Avid Bioservices Selected as Commercial Manufacturer for Critical Enzyme Replacement Therapy by Enzyvant, a Subsidiary of Roi...
February 21 2018 - 08:05AM
Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a company
working to improve patient lives by providing high quality
biologics manufacturing services to biotechnology and
pharmaceutical companies, today announced that Enzyvant, a
subsidiary of Roivant Sciences, has selected Avid as the commercial
drug substance manufacturer for RVT-801, its recombinant human acid
ceramidase enzyme replacement therapy being developed as a
potential treatment for Farber disease. Successful technology
transfer and clinical manufacturing have been underway since
mid-2017 and Avid will complete process characterization and
optimization followed by process validation in support of
Enzyvant’s ongoing development and regulatory activities for
RVT-801, which include the initiation of a first-in-human clinical
study.
RVT-801 will be manufactured in Avid
Bioservices’ 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.
“We are delighted to add Enzyvant to the growing
list of companies that recognize Avid Bioservices’ ability to move
critically important therapeutic products very rapidly into
commercial manufacture,” said Roger Lias, Ph.D., president and
chief executive officer of Avid Bioservices. “We take great pride
in our more than 12-year track record of successfully manufacturing
and releasing commercial biologic products for the US, EU and
numerous other important international markets.”
Alex Tracy, Ph.D., vice president of
pharmaceutical development and manufacturing for Roivant Sciences,
added, “We presented Avid with very ambitious timelines for RVT-801
manufacturing work and we were extremely impressed with the ability
of their team to work creatively with us to design and deliver a
program that meets our needs and contributes significant value. We
look forward to advancing the development of RVT-801 as a potential
therapeutic for Farber’s disease.”
In winning this manufacturing project, Avid
Bioservices was selected by Enzyvant from a large field of
internationally recognized contract development and manufacturing
organizations.
About Farber DiseaseFarber
disease is a rare lysosomal storage disease caused by mutations in
the ASAH1 gene, resulting in deficiency of the lysosomal
enzyme acid ceramidase. This deficiency leads to the accumulation
of the pro-inflammatory sphingolipid ceramide, and a
macrophage-driven inflammatory process causing the development of
typical clinical symptoms.
Farber patients typically present with the
cardinal symptoms of:
- Joint contractures or
arthritis
- Subcutaneous nodules
- Weak or hoarse voice
Patients may also present with systemic
inflammation (including fever), severe pain, peripheral osteolysis,
failure to thrive, and developmental delay. Like other lysosomal
storage diseases, Farber disease has a broad phenotypic spectrum
and is likely underdiagnosed.
About RVT-801RVT-801 is a
recombinant form of human acid ceramidase (rhAC) that Enzyvant is
developing for potential use as an enzyme replacement therapy in
acid ceramidase deficiency, manifesting as Farber disease. Enzyvant
is currently conducting preclinical studies to enable a clinical
trial of rhAC in patients with Farber disease. Orphan drug
designation for RVT-801 has been granted by regulatory agencies
in the United States and the European Union.
About EnzyvantEnzyvant is a
biopharmaceutical company focused on developing innovative
treatments for patients with rare diseases. Enzyvant is conducting
a natural history study of patients with Farber disease to better
define the natural course of disease and the relationship between
specific symptoms, biomarkers, and prognosis. Enzyvant is
simultaneously preparing a clinical trial of RVT-801, an
investigational enzyme replacement therapy for the treatment of
Farber disease.
Enzyvant is also advancing the development of
RVT-802, an investigational tissue-based biologic therapy for the
potential treatment of primary immune deficiency associated with
complete DiGeorge Syndrome. RVT-802 has been granted orphan drug
designation, Breakthrough Therapy designation, Regenerative
Medicine Advanced Therapy designation, and pediatric rare disease
designation by the U.S. Food and Drug Administration. Enzyvant
anticipates a potential BLA filing for RVT-802 later this year.
Enzyvant plans to develop treatments for additional rare diseases
with high unmet need. For more information, please
visit www.enzyvant.com.
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.
www.avidbio.com
Forward-Looking
StatementsStatements 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. These forward-looking
statements include statements regarding the expected closing of the
offering and the intended use of the net proceeds from the
offering, and involve risks and uncertainties. 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.
Contacts:
Kelly Pisarev Lord
Avid Bioservices, Inc.
(800) 987-8256
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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