Avid Bioservices (NASD: CDMO) Selected to Provide Process Development and Clinical Manufacture for Novel Alzheimer's Drug
Published: Mar 01, 2018
TUSTIN, CA, March 1, 2018 -- Avid Bioservices, Inc. (NASDAQ:CDMO)
(NASDAQ:CDMOP), a dedicated 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 Acumen Pharmaceuticals, Inc.
has selected Avid to provide process development and clinical manufacturing
services in support of ACU193, which is being developed for the treatment of
Alzheimer's disease. ACU193 is a fully humanized IgG2 monoclonal antibody
that selectively binds soluble Aβ oligomers, potentially blocking their
toxic effects. Avid and Acumen will immediately commence process
development work with the goal of creating a robust, cost-effective and
scalable process to support cGMP manufacture of ACU193.
Process development and clinical manufacture of ACU193 will take place in
facilities on Avid Bioservices' CDMO campus in Orange County, CA. These
include the company's Myford facility, which is designed with cutting-edge,
single-use equipment to accommodate a fully disposable biomanufacturing
process. A wide range of innovative features are incorporated into this new
facility including monolithic modular clean rooms, dedicated support
utilities for each key processing area, and the industry's most advanced
single-use production systems and flexible solutions. Uni-directional
process flows separate personnel and materials and provide assurance that
the design meets the most stringent regulatory requirements for commercial
biologics API manufacturing.
"This agreement with Acumen is the latest of what we expect will be several
near-term client wins arising from our dedicated efforts to expand and
diversify our customer base. The opportunity to work with Acumen and support
the important work they are undertaking in the field of Alzheimer's disease
is gratifying for the entire Avid team," said Roger Lias, Ph.D., president
and chief executive officer of Avid Bioservices. "We look forward to
delivering exceptional results to Acumen based on our proven ability to work
efficiently and creatively to support the rapid advancement of novel
therapeutics through process development and into cGMP clinical
Dan O'Connell, president and chief executive officer of Acumen, commented,
"In choosing to partner with Avid, we were particularly impressed by the
group's nearly 25 years of experience in successfully producing monoclonal
antibodies like ACU193. We believe that their extensive experience, coupled
with the Avid team's creativity and problem-solving expertise, positions
them as an ideal partner to support the ongoing advancement of this
important program. Alzheimer's disease represents one of the healthcare
industry's most underserved therapeutic areas and this work with Avid will
be critical to our continued development of ACU193 as a potential treatment
option for these patients."
In winning this process development and clinical manufacturing project, Avid
was selected by Acumen from a competitive field of internationally
recognized contract development and manufacturing organizations.
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing
organization (CDMO) focused on development and cGMP manufacturing of
biopharmaceutical products derived from mammalian cell culture. The company
provides a comprehensive range of process development, high quality cGMP
clinical and commercial manufacturing services for the biotechnology and
biopharmaceutical industries. With nearly 25 years of experience producing
monoclonal antibodies and recombinant proteins in batch, fed-batch and
perfusion modes, Avid's services include cGMP clinical and commercial
product manufacturing, purification, bulk packaging, stability testing and
regulatory strategy, submission and support. The company also provides a
variety of process development activities, including cell line development
and optimization, cell culture and feed optimization, analytical methods
development and product characterization.
Statements in this press release which are not purely historical, including statements regarding Avid Bioservices' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk the company may experience delays in engaging new clients. Our business could be affected by a number of other factors, including the risk factors listed from time to time in our reports filed with the Securities and Exchange Commission including, but not limited to, our annual report on Form 10-K for the fiscal year ended April 30, 2017 and subsequent quarterly reports on Form 10-Q, as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. We caution investors not to place undue reliance on the forward-looking statements contained in this press release, and we disclaim any obligation, and do not undertake, to update or revise any forward-looking statements in this press release except as may be required by law.