Astel­las re­joins the au­toim­mune an­ti­body craze with Pan­dion part­ner­ship

Ken­ji Ya­sukawa Astel­las

Over a year ago, Astel­las CEO Ken­ji Ya­sukawa an­nounced a large R&D re­struc­ture: 600 cut jobs, mul­ti­ple re­search sub­sidiaries shut down, and a re­jig­gered ear­ly pipeline ap­proach cen­tered on so-called “fo­cus ar­eas.” Each fo­cus area was de­tailed briefly in a re­port they re­leased, along with how they’d reach the ther­a­py.

But one sub-fo­cus area looked dif­fer­ent. Rather than list the fea­tures of their tech­nol­o­gy, the space be­low au­to-an­ti­bod­ies (a form of au­toim­mune dis­or­der) said sim­ply “de­vel­op­ment of new plat­form.”

Astel­las ap­pears to have found that new plat­form, or at least part of it. They’ve an­nounced a deal worth po­ten­tial­ly $795 mil­lion for pan­cre­at­ic au­toim­mune ther­a­pies with Pan­dion Ther­a­peu­tics, a biotech that launched last year with sig­nif­i­cant fund­ing and pedi­greed founders. The deal will pay Pan­dion up to $45 mil­lion at first, be­tween an un­spec­i­fied up­front fee and mile­stones for iden­ti­fy­ing and de­sign­ing mol­e­cules. They will then stand to earn up to $750 mil­lion in near term mile­stones from Astel­las’ pre­clin­i­cal and clin­i­cal work.

The first tar­get is type 1 di­a­betes, a dis­ease long man­aged with in­sulin in­jec­tions but whose root caus­es have large­ly yet to be ad­dressed.

Rahul Kakkar

“The miss­ing piece is that in­sulin doesn’t slow or stop the ac­tu­al dis­ease pro­gres­sion it­self,” Pan­dion CEO Rahul Kakkar told End­points News. So the miss­ing piece here is to go up­stream, ear­li­er in the dis­ease process, be­fore the pan­creas has been so de­stroyed to the point our bod­ies no longer pro­duce in­sulin… to ac­tu­al­ly try to pre­serve the pan­creas it­self.”

This is not Astel­las first $700 mil­lion-plus for­ay in­to au­toim­mune dis­eases in gen­er­al or type 1 di­a­betes in par­tic­u­lar. In 2015, they joined with Anokion to found Kanyos Bio, a start­up fo­cused on T1 di­a­betes and celi­ac dis­ease, promis­ing to in­vest up to $760 mil­lion. By the time Anokion ful­ly ac­quired Kanyos in Sep­tem­ber, Astel­las had qui­et­ly pulled out of the ven­ture.

Orig­i­nal­ly pi­o­neered in can­cer im­munother­a­py, bis­pe­cif­ic an­ti­bod­ies have emerged as one of the hottest spaces for au­toim­mune re­search. The tech­nol­o­gy works in a sim­i­lar way to the an­ti­body-based mech­a­nism tu­mor cells use to trick the body in­to think­ing they are healthy cells. In­stead of la­bel­ing tu­mor cells healthy, though, you re­la­bel healthy cells the body has mis­tak­en­ly deemed for­eign.

“The idea of re­train­ing — and the sci­en­tif­ic term for that is ‘in­duc­ing tol­er­ance’ or ‘self-tol­er­ance’ — has been an idea with­in the au­toim­mune and sci­en­tif­ic space,” Kakkar said,  “but I think what is dif­fer­ent now is that sci­ence has caught up with the vi­sion.”

Pan­dion launched in Jan­u­ary 2018 with $58 mil­lion from a Po­laris-led Se­ries A fund­ing led and for­mer Pfiz­er ex­ec­u­tive An­tho­ny Coyle at the helm. They’ve spent the year-plus since amass­ing a li­brary of an­ti­bod­ies for spe­cif­ic tis­sues, Kakkar said.

We have been work­ing to ex­pand the ar­rows in our quiver,” he said. 

PT-101, their lead can­di­date, will head in­to the clin­ic for in­flam­ma­to­ry bow­el dis­ease next year, around two years af­ter the com­pa­ny’s launch.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.