#42 – Nicole K. Paulk, CEO & Founder at Siren Biotechnology

Early Inspiration in Gene Therapy

Nicole Paulk’s journey into the world of gene therapy began during her PhD at Oregon Health & Science University (OHSU) in Portland. Despite the challenges of an unpopular field due to halted FDA trials, Nicole was captivated by the elegance of using viruses to replace missing or defective genes. This passion drove her to contribute significantly to the field, publishing six papers in just four years.

Transition from Academia to Entrepreneurship

The shift from academia to entrepreneurship was not common for professors, especially during the peak of COVID-19. Nicole’s frustration with the inability to access her lab at UCSF pushed her to take a bold step. Despite the pandemic’s challenges, including severe restrictions and supply chain issues, Nicole successfully launched Siren Biotechnology, moving her team and equipment to an incubator across the street.

Siren Biotechnology’s Innovative Approach

Siren Biotechnology stands out by pioneering AAV immunogene therapy, a groundbreaking approach that expands the traditional use of gene therapy. Unlike conventional methods targeting rare genetic disorders, Siren’s universal payload project aims to create therapies applicable across multiple diseases. This innovation has the potential to address cost and scalability issues, making gene therapy more accessible for common disorders like cancer, diabetes, and heart failure.

Securing Funding and Navigating Challenges

Nicole’s expertise in grant writing proved invaluable as Siren Biotechnology navigated the complex funding landscape. Initially, securing VC money was straightforward, but as the market adjusted, non-dilutive grant money became crucial. Nicole’s ability to harness this skill set enabled Siren to continue its research and development, ensuring the company’s growth despite market fluctuations.

Transition to Clinical Trials

Siren Biotechnology is at a pivotal moment, transitioning from a preclinical to a clinical company. This involves producing clinical-grade viral vectors, submitting FDA documentation, and conducting IND-enabling animal experiments. The excitement of moving towards dosing human subjects is palpable, marking a significant milestone in the company’s journey.

Conclusion

Nicole Paulk’s dedication and innovative approach are driving Siren Biotechnology to new heights in gene therapy. As the company transitions to clinical trials, the potential for transformative treatments becomes increasingly tangible.