The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR-T cell therapy.
The company’s collaboration partner, Cancer Research UK’s Centre for Drug Development, has sponsored and will conduct the Phase I/II clinical trial.
“The authorisation to clinically evaluate, in collaboration with Cancer Research UK, the potent activity of ALETA-001, our lead biologic CAR-T cell therapy engager, marks important progress for the entire global oncology community – especially patients,” commented Paul Rennert, Chief Executive Officer and Chief Scientific Officer, Aleta Biotherapeutics.
“Aleta’s CTEs act by transforming the expression of any cancer tumour cell to match the CAR T cell therapies circulating in a patient’s blood, importantly restoring and increasing the effectiveness with which CAR-T cells can kill cancer cells.”
Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development, added: “CAR T cell therapy has been transformative for some cancer patients but there remains a critical need to ensure that this therapy is an option for all. ALETA-001 is working to address this treatment gap for people with blood cancers by advancing a potentially life-saving CAR-T cell therapy into the clinic. We are delighted to play a key role in this trial and look forward to seeing this treatment become available for more patients in the future.”
CD19-directed CAR T therapies
Aleta’s lead development programme, ALETA-001, contains the CD19 target protein which is further linked to an CD20 antibody domain. ALETA-001 is designed to improve the effectiveness of CD19-directed CAR-T therapies by increasing CD19 antigen density and restoring lost CD19 expression on the cancer cell. This allows CD19+/CD20+ cancer cells to be easily recognised and killed by CD19-directed CAR-T cells that were previously administered and are already circulating within a patient.
ALETA-001 has received a UK Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) from the MHRA. ILAP designation is granted to medicines that address life-threatening or seriously debilitating conditions, and where there exists a significant patient or public health need.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World
