– Piramal Pharma Solutions (PPS) provides integrated services including formulation development, antibody drug conjugates and lyophilized drug product in vials
– PPS is handling production of Bolt’s Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC), BDC-1001, currently in a first-in-human Phase 1/2 clinical study for treatment of cancer patients
MUMBAI, India, July 29, 2020 /PRNewswire/ — 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 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 industry-leader 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 PPS’ integrated program. Additional cycles are in progress, as are further developments that will benefit future indications and new clinical programs.
About Piramal Pharma Solutions:
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our 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. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
About Piramal Enterprises Limited:
Piramal Enterprises Limited (PEL) is one of India’s large diversified companies, with 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. PEL is also active in the Consumer Products segment in India.
PEL also has a strong presence in Indian financial services sector. PEL is listed on the BSE Limited and the National Stock Exchange of India Limited in India.
About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody™ platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune stimulants to convert cold tumors into immunologically hot tumors, thereby illuminating tumors to the immune system and allowing them to be invaded by tumor-killing cells. Boltbody™ ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients. The company’s first Boltbody™ to enter clinical development, BDC-1001, is currently being evaluated in patients with HER2-expressing solid tumors.
About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics, based in the San Francisco Bay Area, is a private clinical-stage biotechnology company developing Boltbody™ Immune-Stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that combine the precision of antibody targeting with the power of the innate immune system. Boltbody ISACs have eliminated tumors following systemic administration in multiple preclinical studies and spark the development of immunological memory, which may lead to more durable clinical responses for patients. Bolt’s platform technology is applicable to a broad spectrum of antibodies targeting tumor antigens expressed on all types of cancer, including patients who are refractory to the current generation of checkpoint inhibitors. The company was founded by Dr. Ed Engleman, and its platform is based on technology exclusively licensed from Stanford University. The company is financed by world-class investors, including Novo Holdings, Vivo Capital, Pivotal bioVenture Partners, Sofinnova Investments, Nan Fung Life Sciences, RA Capital Management, Surveyor Capital (a Citadel Company), Rock Springs Capital, Pfizer Ventures, and Samsara BioCapital. For more information about Bolt Biotherapeutics, please visit www.boltbio.com.