At Tolka AI Therapeutics, our pipeline represents a structured journey from discovery to delivering groundbreaking therapies to patients. Each stage is meticulously designed to ensure the development of safe, effective, and high-quality cGMP-produced phage products tailored to combat Mycobacterium abscessus.
1. Discovery
We begin by isolating and characterizing bacteriophages from diverse natural resources, including soil and water samples. We identify and optimize phages with high efficacy against M. abscessus using state-of-the-art techniques and patient-specific isolates. Our discovery phase is bolstered by AI tools, enabling rapid phage selection and host-range analysis.
2. Manufacturing
Phages selected during discovery undergo production in our facilities. This stage includes scaling up phage titers, purifying phages to remove endotoxins and exotoxins, and conducting rigorous quality control. We ensure that all phage formulations are stable, safe, and ready for human use.
3. eIND Submission
Our investigational phage products are submitted to the FDA under the Expanded Investigational New Drug (eIND) pathway. This regulatory step ensures the phages meet stringent safety and efficacy standards. In alignment with our mission, the eIND process also enables us to provide access to life-saving phage therapies for patients in critical need, addressing urgent medical challenges with precision and care.
4. Clinical Trials
We will initiate clinical trials to evaluate the safety, efficacy, and tolerability of our personalized phage therapies. These trials are designed to provide robust data to support regulatory approval and expand therapeutic options for patients with M. abscessus.
5. Market
Upon successful clinical trials and FDA approval, our personalized phage therapies will be launched into the US market. This stage focuses on ensuring accessibility and scalability to serve patients worldwide while maintaining our commitment to quality and affordability.