ALX Oncology Holdings Inc Reports Promising Trial Results and Pipeline Progress

ALX Oncology Holdings Inc reported promising new data from the ASPEN-06 trial, highlighting CD47 expression as a key predictive biomarker for evorpacept's clinical response. The company modified its Phase 2 clinical trial in breast cancer to pursue a CD47 and HER2 biomarker-driven strategy. ALX Oncology Holdings Inc is on track to dose its first patient with its novel EGFR-targeted ADC, ALX2004. The partnership with Sanofi in a randomized Phase 1/2 study has completed its initial phase. The company extended its cash runway guidance into the first quarter of 2027.

ALX Oncology Holdings Inc. (Nasdaq: ALXO) recently reported encouraging data from the ASPEN-06 trial, which suggests that CD47 expression is a key predictive biomarker for evorpacept's clinical response in HER2+ gastric cancer. The company has also announced a strategic modification to its Phase 2 clinical trial in breast cancer to incorporate a CD47 and HER2 biomarker-driven strategy. Furthermore, ALX Oncology is on track to commence dosing its first patient with the novel EGFR-targeted ADC, ALX2004, and has completed the initial phase of a partnership with Sanofi in a randomized Phase 1/2 study. The company has extended its cash runway guidance into the first quarter of 2027 [1].

The ASPEN-06 trial revealed that patients with high CD47 expression derived the most clinically meaningful response to evorpacept. In confirmed HER2-positive, CD47-high gastric cancer patients, evorpacept combined with HERCEPTIN® (trastuzumab), CYRAMZA® (ramucirumab) and paclitaxel (TRP) achieved an objective response rate (ORR) of 65% compared to 26% with TRP alone. This data has led ALX Oncology to modify its ASPEN-Breast study in HER2+ breast cancer to evaluate evorpacept in combination with trastuzumab and chemotherapy, using a single-arm design that will be evaluated by CD47 expression. The company aims to optimize enrollment and allow for an interim data readout in Q3 2026 [1].

ALX Oncology's Phase 1 clinical trial of ALX2004 is also progressing well. The company anticipates dosing the first patient in August, with initial safety data expected in the first half of 2026. ALX2004 utilizes a proprietary topoisomerase I inhibitor payload and linker-payload platform, engineered to offer enhanced bystander effect with improved linker stability for on-target delivery of payload, and has an affinity-tuned EGFR antibody with a binding epitope distinct from approved EGFR antibodies. The company has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to advance clinical evaluation of ALX2004 for the treatment of EGFR-positive solid tumors [1].

The partnership with Sanofi in the randomized Phase 1/2 UMBRELLA study, which tests evorpacept with SARCLISA® (isatuximab-irfc) and dexamethasone in patients with previously treated multiple myeloma, has completed its dose escalation portion. The dose optimization portion is set to begin [1].

ALX Oncology has also appointed Dr. Daniel Curran, M.D. to its Board of Directors. Dr. Curran brings extensive experience across business development, corporate strategy, drug discovery, and development, which will offer invaluable perspective to help ALX Oncology reach key inflection points in the months ahead [1].

The company's cash, cash equivalents, and investments as of June 30, 2025, stood at $83.5 million, with the Company believing its cash resources are sufficient to fund planned operations into Q1 of 2027. R&D expenses for the three months ended June 30, 2025, were $18.0 million, a decrease of $16.6 million compared to the prior-year period. G&A expenses were $5.5 million, a decrease of $1.4 million compared to the prior-year period. The GAAP net loss for the three months ended June 30, 2025, was $25.9 million [1].

ALX Oncology will host a teleconference on Tuesday, August 12 at 1:30 p.m. PT/4:30 p.m. ET to discuss its financial results and provide further updates on its clinical trials and pipeline [1].

References:
[1] https://ir.alxoncology.com/news-releases/news-release-details/alx-oncology-reports-second-quarter-2025-financial-results-and