Piramal Pharma Solutions announces integrated development program with Bolt Biotherapeutics for immunostimulating antibody conjugates and sterile final fillings

Friday, July 31, 2020

Piramal Pharma Solutions, a leading contract development and manufacturing company (CDMO), announced that Bolt Biotherapeutics (Bolt) has both the ISAC drug substance BDC-1001 and the drug product for the ongoing phase 1/2 clinical trial in cancer patients.

The Piramal Pharma Solutions (PPS) team applies its integrated drug development model to Bolt's BDC-1001 to treat patients with HER2-expressed solid tumors. The program includes formulation development and ISAC development and manufacturing at PPS's Grangemouth site in the United Kingdom. The drug substance is then filled into lyophilized, sterile vials at the Lexington PPS site in Kentucky, USA . This seamless integration across two PPS locations, which shortens delivery times and speeds up distribution to clinics, is an example of the patient-oriented philosophy of PPS.

Peter DeYoung , Chief Executive Officer of Piramal Pharma Solutions, said: "Bolt's technology platform has shown significant positive data in preclinical models, including the development of tumor immunological memory, and is now in a human clinical trial. Manufacturing ISACs uses essentially the same process as that Manufacture of Antibody Drug Conjugates (ADC), which allows us to use our deep expertise in this area, and our ability to produce these novel ISACs and fill them in an efficient, integrated clinical trial process reduces the time it takes to develop Bolts Drug. We’re still committed to our patient-centric approach and we’re proud to work with an industry leader like Bolt,to reduce the burden of disease on patients. "

Nathan Ihle , VP CMC & Quality at Bolt Biotherapeutics , added: "Bolt is a leader in ISAC technology and our partnership with Piramal Pharma Solutions is important to bring our technology to clinics Manufacturing commercial ADCs, Piramal is a reliable partner for Bolt in the development of BDC-1001. "

The first cycle from the manufacture of a drug substance to the manufacture of the drug itself has been successfully completed through the PPS integrated program. Further cycles are ongoing, as are further developments that will benefit future indications and new clinical programs.