21 January 2020 - - US-based clinical-stage biopharmaceutical company AI Therapeutics has created an artificial intelligence-driven drug development platform for matching drugs to new indications, the company said.

The company said it has made significant recent progress with its four clinical assets and proprietary Guardian Angel algorithm.

LAM-002 is a first-in-class, PIKfyve kinase inhibitor that activates transcription factor EB, the master regulator of lysosomal biogenesis.1 TFEB activation clears toxic aggregates that drive neurodegenerative disorders.

Through its action on the lysosome, LAM-002 also selectively kills tumor cells.

AI Therapeutics has recently completed enrollment in a clinical trial with patients previously treated for follicular lymphoma.

Efficacy has been observed with LAM-002 as a single agent and when combined with rituximab or atezolizumab.

LAM-002 appears to be well-tolerated with patients on continuous treatment for well over a year.

AI Therapeutics said it had a Type C meeting with the US Food and Drug Administration to discuss the registrational programme for LAM-002 in patients with previously treated follicular lymphoma.

At this meeting, AI Therapeutics reached concurrence on the design of a pivotal trial that could support accelerated approval.

The clinical data to support full approval in patients with previously treated follicular lymphoma was also discussed and a path forward was detailed.

LAM-002 has received Fast Track status and Orphan Drug Designation from the FDA for the therapy of follicular lymphoma. The safety and clinical data for LAM-002 are expected to be presented at the American Society of Clinical Oncology conference in 2020.

AI Therapeutics has built a deep learning platform, Guardian Angel, that synthesises public and proprietary data on drugs and diseases and finds new indications for our library of new chemical entities.

Aided by Guardian Angel the company now has four drugs in the clinic, including drugs that shrink cancers, the most promising candidate to treat ALS (Lou Gehrig's disease), and drugs with applications for longevity.

AI Therapeutics is a 4Catalyzer company, and benefits from the advantages of being part of an incubator with >300 scientists and engineers, and offices in Connecticut, New York, Silicon Valley, and Taiwan.