On February 26, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported that results from the Phase 1, first-in-human portion of the ongoing Phase 1/2 PYNNACLE study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation were published in the New England Journal of Medicine (NEJM). The publication provides a summary of the Phase 1 safety and efficacy results across 77 patients.

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The study published in NEJM entitled, "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors," highlighted the antitumor activity of rezatapopt in heavily pretreated patients across multiple solid tumor-types establishing proof-of-concept for p53 reactivation. All responding patients had a TP53 Y220C mutation and were KRAS wild-type. The manuscript can be accessed here.

In the Phase 1 portion of the PYNNACLE clinical trial, 77 heavily pretreated patients with advanced solid tumors harboring a TP53 Y220C mutation received oral rezatapopt across dose-escalation cohorts to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), characterize safety, pharmacokinetics, and biomarker effects. Rezatapopt was generally well tolerated; dose-limiting toxicities were infrequent, supporting selection of the RP2D. Objective responses were observed across multiple tumor types. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.

"Publication of the rezatapopt Phase 1 results in the New England Journal of Medicine underscores the emerging clinical impact of reactivating p53 in patients whose cancers are driven by a TP53 Y220C mutation," said Deepika Jalota, Pharm.D., Chief Development Officer of PMV Pharma. "These peer-reviewed findings further validate our scientific approach, support our registrational Phase 2 strategy and our plan to submit a New Drug Application in platinum-resistant/refractory ovarian cancer in the first quarter of 2027. We remain focused on advancing rezatapopt as a potential first-in-class therapy for ovarian cancer patients harboring a TP53 Y220C mutation, an area of high unmet medical need."

In October 2025, the Company presented updated interim clinical results from the Phase 2 pivotal portion of the PYNNACLE study, highlighting confirmed responses in patients whose tumors were TP53 Y220C mutated and KRAS wild-type across eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma. As of the September 4, 2025 data cutoff date, the overall response rate (ORR) across all cohorts was 34% (35/103 patients), with an ORR of 46% (22/48 patients) in ovarian cancer per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. Across all cohorts, the median time to response was 1.3 months, and the median duration of response was 7.6 months. In the ovarian cancer cohort, the median time to response was 1.3 months and the median duration of response was 8.0 months.

About Rezatapopt
Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, FEB 26, 2026, View Source [SID1234663108])

On February 26, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported completion of enrollment into Cohort C of the ALLOHA study. Patients in Cohort C are being treated using the new commercial-ready manufacturing process. The Company also announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03 for patients with HLA types A*01:01 and A*03:01, respectively.

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"We are excited about the potential of TSC-101 to treat residual disease and prevent relapse in patients undergoing hematopoietic cell transplantation," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We have now enrolled over ten patients in Cohort C of the ALLOHA study where we are treating patients with our new commercial-ready manufacturing process. We look forward to sharing data from this cohort in the second quarter of this year, prior to launching our Phase 3 study. We are also pleased to announce that the FDA has cleared our IND applications for TSC-102-A01 and TSC-102-A03, and we look forward to initiating a Phase 1 trial with these candidates in the second half of this year. We believe the addition of these product candidates will nearly double the addressable U.S. patient population in our heme program."

"During the Tandem Meetings of ASTCT and CIBMTR, we highlighted the relationship between donor chimerism and long-term outcomes in patients following HCT," added Chrystal U. Louis, M.D., Chief Medical Officer. "Specifically, patients that achieved complete donor chimerism by month two after transplant using a high-sensitivity assay have a significantly lower probability of relapse (HR=4.6, p=0.02) compared to those who did not achieve complete donor chimerism. We look forward to sharing early chimerism data from Cohort C and formally initiating our pivotal study for TSC-101."

The Phase 1 ALLOHA study is evaluating TSC-101 in A*02:01-positive patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT). TScan plans to share safety and early chimerism data from Cohort C in the second quarter of 2026. The Company also plans to launch a pivotal trial for TSC-101 in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026.

The U.S. FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 continues the momentum in TScan’s heme program by expanding HLA coverage to include patients who are HLA-A*01:01-positive or HLA-A*03:01-positive, respectively. These TCR-T therapy candidates target CD45, a protein broadly expressed in heme cells but absent in non-heme tissues.

TScan plans to initiate a Phase 1 trial for both TSC-102-A01 and TSC-102-A03 in the second half of 2026. Products will be manufactured using the commercial-ready process and will enroll patients with various hematologic malignancies undergoing allo-HCT using either reduced intensity conditioning or myeloablative conditioning. The multi-center Phase 1 trial is designed to assess safety and initial efficacy of these TCR-T therapy candidates.

(Press release, TScan Therapeutics, FEB 26, 2026, View Source [SID1234663107])

On February 26, 2026 Starton Therapeutics Inc. ("Starton"), a clinical-stage biotechnology company employing standard-of-care therapies with proprietary continuous delivery technologies, reported that it has filed a patent application for the use of multi-specific (i.e., bi- and tri-specific) antibody-based therapies in combination with the Company’s proprietary, continuous low-dose IMiD, which is a subcutaneous administration of lenalidomide, STAR-LLD, for the treatment of cancer.

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"We are pleased to announce the filing of this provisional patent application," stated Pedro Lichtinger, Chairman and Chief Executive Officer of Starton. "Although lenalidomide and other IMiDs are being studied in combination with multi-specific antibodies, side effect profiles are thought to limit widespread acceptance by oncologists. We believe our continuous subcutaneous delivery of a low-dose formulation of lenalidomide has the potential to improve the side effect profile while sustaining T-cell persistence and response durability."

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), and chronic lymphocytic leukemia (CLL). A preclinical proof-of-concept study for subcutaneous STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

(Press release, Starton Therapeutics, FEB 26, 2026, View Source [SID1234663106])

On February 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that a clinical data abstract submission by cancer experts at Moffitt Cancer Center to the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting has been accepted. The meeting will be held April 11-15, 2026, in Toronto, Ontario.

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The abstract, titled "What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer," was submitted by a multidisciplinary team of cancer experts, including Dr. Mustafa Al-Roubaie, an Interventional Radiologist at Moffitt Cancer Center and member of RenovoRx’s Medical Advisory Board. The abstract explores the hypothesis, based on a review of metabolic response observations, that local, targeted intra-arterial delivery of chemotherapy using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform may help address the poor vascularity commonly associated with locally advanced pancreatic cancer (LAPC). The abstract data further evaluates the potential role of metabolic imaging (FDG (fluorodeoxyglucose) PET/CT)) in evaluating therapeutic activity following targeted intra-arterial treatment in patients with refractory disease.

"Patients diagnosed with LAPC carry a difficult prognosis, partly due to a dense, hypovascular stroma that limits the efficacy of traditional systemic (intravenous) chemotherapy," said Dr. Al-Roubaie. "Regional intra-arterial therapeutic delivery, which is the core attribute of RenovoRx’s TAMP therapy platform, aims to overcome this barrier by delivering high-concentration chemotherapy directly near the tumor. We are excited to present our findings at the upcoming 2026 SIR Meeting."

Abstract Details:
Presentation Date & Time: Monday, April 13, 2026, from 4:45-5:45 PM ET
Title: What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer
Location: Metro Toronto Convention Centre – Toronto, Canada
Abstract Number: 2229370

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, FEB 26, 2026, View Source [SID1234663105])

On February 26, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported that the Independent Data Monitoring Committee (IDMC) has issued a second positive recommendation for the ongoing pivotal Phase 3 ARTEMIA trial evaluating Tedopi in advanced non-small cell lung cancer (NSCLC). The IDMC advised that the study should continue as planned, with no protocol changes.

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In line with the predefined study oversight plan, the IDMC, composed of independent clinical and statistical experts, conducted a comprehensive assessment of patient safety, trial conduct and key efficacy indicators. Based on this review, the IDMC recommended that the study continue without modifications, confirming the robustness of the trial’s conduct to date.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutics, commented: "We welcome this new positive assessment from the IDMC. A total of 163 patients had been randomized at the time of the meeting, with 152 included in the analysis reviewed by the IDMC. These figures are fully consistent with our recruitment objectives."

Initiated in 2024, ARTEMIA compares Tedopi monotherapy with standard docetaxel in HLA-A2–positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The trial is enrolling across sites in Europe, the UK, the US and Canada and is designed to generate confirmatory data to support potential regulatory filings.

The next IDMC review is scheduled for October 2026. Study enrollment is expected to conclude by year-end 2026. Tedopi NSCLC Pivotal Phase 3 interim futility analysis is expected in Q3 2026, with overall survival primary endpoint results anticipated in Q1 2028.

(Press release, OSE Immunotherapeutics, FEB 26, 2026, View Source [SID1234663104])