Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for Cancer, and Catalent Inc., the leader in enabling the development and supply of better treatments for patients worldwide, entered a strategic partnership to support the development and manufacturing of Siren Biotechnology’s AAV immuno-gene therapies.

Under the partnership, Catalent will provide process development and cGMP manufacturing of Siren Biotechnology’s adeno-associated viral (AAV) vector-based therapeutic candidates for use in clinical trials. Catalent will further support process optimization at its process and clinical development center in Baltimore, MD.

“We look forward to working with Catalent, a leading CDMO with premier capabilities in AAV vector development and manufacturing, on the development of our AAV Immuno-Gene Therapies,” said Dr. Nicole Paulk, CEO, Founder, and President of Siren Biotechnology. “This partnership demonstrates our commitment to a robust manufacturing process that will move our therapeutic programs into the clinic as quickly as possible. Catalent is the only U.S. CDMO that has received U.S. FDA approval for AAV-based gene therapies to date, and this was a significant factor in our decision to partner with Catalent as we plan for future commercialization of our upcoming clinical drug products.”

David McErlane, Group President of Biologics at Catalent stated, “Catalent is committed to partnering early in the development process with innovative companies like Siren. We are excited to work together to pioneer a pathway for the development and commercial manufacturing of safe, high-quality AAV gene therapies to provide life-saving treatments to patients with cancer.”