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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Chris Kim, Liminatus Pharma CEO

A fledg­ling biotech goes SPAC route to bankroll can­cer vac­cine, CAR-T and CD47

A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.

Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.

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