WALTHAM, Mass., June 10, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced the appointment of Akintunde (Tunde) Bello, Ph.D., to the company’s board of directors. “Tunde is an accomplished leader with a strong track record of successfully developing novel therapies across a broad range of therapeutic areas, including several important cance ...

Core Insights - Xilio Therapeutics announced a preliminary objective response rate (ORR) of 26% in heavily pre-treated patients with metastatic microsatellite stable colorectal cancer (MSS CRC) without liver metastases, demonstrating deep and durable responses lasting up to 37 weeks [1][4][10] - The combination therapy of vilastobart and atezolizumab showed a differentiated safety profile with a low incidence of immune-related adverse events, particularly colitis [2][7][11] - The ongoing Phase 2 trial is evaluating vilastobart in combination with atezolizumab, with plans to expand the study to include a higher dose level [9][13] Patient Data - As of May 12, 2025, 44 patients with metastatic MSS CRC were treated with vilastobart at 100 mg every six weeks and atezolizumab at 1200 mg every three weeks, with a median age of 55 years [3][5] - 80% of patients had previously received three or more lines of anti-cancer therapy, indicating a heavily pre-treated population [3] Anti-Tumor Activity - The preliminary ORR of 26% included seven partial responses, with six confirmed responses, and substantial decreases in tumor biomarkers such as circulating tumor DNA [4][10] - In patients without liver metastases, responses were deep and durable, with reductions in target lesions of up to 71% from baseline [10] Safety Profile - The combination therapy exhibited a low incidence of immune-mediated adverse events, with only 7% of patients experiencing colitis [7][11] - Common treatment-related adverse events included fatigue (30%), infusion-related reactions (23%), and diarrhea (18%) [11] Future Development Plans - Xilio is enrolling a cohort of patients at a higher dose level of 150 mg Q6W for vilastobart in the ongoing Phase 2 trial, with additional data expected in the first half of 2026 [9][12] - The company is seeking partnership opportunities to accelerate the development of the vilastobart program [12]

CRANFORD, N.J., May 14, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal second quarter ended March 31, 2025."In Q2 2025, Citius Oncology advanced its transformation from a development-stage company to a commercial-stage organization. Following FDA approval of LYMPHIR, we intens ...

Clinical data on track for Q4 2025 from Phase 2 trial of BDTX-1535 in 1L patients with non-classical EGFRm NSCLCExpansion of investigator sponsored Phase 0/1 trial into newly diagnosed glioblastoma patients with EGFR alterations initiated in Q1 2025Cash, cash equivalents, and investments of $152.4 million as of March 31, 2025; expected to be sufficient to fund operations into Q4 of 2027 CAMBRIDGE, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncol ...

Positive initial Phase 2 proof-of-concept data for NDV-01 at AUA 2025 showing a 90% overall response rate at any time in non-muscle invasive bladder cancer (US prevalence 600K patients) The Phase 2 study for NDV-01 continues with updates at 6, 9 and 12 month data follow-up over the course of 2025. Plans to start Phase III registration trial in H1 2026 Expecting to initiate a Phase 2 study for sepranolone in Prader-Willi syndrome in H1 2026 (US prevalence 20,000 patients) Conference Call and Webcast Today at ...

Core Insights - Xilio Therapeutics, Inc. is set to present updated data from its Phase 2 clinical trial of vilastobart, an anti-CTLA-4 therapy, in combination with atezolizumab for metastatic microsatellite stable colorectal cancer at the 2025 ASCO Annual Meeting [1] - The presentation will take place on May 31, 2025, during a poster session focused on gastrointestinal cancer [2] Company Overview - Xilio Therapeutics is a clinical-stage biotechnology company focused on developing tumor-activated immuno-oncology therapies aimed at improving cancer treatment outcomes while minimizing systemic side effects [3] - The company utilizes a proprietary platform to create novel tumor-activated immuno-oncology molecules that enhance localized anti-tumor activity within the tumor microenvironment [3] Clinical Trial Details - Vilastobart is designed to block CTLA-4 and deplete regulatory T cells when activated in the tumor microenvironment [2] - In 2023, Xilio entered a collaboration with Roche to co-fund a clinical trial evaluating vilastobart in combination with atezolizumab in a multi-center, open-label Phase 1/2 trial [2] - The ongoing trials include a Phase 1C dose escalation for advanced solid tumors and a Phase 2 trial for metastatic microsatellite stable colorectal cancer, with and without liver metastases [2]

Core Viewpoint - Apollomics Inc. reported financial results for the fiscal year ended December 31, 2024, highlighting its focus on developing oncology drug candidates, particularly vebreltinib, and its strategic collaborations to enhance clinical data and market opportunities [1][9]. Financial Results - As of December 31, 2024, Apollomics had $9.8 million in cash and cash equivalents, a decrease from $37.8 million in 2023 [12]. - The net loss for 2024 was $(53.9) million, or $(52.80) per basic and diluted share, compared to a net loss of $(172.6) million, or $(231.99) per share in 2023 [12][20]. - Research and development expenses for 2024 were $24.6 million, down from $34.2 million in 2023 [12][20]. - Administrative expenses decreased to $17.8 million in 2024 from $20.6 million in 2023 [12][20]. Pipeline and Clinical Updates - Apollomics is focusing on vebreltinib (APL-101), a c-Met inhibitor, which has shown a 43% objective response rate in a Phase 2 clinical trial for non-CNS MET fusion solid tumors [6]. - The company announced a strategic collaboration with LaunXP to develop vebreltinib in combination with an EGFR inhibitor, which includes a $10 million upfront payment and potential milestone payments of up to $50 million [5][12]. - New interim data for vebreltinib includes promising results for treating NSCLC with MET amplification and non-CNS solid tumors with MET fusions [5][6]. Business Highlights - Apollomics raised $5.8 million in a private placement in May 2024 [12]. - The company has terminated collaborations with Glycomimetics and TYG Oncology to focus resources on vebreltinib MET amplification [12]. - The strategic focus on vebreltinib aims to address the unmet medical needs of patients with specific c-Met alterations [12].