Aridis
Pharmaceuticals, Inc. (NASDAQ:
ARDS), a biopharmaceutical company
focused on the discovery and development of novel anti-infective
therapies for treating life-threatening infections, signed an
exclusive term sheet to secure international development and global
commercial rights upon licensure for the pan-Ebola and pan-Marburg
monoclonal antibody (mAbs) programs from Mapp Biopharmaceutical,
Inc. (MappBio), a privately-owned leading developer of novel
pharmaceuticals for the prevention and treatment of infectious
diseases with a focus on unmet needs in global health and
biodefense.
- Aridis and MappBio have committed
to work exclusively with each other to expeditiously complete
definitive licensing agreements
- MappBio’s pan-Ebola and pan-Marburg
mAb programs are currently in Phase 1 clinical studies and both
products have shown best-in-class protection against live virus
challenges in non-human primates
“We are very pleased to continue our history of
collaborations with MappBio, particularly on the acquisition of
clinical-stage assets that have supportive funding in place through
licensure,” said Vu Truong, Ph.D., Chief Executive Officer of
Aridis Pharmaceuticals. “This latest partnership will significantly
expand our antiviral mAb portfolio with product candidates that are
critical to U.S. public health preparedness and enhance the US
government’s Strategic National Stockpile to protect against the
next Ebola or Marburg outbreak.”
The Strategic National Stockpile is a federally
funded program that acquires, stores, and distributes medical
countermeasures in the event of a public health emergency.
“We are delighted at the idea of working with
Aridis on these programs given their team’s strong experience with
antibody development and commercialization,” commented Larry
Zeitlin, Co-Founder and President of MappBio. “The current outbreak
of Sudan Ebola underway in Uganda highlights the importance of
advancing these programs as rapidly as possible.”
“These are important MappBio projects with
strong commercial potential with both government and private market
buyers globally,” added Kevin Whaley, Co-Founder and CEO of
MappBio. “Vu and the Aridis team are tremendous potential
commercial partners for these mAb programs, and we look forward to
completing our full licensing agreement to officially move
forward.”
About pan-Ebola
and pan-Marburg
mAb programs
The pan-Ebola program, MBP134, is a two mAb
cocktail that has demonstrated effectiveness against Sudan virus
(SUDV), Zaire Ebola virus (EBOV), Bundibugyo virus (BDBV), Taï
Forest virus (TAFV), Reston virus (RESTV), and Bombali ebolavirus
(BOMV) in laboratory studies to date, suggesting it has potential
to serve as a broad-spectrum Ebolavirus countermeasure. MBP134
fully protected non-human primates from lethal Sudan Ebola virus
challenge and is currently in Phase 1 studies in healthy adults.
MappBio was recently awarded $110 million by BARDA to further
advance the program, including the development of a lyophilized
(freeze-dried) formulation of MBP134 in order to reduce the need
for cold-chain storage and improve its transportability. The
funding under this new award (up to $837 million, if options are
exercised) covers activities necessary to request regulatory
approval of MBP134, including support for manufacturing, efficacy
and safety evaluations, and regulatory submissions. MBP134 is the
first SUDV therapeutic in BARDA’s portfolio. MBP134 is eligible for
a Priority Review Voucher (PRV).
MBP091 is a single human mAb that is being
developed as an anti-Marburg virus therapeutic for the treatment of
hemorrhagic fevers caused by Marburg virus disease and it has also
been shown to be active against the closely related Ravn virus.
MBP091 has been evaluated in numerous preclinical experiments and
has demonstrated the ability to neutralize Marburg virus in vitro
and fully protect from lethal challenge of Marburg in vivo. A
Phase 1 clinical study evaluating the safety and pharmacokinetics
of MBP091 in healthy adults is underway. MappBio was recently
awarded $80 million in funding from BARDA to continue to advance
the development of MBP091 towards licensure. The funding under this
new award (up to $267 million, if options are exercised) covers
activities necessary to request regulatory approval of MBP091.
MBP091 is the first Marburg virus therapeutic in BARDA’s portfolio.
MBP091 is eligible for a Priority Review Voucher (PRV).
Ebola and Marburg viruses are members of the
filovirus family that cause severe hemorrhagic fevers. Ebola, a
deadly virus that most commonly affects people and non-human
primates, is believed to be animal-borne and can spread through
contact with blood, body fluids and tissues. Marburg virus was
first identified in 1967 and has caused numerous outbreaks (for
example, 2022 in Ghana, 2021 in Guinea, and 2017 in Uganda), with
relatively high mortality rates.
About Mapp Biopharmaceutical, Inc.Mapp
Biopharmaceutical was founded in 2003 by Drs. Kevin Whaley and
Larry Zeitlin to develop novel pharmaceuticals for the prevention
and treatment of infectious diseases, focusing on unmet needs in
global health and biodefense.
About Aridis
Pharmaceuticals, Inc.Aridis Pharmaceuticals, Inc.
discovers and develops novel anti-infective therapies to treat
life-threatening infections, including anti-infectives to be used
as add-on treatments to standard-of-care antibiotics. The Company
is utilizing its proprietary ʎPEXTM and MabIgX®
technology platforms to rapidly identify rare, potent
antibody-producing B-cells from patients who have successfully
overcome an infection, and to rapidly manufacture monoclonal
antibodies (mAbs) for therapeutic treatment of critical infections.
These mAbs are already of human origin and functionally optimized
for high potency by the donor’s immune system; hence, they
typically do not require genetic engineering or further
optimization to achieve full functionality.
The Company is advancing multiple clinical stage
mAbs targeting bacteria that cause life-threatening infections such
as ventilator associated pneumonia (VAP) and hospital
acquired pneumonia (HAP), in addition to preclinical stage
antiviral mAbs. 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 IgG1 mAb targeting
gram-positive Staphylococcus aureus (S.
aureus) alpha-toxin and is being evaluated in a global Phase 3
superiority clinical study as an adjunctive treatment of S. aureus
ventilator associated pneumonia (VAP).
AR-320 (VAP). AR-320
is a fully human IgG1 mAb targeting S. aureus alpha-toxin that
is being evaluated in a Phase 3 clinical study as a preventative
treatment of S. aureus colonized mechanically ventilated patients
who do not yet have VAP.
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 (CF)
patients. This program is currently in Phase 2a clinical
development in CF patients.
AR-701 (COVID-19). AR-701
is a cocktail of fully human mAbs discovered from convalescent
COVID-19 patients that are directed at multiple protein epitopes on
the SARS-CoV-2 virus. It is formulated for delivery via
intramuscular injection or inhalation using a nebulizer.
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-101 (HAP). AR-101
is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical
development targeting Pseudomonas aeruginosa (P.
aeruginosa) liposaccharides serotype O11, which accounts for
approximately 22% of all P. aeruginosa hospital acquired
pneumonia cases worldwide.
AR-201 (RSV infection).
AR-201 is a fully human IgG1 mAb out-licensed 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 need for additional financing, 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 related to business
interruptions, including the outbreak of COVID-19 coronavirus,
which could seriously harm our financial condition and
increase our costs and expenses, 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, 2021 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:Media Communications:Matt
SheldonRedChip Companies Inc. Matt@redchip.com1-917-280-7329
Investor RelationsDave
GentryRedchipDave@redchip.com1-800-733-2447
SOURCE Aridis Pharmaceuticals, Inc.
Aridis Pharmaceuticals (NASDAQ:ARDS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aridis Pharmaceuticals (NASDAQ:ARDS)
Historical Stock Chart
From Apr 2023 to Apr 2024