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HLS Potent, novel inhibitor of fibrinolytic hemorrhage- Phase II

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL137514-02
Agency Tracking Number: R44HL137514
Amount: $2,812,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-15
Award End Date (Contract End Date): 2021-07-31
Small Business Information
Memphis, TN 38112-5410
United States
DUNS: 803592364
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 282-7718
Business Contact
Phone: (617) 726-2000
Research Institution

This SBIR Application is responsive to NHLBI Small Business Topics of Special Interest
(therapeutics) that are of high programmatic interest (HLS-17-04).
Hemorrhage or bleeding is a serious or fatal complication of surgery. Antifibrinolytic agents that inhibit
plasmin-mediated fibrinolysis can significantly reduce blood loss, emergency reoperation, morbidity
and death in patients with severe hemorrhage. Antifibrinolytic agents have been reported to have
value in cardiac surgery, orthopedic surgery, liver transplantation, vascular surgery, thoracic surgery,
gynecological surgery, end-stage renal disease, peripartum bleeding, gastrointestinal bleeding,
prostate surgery, neurosurgery, trauma, traumatic brain injury, intracerebral bleeding and
subarachnoid hemorrhage. However, current antifibrinolytic agents have properties that limit their
efficacy and may cause serious complications including: low potency, poor specificity, accumulation
in renal disease and penetration of the blood brain barrier and placenta. Safer, more specific and
potent antifibrinolytic agents may prevent thousands of deaths per year.
To address this need, Translational Sciences, Inc. seeks to produce a safe, high-affinity, ultra-
specific, antifibrinolytic monoclonal antibody as the first new agent to treat severe hemorrhage in
more than 50 years. This novel antifibrinolytic acts as a non-competitive, direct inhibitor and has
greater specificity and potency than any known agent. It blocks fibrinolysis in human plasma with
several thousand-fold greater potency than the currently used, small molecule antifibrinolytic agents
such as epsilon amino caproic acid (EACA) or tranexamic acid. As a monoclonal antibody this
antifibrinolytic is unlikely to cross the blood brain barrier, which avoids the risk of seizures associated
with tranexamic acid. Also unlike tranexamic acid or EACA, this agent will not significantly cross the
placenta, making it a more attractive agent for use in severe, pregnancy-associated hemorrhage. In
vivo, this antifibrinolytic was significantly more potent at stopping hemorrhage than clinical doses of
EACA. By virtue of its exquisite potency and specificity, this antifibrinolytic agent has extraordinary
potential for improving the treatment of severe and fatal bleeding. We project that, by comparison to
currently available agents, this novel antifibrinolytic will significantly reduce the need for transfusions,
reoperations and mortality in bleeding patients—without serious adverse events. This proposal
follows a successful Phase I project, which converted this potent monoclonal antibody into a
recombinant, first-in-class, antifibrinolytic agent. In this Phase II proposal, we will follow FDA
guidance to develop this novel therapeutic for the treatment of severe clinical hemorrhage, by
pursuing master cell bank creation, bioreactor production and testing, pivotal safety-toxicology
studies, as well as pre-IND and IND submission.Fibrinolysis contributes to severe and fatal hemorrhage in surgery and many other conditions. Current
inhibitors of fibrinolysis are weak and lack specificity, which limits their efficacy and causes serious
complications. We are developing an ultra-specific, high potency, anti-fibrinolytic agent as a more effective
therapy to reduce blood loss and mortality in patients with severe hemorrhage.

* Information listed above is at the time of submission. *

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