Pre-clinical results demonstrate durable response in CD-negative lymphoma

NATICK, MA, USA I December 11, 2021 I Aleta Biotherapeutics, a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, today released a summary of ALETA-001 preclinical results from a poster being presented at the 63rd American Society of Hematology (ASH) Annual Meeting, held in Atlanta, Georgia and in a virtual platform on December 11-14, 2021.

The presentation featured preclinical data that support the upcoming Phase 1/2 clinical trial of ALETA-001 being run in collaboration with Cancer Research UK. ALETA-001 is a multifunctional biologic for injection that contains an anti-CD20 llama VHH linked to an optimized CD19 protein and further linked to an anti-albumin llama VHH. Extensive preclinical in vitro modeling demonstrated that ALETA-001 specifically binds to CD20-positive/CD19 negative lymphoma cells with high affinity, thereby densely coating these cancer cells with the CD19 protein. In the presence of anti-CD19 CAR T cells, ALETA-001 mediated cytotoxicity against CD19 negative lymphoma cells at sub-nM concentrations. The administration of ALETA-001 and anti-CD19 CAR T cells in vivo eliminated systemic CD19 negative lymphoma that otherwise produced lethal disease at doses of ALETA-001 as low as 0.5mg/kg. Further, upon stopping dosing in the in vivo lymphoma model, 40% of ALETA-001-treated animals did not relapse through day 43, more than 2 weeks after the last dose, suggesting apparent cures. Additionally, excess ALETA-001 did not interfere with cytotoxicity. ALETA-001 is designed to be administered to patients who have received CAR19 T cell therapy and who fail to achieve a complete response at the time of their first clinical evaluation, or who relapse from a complete response thereafter. Clinical trial development is underway in collaboration with Cancer Research UK.

About Aleta Biotherapeutics

Our mission is to create cell therapeutics that provide robust and durable clinical benefit for patients suffering from advanced hematologic cancers and refractory solid tumors. Aleta’s CAR-T Engager technology incorporates potent multi-antigen targeting, optimal T cell fitness, and persistence to aggressively attack cancers. We use this technology to build programs that solve specific clinical issues, including cell therapy relapses due to antigen loss and the challenge of overcoming solid tumor heterogeneity. Our lead development program has won landmark clinical support from Cancer Research UK and will enter Phase 1/2 trials in 2022. To discover more about our mission, technologies and pipeline please visit To learn more about the work being done by Cancer Research UK please visit

SOURCE: Aleta Biotherapeutics