On January 7, 2025 Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer and infectious diseases, reported an agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to supply etakafusp alfa (formerly known as AB248), Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, to be evaluated in combination with rilvegostomig, AstraZeneca’s investigational PD-1/TIGIT immuno-oncology bispecific antibody, in patients with advanced or metastatic NSCLC (Press release, Asher Biotherapeutics, JAN 7, 2025, View Source [SID1234649489]).
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"This exciting agreement with AstraZeneca is a reflection of the emerging clinical data from our Phase 1 study of etakafusp alfa. Initial data demonstrate a highly differentiated clinical pharmacodynamic profile with unprecedented levels of selective CD8+ T cell activation as well as initial evidence of anti-tumor effect including confirmed objective responses," said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. "We look forward to collaborating with AstraZeneca to expand the potential impact of our lead cis-targeted immunotherapy in patients worldwide."
As part of this agreement, AstraZeneca will sponsor and operationalize a global study to evaluate the safety and early efficacy of etakafusp alfa as a first-line treatment in combination with rilvegostomig in patients with advanced or metastatic NSCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply AstraZeneca with etakafusp alfa at no cost.
About NSCLC
NSCLC is the most common type of lung cancer, accounting for 80-85% of the ~235,000 new cases in the US this year1. NSCLC originates in cells that line the airways and can invade surrounding tissues or metastasize to other parts of the body. The condition is often diagnosed at an advanced stage when it is harder to treat and is associated with a poor prognosis. Treatment options for NSCLC are tailored to the stage, subtype, and biomarker status of the disease, and may include surgery, radiation, chemotherapy, targeted therapies, immunotherapy, or a combination of these. Lung cancer has a 5-year relative survival rate of only 26.7% 2, representing a significant unmet need for additional treatment options for people living with advanced or metastatic NSCLC.
About Etakafusp Alfa (AB248)
Etakafusp alfa (AB248) is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Asher Bio is currently evaluating etakafusp alfa in a Phase 1a/1b clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support etakafusp alfa’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, including confirmed objective responses, with a generally well-tolerated safety profile. Please refer to www.clinicaltrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial.