Day: June 3, 2023

The clinical trial of the personalized cancer vaccine EVX-01 met its primary endpoints of safety and tolerability Positive clinical responses were reported in 8 out of 12 EVX-01 treated patients High-quality neoantigens, predicted by AI technology, were associated with longer progression-free survival Strong vaccine-specific immune responses were induced in all 12 EVX-01 treated patients  Higher EVX-01 dose induced a stronger immune response and was associated with improved clinical outcomeCOPENHAGEN, Denmark, June 03, 2023 (GLOBE NEWSWIRE) — Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage biotechnology company specializing in the development of AI-powered immunotherapies, today presented promising clinical data from its EVX-01 Phase 1 dose escalation trial in metastatic melanoma at the 2023...

– Consistent with data shared in January 2023, the presentation at ASCO 2023 highlights data from the Phase 1 dose-expansion study for luveltamab tazevibulin, or luvelta, in ovarian cancer, demonstrating that FolRα-selected patients, who represent 80% of the patient population, experienced substantial clinical benefit – – REFRaME-O1, the Phase 2/3 pivotal study of luvelta for patients with platinum-resistant ovarian cancer has been initiated and is open for enrollment – SOUTH SAN FRANCISCO, Calif., June 03, 2023 (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 results from a Phase 1 dose-expansion study of luveltamab tazevibulin (luvelta), a novel...

–  Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients; data immature to estimate progression free survival (PFS) –  Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile –  Cogent to host investor webcast Monday, June 5 at 8:00 a.m. ET WALTHAM, Mass. and BOULDER, Colo., June 03, 2023 (GLOBE NEWSWIRE) — Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced positive lead-in data from its ongoing Phase 3 PEAK trial evaluating the selective KIT D816V inhibitor bezuclastinib in...

Updated data from ongoing IGNYTE anti-PD1 failed melanoma cohort shows RP1 combined with nivolumab continues to demonstrate deep and durable responses with a well-tolerated safety profile; no progression in responding patients since the data snapshot presented in December 2022 Overall response rate (ORR) of 37.4%, with clinically meaningful activity across the range of anti-PD1 failed cutaneous melanoma settings enrolled, including in patients with moderate-high tumor burden and visceral disease RP2 demonstrated an acceptable benefit risk profile and meaningful antitumor activity in patients with uveal melanoma from the ongoing RP2 Phase 1 trial WOBURN, Mass., June 03, 2023 (GLOBE NEWSWIRE) — Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed...

 – Met Primary Endpoint with 63.4% Median Reduction in LDL-C (p

Short-term contract extension for Espoir Ivoirien BW Offshore has signed a short-term extension for the lease and operation of the FPSO Espoir Ivoirien in order to discuss a potential purchase of the FPSO by the client. The firm period has been extended until 9 June 2023. For further information, please contact:Ståle Andreassen, CFO, +47 91 71 86 55Anders S. Platou, Head of Corporate Finance & Strategy, +47 99 50 47 40 IR@bwoffshore.com or www.bwoffshore.com About BW Offshore:BW Offshore engineers innovative floating production solutions. The Company has a fleet of 8 FPSOs with potential and ambition to grow. By leveraging four decades of offshore operations and project execution, the Company creates tailored offshore energy solutions for evolving markets world-wide. BW Offshore has around 2,000 employees and is publicly listed on...

Data update from AFM24-101 phase 1/2 monotherapy study includes 15 patients from the EGFR mutant non-small cell lung cancer (NSCLC) cohort AFM24 showed clinical activity in 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease In line with previous results, the majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile in heavily pretreated patients, an important factor for combination regimens Based on the totality of data available to date, Affimed will focus clinical development of AFM24 on combination approaches, adding an EGFR mutant NSCLC cohort to the AFM24-102 study to evaluate therapeutic potential in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab Company...

Long Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrate Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous TherapiesPresentation Focused on Patients (n=12) Treated with Phase 2 Regimen 67% Overall Response Rate (ORR) and 58% Complete Response (CR) Rate Five Patients (42%) Maintained a CR at Month 6; Four of Five CRs (80%) Ongoing Beyond Six Months, Including Two at 30+ Months and One at 24+ MonthsClinical Safety and Immune Recovery Comparable to Autologous Therapies Robust AlloCAR T Cell Expansion and Persistence Documented in Responding Patients Allogeneic CAR T Treatment Initiated at a Median of Three Days After Enrollment Without Need for Leukapheresis or Bridging Therapy; 100% Received Allogeneic CAR T Product Candidates Meeting Manufacturing Specifications Enrollment...

ELI-002 was shown to be well-tolerated with no dose limiting toxicity or cytokine release syndrome A high proportion of patients had tumor biomarker reduction (77%) with 32% having complete clearance Robust mKRAS-specific T cell responses induced in 87% of patientsBOSTON, June 03, 2023 (GLOBE NEWSWIRE) — Elicio Therapeutics (Nasdaq: ELTX), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced positive interim clinical data from the ongoing Phase 1 (AMPLIFY-201) study of its lead asset, ELI-002, an investigational therapeutic cancer immunotherapy. This study evaluated ELI-002 2P, a 2-peptide formulation designed to treat cancers driven by G12D and G12R mutations in KRAS. ELI-002 was studied as a monotherapy in patients with mutant KRAS-driven tumors...

Zevra is a corporate sponsor of the Hypersomnia Foundation and Beyond Sleepy Conference CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder, will be presented at the Hypersomnia Foundation’s 2023 Beyond Sleepy Conference being held June 2 – 4, 2023, in Indianapolis, IN, for people living with IH, narcolepsy and Kleine-Levin syndrome and their supporters. Zevra is a corporate sponsor of the Hypersomnia Foundation and the Beyond Sleep program. “We are proud to sponsor the Hypersomnia Foundation and the Beyond Sleepy program...