Tonix Pharmaceuticals Appoints Zeil Rosenberg, M.D., M.P.H., as Executive Vice President, Medical for Infectious Disease Programs
January 04 2023 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the appointment of Zeil Rosenberg, M.D., M.P.H. as its
new Executive Vice President, Medical. In this role, Dr. Rosenberg
will be responsible for leading Tonix’s clinical development
efforts for vaccines and antivirals. Dr. Rosenberg will be based in
the Company’s Chatham, N.J. headquarters, and as part of his role
will oversee the clinical development of Tonix’s vaccine for
smallpox and monkeypox, TNX-801, the vaccine for COVID-19,
TNX-1850, and the antiviral anti-SARS-CoV-2 spike protein
monoclonal antibodies, TNX-3600 and TNX-3800, to protect
immunocompromised individuals from severe COVID-19.
“We are pleased to welcome Dr. Rosenberg to
Tonix's clinical team to lead the development of our infectious
disease programs at a time when Tonix continues to make meaningful
progress in the clinical development of multiple programs within
its robust pipeline,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals.
“Dr. Rosenberg brings to our team expertise as
an infectious disease drug developer and we are fortunate to have
someone with Dr. Rosenberg’s skills, vision and operational
expertise join at a pivotal time in the evolution of our infectious
disease product portfolio, with our vaccine candidate for
monkeypox, TNX-801, expected to enter clinical testing in 2023, and
TNX-3600 and TNX-3800 moving ahead in pre-clinical development to
address the need for anti-SARS-CoV-2 monoclonal antibodies for
immune-compromised individuals,” said Gregory Sullivan, M.D., Chief
Medical Officer of Tonix Pharmaceuticals. “At Becton, Dickinson and
Company (BD), Dr. Rosenberg worked on the development of the BD
Bifurcated Needle, a safety-engineered improved bifurcated needle
device for the percutaneous administration of live virus vaccinia
vaccines, as well as BD VaxiNet™, a data monitoring system to
improve patient safety in smallpox vaccine mass immunization
efforts, which we believe have direct relevance to our recombinant
poxvirus (RPV) platform.”
“I am thrilled to join Tonix's executive
management team and lead the clinical development of its infectious
disease portfolio,” said Dr. Rosenberg. “I look forward to working
together with the talented Tonix team to advance the Company’s
portfolio of promising vaccines and antiviral therapies and help
bring them to as many appropriate patients as possible."
Dr. Rosenberg was most recently at PPD, part of
Thermo Fisher Scientific, serving as Executive Director, Biotech
and as Therapeutic Area Head for Vaccines at its Accelerated
Enrollment Solutions Group, where he provided leadership on
multiple successful COVID-19 vaccine clinical trials. At BD he was
Worldwide Business Leader and Medical Director for Immunization,
and was Vice President for Medical Affairs at Admera Health, a
medical diagnostics company focused on precision medicine. He was
key to the launch of a global public private partnership, including
UNICEF and WHO, to help eliminate maternal and neonatal tetanus
through immunization, resulting in the significant reduction of
neonatal mortality. He served as National Immunization Advisor to
the Indonesian Ministry of Health in Jakarta, sponsored by the U.S.
Agency for International Development (USAID), and as Chief
Technical Officer for Immunization at USAID, Washington, D.C.
Dr. Rosenberg received his B.A. with Honors and
Distinction at Stanford University, earned his M.D. at the
University of California, San Francisco and completed his
internship and residency at Mount Sinai and Cornell University
Medical College, respectively. He holds a Masters of Public Health
from Columbia University. Dr. Rosenberg is an elected Fellow of
both the American College of Preventive Medicine and the New York
Academy of Medicine, and Specialty Fellow of the American Academy
of Pediatrics. He has served as AAS Science, Engineering and
Diplomacy Fellow.
Tonix Pharmaceuticals Holding
Corp.*
Tonix is a clinical-stage biopharmaceutical
company focused on discovering, licensing, acquiring and developing
therapeutics to treat and prevent human disease and alleviate
suffering. Tonix’s portfolio is composed of central nervous system
(CNS), rare disease, immunology and infectious disease product
candidates. Tonix’s CNS portfolio includes both small molecules and
biologics to treat pain, neurologic, psychiatric and addiction
conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine
HCl sublingual tablet), is in mid-Phase 3 development for the
management of fibromyalgia with a new Phase 3 study launched in the
second quarter of 2022 and interim data expected in the second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022 and
expects interim data in the third quarter of 2023. TNX-1300
(cocaine esterase) is a biologic designed to treat cocaine
intoxication and has been granted Breakthrough Therapy designation
by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated
in the first quarter of 2023. TNX-1900 (intranasal potentiated
oxytocin), a small molecule in development for chronic migraine, is
expected to enter the clinic with a Phase 2 study in the first
quarter of 2023. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily formulation of tianeptine
being developed as a potential treatment for major depressive
disorder (MDD) with a Phase 2 study expected to be initiated in the
first quarter of 2023. Tonix’s rare disease portfolio includes
TNX-2900 (intranasal potentiated oxytocin) for the treatment of
Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug
designation by the FDA. Tonix’s immunology portfolio includes
biologics to address organ transplant rejection, autoimmunity and
cancer, including TNX-1500, which is a humanized monoclonal
antibody targeting CD40-ligand (CD40L or CD154) being developed for
the prevention of allograft and xenograft rejection and for the
treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is
expected to be initiated in the first half of 2023. Tonix’s
infectious disease pipeline includes a vaccine in development to
prevent smallpox and monkeypox, TNX-801, a next-generation vaccine
to prevent COVID-19, TNX-1850, a platform to make fully human
monoclonal antibodies to treat COVID-19, TNX-3600, and humanized
anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed
from Curia. TNX-801, Tonix’s vaccine in development to prevent
smallpox and monkeypox, also serves as the live virus vaccine
platform or recombinant pox vaccine (RPV) platform for other
infectious diseases. A Phase 1 study of TNX-801 is expected to be
initiated in Kenya in the second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have not been approved
for any indication.
This press release and further information about
Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements may be identified
by the use of forward-looking words such as “anticipate,”
“believe,” “forecast,” “estimate,” “expect,” and “intend,” among
others. These forward-looking statements are based on Tonix's
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, risks
related to the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; risks related to the timing and
progress of clinical development of our product candidates; our
need for additional financing; uncertainties of patent protection
and litigation; uncertainties of government or third party payor
reimbursement; limited research and development efforts and
dependence upon third parties; and substantial competition. As with
any pharmaceutical under development, there are significant risks
in the development, regulatory approval and commercialization of
new products. Tonix does not undertake an obligation to update or
revise any forward-looking statement. Investors should read the
risk factors set forth in the Annual Report on Form 10-K for the
year ended December 31, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, and periodic
reports filed with the SEC on or after the date thereof. All of
Tonix's forward-looking statements are expressly qualified by all
such risk factors and other cautionary statements. The information
set forth herein speaks only as of the date thereof.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 904-8182
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com (646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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