Asher Bio Announces Agreement for AB248 and Rilvegostomig Study in NSCLC

SOUTH SAN FRANCISCO, Calif.--Asher Biotherapeutics, a biotech firm specializing in targeted immunotherapies for cancer and infectious diseases, has partnered with AstraZeneca to advance their investigational therapy, etakafusp alfa. This novel treatment targets CD8+ T cells and will be tested in conjunction with AstraZeneca's experimental PD-1/TIGIT bispecific antibody, rilvegostomig. The focus will be on patients battling advanced or metastatic non-small cell lung cancer (NSCLC).

Asher Biotherapeutics' Chief Business Officer, Don O’Sullivan, Ph.D., expressed enthusiasm about the collaboration, citing promising early data from their Phase 1 trial of etakafusp alfa. The study has shown selective activation of CD8+ T cells and initial signs of anti-tumor effects. This partnership aims to broaden the reach and impact of their lead immunotherapy on a global scale.

Under the agreement, AstraZeneca will manage and sponsor a worldwide clinical study to assess the safety and preliminary efficacy of combining etakafusp alfa and rilvegostomig as a first-line treatment for advanced or metastatic NSCLC. While AstraZeneca takes charge of the study, Asher Bio will maintain full ownership of etakafusp alfa and provide it to AstraZeneca at no cost.

NSCLC is the most prevalent form of lung cancer, accounting for 80-85% of the approximately 235,000 new cases diagnosed in the United States annually. Originating in the cells lining the airways, NSCLC can spread to nearby tissues or distant parts of the body. It is often identified at a late stage, making treatment challenging and associated with a poor prognosis. Current treatment options depend on the stage, subtype, and biomarker status and may include surgery, radiation, chemotherapy, targeted therapies, and immunotherapy. Despite various treatments, lung cancer has a low 5-year relative survival rate of just 26.7%, highlighting the need for new treatment options for advanced or metastatic NSCLC.

Etakafusp alfa is an innovative therapy designed to selectively activate CD8+ T cells by fusing a reduced potency IL-2 mutein with an anti-CD8β antibody. This design aims to avoid activating natural killer cells, which can reduce drug effectiveness and increase toxicity, and regulatory T cells, which suppress the immune response. Asher Bio is conducting a Phase 1a/1b clinical trial, AB248-101, to explore the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in patients with advanced solid tumors who have not responded to previous treatments. Initial results indicate potent and selective CD8+ T cell activation, minimal impact on regulatory and natural killer cells, and early evidence of anti-tumor activity with manageable safety concerns.

Asher Biotherapeutics, founded by Ivana Djuretic and Andy Yeung, with backing from Third Rock Ventures, is committed to developing therapies that specifically engage immune cells to combat cancer and chronic viral infections. Their proprietary cis-targeting platform allows them to create treatments that overcome the limitations of other immune-based therapies by selectively activating disease-fighting immune cells while minimizing the activation of cells that cause toxicity or immune suppression. Besides etakafusp alfa, their pipeline includes AB821, a CD8-targeted IL-21 immunotherapy ready for investigational new drug (IND) application, and programs focusing on CAR-T cells, myeloid cells, and CD4+ T cells. Asher Biotherapeutics operates out of South San Francisco.