{"project":{"acronym":"","projectId":93593,"title":"LGM2605 as a Mitigator of Space Radiation-Induced Vascular Damage","primaryTaxonomyNodes":[{"taxonomyNodeId":10708,"taxonomyRootId":8816,"parentNodeId":10706,"level":3,"code":"TX06.5.2","title":"Radiation Mitigation and Biological Countermeasures","definition":"Radiation mitigation and biological countermeasures aim to minimize or prevent physical, cognitive, and behavioral disorders due to space radiation without adverse side effects and loss of life.","exampleTechnologies":"Countermeasures for in-flight acute radiation syndrome, countermeasures for in-flight CNS effects, countermeasures against degenerative effects, countermeasures against cancer, combined pharmaceutical interaction tool, individual sensitivity toolkit","hasChildren":false,"hasInteriorContent":true}],"startTrl":2,"currentTrl":5,"endTrl":5,"benefits":"LignaMed, LLC is a drug development company with a fast track strategy to approval of LGM2605, an oral small molecule for use as a radiation mitigating agent that reduces harmful effects of radiation exposure of normal tissues. LignaMed, in collaboration with researchers at University of Pennsylvania, plans to identify the detrimental biochemical signals activated with space radiation and evaluate their mitigation by LGM2605. Manned missions to Mars will expose astronauts to solar and galactic cosmic radiation in the form of low dose γ radiation as well as high dose protons from solar particle events (2-4). A mixed radiation environment is unique to space and does not exist on earth and there is a lack of data on space radiation induced biological effects and thus inadequate resources of countermeasures (5). We propose to identify the pathways that lead to injury and damage from space radiation. Inflammation is one of the earliest triggers for tissue damage and an underlying cause of several pathologies including radiation induced diseases. The vasculature is an initiating and converging site of inflammation which is followed by extravasation into tissue and tissue injury. Although radiation-induced damage is largely in the form of circulatory problems, vascular damage in response to space radiation in particular, has never been investigated and due to its unique mechanism, LGM2605 has the potential to mitigate these negative effects of space travel related radiation.
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.","description":"LignaMed, LLC is a drug development company with a fast track strategy to approval of LGM2605, an oral small molecule for use as a radiation mitigating agent that reduces harmful effects of radiation exposure of normal tissues. LignaMed aims to evaluate LGM2605 as a mitigator of space-radiation induced vascular damage. NASA missions to Mars will expose astronauts to solar and galactic cosmic mixed radiation including low dose γ and proton radiation, but data is lacking on the biological and physiological effects in humans of this mixed source radiation. Research on space radiation effects on cellular systems, molecular targets and ultimately organ systems has identified potential harmful short and long-term effects on the health of astronauts. Work at the University of Pennsylvania identified damage to lungs years after a single exposure to low-dose gamma, 56Fe, 28Si and proton radiation exposure in mice. Acute and chronic radiation effects in organs are closely associated with vascular damage and dysfunction. Multiple studies have confirmed single source radiation side effects associated with significant loss of vascular integrity: increased vascular leakiness (edema), an activated inflammatory phenotype and extensive oxidative damage. However, damage to the vascular network under multiple radiation types simultaneously is not understood. LignaMed will employ gene knockout technology in vascular models exposed to space-relevant mixed radiation regimens to investigate the injury to the vasculature. We hypothesize that LGM2605 will mitigate space radiation-induced vascular damage by inhibiting early events that cause inflammation. This study will confirm that 1) space radiation drives endovascular damage via activation of the endothelial inflammatory phenotype resulting in increased permeability and 2) will validate LGM2605 as an effective mitigator of space radiation-induced vascular damage by inhibiting early events that drive long term adverse sequellae.","startYear":2017,"startMonth":6,"endYear":2017,"endMonth":12,"statusDescription":"Completed","principalInvestigators":[{"contactId":460438,"canUserEdit":false,"firstName":"Thais","lastName":"Sielecki","fullName":"Thais Sielecki","fullNameInverted":"Sielecki, Thais","primaryEmail":"Thais.Sielecki@Lignamed.Com","publicEmail":true,"nacontact":false}],"programDirectors":[{"contactId":206378,"canUserEdit":false,"firstName":"Jason","lastName":"Kessler","fullName":"Jason L Kessler","fullNameInverted":"Kessler, Jason L","middleInitial":"L","primaryEmail":"jason.l.kessler@nasa.gov","publicEmail":true,"nacontact":false}],"programExecutives":[{"contactId":215154,"canUserEdit":false,"firstName":"Jennifer","lastName":"Gustetic","fullName":"Jennifer L Gustetic","fullNameInverted":"Gustetic, Jennifer L","middleInitial":"L","primaryEmail":"jennifer.l.gustetic@nasa.gov","publicEmail":true,"nacontact":false}],"programManagers":[{"contactId":62051,"canUserEdit":false,"firstName":"Carlos","lastName":"Torrez","fullName":"Carlos Torrez","fullNameInverted":"Torrez, Carlos","primaryEmail":"carlos.torrez@nasa.gov","publicEmail":true,"nacontact":false}],"projectManagers":[{"contactId":3251486,"canUserEdit":false,"firstName":"Lisa","lastName":"Carnell","fullName":"Lisa Carnell","fullNameInverted":"Carnell, Lisa","primaryEmail":"lisa.a.scottcarnell@nasa.gov","publicEmail":true,"nacontact":false},{"contactId":461333,"canUserEdit":false,"firstName":"Theresa","lastName":"Stanley","fullName":"Theresa M Stanley","fullNameInverted":"Stanley, Theresa M","middleInitial":"M","primaryEmail":"theresa.m.stanley@nasa.gov","publicEmail":true,"nacontact":false}],"website":"","libraryItems":[{"file":{"fileExtension":"pdf","fileId":292051,"fileName":"SBIR_2017_1_BC_H12.01-8754","fileSize":35659,"objectId":288566,"objectType":{"lkuCodeId":889,"code":"LIBRARY_ITEMS","description":"Library Items","lkuCodeTypeId":182,"lkuCodeType":{"codeType":"OBJECT_TYPE","description":"Object Type"}},"objectTypeId":889,"fileSizeString":"34.8 KB"},"files":[{"fileExtension":"pdf","fileId":292051,"fileName":"SBIR_2017_1_BC_H12.01-8754","fileSize":35659,"objectId":288566,"objectType":{"lkuCodeId":889,"code":"LIBRARY_ITEMS","description":"Library Items","lkuCodeTypeId":182,"lkuCodeType":{"codeType":"OBJECT_TYPE","description":"Object Type"}},"objectTypeId":889,"fileSizeString":"34.8 KB"}],"id":288566,"title":"Briefing Chart","description":"LGM2605 as a mitigator of space radiation-induced vascular damage, Phase I Briefing Chart","libraryItemTypeId":1222,"projectId":93593,"primary":false,"publishedDateString":"","contentType":{"lkuCodeId":1222,"code":"DOCUMENT","description":"Document","lkuCodeTypeId":341,"lkuCodeType":{"codeType":"LIBRARY_ITEM_TYPE","description":"Library Item Type"}}},{"caption":"LGM2605 as a mitigator of space radiation-induced vascular damage, Phase I Briefing Chart Image","file":{"fileExtension":"png","fileId":296105,"fileName":"SBIR_2017_1_BC_H12.01-8754","fileSize":27596,"objectId":292633,"objectType":{"lkuCodeId":889,"code":"LIBRARY_ITEMS","description":"Library Items","lkuCodeTypeId":182,"lkuCodeType":{"codeType":"OBJECT_TYPE","description":"Object Type"}},"objectTypeId":889,"fileSizeString":"26.9 KB"},"files":[{"fileExtension":"png","fileId":296105,"fileName":"SBIR_2017_1_BC_H12.01-8754","fileSize":27596,"objectId":292633,"objectType":{"lkuCodeId":889,"code":"LIBRARY_ITEMS","description":"Library Items","lkuCodeTypeId":182,"lkuCodeType":{"codeType":"OBJECT_TYPE","description":"Object Type"}},"objectTypeId":889,"fileSizeString":"26.9 KB"}],"id":292633,"title":"Briefing Chart Image","description":"LGM2605 as a mitigator of space radiation-induced vascular damage, Phase I Briefing Chart Image","libraryItemTypeId":1095,"projectId":93593,"primary":true,"publishedDateString":"","contentType":{"lkuCodeId":1095,"code":"IMAGE","description":"Image","lkuCodeTypeId":341,"lkuCodeType":{"codeType":"LIBRARY_ITEM_TYPE","description":"Library Item Type"}}}],"transitions":[{"transitionId":69422,"projectId":93593,"partner":"Other","transitionDate":"2018-06-01","path":"Advanced To","relatedProjectId":95727,"relatedProject":{"acronym":"","projectId":95727,"title":"LGM2605 as a Mitigator of Space Radiation-Induced Vascular Damage","startTrl":2,"currentTrl":3,"endTrl":3,"benefits":"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.
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.","description":"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.","startYear":2018,"startMonth":6,"endYear":2021,"endMonth":6,"statusDescription":"Completed","website":"","program":{"acronym":"SBIR/STTR","active":true,"description":"
The NASA SBIR and STTR programs fund the research, development, and demonstration of innovative technologies that fulfill NASA needs as described in the annual Solicitations and have significant potential for successful commercialization. If you are a small business concern (SBC) with 500 or fewer employees or a non-profit RI such as a university or a research laboratory with ties to an SBC, then NASA encourages you to learn more about the SBIR and STTR programs as a potential source of seed funding for the development of your innovations.
The SBIR and STTR programs have 3 phases:
The SBIR and STTR Phase I contracts last for 6 months with a maximum funding of $125,000, and Phase II contracts last for 24 months with a maximum funding of $750,000 - $1.5 million.
Opportunity for Continued Technology Development Post-Phase II:
The NASA SBIR/STTR Program currently has in place two initiatives for supporting its small business partners past the basic Phase I and Phase II elements of the program that emphasize opportunities for commercialization. Specifically, the NASA SBIR/STTR Program has the Phase II Enhancement (Phase II-E) and Phase II eXpanded (Phase II-X) contract options.
Please review the links below to obtain more information on the SBIR/STTR programs.
Provides an overview of the SBIR and STTR programs as implemented by NASA
Provides access to the annual SBIR/STTR Solicitations containing detailed information on the program eligibility requirements, proposal instructions and research topics and subtopics
Schedule and links for the SBIR/STTR solicitations and selection announcements
Federal and non-Federal sources of assistance for small business
Search our complete archive of awarded project abstracts to learn about what NASA has funded
Still have questions? Visit the program FAQs
","programId":73,"responsibleMd":{"acronym":"STMD","canUserEdit":false,"city":"","external":false,"linkCount":0,"organizationId":4875,"organizationName":"Space Technology Mission Directorate","organizationType":"NASA_Mission_Directorate","naorganization":false,"organizationTypePretty":"NASA Mission Directorate"},"responsibleMdId":4875,"stockImageFileId":36648,"title":"Small Business Innovation Research/Small Business Tech Transfer"},"lastUpdated":"2024-1-10","releaseStatusString":"Released","viewCount":226,"endDateString":"Jun 2021","startDateString":"Jun 2018"},"infoText":"Advanced within the program","infoTextExtra":"Another project within the program (LGM2605 as a Mitigator of Space Radiation-Induced Vascular Damage)","dateText":"June 2018"}],"primaryImage":{"file":{"fileExtension":"png","fileId":296105,"fileSizeString":"0 Byte"},"id":292633,"description":"LGM2605 as a mitigator of space radiation-induced vascular damage, Phase I Briefing Chart Image","projectId":93593,"publishedDateString":""},"responsibleMd":{"acronym":"STMD","canUserEdit":false,"city":"","external":false,"linkCount":0,"organizationId":4875,"organizationName":"Space Technology Mission Directorate","organizationType":"NASA_Mission_Directorate","naorganization":false,"organizationTypePretty":"NASA Mission Directorate"},"program":{"acronym":"SBIR/STTR","active":true,"description":"The NASA SBIR and STTR programs fund the research, development, and demonstration of innovative technologies that fulfill NASA needs as described in the annual Solicitations and have significant potential for successful commercialization. If you are a small business concern (SBC) with 500 or fewer employees or a non-profit RI such as a university or a research laboratory with ties to an SBC, then NASA encourages you to learn more about the SBIR and STTR programs as a potential source of seed funding for the development of your innovations.
The SBIR and STTR programs have 3 phases:
The SBIR and STTR Phase I contracts last for 6 months with a maximum funding of $125,000, and Phase II contracts last for 24 months with a maximum funding of $750,000 - $1.5 million.
Opportunity for Continued Technology Development Post-Phase II:
The NASA SBIR/STTR Program currently has in place two initiatives for supporting its small business partners past the basic Phase I and Phase II elements of the program that emphasize opportunities for commercialization. Specifically, the NASA SBIR/STTR Program has the Phase II Enhancement (Phase II-E) and Phase II eXpanded (Phase II-X) contract options.
Please review the links below to obtain more information on the SBIR/STTR programs.
Provides an overview of the SBIR and STTR programs as implemented by NASA
Provides access to the annual SBIR/STTR Solicitations containing detailed information on the program eligibility requirements, proposal instructions and research topics and subtopics
Schedule and links for the SBIR/STTR solicitations and selection announcements
Federal and non-Federal sources of assistance for small business
Search our complete archive of awarded project abstracts to learn about what NASA has funded
Still have questions? Visit the program FAQs
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