Indapta Therapeutic — Department of Health and Human Services SBIR Phase I: 102

Description

Project Summary Abstract Multiple myeloma is the second most common hematologic malignancy in the USwith aboutnew cases in the US each yearMost patients with MM relapse and eventually become unresponsive to treatmentAlthough multiple new therapies for MM have come on the markettheir promise is limited by concerns about toxicity and low efficacyand MM remains incurableThereforethere is an urgentdemonstrableand sizeable need for safe and efficacious therapies for MMBy significantly augmenting the efficacy of mAb therapiesour new immuno oncology product will capture a significant share of the market for MM specific mAbsThe proposed project will therefore advance the science of MM focused immunotherapy while meeting an important need in a rapidly growing marketIndapta TherapeuticsInc`Indaptaandaposhas entered into a relationship with the University of CaliforniaSan FranciscoUCSFto develop and test a next generation cancer therapyIndapta aims to become a leader in safe and effective cellular immuno oncology therapy by building on a novel discovery by professors from UCSFMichigan State University and Stanford University confirming a unique synergy between monoclonal antibodiesmAbsand a specific and potent variety of `natural killerandaposNKimmune cell lacking the Fc RIadapterthe g NK cellThe scientific premise is that the conventional NK cells that have mutated after coming into contact with CMV to be lacking the Fc RIadapterG NKwill significantly increase ADCC and favorable apoptosis in the presence of a MAB to increase tumor killingThe product will combine these special g NK cells with a targeting mAbdaratumumab to destroy multiple myelomaMMcells with high precision and efficacyIndapta owns the exclusive license to the patents protecting this technologyThe PI for this grant is DrVaughn SmiderPhD in Immunology from Stanford and immune oncology professor at Scrippswho has commercialized seveal leading monoclonal antibodiesCEO of Indapta has secured two NCI SBIR Fast Track grants totaling $M for his first companywhich has attracted over $M in venture funding as it moves to commercialize its early stage technologyThe UCSF team includes a leader in clinical NK cell therapy for MM and a translational scientist with extensive expertise in preclinical models of MMIndaptaandapos s productpairs g NK cells with daratumumab to target MM cellsThis pairing enables NCT toiharness the high potency of g NK cellsiiidentify MM cells by using a specialized mAbdaratumumabiiilower the risk of adverse immune responsea feature of genetically engineered immunotherapiesbecause g NK cells occur naturallyandivbenefit from the longevitymonthsof g NK cells as compared to conventional NK cellsweeksthereby reducing frequency of infusions as part of the immunologic regimen Project NarrativePublic Health RelevanceMultiple myelomaMMis the second most common hematologic malignancy in the USand accounts for approximatelyof all hematologic cancers and aboutnew cases globallyNearly all patients with MM relapse and eventually become unresponsive to treatmentand although multiple new therapies for MM have come on the marketthere still is no cure for this malignancyIndapta Therapeutics Inchas identified an enhancedpreferential subset of natural killer cells lacking the Fc RIadapterg NKwhichwhen used in combination with a monoclonal antibodymAbshow increased cancer cell killingmaking this combination therapy a promising instrument to augment the current therapeutic responses available for either mAbor NKcell based therapy targeting patients with MM