News brief­ing: Four biotechs an­nounce IPO terms, set­ting the pace to round out a busy year; FDA sets PDU­FA date for Kad­mon's graft-ver­sus-host drug

Four more biotechs set the terms for their IPOs, lin­ing up yet an­oth­er busy week on Wall Street.

Sil­ver­back Ther­a­peu­tics, which ini­tial­ly filed for a $100 mil­lion raise, is now shoot­ing for $125 mil­lion from 7 mil­lion shares at a range of $17 to $19. About $70 mil­lion is tagged for the com­pa­ny’s lead Phase I/Ib an­ti­body-drug con­ju­gate, SBT6050, for ad­vanced or metasta­t­ic HER2-ex­press­ing sol­id tu­mors. In­ter­im da­ta from the Phase I dose-es­ca­la­tion co­horts are ex­pect­ed in the sec­ond half of 2021. An­oth­er $55 mil­lion is set aside for Sil­ver­back’s two oth­er can­di­dates, which have yet to reach the clin­ic.

Kin­nate Bio­phar­ma is look­ing for a $170 mil­lion raise, and set a $16 to $18 range for its 10 mil­lion share of­fer­ing. About $105 is ear­marked for its RAF in­hibitors, in­clud­ing its lead pre­clin­i­cal can­di­date KIN002787 for pa­tients with lung can­cer, melanoma and oth­er sol­id tu­mors. An IND is com­ing in the first half of 2021, the com­pa­ny says. Back in Au­gust, it hooked a $98 mil­lion Se­ries C.

Seer al­so set its shares at a $16 to $18 range. The com­pa­ny, which is work­ing on next-gen pro­teome analy­sis tests, is of­fer­ing 8.8 mil­lion shares, go­ing for a $150 raise. About $65.0 mil­lion would go to its Pro­teo­graph Prod­uct Suite, which al­ready has one col­lab­o­ra­tor and could have a sec­ond by the end of the year.

Sig­ilon Ther­a­peu­tics is seek­ing $101 mil­lion from 5.6 mil­lion shares at a $17 to $19 range. Be­tween $30 to $35 mil­lion will be set aside for its lead can­di­date, SIG-001, which is in a Phase I/II tri­al to pre­vent bleed­ing episodes in pa­tients with he­mo­phil­ia A. An­oth­er $30 to $35 mil­lion would fund a scale-up of the com­pa­ny’s GMP man­u­fac­tur­ing process­es SIG-001 and SIG-005, its pre­clin­i­cal can­di­date for pa­tients with mu­copolysac­cha­ri­do­sis type 1, or MPS-1.

More than 72 biotech and bio­phar­ma com­pa­nies and count­ing have hit Nas­daq so far this year, and head of health­care list­ings Jor­dan Saxe pre­dict­ed round­ing out the year with just un­der $14 bil­lion in pro­ceeds.

FDA sets PDU­FA date for Kad­mon’s graft-ver­sus-host drug

Kad­mon’s chron­ic graft-ver­sus-host drug belu­mo­sudil is in the FDA’s hands.

The agency ac­cept­ed the biotech’s NDA un­der its re­al-time on­col­o­gy re­view (RTOR) pi­lot pro­gram, and set the PDU­FA date for May 30, 2021. The sub­mis­sion was based on pos­i­tive re­sults from a piv­otal, open-la­bel tri­al dubbed ROCK­star, which en­rolled 132 pa­tients who had re­ceived at least two pri­or lines of ther­a­py.

Belu­mo­sudil is de­signed to tamp down the in­flam­ma­to­ry re­sponse seen af­ter hematopoi­et­ic stem cell trans­plant by block­ing Rho-as­so­ci­at­ed coiled-coil ki­nase 2 (ROCK2). In­stead of a com­para­tor arm, Kad­mon set the bar at a 30% over­all re­sponse rate, based on con­ver­sa­tions with the FDA. Pa­tients were giv­en 200 mg of the drug ei­ther once or twice dai­ly. At six months af­ter the com­ple­tion of en­roll­ment, Kad­mon saw an ORR of 73% and 75% in the re­spec­tive arms.

That’s it for da­ta, un­til the full re­port is read out at ASH in De­cem­ber. The com­pa­ny’s stock $KDMN was up 6.68% on Mon­day, at $4.39 per share. Kad­mon was found­ed by Sam Wak­sal, the biotech ex­ec who was sen­tenced to prison for his in­sid­er trad­ing con­vic­tion in­volv­ing Martha Stew­art.

Hookipa Phar­ma reads out in­ter­im re­sults from Phase II CMV vac­cine tri­al

Hookipa Phar­ma said no one from a small group of Phase II par­tic­i­pants treat­ed with its pro­phy­lac­tic cy­tomegalovirus vac­cine came down with the dis­ease, ac­cord­ing to in­ter­im re­sults.

The analy­sis was based on 41 par­tic­i­pants — 8 of whom re­ceived 3 dos­es, 19 of whom re­ceived 2 dos­es, and 14 of whom re­ceived a place­bo. Com­pared to the place­bo, re­searchers saw a 48% re­duc­tion in CMV viremia, and a 42% re­duc­tion in the use of an­tivi­ral ther­a­py. There were no cas­es of CMV dis­ease in the treat­ment arm, com­pared to 2 in the place­bo group.

“While these in­ter­im da­ta are from a small group of pa­tients, they of­fer ear­ly in­sight in­to the po­ten­tial of a three-dose sched­ule of HB-101 to help pro­tect kid­ney trans­plant re­cip­i­ents against CMV dis­ease,” CEO Jo­ern Aldag said in a state­ment.

The can­di­date is go­ing head-to-head with Mod­er­na’s mR­NA-1647, which pro­duced pos­i­tive re­sults from a proof-of-con­cept study back in Jan­u­ary. Re­searchers said they saw an in­creas­ing lev­el of neu­tral­iz­ing an­ti­body titers in those who had re­ceived a third vac­ci­na­tion.

“This could re­al­ly be a com­pa­ny builder,” CEO Stéphane Ban­cel said at the time, adding that the can­di­date could turn in­to a $2 bil­lion to $5 bil­lion an­nu­al fran­chise.

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.

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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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.