Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced the signing of a research collaboration agreement with
Massachusetts General Hospital (MGH), a teaching hospital of
Harvard Medical School, to develop TNX-1500, a humanized monoclonal
antibody (mAb) that targets CD154 for the prevention and treatment
of organ transplant rejection. TNX-1500 is another step in
the strategic broadening of Tonix’s portfolio of high-value
programs, whose risk is mitigated by previous clinical data and
extensive preclinical science. Although transplantation is
the first targeted indication for TNX-1500, it is also a potential
treatment for autoimmune conditions including systemic lupus
erythematosus, rheumatoid arthritis and multiple sclerosis.
Tonix and MGH have agreed to work jointly under
a research agreement which will bring together Tonix’s internally
developed, proprietary anti-CD154 mAb, TNX-1500, with
transplantation experts from MGH, led by Richard N. Pierson III,
M.D., scientific director of the Center for Transplantation
Sciences in the Department of Surgery at MGH and Professor of
Surgery at Harvard Medical School (HMS). The goal of the
collaboration is to advance TNX-1500 as a potential first-in-class
therapeutic for organ transplant rejection. Transplant organ
rejection occurs when the immune system of the organ recipient
attacks the new organ as if it was an infection or tumor.
Tonix’s President and Chief Executive Officer,
Seth Lederman, M.D. said, “A substantial body of evidence in humans
and animals indicates that mAbs targeting CD154 have the potential
to be an important therapeutic option for preventing or treating
transplant organ rejection and as a treatment for autoimmune
disorders. Despite the recognized promise of anti-CD154
therapy, first generation anti-CD154 mAbs were limited because
their constant fragment (Fc) domain interacted with a receptor
called FcγRII, which raised concerns over an increased risk of
thrombosis. Second generation anti-CD154 mAbs had
dramatically reduced binding to FcγRII, but had other issues,
including decreased efficacy.1-3 TNX-1500 is a third generation
anti-CD154 mAb that has been designed by protein engineering to
target CD154 therapeutically, while decreasing FcγRII binding and
the potential for thrombosis.”
Dr. Pierson of MGH and HMS said, “Anti-CD154
therapy has a unique activity in controlling the immune response to
organ transplants.4,5 There remains a significant need for new
treatments with improved activity and tolerability to prevent or
treat organ transplant rejection. Anti-CD154 has shown great
promise to facilitate ‘transplant tolerance’ in multiple
preclinical transplant models. A safe, effective anti-CD154
also has potential to enable use of genetically modified or
‘humanized’ pig organs to treat humans with advanced organ failure
or diabetes, an emerging field known as ‘xenotransplantation.’”
6,7
Dr. Lederman added, “Nearly 30 years ago, the
laboratory that I directed as an Assistant Professor at Columbia
University, discovered and characterized CD154, generated the first
anti-CD154 monoclonal antibody, 5c8, and elucidated the molecular
basis of T cell helper function.8 It is exciting to return to
the anti-CD154 field and to bring forth a third generation
anti-CD154 mAb potential biologic therapeutic for treating and
preventing organ transplant rejection that stands on the shoulders
of previous work. We believe that TNX-1500 has the potential
to maintain therapeutic activity of first generation anti-CD154
mAbs, but with reduced risk of thrombosis. We believe that the
combined expertise of Tonix and MGH will be strongly synergistic.
Preventing and treating organ rejection remains the greatest
obstacles to long term survival in transplantation.”
1 Waters J, Biocentury; October 26, (2018)2
NCT02273960; ClinicalTrials.gov; “Study to Evaluate Safety and
Efficacy in Adult Subjects with ITP (ITP)”; results posted April 1,
2019, accessed July 29, 2019)3 Ferrant JL et al., International
Immunol. (11):1583 (2004)4 OʼNeill NA, et al. Transplantation.
101(9): 2038 (2017) 5 Zhang T, et al. Immunotherapy. 7(8):899
(2015)6 Längin M, et al. Nature. 564(7736):430 (2018)7Pierson RN
3rd. J Thorac Cardiovasc Surg. Jun 13. pii:
S0022-5223(19)31024-4. doi: 10.1016/j.jtcvs.2019.04.087. (2019)8
Lederman, S. & al. J. Exp. Med. 175:1091-1101 (1992)
About CD154
CD154 is a protein expressed on the surface of
activated T lymphocytes that mediates T cell helper function.
CD154 is also known as the CD40-ligand (CD40-L), the T cell-B cell
activating molecule (T-BAM), TRAP or gp39. CD154 is a member
of the Tumor Necrosis Factor (TNF) Super Family. No mAb
against CD154 has been licensed anywhere in the world. Other
TNF Super Family members have proven to be targets for antagonist
mAbs. Licensed mAbs against TNFα include: infliximab
(Remicade®), adalimumab (Humira®), certolizumab pegol (Cimzia®),
and golimumab (Simponi®) for the treatment of certain autoimmune
conditions. Also, etanercept (Enbrel®) is a TNFα antagonist
receptor fusion protein. A licensed mAb against RANKL (CD254)
is denosumab (Prolia® or Xgeva®) for the treatment of osteoporosis,
treatment-induced bone loss, metastases to bone, and giant cell
tumor of bone.
Remicade® and Simponi® are trademarks of
Janssen; Humira® is a trademark of AbbVie Inc.; Cimzia® is a
trademark of UCB S. A.; Enbrel®, Prolia® and Xgeva® are trademarks
of Amgen Inc.
Tonix Pharmaceuticals Holding
Corp.
Tonix is a clinical-stage biopharmaceutical
company focused on discovering and developing small molecules and
biologics to treat psychiatric, pain and addiction conditions, to
improve biodefense through potential medical counter-measures and
to prevent and treat organ transplant rejection. Tonix’s lead
program is for the development of Tonmya* (TNX-102 SL), which is in
Phase 3 development as a bedtime treatment for PTSD. Tonix is also
developing TNX-102 SL as a bedtime treatment for fibromyalgia,
agitation in Alzheimer’s disease and alcohol use disorder, to be
developed under separate Investigational New Drug applications
(INDs) to support potential pivotal efficacy studies. The
fibromyalgia program is in Phase 3 development, the agitation in
Alzheimer’s program is Phase 2 ready and the alcohol use disorder
program is in the pre-IND application stage. TNX-1300**
(double-mutant cocaine esterase) is being developed under an IND
and is in Phase 2 development for the treatment of cocaine
intoxication. Tonix has two other programs in the pre-IND
application stage of development for PTSD, but with different
mechanisms than TNX-102 SL and designed for daytime dosing: TNX-601
(tianeptine oxalate) and TNX-1600***, a triple reuptake inhibitor.
TNX-601 is also in development for a potential indication -
neurocognitive dysfunction associated with corticosteroid use. Data
is expected in the second half of 2019 for a Phase 1 clinical
formulation selection pharmacokinetic study of TNX-601 that is
being conducted outside of the U.S. TNX-801 (live virus vaccine for
percutaneous (scarification) administration) is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
Finally, TNX-1500 is being developed to prevent and treat organ
transplant rejection, as well as to treat autoimmune conditions,
and is in the pre-IND application stage.
*Tonmya has been conditionally accepted by the
U.S. Food and Drug Administration (FDA) as the proposed trade name
for TNX-102 SL for the treatment of PTSD. TNX-102 SL
(cyclobenzaprine HCl sublingual tablets) is an investigational new
drug and has not been approved for any indication.
**TNX-1300 (T172R/G173Q double-mutant cocaine
esterase 200 mg, i.v. solution) is an investigational new biologic
and has not been approved for any indication.
***TNX-1600
((2S,4R,5R)-5-(((2-aminobenzo[d]thiazol-6-yl)methyl)amino)-2-(bis(4-fluorophenyl)methyl)tetrahydro-2H-pyran-4-ol)
is an inhibitor of reuptake of three monoamine neurotransmitters
(serotonin, norepinephrine and dopamine), or a “triple
reuptake” inhibitor.
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 failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; 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, 2018, as filed with the Securities and Exchange
Commission (the “SEC”) on March 18, 2019, and periodic reports on
Form 10-Q filed with the SEC on or after the date thereof. Tonix
does not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
Contacts
Jessica Morris (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 980-9159
Scott Stachowiak (media)Russo
Partnersscott.stachowiak@russopartnersllc.com (646) 942-5630
Peter Vozzo
(investors)Westwickepeter.vozzo@westwicke.com (443) 213-0505
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