On March 31, 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 it will present new non clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place on April 25-30, 2025 in Chicago, Illinois (Press release, MaaT Pharma, MAR 31, 2025, View Source [SID1234651679]).
MaaT034 is the Company’s next-generation full ecosystem synthetic microbiome therapy and the first candidate from its proprietary MET-C platform. Developed using a co-culturing technology optimized for large-scale production, MaaT034 is designed to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors.

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The key findings, obtained from studies conducted in germ-free mice, demonstrate that MaaT034:

Effectively engrafts, thus ensuring an enduring presence of beneficial bacteria in the gut environment.
Potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade.
Leads to the production of key microbial-derived metabolites in germ-free mice.
Improves gastrointestinal physiological functions.
In parallel, the Company is developing donor-derived microbiome therapies that are being explored in multiple clinical trials. Among these, MaaT013 has been tested in patients with acute Graft-versus-Host Disease (aGvHD) and advanced melanoma receiving immune checkpoint inhibitors (PICASSO trial).

"While the PICASSO trial builds on MaaT013’s established safety and efficacy to potentially unlock significant new market opportunities in oncology, our next-generation candidate, MaaT034 — to be featured at AACR (Free AACR Whitepaper) — is designed with an optimized microbiome composition that eliminates the need for donors and incorporates defined and reproducible immunomodulatory properties, offering enhanced therapeutic potential across a broader range of oncology indications," stated Hervé Affagard, CEO and co-founder of MaaT Pharma.

AACR Poster Presentation details:

Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, is capable to safely colonize the gastro-intestinal tract of germ-free mice to restore a healthy gut physiology and to stimulate immunity
Abstract Number: 2209
Session Category: Immunology
Session Title: Microbiome, Inflammation, and Cancer
Session Date/ Time: Monday April 28th, 2025 – 9:00:00 AM U.S Central Time
About Picasso

PICASSO is a Phase 2a clinical trial sponsored by AP-HP and in collaboration with INRAE and Institut Gustave Roussy, evaluating MaaT013 in combination with immune checkpoint inhibitors, ipilimumab (Yervoy) and nivolumab (Opdivo). The trial is fully recruited and have enrolled 70 patients. Key study endpoints include MaaT013 safety profile and best-overall response rate vs placebo as add-on treatment to Ipilimumab + Nivolumab. Clinical Trials.gov: NCT04988841

About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.

On March 31, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE’s proprietary compound LB-100 (Press release, Lixte Biotechnology, MAR 31, 2025, View Source [SID1234651678]).

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"In addition to our ongoing clinical trials in ovarian and colorectal cancer, this study represents a new opportunity in cancer prevention," said Bas van der Baan, LIXTE’s Chief Executive Officer. "Thus far in our Phase 1 clinical trials, LB-100 has shown patient tolerance, with little toxicity, making it a promising candidate as a broad and effective cancer prevention modality."

Increasing evidence indicates that as individuals age, certain mutations accumulate that are found in cancer cells. While these "initiated" cells behave essentially normally, they can propagate to form reservoirs of pre-malignant cells from which malignant cells may eventually emerge. Recent data from LIXTE’s ongoing clinical collaboration with NKI shows that LB-100 activates oncogenic signaling and that this is detrimental to cancer cells.

The new study in animal models will investigate whether "initiated" cells, harboring a mutant RAS oncogene, can be eliminated with LB-100. If successful, LB-100 could have a significant role in the elimination of initiated cells in aged individuals and could reduce the risk of developing a wide range of cancers as a person ages.

The study will be led by René Bernards, Ph.D., a global leader in the field of molecular carcinogenesis and Senior Staff Scientist at NKI, one of the world’s leading comprehensive cancer centers. Dr. Bernards also is a member of LIXTE’s Board of Directors.

On March 31, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or "the Company"), an oncology-focused drug development company, reported the sale of all intellectual property and trademarks rights to Cantrixil for USD $1 million (Press release, Kazia Therapeutics, MAR 31, 2025, View Source [SID1234651677]).

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In March 2021, Vivesto licensed the exclusive global development and commercialization rights for Cantrixil from Kazia Therapeutics. Having decided not to pursue development of Cantrixil in ovarian cancer, as originally anticipated under the license, Vivesto is currently exploring Cantrixil preclinically for the treatment of hematological cancers. Cantrixil, a legacy molecule in the Kazia pipeline, is a product candidate consisting of the active molecule, a potent and selective third generation benzopyran SMETI inhibitor named TRXE-002-01, encapsulated in α-cyclodextrin.

"We are pleased to enter into this agreement with Vivesto, which provides a source of non-dilutive funding that will help advance our proprietary, clinical-stage pipeline," said John Friend, M.D., Chief Executive Officer of Kazia Therapeutics.

On March 31, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported a poster presentation on its potentially breakthrough next generation γδ T cell-based T cell engager (TCE) platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, taking place April 25-30, 2025 in Chicago, IL (Press release, In8bio, MAR 31, 2025, View Source [SID1234651676]).

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"T cell engagers are an exciting area of immunotherapy that remains in the early innings of development. We believe gamma-delta T cells offer unique properties, including tissue residence, phagocytosis and low IL-6 secretion, representing a powerful modality with the potential to overcome the limitations of current CD-3 based engager therapies," said William Ho, CEO, and co-founder of IN8bio. Our novel gamma-delta T cell engager platform, presented for the first time at AACR (Free AACR Whitepaper) 2025, demonstrates how we can combine the innate tumor-recognition capabilities of gamma-delta T cells with the capacity for significant cell expansion and the specificity of bispecific engagers to drive a potent, targeted immune response against multiple target antigens. These early findings in AML and B-ALL support our broader strategy to harness the unique biology of these cells across a range of cancers."

AACR Poster Presentation Details

Poster Title: A novel gamma-delta T cell engager platform for cancer immunotherapy

Abstract Presentation Number: 7321 (Poster Board 7)

Session Title: Immunology/T Cell Engagers and Novel Antibody-Based Therapies

Session Date and Time: Wednesday, April 30, 2025, 9:00 AM – 12:00 PM CT

For more details visit: www.aacr.org/meeting/aacr-annual-meeting-2025/abstracts.

On March 31, 2025 Genmab A/S (Nasdaq: GMAB) reported that the European Commission (EC) has granted marketing authorization for TIVDAK (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy (Press release, Genmab, MAR 31, 2025, View Source [SID1234651675]). TIVDAK is the first and only ADC to be granted European Union (EU) marketing authorization for people living with recurrent or metastatic cervical cancer.

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Despite progress in cervical cancer prevention and early detection, there remains a high need for new treatment options, particularly in advanced forms of the disease. In fact, cervical cancer is the fourth most common cause of cancer death among women globally.i In the European Union, cervical cancer is the 11th most frequently occurring cancer among women.ii Up to 15% of adults with cervical cancer present with metastatic disease at diagnosisiii,iv and, for those diagnosed at earlier stages who receive treatment, up to 61%v will experience disease recurrence. For these patients, the prognosis can be poor.vi

"Recurrent or metastatic cervical cancer is a devastating disease, and patients can face a difficult treatment journey with limited options," said Ignace Vergote, M.D., Ph.D., University Hospitals Leuven, co-founder of European Network of Gynaecological Oncological Trial groups (ENGOT), and lead investigator on the innovaTV 301 clinical trial. "In clinical trials, TIVDAK demonstrated a superior overall survival benefit and manageable safety profile compared to chemotherapy, supporting its position to become a potential new standard of care in this setting with a novel mechanism of action. This approval is an important step forward in the treatment landscape for advanced cervical cancer."

The approval is supported by data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628) that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy. The trial met its primary endpoint of overall survival (OS), demonstrating a 30% reduction in risk of death (HR: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038) compared to chemotherapy. Median OS was 11.5 months [95% CI: 9.8-14.9] among patients treated with TIVDAK compared to 9.5 months [95% CI: 7.9-10.7] for patients who received chemotherapy. Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) were also met, further validating its clinical benefit. PFS results were statistically significant, with TIVDAK demonstrating a 33% reduction in the risk of disease progression compared with chemotherapy (HR: 0.67 [95% CI, 0.54-0.82], p<0.0001). Data from the innovaTV 204 (NCT03438396) pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer was also included in the marketing authorization application (MAA).

The most common (≥25%) adverse reactions, including laboratory abnormalities, in patients receiving tisotumab vedotin were peripheral neuropathy (39%), nausea (37%), epistaxis (33%), conjunctivitis (32%), alopecia (31%), anaemia (27%), and diarrhoea (25%).

"We recognize the urgent need to accelerate science and innovate new treatment options for gynecologic cancers, including cervical cancer," said Brad Bailey, Executive Vice President and Chief Commercial Officer of Genmab. "The European Commission approval of TIVDAK marks a milestone in our work to transform the treatment paradigm and help improve outcomes for patients. As the first medicine that Genmab will bring to patients in Europe independently, we’re committed to bringing this important option to as many patients in Europe with previously treated recurrent or metastatic cervical cancer as possible."

About the innovaTV 301 Trial
The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received one or two prior systemic regimens in the recurrent or metastatic setting.

Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate.

The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups. For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

About Tisotumab Vedotin
Tisotumab vedotin (approved under the brand name TIVDAK in the EU, U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.