NASA SBIR 2017 Solicitation

FORM B - PROPOSAL SUMMARY


PROPOSAL NUMBER: 17-2 H12.01-8754
PHASE 1 CONTRACT NUMBER: NNX17CL73P
SUBTOPIC TITLE: Radioprotectors and Mitigators of Space Radiation-induced Health Risks
PROPOSAL TITLE: LGM2605 as a Mitigator of Space Radiation-Induced Vascular Damage

SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
LignaMed, LLC
3711 Market Street
Philadelphia, PA 19104 - 5501
(215) 206-2754

PRINCIPAL INVESTIGATOR/PROJECT MANAGER (Name, E-mail, Mail Address, City/State/Zip, Phone)
Dr. Thais M Sielecki-Dzurdz
thais.sielecki@lignamed.com
3711 Market Stree, Suite 866
Philadelphia, PA 19104 - 5501
(610) 299-7482

CORPORATE/BUSINESS OFFICIAL (Name, E-mail, Mail Address, City/State/Zip, Phone)
Mr James Harris
jim.harris@lignamed.com
3711 Market Street
Philadelphia, PA 19104 - 5501
(215) 206-2754

Estimated Technology Readiness Level (TRL) at beginning and end of contract:
Begin: 2
End: 3

Technology Available (TAV) Subtopics
Radioprotectors and Mitigators of Space Radiation-induced Health Risks is a Technology Available (TAV) subtopic that includes NASA Intellectual Property (IP). Do you plan to use the NASA IP under the award?
No

TECHNICAL ABSTRACT (Limit 2000 characters, approximately 200 words)

LignaMed, LLC is developing LGM2605, an oral small molecule for use as a radiation mitigating agent. Here we aim to evaluate LGM2605 as a mitigator of space-radiation induced damage. NASA missions to Mars will expose astronauts to solar/galactic cosmic mixed radiation including low dose g and proton radiation, a source of harmful short and long-term health effects. Damage to the vascular network under mixed radiation types is not understood. Findings from our NASA-funded Phase I studies provided novel evidence that LGM2605 is an effective mitigator of radiation toxicity in cells exposed to mixed-field space-relevant radiation (high LET protons and gamma rays). In this application, LignaMed in collaboration with the researchers at the University of Pennsylvania will extend these initial studies to evaluate LGM2605 in an in vivo model for protection from radiation-induced i) carcinogenesis in lung, liver and all major organs (Task 1) and accelerated lethality as a secondary endpoint and ii) tissue degeneration (Task 2) by evaluating long term lung deterioration and long-term damage mixed gender adult mice. We hypothesize that mixed space radiation increases cancer risk and induces chronic, pro-inflammatory changes in tissues leading to accelerated degeneration of the cardiovascular and pulmonary system. We propose that LGM2605 will mitigate space radiation-induced carcinogenesis and tissue degeneration.

POTENTIAL NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
LignaMed, LLC is developing LGM2605, a safe oral small molecule for use as a radiation mitigating agent. Here we aim to evaluate LGM2605 as a mitigator of space-radiation induced damage. The future space explorations of NASA in the form of manned missions to Mars will expose astronauts to solar and galactic cosmic radiation (GCR), which ranges from high energy protons to high charge and energy (HZE) particles and secondary neutrons produced by galactic cosmic rays (GCR). Such a mixed radiation environment does not exist on earth and is unique to space. Thus there is a lack of data defining the biological and physiological effects during and following exposure to such mixed-field space radiation exposure. This work will help understand the effects of GCR on cell signaling and demonstrate the protective effects of LGM2605 to prevent this long-term damage. Ultimately, LGM2605 will be developed for use by astronauts during space travel.

POTENTIAL NON-NASA COMMERCIAL APPLICATIONS (Limit 1500 characters, approximately 150 words)
Lignamed LLC is a biopharmaceutical company developing LGM-2605 as adjunct therapy to reduce side effects and improve cure rates of radiation treatment of chest cancers. The market size is $5 billion. Chest cancers are a deadly and costly disease. They include breast cancer, lung cancer, sarcomas, lymphomas and esophageal cancer. According to the American Cancer Society, more than 500,000 new chest cancer cases will be diagnosed in the United States in 2014 and they project the number to increase in the years ahead. About 50 to 60 percent of cancer patients are treated with radiation at some time during their disease. Combinations of surgery, chemotherapy and radiation treatments are the standard for modern cancer therapy. Success is often determined by the ability of patients to tolerate the most aggressive regimen. The ability to deliver effective radiation therapy is limited by toxic side effects to healthy normal lung tissues. These side effects often cause breaks in treatment or dose-limiting toxicity after treatment, and, therefore, limit the amount of radiation that can be delivered to the tumor. No current therapies are effective to protect healthy normal lung tissue from the damaging effects of radiotherapy. A significant unmet need exists for a safe radioprotection agent that will ameliorate radiation side effects to normal tissue without "protecting" the tumor. The US market opportunity is estimated at $5 billion per year.

TECHNOLOGY TAXONOMY MAPPING (NASA's technology taxonomy has been developed by the SBIR-STTR program to disseminate awareness of proposed and awarded R/R&D in the agency. It is a listing of over 100 technologies, sorted into broad categories, of interest to NASA.)
Isolation/Protection/Radiation Shielding (see also Mechanical Systems)
Medical

Form Generated on 03-05-18 17:24