ALX Oncology Announces Initiation of Phase 2 Investigator-Sponsored Trial of Neoadjuvant Radiation and Evorpacept in Combination with Pembrolizumab in Patients with Untreated HPV-Mediated Oropharyngeal Cancer

SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, today announced the initiation of a Phase 2 investigator-sponsored trial (“IST”) of neoadjuvant radiation and evorpacept, a next-generation CD47 blocker, in combination KEYTRUDA (pembrolizumab) in patients with previously untreated and early-stage locally advanced, resectable, human papillomavirus-mediated oropharyngeal cancer (“HPVOC”). This multi-center, single-arm, open-label Phase 2 IST is being led by Joseph A. Califano III, M.D., Director of the Hanna and Mark Gleiberman Head and Neck Cancer Center at the University of California, San Diego (NCT05787639).

“Despite standard immune and chemoradiation neoadjuvant therapies for patients with locoregionally advanced HPVOC, associated severe toxicities and lack of durable responses underscore the need for novel therapies” said Dr. Califano. “Early clinical studies with immunotherapy in combination with stereotactic body radiation therapy, which precisely delivers high doses of radiation to a small target, have shown encouraging immune-mediated anti-tumor responses in these patients. Radiotherapy induces the release of tumor-associated antigens and upregulates PD-L1 expression by tumor cells. Blocking the CD47/SIRPα axis may yield a synergistic anti-tumor effect when combined with radiotherapy and immunotherapy. The addition of evorpacept to neoadjuvant immunoradiotherapy is a promising concept that could be an effective new strategy to downstage patients prior to surgery.”

About Oropharyngeal Cancer

Approximately 58,000 people in the U.S. are diagnosed with pharyngeal and oral cavity cancers, a form of HNSCC, each year.¹ The most frequently cited risk factors for these cancers are tobacco and alcohol use. More recently, epidemiologic and experimental data have reported increased rates of HPV being present upon a patient receiving diagnosis of oropharyngeal cancer. Standard treatment options for intermediate risk HPVOPC include 7 weeks of definitive chemoradiation, or surgery plus 6 weeks of risk adapted adjuvant radiation +/- chemotherapy. Despite advances in treatment, 5-year survival for localized disease is 88% and declines to 38% for metastatic disease.¹