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Development of MTX-211 for the Treatment of KRAS Mutant Colorectal Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44CA213715-02
Agency Tracking Number: R44CA213715
Amount: $888,572.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-03-12
Award End Date (Contract End Date): 2021-02-28
Small Business Information
7117 MARSHCREEK DR, Ypsilanti, MI, 48197-6054
DUNS: 079942146
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (734) 998-8327
Business Contact
Phone: (734) 998-8327
Research Institution
PROJECT SUMMARY Mekanistic Therapeutics seeks to designdiscoverand develop anti cancer agents that selectively inhibit multiple oncogenic pathwaysIts lead agent MTXwas discovered in collaboration with the Leopold laboratory at University of MichiganThe overall objective of this project is to expediently advance MTXinto development for the treatment of KRAS mutant colorectal cancerCRCEvery year andgtnew patients are diagnosed with colorectal cancerAt the time of diagnosisapproximatelyof these patients present with metastatic diseaseCurrentlythere are no approved treatments for metastatic CRC patients with activating mutations in KRASMTXis a first in class highly selective dual inhibitor of PI K and EGFR kinasesdesigned to attack KRAS oncogenic signaling using two orthogonal mechanismsAs suchit embodies a combination approach in a single moleculePhase I aims focused on optimizing the synthetic process to scale up production of MTXand conducting a pilot mouse trial of primary xenograft models established from six different patients diagnosed with KRAS mutant CRCAll milestones were achieved providing preclinical proof of concept for pursuit of a clinical development path for MTXthat specifically targets the KRAS mutant CRC populationIn Phase IIwe propose to test a broader panel of KRAS mutant CRC models in an expanded efficacy trial that incorporates molecular profiling to identify prognostic markers that correlate with therapeutic outcomeAt the same timewe propose to carry out early safety studies to further de risk MTXand strengthen the case for moving forward to future IND enabling toxicology studies NARRATIVE Public Health ImpactThere is an urgent need to develop more effective therapies to improve the low survival rate for metastatic colorectal cancerwhere the prognosis for patients diagnosed with KRAS mutant disease is especially poorThis project is focused on evaluation of MTXa novel first in class agentthat selectively targets EGFR and PIkinasekey signaling molecules implicated in the progression of KRAS mutant colorectal cancer

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

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