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Ataraxis AI Publishes Landmark Studies Showing Causal AI Predicts Chemotherapy Benefit in Multiple Solid Tumors

On September 14, 2026 Ataraxis AI, a company building clinical AI tools to personalize cancer care, reported scientific breakthroughs and validation results of Ataraxis’s AI models.

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Ataraxis developed breakthrough causal AI methods that learn from large-scale, longitudinal data to predict patient outcomes in counterfactual treatment scenarios. These methods were encompassed in an AI world model called Ataraxis Tau.
Ataraxis Tau was applied to breast cancer, developing a model simulating patient outcomes with and without adjuvant chemotherapy.
In three clinical validation studies encompassing 18,426 patients, including analyses of Phase 3 randomized controlled trials TAILORx and UNIRAD, Ataraxis’s models were successfully confirmed to be prognostic and predictive of chemotherapy benefit.
Ataraxis Tau generalizes its prognostic and predictive capabilities zero-shot to multiple other solid tumors beyond breast cancer in an analysis of 6,692 patients across 16 other cancer types.
Instead of relying on population-level patient characteristics and biomarkers, Ataraxis developed causal AI methods that simulate individual patient outcomes in counterfactual treatment scenarios. These methods learn to recover treatment effects from routine, longitudinal clinical data as well as from randomized trials. These methods have been incorporated into Ataraxis’s broader AI world model, dubbed Ataraxis Tau.

The first version of Ataraxis Tau was trained primarily with breast cancer data to predict outcomes in patients with hormone receptor-positive, HER2-negative early-stage breast cancer. Specifically, Tau was originally trained to predict outcomes in patients treated with and without chemotherapy. This design allows Ataraxis, for the first time ever, to identify patients who–despite having high baseline risk of recurrence–might not benefit from adjuvant chemotherapy and who might be considered for other adjuvant therapy options.

Ataraxis’s capabilities in breast cancer were confirmed in three clinical validation studies released today: analyses of TAILORx and UNIRAD Phase 3 trials and a real-world multi-institutional study encompassing over 10,000 patients from 17 cohorts in 10 countries.

In the analysis of the TAILORx trial, Ataraxis was found to be predictive of adjuvant chemotherapy benefit (interaction p = 0.016) within the intermediate-risk-score group. Today, these patients are de-escalated to endocrine therapy alone. In Ataraxis’s analysis, the AI model identified patients who benefit from adjuvant chemotherapy with improved 5-year disease-free survival (95.2% vs. 89.6%), while patients predicted to not benefit from chemotherapy had no significant difference in outcomes.
In the analysis of the UNIRAD trial, Ataraxis identified patients within clinically high-risk, node-positive patients who have good long-term outcomes with standard of care therapy. Today, these patients are considered for escalation with drugs such as adjuvant CDK4/6 inhibitors, with no validated biomarkers to help in choices between adjuvant therapy options. Additionally, Ataraxis’s AI model was found to be predictive (p=0.01) of everolimus (mTOR inhibitor) benefit in an identified subgroup.
In a study describing the development and validation of a causal AI model for chemotherapy benefit, Ataraxis included data encompassing 11,135 breast cancer patients from 17 cohorts in 10 countries. The AI model had near-perfect calibration across the full range of predicted risk and was predictive of chemotherapy benefit (p<0.001). Additionally, within a subgroup of 983 patients tested with Oncotype DX, a legacy molecular assay, Ataraxis’s AI model had more robust predictive performance (p=9.7 × 10⁻⁴ versus p=0.025).
Finally, prognostic and predictive capabilities of the Ataraxis Tau world model generalized to cancers it was never trained on. In the real-world study, Ataraxis Tau was applied zero-shot to 6,692 patients spanning 16 cancer types. Ataraxis Tau was prognostic in 11 tumor types, including gastrointestinal cancers, lung cancers, skin cancers, and others. Chemotherapy benefit prediction also transferred zero-shot to five of the seven cancers treated with platinum- or taxane-based regimens, which are shared with breast chemotherapy, showing that Tau learned a treatment-specific predictive signal.

"Today’s results mark a major milestone for Ataraxis. We have previously shown that our AI models can accurately predict outcomes and treatment response in breast cancer. Now, we have gold-standard evidence supporting those findings and the broader clinical use of our tools. These results also bring us closer to a new era of personalized treatment. Our AI world model, Ataraxis Tau, can predict recurrence and treatment benefit across cancer types. As we scale Tau, it will serve as the foundation for future tools designed to help personalize treatment for every cancer patient," said co-founder and CEO of Ataraxis AI, Jan Witowski, MD, PhD.

This distinguishes the result from prior pan-cancer analyses of AI pathology models, which have reported performance only after fitting or fine-tuning a separate model for each cancer type. A causal model trained on breast cancer alone identified risk and chemosensitivity across most other cancers, suggesting it has learned determinants of treatment response that are shared across malignancies rather than specific to one disease.

Ataraxis is building on that foundation, extending individualized benefit prediction to additional therapies and tumor types and working toward a causal model of treatment response that spans oncology, so that any patient facing a treatment decision can be told not just how aggressive their cancer is, but what a given therapy is likely to do for them.

(Press release, Ataraxis AI, SEP 14, 2026, View Source [SID1234670844])

Biomunex Announces the Upcoming Start of Clinical Development of IPN60330, the First MAIT Engager, a New Therapeutic Class in Oncology, Following the Completion of the FDA Review Period

On September 14, 2026 Biomunex Pharmaceuticals, a biopharmaceutical company specialized in the discovery and development of innovative therapeutic approaches, reported that the U.S. Food and Drug Administration (FDA) has completed its Investigational New Drug (IND) review period for Ipsen’s IPN60330 (formerly BMX-502), the first MAIT cell engager (also referred to as a "MAIT engager") based on Biomunex’s proprietary BiXAb technology platforms, and for which Biomunex and Ipsen announced an exclusive global licensing agreement for development, manufacture and commercialization rights in 2024.

This key step is the result of an intensive preclinical development effort, encompassing full drug bioproduction for the Phase 1 trial, regulatory studies and animal toxicology studies, conducted by the Biomunex team in partnership with Ipsen. It marks the upcoming initiation of Ipsen’s Phase I clinical trial in the USA, a significant step forward in the development of this novel therapeutic class in immuno-oncology.

IPN60330 is a bispecific antibody designed to selectively engage and activate MAIT cells (Mucosal-Associated Invariant T cells), a subset of T cells present throughout the body, which are particularly enriched in mucosal and barrier tissues, and targets the GPC3 tumor antigen to kill cancer cells. GPC3 is a clinically validated target, highly expressed across several cancer types.

The completion of the FDA review period is a further demonstration of the quality of Biomunex’s proprietary BiXAb technologies. This first MAIT engager should overcome some of the limitations of classical pan-T cell engagers, which activate all T cells, including regulatory T cells, and can induce cytokine release syndrome, a potentially serious dose-limiting toxicity that represents a true problem for physicians and their cancer patients. MAIT engagers have the potential to provide a broader therapeutic window compared to classical pan-T cell engagers for treating specific tumor types. Moreover, an improved therapeutic window with MAIT engagers should permit a stronger response from the adaptive immune system leading to improved and durable responses.

This new milestone has triggered a milestone payment linked to the completion of the FDA IND review period ahead of the upcoming entry into clinical development, under the exclusive global licensing agreement entered into between Ipsen and Biomunex in November 2024. In the context of this agreement, Biomunex is eligible to receive up to $610 million in total, including an upfront already received, contingent upon successful development, regulatory and commercial milestones, in addition to tiered global royalties on sales.

"The upcoming start of the clinical development program in the United States for IPN60330 is a recognition of the quality of our collaboration with Ipsen. Moreover, that’s a major milestone in our development, demonstrating the strength of our BiXAb technology platforms, as well as the expertise of our teams in generating breakthrough innovation," said Dr Simon Plyte, CSO of Biomunex. "It finally underscores our ability to develop innovative programs in partnership with a world-renowned pharmaceutical partner, with the potential to open new avenues in cancer immunotherapy," added Dr Pierre-Emmanuel Gerard, founder, President and CEO of Biomunex.

(Press release, BIOMUNEX Pharmaceuticals, SEP 14, 2026, View Source [SID1234670843])

Shennon Biotechnologies Raises $12M in Financing, Appoints Cyril Konto, M.D., as Chief Executive Officer and Unveils Precision Immunotherapy Pipeline

On September 14, 2026 Shennon Biotechnologies ("ShennonBio"), a biotechnology company developing precision immunotherapies for cancer, reported that it has raised $12M in financing from Future Ventures, NextGen Venture Partners, Samos Investments, Atypical Ventures and Saras Capital, with continued support from existing investors DCVC, Foundation Capital, and AV8 Ventures. The company has raised $25M to date.

In addition to the funding, the Company has appointed biotechnology industry veteran Cyril Konto, M.D. as Chief Executive Officer. Founder and current CEO Li Sun, Ph.D., will transition to President and Chief Technology Officer, continuing to lead the Company’s scientific strategy, technology development and pipeline innovation.

The new financing will support continued development of ShennonBio’s integrated technology platform and advancement of its emerging oncology pipeline that currently includes three T-cell engager (TCE) programs in small cell lung cancer, ovarian cancer and hepatocellular carcinoma.

Since its founding in 2021, ShennonBio has built a proprietary technology engine spanning target discovery, ultra-high-throughput functional screening, computational binder prediction and optimization, and AI-enabled safety assessment. The Company has also established approximately 6,000 square feet of laboratory space in San Francisco near UCSF Mission Bay and assembled proprietary datasets with fresh tumor samples from strong partnerships with hospitals and academic institutions.

"ShennonBio was founded to address fundamental challenges that have limited the development of precision immunotherapies, from identifying differentiated targets and highly functional therapeutic binders to predicting potential safety risks before candidates reach the clinic," said Li Sun, Ph.D., Founder, President and Chief Technology Officer, ShennonBio. "We have built an integrated technology platform, generated proprietary human datasets and begun translating those capabilities into a pipeline of precision immunotherapies. With $25 million raised to date, and Cyril joining as CEO, we are entering an important new stage for ShennonBio as we advance our first TCE programs toward the clinic."

Building an Integrated Platform for Precision Immunotherapy

ShennonBio is developing both antibody-based T-cell engagers (Ab-TCEs), which can address targets expressed on the surface of tumor cells, and TCR-based T-cell engagers (TCR-TCEs), which can potentially access intracellular cancer targets presented through HLA. This dual approach is designed to substantially expand the universe of cancer biology that can potentially be addressed through T-cell engagers.

The Company’s integrated platform combines four proprietary capabilities:

PINTRA, which uses proprietary human tumor datasets and advanced computational approaches to identify differentiated surface and intracellular therapeutic targets;
TCELERATOR, an ultra-high-throughput functional screening platform capable of evaluating more than 10 million single-cell interactions concurrently and millions of therapeutic candidates;
AFFINIS, a computational platform for predicting, designing and optimizing antibody binders and TCR; and
SERIS, an AI-enabled safety platform designed to identify potential off-target cross-reactivity earlier in therapeutic development.
Together, these technologies create an integrated discovery and development engine spanning target identification, functional screening, therapeutic optimization and safety assessment.

A central component of ShennonBio’s approach is its growing proprietary human dataset. The Company has assembled data encompassing >10,000 tumor samples, >11 million single cells and a substantial collection of TCR sequences. ShennonBio continues to expand these datasets through relationships involving more than 15 institutions and across multiple cancer types and other diseases.

Advancing a Diversified Oncology Pipeline

ShennonBio has translated its platform into three initial oncology programs spanning both antibody- and TCR-based T-cell engagers.

SBT-121 is a dual-targeting trispecific Ab-TCE being developed for small cell lung cancer.

SBT-201 is an Ab-TCE being developed for ovarian cancer.

SBT-425 is a TCR-TCE being developed for hepatocellular carcinoma.

Together, the programs reflect ShennonBio’s strategy of combining established T-cell engager biology with its proprietary discovery and screening capabilities to pursue differentiated therapeutic opportunities across solid tumors.

As ShennonBio advances from platform development toward development-stage execution, the Company has appointed Cyril Konto, M.D., as Chief Executive Officer. Dr. Sun, ShennonBio’s founder and current CEO, will transition to President and Chief Technology Officer, and will remain deeply committed to the Company, leading scientific strategy, technology development and pipeline innovation.

Dr. Konto brings more than 20 years of experience in oncology drug development, company building and strategic transactions. Most recently, he served as President and Chief Executive Officer of Ichnos Glenmark Innovation (IGI), where he led a strategic and operational transformation of the organization, focused its portfolio on oncology and built its multispecifics franchise.

During his tenure, IGI completed three external partnerships, including an agreement with AbbVie for a Phase 1 trispecific T-cell engager that included $700 million upfront and up to $1.9 billion in total potential value plus royalties. He previously held senior oncology development leadership roles at Allogene Therapeutics, Pfizer and Bristol Myers Squibb.

"ShennonBio has spent the last several years building a differentiated foundation spanning proprietary human data, target discovery, functional screening, therapeutic design and safety prediction," said Dr. Konto. "What attracted me to the Company is the opportunity to translate those capabilities into a new generation of precision immunotherapies. I look forward to working closely with Li and the team to advance our pipeline toward the clinic, establish strategic partnerships and build ShennonBio for its next stage of growth."

Over the next two years, ShennonBio plans to advance a development candidate toward IND filing and Phase 1 clinical development, pursue licensing opportunities for selected therapeutic programs and explore partnerships around its platform capabilities, including binder prediction and generation, clinical toxicity prediction and its proprietary datasets.

(Press release, Shennon Biotechnologies, SEP 14, 2026, View Source [SID1234670842])

Vyriad Begins Phase 1 Clinical Trial for Lead In Vivo CAR T Cell Therapy VV169 Following FDA Acceptance of IND Application

On September 14, 2026 Vyriad, Inc., a clinical-stage biotechnology company developing targeted genetic therapies for cancer and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a clinical trial of VV169, an off-the-shelf, in vivo CAR T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma. The Phase 1 trial is now open for enrollment at Mayo Clinic.

"VV169 is designed to create CAR-T cells directly inside the body, offering a new way of delivering this powerful therapeutic approach to patients with multiple myeloma. The Phase 1 clinical trial for VV169 being open for enrollment is a significant milestone for Vyriad and we are proud to reach it alongside Dr. Yi Lin and her team at Mayo Clinic," said Luke Russell, Ph.D., MBA, President of Vyriad. "This reflects years of sustained effort from investigators, study staff, and the R&D and manufacturing teams here in Rochester. We are grateful to everyone who made it happen, and to the patients who choose to take part."

VV169 was developed using Vyriad’s proprietary in vivo lentiviral platform centered on blinded and retargeted VSV-G pseudotyping. To enable direct in vivo delivery, VV169 utilizes the targeted lentiviral vector to deliver a potent anti-BCMA CAR payload. Upon intravenous administration, the vehicle specifically targets and transduces T cells, enabling rapid generation of functional CAR T cells. This targeted approach results in highly specific payload expression and minimizes the risk of infusional toxicities.

"For patients with aggressive multiple myeloma, waiting weeks for a therapy to be manufactured can be a significant barrier," said Chief Scientific Officer Stephen Russell, M.D., Ph.D. "VV169 is designed to change that by creating CAR T cells directly inside the body, thereby making this off-the-shelf approach to CAR T more accessible for patients. We look forward to evaluating the potential of this program in the clinic."

The Phase 1 trial will evaluate the safety and initial efficacy signals of VV169 in up to 40 patients with relapsed/refractory multiple myeloma. The trial, conducted at Mayo Clinic by principal investigator Yi Lin, M.D., Ph.D., head of the center’s in vivo CAR T program, will have key primary objectives to assess overall safety, identify dose-limiting toxicities, and determine the recommended Phase 2 dose. The secondary objective will focus on assessing preliminary efficacy signals of VV169 and evaluating in vivo CAR T cell expansion and persistence.

For more information, including trial details and eligibility criteria, please visit the study page on clinicaltrials.gov (NCT07802717).

(Press release, Vyriad, SEP 14, 2026, View Source [SID1234670841])

MaaT Pharma Receives Negative CHMP Trend Vote for MaaT013 (Xervyteg®) Following Re-Examination for its Conditional Marketing Authorization Application in Europe

On September 14, 2026 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 been informed by the CHMP of the European Medicines Agency (EMA) of a "negative trend" opinion following the Oral Explanation, as part of the re-examination procedure of its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg) for the treatment of aGvHD, following yesterday’s CHMP oral explanation.

"We are deeply disappointed by this outcome. Patients suffering from gastrointestinal-aGvHD continue to face a life-threatening condition with significant unmet medical need and limited treatment options," said Hervé Affagard, Chief Executive Officer and co-founder of MaaT Pharma. "Together with the hematology community, we remain committed to these patients and will evaluate all available options to make this potentially important treatment accessible to patients worldwide."

Based on the feedback received post Oral Explanation, the CHMP maintained its view that the available clinical data package, primarily in the absence of a randomized control trial, does not allow sufficient characterization of the benefit/risk of MaaT013 (Xervyteg).

The Company will provide additional details following the formal CHMP opinion, which is expected to be communicated on September 18, 2026. The Company will assess the implications of the decision and evaluate all available options and will provide an update to the market as appropriate.

(Press release, MaaT Pharma, SEP 14, 2026, View Source [SID1234670840])