Piramal Pharma Solutions, a leading contract development and manufacturing organization (CDMO), today announced that it is providing Bolt Biotherapeutics (Bolt) with the supply of both the BDC-1001 ISAC drug substance and the drug product for Bolt’s ongoing Phase 1/2 clinical study in cancer patients.

The Piramal Pharma Solutions (PPS) team is applying its integrated drug development model to Bolt’s BDC-1001 for the treatment of patients with HER2-expressed solid tumors. The program encompasses formulation development and ISAC development and manufacture at PPS’ Grangemouth, UK site. The drug substance is then processed into lyophilized, sterile fill-finish vials at PPS’s Lexington, KY, U.S. site. This seamless integration across two PPS sites, which shortens delivery timelines and expedites distribution to the clinic, is an example of PPS’ patient-centric philosophy. 

According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, “Bolt’s technology platform has demonstrated significant, positive data in preclinical models, including the development of immunological memory against tumors, and is now in a human clinical trial. The manufacturing of ISACs utilizes essentially the same process as antibody drug conjugate (ADC) manufacturing, enabling us to capitalize on our deep expertise in this space. Our ability to produce these novel ISACs and package them for clinical trials in one efficient, integrated process compresses the timeline of the development of Bolt’s drug. We remain committed to our patient-centric approach and are proud to  partner with an industryleader like Bolt to help reduce the burden of disease on patients.”

Nathan Ihle, VP CMC & Quality for Bolt Biotherapeutics, added, “Bolt is a leader in ISAC technology, and our partnership with Piramal Pharma Solutions is important to bring our technology to the clinic. Piramal’s experience in the manufacture of commercial ADCs provides Bolt with a reliable partner for the development of BDC-1001.” 

The first cycle of drug substance to drug product manufacturing has been successfully completed through the PPS’ integrated program. Additional cycles are in progress, as are further development that will benefit future indications and new clinical programs.

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. They serve their clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. They also offer specialized services like the development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Their capability as an integrated service provider & experience with various technologies enables them to serve Innovator and Generic companies worldwide.

Piramal Enterprises Limited (PEL) is one of India’s large diversified companies, with a presence in Financial Services and Pharmaceuticals. PEL’s consolidated revenues were ~US$1.7 billion in FY2020, with ~34% of revenues generated from outside India.

Piramal Pharma Solutions is a part of PEL’s Pharma business that provides an entire pool of pharma services (including in the areas of injectable, HPAPI, etc.) and sells a portfolio of niche differentiated pharma products leveraging its end-to-end manufacturing capabilities across 14 global facilities and a large global distribution network to over 100 countries.