ALX Oncology doses first patient in phase 1 trial of EGFR cancer drug

Published 19/08/2025, 13:08
ALX Oncology doses first patient in phase 1 trial of EGFR cancer drug

SOUTH SAN FRANCISCO - ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage biotechnology company with a current market capitalization of $53 million, announced Tuesday that the first patient has been dosed in its Phase 1 clinical trial for ALX2004, an antibody-drug conjugate targeting EGFR-expressing solid tumors. The company maintains a strong liquidity position with a current ratio of 4.52, indicating robust short-term financial stability.

The first-in-human trial (NCT07085091) is evaluating ALX2004 in patients with advanced or metastatic solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer.

The study consists of a Phase 1a dose escalation portion followed by dose exploration, and a Phase 1b dose expansion. Initial safety data is expected in the first half of 2026, according to the company.

The announcement comes as ALX Oncology’s stock has shown significant momentum, with a 58% return over the past week. "Dosing of the first patient in the Phase 1 trial is an important milestone in ALX Oncology’s mission to develop a pipeline of best-in-class drugs," said Jason Lettmann, Chief Executive Officer at ALX Oncology. For detailed analysis and valuation metrics, investors can access the comprehensive Pro Research Report available on InvestingPro.

ALX2004 is designed with an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies, and includes a proprietary topoisomerase I inhibitor payload. The company claims the drug’s components are optimized to maximize therapeutic window by reducing toxicity.

In preclinical studies, ALX2004 demonstrated dose-dependent anti-tumor activity across various tumor types with different EGFR expression levels and mutations, according to the press release statement. The company reports that preclinical models did not show EGFR-related skin toxicity at clinically relevant doses.

ALX2004 represents the company’s second pipeline candidate, following evorpacept, which is being evaluated in multiple ongoing clinical trials across various cancer indications.

In other recent news, ALS Oncology Holdings reported its second-quarter 2025 earnings, revealing an earnings per share (EPS) of -0.49 USD. This result fell short of analysts’ expectations, which had projected an EPS of -0.43 USD. The earnings miss indicates that the company’s performance did not meet market forecasts, potentially raising concerns among investors. These developments highlight the importance of closely monitoring ALS Oncology’s financial health and future earnings reports. The company’s recent earnings announcement is a critical piece of information for investors assessing the company’s current financial standing.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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