Positive pre-IND feedback from FDA for ALA-101
Highlights:
Positive pre-Investigational New Drug (pre-IND) meeting response from the US Food and Drug Administration (FDA) has been received by Arovella for the development of ALA-101 in first-in-human clinical trials for lymphoma and leukaemia
FDA Feedback provides clear and achievable requirements for the submission of an IND for ALA-101 with IND submission expected in early Q1 CY2025
The pre-IND guidance includes a review of Arovella’s Chemistry, Manufacturing and Controls (CMC) program, plan for nonclinical safety and efficacy studies, and proposed phase 1 clinical trial design
MELBOURNE, AUSTRALIA 7 August 2024: Arovella Therapeutics Ltd (ASX: ALA), a biotechnology company focused on developing its invariant Natural Killer T (iNKT) cell therapy platform, is pleased to announce that it has received positive feedback from the FDA during a pre-IND meeting in the lead up to its phase 1 study of ALA-101 as a treatment for CD19+ blood cancers.
Feedback from the pre-IND meeting, which was held via teleconference with the FDA, supported Arovella’s development plans to commence a phase 1, first-in-human clinical trial. The meeting provided a clear path forward to submitting an IND for ALA-101, with no major changes proposed for the development program. Allogeneic CAR-iNKT cell therapy manufacturing is highly complex and very few allogeneic CAR-iNKT cells have a received an IND acceptance to start first-in-human trials, so pre-IND feedback was critical to ensure that Arovella’s development plan for ALA-101 aligns with FDA expectations. The FDA guidance included a review of Arovella’s CMC program, a plan for nonclinical safety and efficacy studies, and the proposed phase 1 clinical trial design.
Based on the precise information provided by the FDA, Arovella expects to file its IND for ALA-101 in early Q1 CY2025.
Arovella’s Chief Executive Officer and Managing Director, Dr Michael Baker, commented, “The valuable and positive feedback we received from the FDA was excellent and aligns clearly with our development plans for ALA-101. For a complex therapeutic like off-the-shelf CAR-iNKT cells, our team has done a commendable job reaching this key milestone. We look forward to receiving acceptance for our IND and executing our plan to advance ALA-101 into the clinic over the coming months. Due to the platform nature of Arovella’s CAR-iNKT cells, the learnings for ALA-101 throughout the IND application process can be applied to our additional solid tumour programs, such as ALA-105.”