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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Josep Bassaganya-Riera, NImmune Biopharma

Ex­clu­sive: Af­ter get­ting his drug back, Lan­dos founder as­sem­bles new start­up for the big PhI­II test

By the time Josep Bassaganya-Riera stepped down as founding CEO of Landos Biopharma in 2021, the company had racked up Phase II data for its top autoimmune program, completed what he called a positive end-of-Phase-II meeting with the FDA and plans to launch pivotal Phase III trials.

Since then, though, the new leaders at Landos have reshuffled their plans for the drug, omilancor, first announcing they will run a Phase IIb ahead of a Phase III and eventually shelving it altogether.

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