A se­r­i­al biotech start­up team is back in busi­ness, armed with $40M and a fo­cus on NASH

Bob Bal­tera

Bob Bal­tera’s last stint as a biotech CEO was brief. In less than a year at the helm of La­gu­na he and the com­pa­ny pro­duced some in­ter­est­ing late-stage da­ta and a trou­bling set of safe­ty is­sues that scut­tled their work on atri­al fib­ril­la­tion.

“We shut that down and gave about half of the mon­ey (which would have been about $15 mil­lion) back to the in­vestors,” he tells me in an ex­pe­ri­enced tone that sug­gests some things in this busi­ness just don’t work out the way you want it.

Howard Dit­trich

But out of that fast fail came a new op­por­tu­ni­ty. Fra­zier Health­care Part­ners ap­proached Bal­tera — who suc­ceed­ed in turn­ing Ami­ra in­to a very lu­cra­tive M&A deal with Bris­tol-My­ers in a $475 mil­lion deal back in 2011 — and two col­leagues, Howard Dit­trich and Bri­an Farmer, of­fer­ing to keep the team to­geth­er as en­tre­pre­neurs-in-res­i­dence. And to­day they’re step­ping out with their next ven­ture, armed with a $40 mil­lion Se­ries A led by Fra­zier and No­vo A/S.

The com­pa­ny is Cir­ius Ther­a­peu­tics, for­mer­ly Octe­ta, a Kala­ma­zoo, MI-based com­pa­ny that had been spun out of a lo­cal out­fit to go af­ter NASH and liv­er fi­bro­sis — two big-mar­ket tar­gets that have aroused a va­ri­ety of late-stage tries with vary­ing ther­a­peu­tic strate­gies. At Cir­ius, the tar­get is in­sulin sen­si­ti­za­tion, which has been a key fo­cus in the field.

Bri­an Farmer

“If you look at NASH,” says Bal­tera, about half of all pa­tients are Type 2 di­a­bet­ics. “It ap­pears that in­sulin re­sis­tance is re­al­ly a trig­ger of liv­er dis­or­der, and there’s been some clin­i­cal work that looks at first-gen­er­a­tion in­sulin sen­si­tiz­ers, which showed a large im­pact on the dis­ease.”

But there have al­so been safe­ty is­sues that would threat­en any drug head­ed for a mass mar­ket. Cir­ius will set out to cre­ate a next-gen in­sulin sen­si­tiz­er with­out the safe­ty is­sues dri­ven by PPAR gam­ma. Co-founder Jer­ry Col­ca, who worked on Ac­tos (pi­ogli­ta­zone), is be­hind the new ef­fort to de­vel­op their ex­per­i­men­tal drug, MS­DC-0602K. Back in 2013, he put a sim­i­lar drug through mid-stage tests on Type 2 di­a­betes be­fore switch­ing fo­cus.

There’s an on­go­ing Phase IIb of MS­DC-0602K that will wrap in 2019, which should pro­vide sol­id safe­ty and ef­fi­ca­cy da­ta to show if they’re on the right track to Phase III.

Bal­tera and his crew are stay­ing in San Diego, with a hand­ful of re­search staffers re­main­ing in Kala­ma­zoo. Right now, they to­tal about 10 and the CEO doesn’t ever ex­pect that head count to get past 15.

Small com­pa­ny. Sin­gle as­set. Po­ten­tial­ly a ma­jor mar­ket drug with a huge Phase III re­quire­ment. That’s the pro­file of a com­pa­ny styling it­self for a trade sale ahead of a piv­otal pro­gram, which few pri­vate, ven­ture-backed biotechs could ever af­ford to pay for.

Bal­tera is quick to con­cede that a post-Phase IIb sale could be one suc­cess­ful out­come. But he of­fers one oth­er sce­nario: Mount­ing an IPO and us­ing the mon­ey from that to pay for Phase III.

Sums up Bal­tera: “All op­tions are on the ta­ble.”

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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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

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.

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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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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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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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.