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.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.