Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

Spring­Works and Sat­suma — both biotech spin­outs that have closed B rounds in April — are load­ing up with IPO cash to boost their re­spec­tive late-stage plans.

Spring­Works

Lara Sul­li­van

Bain-backed Spring­Works is the bet­ter-known com­pa­ny of the two, and it’s gun­ning for a larg­er wind­fall of $115 mil­lion to add to $228 mil­lion from pre­vi­ous fi­nanc­ings. In the process, the Stam­ford, CT-based team is al­so draw­ing the cur­tains on the part­ner­ships it has in mind for the pair of as­sets it had ini­tial­ly li­censed from Pfiz­er.

To be sure, the com­pa­ny is still flush with cash. In an SEC fil­ing, Spring­Works says it’s been go­ing through the $102 mil­lion Se­ries A for the op­er­a­tions, with $185.3 in cash and cash equiv­a­lents re­main­ing at last count. The new in­fu­sion from a pub­lic de­but should ex­tend the run­way to 2022.

Pfiz­er’s Lara Sul­li­van got the sup­port in Au­gust 2017 to split off four promis­ing as­sets that nev­er­the­less didn’t make the in­ter­nal R&D cut in­to a new shop. As soon as the deal was sealed ex­ecs got to work re­pur­pos­ing the drugs for rare tu­mors, rack­ing up or­phan drug and fast track des­ig­na­tions along the way. Nirogace­s­tat, a gam­ma sec­re­tase in­hibitor, is in a Phase III tri­al for the treat­ment of desmoid tu­mors (rare soft tis­sue tu­mors); mir­dame­tinib, a MEK in­hibitor, is be­ing test­ed in Phase IIb for neu­rofi­bro­mato­sis type 1-as­so­ci­at­ed plex­i­form neu­rofi­bro­mas.

Both of these tar­gets are well de­fined, with mul­ti­ple tri­als for re­lat­ed drugs over the past decade or more. The gam­ma sec­re­tase in­hibitor was born in the Alzheimer’s field, where Eli Lil­ly ex­pe­ri­enced a colos­sal dis­as­ter years ago. That MEK in­hibitor, Spring­Works ex­ecs say, al­so has po­ten­tial to make good as a back­bone com­bi­na­tion drug in on­col­o­gy, fol­low­ing oth­er ap­proved ther­a­pies. In fact, Pfiz­er had re­cent­ly bagged one such drug — Mek­tovi — in its $11.4 bil­lion buy­out of Ar­ray Bio­phar­ma.

With po­ten­tial­ly reg­is­tra­tional tri­als on the way, Pfiz­er stands to re­ceive $462 mil­lion in mile­stones — or more if Spring­Works in-li­cens­es some of the com­pounds that the phar­ma gi­ant has agreed to make avail­able once a year un­til next Oc­to­ber.

Mean­while, Saqib Is­lam, who was pro­mot­ed to CEO af­ter serv­ing as the first CFO and CBO, has al­so cham­pi­oned a cou­ple of col­lab­o­ra­tions with BeiGene and Glax­o­SmithK­line.

The for­mer fea­tures a Phase Ib com­bo tri­al of mir­dame­tinib and li­fi­rafenib for a one-two punch of MEK and RAF in sol­id tu­mors. The lat­ter pairs nirogace­s­tat with be­lan­tam­ab mafodotin, an an­ti-BC­MA ADC that GSK R&D chief Hal Bar­ron has tout­ed for tough cas­es of mul­ti­ple myelo­ma.

Then there’s BGB-3245, a pre­clin­i­cal BRAF in­hibitor from BeiGene that cov­ers both V600 and non-V600 BRAF mu­ta­tions. Owned by a joint ven­ture with the Chi­na-based part­ner dubbed Map­Kure, the drug can even­tu­al­ly form the back­bone of a reg­i­men (again, to­geth­er with mir­dame­tinib) that com­petes di­rect­ly with Pfiz­er.

For all his ef­forts Is­lam was re­ward­ed with a com­pen­sa­tion pack­age worth more than $1.7 mil­lion, the ma­jor­i­ty of which was in stock. Sul­li­van, the for­mer pres­i­dent, re­ceived close to $1.3 mil­lion in 2018.

Sat­suma

John Kollins and his team at Sat­suma Phar­ma­ceu­ti­cals have been much more laser-fo­cused, but still busy. The San Fran­cis­co biotech closed a $62 mil­lion Se­ries B in April, bring­ing in a slate of new in­vestors, and jumped right in­to a Phase III ef­fi­ca­cy tri­al for its mi­graine drug/de­vice last month. Now it’s look­ing to pile up its cash re­serves as it pen­cils in a $86 mil­lion IPO.

The com­pa­ny was spun out of Japan’s Shin Nip­pon Bio­med­ical Lab­o­ra­to­ries two years ago with a sin­gu­lar mis­sion: To de­vel­op a dry-pow­der nasal for­mu­la­tion of the gener­ic drug di­hy­droer­go­t­a­mine, de­liv­ered by a tech from the par­ent com­pa­ny.

DHE works by tight­en­ing blood ves­sels in the brain and in­hibit­ing the re­lease of pro-in­flam­ma­to­ry sub­stances. Un­like the much-watched CGRP class, it is de­signed for acute treat­ment in­stead of pre­ven­tion. Al­though nasal sprays are cur­rent­ly avail­able, they are gen­er­al­ly con­sid­ered less ef­fec­tive than the in­jectable ver­sions — some­thing Sat­suma is out to change.

A Phase I tri­al among 42 healthy vol­un­teers showed that STS101 in­duced the tar­get DHE plas­ma con­cen­tra­tion with­in 10 min­utes, and hit all mea­sures of drug ex­po­sure.

Sat­suma in­tends to re­cruit 1,140 pa­tients for the Phase III study it’s just kick­start­ed, re­lease topline da­ta and com­mence a 12-month safe­ty tri­al in Q2 2020, then file an NDA by the end of 2021.

CEO Kollins — an alum of Athena Neu­ro­sciences and Am­gen-ac­quired Im­munex — and his head of op­er­a­tions, Mic Iwashima, have spent $23.9 mil­lion ex­e­cut­ing the quick leap to late-stage de­vel­op­ment. There’s still $47.6 mil­lion in the bank, in­clud­ing a $5 mil­lion loan from Sil­i­con Val­ley Bank. The cur­rent head­count of full-time em­ploy­ees sits at 11.

To re­al­ize all of its plans, though, Sat­suma will like­ly need to ex­pand dras­ti­cal­ly. From the S-1:

If ap­proved, we plan to com­mer­cial­ize STS101 in the Unit­ed States by build­ing a spe­cial­ized sales or­ga­ni­za­tion fo­cus­ing on headache spe­cial­ists, as well as gen­er­al neu­rol­o­gists and pri­ma­ry care physi­cians who are high pre­scribers of mi­graine ther­a­peu­tics.

Its plans to seek ex-US part­ners for the drug al­so calls for a larg­er busi­ness de­vel­op­ment team.

For now, though, much of the IPO pro­ceeds should go to­ward the Phase III tri­als.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.