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Novel monoclonal antibody for single dose treatment of acute CNS injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS115249-01
Agency Tracking Number: R41NS115249
Amount: $456,047.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NINDS
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-30
Award End Date (Contract End Date): 2021-08-31
Small Business Information
409 ILLINOIS ST, San Francisco, CA, 94158-2509
DUNS: 968433743
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Anne-Marie Carbonell
 (415) 654-3548
Business Contact
Phone: (415) 654-3548
Research Institution
PHILADELPHIA, PA, 19146-2305
 Domestic nonprofit research organization
PROJECT SUMMARY Traumatic brain injuryTBIrepresents a significant societal and economic impactTo datethere are no FDAapproved pharmacotherapies to prevent or reverse TBIThe standard of care in an emergency setting focuses first on stabilizing the patient and secondly on management of cerebral hemodynamicsThe patient may undergo surgery to remove hematomasrepair skull fracturesand relieve intracranial pressurePharmacological interventions are aimed at symptom management and may include anticoagulantsanticonvulsantsanxiolyticsand antidepressantsUltimatelythe current approaches to treating TBI are ameliorative and do not mitigate the biochemical insult that is the cause of brain damageHencethere is a significant unmet need for pharmacological agents to limit or prevent secondary neurological damage associated with TBITBI is a multisystem pathology with complex interactions between the brainthe peripheryand the immune systemIn recent yearsmounting evidence from both TBI patients and animal models of brain injury suggest a critical role for peripheral immune activation in the potentiation of TBI induced neurological dysfunction and brain pathologyImportantlycerebral invasion of lymphocytes crucially depends on the interaction of the leukocyte very late antigenVLAintegrinwith vascular cell adhesion moleculeVCAMon endothelial cellsHoweverotherintegrins may also be involvedcreating a potential escape mechanismHencetargeting multipleintegrins which may mediate leukocyte invasion of the CNS has therapeutic potential to limit or prevent secondary neurological damage associated with TBIOncoSynergy has developed OSa proprietaryfirstin class humanized monoclonal pan CDintegrin ITGBantibodyOur IND enabling studies demonstrated that repeat weekly intravenous dosing of OSis well tolerated in non human primates with no mortalityclinical signsgross pathologyor maximum tolerated doseMTDreachedup tomg kgIn MarchFDA cleared our IND to initiate a Phase I clinical trial in patients with recurrent glioblastoma using intracerebral delivery of OSThe known pharmacology and safety profiles of OSprovide a strong support to quickly translate this drug to clinical trials for TBIupon the successful completion of the proof of concept studyHencewe propose to collaborate with DrTodd Kilbaugh at Childrenandapos s Hospital of Philadelphia to conduct this Phase I STTR project to evaluate the efficacy of OSin a high fidelity porcine model of TBISuccessful achievement of this Phase I STTR project will enable further Phase II studies to optimize the treatment regimen of OSin multiple porcine models of TBI and advance OSto Phaseproof of concept efficacy studies in TBI patients PROJECT NARRATIVE To datethere are no FDA approved pharmacotherapies to mitigate or prevent neurological damage associated with traumatic brain injuryTBIOncoSynergy has developed a novel monoclonal antibody against CDintegrin ITGBfor the prevention of TBI induced secondary injury

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

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