Mark Smith (Finch)

Past a turn­ing point, Finch scores $90M to com­plete the fi­nal stretch for oral mi­cro­bio­me ther­a­py

Back in 2017, Finch Ther­a­peu­tics was born, shroud­ed in the ash­es of an im­plo­sion at Seres Ther­a­peu­tics that cloud­ed the whole mi­cro­bio­me field. But co-founder Mark Smith man­aged to pool to­geth­er some an­gel mon­ey and a $5.5 mil­lion Se­ries A be­fore land­ing $10 mil­lion up­front from a pact with Take­da.

Smith slow­ly at­tract­ed more be­liev­ers — rack­ing up a break­through ther­a­py des­ig­na­tion, grab­bing a new lead pro­gram through a merg­er with Cresto­vo, ex­pand­ing the Take­da part­ner­ship — and brought in $53 mil­lion in Se­ries B cash to fund a cru­cial Phase II study.

The da­ta came in June, right ahead of the dead­line Smith has set for his team. And they were pos­i­tive.

That trig­gered a phase shift, Smith said. Even in­vestors who have been sit­ting on the side­lines are chim­ing in for a $90 mil­lion C round, de­signed to pro­pel Finch in­to the fi­nal con­fir­ma­to­ry study and get the com­mer­cial-scale man­u­fac­tur­ing set­up in place.

“We’ve been re­al­ly build­ing up to this sum­mer for quite a long time,” he told End­points News. “Now all of a sud­den every­one is like, ‘Oh wait, this could be the next big modal­i­ty, we want to make sure we don’t miss it.’”

Next stop: A sec­ond tri­al test­ing CP101 in C. dif­fi­cile to con­firm that the oral cap­sule can in­deed cure pa­tients and pre­vent the in­fec­tion from re­turn­ing, up to eight weeks. Slat­ed for the first half of 2021, the study will like­ly have a sim­i­lar de­sign and size with PRISM-3 — where, among 206 pa­tients, those giv­en CP101 had a 74.5% chance of re­cur­rence-free bac­te­ria clear­ance ver­sus 61.5% on the place­bo arm.

Al­most a decade in­to a ca­reer en­trenched in the mi­cro­bio­me (start­ing with the stool bank Open­Bio­me), Smith sees Finch’s da­ta con­tribut­ing to a turn­ing point for the idea that one can pack all the ben­e­fits of a fe­cal mi­cro­bio­ta trans­plant (FMT) in­to a pill and skip the cum­ber­some pro­ce­dure. Hav­ing clin­i­cal da­ta be­hind FMT is a “unique su­per­pow­er” — but the chal­lenge has been to pre­serve those ben­e­fits in the trans­la­tion process.

Seres took more risk, Smith sug­gest­ed, in go­ing fast. The sci­en­tists there had se­lect­ed cer­tain bac­te­ria that they thought had the best ef­fects to make their drug can­di­date — which failed a Phase II.

In con­trast, Finch takes the en­tire com­mu­ni­ty of bac­te­ria present in donor sam­ples and, af­ter screen­ing for pathogens, freeze-dries the ma­te­r­i­al, mills it, and puts the re­sult­ing pow­der in a cap­sule. And un­like with blood prod­ucts, where you need 330,000 donors to de­liv­er a mil­lion units of blood, Smith said it on­ly takes 2,000 donors to make a mil­lion units of CP-101 — which pa­tients on­ly need to take once, at least for C. diff.

For its part, Seres con­clud­ed that mis­di­ag­no­sis con­tributed to the fail­ure, and just re­cent­ly claimed a come­back with a new Phase III read­out that they said should take them straight to the FDA.

To be sure, Finch isn’t rul­ing out the po­ten­tial val­ue of iso­lat­ing in­di­vid­ual bac­te­ria and grow­ing them ar­ti­fi­cial­ly. CP101 is their on­ly full spec­trum prod­uct, Smith point­ed out. Both the ul­cer­a­tive col­i­tis and Crohn’s com­pounds in the Take­da col­lab­o­ra­tion are “ra­tio­nal­ly de­signed,” con­sist­ing of in­di­vid­ual or­gan­isms that ap­pear to be dri­ving pos­i­tive out­comes across clin­i­cal stud­ies of FMT.

Then there’s FIN-211, the hy­brid pro­gram for autis­tic con­sti­pa­tion that com­bines CP101 with a spe­cial strain, not found in most donor sam­ples, that seemed im­por­tant in in­duc­ing oxy­tocin pro­duc­tion in the lab.

The first-in-hu­man study should take place lat­er in 2021, fol­low­ing an­oth­er tri­al for CP101 in chron­ic he­pati­tis B. Emerg­ing re­search in the gut-brain ax­is sug­gests FIN-211 might have an im­pact on be­hav­ioral symp­toms of autism — some­thing Smith said Finch would mon­i­tor as they stay close to their roots in GI.

“The way I think about this space in gen­er­al, I sort of see this jour­ney of re­duc­tion­ism where we’re gonna start off with, OK, just take the en­tire in­tact com­mu­ni­ty from a healthy donor, de­liv­er that to pa­tients, see if that works. Over time, we’ll iden­ti­fy the in­di­vid­ual bugs that make it work, iso­late those, de­vel­op those as ther­a­pies. and maybe some­day we’ll fig­ure out the spe­cif­ic ef­fec­tor mol­e­cules that are dri­ving those ef­fects and de­liv­er those as third gen­er­a­tion prod­ucts,” he said. “We want to crawl be­fore we walk be­fore we run.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.

Work taking place in the clean rooms at Vor (Credit: Vor)

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

While it is not uncommon for a biotech to go down the route of having the product manufactured by a contract organization, one small biotech is looking to keep its card close to its chest.

Vor Biopharma has started manufacturing operations at an in-house facility at its HQ in Cambridge, MA after beginning construction last summer.

According to the biotech, the facility aims to develop Vor’s hematopoietic stem cells (eHSCs) and CAR-T therapies for patients with blood cancers. The site will initially manufacture a clinical supply of its candidate VCAR33allo to support its IND, which is slated to be submitted in the first half of next year. It also plans to transfer the production of VOR33 to the facility. Vor is getting to work quickly as engineering runs for VCAR33allo has started this week.

Aim­ing for fourth nod, Sarep­ta files an­oth­er DMD gene ther­a­py to FDA; Ax­some head­ed to­ward mi­graine re­sub­mis­sion

Sarepta Therapeutics has filed the data needed for an FDA accelerated approval, which would be the biotech’s fourth if granted by the agency.

The biotech has yet to complete confirmatory trials for those first three conditional nods. The filing for its fourth Duchenne muscular dystrophy treatment, disclosed Thursday, is not a surprise. Sarepta said in late-July it would do so after releasing positive results for the Roche-partnered gene therapy.

Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US government is all set to buy $10.7 million worth of Siga Technologies’ monkeypox oral antiviral, the company announced Thursday.

Of the total doses, $5.1 million worth of oral antivirals called Tpoxx (tecovirimat) will be delivered this year, with the US Department of Defense having the option of buying the rest at a later point.

The new contract follows an earlier one in which the government had purchased $7.4 million worth of Tpoxx from the company.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,200+ biopharma pros reading Endpoints daily — and it's free.