Avid Bioservices to Serve as Commercial Manufacturer for ADC Therapeutics’ ZYNLONTA™ (Loncastuximab Tesirine-Lpyl)
Avid Bioservices has been selected as the commercial manufacturer for ZYNLONTA™, a newly approved CD19-targeted antibody drug conjugate for adults with relapsed or refractory large B-cell lymphoma (DLBCL). This follows the FDA's approval of ZYNLONTA in April 2021. Avid has had a partnership with ADC Therapeutics since 2017 for clinical manufacturing and is expanding this relationship for commercial manufacturing. The expansion demonstrates Avid's experience and quality in supporting innovative biologic therapies.
- Expansion of manufacturing relationship with ADC Therapeutics for ZYNLONTA.
- Experience with ZYNLONTA and established client relationship with ADC Therapeutics.
- Successful FDA Pre-License Inspection with no 483 observations.
- None.
ZYNLONTA™ Recently Approved as First and Only CD19-Targeted Antibody Drug Conjugate for Single-Agent Treatment for Adult Patients with Relapsed or Refractory (r/r) Diffuse Large B-cell Lymphoma (DLBCL)
TUSTIN, Calif., May 25, 2021 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced that it will serve as the commercial manufacturer for the humanized monoclonal antibody portion of ZYNLONTA™ (loncastuximab tesirine-lpyl), a recently approved cancer treatment developed by ADC Therapeutics SA (NYSE: ADCT). Avid has provided clinical manufacturing services to ADC Therapeutics to support development of the product since 2017 and will now expand its manufacturing relationship with ADC Therapeutics to include commercial manufacturing activities for ZYNLONTA.
ZYNLONTA is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. In April 2021, ADC Therapeutics received U.S. Food and Drug Administration (FDA) approval for ZYNLONTA for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. As part of the ZYNLONTA approval process, Avid hosted the FDA earlier this year for the Pre-License Inspection (PLI), which was completed with no 483 observations.
“ADC Therapeutics is a highly valued client and we are pleased it has elected to expand the scope of our work to include commercial manufacturing of ZYNLONTA. We have worked closely with the company to provide clinical manufacturing services in support of this program as it advanced through clinical development and regulatory approval. Our experience with this innovative product, our strong relationship with the ADC team and exceptional quality systems will allow us to seamlessly transition efforts to producing commercial supply,” said Timothy Compton, chief commercial officer of Avid. “Our experience with ADC Therapeutics provides an excellent case study in how Avid is well positioned to support the evolving needs of our clients as they advance innovative biologics through the clinical development and regulatory approval processes. Starting with early-stage clinical manufacturing and advancing into commercial supply production, Avid offers clients like ADC Therapeutics the opportunity to work with a single trusted partner throughout the development life cycle.”
“We are delighted to expand our relationship with the team at Avid as they have significant experience producing monoclonal antibodies,” said Mike Mulkerrin, VP, Head of Chemistry, Manufacturing and Control of ADC Therapeutics. “Avid has been a trusted and responsive manufacturing partner for the last four years and we look forward to collaborating with them in this next phase of our work to bring ZYNLONTA to more patients in need of a new therapeutic option.”
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical drug substances derived from mammalian cell culture. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 28 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization. www.avidbio.com
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