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.

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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])

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Agreement / Collaboration / M&A HanchorBio and WuXi Biologics Enter Strategic Partnership to Advance Next-Generation Bi-and Multi-Functional Fusion Protein Pipeline MS Pharma Group Signs Exclusive Biosimilars Partnership Agreement with Hetero StarkAge Therapeutics Announces Research Collaboration with Gustave Roussy to Advance Senolytic Therapies in Digestive Cancers Insilico Medicine and Qilu Pharmaceutical Reach Near $120 Million Drug Development Collaboration to Accelerate Novel Cardiometabolic Therapies Boehringer Ingelheim and Simcere partner to advance a dual-target antibody treatment to address unmet needs in inflammatory bowel disease Defence Therapeutics Expands Collaboration With Canadian Nuclear Laboratories To Accelerate Its Proprietary Radiopharmaceutical Pipeline Physiomics Awarded New Contract by Numab Therapeutic InSysBio to announce a new collaborative project with BeOne Medicines WuXi Biologics and Sinorda Biomedicine Enter Strategic Collaboration to Accelerate Development and Manufacturing of Innovative Bispecific Antibody Repare Announces Completion of Acquisition by XenoTherapeutics, Inc. Accent Therapeutics to Utilize Inocras’ CancerVision and MRDVision Platforms in Phase 1/2 ATX-295 Clinical Study Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer RECORDATI ANNOUNCES STRATEGIC COLLABORATION WITH MODERNA TO DEVELOP AND COMMERCIALIZE WORLDWIDE mRNA 3927 FOR THE TREATMENT OF PROPIONIC ACIDEMIA Immuto Scientific and University of Wisconsin–Madison Announce Collaboration to Advance Discovery of Novel Cancer Targets Illumina completes acquisition of SomaLogic Cycle Pharmaceuticals Announces Extension of Applied Therapeutics Tender Offer Funding BioMarin Announces Proposed Private Offering of Senior Notes and Syndication of New Senior Secured Term Loan Facility Primmune Therapeutics Announces Additional Close of Series B Financing Fortitude Biomedicines Launches With $13M in Financing to Advance Novel Antibody-based Therapies for Treatment of Autoimmune Diseases and Cancer AIM ImmunoTech Announces Changes to Key Dates and Terms Related to 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of Senior Notes and Completion of Syndication of New Senior Secured Term Loan Facility LEXICON ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK Altimmune Announces Closing of $75 Million Registered Direct Offering of Common Stock ALX Oncology Announces Pricing of Underwritten Offering Submission / Acceptance / Opinion / Approval Cogent Biosciences Announces Breakthrough Therapy Designation for Bezuclastinib in Combination with Sunitinib for Patients with Gastrointestinal Stromal Tumors (GIST) Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma Chugai Files for Additional Indication of Tecentriq for the Treatment of Adjuvant Therapy for MRD-Positive Bladder Cancer DARZALEX FASPRO-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib 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Provides Corporate Update and Key Value Drivers for 2026 PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI Alpha Tau Issues Letter to Shareholders: Five Concurrent Trials in the U.S. with Multiple Significant Value-Driving Milestones Ahead Aprea Therapeutics Announces Early Clinical Proof-Of-Concept in the Ongoing ACESOT-1051 Dose-Escalation Trial Evaluating WEE1 Inhibitor APR-1051, Including Partial Response Observed on First Scan New Data Demonstrate CD47 Expression Level Helps Predict Response to ALX Oncology’s Evorpacept in Combination with Ziihera (zanidatamab-hrii) in Advanced HER2-Positive Breast Cancer Trial Initiation / Enrollment First Site Activated and First Patient Randomised in new brain cancer study VIGOR – EORTC‑2427‑BTG CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer Four additional sites open for recruitment in Oncoinvent’s Phase 2 trial Revolution Medicines Doses First Patient in Clinical Trial Evaluating RMC-5127, a RAS(ON) G12V-Selective Inhibitor Preclinical New publication in Cell Death & Disease demonstrates the versatility and safety of Vartumab for cytotoxic payload delivery in oncology Preclinical Results of the Anti-CTLA-4 Switch Antibody ROSE12 Published in the Journal for ImmunoTherapy of Cancer ME THERAPEUTICS SCIETIFIC AND CORPORATE UPDATE Kazia Therapeutics Announces Compelling Preclinical and Translational Data for Nuclear PD-L1 Degrader (NDL2) Biomarker Tempus Reveals Its AI-Driven IPS Test More Accurately Predicts Immunotherapy Benefit Compared to Conventional Biomarkers Caris Life Sciences’ Real-World Data Uncovers Metastatic Breast Cancer Patient Responses and Resistance to Trastuzumab Deruxtecan GRAIL Submits FDA Premarket Approval Application for the Galleri Multi-Cancer Early Detection Test Patents Akari 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2026 Other Greenwich LifeSciences Provides Update on FLAMINGO-01 Cash Burn Rate and Financing Strategy

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On February 3, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported that the U.S. Food and Drug Administration (FDA) cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application (IND) for PRT12396, a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms (MPNs). The Company anticipates dosing the first patient by Q2 of 2026.

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"The FDA’s clearance of our IND for PRT12396 marks a pivotal first milestone in the strategic transformation and development focus on our JAK2 and KAT6 programs that we outlined last quarter," stated Kris Vaddi, Chief Executive Officer of Prelude. "This achievement demonstrates our ability to translate high-quality science rapidly into clinical progress and our clear focus on executing these programs that represent the potential to reshape the treatment landscape for the target patient populations. We look forward to advancing PRT12396 into the phase 1 study in patients with polycythemia vera and myelofibrosis in parallel."

The Phase 1 study of PRT12396 is an open-label, multi-center, safety and efficacy study in patients with high-risk polycythemia vera (PV) and intermediate and high-risk myelofibrosis (MF). The primary endpoints of the study include safety, efficacy and PK profile.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

(Press release, Prelude Therapeutics, FEB 3, 2026, View Source [SID1234662430])

On February 3, 2026 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to zovegalisib (RLY-2608) in combination with fulvestrant for the treatment of adults with PIK3CA mutant, hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

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"Approximately 40% of patients with HR+/HER2- advanced breast cancer harbor PIK3CA mutations, and most experience disease recurrence or progression following treatment with CDK4/6 inhibitors, leaving limited therapeutic options," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. "This Breakthrough Therapy designation underscores the FDA’s recognition of the potential of zovegalisib in combination with fulvestrant to meaningfully improve outcomes for these patients, reinforcing the impact of the encouraging clinical evidence we have demonstrated to date. We look forward to continuing to collaborate closely with the FDA as we work to advance this program as efficiently as possible for patients."

The FDA’s BTD is designed to accelerate the development and review of therapies for serious conditions when early clinical evidence suggests the potential for substantial improvement over available treatments. BTD provides eligibility for all Fast Track designation features, along with enhanced FDA guidance on development and increased engagement with senior FDA leadership.

BTD for zovegalisib was supported by clinical data generated to date from the Phase 1/2 ReDiscover trial, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of zovegalisib in combination with fulvestrant, and in combination with fulvestrant and CDK inhibitors. Specifically, the application included data across all PIK3CA mutations (kinase and non-kinase) for two doses with comparable exposures: 600mg BID fasted (N=52) and 400mg BID fed (N=57), the dose being used in the ongoing Phase 3 trial, ReDiscover-2.

Safety and efficacy from the 600mg BID fasted data referenced above were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting, with an additional efficacy subgroup analysis presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).

Data for the 400mg BID fed (the Phase 3 dose) will be presented for the first time at ESMO (Free ESMO Whitepaper) Targeted Anticancer Congress 2026 on Monday, March 16.

About Zovegalisib

Zovegalisib is the lead program in Relay Therapeutics’ efforts to discover and develop mutant selective inhibitors of PI3Kα, the most frequently mutated kinase in all cancers and all vascular anomalies. Zovegalisib has the potential, if approved, to address a significant portion of the approximately 140,000 patients with HR+, HER2- breast cancer with a PI3Kα mutation per year in the United States and the estimated 170,000 patients with vascular anomalies driven by a PI3Kα mutation per year in the United States.

Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric, site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type (WT) PI3Kα and off-isoform activity. Toxicity related to inhibition of WT PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. The Dynamo platform enabled the discovery of zovegalisib, the first known allosteric, pan-mutant, and isoform-selective PI3Kα inhibitor, designed to overcome these limitations. Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between WT and mutant PI3Kα, and leveraged these insights to support the design of zovegalisib. Zovegalisib is currently being evaluated in multiple metastatic breast cancer studies and a first-in-human study designed to treat patients with PIK3CA (PI3Kα) mutation driven vascular anomalies. For more information on zovegalisib, please visit here.

About PIK3CA-mutated, HR+/HER2- Advanced Breast Cancer

Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer is the most common subtype of breast cancer. Approximately 40% of patients with HR+/HER2- breast cancer harbor activating mutations in the PIK3CA gene, which drive tumor growth and are associated with poorer outcomes compared to patients without these mutations. Despite CDK4/6 inhibitors plus endocrine therapy being the standard of care in advanced disease, many patients with PIK3CA-mutated tumors have poorer outcomes and there are no approved regimens incorporating a pan-mutant selective PI3Kα inhibitor.

(Press release, Relay Therapeutics, FEB 3, 2026, View Source [SID1234662431])

On February 3, 2026 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported financial results for the fiscal third quarter ended December 31, 2025 and provided a business update.

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The Company’s Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in anti-PD-1 failed melanoma was accepted by the FDA in October 2025 with a Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2026. Commercial readiness activities are well underway to support a potential launch, if approved.

The Company has amended its existing loan agreement with Hercules Capital, Inc. The amendment included the draw down of $35 million upon closing and the potential to draw another $120 million at post approval milestones. The amendment also delays the repayment of debt from 2026 to 2027. The Company has extended its cash runway late into to the first quarter of 2027.

"We have been engaged with the FDA in the review of the BLA resubmission for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "Advanced melanoma patients can progress quickly and are in urgent need of safe and effective treatment options. Our team remains ready to launch RP1 with commercial supply produced and the commercial organization prepared to engage with our target accounts rapidly, assuming FDA approval."

Program Highlights & Milestones

RP1 (vusolimogene oderparepvec)

IGNYTE-3 Confirmatory Study: The global Phase 3 trial will enroll approximately 400 patients and is assessing RP1 in combination with nivolumab versus physician’s choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. The primary endpoint of this trial is overall survival, and key secondary endpoints are progression free survival and overall response rate.
Acral Melanoma: Recent data for RP1 plus nivolumab was recently presented at the ESMO (Free ESMO Whitepaper) Congress 2025. The analysis of acral melanoma data from the IGNYTE anti-PD-1 failed melanoma cohort showed treatment with RP1 combined with nivolumab resulted in an objective response rate (ORR) of 44% (8/18) with a median duration of response of 11.9 months. The safety profile was favorable with generally transient grade 1 and 2 treatment related adverse events.
Advanced Non-melanoma Skin Cancer (NMSC) Studies: Additionally, a poster from ESMO (Free ESMO Whitepaper) featuring data from the IGNYTE clinical trial showed that RP1 plus nivolumab provided responses across multiple advanced non-melanoma skin cancer (NMSC) tumor types, including anti–PD-1 naïve and failed disease, as well as both in locally advanced and metastatic disease. The ORR was 100.0%, 33.3%, 66.7%, and 56.3% in patients with anti–PD-1 naïve MCC, BCC, angiosarcoma, and CSCC, respectively. The ORR was 26.3%, 30.0%, 37.5%, and 15.2% in patients with anti–PD-1 failed MCC, BCC, angiosarcoma, and CSCC, respectively. The IGNYTE clinical trial cohort in NMSC is ongoing, however, enrollment was stopped in Q4 2025.
ARTACUS Study: Data from the ongoing ARTACUS Phase 2 trial evaluating the potential of RP1 as monotherapy in cutaneous squamous cell carcinoma patients following organ transplant were recently presented during an oral session at the Society for Melanoma Research 22nd International Congress. RP1 monotherapy showed robust anti-tumor activity in locally advanced CSCC with an ORR of 34.6% (CR rate was 23.1%) and 2-year duration of response of 61.0%. RP1 monotherapy was well tolerated, and the safety profile was similar to that observed in non-immunocompromised patients with advanced skin cancers.
RP2

REVEAL Study: The registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. The trial is evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab in approximately 280 patients. The primary endpoints of the trial are overall survival and progression free survival, and key secondary endpoints are overall response rate and disease control rate. Phase 2/3 transition is expected in Q1 2027, with PFS analysis potentially supporting accelerated approval.
Liver-focused Studies: The Phase 2 clinical trial of RP2 combined with atezolizumab and bevacizumab in anti-PD-1/PD-L1 progressed hepatocellular carcinoma is currently enrolling. The protocol was amended to include RP2 as monotherapy with data planned by the end of 2026. The trial is being conducted under a collaboration and supply agreement with Roche. The Company also has enrolled its first patients in a cohort evaluating RP2 in patients with biliary tract cancer. This cohort will evaluate RP2 combined with durvalumab.
Financial Highlights

Cash Position: As of December 31, 2025, cash, cash equivalents and short-term investments were $269.1 million, as compared to $483.8 million as of fiscal year ended March 31, 2025. The decrease in cash balance was a result of cash burn related to operating activities in advancing the company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments will enable us to fund operations late into the first quarter of calendar 2027. This includes the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes and excludes any potential revenue.
R&D Expenses: Research and development expenses were $53.1 million for the fiscal third quarter and $48.0 million for the fiscal third quarter ended December 31, 2024. This increase was primarily due to an increase in RP1 direct research costs related to the IGNYTE-3 confirmatory study and other study costs including lab and operating supplies, as well as increased RP2 study costs. In addition, personnel-related costs increased as we continued to prepare for a potential commercial launch of RP1. Research and development expenses included $3.6 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
S,G&A Expenses: Selling, general and administrative expenses were $18.7 million for the fiscal third quarter ended December 31, 2025, as compared to $18.0 million for the fiscal third quarter ended December 31, 2024. Selling, general and administrative expenses included $3.4 million in stock-based compensation expenses for the fiscal third quarter ended December 31, 2025.
Net Loss: Net loss was $70.9 million for the fiscal third quarter ended December 31, 2025 and $66.3 million for the fiscal third quarter ended December 31, 2024.
About RP1

RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2

RP2 is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response. RP2 additionally expresses an anti-CTLA-4 antibody-like molecule, as well as GALV-GP R- and GM-CSF. RP2 is intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic-immune-based efficacy on tumors and limiting off-target toxicity.

(Press release, Replimune, FEB 3, 2026, View Source [SID1234662432])