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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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