Author: Customer Service
― Clear dose-response observed, with a robust and clinically meaningful fetal hemoglobin (HbF) induction at the Week 6 timepoint (n=12): mean absolute HbF in the 20 mg cohort increased by 9.9% at Week 6 (vs. 5.6% at Week 6 in the 12 mg cohort); 7 of 12 patients in the 20 mg cohort (58%) achieved absolute HbF levels ≥20% ―
― >3.75-fold mean induction of HbF at Week 12 in the 20 mg cohort among patients who reached the Week 12 visit as of November 11, 2025 data cutoff (n=6), compared to a 2.4-fold induction at Week 12 in the 12 mg cohort ―
― Consistent early evidence of pan-cellular HbF induction, improvements in markers of hemolysis and anemia, and encouraging trends in vaso-occlusive crisis (VOC) reduction ―
― Pociredir continued to be generally well-tolerated, with no treatment-related serious adverse events (SAEs) ―
― Fulcrum to host...
TScan Therapeutics Announces Positive Updated Data from the ALLOHA™ Phase 1 Heme Trial at the 67th American Society of Hematology Annual Meeting and Exposition
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Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52)
3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free vs. 1/4 (25%) in the control arm
TSC-101 was well-tolerated with no dose-limiting toxicities observed
Company to host virtual KOL event featuring Ran Reshef, M.D., M.Sc. on Monday, December 8, at 8:00 a.m. ET
WALTHAM, Mass., Dec. 06, 2025 (GLOBE NEWSWIRE) — 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, today announced updated results from the ongoing ALLOHA™ Phase 1 trial (NCT05473910) of TSC-101 in patients with heme malignancies undergoing allogeneic...
BioNTech and OncoC4 Announce Clinically Meaningful Overall Survival Benefit for Selective Treg Modulator Gotistobart in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer
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Selective Treg modulator gotistobart (BNT316/ONC-392) showed a reduction in the risk of death by more than half compared to standard of care chemotherapy and a manageable safety profile in the first of two stages of the global Phase 3 trial PRESERVE-003 in patients with squamous non-small cell lung cancer (“sqNSCLC”) who have progressed on prior immunotherapy plus chemotherapy
Median OS with gotistobart has not been reached at almost 15 months of follow-up, compared to a median OS of 10 months observed with chemotherapy
As a chemotherapy-free monotherapy, gotistobart has the potential to become an alternative to traditional cytotoxic treatment for a patient population with high unmet medical need
Gotistobart was granted Fast Track Designation by the U.S. Food and Drug Administration (“FDA”) for the treatment of patients with metastatic...
Legend Biotech Highlights New CARVYKTI® Data in Multiple Myeloma and First-in-Human Results from Novel CAR-T Platform in Non-Hodgkin Lymphoma at ASH 2025
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Triple-class exposed patients with three prior lines of therapy in CARTITUDE-1 and CARTITUDE-4 achieved a median PFS of 50.4 months after a single infusion of CARVYKTI®Translational analyses show stronger immune fitness and a more immunocompetent TME when CARVYKTI® is used earlier in the treatment journeyEighty percent of as-treated patients in CARTITUDE-4 with standard-risk cytogenetics remained progression-free and off treatment at 30 months after a single infusion of CARVYKTI®Promising first-in-human results from allogeneic CAR-T candidate LUCAR-G39D demonstrate encouraging safety and efficacy in B-cell non-Hodgkin lymphomaSOMERSET, N.J., Dec. 06, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced new long-term clinical and translational...
Evaxion presents new data for EVX-04, a cancer vaccine candidate for acute myeloid leukemia at ASH Annual Meeting
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Designed with our proprietary AI-Immunology™ platform based on patient sequencing data, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens
EVX-04 induces targeted immune responses and prevents tumor growth in preclinical models
EVX-04 is an off-the-shelf therapeutic cancer vaccine developed for acute myeloid leukemia (AML), a disease characterized by high mortality rates and massive unmet medical need
The off-the-shelf vaccine concept behind EVX-04 is broadly applicable with potential across other hard-to-treat cancersCOPENHAGEN, Denmark, December 6, 2025 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data demonstrating that its AML vaccine candidate, EVX-04, triggers strong specific...
Prelude Therapeutics Presents Data at the 2025 ASH Annual Meeting from its Myeloproliferative Neoplasm (MPN) Programs
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First disclosure of PRT12396, a JAK2V617F-selective JH2 inhibitor demonstrates disease modifying potential in myeloproliferative neoplasms
PRT12396 has completed GLP toxicology studies and is on track for IND filing in the first quarter 2026
First disclosure of a mutant calreticulin (mCALR) targeted degrader antibody conjugate (DAC) with a novel CDK9 degrader payload
JAK2V617F and mCALR are the two primary driver mutations responsible for disease progression and poor prognosis in the majority of MPN patients
WILMINGTON, Del., Dec. 06, 2025 (GLOBE NEWSWIRE) — Prelude Therapeutics Incorporated (Nasdaq: PRLD) (“Prelude” or the “Company”), a precision oncology company, presented earlier today the first preclinical data on its JAK2V617F mutant selective JH2 inhibitors and additional preclinical data from its mCALR-targeted degrader...
Ascentage Pharma Presents Pivotal China Registrational Study Data for Lisaftoclax in Oral Report at 2025 American Society of Hematology (ASH) Annual Meeting
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Lisaftoclax monotherapy demonstrated significant and durable clinical efficacy and a manageable safety profile in patients with heavily pretreated BTK-refractory R/R CLL/SLL, underscoring its utility as a potential new treatment optionLisaftoclax achieved a 62.5% objective response rate (ORR) in heavily pretreated, BTKi-refractory patients, nearly half with complex karyotypeLisaftoclax monotherapy demonstrated a median progression-free survival of 23.89 months in patients with heavily pretreated BTK-refractory R/R CLL/SLL, with no tumor lysis syndrome reportedROCKVILLE, Md. and SUZHOU, China, Dec. 06, 2025 (GLOBE NEWSWIRE) — Ascentage Pharma Group International Inc. (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization novel,...
Cogent Biosciences Presents Full SUMMIT Results of Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 67th Annual Meeting of the American Society of Hematology (ASH)
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— Bezuclastinib achieves clear clinical benefit across all symptom domains including significant improvements on 11 individual symptoms plus the most severe symptom at baseline —
— Bezuclastinib demonstrates that reducing objective measures of disease, including serum tryptase, correlates with improvement in symptom severity; the first time this has been shown in NonAdvSM patients —
— New 48-week data demonstrate a clear, continued deepening of symptomatic improvement over time —
— Bezuclastinib demonstrated a favorable safety and tolerability profile supporting chronic use —
— Granted Breakthrough Therapy Designation for bezuclastinib in October 2025; New Drug Application (NDA) on track for submission in December 2025 —
— Cogent to host investor conference call and...
Nurix Therapeutics Presents New Data Demonstrating Durable, Deepening Responses in Phase 1 Trial of Bexobrutideg (NX-5948) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition
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Objective response rate (ORR) of 83% including two complete responses in CLL patients in Phase 1a study with median progression free survival (PFS) of 22.1 months across all doses tested
Emerging data from randomized Phase 1b cohorts points to higher ORR and longer progression free survival at the 600 mg recommended Phase 2 dose (RP2D) compared to the 200 mg dose
Bexobrutideg was well tolerated with a consistent safety profile between the 600 mg RP2D and the overall study population
Phase 2 clinical trial of bexobrutideg (DAYBreak-CLL-201) currently enrolling globally
Company will host a webcast to discuss the data on Monday, December 8, 2025, at 8:15 p.m. ET
BRISBANE, Calif., Dec. 06, 2025 (GLOBE NEWSWIRE) — Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development...
Genmab Announces Data From Multiple Clinical Trials Showing Treatment with Fixed-Duration Epcoritamab Led to Remissions in First-Line Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)
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Media Release
COPENHAGEN, Denmark; December 6, 2025New two- and three-year EPCORE® NHL-2 follow-up data evaluating epcoritamab in combination with standard of care regimens demonstrate remission in patients with DLBCL and FL
Latest EPCORE DLBCL-3 trial results show encouraging overall response and complete response rates for epcoritamab monotherapy in newly-diagnosed, elderly patients with DLBCL
Data presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) reinforce the potential utility of epcoritamab in earlier lines of therapy with a fixed treatment durationGenmab A/S (Nasdaq: GMAB) today announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination...
