Catalent will offer process development and cGMP manufacturing of Siren’s AAV vector-based therapeutic candidates for use in clinical trials, and will further support process optimisation at its process and clinical development centre in Baltimore
Catalent will manufacture Siren’s AAV therapeutics. (Credit: Trnava University on Unsplash)
Siren Biotechnology has teamed up with Catalent to support the development and manufacturing of its AAV (adeno-associated viruses) immuno-gene therapies.
Catalent is a US-based contract development and manufacturing organisation (CDMO).
Under the strategic partnership, Catalent will offer process development and cGMP manufacturing for Siren’s AAV vector-based therapeutic candidates for use in clinical trials.
The US-based CDMO will further support process optimisation at its process and clinical development centre in Baltimore, Maryland.
Catalent Group biologics president David McErlane said: “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.”
Siren Biotechnology is engaged in developing universal AAV immuno-gene therapy for cancer, which comprises the two transformative therapeutic technologies.
It combines AAV gene therapy and cytokine immunotherapy into a single modality, which the company believes to change the way tumour cells are destroyed to elicit anti-tumour immunity.
Furthermore, the biotechnology company aims to make its universal AAV immuno-gene therapy the standard of care for any solid tumour cancer.
Siren Biotechnology CEO, founder, and president Nicole Paulk said: “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.
“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 CDMO in the US that has received 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.”
Earlier this year, Novo Holdings, the parent company of Danish drugmaker Novo Nordisk, agreed to acquire Catalent for $16.5bn, which is expected to close by the end of this year.