On June 19, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported a business update and highlights its key milestones expected for the second half of 2025 (Press release, MaaT Pharma, JUN 19, 2025, View Source [SID1234654006]).

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"Following the submission of the Marketing Authorization Application to the EMA for our lead asset, Xervyteg, earlier this month, we are excited to advance Xervyteg toward commercialization — a potential world first for a microbiota therapeutic in oncology — and are now fully focused on progressing registration activities across Europe ", said Hervé Affagard, CEO and co-founder of MaaT Pharma. " This marks a major step in confirming our commitment to address high unmet medical needs and, importantly, it serves as a stepping stone toward international expansion, as we aim to bring our therapies to patients worldwide ".

Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) – Xervyteg (MaaT013)

In January 2025, the Company announced positive topline results from the pivotal Phase 3 ARES Study evaluating Xervyteg (MaaT013) in aGvHD. The study met its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62% and demonstrates the unprecedented efficacy of Xervyteg as third-line treatment of aGvHD with gastrointestinal involvement (GI-aGvHD) consistent with communicated EAP results.
On June 02, 2025, the Company announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its lead drug candidate MaaT013, under the registered brand name of Xervyteg. If approved, the Marketing Authorization would establish Xervyteg as the first microbiota therapeutic approved by the EMA, the first one in hemato-oncology worldwide and the first approved therapy in third-line GI-aGvHD.
On June 13, 2025, the Company presented positive updated data in Early Access Program for 173 patients at the 2025 annual EHA (Free EHA Whitepaper) Congress supporting the high efficacy and good safety profile of Xervyteg. This dataset confirms the breakthrough potential of Xervyteg for aGvHD patients with limited treatment options.
Final results from the pivotal ARES study, including 12-month overall survival data, are expected before the end of 2025 and will be incorporated into the filing dossier.
The potential marketing authorization could be delivered around mid-2026, enabling the start of the commercialization of Xervyteg in Europe.
MaaT Pharma is advancing discussions with potential partners to accelerate the commercialization plan across Europe.
MaaT Pharma primarily focuses on the commercialization of its most advanced asset with the completion of regulatory steps in Europe, and dedicated preparation activities for the European launch of Xervyteg.
In parallel, the Company continues discussions with the FDA to optimize a dedicated pivotal study in the U.S., with the objective of enabling the earliest possible access to Xervyteg for U.S. patients. Such a study could be initiated in 2026 (instead of Q4 2025), subject to regulatory confirmation as MaaT Pharma continues watching the evolving regulatory policies and process in the United States.
The Company continues the ongoing Early Access Program in the United States, initiated in December 2024.
Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) – MaaT033

Over the past 12 months, three DSMB safety assessments were conducted for MaaT033 in the Phase 2b PHOEBUS randomized trial designed to be pivotal: two routine evaluations and one interim analysis focused on excess mortality. All confirmed a favorable safety profile and recommended continuation of the trial without modifications.
The last patient enrollment in the trial is anticipated for mid-2026 while the 1-year OS results are expected in H2 2027.
In Immuno-Oncology

Xervyteg and MaaT033 – Proof-of-Concept trials using the MET-N platform (donor derived conducted as Investigator-Sponsored Trials (ISTs).

In March 2024, the Company completed patient recruitment for the Phase 2a randomized clinical trial (NCT04988841) (PICASSO) sponsored by AP-HP in Paris and in collaboration with INRAE and Institut Gustave Roussy, evaluating Xervyteg in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo), in metastatic melanoma patients. The Company provided its Xervyteg drug candidate and placebo and contributes to the microbiome profiling of patients using its proprietary gutPrint AI research engine, while the trial investigator-sponsor handled recruitment, treatment and is overseeing data collection and analysis. Data readout is expected in H2 2025 as previously announced.
In May 2024, the Company announced its participation in the IMMUNOLIFE ‘RHU’ (university hospital trial) program, a consortium including academic partners, such as Institut Gustave Roussy (IGR), a world-renowned center in the field of cancer treatment, and biotech companies. MaaT033 will be tested as a concomitant treatment to cemiplimab (Regeneron), an anti-PD1 therapy, to assess the potential increase in response rate in patients having received antibiotics. This investigator-sponsored, randomized, multicenter Phase 2 trial will evaluate MaaT033 in patients with advanced non-small cell lung cancer (NSCLC), with MaaT Pharma supplying the investigational product. The trial is expected by the sponsor to start mid-2025.
MaaT034 – Next-generation drug candidates with co-cultured technology (MET-C platform)

In April 2025, the Company presented new preclinical data for MaaT034, its next generation product, showing compelling anti-tumor efficacy results in germ-free mice at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. Key results included:
Metagenomic analysis shows that MaaT034 reproduces the microbial functions of Xervyteg
MaaT034 improves DC-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment.
MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphilabacteria).
In Neurodegenerative Diseases

In May 2025, MaaT Pharma announced positive final Phase 1b results for MaaT033 in Amyotrophic Lateral Sclerosis (ALS), showing a favorable safety and tolerability profile supported by biomarker and microbiome analyses. Moving forward, the Company is seeking a partner to further advance clinical evaluation in ALS.
As a reminder, the Company’s Annual General Meeting will take place on Friday, June 20, 2025, at 9:30am CET at the Company’s headquarter in France located at 70 avenue Tony Garnier, 69007 Lyon and will also be broadcasted live. A presentation by the management team on recent developments and perspectives will take place from 9:00 to 9:30 a.m. CET, prior to the General Meeting. For more information, please visit the investors section on the Company’s website.

On June 19, 2025 Dizal reported the completion of patient enrollment for its WU-KONG28 clinical trial: a multinational, randomized phase III study evaluating the efficacy and safety of sunvozertinib versus platinum-based doublet chemotherapies as a first-line treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) (Press release, Dizal Pharma, JUN 19, 2025, View Source [SID1234654007]).

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EGFR exon20ins have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity. Patients with EGFR exon20ins NSCLC face a poor prognosis and limited treatment options due to the limited efficacy of first- to third-generation EGFR tyrosine kinase inhibitors (TKIs).

Sunvozertinib, the only oral treatment for NSCLC patients with EGFR exon20ins approved, has demonstrated significant efficacy and a favorable safety profile in this patient population. Both the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) have granted Breakthrough Therapy designation to sunvozertinib for the treatment of EGFR exon20ins NSCLC.

WU-KONG28 is a phase III, multinational, randomized clinical trial investigating sunvozertinib compared to platinum-based doublet chemotherapies in treatment-naïve NSCLC patients with EGFR exon20ins. The study is being conducted across 16 countries and regions in Asia, Europe, North America, and South America.

At the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, Dizal reported that sunvozertinib, as a single oral agent, achieved 100% reduction of target lesions, a confirmed objective response rate (ORR) of 78.6%, and a median progression-free survival (mPFS) of 12.4 months, in treatment-naïve patients with advanced or metastatic NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated a well-tolerated safety profile compaired to other EGFR TKIs.

Sunvozertinib is approved in China for the treatment of relapsed and refractory NSCLC with EGFR exon20ins. U.S. FDA granted priority review for its NDA for the same indication with a PDUFA date of July 7, 2025.

About sunvozertinib (DZD9008)

Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins.

Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine.

On June 18, 2025 Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, reported positive topline data from the Phase 1/2a clinical trial (RAD-18-002) evaluating Radspherin in patients with peritoneal metastases originating from colorectal cancer (Press release, Oncoinvent, JUN 18, 2025, https://www.oncoinvent.com/press-release/oncoinvent-announces-positive-final-data-from-phase-1-2a-trial-of-radspherin-in-patients-with-colorectal-peritoneal-metastases/?utm_source=mailpoet&utm_medium=email&utm_source_platform=mailpoet [SID1234653958]).

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Reducing peritoneal recurrence in colorectal cancer is critically important because peritoneal metastases are associated with a particularly poor prognosis and significantly lower overall survival compared to other forms of recurrence[1]. The development of peritoneal metastases is not only linked to worse survival, but also to distressing symptoms, making disease management more challenging and often resulting in treatment interruptions and repeated hospitalizations.

Standard therapies for peritoneal metastases are limited, and the only treatment option with curative intent is surgery, which aims to remove as much tumor as possible in the peritoneal cavity. However, surgical resection leaves behind microscopic deposits of cancer cells, giving rise to new peritoneal metastases and disease progression. Radspherin, direct intraperitoneal targeting with the alpha-emitter radium-224, aims to eliminate these post-surgery micro-metastases and thereby prevent or delay peritoneal recurrence.

In this single-arm trial of 47 patients, 36 received Radspherin at a 7 MBq dose. The primary endpoint—peritoneal recurrence-free survival (pRFS)—yielded remarkable results:

Only 27.8%(10 of 36) experienced peritoneal disease recurrence at 18 months, a marked reduction compared to published data for standard of care, where approximately 50% of patients typically see peritoneal recurrence at this stage[2]
At 18 months, 61.1%(22 of 36) of patients had experienced any recurrence, but notably, just 22.7% (5 of 22) had peritoneum as the first site of recurrence
Final data from all 47 treated patients across dose levels further reinforce the favorable safety profile of Radspherin
Additional results will be published upon completion of the full dataset analysis.

"It’s highly encouraging to see patients treated with Radspherin achieving outcomes that exceed expectations for this challenging population. As a clinician, I’m hopeful that this promising therapy will become an option I can offer to future patients in need," said Dr. Stein Gunnar Larsen, Principal Investigator at the Oslo University Hospital, Norway.

Prof. Dr. Wilhelm Graf, Principal Investigator at Uppsala University Hospital, Sweden, added: "Colorectal peritoneal metastases present a major therapeutic challenge with limited effective options, and these findings support the potential of a novel approach that demonstrates both clinical promise and a favorable safety profile."

"We are inspired and motivated by these compelling data. They reinforce our belief in Radspherin’s potential as a novel treatment targeting peritoneal metastases and justify continued advancement of the program," said Oystein Soug, CEO of Oncoinvent. "We extend our deepest gratitude to the patients, investigators, and clinical teams who made this trial possible."

Radspherin is currently investigated in an ongoing phase 2 trial evaluating the treatment of peritoneal carcinomatosis from ovarian cancer. A positive safety review of the lead-in cohort was announced in Q1 2025, and the trial is currently recruiting patients according to plan in European and US sites in the randomized phase.

About RAD-18-002

RAD-18-002 was an open label Phase 1/2a trial conducted in patients with colorectal peritoneal metastases. The trial was designed to evaluate dosing, safety and tolerability, and signal of efficacy of intraperitoneally administered Radspherin following complete surgical resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC). A total of 47 patients were enrolled across sites in Norway and Sweden, with 36 patients receiving the recommended dose of 7 MBq.

About Radspherin

Radspherin is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors.

On June 18, 2025 Merck reported the first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor (Press release, Merck & Co, JUN 18, 2025, View Source [SID1234653976]).

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage.1 Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy.2-5 However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes.6

"Despite the emergence of new therapies, the current treatment landscape for patients with metastatic castration-resistant prostate cancer is challenging, and there is a need for new treatments," said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. "Following the promising results seen in our earlier phase trial, IDeate-Prostate01 has been initiated to evaluate whether ifinatamab deruxtecan may replace standard taxane-based chemotherapy as a potential treatment strategy in patients with metastatic castration-resistant prostate cancer with disease progression during or after treatment with androgen receptor pathway inhibitors."

"IDeate-Prostate01 marks the initiation of the third pivotal trial in the ifinatamab deruxtecan development program and reinforces our commitment to addressing critical unmet needs for patients," said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. "Our continued progress in the exploration of this potential first-in-class B7-H3 antibody drug conjugate in collaboration with Daiichi Sankyo, speaks to our pursuit of novel science in the hopes of making a difference for patients in need of new options."

The initiation of IDeate-Prostate01 is based on results from the IDeate-PanTumor01 phase 1/2 trial previously presented at the 2022 and 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congresses where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with mCRPC.

About the IDeate-Prostate01 Trial

IDeate-Prostate01 is a multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus docetaxel (75 mg/m2) plus corticosteroid in patients with mCRPC. Eligible patients must have received prior treatment with one or two androgen receptor pathway inhibitors and experienced disease progression during or after at least eight weeks of treatment.

The dual primary endpoints of IDeate-Prostate01 are overall survival and radiographic progression-free survival. Secondary endpoints include objective response rate, time to first subsequent therapy, duration of response, time to pain progression, time to prostate-specific antigen (PSA) progression, PSA response, time to first symptomatic skeletal-related event and safety.

IDeate-Prostate01 will enroll approximately 1,440 patients across Asia, Europe, North America and Oceania. For more information, please visit ClinicalTrials.gov.

About Metastatic Castration-Resistant Prostate Cancer

Prostate cancer is the second most common cancer in men, and the fifth leading cause of cancer death in men worldwide.7 Nearly 1.5 million prostate cancer cases were diagnosed in 2022, with approximately 400,000 deaths globally.7

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in advanced or metastatic stage.1 Approximately 10% to 20% of early-stage prostate cancer cases progress to metastatic disease within five years of treatment on hormonal therapies such as androgen deprivation therapy.8,9 Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy. However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes.6

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1.10,11 B7-H3 is overexpressed in a wide range of cancer types, including mCRPC and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.12-15 There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About Ifinatamab Deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. Food and Drug Administration, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of small cell lung cancer.

About the Ifinatamab Deruxtecan Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan across multiple B7-H3 targetable cancers. Trials in combination with other anticancer treatments also are underway.

On June 18, 2025 Pimera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing breakthrough medicines for cancer and other diseases with high unmet medical need, reported a grant award from the Medical Research Future Fund (MRFF) that will enable the expansion of a Phase 1a/b study evaluating its lead program, PMR-116, for multiple difficult-to-treat cancer indications (Press release, Pimera Therapeutics, JUN 18, 2025, View Source [SID1234653991]).

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Pimera has demonstrated robust preclinical efficacy in multiple MYC-driven models with PMR-116, including those that are resistant to standard-of-care treatments. PMR-116 has moved through dose escalation in the Phase 1a/b clinical trial, and with this new grant, the Company can expand the development of PMR-116 in patients with MYC overexpressing solid tumors in a tumor type-agnostic approach.

"In the ongoing Phase 1 study, PMR-116 demonstrated favorable target engagement and early clinical efficacy signals in multiple solid tumor patients, which is very encouraging," said Mustapha Haddach, Ph.D., President and CEO of Pimera. "We look forward to expanding the study into MYC overexpressing solid tumors with ANU and MRFF."

Pimera has partnered with The Australian National University (ANU) to lead the research. The Phase 1a/b trial, which is funded by the Medical Research Future Fund (MRFF), targets MYC-driven cancers – a group that includes multiple cancer types, such as prostate, breast, ovarian, and haematological cancers. Historically, the MYC protein is a key regulator of cell growth and is often implicated in cancer, contributing to tumor development.

Professor Ross Hannan, Chief Scientific Officer of Pimera, commented, "PMR-116 targets MYC-driven cancers by inhibiting an enzyme to disrupt ribosomal biogenesis – a crucial process hijacked in these cancers. We are pleased to receive this grant and partner with ANU to bring PMR-116 closer to patients in need."

Hematologist at Canberra Health Services and ANU Professor Mark Polizzotto will lead the clinical trial, known as a "basket trial", a study design that brings together patients with different cancer types based on the involvement of the MYC protein, rather than the patient’s cancer type.

"Approximately 70 percent of all cancers are fueled by abnormal MYC activity," commented Dr. Polizzotto. "MYC is one of the most notorious cancer-causing genes, and tumors driven by MYC overexpression are often among the most aggressive and difficult to treat. The trial aims to address unmet clinical needs in difficult-to-treat cancers, and its design is efficient, saving time and resources compared to having separate trials for each cancer type."

The ongoing clinical trial of PMR-116 will be conducted at hospitals including Canberra Hospital, Peter MacCallum Cancer Centre in Victoria, and St Vincent’s Hospital in Sydney. For more information about the ongoing clinical trial, please visit ANZCTR.

About PMR-116

PMR-116 is our lead therapeutic in clinical development for multiple cancer indications including solid tumors. PMR-116 acts through a novel mechanism of action, targeting the RNA polymerase I, or POL I, a transcription factor for MYC driven cancers and other diseases with high unmet medical need. In preclinical studies, PMR-116 has demonstrated robust preclinical efficacy in multiple MYC-driven models, including those that are resistant to standard-of-care treatments. PMR-116 is currently in the dose escalation stage of a Phase 1a/b clinical trial being conducted in Australia. Pimera intends to expand the development of PMR-116 in patients with MYC overexpressing solid tumors in a tumor type-agnostic approach.