David de Graaf, Abcuro CEO (Photo: Partners Innovation Fund)

Abcuro will take an an­ti-KL­RG1 an­ti­body in­to the clin­ic with new fund­ing, and has big plans for an­oth­er

A lit­tle over two years af­ter pulling in its first Se­ries A raise, au­toim­mune dis­ease and can­cer play­er Abcuro has some more cash to play with.

The New­ton, MA-based biotech com­plet­ed what it’s call­ing a Se­ries A-1 fundrais­ing round, net­ting $42 mil­lion to ad­vance two an­ti­bod­ies that tar­get KL­RG1 in the hopes of mod­u­lat­ing cy­to­tox­ic T and NK cells. Abcuro’s raise gives it a lit­tle over two years of run­way, CEO David de Graaf told End­points News, and enough fund­ing to run two clin­i­cal tri­als for a lead an­ti­body and pre­pare its sec­ond an­ti­body for IND stud­ies.

That lead can­di­date is an­ti­body ABC008, seek­ing to treat spo­radic in­clu­sion body myosi­tis, an au­toim­mune dis­ease where pa­tients’ skele­tal mus­cles are at­tacked. In this in­di­ca­tion, the T cells present KL­RG1 and en­ter the mus­cle fibers them­selves, lead­ing to a chron­ic pro­gres­sion of the dis­ease.

Where­as oth­er im­mune dis­eases may wax and wane, de Graaf said, IBM pa­tients suf­fer ap­prox­i­mate­ly 10% skele­tal mus­cle loss each year and ul­ti­mate­ly end up bedrid­den over 10 to 15 years. The symp­toms start small, with in­di­vid­u­als first los­ing fine mo­tor func­tion and notic­ing they may not be able to but­ton their coats, for ex­am­ple. But with no avail­able treat­ment, the dis­ease ends up af­fect­ing pa­tients’ qual­i­ty of life while they’re es­sen­tial­ly forced to just roll with the punch­es.

Cor­ti­cos­teroids, a treat­ment typ­i­cal­ly used in oth­er au­toim­mune dis­eases, have not shown to be ef­fec­tive in IBM, de Graaf said. Oth­er tri­als have been run to try to build up mus­cle mass, but Abcuro aims to dif­fer­en­ti­ate it­self by in­stead try­ing to get rid of the T cells in the mus­cles them­selves.

“The T cells in the com­plex of the mus­cle are ex­treme­ly abun­dant,” de Graaf said. “No one has just tried to af­fect those T cells to see if that would help out the dis­ease. That’s the the­sis be­hind the com­pa­ny.”

Abcuro ex­pects to launch a sin­gle as­cend­ing-dose tri­al in IBM in the first half of this year that will en­roll be­tween 20 and 35 pa­tients. Ear­ly signs have shown that one dose of the an­ti­body can af­fect T cell lev­els for any­where be­tween 1 and 3 months, de Graaf said.

ABC008 is al­so be­ing de­vel­oped for a sec­ond, un­named in­di­ca­tion.

Abcuro’s oth­er an­ti­body is known as ABC015, seek­ing to re­store T and NK cell func­tion in sol­id tu­mors. This an­ti­body, as op­posed to its coun­ter­part, helps the body re­al­ize it’s host­ing a tu­mor and tries to di­rect the im­mune sys­tem to at­tack it.

First be­ing stud­ied in mul­ti­ple myelo­ma, ABC015 works sim­i­lar­ly to oth­er check­point in­hibitors such as those tar­get­ing PD1. But the tar­get, KL­RG1, is the same as ABC008, even if the process is dif­fer­ent.

“ABC008 on­ly us­es KL­RG1 re­al­ly as an ad­dress. Es­sen­tial­ly it iden­ti­fies the cells and we kill the whole cell. We don’t af­fect the func­tion, we just count on its pres­ence. In can­cer [with ABC015], we’re try­ing to dis­rupt the func­tion as an in­hibito­ry re­cep­tor,” de Graaf said. “But our ini­tial fo­cus is re­al­ly on ex­ploit­ing every­thing we know about KL­RG1 and its bi­ol­o­gy.”

Mass Gen­er­al Brigham Ven­tures and Sanofi Ven­tures co-led the round, which al­so in­clud­ed Pon­tif­ax Ven­ture Cap­i­tal, Hongsen In­vest­ment Group, RA Cap­i­tal Man­age­ment and Sam­sara Bio­Cap­i­tal, among oth­ers.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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