Seek­ing an edge in the glob­al I/O race, Al­pham­ab On­col­o­gy loads up $100M-plus from mar­quee back­ers

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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Cy­to­ki­net­ics’ ALS drug fails PhI­II, leav­ing the biotech with a sin­gle late-stage prospect

Cytokinetics’ candidate for the muscle disease amyotrophic lateral sclerosis, or ALS, failed a Phase III trial, the Bay Area biotech announced Friday morning.

At a second interim analysis of the trial, an independent review committee recommended that Cytokinetics discontinue its COURAGE-ALS trial for reldesemtiv, as it “found no evidence of effect” compared to placebo on the primary or key secondary endpoints.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CHMP gives thumbs-up for We­govy use in ado­les­cents, along with nine new drug rec­om­men­da­tions

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.

Green­Light re­ceives buy­out of­fer; Apol­lomics com­pletes SPAC merg­er

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.

Sar­to­rius to ac­quire French man­u­fac­tur­er for $2.6B+ in cell and gene ther­a­py play

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.

TScan Therapeutics' departing CEO David Southwell and CSO/COO Gavin MacBeath

TCR up­start an­nounces CEO ex­it, with CSO now act­ing re­place­ment

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.

Austin biotech Mol­e­c­u­lar Tem­plates lays off more than 100 staffers as pipeline nar­rows

Molecular Templates is ridding itself of a Phase I HER2 asset and fine-tuning its pipeline to focus on three programs and a preclinical Bristol Myers Squibb collaboration. With the narrowed scope on its so-called engineered toxin bodies, the Austin, TX biotech is laying off about half of its staff.

That’s a little more than 100 employees, per an SEC filing. Molecular’s layoffs, approved by its board Wednesday, add to the dozens of pullbacks in the industry in the first three months of 2023.

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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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