【行业研究报告】天境生物-Ph2 data of lemzoparlimab (CD47) in 1L MDS released

13Sep2022
CMBInternationalGlobalMarkets|EquityResearch|CompanyUpdate
I-Mab(IMABUS)
Ph2dataoflemzoparlimab(CD47)in1LMDS
released
Encouragingefficacyoflemzoparlimabin1LMDS.I-Mabannounced
positivePh2(NCT04202003)dataoflemzoparlimabincombinationwith
positivePh2(NCT04202003)dataoflemzoparlimabincombinationwith
azacitidine(AZA)inpatientswithnewlydiagnosedhigherriskMDSatESMO
2022(link).Atotalof53patientswereenrolledasof31Mar2022.Top-linedata
showedthatforpatientswhoreceivedinitialdoseofoversixmonths(n=15),the
ORRandCRRwere86.7%and40%,respectively.Asacross-trialcomparison,
theefficacyoflemzoparlimabwasbetterthanthatofmagrolimab(CD47from
Gilead;75%ORRand33%CRR;link)andcomparabletoIBI-188(CD47from
Innovent;85.7%ORRand39%CRR;link).Theimprovementson
haemoglobin/plateletandtransfusionwereobservedinlemzoparlimab’strial.9
of29patients(31%)withbloodtransfusiondependenceatbaselinebecame
transfusionindependentatthetimeofanalysis.Furthermore,themajorityofCR
patientsshowedareductioninMDS-relatedgenemutationburdens,including
TP53,TET2andRUNX1,with56%achievingMRDnegativity.
Satisfyingsafetyprofileoflemzoparlimab,whilemoredatarequiredto
makecross-trialcomparisons.40%patientsinlemzoparlimab’strialhad
Grade≥3anemia(TRAEs),whileGrade≥3anemiaoccurredin47%patients
(TEAEs)inmagrolimab’strialmentionedabove.11.3%patientsin
lemzoparlimab’strialdiscontinuedduetoTEAEsandGrade5TEAEsoccurred
in5.7%patients.Incomparison,6.3%patientsinmagrolimab’strial
discontinuedduetoAEsand60-daymortalitywas2%.Inlemzoparlimab’strial,
74%patientshadGrade≥3anemiaatbaseline,whiletheanemiabaselinestatus
wasnotreleasedinmagrolimab’strial.Itishardtomakedirectcomparisonof
safetyprofilebetweenthetwodrugcandidatesduetothedifferencesindata
release(TRAEorTEAE)andthecross-trialvariance.Innoventhasnotyet
releasedthedetailedsafetydataofIBI-181+AZAinMDS,whileitisnotable
thatAK117(CD47fromAkeso)couldbebetteroffinsafetywith29.7%patients
havinganemia(anyGrade)initsPh1/2trialNCT04900350.Moreover,
preliminaryresultsshowedAK117realized60%CRinthefiveMDSpatients
whoreceived30mg/kgQ2WAK117andAZAforatleastfourmonths.Moredata
isrequiredtomakecross-trialcomparisonsofdifferentCD47antibodies.
MaintainBUY.I-MabexpectstoinitiateaPh3trialin1LMDSpatientsin
Chinain2H22E,whiletheCompanywillcollaboratewithAbbVieindeveloping
anewpre-INDanti-CD47antibodyoverseas(ledbyAbbVie).Wemaintainour
DCF-basedTPunchangedatUS$43.06(WACC:10.0%,terminalgrowthrate:
2.0%).