Company will share data demonstrating CD47 overexpression as key predictive biomarker for response with the Company’s lead candidate, evorpacept, in HER2+ gastric cancer SOUTH SAN FRANCISCO, Calif., Oct. 03, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced updated data from its Phase 2 ASPEN-06 (NCT05002127) ...

Core Insights - Cardiff Oncology, Inc. announced positive results from a Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel for metastatic triple-negative breast cancer (mTNBC), showing a 40% objective response rate [1][2][5] - The trial demonstrated that the combination was well-tolerated with a manageable toxicity profile, primarily myelosuppression being the most common adverse event [5] Company Overview - Cardiff Oncology is a clinical-stage biotechnology company focused on developing novel therapies leveraging PLK1 inhibition across various cancers, with onvansertib as its lead asset [4] - The company is also exploring onvansertib in combination with standard of care treatments for other indications, including RAS-mutated metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma, and small cell lung cancer [4] Clinical Trial Details - The Phase 1b trial was led by Antonio Giordano, MD, PhD, at Dana-Farber Cancer Institute, focusing on the safety, pharmacokinetics, and pharmacodynamics of the drug combination [5] - The study's primary endpoint was to assess safety and determine the recommended Phase 2 dose (RP2D), with secondary endpoints including pharmacokinetics and pharmacodynamics [5] - Patients in the trial had a median of 3 prior lines of chemotherapy, and the highest dose of onvansertib (18 mg/m²) resulted in a 40% objective response rate [5]

Core Insights - Compass Therapeutics announced statistically significant top-line data from the COMPANION-002 trial, indicating the efficacy of tovecimig in combination with paclitaxel for patients with advanced biliary tract cancer (BTC) [1][2][6] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology [12] - The company aims to address critical biological pathways involved in tumor growth and angiogenesis [12] Clinical Trial Details - The COMPANION-002 trial is a Phase 2/3 randomized study involving 168 adult patients with unresectable advanced BTC, comparing tovecimig plus paclitaxel to paclitaxel alone [4][6] - Patients in the trial were randomized in a 2:1 ratio, with 111 receiving the combination therapy and 57 receiving paclitaxel alone [4] Efficacy Results - The primary endpoint of the trial, overall response rate (ORR), was 17.1% for the combination therapy compared to 5.3% for paclitaxel alone, demonstrating a statistically significant difference (p=0.031) [5][6][7] - The combination therapy also showed a lower progressive disease (PD) rate of 16.2% compared to 42.1% for paclitaxel alone [6][8] Patient Population and Need - Biliary tract cancer affects approximately 23,000 patients annually in the U.S., with 85% of patients lacking FDA-approved second-line treatment options [3] - Current second-line therapies have an ORR of ~5% or less, with a median overall survival of about six months [3] Future Expectations - The company plans to report additional data, including key secondary endpoints, in Q4 2025 [5][13] - Safety data will also be reported alongside the secondary endpoint analyses, with an independent Data Monitoring Committee recommending the continuation of the study without modifications [13]