On March 12, 2026 Meiji Seika Pharma Co., Ltd. (Headquarters: Chuo-ku, Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) announced today that it has initiated a Phase I clinical trial of ME3241 (development code), an anti-PD-1 agonist monoclonal antibody discovered through collaborative research with the Foundation for Biomedical Research and Innovation at Kobe (Headquarters: Kobe, Japan; President: Shuh Narumiya; hereinafter "FBRI"). The Phase I clinical trial is designed as a randomized, placebo-controlled, double-blind study, with the objective of evaluating the safety and tolerability of ME3241 following single and multiple dosing, as well as its pharmacokinetics and pharmacodynamics (ClinicalTrials.gov: NCT07422207).

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ME3241 was discovered through a collaborative research program led by Program Director Tasuku Honjo, a professor emeritus at Kyoto University. PD-1 is a molecule expressed on activated T cells and other lymphocytes that suppresses immune responses. Through this research, Meiji Seika Pharma and FBRI identified the conditions required to induce immunosuppression by stimulating PD-1 with antibodies, and these findings were published in Science Immunology on January 13, 2023. ME3241 is a unique anti-PD-1 agonist antibody with enhanced PD-1 agonist activity and has the potential to advance clinical development as a therapeutic agent for inflammatory diseases, including autoimmune diseases caused by excessive immune responses.

Meiji Seika Pharma and FBRI will continue to collaborate to advance the development of ME3241 and strive to provide meaningful benefits to patients with autoimmune diseases at the earliest opportunity.

Message from Tasuku Honjo, Program Director, Honorary President, Foundation for Biomedical Research and Innovation at Kobe (FBRI)

The initiation of the Phase I clinical trial of an autoimmune disease therapy by a PD-1 agonist antibody is highly significant, as our finding marks a major milestone in taking a step toward potential therapeutic application for human disease.

This therapeutic approach, which is completely opposite of the widely used cancer therapy employing a PD-1 antagonist antibody, originated from basic research initiated shortly after my appointment as director. After achieving robust results in animal models, we have now reached this clinical stage.

Should safety be confirmed in Phase I, there is strong expectation that the program will progress to Phase II to evaluate efficacy, and subsequently to Phase III with the aim of practical implementation. I am truly delighted by this advancement toward the practical realization of the vision of Kobe Biomedical Innovation Cluster.

Message from Takeshi Naruse, Senior Managing Executive Officer and Head of Research & Development, Meiji Seika Pharma

We have been advancing collaborative research with Professor Tasuku Honjo to discover and develop new drug candidates for inflammatory diseases, an area closely related to Meiji Seika Pharma’s focus on infectious diseases. We are pleased to begin a Phase I clinical trial of ME3241, a unique PD-1 agonist antibody established based on robust foundational research with Professor Honjo and his colleagues. We will expedite the development of ME3241 and strive to deliver it to patients with autoimmune diseases as soon as possible.

On March 12, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2025.

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"Adicet closed the year with solid momentum, driven by strong enrollment progress and the positive data from the prula-cel Phase 1 autoimmune study reported during the fourth quarter. Enrollment in our Phase 1 prula‑cel autoimmune study continues advancing ahead of expectations, supported by significant physician and patient interest in the study and FDA alignment that enables outpatient dosing for LN and SLE patients. We look forward to providing a clinical update in LN, SLE and SSc in the first half of this year," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Beyond prula-cel, we expect to submit a regulatory filing for ADI-212 for the treatment of mCPRC in the third quarter of 2026 with enrollment expected to begin in the fourth quarter of 2026. Adicet is well positioned for continued execution and poised to deliver meaningful, value‑driving milestones in the year ahead."

Fourth Quarter 2025 and Recent Operational Highlights:

Autoimmune diseases

Phase 1 trial of prula‑cel demonstrating strong enrollment momentum across multiple autoimmune indications, with next clinical update expected in the first half of 2026. Adicet continues to advance its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune diseases. Prula-cel has received Fast Track Designation from the FDA for the potential treatment of relapsed/refractory Class III or Class IV LN, refractory SLE with extrarenal involvement, and systemic sclerosis (SSc). The next clinical update is expected in the first half of 2026, with plans to provide an additional clinical update from the study in the second half of 2026. Adicet plans to meet with the FDA in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.
Alignment with FDA allows outpatient dosing for LN and SLE patients. In November 2025, the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.
Phase 1 study underway in treatment-refractory rheumatoid arthritis (RA) patients to evaluate the potential to reduce conditioning requirements. In October 2025, Adicet dosed the first patient in a Phase 1 study of prula-cel in treatment refractory RA. The study is evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide in combination with fludarabine. The primary objective of the study is to assess the safety and tolerability of prula-cel, with secondary objectives including evaluation of cellular kinetics, pharmacodynamics, and disease activity scores. The next clinical update on this trial is expected in the second half of 2026.
Solid tumor indications

Preclinical development ongoing for ADI‑212, with a regulatory filing expected in the third quarter of 2026, which is expected to enable Phase 1 enrollment beginning in the fourth quarter of 2026. Adicet continues to advance preclinical development of ADI‑212, a next‑generation gene‑edited and armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI‑212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor‑specific recognition. It integrates membrane‑tethered IL‑12 armoring, and CRISPR/Cas9‑mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti‑tumor mechanisms of action within the tumor microenvironment. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with Phase 1 enrollment expected to begin in the fourth quarter of 2026, subject to regulatory clearance.
ADI‑212 preclinical data presented at scientific meeting. In October 2025, Adicet presented preclinical data from its ADI‑212 program at the 32nd Annual Prostate Cancer Foundation Scientific Retreat. The data supported the rationale for the program’s design features and demonstrated functional enhancements across multiple preclinical models of disease.
Financial Results for Fourth Quarter and Full Year 2025:

Three months ended December 31, 2025

Research and Development (R&D) Expenses: R&D expenses were $25.0 million for the three months ended December 31, 2025, compared to $23.3 million during the same period in 2024. The increase in R&D expenses was primarily due to a $6.1 million increase in expenses related to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), partially offset by a $2.7 million decrease in payroll and personnel expenses due to lower headcount and a $1.0 million decrease in facilities related expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended December 31, 2025, compared to $7.5 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.3 million decrease in rent and office related expenses and a $0.7 million decrease in professional services and consultants, partially offset by a $1.6 million increase in payroll and personnel expenses primarily related to stock-based compensation.
Net Loss: Net loss for the three months ended December 31, 2025 was $30.5 million, or a net loss of $2.94 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $28.7 million, or a net loss of $5.06 per basic and diluted share, including non-cash stock-based compensation expense of $3.8 million during the same period in 2024.
Twelve months ended December 31, 2025

Research and Development (R&D) Expenses: R&D expenses were $99.1 million for the year ended December 31, 2025, compared to $99.3 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily due to a $5.1 million decrease in payroll and personnel expenses related to lower headcount and a $0.7 million decrease in lab supplies and materials. The decrease was partially offset by a $5.6 million increase in CRO costs primarily for autoimmune studies.
General and Administrative (G&A) Expenses: G&A expenses were $23.0 million for the year ended December 31, 2025, compared to $28.3 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to a decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation of $3.6 million, a $1.6 million decrease in office related expenses, and a $0.3 million decrease in rent expense.
Net Loss: Net loss for the year ended December 31, 2025 was $116.8 million, or a net loss of $16.95 per basic and diluted share, including non-cash stock-based compensation expense of $14.3 million, as compared to a net loss of $117.1 million, or a net loss of $21.33 per basic and diluted share, including non-cash stock-based compensation expense of $22.2 million during the same period in 2024.
Cash Position: Cash, cash equivalents and short-term investments were $158.5 million as of December 31, 2025, compared to $176.3 million as of December 31, 2024. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities. The Company expects that current cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, MAR 12, 2026, View Source [SID1234663522])

On March 12, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of the PREDICT-DNA study in the Journal of Clinical Oncology. The article, "The Pathologic Response Evaluation and Detection In Circulating Tumor-DNA (PREDICT-DNA) study: Ultrasensitive ctDNA Assessment of Breast Cancer Minimal Residual Disease," showed that ultrasensitive molecular residual disease (MRD) testing with NeXT Personal can perform better than current standard approaches in predicting patient outcomes following neoadjuvant therapy (NAT).

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The prospective study followed 227 patients with Triple-Negative (TNBC) and HER2+ breast cancer across more than 24 leading US cancer centers. The results demonstrate the ability of NeXT Personal to provide a more precise risk-stratification for patients who have received NAT.

A key finding of the study was the necessity of the ultrasensitive range for accurately tracking patient response to neoadjuvant therapy. Of note, 55% of all ctDNA detections following NAT occurred at levels below 100 parts per million, detections that could be missed with less sensitive tests.

"Many breast cancer patients receive neoadjuvant therapy as standard of care, prior to surgery. The results of this study suggest that an ultrasensitive ctDNA assay like NeXT Personal could help patients better understand their response to neoadjuvant therapy, with the potential to help inform the need for additional therapy," said Richard Chen, MD, Chief Medical Officer and Executive Vice President, R&D at Personalis. "The publication of this data is important as we look to expand reimbursement and improve the tools used in neoadjuvant monitoring."

Key study highlights include:

High Prognostic Power: Detectable ctDNA post-NAT was associated with a 4 to 9 times higher likelihood of relapse.
Superior to Traditional Metrics: In multivariate analyses, ctDNA status was the most significant independent prognostic signal, performing better than nodal status, tumor grade, and pathologic complete response (pCR) status. In addition, ctDNA detection post-NAT was a stronger predictor of recurrence than pCR status.
Identification of Low Risk: Patients who were ctDNA-negative post-NAT showed excellent outcomes, regardless of pCR status.
Post-Surgical Relapse Prediction: Patients with detectable ctDNA up to 12 months post-surgery were more than 100 times more likely to experience disease recurrence.
"We partnered with Personalis because their technology offers a level of sensitivity down to 1 to 3 parts per million that allows for a higher cancer detection rate," said Dr. Ben Park, MD, PhD, Director of the Vanderbilt-Ingram Cancer Center. "The PREDICT-DNA results show that if a patient clears their ctDNA, their outcomes are excellent even if residual disease is found at surgery. Conversely, detectable ctDNA signals a very high risk. These insights allow us to more precisely risk-stratify breast cancer patients in future trials and clinical practice."

The findings reinforce the NeXT Personal test’s ability to detect ctDNA at ultrasensitive levels, providing a window for earlier clinical intervention that other approaches may miss. The NeXT Personal test achieves ultrasensitive detection of small traces of ctDNA from a patient’s blood sample using a personalized approach that tracks up to ~1,800 tumor-specific variants unique to each patient’s tumor.

(Press release, Personalis, MAR 12, 2026, View Source [SID1234663521])

On March 12, 2026 Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported the first patient has been dosed in its Phase 1 clinical trial evaluating PLT012, a first-in-class anti-CD36 monoclonal antibody for the treatment of advanced solid tumors. The first patient was treated at Next Oncology in Houston, Texas.

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PLT012 recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. The antibody target, CD36, is a key regulator of lipid uptake and metabolic adaptation within the tumor microenvironment (TME). By blocking CD36-mediated fatty acid uptake, PLT012 aims to invigorate innate and adaptive effector cells, reduce immunosuppressive cell populations, and elicit durable tumoricidal immune responses.

"Dosing our first patient is an important milestone for Pilatus and validates our work advancing a new immuno-metabolic approach to cancer therapy," said Raven Lin, CEO and Co-Founder, Pilatus Biosciences. "Many solid tumors create a metabolically hostile microenvironment that drives immune exhaustion and resistance to existing therapies. PLT012 is designed to directly address this metabolic suppression, with the goal of restoring effective antitumor immunity for patients with limited treatment options."

"Many advanced solid tumors suppress immune responses through metabolic mechanisms, limiting the effectiveness of current immunotherapies," said Anthony B. El-Khoueiry, MD, principal investigator of the trial, who also serves as chief of section of developmental therapeutics and associate director for clinical research at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC. "CD36 is a key regulator of lipid uptake and immune dysfunction in the tumor microenvironment, making it a compelling target. This Phase 1 study will evaluate the safety of PLT012 and help determine whether targeting metabolic checkpoints can restore immune activity for patients with difficult-to-treat cancers."

The open-label, multi-center Phase 1 study is evaluating PLT012 in patients with advanced solid tumors, with expansion cohorts planned in tumor types characterized by lipid-driven metabolic dysregulation, including, but not limited to, liver cancers and tumors with liver metastases. The primary objectives of the study are to assess safety and tolerability, and to determine the maximum tolerated dose and the recommended Phase 2 dose of PLT012.

Additional endpoints will look at pharmacokinetics/pharmacodynamics, biomarkers, and early signs of clinical response. In addition to pharmacokinetics and immunogenicity, a comprehensive biomarker strategy centered on CD36 biology has been designed to support translational insights and guide future clinical development. This approach is intended to enable more precise patient stratification in expansion cohorts and subsequent trials, with the goal of enriching for lipid-enriched tumor types and CD36-high patient populations.

"There is a significant unmet need for patients whose tumors do not respond adequately to current immunotherapies," said George E. Peoples, MD, Chief Medical Officer, Pilatus Biosciences. "Targeting CD36 represents a differentiated approach to reshape the tumor microenvironment by addressing lipid-driven immune dysfunction. The comprehensive clinical and biomarker assessments incorporated into this study will be essential to understanding how PLT012 reprograms the TME and to guiding further development."

Preclinical studies demonstrated that PLT012 blocked CD36-mediated metabolic reprogramming in regulatory T cells (Tregs) and CD8+ tumor-infiltrating lymphocytes, resulting in enhanced antitumor immune activity. In murine models of liver metastasis, PLT012 significantly reduced tumor growth in both hepatic and subcutaneous tumors. These effects were associated with favorable remodeling of the TME, including reduced M2 macrophages and Treg populations, and increased CD8+ T cell infiltration.

Additionally, PLT012 mitigated liver metastasis–associated resistance to immune checkpoint inhibitors and resensitized tumors to anti-PD-1 therapy in preclinical models. Together, these findings support the potential of CD36-targeted immunometabolic therapy as a complementary strategy to existing checkpoint blockade treatments.

Building on previously reported preclinical data demonstrating PLT012’s robust anti-tumor activity in both inflamed and immune-cold HCC murine models, PLT012 received Orphan Drug Designation from the FDA in December 2024 for the treatment of hepatocellular carcinoma (HCC) and intrahepatic bile duct cancers, underscoring the significant unmet medical need in these indications. Pilatus also received FDA Fast Track Designation for PLT012 for the treatment of HCC on February 14, 2026.

This announcement is intended to share information about this study and is not soliciting participants.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing antitumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, MAR 12, 2026, View Source [SID1234663520])

On March 12, 2026 PRISM BioLab Co., Ltd. ("PRISM") and Receptor.AI Inc. reported that they have entered into a drug discovery collaboration agreement (the "Collaboration") to develop an integrated, AI-navigated, physics-guided platform for the discovery of orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins, and complex receptor systems.

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The Collaboration unites PRISM’s PepMetics chemistry — conformationally rigid, three-dimensional small molecules engineered to mimic α-helix and β-turn motifs — with Receptor.AI’s physics-informed, multi-objective AI navigation engine. By integrating their technologies, the companies aim to generate innovative hit, lead and clinical candidate compounds against PPI and membrane-protein targets that have proven challenging for conventional small molecule drug discovery, with an initial focus on metabolic diseases, including obesity.

The Collaboration will initially focus on one selected receptor target for metabolic disease. Receptor.AI will carry out molecular design using the combination of PRISM’s chemical space and Receptor.AI’s design algorithms. In parallel, the companies will jointly engage pharmaceutical partners interested in utilizing the combined capabilities of both technologies.

The Collaboration aims not only to generate clinical candidates—typically the goal of joint research — but also to showcase the power of combined technologies and to acquire specialized know‑how, which will be the basis for proposals to potential partner companies, enabling the expansion of future collaborative opportunities.

"We are very pleased to partner with Receptor.AI on this exciting project," said Dai Takehara, President & CEO of PRISM BioLab. "We have developed PepMetics Technology, a highly effective drug discovery platform targeting PPIs, and possess a unique peptide‑mimetic small‑molecule library, the PepMetics Library. We believe this library can be applied not only for intracellular PPI drug discovery but also for membrane proteins, which are not easily targeted by small molecules. With Receptor.AI’s AI‑based molecular design technologies ranging from peptides to small molecules, we expect the potential of the PepMetics Library to expand even further."

"We’re excited to partner with PRISM BioLab to move intracellular and receptor-driven discovery from ‘screening harder’ to navigating smarter," said Dr. Alan Nafiiev, Founder & CEO of Receptor.AI. "PRISM contributes a high-quality, structurally constrained virtual chemical space designed for practical progression. We’re bringing QuorumMap — our chemical space navigation engine — together with structure- and physics-informed modeling and multi-objective optimization to continuously reallocate compute and experimental focus toward the compounds most likely to translate: not just binders, but candidates that balance selectivity with the permeability and stability needed for oral exposure. The goal is a repeatable, decision-driven loop that turns difficult intracellular biology into actionable chemical hypotheses and ranked molecules ready for synthesis and testing."

PRISM and Receptor.AI share a common philosophy of "pursuing new approaches to drug discovery"—creating innovative therapeutics more rapidly, rationally, and with scientific rigor. Through this Collaboration, the companies aim to create synergies by mutually adopting state‑of‑the‑art drug discovery methods.

(Press release, PRISM BioLab, MAR 12, 2026, View Source [SID1234663519])