LOS GATOS, Calif., July 19, 2021 /PRNewswire/ -- Aridis
Pharmaceuticals, Inc. (Nasdaq: ARDS) today announced that it has
entered into an exclusive, worldwide licensing agreement with
AstraZeneca (LSE/STO/Nasdaq: AZN) to in-license the late stage
monoclonal antibody candidate, suvratoxumab.
The highlights of the agreement are:
- Phase 3-ready candidate. Suvratoxumab monoclonal
antibody (mAb) for prevention of pneumonia has been licensed from
AstraZeneca. Suvratoxumab extends Aridis' pneumonia franchise by
complementing the existing AR-301 Phase 3 pneumonia treatment
program.
- Lancet ID publication. Phase 2 data involving n=196
patients recently published in The Lancet Infectious Diseases
journal showed safety and a statistically significant (47%)
relative reduction of pneumonia in S. aureus colonized,
mechanically ventilated patients less than 65 years old, with
corresponding reduction in the number of days needed in the ICU and
hospital.i
- Up to €25 million Euros funding (approximately
$30 million). EU
Commission's Innovative Medicines Initiatives (IMI) funding for
suvratoxumab Phase 3 clinical trial
- AstraZeneca's equity stake in Aridis. AstraZeneca
becomes a shareholder of Aridis through the issuance of common
stock and has right of first negotiation for future licensing of
suvratoxumab.
Monoclonal
Antibody
|
Targeting
|
Disease
|
Development
Status
|
Next
Milestone
|
suvratoxumab or
'AR-320'
|
Staphylococcus
aureus alpha
toxin
|
S. aureus
colonized
patients at high risk
of developing
pneumonia
|
Phase 2
completed
|
Phase 3
launch
4Q-2021
|
Deal Highlights
- Aridis acquires
global exclusive rights for development and commercialization
of
suvratoxumab for all indications
|
- AstraZeneca retains
rights of first negotiation for future licensing
|
- Aridis will make an
upfront payment to AstraZeneca of $11m in cash and Aridis
common
stock. AstraZeneca will also receive up to a further $115m on
achievement of certain
development and sales-related milestones, in addition to tiered
royalties on net sales
|
- Up to €25 million
Euros (approximately $30m) from EU Commission's Innovative
Medicines
Initiative (IMI) COMBACTE clinical trial consortium for the Phase 3
trial for suvratoxumab
|
Development Overview: Suvratoxumab Phase 3 Clinical
Study
Suvratoxumab and AR-301 are complementary products.
Suvratoxumab's focus on preventive treatment of S. aureus
pneumonia complements Aridis' AR-301 Phase 3 mAb program which is
being developed as a therapeutic treatment of S. aureus
pneumonia.
A multinational, randomized, double blinded, placebo controlled
Phase 2 study (n=196 patients) showed that mechanically ventilated
ICU patients colonized with S. aureus who are treated with
suvratoxumab saw a relative risk reduction of pneumonia by 32% in
the overall intend to treat (ITT) study population, and by 47% in
the under 65 year old population, which is the target population in
the planned Phase 3 study. The relative risk reduction in the
target population reached statistical significance, and was also
associated with a substantial reduction in the duration of care
needed in the ICU and hospital.i [see
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30995-6/fulltext]
Aridis believes that suvratoxumab (product code name 'AR-320')
will be first-line treatment, first to market, first-in-class
pre-emptive treatment of S. aureus colonized patients. The
same first-line, first to market and first-in-class strategy
applies to the acute treatment with the monoclonal antibody AR-301
which the Company believes makes Aridis a globally dominant leader
in this space.
Aridis comments
"We are pleased to have been selected
as AstraZeneca's licensee. The strong data from the Phase 2 trial
gives us an advantage to define the patient population, primary
endpoint, and the Phase 3 clinical study design to support a clear
path to the Phase 3 confirmatory trial," said Vu Truong, Ph.D., Aridis' Chief Executive
Officer.
"We intend to efficiently leverage our collaboration with the
globally renowned HAP/VAP experts in the EU Commission's Innovative
Medicines Initiative (IMI) COMBACTE consortium and our global
network of existing clinical sites to launch the Phase 3 study for
AR-320 in the 4th quarter this year," said Hasan Jafri, M.D., Aridis' Chief Medical
Officer. "We are delighted that this Phase 3-ready candidate is
supported by IMI through the COMBACTE consortium and are excited to
demonstrate the potential for suvratoxumab to fulfill an unmet
medical need in a highly vulnerable and high-risk population, while
also offering substantial pharmacoeconomic benefits," said Dr.
Jafri.
AstraZeneca comments
Mark
Esser, Vice President, Microbial Sciences,
BioPharmaceuticals R&D, AstraZeneca said: "Suvratoxumab has the
potential to transform pulmonary infection management in ventilated
patients. We are pleased to complete this licensing deal with
Aridis who we believe are well placed to take suvratoxumab
forward."
IMI's COMBACTE consortium comments
"On behalf of IMI's
COMBACTE consortium, I would like to express our continued support
and strong enthusiasm for suvratoxumab," said Dr. Marc JM Bonten,
MD/PhD, Managing Entity and Scientific and Academic coordinator of
COMBACTE (University Medical Center, Utrecht). "We plan to leverage the
consortium's vast network of clinical sites and principal
investigators across Europe to
facilitate the execution of this important Phase 3 study to its
timely completion," said Dr. Bonten.
Dr. Bruno Francois, a world
renowned VAP expert and the Academic COMBACTE Lead for the Phase 3
study (University Hospital of Limoges) further added,
"After the very promising SAATELLITE phase 2 trial, starting
this phase 3 is very exciting as it could bring a new class of
molecules to treat severe bacterial infections, to patients.
The COVID pandemic has highlighted the importance of having
therapeutic options to address emerging infectious threats and
antimicrobial resistance (AMR) remains a serious threat.
In this context, the AR-320 study is very timely. Lastly,
the public-private partnership approach which made the
phase 2 study successful, will undoubtedly be one of the major
strengths of the coming phase 3 study."
About suvratoxumab ('AR-320')
Suvratoxumab (also
referred to as MEDI4893) is a fully human, half-life extended IgG1
monoclonal antibody targeting S. aureus alpha toxin.
Alpha-toxin is a key virulence factor that is secreted by both
methicillin-resistant S. aureus (MRSA) and
methicillin-susceptible S. aureus (MSSA). It is believed
that AR-320 protects against alpha-toxin mediated destruction of
host cells, preserving the human immune cells. AR-320's mode of
action is independent of the antibiotic resistance profile of S.
aureus and it is active against infections caused by both MRSA
and MSSA.
About IMI's COMBACTE Consortium
The European
Commission's Innovative Medicines Initiative (IMI) is the world's
biggest public-private partnership in the life sciences, whose goal
is to develop next generation vaccines, medicines and treatments,
such as new antibiotics [see https://www.imi.europa.eu/]. The
IMI-funded COMBACTE project aims to give antibiotic drug
development a much-needed boost by pioneering new ways of designing
and implementing efficient clinical trials for novel antibiotics.
COMBACTE forms part of the New Drugs for Bad Bugs (ND4BB)
initiative, IMI's wider program to tackle AMR. The COMBACTE
consortium comprises a large network of over 1,000 hospitals in
Europe that are potential clinical
sites for clinical trial conduction [see
https://www.imi.europa.eu/projects-results/project-factsheets/combacte-net]
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 ⅄PEXTM 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 technically do not
require genetic engineering or further optimization to achieve full
functionality.
The Company has generated multiple clinical stage mAbs targeting
bacteria and respiratory viruses that cause life-threatening
infections such as pneumonia, bacteremia, and COVID-19. 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 currently in Phase 3 clinical development
targeting gram-positive Staphylococcus
aureus (S. aureus) alpha-toxin in
VAP patients.
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-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 Phase 2a
clinical development in 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-701 (COVID-19). AR-701 is a cocktail of fully
human mAbs discovered from convalescent COVID-19 patients that are
directed at multiple envelope proteins of the SARS-CoV-2 virus.
AR-712 (COVID-19). AR-712 is a cocktail of fully
human mAbs (AR-711 and AR-720) that are directed against the
receptor binding domain of the SARS-CoV-2 virus. It is formulated
for delivery via inhalation using a nebulizer.
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, 2019
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
Dave Gentry
Redchip
Dave@redchip.com
1-800-733-2447
i François B, Jafri HS, Chastre J et al. Efficacy and
safety of suvratoxumab for prevention of Staphylococcus aureus
ventilator-associated pneumonia (SAATELLITE): a multicentre,
randomised, double-blind, placebo-controlled, parallel-group, phase
2 pilot trial. Lancet Infectious Diseases. 2021.
https://doi.org/10.1016/S1473-3099(20)30995-6
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SOURCE Aridis Pharmaceuticals, Inc.