Al­pham­ab On­col­o­gy be­lieves it has what it takes to stand out from the del­uge of check­point in­hibitors cur­rent­ly in de­vel­op­ment — not just in Chi­na but glob­al­ly. A syn­di­cate of well-heeled in­vestors now shares that con­fi­dence, in­fus­ing more than $100 mil­lion to fu­el an am­bi­tious dri­ve through the clin­ic.

Ting Xu

Ad­van­tech, PAG and Chi­na Ven­ture Cap­i­tal Fund led the Se­ries A, which is ex­pect­ed to sup­port Al­pham­ab’s lead as­set, KN035, all the way up to reg­is­tra­tional tri­als and fund late-stage pro­grams for three oth­er clin­i­cal drug can­di­dates. Or­biMed, Her­itage Provider Net­work and Jan­chor Part­ners al­so chipped in.

Spun out of Suzhou Al­pham­ab, Al­pham­ab On­col­o­gy in­her­it­ed all can­cer-re­lat­ed work done over the last nine years at the par­ent com­pa­ny un­der CEO Ting Xu, the founder of both en­ti­ties and a for­mer se­nior re­searcher at Bio­gen and Serono.

Back when the team start­ed its pro­grams sev­er­al years ago, Xu tells me in an email, they en­vi­sioned a high­ly com­pet­i­tive PD-(L)1 field. Their strat­e­gy in re­sponse fea­tures plays in both “I/O 1.0” — a sub­cu­ta­neous­ly ad­min­is­tered PD-L1 an­ti­body — and “I/O 2.0” with a bis­pe­cif­ic tar­get­ing both PD-L1 and CT­LA-4.

KN035, or en­vafolimab, the PD-L1 an­ti­body cur­rent­ly in piv­otal tri­als, rep­re­sents the most ad­vanced pro­gram in Al­pham­ab On­col­o­gy’s pipeline. Giv­en that fre­quent in­tra­venous ad­min­is­tra­tion is a ma­jor draw­back to com­pli­ance and con­ve­nience, Xu says, the “user-friend­li­ness” of a sub­cu­ta­neous prod­uct, with a short­er ad­min­is­tra­tion time and po­ten­tial for home-use, can make it at­trac­tive in the ad­ju­vant/neoad­ju­vant set­ting and as a main­te­nance ther­a­py.

It’s a com­pet­i­tive ad­van­tage al­so be­ing pur­sued by Bris­tol-My­ers Squibb through a pact with San Diego-based Halozyme, which is pro­vid­ing its hyaluronidase en­zyme-based tech to see if the check­point leader can de­liv­er its I/O drugs with a sub­cu­ta­neous jab.

Al­pham­ab is part­ner­ing with 3D Med­i­cines, a Chi­na-based pre­ci­sion med­i­cine com­pa­ny, on the clin­i­cal de­vel­op­ment while build­ing a com­mer­cial man­u­fac­tur­ing site to pre­pare for po­ten­tial ap­proval.

The PD-L1/CT­LA-4 bis­pe­cif­ic dubbed KN046, on the oth­er hand, is aimed at over­com­ing the safe­ty lim­i­ta­tions of cur­rent CT­LA-4 an­ti­bod­ies.

“We will ex­plore the op­por­tu­ni­ties in two fronts: In­crease the re­sponse rate in large in­di­ca­tions like NSCLC, HCC etc. while ad­dress­ing some PD-(L)1 non-re­sponse tu­mor types,” Xu adds.

Both pro­grams, like the rest of the pipeline, are be­ing po­si­tioned for the US, EU and Japan mar­kets in ad­di­tion to Chi­na. Some ear­ly-stage clin­i­cal tri­als will be con­duct­ed in Aus­tralia through an Al­pham­ab sub­sidiary there.

The new funds will al­so go to­ward an ag­gres­sive re­cruit­ment plan: At 100 staffers now, the com­pa­ny plans to dou­ble its size by the end of 2019.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.