Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal tri­al

With a break­through des­ig­na­tion in one hand and a fresh $53 mil­lion in ven­ture back­ing in the oth­er, Somerville, MA-based Finch Ther­a­peu­tics is tak­ing a shot at a one-tri­al path­way to a pos­si­ble FDA OK for their new treat­ment for pre­vent­ing re­cur­rent C. dif­fi­cile in­fec­tions.

The fund­ing brings their to­tal raise for the mi­cro­bio­me com­pa­ny to $130 mil­lion, CEO Mark Smith tells me — enough mon­ey to pave a run­way past the FDA ap­proval they’ve sketched in­to the most op­ti­mistic ver­sion for their near-term fu­ture. 

Smith says that based on their talks with reg­u­la­tors, the FDA would be sat­is­fied if they could see high ef­fi­ca­cy in this tri­al. If the p val­ue comes in low­er, it would serve as the first of two, with reg­u­la­tors look­ing for con­fir­ma­tion of the ef­fect in a fol­low-up study.

Based on ear­li­er re­sults, Smith says a win­ning com­par­i­son would be around 80% ef­fi­ca­cy in the treat­ment arm com­pared to a con­trol arm ef­fect — where pa­tients just get an­tibi­otics — in the 40% to 50% mark.

“We were re­al­ly pleased with the out­come of the con­ver­sa­tion,” says the CEO.  “It’s a high bar for the ef­fect size we’re look­ing for.”

It’s no sure thing. Finch — who struck a deal to col­lab­o­rate with Take­da on IBD — is work­ing with da­ta they gath­ered in a small study, where they saw an 88% rate of ef­fi­ca­cy. Ef­fi­ca­cy was de­fined as two months with no re­cur­rence of the C. diff. That per­suad­ed them to see if they could blaze a path for­ward with a sin­gle piv­otal study, which would take them past a num­ber of ri­vals al­so fo­cused on the same tar­get.

That ef­fect, though, is “right in line” with fe­cal trans­plan­ta­tion. So why not con­tin­ue with the fe­cal ma­te­r­i­al?

In part be­cause it in­volves a pro­ce­dure, Smith replies, which a ther­a­py would cut out of the equa­tion. Sec­ond, if they can land an FDA ap­proval, reg­u­la­tors will like­ly re­quire the ap­proved ther­a­py over fe­cal trans­plan­ta­tion, which is still ex­per­i­men­tal. In ad­di­tion, the FDA is wary about fe­cal trans­plan­ta­tion, re­cent­ly not­ing a death due to an in­fec­tion from a mul­ti-drug re­sis­tant or­gan­ism picked up in one pro­ce­dure. 

Smith has some in­sights in­to the fe­cal trans­plan­ta­tion world gar­nered from a front-row seat. He’s been build­ing Finch Ther­a­peu­tics on the foun­da­tion pro­vid­ed by Open­Bio­me, a fe­cal trans­plant com­pa­ny he found­ed. And he’s been en­gi­neer­ing new prod­ucts based on that ex­pe­ri­ence with the gut.

And they’ve been mov­ing fast, pick­ing up their lead drug CP101 in a merg­er with Cresto­vo — which brought in ad­di­tion­al sup­port from Chris Shumway of Shumway Cap­i­tal — ex­e­cut­ing a $36 mil­lion C round a lit­tle more than a year ago.

Their time­line takes them to a tri­al read­out in H1 2020.

Suc­cess here would al­so ac­cel­er­ate their work on autism, which fol­lows up on some ev­i­dence that fe­cal trans­plan­ta­tion has an ef­fect here as well.

New in­vestors in­clud­ing OCV Part­ners, Susque­han­na In­ter­na­tion­al Group and Trans-Pa­cif­ic Tech­nol­o­gy Fund jumped in to the syn­di­cate, along­side ex­ist­ing in­vestors Avenir Growth Cap­i­tal, Mor­gan No­ble, Shumway Cap­i­tal, and Wil­lett Ad­vi­sors.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Robert Davis, Merck CEO

Mer­ck shares slide as re­sponse to its oral Covid an­tivi­ral plunges on lat­est up­date

After a second look, Merck says that its big breakthrough on the Covid front doesn’t look so good.

The pharma giant updated its data on its oral antiviral molnupiravir on Friday, and said that its drug reduced the rate of hospitalization and death by 30% — a sharp plunge from the 50% rate reported at the beginning of October during their interim readout.

And the news sparked a sharp retreat on Merck’s shares, which fell 4% ahead of the bell on Friday.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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