Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since clos­ing a $28 mil­lion Se­ries A, a San Diego pro­tein-degra­da­tion up­start re­turned to the ven­ture well Thurs­day with an ex­ten­sion of that round and some new hires, in­clud­ing one of the city’s best-con­nect­ed biotech ex­ecs.

Plex­i­um has bagged an ad­di­tion­al $35 mil­lion in fi­nanc­ing, the biotech said, mon­ey that will push undis­closed on­col­o­gy and im­muno-on­col­o­gy pro­grams in­to the clin­ic. In ad­di­tion, long­time in­dus­try vet Mike Grey is jump­ing on as chair­man of the board, and two oth­ers from Thurs­day’s leads — Adam Goul­burn from Lux Cap­i­tal and Rob Hopfn­er from Piv­otal bioVen­tures — joined the board too.

Kan­daswamy Vi­jayan

“Mike Grey has a long his­to­ry in the phar­ma­ceu­ti­cal in­dus­try, as an en­tre­pre­neur, as an ex­ec­u­tive, as a mul­ti­ple-time CEO,” CEO Swamy Vi­jayan told End­points News. “More specif­i­cal­ly, he has led and has been CEO of plat­form com­pa­nies, uti­liz­ing tech­nol­o­gy to de­rive ther­a­peu­tic pro­grams and ad­vanc­ing them in­to the clin­ic. He brings that per­spec­tive.”

Since the com­pa­ny’s found­ing in 2018, Vi­jayan has fo­cused on what he says is an atyp­i­cal ap­proach to pro­tein degra­da­tion. Where most big play­ers in the field like Arv­inas and Kymera fo­cus on small mol­e­cules that bind to a pro­tein’s ac­tive site, Vi­jayan said, Plex­i­um re­searchers put their ef­forts to­ward “mono­va­lent” pro­tein de­graders that bind ei­ther to a cell’s ma­chin­ery or the cell it­self.

The pre­vi­ous fi­nanc­ing was main­ly used to scale up the biotech’s screen­ing plat­form, which builds on DNA en­cod­ed li­braries and in­te­grates cell-based as­says to al­low for deep­er ex­plo­ration of the tests. Vi­jayan said it amounts to an en­tire drug dis­cov­ery in­fra­struc­ture in a bench-top de­vice, al­low­ing for any­where be­tween 150,000 to 1 mil­lion ex­per­i­ments to take place at once.

“It’s not a tra­di­tion­al phar­ma where you have chem­istry and bi­ol­o­gy; you ac­tu­al­ly have an en­gi­neer­ing team … to al­low drug dis­cov­ery at this scale,” Vi­jayan said of the plat­form.

Thurs­day’s raise helps ad­vance their in-house mono­va­lent can­di­dates, how­ev­er, uti­liz­ing a method Vi­jayan said goes af­ter tar­gets many con­sid­er un­drug­gable and opens the door to us­ing pro­tein degra­da­tion as a modal­i­ty. By run­ning so many ex­per­i­ments in the screen­ing process, Plex­i­um is able to pre­dict how pro­teins might re­act to cer­tain com­pounds.

“Ba­si­cal­ly you want to push the pro­tein in­to a con­for­ma­tion it nor­mal­ly doesn’t ex­ist in,” Vi­jayan said. Plex­i­um’s pro­grams “push and per­turb” pro­tein sur­faces in­to a new con­for­ma­tion, ul­ti­mate­ly lead­ing to degra­da­tion be­cause “the cell now doesn’t know what to do with it” and reg­is­ters the pro­tein as mis­fold­ed.

In the con­text of can­cer, Plex­i­um claims its pro­grams can tamp down on the over­ex­pres­sion of cer­tain tran­scrip­tion fac­tors that cause tu­mor growth. Rather than cre­at­ing a drug to in­flu­ence this process, Vi­jayan’s goal is to de­grade the pro­teins here al­to­geth­er.

With the new fund­ing Thurs­day, Plex­i­um will have enough cash for the next two years, al­low­ing the com­pa­ny to nom­i­nate a pro­gram for clin­i­cal de­vel­op­ment by the end of 2021 and hope­ful­ly wrap up IND-en­abling stud­ies as 2022 comes to a close.

Thurs­day’s fund­ing was led by Lux Cap­i­tal and Piv­otal bioVen­tures, with par­tic­i­pa­tion from The Col­umn Group, DCVC Bio and oth­er cur­rent in­vestors.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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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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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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CEO David Campbell (Janux)

Fresh off $1B+ Mer­ck deal, Janux locks down first pri­vate fundraise for its T cell en­gagers

Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers.

As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.

Rachel Haurwitz, Caribou CEO (Kimberly White/Getty Images for TechCrunch)

A Jen­nifer Doud­na-launched up­start nabs $115M for off-the-shelf CAR-Ts

There is no shortage of biotechs pursuing off-the-shelf CAR-Ts, a so-called Holy Grail in oncology R&D. Now, less than a month after teaming up with AbbVie, a California player launched by CRISPR pioneer Jennifer Doudna has returned to the venture well, scooping up a big crossover round to help it along.

Caribou Biosciences took the wraps off a $115 million Series C on Wednesday morning, bringing their total raise to around $157 million, CEO Rachel Haurwitz said.

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