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Kura Oncology and Kyowa Kirin Announce Global Strategic Collaboration to Develop and Commercialize Ziftomenib in Acute Leukemias
KNBWYKirin Holdings(KNBWY) GlobeNewswire News Room·2024-11-20 22:00

Collaboration Overview - Kura Oncology and Kyowa Kirin have entered into a global strategic collaboration to develop and commercialize ziftomenib, a selective oral menin inhibitor for treating acute myeloid leukemia (AML) and other hematologic malignancies [1] - Kura will receive a 330millionupfrontpaymentandupto330 million upfront payment and up to 1.2 billion in total milestone payments, including 420millioninnear−termmilestonepayments[1][2]−Thecollaborationincludesa50/50profitshareintheU.S.,withKuraleadingU.S.developmentandcommercialactivities,whileKyowaKirinhasexclusivecommercializationrightsoutsidetheU.S.[1][3][4]FinancialandCommercialTerms−Kuraiseligibleforadditionalmilestonepaymentstotaling420 million in near-term milestone payments [1][2] - The collaboration includes a 50/50 profit share in the U.S., with Kura leading U.S. development and commercial activities, while Kyowa Kirin has exclusive commercialization rights outside the U.S. [1][3][4] Financial and Commercial Terms - Kura is eligible for additional milestone payments totaling 741 million, bringing the total potential payments to 1.161billion,includingtheopt−inforsolidtumorindications[2]−IntheU.S.,Kurawillbooksalesandleadcommercialstrategy,sharingprofitsandlossesequallywithKyowaKirin[3][9]−OutsidetheU.S.,KyowaKirinwillleadcommercialization,andKurawillreceivetiereddouble−digitroyaltiesonnetproductsales[4][9]DevelopmentandClinicalPlans−Thecompanieswilljointlypursueabroaddevelopmentprogramtargetingacuteleukemias,includingfrontlineindications,combinationswithtargetedtherapies,andpost−transplantmaintenancesettings[1][6]−Kuraanticipatesthatthecollaborationfunding,combinedwithitscurrentcashbalance,willsupporttheAMLprogramthroughcommercializationinfrontlinecombinationtherapy[1][8]−ThecompaniesplantolaunchmultiplePhase2andPhase3studiesofziftomenibinAMLandotherhematologicmalignanciesoverthenextseveralyears[10]RegulatoryandMarketPotential−ZiftomenibhasreceivedBreakthroughTherapyDesignationfromtheFDAforthetreatmentofrelapsed/refractoryNPM1−mutantAML,amutationassociatedwithpooroutcomes[6][14]−KuraexpectstosubmitaNewDrugApplication(NDA)in2025andinitiateregistrationalPhase3frontlinestudiesinbothfitandunfitAMLpatientpopulationsin2025[6][8]−TheU.S.marketopportunityforziftomenibinthefrontlinesettingisestimatedatupto1.161 billion, including the opt-in for solid tumor indications [2] - In the U.S., Kura will book sales and lead commercial strategy, sharing profits and losses equally with Kyowa Kirin [3][9] - Outside the U.S., Kyowa Kirin will lead commercialization, and Kura will receive tiered double-digit royalties on net product sales [4][9] Development and Clinical Plans - The companies will jointly pursue a broad development program targeting acute leukemias, including frontline indications, combinations with targeted therapies, and post-transplant maintenance settings [1][6] - Kura anticipates that the collaboration funding, combined with its current cash balance, will support the AML program through commercialization in frontline combination therapy [1][8] - The companies plan to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies over the next several years [10] Regulatory and Market Potential - Ziftomenib has received Breakthrough Therapy Designation from the FDA for the treatment of relapsed/refractory NPM1-mutant AML, a mutation associated with poor outcomes [6][14] - Kura expects to submit a New Drug Application (NDA) in 2025 and initiate registrational Phase 3 frontline studies in both fit and unfit AML patient populations in 2025 [6][8] - The U.S. market opportunity for ziftomenib in the frontline setting is estimated at up to 3 billion annually [8] Additional Collaboration Details - Kura will fund development costs until the end of 2028, after which both companies will share costs at a 50:50 ratio [10] - Kyowa Kirin has an option to participate in the development and commercialization of ziftomenib in gastrointestinal stromal tumors (GIST) and other solid tumor indications, with Kura eligible for additional upfront and milestone payments totaling $228 million if the option is exercised [11] - The collaboration excludes Kura's ongoing efforts to advance next-generation menin inhibitor drug candidates targeting oncology indications, diabetes, and other metabolic diseases [11]