ContraFect Corporation
(Nasdaq:CFRX), a clinical-stage biotechnology
company focused on the discovery and development of direct lytic
agents (DLAs), including lysins and amurin peptides, as new medical
modalities for the treatment of life-threatening,
antibiotic-resistant infections, today announced that CARB-X
(Combating Antibiotic Resistant Bacteria Biopharmaceutical
Accelerator), a global non-profit partnership dedicated to
accelerating antibacterial research and development, is awarding
the Company up to $18.9 million in additional non-dilutive capital
to progress its second product candidate, CF-370, an engineered
lysin targeting Pseudomonas aeruginosa (P. aeruginosa), in
IND-enabling activities toward future Phase 1 clinical trials. This
award provides initial funding of $4.9 million, and ContraFect
could receive additional funding if certain project milestones are
met. Any funding beyond the initial $4.9 million is at the
sole discretion of CARB-X and subject to available funds.
CF-370 was nominated as a product candidate for
further development based on its potent in vitro bactericidal and
antibiofilm activities, in vivo activity and initial safety
profile, as well as its favorable manufacturing profile and its
potential for patentability.
“As a leader in bringing new potential medical
modalities to combat lethal and highly-resistant bacterial
pathogens, it is important that we were recognized by CARB-X for
the significant progress we have made with an investigative therapy
for invasive Pseudomonas infections, which have some of the highest
rates of mortality among hospital acquired infections,” said Roger
J. Pomerantz, M.D., President, Chief Executive Officer, and
Chairman of ContraFect. “The current experience fighting COVID-19
reminds the world of the urgent need for new therapies that can
positively impact the lives of patients infected with potentially
fatal microorganisms. At ContraFect, we remain committed to
developing superior therapeutic agents with the potential to
improve clinical outcomes and save lives.”
“CF-370 was discovered at ContraFect and is the
first lysin to demonstrate potent in vivo antibacterial activity
against a resistant Gram-negative pathogen when administered
intravenously to treat systemic infection. The promising data from
animal models support the potential therapeutic utility of CF-370
for the treatment of serious infections caused by P. aeruginosa,
including hospital-acquired and ventilator-associated pneumonias
and pulmonary exacerbations of cystic fibrosis. We thank CARB-X for
their support over the past three years which brought our
Gram-negative lysin discovery program to this important milestone
and underscores the power of our productive public-private
partnership. We look forward to progressing CF-370 through IND
enabling activities towards the clinic with CARB-X’s support,” said
Cara Casino, M.D., Executive Vice President of Research &
Development and Chief Medical Officer of ContraFect.
The new funding announced today is in addition
to $3.4 million awarded in 2017 and 2019.
About Pseudomonas aeruginosa (P.
aeruginosa):
P. aeruginosa is a Gram-negative pathogen which
readily develops resistance to conventional antibiotics resulting
in the emergence of multidrug-resistant (MDR) strains, which have
become common in many hospitals and regions. Invasive P. aeruginosa
infections, including ventilator-associated pneumonia, blood stream
infections, complicated urinary tract infections, and infections
following surgery carry some of the highest rates of mortality
among hospital acquired infections. Infections caused by MDR
P. aeruginosa are associated with high all-cause mortality,
hospital mortality and higher health-care related costs, as
compared to infections caused by susceptible strains. P. aeruginosa
is the most common pathogen isolated from adults with cystic
fibrosis, and is the most common cause of respiratory failure in
cystic fibrosis and responsible for the deaths of the majority of
these patients.
About CARB-X:
Combating Antibiotic-Resistant Bacteria
Biopharmaceutical Accelerator (CARB-X) is a global non-profit
partnership dedicated to accelerating early stage antibacterial
R&D to address the rising global threat of drug-resistant
bacteria. CARB-X is investing up to $500 million between 2016 and
2021 to support innovative antibiotics, vaccines, rapid
diagnostics, and other life-saving products. CARB-X focuses
exclusively on high-priority drug-resistant bacteria, especially
Gram-negatives. The scope of CARB-X funding is restricted to
projects that target drug-resistant bacteria highlighted on the
Centers for Disease Control and Prevention (CDC)’s 2019 Antibiotic
Resistant Threats list, or the Priority Bacterial Pathogens
list published by the World Health Organization (WHO) in
2017 – with a priority on those pathogens deemed Serious or
Urgent on the CDC list or Critical or High on the WHO list. CARB-X
is led by Boston University. CARB-X funding is provided
by the Biomedical Advanced Research and Development
Authority (BARDA), part of the Office of the Assistant
Secretary for Preparedness and Response (ASPR) in the US Department
of Health and Human Services (HHS), the Wellcome
Trust, a global charity based in the UK working to improve
health globally, Germany’s Federal Ministry of Education and
Research (BMBF), the UK Department of Health and Social
Care’s Global Antimicrobial Resistance Innovation Fund
(GAMRIF), the Bill & Melinda Gates Foundation, and with
in-kind support from National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National
Institutes of Health (NIH). CARB-X is headquartered at Boston
University School of Law. Follow us on Twitter @CARB_X.
About ContraFect:
ContraFect is a biotechnology company focused on
the discovery and development of direct lytic agents (DLAs),
including lysins and amurin peptides, as new medical modalities for
the treatment of life-threatening, antibiotic-resistant infections.
An estimated 700,000 deaths worldwide each year are attributed to
antimicrobial-resistant infections. We intend to address life
threatening infections using our therapeutic product candidates
from our platform of DLAs, which include lysins and amurin
peptides. Lysins are a new class of DLAs which are recombinantly
produced antimicrobial proteins with a novel mechanism of action
associated with the rapid killing of target bacteria, eradication
of biofilms and synergy with conventional antibiotics. Amurin
peptides are a novel class of DLAs which exhibit broad-spectrum
activity against a wide range of antibiotic-resistant Gram-negative
pathogens, including Pseudomonas aeruginosa (P. aeruginosa),
Acinetobacter baumannii, and Enterobacter species. We believe that
the properties of our lysins and amurin peptides will make them
suitable for targeting antibiotic-resistant organisms, such as
methicillin-resistant Staph aureus (MRSA) and P. aeruginosa, which
can cause serious infections such as bacteremia, pneumonia and
osteomyelitis. We have completed a Phase 2 clinical trial for the
treatment of Staph aureus bacteremia, including endocarditis, with
our lead lysin candidate, exebacase, which is the first lysin to
enter clinical studies in the U.S. Exebacase, currently being
studied in a pivotal Phase 3 clinical study, was granted
Breakthrough Therapy designation by the FDA for the treatment of
MRSA bloodstream infections (bacteremia), including right-sided
endocarditis, when used in addition to standard-of-care
anti-staphylococcal antibiotics in adult patients.
Follow ContraFect on Twitter @ContraFectCorp and LinkedIn.
Forward-Looking
Statements:
This press release contains, and our officers
and representatives may make from time to time, “forward-looking
statements” within the meaning of the U.S. federal securities
laws. Forward-looking statements can be identified by words
such as “projects,” “may,” “will,” “could,” “would,” “should,”
“believes,” “expects,” “anticipates,” “estimates,” “intends,”
“plans,” “potential,” “promise” or similar references to future
periods. Examples of forward-looking statements in this release
include, without limitation, statements regarding: ContraFect’s
ability to discover and develop DLAs as new medical modalities for
the treatment of life-threatening, antibiotic-resistant infections,
whether CARB-X will award the Company up to $18.9 million, whether
the Company receives the $4.9 million, the Company’s ability to
meet project milestones and receive additional funding, the
availability of funding, CF-370 characteristics, including its in
vivo and in vitro activity, manufacturing profile and
patentability, statements made by Dr. Pomerantz and Dr. Cassino,
ContraFect’s ability to address life threatening infections using
its DLA platform, whether lysins are a new class of DLAs
which are recombinantly produced, antimicrobial proteins with a
novel mechanism of action associated with the rapid killing of
target bacteria, eradication of biofilms and synergy with
conventional antibiotics, whether amurins exhibit broad-spectrum
activity against a wide range of antibiotic-resistant Gram-negative
pathogens, and whether the properties of ContraFect’s lysins and
amurins will make them suitable for targeting antibiotic-resistant
organisms, such as MRSA and P. aeruginosa. Forward-looking
statements are statements that are not historical facts, nor
assurances of future performance. Instead, they are based on
ContraFect’s current beliefs, expectations and assumptions
regarding the future of its business, future plans, strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent risks, uncertainties and
changes in circumstances that are difficult to predict and many of
which are beyond ContraFect’s control, including those detailed
under the caption “Risk Factors” in ContraFect's filings with the
Securities and Exchange Commission. Actual results may differ
from those set forth in the forward-looking statements. Important
factors that could cause actual results to differ include, among
others, our ability to develop treatments for drug-resistant
infectious diseases. Any forward-looking statement made by
ContraFect in this press release is based only on information
currently available and speaks only as of the date on which it is
made. Except as required by applicable law, ContraFect expressly
disclaims any obligations to publicly update any forward-looking
statements, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise. Research reported in this release is supported by the
Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an
award from Wellcome Trust, as administrated by CARB-X. The content
is solely the responsibility of the authors and does not
necessarily represent the official views of the Department of
Health and Human Services Office of the Assistant Secretary
for Preparedness and Response, other funders, or CARB-X.
Investor Relations
Contacts:
Michael MessingerContraFect CorporationTel: 914-207-2300Email:
mmessinger@contrafect.com
Carlo TanziKendall Investor RelationsTel: 617-914-0008Email:
ctanzi@kendallir.com
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