First Patient Receives ALETA-001 in Phase 1/2 Trial for Relapsed/Refractory B-Cell Cancer

A significant advancement in the field of immuno-oncology has been announced by Aleta Biotherapeutics, a clinical-stage company specializing in CAR T-Cell Engager (CTE) platforms. The company has initiated a Phase 1/2 clinical trial for its innovative biologic CAR T-Cell Engager, ALETA-001, which is designed to enhance the efficacy of cancer treatments for patients with B-cell malignancies. The trial marks a crucial step towards offering a novel therapeutic option for individuals whose cancers have become resistant or relapsed following CD19-targeted CAR T-cell therapy.

The trial is being sponsored and conducted by Cancer Research UK’s Centre for Drug Development, a renowned institution with a track record of developing and bringing new cancer treatments to the market. The trial is an open-label, dose-expansion study aimed at assessing the safety, tolerability, and pharmacological effects of ALETA-001, as well as its early clinical efficacy as a standalone treatment.

Dr. Paul Rennert, President and Chief Scientific Officer of Aleta Biotherapeutics, expressed his enthusiasm for the clinical evaluation of ALETA-001, highlighting its potential to restore and amplify the effectiveness of CAR T-cells in eliminating cancer cells. The treatment is expected to provide a much-needed alternative for cancer patients whose existing CAR T-cell therapies have ceased to be effective.

ALETA-001 is a unique molecule with a novel mechanism of action. It coats tumor cells with a high density of target antigens, thereby enhancing the ability of activated CAR T-cells to target and destroy cancer cells. This innovative approach is being explored to improve outcomes for patients with lymphomas who have a poor prognosis after experiencing disease progression post CAR T-cell therapy.

Dr. Lars Erwig, Director of Drug Development at Cancer Research UK, emphasized the importance of ALETA-001 in offering a better chance for a successful treatment outcome for patients with blood cancers who have relapsed following CD19-directed CAR T-cell therapy. The clinical potential of ALETA-001 is seen as transformative for patient treatment journeys, potentially offering life-saving benefits.

Aleta Biotherapeutics is at the forefront of transforming cancer treatment by enhancing the effectiveness of CAR T-cell therapies. The company's multi-antigen CAR T Engagers (CTEs) are potent biologic therapies that aim to produce deeper and more durable responses in patients. ALETA-001, the lead clinical program, is specifically designed for B-cell malignancies in patients at risk of treatment failure following CD19-directed CAR T-cell therapy.

Aleta has received significant clinical support and funding from Cancer Research UK for the ALETA-001 trial and has been granted a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA). This designation is reserved for medicines addressing life-threatening conditions with significant patient or public health needs.

The Cancer Research UK Centre for Drug Development has been instrumental in the development of over 160 potential new anti-cancer agents, with six already on the market and 13 others in active development. The center's expertise and resources are expected to play a pivotal role in the success of the ALETA-001 clinical trial.