SAN JOSE, Calif., Sept. 30, 2019 /PRNewswire/ -- Aridis
Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical
company focused on the discovery and development of novel
anti-infective therapies to treat life-threatening bacterial
infections, announced today that it has consummated a licensing
agreement with Serum AMR, an affiliate of Serum International BV
(SIBV) and the Serum Institute of India, Ltd. The agreement grants Serum
AMR a license to multiple programs from Aridis for certain limited
territories and access the Company's MabIgX® platform technology
for asset identification and selection.
As part of the agreement, Aridis will receive the remaining
upfront cash payment of $10 million,
which is in addition to the $5
million that was initially received when the companies
signed an option agreement on July 30,
2019. Moving forward, Aridis is eligible for future
milestone payments for achieving product development and commercial
objectives, along with royalties on net sales.
"Establishing this licensing relationship with a leading
monoclonal antibody developer with specific commercial expertise in
emerging markets is an important milestone for the company as we
continue to advance our pipeline of assets and identify new
opportunities from the MabIgX® platform," commented Vu Truong,
Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.
Under the terms of the agreement, Serum AMR is granted a license
to Aridis' clinical stage programs AR-301 (ventilator associated
pneumonia), AR-105 (ventilator associated pneumonia), and AR-101
(hospital acquired pneumonia): these license rights will be
exclusive and to a limited territory, which includes territories
outside of the U.S., Europe,
Canada, UK, China, Australia, New
Zealand and Japan. The
option includes the right to acquire an exclusive, worldwide
license (excluding China) to
AR-201, a preclinical fully human mAb for the prevention of
respiratory syncytial virus (RSV). In addition, under the agreement
Serum AMR may elect to collaborate with Aridis to utilize MabIgX®
to identify and advance up to 5 wholly-owned programs for the
treatment of infectious diseases of import to the developing world.
MabIgX® is Aridis' proprietary technology platform to rapidly
identify rare, potent antibody-producing B-cells from directly from
convalescent patients.
"As with our prior out-licensing transaction involving several
of the company's mAb programs to Shenzhen Hepalink Pharmaceuticals
for the China territory, this
transaction allows for the introduction of innovative
anti-infective therapies that are effective against antibiotic
resistant infections to a broader area of the world where
antimicrobial resistance is particularly high," concluded Dr.
Truong.
About Serum Institute of India, Ltd.
Serum Institute of
India Pvt. Ltd. (SIIL) is the world's largest vaccine manufacturer
by number of doses produced and sold globally (more than 1.3
billion doses) which includes Polio vaccine as well as Diphtheria,
Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and
Rubella vaccines. It is estimated that about 65% of the children in
the world receive at least one vaccine manufactured by Serum
Institute. Vaccines manufactured by the Serum Institute are
accredited by the World Health Organization, Geneva and are being used in around 170
countries across the globe in their national immunization programs,
saving millions of lives throughout the world. The Serum
Institute also manufactures and commercializes recombinant protein
products such as anti-sera, monoclonal antibodies, human
erythropoietin.
Serum Institute of India is
ranked as India's No. 1
biotechnology company, manufacturing highly specialized life-saving
biologicals using cutting edge genetic and cell-based technologies,
antisera and other medical specialties.
Serum Institute of India was
founded in 1966 by Dr. Cyrus
Poonawalla with the aim of manufacturing life-saving
immuno-biologicals, which were in shortage in the country and
imported at high prices. Thereafter, several life-saving
biologicals were manufactured at prices affordable to the common
man and in abundance, with the result that the country was made
self-sufficient for Tetanus Anti-toxin and Anti-snake Venom serum,
followed by DTP (Diphtheria, Tetanus and Pertussis) group of
Vaccines and then later on MMR (Measles, Mumps and Rubella) group
of vaccines. SIBV and Serum AMR are wholly-own European subsidiary
entities of SIIL. Additional information is available at the
Company's website at www.seruminstitute.com.
About Aridis Pharmaceuticals, Inc.
Aridis
Pharmaceuticals, Inc. discovers and develops anti-infectives to be
used as add-on treatments to standard-of-care antibiotics. The
Company is utilizing its proprietary MabIgX® technology platform to
rapidly identify rare, potent antibody-producing B-cells from
patients who have successfully overcome an infection to produce
mAbs. These mAbs are already of human origin and functionally
optimized for high potency by the donor's immune system; hence,
they do not require genetic engineering or further optimization to
achieve full functionality. MabIgX® also allows for the selection
of any antibody isotype depending on the optimal effector function
required for treating the target infection. By bypassing the
humanization and binding sequence optimization steps, and the
entire process of generation of genetically engineered antibody
producing cell lines, MabIgX® enables high gross-margins and
expedited progression to clinical development.
The Company has generated multiple clinical stage mAbs targeting
bacteria that cause life-threatening infections such as
VAP and HAP. The use of mAbs as anti-infective treatments
represents an innovative therapeutic approach that harnesses the
human immune system to fight infections and is designed to overcome
the deficiencies associated with the current standard of care which
is broad spectrum antibiotics. Such deficiencies include, but are
not limited to, increasing drug resistance, short duration of
efficacy, disruption of the normal flora of the human microbiome
and lack of differentiation among current treatments. The mAb
portfolio is complemented by a non-antibiotic novel mechanism small
molecule anti-infective candidate being developed to treat lung
infections in cystic fibrosis patients. The company's pipeline is
highlighted below:
Aridis' Pipeline
AR-301 (VAP). AR-301
is a fully human immunoglobulin 1, or IgG1, mAb currently in Phase
3 clinical development targeting gram-positive S.
aureus alpha-toxin in VAP patients.
AR-101 (HAP). AR-101 is a fully human
immunoglobulin M, or IgM, mAb targeting P.
aeruginosa liposaccharides serotype O11, which accounts
for approximately 22% of all P.
aeruginosa hospital acquired pneumonia cases
worldwide.
AR-501 (cystic fibrosis). AR-501 is an inhaled
formulation of gallium citrate with broad-spectrum anti-infective
activity being developed to treat chronic lung infections in cystic
fibrosis patients. This program is currently in a Phase 1/2a
clinical study in healthy volunteers and CF patients.
AR-401 (blood stream infections). AR-401 is a
fully human mAb preclinical program aimed at treating infections
caused by gram-negative Acinetobacter baumannii.
AR-201 (RSV infection). AR-201 is a fully human IgG1
mAb preclinical program aimed at neutralizing diverse clinical
isolates of respiratory syncytial virus (RSV).
For additional information on Aridis Pharmaceuticals, please
visit https://aridispharma.com/.
Forward-Looking Statements
Certain statements in this
press release are forward-looking statements that involve a number
of risks and uncertainties. These statements may be
identified by the use of words such as "anticipate," "believe,"
"forecast," "estimated" and "intend" or other similar terms or
expressions that concern Aridis' expectations, strategy, plans or
intentions. These forward-looking statements are based on Aridis'
current expectations and actual results could differ materially.
There are a number of factors that could cause actual events
to differ materially from those indicated by such forward-looking
statements. These factors include, but are not limited to,
the timing of regulatory submissions, Aridis' ability to obtain and
maintain regulatory approval of its existing product candidates and
any other product candidates it may develop, approvals for clinical
trials may be delayed or withheld by regulatory agencies, risks
relating to the timing and costs of clinical trials, risks
associated with obtaining funding from third parties, management
and employee operations and execution risks, loss of key personnel,
competition, risks related to market acceptance of products,
intellectual property risks, risks associated with the uncertainty
of future financial results, Aridis' ability to attract
collaborators and partners and risks associated with Aridis'
reliance on third party organizations. While the list of
factors presented here is considered representative, no such list
should be considered to be a complete statement of all potential
risks and uncertainties. Unlisted factors may present significant
additional obstacles to the realization of forward-looking
statements. Actual results could differ materially from those
described or implied by such forward-looking statements as a result
of various important factors, including, without limitation, market
conditions and the factors described under the caption "Risk
Factors" in Aridis' 10-K for the year ended December 31, 2018 and Aridis' other filings
made with the Securities and Exchange
Commission. Forward-looking statements included herein are
made as of the date hereof, and Aridis does not undertake any
obligation to update publicly such statements to reflect subsequent
events or circumstances.
Contact:
Investor Relations
Jason Wong
Blueprint Life Science Group
jwong@bplifescience.com
(415) 375-3340 Ext. 4
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SOURCE Aridis Pharmaceuticals, Inc.