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

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.