News brief­ing: Boehringer In­gel­heim ex­pands pro­tein degra­da­tion ef­forts; Pfiz­er en­lists a new AI part­ner

Boehringer In­gel­heim is ex­pand­ing its ef­forts in pro­tein degra­da­tion, sign­ing a pact with the Aus­tri­an biotech Prox­y­gen to de­vel­op a tech­nol­o­gy known as “mol­e­c­u­lar glue de­graders.”

Sim­i­lar to the PRO­TACS that com­pa­nies have fo­cused on to date, mol­e­c­u­lar glue de­graders are de­signed to bridge pro­teins to the body’s own in­ter­nal dis­pos­al sys­tem, al­low­ing re­searchers to tar­get pro­teins that can’t be hit by tra­di­tion­al small mol­e­cules. The mul­ti­ple myelo­ma drugs Revlim­id and Po­m­a­lyst work in this man­ner. Found­ed in 2016, Prox­y­gen has worked to de­vel­op meth­ods of sys­tem­at­i­cal­ly find­ing new ones.

The col­lab­o­ra­tion will fo­cus on can­cer, an ear Boehringer has di­rect­ed much of its pro­tein degra­da­tion work to date. In 2016, the Ger­man com­pa­ny be­came one of the first Big Phar­mas to go in on the field, sign­ing a can­cer pact with the Uni­ver­si­ty of Dundee.  — Ja­son Mast

FDA rolls out red car­pet for Scynex­is’ su­per bug an­tibi­ot­ic.

Scynex­is is get­ting a ready wel­come as it heads for its first an­ti-fun­gal ap­proval.

The New Jer­sey biotech an­nounced Mon­day that its ap­pli­ca­tion for ap­proval for the drug ibrex­a­fungerp for vagi­nal yeast in­fec­tions had been ac­cept­ed and giv­en pri­or­i­ty re­view by the agency. The drug suc­ceed­ed in a 376-per­son Phase III tri­al last year, clear­ing pa­tients of in­fec­tion bet­ter than in­fec­tion.

Vagi­nal yeast in­fec­tion has long been their lead in­di­ca­tions, but Scynex­is al­so be­came fa­mous last year for hav­ing one of the drugs in de­vel­op­ment for Can­di­da Au­ris, a fun­gal in­fec­tion that has cropped up around the world, alarm­ing health of­fi­cials. Stud­ies in that in­di­ca­tion are on­go­ing. — Ja­son Mast

4D is ready to throw down as the red-hot biotech IPO mar­ket rocks on

4D Mol­e­c­u­lar Ther­a­peu­tics is lin­ing up the lat­est IPO in the trendy gene ther­a­py field.

The AAV biotech is look­ing to raise $100 mil­lion-plus from the IPO, auc­tion­ing off close to 5 mil­lion shares at a range of $20 to $25 a share.

Those up­sized num­bers put 4D back in the hunt for the 9-fig­ure sum it had in mind when the ex­ecs first filed to go pub­lic in the fall of 2019.

There have been 82 biotech IPOs count­ed in the US this year, a record num­ber that brought in a chart-top­ping $15 bil­lion in pro­ceeds. And Nas­daq clear­ly isn’t ready to close the win­dow on 2020. — John Car­roll

Pfiz­er col­labs with AI play­er PostEra to de­vel­op new pre­clin­i­cal drug mod­els

Pfiz­er has a new part­ner in the nascent field of gen­er­a­tive chem­istry.

The big phar­ma is team­ing up with PostEra, a San Fran­cis­co com­pa­ny found­ed last year that fo­cus­es on the AI-in­flu­enced field and spe­cial­izes in min­ing large datasets. Fi­nan­cial terms of the deal were not dis­closed, but PostEra re­ceived an up­front pay­ment with po­ten­tial mile­stones avail­able down the road. PostEra not­ed that it will re­tain own­er­ship rights to all al­go­rithms de­vel­oped dur­ing the col­lab­o­ra­tion.

PostEra has de­vel­oped a ma­chine learn­ing-based plat­form that it says de­signs mol­e­c­u­lar struc­tures with op­ti­mized po­ten­cy and drug-like prop­er­ties. Ul­ti­mate­ly, PostEra hopes that its mod­el can help ac­cel­er­ate the drug de­vel­op­ment process.

Mon­day’s col­lab­o­ra­tion will pair Pfiz­er’s vast reach and re­sources with PostEra’s tech­nol­o­gy, in an ef­fort to both ad­vance the field of gen­er­a­tive chem­istry and pro­duce scal­able mod­els for in-house, pre­clin­i­cal drug dis­cov­ery projects.

The com­pa­ny orig­i­nal­ly spawned out of aca­d­e­m­ic re­search from the Uni­ver­si­ty of Cam­bridge. Ear­li­er this year, PostEra al­so launched Covid Moon­shot, a crowd­sourced ini­tia­tive to speed the de­vel­op­ment of an an­tivi­ral for Covid-19. — Max Gel­man

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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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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Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

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.

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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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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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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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.