Day: December 11, 2022

A single dose of KT-253 induced rapid apoptosis and sustained tumor regression in xenograft models of AML KT-253 showed combinatorial benefit with BCL-2 inhibitor venetoclax in model of venetoclax-resistant AML KT-253 also active in other hematologic malignancies including DLBCL WATERTOWN, Mass., Dec. 11, 2022 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today presented preclinical data showing that KT-253, a novel MDM2 degrader, inhibited tumor growth as single agent and in combination with venetoclax in AML xenograft models. The data was presented at the American Society of Hematology (ASH) Annual Meeting, taking place from December 10 – 13, 2022 in New Orleans, Louisiana. The...

HOUSTON, Dec. 11, 2022 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced a poster presentation by the University of North Carolina Lineberger Comprehensive Cancer Center (UNC Lineberger) team at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition being held in New Orleans December 10-13, 2022. The presentation, scheduled for today at 6 p.m. CT, will provide data on four patients who received rimiducid to activate the CaspaCIDe® safety switch in an investigator sponsored trial. The poster titled “Abrogation of Immune Effector Cell Neurotoxicity Syndrome (ICANS) By Rimiducid (RIM) in Patients Treated with CD19-Specific Chimeric Antigen Receptor Modified T-Cells (CAR-T) Engineered with an Inducible...

Clinically active across a wide dose range (2.15 to 24 mg) in a Phase 1 trial of heavily pretreated patients with relapsed/refractory multiple myeloma 77% (10/13) objective response rate (ORR) observed across highest doses (12 and 24 mg) Responses were durable, with many patients on treatment longer than a year Generally well-tolerated with a low incidence of cytokine release syndrome (CRS): Low-grade CRS in 29% of patients across highest step dose regimens; 95% of events occurred following first or second dose; no Grade 3 or higher CRS Dose and schedule optimization is ongoing; maximum tolerated dose not yet reached in step dose regimen Management to host webcast and conference call to review the HPN217 data presented at ASH and provide a pipeline update on Monday, December 12, 2022, at 4:30 Eastern Time/3:30 Central TimeSOUTH SAN...

Vincerx’s proprietary payload and linker technology and VIP943, a novel anti-CD123 antibody drug conjugate (ADC), demonstrated superiority with significant improved safety in non-human primates (NHP) when compared with Mylotarg™ (gemtuzumab ozogamicin) VIP943 demonstrated monotherapy activity in ex vivo AML models and in vivo activity with significant tumor regression in combination with venetoclax and azacitidine in an acute myeloid leukemia (AML) mouse model VIP943 IND-enabling studies continue to advance, with IND filing expected mid-2023 PALO ALTO, Calif., Dec. 11, 2022 (GLOBE NEWSWIRE) — Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced a poster presentation of preclinical data...

Company Provides Comprehensive Clinical Update from Phase 1/2 Trial Tuspetinib Continues to Deliver Single Agent Responses in r/r AML Patients Tuspetinib Safety and Efficacy Profile may Position Drug to Become the Preferred Kinase Inhibitor for Triplet Combination, Maintenance Therapy, and Patients Failed by Prior FLT3 Inhibitors Tuspetinib Enrolling APTIVATE Expansion Trial for Monotherapy and Combination Therapy Luxeptinib Original Formulation Delivers New CR in DLBCL Patient Luxeptinib New G3 Formulation Continuous Dosing Ongoing in R/R AML PatientsAptose to Hold a Corporate Clinical Update and Data Review at 10:00 am ESTSAN DIEGO and TORONTO and NEW ORLEANS, Dec. 11, 2022 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today provided a clinical update of its lead oral myeloid kinome inhibitor,...

– ASH poster presentation summarizes preclinical data from SENTI-202, an off-the-shelf CAR-NK cell therapy candidate engineered with a logic-gated gene circuit and multi-armed with crIL-15, that is advancing toward clinical development for hematologic malignancies – – SENTI-202 is on track for IND filing in 2H 2023 – – SENTI-202 aims to more precisely target tumor cells in CD33 and/or FLT3 expressing tumors such as acute myeloid leukemia and myelodysplastic syndrome, while sparing healthy cells – – Senti Bio Investor Event to include an AML expert; in-person and webcast at 12:30 p.m. ET/11:30 a.m. CT today – NEW ORLEANS, Dec. 11, 2022 (GLOBE NEWSWIRE) — Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company innovating next-generation cell and gene therapies using its proprietary gene circuit platform, today...

The phase III COMMODORE 3 study of crovalimab met primary endpoints of transfusion avoidance and haemolysis control in people with paroxysmal nocturnal hemoglobinuria (PNH) 1 COMMODORE 3 is the first China-specific study in PNH. Current treatment options are extremely limited in China, resulting in significant levels of disease-related morbidity and mortality for people living with PNH 2 Based on these data crovalimab has received Breakthrough Therapy Designation and is under Priority Review for approval in ChinaBasel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive new data from the phase III COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody, is efficacious and well-tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH). The study...

The HAVEN 7 study was designed to further confirm the benefit of preventative treatment (prophylaxis) with Hemlibra from birth in previously untreated or minimally treated infants with severe haemophilia A without inhibitors In the study, 77.8% of participants had no bleeding episodes that required treatment1 In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented 2,3Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a favourable safety profile in infants (up to 12 months) with severe haemophilia A, without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any...

— Preliminary study results show that tifcemalimab is well-tolerated at all administered doses. The observed clinical activity of tifcemalimab in combination with toripalimab in lymphoma patients refractory to checkpoint inhibitors warrants further evaluation. Combination dose expansion is under way. — Among the 28 evaluable patients who received the combination regimen, while 85.7% of the patients progressed upon prior anti-PD-1, 39.3% achieved ORR, and median DoR has not yet been reached. SHANGHAI, China, Dec. 10, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced today that the updated preliminary data from a...

– Actively Enrolling Phase 3 ENERGIZE and ENERGIZE-T Studies Evaluating PYRUKYND® in Adults with Non-transfusion-dependent and Transfusion-dependent α- or β-Thalassemia, Respectively – – Agios to Host Live and Webcast Investor Event on Dec. 12, 2022, at 7 a.m. CT – CAMBRIDGE, Mass., Dec. 10, 2022 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today reported new data from the ongoing long-term extension period of the Phase 2 open-label study of PYRUKYND® (mitapivat), a first-in-class, oral, small molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase (PK) enzymes, in adults with non-transfusion dependent α- or β-thalassemia. Data from the study were featured in a poster presentation (abstract #1030) at...