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.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Raul Rodriguez, Rigel Pharma CEO

Rigel Phar­ma scores FDA ap­proval for leukemia, kick­ing off show­down with Servi­er in IDH1

When Rigel Pharma bought olutasidenib from Forma Therapeutics, it acquired a drug that already secured a PDUFA date at the FDA — for February 2023. But regulators are ready to give their OK sooner than that.

The FDA has approved the IDH1 inhibitor as a treatment for adult patients with relapsed or refractory acute myeloid leukemia who have a susceptible IDH-1 (isocitrate dehydrogenase-1) mutation as detected by an FDA-greenlit test. Rigel will market it as Rezlidhia.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Philip Tagari switch­es Am­gen's dis­cov­ery lab for in­sitro's ma­chine learn­ing tools; CEO Joaquin Du­a­to to chair J&J's board

In February, Philip Tagari will take a few days of retirement and then immediately return to industry. He won’t be leading the therapeutics discovery unit for a large biopharma, though.

He’ll trade in his Amgen hat for chief scientist at a machine learning startup that has reeled in hundreds of millions in capital to lay the groundwork for a much-hyped new model of drug discovery that aims to speed up the time to new clinical assets.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”