Day: December 10, 2022

Oral presentation at American Society of Hematology (ASH) Annual Meeting highlights continued favorable safety and tolerability profile and sustained long-term efficacy results for SerpinPC:93% reduction in median ABR for both all-bleeds and spontaneous joint bleeds in highest dose tested No thromboembolic events or treatment-related sustained elevations of D-dimer observedPivotal program for SerpinPC in hemophilia B advancing; PRESent-5 observation study to begin in the coming weeksBOSTON and LONDON, Dec. 10, 2022 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), today announced new data from an additional 18-months of continued treatment with SerpinPC, an investigational, subcutaneously administered novel inhibitor of activated protein C (APC), from the open-label extension (OLE) of the Phase 2a study of...

Updated MCL and CLL data from the ongoing Phase 1/2 study of zilovertamab and ibrutinib are encouraging and continue to improve over prior reporting The ORR of 89% and CR rate of 43% for patients with MCL treated with zilovertamab plus ibrutinib compare favorably to the historical ORR of 66% and CR rate of 20% for ibrutinib monotherapy Median PFS and OS have not been reached after a median follow up of 19.5 months for patients with MCL treated with zilovertamab plus ibrutinib, which compares favorably to the historical median PFS and OS of 12.8 months and 25 months, respectively, for ibrutinib monotherapy Landmark PFS was 100% at 42 months for patients with CLL expressing p53 mutation/del(17p) treated with zilovertamab plus ibrutinibSAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) — Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a...

Data from REDIRECT establish that AFM13 monotherapy is effective in the treatment of relapsed/refractory peripheral T cell lymphoma (r/r PTCL) patients with a differentiated safety profileAFM13 demonstrated robust activity on the primary end point with an objective response rate (ORR) of 32.4% Other measures of efficacy included median duration of response (DoR) of 2.3 months, median progression free survival (PFS) of 3.5 months and median overall survival (OS) of 13.8 months in advanced-stage r/r PTCL patients who have undergone a mean of 2.7 prior lines of therapy Comparable response rates observed in patients with high and low CD30 expression levels and regardless of prior brentuximab vedotin treatment Based on substantial synergy observed in AFM13 combined with NK cells in Hodgkin lymphoma, Affimed plans to focus future investment...

Interim Phase 1 Data of FT576 BCMA-targeted Product Candidate Show Clinical Activity in Initial Single-dose Escalation Cohorts as Monotherapy and in Combination with Daratumumab Preclinical Data under Janssen Collaboration with FT555 GPRC5D-targeted Product Candidate Demonstrate Robust and Durable Tumor Clearance in Highly Aggressive Myeloma Model SAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today presented interim clinical data from the dose-escalation stage of its ongoing Phase 1 study of FT576 for patients with relapsed / refractory multiple myeloma (r/r MM) at the 64th American Society of Hematology Annual Meeting and Exposition. The off-the-shelf product...

AFM13 in combination with NK cells shows very high overall and complete response rates in 41 heavily pre-treated CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients Patients had a median of seven prior lines of treatment; of note, all patients failed to demonstrate objective response to immediate prior line of therapy 31 Hodgkin lymphoma patients treated at the recommended phase 2 dose (RP2D) showed an objective response rate (ORR) of 97% and a complete response (CR) rate of 77% Three of four NHL patients treated at the RP2D achieved an objective response, including one CR 63% of patients treated at the RP2D with at least 6 months follow-up after initial infusion (n=24) remain in complete response for at least 6 months Treatment continues to be well tolerated; no instances of cytokine release syndrome, immune effector...

First immune thrombocytopenia (ITP) plenary selection in 15 years underscores significant unmet need in this rare, serious autoimmune bleeding disease VYVGART showed rapid, clinically and statistically significant improvements in platelet counts compared with placebo; safety profile consistent with previous trials Topline data from ADVANCE-SC trial of subcutaneously (SC) administered VYVGART for ITP expected in second half of 2023 Amsterdam, the Netherlands – December 10, 2022 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADVANCE trial will be presented during the plenary session at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition in New Orleans, LA (Sunday,...

– 30% CR rate at 600 mg in 20 patients with relapsed/refractory NPM1-mutant AML –– Low frequency of differentiation syndrome, including 5% rate (1/20) of ≥ Grade 3 among NPM1-mutant patients treated at 600 mg –– 600 mg determined as recommended Phase 2 dose for ziftomenib in NPM1-mutant AML following positive Type C meeting with FDA –– Company expects to dose first patient in Phase 2 registration-directed trial in NPM1-mutant AML in first quarter of 2023 –– Further clinical development of KTM2A-rearranged AML to be pursued in combination with standards of care –– Multiple combination studies of ziftomenib in NPM1-mutant and KMT2A-rearranged AML anticipated in 2023 –– Management to host investor event today at 11:15 a.m. CT / 12:15 p.m. ET – SAN DIEGO, Dec. 10, 2022 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage...

– A total of 17 pediatric patients were treated with STRO-002 on a compassionate use basis; eight patients achieved complete remission, of which seven patients were MRD negative – – Safety and efficacy profile in this patient population provides added confidence to advance clinical development of STRO-002, which is currently being studied in patients with advanced ovarian and endometrial cancers – – FDA recently granted Orphan Drug Designation to STRO-002 in this patient population – SOUTH SAN FRANCISCO, Calif., Dec. 10, 2022 (GLOBE NEWSWIRE) — Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that its research collaborators at Fred Hutchinson Cancer Research...

Poster presentation to include initial data from subcutaneous administration and updates on intravenous dosing-cohorts UTRECHT, The Netherlands and PHILADELPHIA, Pa., Dec. 10, 2022 (GLOBE NEWSWIRE) — LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody™ platform of bispecific gamma delta T cell engagers to transform the treatment of cancer, today announced a poster presentation highlighting updated data, including safety, pharmacodynamics (PD) and pharmacokinetics (PK) from the ongoing Phase 1/2a clinical trial of LAVA-051 in patients with relapsing/refractory (R/R) chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place in New Orleans, Louisiana and...

Data from ESCAPE-1 and ESCAPE-2 Approaches to Be Presented During Poster Sessions at the 64th ASH Annual Meeting and Exposition CAMBRIDGE, Mass., Dec. 10, 2022 (GLOBE NEWSWIRE) — Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced new preclinical data from its Engineered Stem Cell Antibody Paired Evasion (ESCAPE) conditioning approach aimed at overcoming toxicity challenges associated with currently available conditioning regimens. Beam is advancing ESCAPE as part of its long-term strategy to support broad accessibility of base editing treatments for patients with sickle cell disease (SCD) and other hematologic diseases. “Wave 2” of this strategy is focused on improving the safety and tolerability of conditioning regimens, a required pretreatment...