Judy Chou, AltruBio CEO (AltruBio)

Af­ter a ma­jor facelift, Al­tru­Bio says it's ready for a piv­otal fight against graft-ver­sus-host dis­ease

Al­tru­Bio got a makeover, and now it’s ready for its close­up.

CEO Judy Chou took over last Jan­u­ary — when the biotech was still known as AbGe­momics — on a mis­sion to re­build and re­brand. She culled the com­pa­ny’s on­col­o­gy pro­gram to laser in on an old im­munol­o­gy can­di­date. Now with a new board, a new name and new cash, the com­pa­ny has its eyes set on a piv­otal study.

On Thurs­day, Al­tru­Bio un­veiled a $63 mil­lion Se­ries A round to fund its trans­for­ma­tion. Its lead can­di­date, nei­hulizum­ab (al­so known as AbGn-168H), is an im­mune check­point reg­u­la­tor tar­get­ing PS­GL-1, a gly­co­pro­tein found on white blood cells and en­dothe­lial cells. Ear­li­er this month, the Phase Ib can­di­date nabbed FDA fast track des­ig­na­tion in steroid re­frac­to­ry acute graft-ver­sus-host dis­ease (SR-aGVHD).

Af­ter tak­ing the helm, Chou de­cid­ed to put the com­pa­ny’s GI can­cer can­di­date AbGn-107 on the shelf to fo­cus main­ly on nei­hulizum­ab. The com­pa­ny read out Phase Ia re­sults for AbGn-107 at AS­CO 2020, which sug­gest­ed the can­di­date was “well tol­er­at­ed with pre­lim­i­nary signs of ef­fi­ca­cy.” Five of 35 pa­tients treat­ed ex­pe­ri­enced Grade 3 or 4 neu­trope­nia, all at high­er dose lev­els, with 1 episode of febrile neu­trope­nia, ac­cord­ing to the re­sults. And two pa­tients ex­pe­ri­enced sta­ble dis­ease last­ing longer than 6 months.

“I don’t want to spend an­oth­er 20 years to get the prod­uct to the mar­ket so I need to be very con­cen­trat­ed on what we can de­liv­er and get it to the fin­ish line soon­er,” she said.

Un­der for­mer CEO and founder Rong-Hwa Lin, AbGe­nomics had been de­vel­op­ing nei­hulizum­ab for pso­ri­a­sis and oth­er im­muno­log­i­cal dis­eases. Boehringer In­gel­heim struck a col­lab­o­ra­tion deal around the can­di­date in 2005, then re­turned the rights in 2011. Al­tru­Bio how­ev­er, is still col­lab­o­rat­ing with BI on man­u­fac­tur­ing, Chou said.

“While we will con­tin­ue to de­vel­op AbGn-168H for pso­ri­a­sis, re­gain­ing the glob­al rights will al­so per­mit us to con­sid­er oth­er in­di­ca­tions that will take ad­van­tage of the full ther­a­peu­tic po­ten­tial of this drug,” Lin said at the time.

He passed the torch to Chou last Jan­u­ary, then stuck around as CSO be­fore re­tir­ing in Oc­to­ber. Be­fore Al­tru­Bio, Chou was glob­al head of biotech at Bay­er.

Chou says the com­pa­ny is no longer go­ing for in­di­ca­tions in pso­ri­a­sis or pso­ri­at­ic arthri­tis, “pure­ly be­cause of mar­ket com­pe­ti­tion.” The can­di­date is cur­rent­ly in a Phase Ib study for SR-aGVHD, and Chou ex­pects to read out the da­ta in Q1 or Q2 of next year. She said the team is plan­ning to meet with reg­u­la­tors in the hopes of jump­ing right in­to a piv­otal study.

Al­tru­Bio’s lead pre­clin­i­cal can­di­date, leiolizum­ab (AbGn-268), has demon­strat­ed high­er po­ten­cy than nei­hulizum­ab, ac­cord­ing to the com­pa­ny. Chou hopes to en­ter that can­di­date in the clin­ic around Q2 next year.

aMoon led the Se­ries A round, along with BVF Part­ners, CAM Cap­i­tal and oth­er ex­ist­ing in­vestors.

The com­pa­ny’s new board of di­rec­tors is chaired by Patrick Yang, who was most re­cent­ly ex­ec­u­tive VP at Juno Ther­a­peu­tics, but pre­vi­ous­ly served as Roche’s Glob­al Head of Tech­ni­cal Op­er­a­tions. The board al­so in­cludes Ole­ma On­col­o­gy CEO Sean Bo­hen, Genen­tech vet Stephen Juels­gaard, for­mer Cast­light Health CEO John Doyle, aMoon part­ner Gur Rosh­walb, and Cel­gene and Juno alum Corsee Sanders.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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Lan Huang, BeyondSpring CEO

Months af­ter shock­ing in­vestors with lung can­cer win, Be­yond­Spring's lead drug hits road­block at the FDA

BeyondSpring shocked investors in early August after its once-marginal lead drug suddenly showed a lot of promise in a common form of lung cancer. With hopes high, the FDA has now slammed the door on that drug in another indication — does that spell bad news for BeyondSpring’s Cinderella story?

The FDA issued BeyondSpring a complete response letter for its plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia, effectively shutting down the drug’s immediate chances at a marketing approval, the biotech said Wednesday.

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What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The nonprofit Institute for Clinical and Economic Review on Wednesday released a new report highlighting the ways in which payers are generally ensuring fair access to prescription drugs, even when based on a set of criteria set by the nonprofit.

While noting the lack of transparency hindered the report’s results, ICER said that the “great majority” of payer policies in the formularies evaluated are structured in a way to support many key elements of how ICER defines “fair access.”