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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

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.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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