Core Insights - Y-mAbs Therapeutics, Inc. presented preclinical and translational pharmacokinetics (PK) data of CD38-SADA at the 2025 AACR Annual Meeting, focusing on its potential for cancer treatment [1][2] Group 1: Presentation Details - The poster titled "Preclinical and translational pharmacokinetic (PK) modeling of the self-assembling and disassembling (SADA) bispecific fusion protein CD38-SADA for first-in-human (FIH) pretargeted radioimmunotherapy (PRIT)" was presented, detailing plasma concentrations of CD38-SADA in animal models [2][5] - The presentation took place on April 27, 2025, from 2:00 p.m. to 5:00 p.m. CT at Poster Section 25 [5] Group 2: Research Findings - The study characterized the concentration- and time-dependent equilibrium between CD38-SADA tetramers and monomers, with the model showing that low molecular weight CD38-SADA monomers cleared from plasma 20 times faster than the tetramers [3] - The preclinical PK model provided insights into the circulating levels of CD38-SADA protein in vivo, which informed the design and initial dosing regimen of the first-in-human Phase 1 Trial 1201 [4] Group 3: Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [6] - The company's product pipeline includes DANYELZA®, the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [6] Group 4: CD38-SADA PRIT Technology - CD38-SADA is a bispecific fusion protein that binds to CD38 and Lu-DOTA, facilitating a two-step pre-targeted radioimmunotherapy process [7][8] - The technology has shown robust anti-tumor efficacy in preclinical studies and is currently being investigated in adults with relapsed, progressive, or refractory non-Hodgkin lymphoma [8]

Core Insights - CG Oncology presented promising data on cretostimogene grenadenorepvec monotherapy for high-risk non-muscle invasive bladder cancer (NMIBC) at the 2025 AUA Annual Meeting, indicating its potential as a backbone therapy for bladder cancer treatment [2][6] Efficacy Data - The Phase 3 BOND-003 Cohort C study reported a robust 24-month complete response (CR) rate of 42.3% by Kaplan-Meier (K-M) estimation, with 75.5% achieving CR at any time [1][3] - 58.3% of patients demonstrated durable complete responses at 24 months, and 97.3% remained free from progression to muscle-invasive bladder cancer (MIBC) [1][3] - The median duration of response (DOR) was 28 months, with no Grade 3 or greater treatment-related adverse events reported [1][5] Safety Profile - The treatment was well-tolerated, with 97.3% of patients completing all expected treatments and a median resolution time of one day for any treatment-related adverse events [5][6] - The most common treatment-related adverse events (≥10%) included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria [5] Study Population - The BOND-003 Cohort C study included 110 highly pretreated patients, with a median of 12 prior Bacillus Calmette Guerin (BCG) doses, some patients having received as many as 66 doses [5][6] - Cohort P data indicated a high-grade recurrence-free survival rate of 90.5% at 3 and 9 months in patients with BCG-unresponsive Ta/T1 disease [4][5] Future Outlook - CG Oncology is actively investigating the potential of cretostimogene in addressing unmet needs in bladder cancer treatment, with ongoing studies and an Expanded Access Program initiated for eligible patients [6][8]

Core Insights - IO Biotech is advancing novel immune-modulatory therapeutic cancer vaccines, with a focus on reshaping the tumor microenvironment and enhancing T cell activation [1][2][3] Company Overview - IO Biotech is a clinical-stage biopharmaceutical company based in Copenhagen, Denmark, with a US headquarters in New York, specializing in off-the-shelf therapeutic cancer vaccines [3] - The company is developing its lead investigational cancer vaccine candidate, Cylembio® (IO102-IO103), which has received Breakthrough Therapy Designation from the FDA for advanced melanoma treatment [3] Scientific Contributions - Dr. Mads Hald Andersen, a co-founder of IO Biotech, presented at the 2025 AACR Annual Meeting, discussing advancements in cancer vaccine research and the dual mechanism of action of IO102-IO103 [1][2] - The vaccine targets both tumor cells and immune-suppressive cells, potentially reprogramming the tumor microenvironment to be more immune-permissive [2] Research and Development - The educational session at AACR highlighted key developments in RNA-based and immune-modulatory vaccines, showcasing the latest innovations in cancer immunotherapy [1][2] - IO Biotech's T-win® platform is designed to activate T cells against both tumor and immune-suppressive cells, representing a novel approach in cancer vaccine development [3]

Core Insights - Y-mAbs Therapeutics has initiated its Phase 1 clinical trial (Trial 1201) for the CD38-SADA Pre-targeted Radioimmunotherapy (PRIT) platform aimed at treating relapsed or refractory non-Hodgkin Lymphoma (r/r NHL) [1][3] - The trial focuses on the safety and tolerability of the CD38-SADA: Lu-DOTA Drug Complex, with the first patient successfully administered both the protein and imaging doses [1][2] - The SADA PRIT platform is designed to enhance targeted delivery of therapeutic agents while minimizing radiation exposure to normal tissues [2][6] Company Overview - Y-mAbs is a commercial-stage biopharmaceutical company specializing in novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment [5] - The company’s product pipeline includes DANYELZA® (naxitamab-gqgk), the first FDA-approved treatment for relapsed or refractory high-risk neuroblastoma [5] Technology and Innovation - The CD38-SADA is a bispecific fusion protein that binds to CD38-expressing lymphoma cells and delivers a radioactive payload for localized irradiation [6] - The SADA technology was developed by researchers at MSK and is exclusively licensed to Y-mAbs, indicating a strong collaboration between the two entities [4]

Core Insights - BriaCell Therapeutics Corp. has confirmed the complete resolution of lung metastasis in a patient with metastatic breast cancer after treatment with its Bria-OTS immunotherapy, marking a significant milestone in the ongoing Phase 1/2a study [1][6][8] Group 1: Treatment Efficacy - The Bria-OTS monotherapy resulted in a 100% resolution of lung tumors in a 78-year-old female patient after two months of therapy, with confirmation of this resolution at the four-month follow-up [2][5] - The patient had extensive metastases prior to treatment and showed stable disease in other areas after receiving Bria-OTS injections [5][6] - The treatment was well-tolerated, and the patient remains in the study with stable disease elsewhere [6][8] Group 2: Study Details - Bria-OTS is currently being investigated in a Phase 1/2a dose escalation study for metastatic recurrent breast cancer, with a focus on safety and efficacy as a monotherapy [9] - This study represents a next-generation advancement of BriaCell's lead candidate, Bria-IMT™, which is in a pivotal Phase 3 study for metastatic breast cancer [9] Group 3: Industry Context - The results from the Bria-OTS study are particularly significant given the limited treatment options available for patients with hormone receptor-positive metastatic breast cancer, despite advancements in antibody-drug conjugates and immune checkpoint inhibitors [8] - The initial data from the Bria-OTS study demonstrates promising anti-tumor activity, providing early validation for BriaCell's personalized immunotherapy approach [8][9]

Core Insights - Corvus Pharmaceuticals announced new interim data from a Phase 1 clinical trial of soquelitinib for moderate to severe atopic dermatitis, which will be presented at the Society for Investigative Dermatology 2025 Annual Meeting [1][2] - The company will discuss this data during its first quarter 2025 business update conference call scheduled for May 8, 2025 [1][3] Presentation Details - The presentation titled "Selective Soquelitinib, a selective ITK inhibitor demonstrates activity in atopic dermatitis phase 1 clinical trial by a novel mechanism of action" will be delivered by Dr. Albert S. Chiou [2] - The poster presentation is set for May 8, 2025, from 4:30 – 6:00 pm PT, while the oral presentation will occur on May 10, 2025, from 9:50 – 10:00 am PT [2] Company Overview - Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on ITK inhibition as a novel immunotherapy approach for various cancers and immune diseases [4] - The lead product candidate, soquelitinib, is an investigational oral small molecule drug that selectively inhibits ITK, with other candidates in development for different cancer indications [4]

NEEDHAM, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 to June 3, 2025, in Chicago, IL. The oral presentation will feature data from the Company’s phase ...

PHILADELPHIA and VANCOUVER, British Columbia, April 23, 2025 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ:BCTX, BCTXW)) (TSX:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, is pleased to announce three clinical data poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3 at McCormick Place, Chicago, IL. The details ...

Core Insights - BriaCell Therapeutics Corp. is conducting a pivotal Phase 3 clinical study for its lead candidate, Bria-IMT, in advanced metastatic breast cancer, with over 75 patients enrolled and more than 100 consented [1][2][9] - The company expects to complete patient enrollment by late 2025 or early 2026 and may report top-line data as early as the first half of 2026 [1][5] - The study is being conducted at 54 clinical sites across 15 states in the US, with a focus on evaluating overall survival compared to physician's choice treatment [4][5][9] Company Statements - Dr. William V. Williams, President & CEO, expressed optimism about the expanding patient enrollment and the potential of Bria-IMT to transform cancer care for metastatic breast cancer patients [3] - Dr. Giuseppe Del Priore, Chief Medical Officer, noted that the enrollment pace and clinical investigator interest are higher than previously observed, highlighting the dedication of clinical investigators and patients [3] Study Details - The primary endpoint of the study is overall survival, with interim data analysis planned once 144 patient events occur [5] - The Bria-IMT combination regimen has received FDA Fast Track designation, indicating its potential for expedited development and review [5] - Positive results from the Phase 3 study could lead to full approval and marketing authorization for Bria-IMT in metastatic breast cancer patients [5]

Nes-Ziona, Israel, April 21, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (NASDAQ:ENLV, the "Company")), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage.   Oren Hershkovitz, Ph.D, CEO of Enlivex, co ...