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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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