At Tolka AI Therapeutics, our pipeline is designed to move at the speed of software. Instead of the traditional linear hand-off from preclinical work to animal studies to Phase 1, Phase 2, and Phase 3, we are building a platform for a continuous loop of preclinical development, expanded access, and one focused pivotal trial, so personalized therapies can reach the patients who need them sooner.
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.
Tolka has assembled the world’s largest phage library targeting Mycobacterium abscessus, combining phages isolated in-house with contributions from leading academic partners. Phage therapy has been clinically de-risked through prior published trials, giving us confidence in the modality as we advance our personalized program.
2. Manufacturing
Phages selected during discovery are manufactured at our Miami facility. We are building the SWIFT Platform, our agentic AI system, to author FDA-compliant batch records, operate manual laboratory steps through robotics, and automate QA verification in parallel. The goal is to iterate on thousands of small batches per year with a fraction of the headcount of a conventional plant.
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
Alongside our trial program, we work to make our investigational therapy available to eligible patients through the FDA’s expanded access (compassionate use) pathway, so patients with few remaining options do not have to wait years for access. Real-world outcomes help inform the design of a focused pivotal trial.
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.