On November 5, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the third quarter ended September 30, 2025 and provided recent business and clinical program updates.

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"Xencor’s two novel, first-in-class, CD3 T-cell engaging bispecific antibodies, XmAb819 and XmAb541, have demonstrated compelling clinical data in advanced clear cell renal cell carcinoma and advanced gynecologic and germ cell tumors, respectively. As we continue to advance through dose escalation and cohort expansions in Phase 1 studies evaluating these programs, we expect to identify recommended Phase 3 doses during 2026 to support initiation of pivotal studies during 2027," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "The accelerating tempo of clinical development extends to our autoimmune portfolio. In the third quarter we dosed the first patient in our Phase 2b XENITH-UC study of XmAb942, our potential best-in-class antibody targeting TL1A for inflammatory bowel disease, to rapidly identify a pivotal dose regimen for those with moderately to severely active ulcerative colitis, and we dosed the first patient in our Phase 1b study of plamotamab in rheumatoid arthritis. We remain on-track to start clinical studies of XmAb657, our B-cell depleting TCE for the treatment of patients with autoimmune disease by year end 2025, and our lead TL1A x IL23p19 bispecific antibody, now designated XmAb412, in 2026."

Clinical Program Updates

Oncology

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). The first dose-expansion cohort in the ongoing Phase 1 study is enrolling patients as dose-escalation continues. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study in advanced ccRCC during 2027.

At the AACR (Free AACR Whitepaper)-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in October 2025, Xencor presented initial results from the ongoing Phase 1 dose-escalation study of XmAb819. As of the data cut-off, 69 patients had received XmAb819 across 15 dose cohorts; patients were heavily pre-treated, having received a median of 4 prior lines of therapy. All patients received prior anti-PD1 therapy and prior VEGF-TKI therapy, and 36% of patients were previously treated with a HIF2α inhibitor. XmAb819 demonstrated evidence of anti-tumor activity and an acceptable safety profile that was generally well tolerated across dose levels. Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (PR, per RECIST v1.1) as best response with a 70% disease control rate. The most common treatment-emergent adverse events (AEs) were cytokine release syndrome, rash and gastrointestinal-related toxicities that were primarily Grade 1 or 2 in severity and predominantly associated with prime-step dosing in the first four weeks of treatment. No cases of treatment-related immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. No Grade 5 events were reported. Four patients (6%) were dose-reduced due to treatment-related AEs, and three patients (4%) discontinued treatment due to treatment-related AEs.
XmAb541 (CLDN6 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced gynecologic and germ cell tumors. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study during 2027.

In October 2025, Xencor presented early efficacy data from a cohort in the ongoing Phase 1 dose-escalation study of XmAb541, ahead of previously guided timelines to begin characterizing target dose range cohorts by year-end 2025. As of the data cut-off, nine patients received XmAb541 in the most recently completed escalation cohort. Confirmed partial responses per RECIST v1.1 were observed in three patients: one patient with ovarian cancer and two patients with germ cell tumors.
Autoimmune & Inflammatory Diseases

Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in development for patients with rheumatoid arthritis (RA). Xencor is evaluating plamotamab in a Phase 1b proof-of-concept study, for patients with RA who have progressed through prior standard-of-care treatment. The first patient has been dosed in the study, and enrollment is ongoing.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. Xencor is conducting the global XENITH-UC Study, a Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. Patient enrollment in the study is ongoing.
Recent Partnership Developments

Amgen: Amgen initiated the Phase 3 XALience study of xaluritamig, a STEAP1 x CD3 XmAb 2+1 bispecific T-cell engager, in combination with abiraterone versus investigator’s choice therapy in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer. XALute, a Phase 3 monotherapy study of xaluritamig in patients who have previously been treated with taxane-based chemotherapy, is enrolling. Amgen is exploring xaluritamig in other combinations and in earlier stages of prostate cancer with multiple Phase 1b studies ongoing. Xencor is eligible to receive $225 million in future milestone payments and tiered royalties on net sales that range from mid- to high-single digit percentages.
Astellas: In October 2025, the first clinical data from Astellas’ investigational Claudin18.2-targeted, XmAb 2+1 bispecific CD3 T-cell engager, ASP2138, both as a monotherapy and in combination with standard of care therapies, were presented during the European Society for Medical Oncology congress in Berlin. Astellas is advancing ASP2138 for the treatment of patients with gastric, gastroesophageal junction and pancreatic cancers, and Astellas has announced that planning is ongoing to potentially initiate registrational studies. ASP2138 utilizes the XmAb 2+1 multivalent format to enable activation of T cells against Claudin-18.2 expressing tumor cells. Xencor is eligible to receive $232.5 million in future milestone payments and tiered royalties on net sales that range from high-single to low-double digit percentages.
Zenas Biopharma: In October 2025, Zenas announced positive results from the Phase 2 MoonStone trial of obexelimab in relapsing multiple sclerosis, in which the primary endpoint of the study was met. Zenas announced it expects to report topline results for the pivotal study of obexelimab in IgG4-Related Disease around year-end with additional readouts through mid-2026. Obexelimab targets CD19 with its variable domain and uses an XmAb Immune Inhibitor Fc Domain. In November 2021, Xencor licensed obexelimab to Zenas. Xencor is eligible to receive $460 million in future milestone payments and tiered royalties on net sales that range from mid-single-digit to mid-teen percentages, dependent on geography. As of September 30, 2025, Xencor owns 3,098,380 shares of common stock in Zenas.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $570 million and $590 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the Third Quarter Ended September 30, 2025

Cash, cash equivalents and marketable debt securities totaled $633.9 million as of September 30, 2025, compared to $706.7 million as of December 31, 2024.

Revenue for the third quarter ended September 30, 2025 was $21.0 million, compared to $17.8 million for the same period in 2024. Revenue earned in the third quarters of 2025 and 2024 was primarily non-cash royalty revenue from Alexion and Incyte.

Research and development (R&D) expenses for the third quarter ended September 30, 2025 were $54.4 million, compared to $58.2 million for the same period in 2024. Decreased R&D spending for the third quarter of 2025 compared to 2024 reflects lower stock-based compensation and lower costs related to programs that are winding down or have been terminated.

General and administrative (G&A) expenses for the third quarter ended September 30, 2025 were $14.2 million, compared to $14.8 million for the same period in 2024. G&A spending for the third quarter of 2025 remained relatively consistent compared to the same period in 2024.

Other income, net, for the third quarter ended September 30, 2025 was $41.5 million, compared to $7.8 million for the same period in 2024. The increase for the third quarter of 2025, compared to 2024, is primarily driven by unrealized gains from marketable equity securities.

Net loss attributable to Xencor for the third quarter ended September 30, 2025 was $6.0 million, or $(0.08) on a fully diluted per share basis, compared to net loss of $46.3 million, or $(0.72) on a fully diluted per share basis, for the same period in 2024.

(Press release, Xencor, NOV 5, 2025, View Source [SID1234659480])

On November 5, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for the treatment of patients with epidermal growth factor receptor ("EGFR")-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer ("NSCLC") following progression on treatment with TAGRISSO. The last patient was randomized on October 31, 2025.

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This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor ("TKI"), and was granted approval in China in June 2025 based on the results of the SACHI randomized Phase III trial. ORPATHYS is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

SAFFRON is a global Phase III, open-label, randomized, multicenter study to investigate the efficacy and safety of ORPATHYS administered orally in combination with TAGRISSO versus platinum-based doublet chemotherapy in participants with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with TAGRISSO as the most recent therapy. The primary endpoint of the study is progression free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. Other endpoints include overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. This study randomized 338 patients, screened from over 230 sites across 29 countries. Additional details may be found at clinicaltrials.gov, using identifier NCT05261399.

Topline results from the SAFFRON study are estimated to be reported in the first half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results could support global regulatory filings for the ORPATHYS and TAGRISSO combination.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

SACHI: This Phase III trial in China evaluated the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The treatment combination received approval in China in June 2025.

SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. This received Fast Track Designation from the US Food and Drug Administration (FDA) and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings.

SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS and TAGRISSO compared to TAGRISSO monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025.

(Press release, Hutchison China MediTech, NOV 5, 2025, https://www.hutch-med.com/saffron-global-phiii-enrollment-completion/ [SID1234659385])

On November 5, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported financial results for the quarter ended September 30, 2025.

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"We are excited that our partner Takeda plans to advance elritercept into a Phase 3 clinical trial to evaluate elritercept in the first-line setting in myelodysplastic syndromes," said Jasbir S. Seehra, Ph.D., President and Chief Executive Officer. "We are pleased with the continued progress of both our partner and our internal pipeline, as we advance toward initiating a Phase 2 clinical trial of KER-065 in patients with Duchenne muscular dystrophy."

Third Quarter 2025 Financial Results

Keros reported a net loss of $7.3 million in the third quarter of 2025 as compared to a net loss of $53.0 million in the third quarter of 2024. The decrease of $45.7 million was largely due to revenue recognized related to Keros’ license agreement with Takeda Pharmaceuticals U.S.A., Inc. ("Takeda"), partially offset by research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.

Research and development expenses were $19.5 million for the third quarter of 2025 as compared to $49.2 million for the same period in 2024. The decrease of $29.7 million was primarily due to the transition of elritercept-related research and development expenses to Takeda.

General and administrative expenses were $10.1 million for the third quarter of 2025 as compared to $9.8 million for the same period in 2024. The increase of $0.3 million was primarily due to an increase in other external expenses partially offset by a decrease in compensation costs, including stock-based compensation costs, in connection with a reduction in headcount.

Keros’ cash and cash equivalents as of September 30, 2025 was $693.5 million compared to $559.9 million as of December 31, 2024. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of September 30, 2025, less $375.0 million of excess capital that the Company’s Board of Directors has determined to return to stockholders, will enable Keros to fund its operating expenses and capital expenditure requirements into the first half of 2028.

(Press release, Keros Therapeutics, NOV 5, 2025, View Source [SID1234659465])

On November 5, 2025 Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, reported that members of the Company’s management team will participate and be available for one-on-one meetings at the following investor conferences:

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Stifel 2025 Healthcare Conference
Wednesday, November 12, 2025
Fireside Chat at 10:00 a.m. ET
Jefferies Global Healthcare Conference
Thursday, November 20, 2025
Fireside Chat at 9:30 a.m. GMT
The sessions will be webcast and can be accessed by visiting the Events section of the Altimmune website.

(Press release, Altimmune, NOV 5, 2025, View Source [SID1234659482])

On November 5, 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 the presentation of updated preclinical data for MaaT034, its next generation drug candidate to be evaluated to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors at the 40th Society for Immunotherapy Cancer Annual Meeting in National Harbor, MD held from November 5 to 9, 2025. The SITC (Free SITC Whitepaper) Annual Meeting is one of the world’s leading scientific and medical conferences focused on cancer immunotherapy. The dataset demonstrates compelling anti-tumor efficacy results and immune activation in germ-free mouse models. New analyses of multi-omic data from these models amplify the results previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2025.

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MaaT034, the first-in-class co-cultured full ecosystem product, is designed to optimize intestinal microbiome functions and improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors (ICIs). MaaT034 is part of the Company’s MET-C platform, which leverages AI-driven co-culture technology to create donor-independent synthetic microbiome ecosystems at industrial scale, targeting specific disease indications.

To guide further development of MaaT034 in immuno-oncology, and in addition to its preclinical program, MaaT Pharma is also participating in two exploratory, investigator-sponsored clinical trials evaluating its donor-derived drug candidates (MaaT013 and MaaT033), respectively in metastatic melanoma and in non-small cell lung cancer (NSCLC).

Key findings from the presentation at SITC (Free SITC Whitepaper) include:

Metagenomic analysis shows that MaaT034 successfully engrafts in the gut of germ-free mice and reproduces the microbial functions of native-based microbiome ecosystems.
MaaT034 improves dendritic cell (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.In human FMT studies, the level of engraftment is significantly associated with positive clinical outcomes across multiple indications, as shown by a recent comprehensive meta-analysis[1].
MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids, secondary bile acids, and tryptophan metabolites 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 muciniphila[2] bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.
"With MaaT034, we are entering a new phase in our drug platform development, one that leverages our deep experience in the development of complex microbiome therapies and cutting-edge computational analysis to build a next-generation drug candidate capable of enhancing patient response to immunotherapy," said Sheri Simmons, PhD, Acting Chief Scientific Officer, MaaT Pharma. "These findings strongly support advancing our donor-independent, synthetic microbiome therapy and we look forward to bringing MaaT034 into clinical development."

Details of poster presentation:

Abstract number: 1150
Title: MaaT034, a new co-cultured microbiome ecosystem therapy candidate, potentiates anti-PD1 mediated antitumoral activity in germ-free mice
Presentation Day: Saturday, Nov. 8, 2025
Primary Category: Microbiome and Other Environmental Factors
Upcoming investor and medical conferences participation

November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA
[1] Ianiro, G., Punčochář, M., Karcher, N. et al. Variability of strain engraftment and predictability of microbiome composition after fecal microbiota transplantation across different diseases. Nat Med 28, 1913–1923 (2022). View Source
[2] Akkermansia muciniphila is a commensal bacterium naturally present in large quantities in the gut microbiota of healthy people.

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.

(Press release, MaaT Pharma, NOV 5, 2025, View Source [SID1234659466])