Usama Malik, Fore Biotherapeutics

A di­ag­nos­tics com­pa­ny com­pletes its phar­ma makeover, re­brand­ing as Fore with Im­munomedics vet at the helm

Fore! Watch out, there’s a biotech in town that’s got a new name.

The Is­raeli di­ag­nos­tics com­pa­ny Nov­el­lus has un­der­gone a re­brand­ing, mak­ing the tran­si­tion to phar­ma­ceu­ti­cals as Fore Bio­ther­a­peu­tics, the com­pa­ny an­nounced Mon­day. As part of the change in di­rec­tion, Fore has ap­point­ed Us­ama Ma­lik as CEO, a for­mer key play­er at Im­munomedics dur­ing their $21 bil­lion ac­qui­si­tion by Gilead.

Though they have made the full turn to­ward ther­a­peu­tics, Fore’s busi­ness mod­el does not fo­cus on drug dis­cov­ery, Ma­lik told End­points News. Rather, the com­pa­ny is plan­ning to uti­lize its ge­nomics-based plat­form to in-li­cense pro­grams and screen them to see where they could be best put to use.

The process will fo­cus on pa­tients with “un­ad­dressed” tu­mor mu­ta­tions, Ma­lik said. Pre­vi­ous­ly, Fore had mar­ket­ed the plat­form to­ward acad­e­mia and phar­ma com­pa­nies as a di­ag­nos­tic prod­uct to see where cer­tain drugs may or may not work.

“The ex­ist­ing busi­ness mod­els are around new tar­get iden­ti­fi­ca­tion and drug dis­cov­ery,” Ma­lik said. “We’re start­ing by look­ing at ex­ist­ing tar­gets and iden­ti­fy­ing com­mer­cial­ly vi­able mu­ta­tions, where there’s suf­fi­cient­ly built pa­tient pop­u­la­tions where we can make a re­al im­pact, and then find­ing drugs in the clin­ic where there’s clin­i­cal da­ta.”

Com­ing from Im­munomedics, Ma­lik wouldn’t say whether or not he’s fo­cused on steer­ing Fore to­ward a sim­i­lar buy­out di­rec­tion. He had served as CFO of the com­pa­ny when it was bought out by Gilead last Sep­tem­ber, in a deal that cen­tered around the biotech’s re­cent­ly ap­proved drug Trodelvy.

Ma­lik is, how­ev­er, look­ing to ag­gres­sive­ly build up Fore’s pipeline. The com­pa­ny al­ready owns a Class I/II BRAF in­hibitor that’s com­plet­ed Phase I stud­ies, and Ma­lik says he wants to in-li­cense an­oth­er 2 to 4 ex­per­i­men­tal drugs by the end of 2022. These will like­ly be pro­grams that have failed tri­als in known tar­gets and can be redi­rect­ed to spe­cif­ic pop­u­la­tions.

That match­es up with how the com­pa­ny de­cid­ed on Fore as its new name. Ma­lik said he and his team went through sev­er­al names over the last few weeks, but de­cid­ed on Fore be­cause it evokes a for­ward-think­ing mind­set, like in the words “fore­cast” and “fore­sight.”

The BRAF pro­gram, dubbed PLX8394, em­bod­ies Fore’s new di­rec­tion as it seeks to ex­pand up­on the cur­rent BRAF space. Where­as most drugs on the mar­ket on­ly fo­cus on V600 mu­ta­tions, ac­count­ing for rough­ly 50% of pa­tients, PLX8394 is look­ing at tar­get­ing both V600 and “a good chunk” of non-V600 mu­ta­tions, Ma­lik said. It’s here where the un­ad­dressed mu­ta­tions lie.

Most oth­er next-gen­er­a­tion BRAF pro­grams are still in the pre­clin­i­cal stage, but Ma­lik said he’s ex­cit­ed about Fore’s can­di­date be­cause it’s al­ready been test­ed in hu­mans.

Fore raised $57 mil­lion to launch a Phase II tri­al for the drug last Sep­tem­ber, and is ex­pect­ed to launch the study by the end of the year once meet­ings with the FDA over the de­sign have con­clud­ed. No­var­tis and SR One both backed the ef­fort, and if all goes well Fore is hop­ing for a po­ten­tial ap­proval some­time in 2024.

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, 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.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actemra’s failure to hit the primary endpoint in a Phase III study didn’t stop the FDA from granting Roche priority review. And it’s certainly not standing in the way of a sixth approval for Roche’s IL-6 drug.

Regulators have cleared Actemra, or tocilizumab, for systemic sclerosis-associated interstitial lung disease in adult patients. Roche’s big Genentech subsidiary notes that it is the first biologic approved for this rare disease.

Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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