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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Paul Hudson, Sanofi CEO (Photographer: Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

Sanofi chief executive Paul Hudson told investors earlier this year that the Big Pharma was going to emphasize its sales kingpin Dupixent moving forward.

He wasn’t joking — the megablockbuster drug and sales king, recording just shy of $2 billion in sales this past quarter, has now officially secured its fifth indication from the FDA.

Sanofi and Regeneron, who jointly work on Dupixent development and commercialization, announced the new development on Thursday, saying that the FDA gave the all-clear to Dupixent to treat patients with prurigo nodularis, a rare autoimmune disorder characterized by a persistent, severe itch — and also visualized by hard, extremely itchy bumps known as nodules that form on the skin. The FDA noted in its announcement that it is the agency’s first approval for the disease.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images))

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would eliminate a federal mandate for animal testing for new drugs.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

The European Medicines Agency said Thursday that it’s launching a new pilot program to help academic and other nonprofit researchers developing advanced therapy medicinal products, which includes cell and gene therapies.

Academics have proven to be enormously useful in feeding new products, like chimeric antigen receptor (CAR)-T cell therapies first developed by Memorial Sloan Kettering, and ushered to the market by biopharma companies. Jean Bennett, formerly with the University of Pennsylvania, also saw her research lead to the approval of gene therapy Luxturna, which Roche now owns.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.