease via next-generation sequencing. Upon disease progression the participant may screen for enrollment in DENALI-1.

A2B395 uses a Tmod logic-gate: an activator targeting EGFR and a blocker targeting HLA-A*02. In patients with HLA-A*02 loss of heterozygosity (LOH), the blocker inhibits both CAR and endogenous T-cell receptor (TCR) activity on normal tissue, providing tumor selectivity without gene editing, reducing on-target, off-tumor toxicity, and mitigating graft-versus-host disease.

DENALI-1 is currently enrolling patients with recurrent unresectable, locally advanced, or metastatic colorectal, non-small cell lung, triple-negative breast, head and neck squamous cell, and renal cell cancer, cholangiocarcinoma, and cancer of unknown primary or other solid tumors associated with EGFR expression.

Patients are not required to undergo leukapheresis to receive treatment on DENALI-1 because A2B395 is an allogeneic treatment.

More information about DENALI-1 and clinical trial sites participating in the study are available on the A2 Bio clinical trials website.

About the Tmod Platform

Invented at A2 Bio, the TmodTM platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

(Press release, A2 Biotherapeutics, SEP 15, 2026, View Source [SID1234670860])

Interim Results for the six months ended 30 June 2026

On September 15, 2026 ImmuPharma PLC (LSE:IMM), ("ImmuPharma", the Group or the "Company"), the specialist drug discovery and development company, reported its unaudited interim results for the six months ended 30 June 2026 (the "Period").

Key Highlights (including post Period review)

Financials

For the period ended 30 June 2026, the Group reported an operating loss of £1.1 million, compared to an operating loss of £1.2 million for the same period in 2025. R&D expenses amounted to £0.6 million compared to £0.7 million for 2025, with administrative expenses of £0.4 million in line with 2025. Share-based payments for the period were £0.04 million, compared with £0.05 million in the prior period.

The overall reported loss for the period was £4.7 million compared with a loss of £1.9 million for the same period in 2025. The increase is due to the Company completing a calculation of fair value of the derivative financial asset that resulted in a finance loss of £3,355,774 which was recorded in the income statement. The restatement to fair value is calculated at the end of each accounting period and will vary according to the Company’s share price performance, which as seen previously can result in either a finance gain or loss.

As at 30 June 2026, the Group held a cash balance of £0.7 million, representing a increase from £0.4 million at 30 June 2025. The derivative financial asset was valued at £2 million, up from £0.6 million a year earlier.

In March 2026, the Company announced an equity fundraising principally intended to support the accelerated development of Kapiglucagon while maintaining P140 as its principal development and partnering priority.

Following shareholder’s approval at a General Meeting on 7 April 2026, the Company completed a £6.0 million subscription with long-standing shareholder Lanstead Capital Investors L.P., together with approximately £0.47 million raised through a WRAP Retail Offer, resulting in aggregate gross fundraising proceeds of approximately £6.47 million.

The Lanstead subscription is subject to a 20-month Sharing Agreement under which the ultimate cash proceeds received by the Company may be higher or lower than the £6.0 million subscription amount depending upon ImmuPharma’s share price performance relative to the agreed benchmark price. At the time of the fundraising, the Directors stated that the new financing, together with existing funding, was expected to provide a cash runway to at least the second half of 2028, based on the assumptions set out in the fundraising announcement.

P140 technology platform

P140 remains the Company’s lead asset and a core value driver, with continued progress during the Period across its scientific, precision medicine and intellectual property strategy.
In March 2026, the Company received its first Combined Search and Examination Report ("CSER") relating to the UK patent application filed in August 2025. The response represented an important milestone in the examination process.
During the 12-month priority period, ImmuPharma continued the experimental program supporting the P140 and Type M precision medicine approach and generated additional data supporting the scientific basis of the program.
Post period end, the Company filed an international Patent Cooperation Treaty ("PCT") application relating to P140 and Type M. The additional experimental data generated during the priority period were incorporated into the PCT application. See separate announcement made today.
During the priority period, ImmuPharma generated additional experimental data supporting the Type M precision medicine approach and further characterising the biologically defined patient population associated with an increased likelihood or magnitude of response to P140.
In June 2026, the Company noted early-stage research published by the University of Murcia in Autophagy relating to P140 and its potential application in glioblastoma. The findings provide further scientific evidence relating to P140 outside its original autoimmune setting, while the Company’s primary development focus remains autoimmune disease.
Post period end, further peer-reviewed research from CNRS and the University of Strasbourg reported P140 activity in a preclinical model of metabolic dysfunction-associated steatohepatitis ("MASH"), providing additional evidence of P140 biological activity outside its original lupus setting. See separate announcement made today.
P140 partnering

The Company continues to engage with Avion Pharmaceuticals, its US licensing partner for P140. Recent discussions have been constructive, with Avion supportive of the recent scientific and intellectual property progress across the P140 program
Commercial partnering remained a key focus throughout the period. Discussions are advancing with the objective of securing a value-enhancing commercial deal for P140 in 2026.
Kapiglucagon

During the Period, ImmuPharma completed and approved the overall development plan for Kapiglucagon, establishing the regulatory, manufacturing, nonclinical and bioanalytical activities required to progress the asset towards clinical development.
During the Period and subsequently, the Kapiglucagon program moved from development planning into active execution, with regulatory, API manufacturing, drug product development and bioanalytical activities initiated.
Specialist development partners have been selected across these workstreams to support progression of the program towards IND-enabling development and first-in-human clinical studies.
The regulatory strategy for Kapiglucagon was further developed during the Period, including preparation for interaction with the US FDA to inform key elements of the IND-enabling program and subsequent clinical development.
Commenting on the statement and outlook Tim McCarthy, CEO and Chairman, said:

"In the first half of 2026 and subsequently, we have completed additional studies to support the P140 and Type M precision medicine approach and generated additional data supporting the scientific basis of the program. These results have expanded the scientific package for the P140 patent application, which has now also been filed under the international Patent Cooperation Treaty.

In April, we completed a successful fundraising of £6.47 million and initiated the accelerated development programme of Kapiglucagon.

We remain focused on progressing our two key assets, P140 and Kapiglucagon, through their development programmes and in particular securing a value-enhancing commercial deal for P140 in 2026.

In closing, I would like to thank our shareholders for their support as well as our staff, corporate and scientific advisers and our partners including CNRS and Avion."

(Press release, ImmuPharma, SEP 15, 2026, View Source [SID1234670859])

AMPLIA AND ANZGOG FINALISE PROTOCOL FOR OVARIAN CANCER CLINICAL TRIAL

On September 15, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) reported that the clinical trial protocol for the planned PRROSE Phase 2 ovarian cancer study has been finalised, marking an important milestone toward study commencement.

The ANZGOG and Amplia teams have worked collaboratively over the last three months to finalise the PRROSE trial protocol. With this completed, submission for ethics and site governance approvals will be undertaken, with site activation and patient recruitment planned before the end of 2026.

The PRROSE trial will explore the combination of Amplia’s FAK inhibitor, narmafotinib, in combination with standard-of-care chemotherapy, in women with high-grade serous ovarian cancer (HGSOC). The study will focus on patients whose tumours demonstrate a poor response to chemotherapy prior to planned interval debulking surgery, a group with a significant unmet medical need.

The study will be led by Dr Gwo Yaw Ho of Monash Health and Monash University and will be sponsored and coordinated by ANZGOG. Approximately 26 patients across selected clinical sites in Australia and New Zealand are expected to be enrolled into the trial.

Dr Chris Burns, CEO and Managing Director of Amplia, commented: "This is an important study for a patient population who currently have limited treatment options. We are grateful to the ANZGOG team, working closely with our clinical team at Amplia, for their diligent efforts to complete the trial protocol. We now look forward to finalising ethics submissions with the goal of opening trial sites before the end of the year."

Dr Gwo Yaw Ho, Lead Investigator, said: "Completion of the study protocol enables us to move towards evaluating this promising therapeutic approach in patients with high-grade serous ovarian cancer who are at increased risk of poor outcomes. We look forward to initiating the study and exploring the potential clinical benefit of combining narmafotinib with chemotherapy."

The PRROSE study was first announced in May 20261 and is designed to explore the potential role of FAK inhibition in improving outcomes for patients with ovarian cancer.

(Press release, Amplia Therapeutics, SEP 15, 2026, View Source [SID1234670856])