Yaron Pereg, KAHR CEO

An Is­raeli biotech is look­ing to make its name in the jam-packed CD47 space. Is bi­func­tion­al­i­ty the an­swer?

Jerusalem’s KAHR Med­ical had been work­ing on fu­sion pro­teins for au­toim­mune dis­or­ders for about 10 years, be­fore “is­sues in de­vel­op­ment” spurred then-new CEO Yaron Pereg to change gears in 2017.

“We had done our gap analy­sis and thought, ‘This is a very cool tech­nol­o­gy and very in­ter­est­ing plat­form, why won’t we start from scratch, do things dif­fer­ent and al­so se­lect more nov­el tar­gets?’” he said.

The com­pa­ny with­drew a Phase I/II ap­pli­ca­tion for its lead can­di­date, KAHR-102, be­fore any pa­tients were en­rolled, and shift­ed to im­muno-on­col­o­gy.

“Back then, you know, end of 2017, CD47 was not that at­trac­tive or as val­i­dat­ed as it is to­day,” Pereg said. “Every­body went af­ter adap­tive im­mune cells — PD-1, PD-L1, CAR-Ts — and we thought the in­nate im­mune side of things could be very in­ter­est­ing.”

On Wednes­day, KAHR un­veiled its sec­ond fi­nanc­ing since the big piv­ot, rak­ing in $46.5 mil­lion to ad­vance its lead pro­gram, a CD47x41BB tar­get­ing fu­sion pro­tein called DSP107. The com­pa­ny’s al­so set­ting some mon­ey aside to push two pre­clin­i­cal can­di­dates — a TIG­ITx­PD1 fu­sion pro­tein and a LIL­RB2xSIR­Pa fu­sion pro­tein — through IND-en­abling stud­ies.

aMoon led the round, with some help from BVF Part­ners LP, DAF­NA Cap­i­tal Man­age­ment LLC, Pere­grine Ven­tures, Shav­it Cap­i­tal, the Can­cer Fo­cus Fund, Flerie In­vest AB, Oriel­la Lim­it­ed, Pavil­ion Cap­i­tal, Had­a­sit Bio Hold­ings Ltd and Mi­rae As­set.

KAHR’s can­di­dates are de­signed to con­vert can­cer’s cam­ou­flage in­to a bea­con for the im­mune sys­tem to at­tack. Like oth­er can­di­dates in the space, DSP107 does so by bind­ing to CD47 and block­ing its in­fa­mous “don’t eat me sig­nal.”

Com­pe­ti­tion is stiff: Gilead’s $4.9 bil­lion bet on Forty Sev­en last year ap­peared to trig­ger a wave of Big Phar­mas join­ing the hunt for an ef­fec­tive CD47 drug, in­clud­ing Ab­b­Vie and Pfiz­er. Boehringer In­gel­heim jumped on the band­wag­on ear­ly, snag­ging the rights to a can­di­date from OSE Im­munother­a­peu­tics back in 2018. Gilead’s ma­grolimab snared fast track des­ig­na­tion last Sep­tem­ber. And just a cou­ple of months ago, Arch On­col­o­gy reeled in $105 mil­lion to fu­el its CD47 mis­sion.

Where KAHR stands out, Pereg says, is that its fu­sion pro­tein is bi­func­tion­al. It si­mul­ta­ne­ous­ly binds to 41BB on T-cells. So while weak­en­ing the tu­mor’s de­fens­es, it’s al­so de­signed to ac­ti­vate a nat­ur­al and adap­tive im­mune re­sponse, the CEO said.

Up­on com­plet­ing the safe­ty por­tion of the Phase I/II study “in the com­ing months,” Pereg plans to launch the can­di­date in­to two ef­fi­ca­cy pro­grams: One test­ing DSP107 as a monother­a­py and in com­bi­na­tion with Roche’s PD-L1 drug Tecen­triq in ad­vanced sol­id tu­mors; and an­oth­er test­ing DSP107 alone and in com­bi­na­tion with azac­i­ti­dine or azac­i­ti­dine plus vene­to­clax in pa­tients with acute myeloid leukemia (AML), myelodys­plas­tic syn­drome (MDS) and T-cell lym­pho­pro­lif­er­a­tive dis­eases.

Both the pre­clin­i­cal can­di­dates should be ready for IND sub­mis­sion by the end of 2022, ac­cord­ing to Pereg.

“Can­cer treat­ment is chal­leng­ing in that can­cer cells con­tin­u­ous­ly change and de­vel­op re­sis­tance to ex­ist­ing treat­ments,” he said in a state­ment, adding that the com­pa­ny’s can­di­dates could ben­e­fit pa­tients who are non-re­spon­sive or re­frac­to­ry to ex­ist­ing im­munother­a­pies.

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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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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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.

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.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

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.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.