Avid Bioservices to Serve as Commercial Manufacturer for ADC Therapeutics’ ZYNLONTA™ (Loncastuximab Tesirine-Lpyl)
May 25 2021 - 8:05AM
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
Contacts:
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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