On November 4, 2025 Ensoma, an in vivo hematopoietic stem cell (HSC) engineering company with a mission to advance the future of medicine through one-time therapies, reported new preclinical data demonstrating proof-of-concept for its in vivo, HSC-derived CAR-M, NK, and T cell platform, including its potential to durably generate lineage-restricted CAR cells in solid tumors. The data will be presented in two poster sessions this week at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place November 5-9 in National Harbor, Md.

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"While ex vivo CAR-T therapies have transformed treatment for blood cancers, use in solid tumors has been limited by multiple factors, including poor T cell infiltration and persistence in the immunosuppressive tumor microenvironment, as well as manufacturing cost and complexity," said Jim Burns, CEO of Ensoma. "By engineering HSCs in vivo, we can develop off-the-shelf therapies that turn the body into its own cell factory—capable of continuously producing multiple CAR immune cell types that work together against solid tumors. These data move us closer to realizing this vision as we advance toward our first in vivo, HSC-derived CAR-M, NK, and T development candidate early next year."

Ensoma SITC (Free SITC Whitepaper) poster presentations:

In vivo HSC engineering with Ensoma’s virus like particles (VLPs) generates lineage-restricted, multiplexed CAR-M, NK, and T cells to cooperatively mediate solid tumor control in pre-clinical models

Abstract Number: 302

Poster Presentation Time/Date: Saturday, November 8, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Yiwen Zhao, Ph.D., Ensoma

This study in HER2-positive orthotopic tumor-bearing mouse models, validates proof-of-concept for anti-tumor activity driven by in vivo CAR therapy via HSC engineering. Administration of VLPs encoding lineage-specific HER2 CARs successfully generated durable CAR-expressing myeloid, NK, and T cells from HSCs that:

Exhibited tumor suppression in vivo and ex vivo
Remodeled the cold solid tumor microenvironment, marked by macrophage M1 polarization, increased lymphocyte recruitment, and production of inflammatory cytokines and chemokines.
Discovery of lineage specific regulatory elements for development of in vivo CAR immune cell therapy via hematopoietic stem cell engineering

Abstract Number: 1019

Poster Presentation Time/Date: Friday, November 7, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Alvin Pratama, Ph.D., Ensoma

This research supports the ability of the Ensoma platform to precisely identify and validate genetic regulatory elements that have the potential to drive robust lineage-restricted CAR expression in effector immune cells, potentially improving safety and functional control. Using Ensoma’s HSC-targeted VLPs to deliver lineage-restricted CAR payloads, the team achieved stable integration and selective CAR expression across myeloid, NK and T cells in human CD46 transgenic mouse models. The lineage-restricted CAR cells displayed potent, antigen-dependent cytotoxicity and cytokine production comparable to ubiquitous CAG-driven CARs, supporting the platform’s potential for precise, scalable and lineage-controlled in vivo CAR delivery.

(Press release, Ensoma, NOV 4, 2025, View Source [SID1234659406])

On November 4, 2025 Dispatch Bio, a biotechnology company developing a universal treatment for solid tumors, reported preclinical data supporting its first therapeutic program planned to enter the clinic, DISP-10, and its first-in-class Flare platform, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting.

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Immunotherapies have had limited success in solid tumors due to the lack of tumor-specific targets and a profoundly immunosuppressive microenvironment. Dispatch’s Flare platform addresses these barriers by systemically delivering a tumor-specific virus that paints a universal synthetic antigen (Flare) on tumor cells, enabling precise recognition by T cells, while reshaping the tumor microenvironment to support immune activity. Data presented at SITC (Free SITC Whitepaper) (Abstract 394) demonstrate strong and consistent tumor labeling, iterative viral amplification and tumor cell clearance across multiple epithelial tumor models.

"These data show that delivering engineered targets specifically to tumor cells allows us to control antigen specificity, while also reprogramming the tumor microenvironment," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "We are excited to start with CAR T as our first program, and because the Flare approach is modular and not restricted to CAR T cells, it can be extended across multiple immunotherapy modalities."

The company also presented preclinical findings from DISP-10, its first therapeutic candidate (Abstract 393). DISP-10 pairs DV-10, a tumor-targeted virus expressing a modified BCMA antigen (dBCMA) and the immune-stimulatory cytokine IL-18 and chemokine CXCL9, with a clinically validated BCMA-directed CAR T. The viral component installs the target and drives local immune activation, enabling robust CAR T function in solid tumors. DISP-10 demonstrated potent anti-tumor responses in numerous in vitro and in vivo models, with no activity observed in healthy cells. Dispatch plans to initiate a first-in-human Phase 1 study in 2026 to evaluate DISP-10 across multiple solid tumor types.

"DISP-10 creates the right biological context for CAR T cells to function in solid tumors," said Barbra Sasu, Ph.D., Chief Scientific Officer. "The consistency of activity seen with various BCMA-targeted therapies across tumor models gives us confidence in its clinical potential."

(Press release, Dispatch Bio, NOV 4, 2025, View Source [SID1234659405])

On November 4, 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 financial update and announced its cash position as of September 30, 2025.

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"MaaT Pharma is actively executing its financing strategy, building on the momentum of our outstanding Phase 3 results with Xervyteg in acute Graft-versus Host disease patients. With funding secured through February 2026, we are leveraging a balanced mix of dilutive and non-dilutive sources to support our development programs and preserve shareholder value. The recent partnership with Clinigen and the loan agreement with the European Investment Bank are key milestones in this strategy, providing capital-efficient solutions we intend to build upon to sustain our growth throughout 2026," said Eric Soyer, Chief Financial Officer of MaaT Pharma.

Corporate and Financing Update

In July 2025, the Company announced that it has secured a €37.5 million, 4-tranche loan financing from the European Investment Bank (EIB). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, 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 allo-HSCT.
The Company announces the successful drawdown in October 2025 of Tranche A for an amount of €3.5 million, together with the issuance, in accordance with the terms of the 24th resolution of the shareholders’ meeting held on June 20, 2025 and Articles L. 228-91 and seq. of the French Commercial Code, of 468,772 warrants to the EIB with an exercise price of 4.5898€, as per the Loan and Warrant agreements with the EIB. The Tranche A loan is payable over two years after a grace period of 4 years, and bears an interest rate of 7% per annum.
In July 2025, the Company announced the signature of an exclusive license and distribution agreement with Clinigen, the global pathfinder accelerating access to critical medicines and a leading European player in hospital distribution and market access, to support market access to Xervyteg for 3rd-line aGvHD patients across Europe, should the submission for Marketing Authorisation be successful. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring commercial scale-up.
The Company received an upfront payment of €10.5 million in July 2025 and may receive up to an additional €18 million, including €12 million upon Marketing Authorization approval and €6 million in commercial milestones. The Company is also eligible for royalty payments on net sales, with a rate in the mid-thirties, as well as recurring cash flows under the supply agreement, with products being sold to the partner at a pre-agreed price.
In September 2025, MaaT Pharma has been awarded the Innovative Company label ("Entreprise Innovante") by Bpifrance.
Cash position1

As of September 30, 2025, total cash and cash equivalents were EUR 22.4 million, as compared to EUR 15.0 million as of June 30, 2025, and EUR 20.2 million as of December 31, 2024.
The Company believes it has sufficient cash to cover its current operating needs and development programs until the end of February 2026.
Revenues in Q3 20251

MaaT Pharma reported revenues from France from its Early Access Program of EUR 1.0 million for the quarter ended September 30, 2025, a 56% increase over the third quarter of 2024. Total revenues for the first nine months of 2025 amounted to EUR 3.4 million compared with EUR 2.3 million for the same period of 2024, a year-over-year increase of 45%1, reflecting the continued demand from the medical community for MaaT Pharma’s drug candidate Xervyteg(MaaT013).
Upcoming financial communication*

March 30th, 2026 – Q4 and Full year 2025 financial results
*Indicative calendar that may be subject to change.

Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
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

(Press release, MaaT Pharma, NOV 4, 2025, View Source [SID1234659404])

On November 4, 2025 Agendia, Inc., a leader in precision oncology for breast cancer, reported it will present new results from the ongoing real-world FLEX Study (NCT03053193) at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9-12 in San Antonio, Texas.

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The company will present five posters, led by Agendia investigators and independent academic collaborators, that collectively highlight the broad clinical impact of MammaPrint + BluePrint genomic profiling in optimizing treatment decisions and improving outcomes for patients with hormone receptor positive, HER2-negative (HR+/HER2–) early breast cancer (EBC).

"We look forward to sharing these new findings from the FLEX Study, which spans more than 20,000 participants across 100 global sites, making it the largest and most diverse real-world evidence cohort for early-stage breast cancer," said William Audeh, M.D., Chief Medical Officer at Agendia. "These results underscore our commitment to generating robust clinical evidence in settings beyond traditional clinical trials, ensuring the results can inform personalized treatment decisions across diverse patient populations and everyday clinical practice."

The full list of abstracts & poster presentations is as follows:

3.2yr Updated Outcome Analysis of ACT-T Benefit by MammaPrint Risk Result
Improved 3-year IDFS with anthracycline-based therapy for patients with 70-gene signature High 2, Luminal B, HR+HER2– EBC
Poster #PS2-07-03 | Dec. 10, 5:00 PM – 6:30 PM | Presenter: Joyce O’Shaughnessy

MammaPrint Provides Stronger Prognostic Value Than Histologic Grade
70-gene signature high risk classification provides stronger prognostic value than histologic grade in HR+HER2– EBC
Poster # PS5-04-19 | Dec. 12, 12:30-2:00 PM | Presenter: Erin Cobain

Older Patients with Aggressive Breast Cancer May Benefit from Chemotherapy
HR+HER2– Patients Aged ≥70 with High Risk MammaPrint Benefit from Chemotherapy
Poster #PS3-08-17 | Dec. 11, 12.30 PM – 2 PM | Presenter: Reshma Mahtani

Understanding Breast Cancer in Overweight Latin American Patients
Distinct Immune and Metabolic Profiles in Latin American Breast Cancer Patients with Obesity
Poster #PS4-09-09 | Dec. 11, 5:00 PM – 6:30 PM | Presenter: Marcela Mazo Canola

30,000-Patient Study Expanding to Improve Breast Cancer Outcomes
FLEX: From Genomic Profiling to Real-World Insights in 30,000 Patients with Early-Stage Breast Cancer
Poster #PS5-09-19 | Dec. 12 12:30-2:00 PM | Presenter: Linsey P. Gold

(Press release, Agendia, NOV 4, 2025, View Source [SID1234659403])

On November 4, 2025 Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, reported that it will have an oral and a poster presentation at the upcoming 67th Annual American Society for Hematology (ASH) (Free ASH Whitepaper) conference, taking place December 6-9, 2025, in Orlando, FL. The presentations will focus on the company’s novel, multi-functional protein degrader program and OPN-2853, a bromodomain and extra-terminal motif (BET) inhibitor currently being tested in a Phase 1 combination study with ruxolitinib in patients with advanced myelofibrosis. Presentation details are included below.

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The oral presentation will feature preclinical data from Opna’s protein degrader program, which is focused on creating novel therapeutics designed to block multiple oncogenic targets – EP300, CBP, IKZF1 and IKZF3 – concurrently in the same cancer cell. The data highlights the preclinical compound’s potential for activity as a single agent in hematological malignancies such as multiple myeloma and lymphoma.

"Our protein degrader program builds on compelling preclinical data presented at ASH (Free ASH Whitepaper) in 2024 showing strong synergy when combining immunomodulatory (IMiD) drugs and OPN-6602," said Gideon Bollag, PhD, chief scientific officer of Opna Bio. "OPN-6602, an oral, small molecule EP300/CBP inhibitor, is currently being tested in a Phase 1 study in patients with relapsed or refractory multiple myeloma at multiple sites in the U.S."

The poster presentation will highlight updated interim data from the ongoing Phase 1 study of OPN-2853 in patients with myelofibrosis who are no longer responding to ruxolitinib. This investigator-initiated study is led by Professor Adam Mead at the University of Oxford through a collaboration with Cancer Research UK (CRUK) and is run through the Cancer Research UK Clinical Trials Unit at the University of Birmingham.

ASH Presentation Details:

Title: Novel multifunctional degraders of EP300/CBP and IKZF1/3 with potent anti-myeloma activity
Publication Number: 573
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational: Emerging Myeloma Disease Mechanisms and Therapeutic Strategies
Date and Session Time : December 7, 2025, 12:00 PM – 1:30 PM ET
Presentation Time: 12:30 PM – 12:45 PM ET
Presenter: Pan-Yu Chen, PhD, Associate Director, Translational Medicine, Opna Bio

Title: Interim analysis of PROMise, a clinical study combining the BET inhibitor OPN-2853 with ruxolitinib in patients with advanced myelofibrosis experiencing an inadequate response to ruxolitinib
Publication Number: 3794
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II
Date and Session Time: December 7, 2025, 6:00 PM – 8:00 PM ET
Presentation Time: 6:00 PM – 8:00 PM ET
Presenter: Adam Mead, PhD, Professor of Haematology, Radcliffe Department of Medicine, CRUK Senior Cancer Research Fellow

(Press release, Opna Bio, NOV 4, 2025, View Source [SID1234659402])