Ready to har­vest its PD-L1, Al­pham­ab re­loads with $60M to nur­ture the bis­pe­cif­ic patch

Al­pham­ab’s $100 mil­lion Se­ries A last No­vem­ber for the on­col­o­gy unit marked its first ven­ture round in al­most 10 years of ex­is­tence. As it turned out, it was al­so a sig­nal that founder and CEO Ting Xu was ready to bring in the cash flow he needs to com­plete the reg­u­la­to­ry jour­ney for his lead check­point in­hibitor and dive in­to the bis­pe­cif­ic project he’s en­vi­sioned for years.

Ting Xu Al­pham­ab

The Suzhou-based com­pa­ny un­veiled its lat­est fi­nanc­ing on Tues­day, in­fus­ing $60 mil­lion in­to pipeline de­vel­op­ment and a po­ten­tial com­mer­cial launch as well as a new R&D and man­u­fac­tur­ing site. Hud­son Bay Cap­i­tal Man­age­ment led the Se­ries B and Adri­an Cheng, the heir of a re­al es­tate em­pire in Hong Kong, par­tic­i­pat­ed along­side ex­ist­ing in­vestors.

If ap­proved, KN035 (en­vafolimab) would be­come the first PD-L1 agent to fol­low four PD-1 drugs on the mar­ket: Mer­ck’s Keytru­da, Bris­tol-My­ers Squibb’s Op­di­vo, Jun­shi’s Tuoyi and In­novent’s Tyvyt.

Xu — a vet­er­an of Serono and Bio­gen — knows he’s get­ting in­to a com­pet­i­tive land­scape set to be­come much more crowd­ed, but hopes that the user-friend­li­ness of KN035’s sub­cu­ta­neous ad­min­is­tra­tion will make it at­trac­tive in the ad­ju­vant/neoad­ju­vant set­ting and as a main­te­nance ther­a­py. Bris­tol-​My­ers Squibb is al­so ex­plor­ing a sim­i­lar strat­e­gy through a pact with San Diego-​based Halozyme.

Be­sides, KN035 is on­ly the “I/O 1.0” part of his strat­e­gy; it’s “I/O 2.0” where he is eye­ing the biggest break­throughs.

Af­ter spend­ing over six years fine-tun­ing its plat­form tech and man­u­fac­tur­ing know-how, Al­pham­ab is now well po­si­tioned to go all in on bis­pecifics with six as­sets in the pipeline, Xu said in a re­cent in­ter­view with Chi­na’s Pharm­Cube.

Back then, chart­ing a path for bis­pecifics be­fore most in­vestors had heard of the con­cept al­so meant find­ing al­ter­na­tive sources of mon­ey, such as de­vel­op­ing ear­ly-stage biosim­i­lars then sell­ing them to oth­er com­pa­nies. It in­clud­ed a re­com­bi­nant Fac­tor VI­II prod­uct, now de­vel­oped by Nan­jing CT­TQ.

Two of Al­pham­ab’s bis­pecifics are now in Phase II test­ing, in­clud­ing KN046 (PD-L1/CT­LA4) and KN026 (HER2). For the lat­ter, Xu is plot­ting three routes of at­tack: a head-to-head with Her­ceptin in front­line breast can­cer; tri­als in pa­tients with low ex­pres­sion or re­sis­tance to Her­ceptin; and a bio­mark­er-dri­ven ap­proach, he told Pharm­Cube.

The new round of cash will al­so fund an on­go­ing Phase II study of CD80-tar­get­ing im­munomod­u­la­tor KN019 for au­toim­mune con­di­tions.

Im­age: Shut­ter­stock

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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Levi Garraway. Broad Institute via Youtube

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Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

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