On February 3, 2025 BostonGene, the developer of the leading AI foundation model for tumor and immune biology, reported another major independent validation of its AI and machine learning (ML) capabilities in a landmark blinded, multi-vendor HER2 benchmarking study. The results, published in the Modern Pathology article, "Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images" were conducted in collaboration with Friends of Cancer Research and supported by leading global pharmaceutical companies and patient advocacy stakeholders.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This publication adds to a growing body of external evidence validating the technical rigor, performance, and real-world relevance of BostonGene’s AI-driven approach. By evaluating algorithmic and AI-based methods under an independent framework, the study mirrors the stringent benchmarks that drug developers and regulators increasingly use to assess advanced analytics technologies. Such multi-site validation is critical for increasing confidence in AI-driven biomarkers and de-risking regulatory, clinical, and companion diagnostic development. These blinded, ecosystem level evaluations confirm BostonGene’s position among a select group of companies operating at the highest threshold of scientific and technical excellence for clinical-grade AI.

BostonGene’s AI and machine learning capabilities are built on a foundation model of cancer and immune system that integrates multiomic, RNA, DNA, TCR, spatial, and clinical data at scale. This multidimensional approach enables deep characterization of tumors and the immune microenvironment, supporting critical decisions across the drug development lifecycle, from early-stage target discovery to research to patient stratification and trial optimization.

As HER2 remains one of the most critical biomarkers in oncology, the terminology and evaluation frameworks outlined in this publication are expected to set the benchmark for how AI and ML tools are assessed by drug developers going forward. BostonGene’s inclusion in this initiative reflects the industry’s sustained confidence in the company’s ability to deliver transparent, reproducible and clinically meaningful AI.

"This is not an isolated result," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We continue to see independent, external validation of the AI and ML algorithms that power our foundation model. These blinded, real-world evaluations provide the high-stakes certainty that drug developers trust when accelerating life-saving therapies."

Pharmaceutical organizations supporting the study included AstraZeneca, Bristol Myers Squibb, Amgen, Merck, and GlaxoSmithKline. BostonGene continues to partner with these and other leading pharmaceutical companies on strategic programs where its AI-driven insights directly inform biomarker strategy and clinical execution.

(Press release, BostonGene, FEB 3, 2026, View Source [SID1234662445])

On February 3, 2026 The National Medical Products Administration (NMPA) reported it has approved the OncoMate Microsatellite Instability (MSI) Detection Kit as a Class III in vitro diagnostic medical device in China. It is intended for use as a companion diagnostic to identify MSI-High (MSI-H) solid tumor patients for treatment with KEYTRUDA (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy. This is the first Promega companion diagnostic to receive NMPA approval.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This approval represents a step toward more personalized and effective cancer treatment in China," says Alok Sharma, Global Clinical Market Director at Promega. "We are proud to collaborate with pharmaceutical companies to deliver global solutions that expand access to innovative technologies and life-saving, effective therapies."

China continues to face one of the world’s highest cancer burdens, with solid tumors representing the vast majority of diagnoses nationwide. Despite advances in oncology care, most patients with advanced solid tumors ultimately progress after first-line therapy, creating a critical need for tools that can guide more effective alternative treatment strategies. The OncoMate MSI Detection Kit is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in solid tumors.

The approval was supported through a collaboration with Merck & Co., Inc., Rahway, NJ, USA, which markets KEYTRUDA. The collaboration reflects a shared commitment to improving access to diagnostics that guide therapeutic decision-making.

Promega MSI technology has received additional regulatory approvals in China, the European Union and the United States. OncoMate MSI Dx Analysis System was recently approved by the FDA as a companion diagnostic designed to identify patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA plus LENVIMA (Lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

OncoMate MSI Detection Kit will soon be available for purchase in China.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Promega, FEB 3, 2026, View Source [SID1234662444])

On February 3, 2026 CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high‑value healthcare solutions for transplant patients and caregivers, reported that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held February 4-7, 2026, in Salt Lake City, Utah.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ACROBAT study is a prospective, multi-center, blinded clinical trial evaluating AlloHeme, CareDx’s AI-powered next-generation sequencing (NGS)-based peripheral blood test for monitoring relapse after allogeneic hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. AlloHeme identifies cancer relapse ahead of traditional detection methods, potentially enabling timely clinical interventions. The ACROBAT study includes patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) monitored with AlloHeme for cancer relapse at 11 hematopoietic stem cell transplant centers across the U.S.

The oral presentation will feature the complete 24-month follow-up results, building upon 18-month interim results published in the conference abstract, available online here.

In addition, on February 12, 2025, CareDx will host an investor webcast and conference call to discuss the study findings and commercial launch timeline.

Tandem Presentation Details:

Presentation ID 61: Acrobat Interim Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance in Post-HCT AML and MDS Patients
Presenter: Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center
Date & Time: Friday, February 6, 3:15 p.m. MT
Location: Ballroom I, Salt Palace Convention Center
Investor Webcast Details:

Presentation: AlloHeme Clinical Validation Data Review and Launch Timeline
Date & Time: Thursday, February 12, 7 a.m. PT / 10 a.m. ET
The one-hour event will feature presentations by members of the CareDx’s leadership team and ACROBAT study site Principal Investigator, Dr. Ran Reshef.
A live and archived webcast can be accessed on the Events & Presentations section of CareDx’s Investor Relations website at investors.caredx.com. To participate in the live conference call via telephone, register here. Upon registering, a dial-in number and unique PIN will be provided.

(Press release, CareDx, FEB 3, 2026, View Source [SID1234662443])

On February 3, 2026 Estrella Immunopharma, Inc. (Nasdaq: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported its STARLIGHT-1 phase I result will be orally presented at the 2026 ASTCT & CIBMTR Tandem Meetings (American Society for Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will highlight clinical data from the Company’s ongoing STARLIGHT-1 study evaluating EB103, a CD19-redirected ARTEMIS T-cell therapy, in patients with aggressive B-cell Non-Hodgkin Lymphoma (NHL).

Estrella’s late-breaking abstract will be available on February 4, 2026, at 12:00 a.m. CT, via the conference website at www.tandemmeetings.com.

Details of the Late-Breaking Oral Presentation:

Final Paper Number: LBA-1
Abstract ID & Title: 29644: Phase-1 Study of CD19-ARTEMIS T Cells (EB103) in Patients with Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)
Session: Late Breaking Abstracts
Session Date/Time: Saturday, February 7, 2026, 3:15 p.m. MST
Presenting Author: Naseem Esteghamat, MD MS
About EB103

EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.

(Press release, Estrella Biopharma, FEB 3, 2026, View Source [SID1234662442])

On February 3, 2026 Cycle Group Holdings Limited ("Cycle") reported it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ: APLT; "Applied"), a clinical-stage biopharmaceutical company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Applied’s lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), for which there are currently no FDA approved treatment options available.

"Cycle was founded with a commitment to support patients living with rare metabolic diseases. From our beginnings with NITYR, we have grown to offer three therapies for this community. With Applied Therapeutics now a part of the Cycle group, we can look to expand further in this area. Our focus remains the same: to bring meaningful, reliable treatments to the patients and families who need them most." says James Harrison, CEO of Cycle.

The transaction is to be funded from cash on hand.

For Cycle, Goodwin Procter LLP acted as legal counsel. For Applied, Aquilo Partners, L.P. provided a fairness opinion, and Ropes & Gray LLP acted as legal counsel.

©2026 Cycle Pharmaceuticals Ltd. All rights reserved. NITYR is a registered trademark of Cycle Pharmaceuticals Ltd in the United States.

(Press release, Cycle Pharmaceuticals, FEB 3, 2026, View Source [SID1234662441])