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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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FDA's ODAC shrugs off ob­jec­tions to Mesoblast's GVHD drug for chil­dren, vot­ing 8-2 in fa­vor and im­prov­ing the odds of an ap­proval

The FDA’s Oncologic Drugs Advisory Committee once again waved through an investigational drug, clearing the potential final hurdle before the agency’s decision.

Thursday’s winner was Mesoblast $MESO, an Australian stem-cell company that submitted its Ryoncil drug for the treatment of steroid refractory acute graft-versus-host disease in children younger than 12. ODAC gave Ryoncil the thumbs up by an 8-2 vote, shrugging off concerns about trial design and pushing aside the need for an additional study.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.