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.

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!

"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.

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!

"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.

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 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.

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!

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])

On February 26, 2026 Boehringer Ingelheim reported that the U.S. Food and Drug Administration (FDA) approved HERNEXEOS (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1

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 indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Boehringer is currently enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. (NCT06151574).

Accelerated approval is based on data from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion LUNG-1 trial which demonstrated an objective response rate of 76%, including 11% of patients with a complete response and 65% of patients with a partial response.1 Zongertinib demonstrated a duration of response of ≥6 months in 64% of patients.1 This data builds upon the FDA accelerated approval of HERNEXEOS for previously treated patients in August 2025.

"Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy, a manageable safety profile, and once daily oral administration," said coordinating investigator for the Beamion LUNG-1 trial, Dr. John Heymach, MD, PhD, chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "Now these patients finally have a targeted treatment option that they can receive immediately following identification of a HER2 mutation."

"With HERNEXEOS now approved for patients with HER2-mutant advanced NSCLC as an initial treatment option, we are delivering on our promise to transform care for people with this rare and aggressive cancer," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "This approval marks a shift towards personalized care with a targeted treatment option for patients with HER2 mutated lung cancer. It underscores our relentless focus on accelerating innovation to address a significant unmet need."

HER2 (ERBB2) mutations occur in approximately 2-4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.2,3,4 Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.2,4

"We first learned about the HER2 genetic mutation as a lung cancer driver in a small subset of patients more than 20 years ago," said Danielle Hicks, Chief Patient Officer of GO2 for Lung Cancer. "Half of these people do not respond to the current standard of care, which is why it is vital to provide them with a treatment option that has been designed specifically for their disease. Understanding your biomarkers is so important because it can unlock more personalized and effective treatment options."

Zongertinib demonstrated a manageable safety profile as an initial treatment that was consistent with that observed and reported in previously treated patients. Adverse events led to dose discontinuations in 6% of patients.1 In a pooled safety population, which included 292 patients with HER2 (ERBB2)-mutant NSCLC, both treatment-naïve and previously treated, the most common (>20%) adverse reactions were diarrhea (54%), rash (28%), hepatotoxicity (27%), fatigue (25%), nausea (23%), musculoskeletal pain (21%), and upper respiratory tract infection (20%).1

The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner’s National Priority Voucher for zongertinib, underscoring its potential to meet critical patient needs for this rare and aggressive cancer.

About HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.2 The condition is often diagnosed at a late stage, and fewer than 1 in 10 patients are alive five years after diagnosis.6,7 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.8,9,10 There remains a high unmet need for additional treatment options for people living with advanced NSCLC.

Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.2

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that inhibits HER2 (ERBB2).1,11 HERNEXEOS has been approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer.

Comprehensive biomarker testing using next generation sequencing determines a patient’s eligibility for treatment with HERNEXEOS by identifying HER2 (ERBB2)-mutant advanced NSCLC.1,4

The treatment is being evaluated in ongoing trials, across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574). Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, FEB 26, 2026, View Source [SID1234663103])