MaaT Pharma Secures €37.5 Million Loan From European Investment Bank (EIB) Marking a New Step in Advancing its Clinical Program in Hemato-Oncology

On July 28, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported that it has secured a €37.5 million, 4-tranche financing from the European Investment Bank (EIB) (Press release, MaaT Pharma, JUL 28, 2025, View Source [SID1234654558]). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, recently partnered with Clinigen in Europe, and currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host Disease (aGvHD) and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allogeneic stem cell transplants.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With robust cGMP manufacturing, proprietary therapies, and a development platform, MaaT Pharma is a global leader in microbiome-based oncology, pioneering full-ecosystem therapies to improve survival in oncology. Since completing enrollment in the ARES trial for Xervyteg (MaaT013) in October 2024, MaaT Pharma has steadily advanced its roadmap, reporting topline results in January 2025, submitting the Marketing Authorization Application with the European Medicines Agency in June 2025, and signing an exclusive agreement for marketing and distribution in Europe with Clinigen in July 2025.

The €37.5 million financing from the EIB follows a rigorous due diligence process by the EIB and further confirms MaaT Pharma’s innovation, strategic vision and operational maturity. This funding is part of a global financial strategy to support the Company’s development that combines various non-dilutive and dilutive sources to best preserve shareholder value.

Eric Soyer, Chief Financial Officer, MaaT Pharma, said: "We are grateful for the confidence shown in MaaT Pharma and the support from the EIB, which is a further foundation towards the next phase of MaaT Pharma’s growth on bringing the potential first microbiome-based therapy to market in Europe. Each operational and financing step strengthens our track record. Following the regulatory submission to the EMA for Xervyteg(MaaT013) and our recent partnership with Clinigen for its commercialization, the EIB financing represents another step in reinforcing the Company’s financial position. As previously announced, MaaT Pharma intends to fund its plans and development programs while preserving shareholder value in the best manner possible with a mix of non-dilutive and dilutive financial sources, and the recent announcements of both partnership financing with the Clinigen agreement and debt financing with the EIB agreement, are benchmarks to reflect that strategy."

Summary of the main terms and conditions of the Loan and Warrants

The loan would be available in four (4) tranches, respectively of €3.5 million for Tranche A, €6.0 million for Tranche B, €8.0 million for Tranche C, and €20.0 million for Tranche D, each tranche with Warrants attached. Disbursement of Tranches 2 to 4 are subject to operational and financing conditions. All Tranches are redeemable after a grace period of 4 years from the date of drawing, with reimbursement over a period of 2 years (Tranche A, B and C, i.e. a maturity of 6 years) to 4 years (Tranche D, i.e. a maturity of 8 years). Each tranche will bear interests at 7%, it being provided that some interests will be deferred and paid at maturity and for Tranche C and Tranche D part of the interest will be paid quarterly.

MaaT Pharma will issue warrants to the benefit of EIB at the time of (and subject to) disbursement of each tranche in a number depending, for each relevant tranche, on the amount of the relevant tranche and the average price per share paid by investors in the context of equity injection made prior to disbursement of the relevant tranche (except for tranche A where the average price per share over the last trading days preceding the date of execution of the financing agreement). Each warrant will give right to subscribe to one share at a price per warrant equal to 99% of the average price over a period of 5 trading days preceding the issuance of each Warrant. The Warrants may be exercised at any time following maturity of Tranche A. The Warrants will have a 20-year term.

EIB and MaaT Pharma have also agreed on (i) a put option to the benefit of EIB under which MaaT Pharma undertook to acquire from EIB all or part of the Warrants upon occurrence of certain events and (ii) a call option to the benefit of MaaT Pharma under which EIB undertook to sell all its Warrants, upon occurrence of a public tender offer over the securities issued by MaaT Pharma.

The Warrants are not transferable, except to affiliates of EIB or except in case of occurrence of certain events (including maturity date of Tranche D). In case of transfer of Warrants to third party, MaaT Pharma shall benefit from a preemptive right to acquire the Warrants first.

MaaT Pharma was assisted in this transaction by Mr. Eric Briole and by Van Lanschot Kempen as Financial Advisors and McDermott Will & Emery as Legal Advisor.

Arrowhead Pharmaceuticals Earns $100 Million Milestone from Sarepta Therapeutics

On July 28, 2025 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported that it has earned a $100 million milestone payment from Sarepta Therapeutics (NASDAQ: SRPT) (Press release, Arrowhead Pharmaceuticals, JUL 28, 2025, View Source [SID1234654578]). The milestone was triggered when Arrowhead reached the first of two prespecified enrollment targets and subsequent authorization to dose escalate in a Phase 1/2 clinical study of ARO-DM1, an investigational RNA interference (RNAi) therapeutic for the treatment of type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy. Arrowhead currently expects to achieve the second enrollment target by the end of 2025, which would trigger an additional $200 million milestone payment from Sarepta.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In accordance with the license and collaboration agreement, Arrowhead expects to receive this payment within 60 days.

About the Arrowhead-Sarepta Agreement

Arrowhead and Sarepta signed a global licensing and collaboration agreement in November 2024, which closed in February 2025, whereby Sarepta received rights to multiple investigational treatments that leverage Arrowhead’s leading Targeted RNAi Molecule (TRiMTM) platform. The agreement covers multiple clinical and preclinical programs in rare, genetic diseases of the muscle, central nervous system, and the lungs, and also allows Sarepta to select up to six new targets for Arrowhead to conduct discovery and preclinical development activities in areas complementary to Sarepta’s leadership in precision genetic medicine for rare diseases.

Summary Financial Terms

Upon closing, Arrowhead received a $500 million upfront payment and $325 million through the purchase by Sarepta of Arrowhead common stock priced at $27.25 per share, representing a 35% premium to the 30-day volume weighted average price (VWAP) when the agreement was signed. Arrowhead will also receive $250 million to be paid in annual installments of $50 million over five years, and has the potential to receive an additional $300 million in near-term milestone payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study of ARO-DM1, $100 million of which has now been earned.

Arrowhead is also eligible to receive further development milestone payments of between $110 million and $180 million per program, sales milestone payments of between $500 million and $700 million per program, and tiered royalties on commercial sales up to the low double digits.

Summary of Programs Under the License and Collaboration Agreement

Clinical Stage

ARO-DUX4, which is designed to target the gene that encodes the DUX4 protein as a potential treatment for patients with facioscapulohumeral muscular dystrophy type 1, currently dosing patients in a Phase 1/2 clinical study.
ARO-DM1, which is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK), gene in skeletal muscle as a potential treatment for patients with type 1 myotonic dystrophy, currently dosing patients in a Phase 1/2 clinical study.
ARO-MMP7, which is designed to reduce expression of matrix metalloproteinase 7 (MMP7) in the lung as a potential treatment for idiopathic pulmonary fibrosis, currently dosing patients in a Phase 1/2 clinical study.
ARO-ATXN2, which is designed to silence expression of the toxic ATXN2 protein in the CNS as a potential treatment for spinocerebellar ataxia 2 (SCA2), currently in a Phase 1/2 study that is open for enrollment.
Preclinical Stage

ARO-HTT for patients with Huntington’s disease, expected to be CTA-ready in 2025
ARO-ATXN1 for patients with spinocerebellar ataxia 1 (SCA1) expected to be CTA-ready in 2026
ARO-ATXN3 for patients with spinocerebellar ataxia 3 (SCA3) expected to be CTA-ready in 2026
Discovery

During the five-year term, Sarepta can propose up to six new CNS or muscle targets for which Arrowhead will perform discovery and preclinical development. Sarepta would then receive an exclusive license to those programs and would be responsible for subsequent clinical development and commercialization.

Drug Manufacturing

Under the terms of the agreement, Arrowhead will manufacture clinical drug supply for all programs arising out of the license and collaboration, and commercial drug product for the four programs currently in clinical trials.

Imfinzi granted Priority Review and Breakthrough Therapy Designation in the US for patients with resectable early-stage gastric and gastroesophageal junction cancers

On July 28, 2025 AstraZeneca reported supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers (Press release, AstraZeneca, JUL 28, 2025, View Source [SID1234654559]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2025.

Imfinzi was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.2

Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.3 In 2024, there were approximately 6,500 drug-treated patients in the US with early-stage and locally advanced gastric or GEJ cancer. 4

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential for a perioperative approach with Imfinzi to transform care for patients with early gastric and gastroesophageal junction cancers, who frequently face disease recurrence or progression even after curative-intent surgery and perioperative chemotherapy. This novel treatment is the only immunotherapy-based regimen to show a statistically significant reduction in the risk of progression, recurrence or death in this setting, and if approved, is poised to change the clinical paradigm."

The sBLA is based on data from the MATTERHORN Phase III trial which was presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

In the trial, patients were treated with neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy. In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone (based on an event-free survival [EFS] hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively, signalling a greater magnitude of benefit over time for the Imfinzi-based regimen.

For the key secondary endpoint of overall survival (OS), a strong trend was observed in favour of the Imfinzi-based perioperative regimen (HR=0.78; 95% CI 0.62-0.97; p=0.025). The trial will continue to follow OS, which will be formally assessed at the final analysis.

The safety profile for Imfinzi and FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy was consistent with the known profiles of each medicine, and the percentage of patients that completed surgery was similar compared to chemotherapy alone. Grade 3 or higher adverse events due to any cause were similar between the two arms.

Regulatory applications are currently under review in the EU, Japan and several other countries based on the MATTERHORN results.

Notes

Gastric and gastroesophageal junction cancers
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-highest leading cause of cancer mortality.3 Nearly one million new patients were diagnosed with gastric cancer in 2022, with approximately 660,000 deaths reported globally.3 In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 In 2024, there were approximately 43,000 drug-treated patients in the US, European Union (EU), and Japan with early-stage and locally advanced gastric or GEJ cancer.4 Approximately 62,000 patients in these regions are expected to be newly diagnosed in this setting by 2030.6

GEJ cancer is a type of gastric cancer that arises from and spans the area where the oesophagus connects to the stomach.7

Disease recurrence is common in patients with resectable gastric cancer despite undergoing surgery with curative intent and treatment with neoadjuvant/adjuvant chemotherapy. Approximately one in four patients with gastric cancer who undergo surgery develop recurrent disease within one year, and one in four patients do not survive beyond two years, reflecting a high unmet medical need.8-9 Additionally, the five-year survival rate remains poor, with less than half of patients alive at five years.10

MATTERHORN
MATTERHORN is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage II-IVA gastric and GEJ cancers. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 948 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus FLOT chemotherapy or placebo plus FLOT chemotherapy every four weeks for two cycles prior to surgery. This was followed by Imfinzi or placebo every four weeks for up to 12 cycles after surgery (including two cycles of Imfinzi or placebo plus FLOT chemotherapy and 10 additional cycles of Imfinzi or placebo monotherapy).

In the MATTERHORN trial, the primary endpoint is EFS, defined as time from randomisation until the date of one of the following events (whichever occurred first): RECIST (version 1.1, per blinded independent central review assessment) progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period; RECIST progression/recurrence during the adjuvant period; non-RECIST progression that precludes surgery or requires non-protocol therapy during the neoadjuvant period or discovered during surgery; progression/recurrence confirmed by biopsy post-surgery; or death due to any cause. Key secondary endpoints include pathologic complete response rate, defined as the proportion of patients who have no detectable cancer cells in resected tumour tissue following neoadjuvant therapy, and OS. The trial enrolled participants in 176 centres in 20 countries, including in the US, Canada, Europe, South America and Asia.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In GI cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU.

In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC.

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan.

Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers.

BeOne Medicines Receives Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment

On July 28, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence (Press release, BeOne Medicines, JUL 28, 2025, View Source [SID1234654579]). This recommendation is based on the Phase 3 RATIONALE-315 study (NCT04379635).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Patients with resectable, early-stage NSCLC face an urgent challenge – despite surgery and current therapies, recurrence rates remain alarmingly high," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at the Faculty of Medicine of Universidad Autonoma de Madrid in Spain. "The significant clinical benefit observed in the RATIONALE-315 study has important implications for patients. If approved, perioperative tislelizumab will offer oncologists a powerful new option to improve outcomes and potentially alter the course of this difficult-to-treat disease."

RATIONALE-315 is a double-blind, placebo-controlled, multicenter, Phase 3 study that randomized 453 patients with resectable NSCLC 1:1 to receive either TEVIMBRA plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by TEVIMBRA as adjuvant treatment or placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment. As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress Virtual Plenary in February 20241, the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses of the RATIONALE-315 study. Results include:

Statistically significant and clinically meaningful improvement in MPR and pathological complete response (pCR) rates:
56.2% of NSCLC patients treated with TEVIMBRA in combination with chemotherapy before surgery achieved MPR compared to 15.0% of patients treated with chemotherapy in combination with placebo (difference: 41.1%; 95% CI: 33.2-49.1, p<0.0001)
40.7% of patients on the TEVIMBRA-based regimen achieved pCR, compared to 5.7% of patients treated with chemotherapy in combination with placebo (difference: 35.0%; 95% CI: 27.9-42.1, p<0.0001)
Statistically significant EFS (HR [95% CI], 0.56 [0.40–0.79]; 1-sided P=0.0003) and trend for overall survival (OS) (HR [95% CI], 0.62 [0.39–0.98]; 1-sided P=0.0193) benefits favoring TEVIMBRA in early data.
Consistent safety profile of the TEVIMBRA arm with that of individual therapies, with 72.1% of patients in the TEVIMBRA arm (vs. 66.4% in the placebo arm) experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% of patients in the TEVIMBRA arm (vs. 8.0% in the placebo arm) experiencing serious TRAEs. There were no new safety signals identified with this regimen, and the most common Grade 3 or 4 TRAEs (≥ 10%) in the TEVIMBRA arm were decreased neutrophil count and decreased white blood cell count.
No impact on the feasibility and completeness of surgery, a key concern around neoadjuvant treatment.
Updated EFS and OS data from the pre-planned final analysis of RATIONALE-315 will be submitted for presentation at an upcoming medical conference.

"TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "As the foundational asset of our solid tumor portfolio, TEVIMBRA continues to demonstrate its strength and versatility across the continuum of care, bringing us closer to our goal of delivering more comprehensive and effective cancer treatment to more patients."

In lung cancer, TEVIMBRA is already approved in the EU for the first-line treatment of patients with squamous NSCLC, for the first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression, for the treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy, and as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). It is also approved as a first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, and as a first-line treatment for patients with nasopharyngeal carcinoma (NPC).

About NSCLC

Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.2 In Europe, lung cancer is the third most frequent cancer with 484,306 new cases diagnosed in 2022.3 NSCLC accounts for 80–90% of all lung cancers4, of which resectable NSCLC patients at diagnosis represent around 25–30%5.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global audience. Product indications vary by region.

Immutep Announces Abstracts Accepted for Presentation at the European Society for Medical Oncology Congress 2025

On July 28, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported three abstracts for clinical trials evaluating its first-in-class MHC Class II agonist, eftilagimod alfa (efti), have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 taking place 17-21 October in Berlin, Germany (Press release, Immutep, JUL 28, 2025, View Source [SID1234654580]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Proffered Paper oral presentation will detail results from EFTISARC-NEO, a Phase II investigator-initiated trial in resectable soft tissue sarcoma, and data from the INSIGHT-003 Phase I investigator-initiated trial in first-line non-small cell lung cancer (1L NSCLC) has been accepted for poster presentation. Additionally, an abstract on the Company’s pivotal TACTI-004 Phase III in 1L NSCLC has been accepted for a Trials in Progress ePoster. Details of the presentations are as follows:

Title: EFTISARC-NEO: A phase II study of neoadjuvant eftilagimod alpha, pembrolizumab and radiotherapy in patients with resectable soft tissue sarcoma
Presenter: Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland
Session Category: Proffered Paper
Session Title: Sarcoma
Presentation #: 2686O
Date and Time: Sunday, 19 October 2025 at 16:30 – 18:00 PM CET

Title: Eftilagimod alpha (soluble LAG-3 protein) combined with 1st line chemo-immunotherapy in metastatic non-squamous non-small cell lung cancer (NSCLC) –Updates from INSIGHT-003 (IKF614)
Presenter: Dr. med. Akin Atmaca, Department of Hematology and Oncology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany
Session Category: Poster
Session Title: NSCLC, metastatic
Presentation #: 1857P
Date and Time: Saturday, 18 October 2025 at 12:00 – 12:45 PM CET

Title: TACTI-004, a double-blinded, randomised phase 3 trial of eftilagimod alfa plus pembrolizumab (P) + chemotherapy (C) vs placebo + P + C in 1st line advanced/metastatic NSCLC
Presenter: Prof. Dr. med. Hans-Georg Kopp, Robert Bosch Hospital, Stuttgart, Germany
Session Category: ePoster
Session Title: NSCLC, metastatic
Presentation #: 2086eTiP

Proffered Papers at ESMO (Free ESMO Whitepaper) are oral presentations of original data of superior quality, followed by expert discussion and perspectives.

Abstracts will be made available on the ESMO (Free ESMO Whitepaper) website on 13 October 2025 at 00.05 CET. The posters will be available on the Posters & Publications section of Immutep’s website after their presentations.