Four IPOs and a SPAC pitch a new slate of mi­cro­bio­me, can­cer and in­flam­ma­to­ry drugs to Wall Street

Biotech IPOs are still com­ing in all sorts of fla­vors these days.

Just look at what’s on the menu from Fri­day: There’s Finch Ther­a­peu­tics, which needs the mon­ey to com­plete a sec­ond piv­otal tri­al and start plot­ting com­mer­cial­iza­tion of its mi­cro­bio­me-based prod­ucts; Con­nect Bio­phar­ma, a Chi­nese out­fit go­ing through mid-stage stud­ies in T cell-dri­ven in­flam­ma­to­ry dis­eases; In­stil Bio, whose team is try­ing to ride a com­pas­sion­ate use pro­gram with their au­tol­o­gous tu­mor in­fil­trat­ing lym­pho­cytes straight in­to Phase II; Transcode Ther­a­peu­tics, an un­der-the-radar can­cer ther­a­py de­vel­op­er lever­ag­ing mul­ti­ple RNA modal­i­ties; and then there’s a SPAC — Fore­site Cap­i­tal’s third.

With the ex­cep­tion of Transcode, all the pub­lic com­pa­ny wannabes pen­ciled in $100 mil­lion in their ini­tial fil­ings, a num­ber that’s in­creas­ing­ly un­re­li­able as a place­hold­er. Fore­site, mean­while, is look­ing to raise $250 mil­lion for its blank check com­pa­ny.

To keep up to date with the tra­vails of all biotechs go­ing pub­lic, check out the End­points News IPO Track­er.

Now 2-in-1, Finch Ther­a­peu­tics looks to turn the cor­ner on mi­cro­bio­me ther­a­pies

When Mark Smith helped start the non­prof­it stool bank Open­Bio­me in 2012, there weren’t re­li­able, stan­dard­ized ways to man­u­fac­ture and dis­trib­ute stool prepa­ra­tions for fe­cal mi­cro­bio­ta trans­plants. More than eight years lat­er, he be­lieves new al­ter­na­tives are on the hori­zon.

Finch Ther­a­peu­tics’ S-1 dropped just days af­ter Open­Bio­me an­nounced it’s phas­ing out pro­duc­tion of new treat­ments, with an aim to save enough in­ven­to­ry to meet de­mand through­out 2021 “as a bridge to FDA-ap­proved ther­a­pies.”

The biotech wants to bring one of those ther­a­pies to the mar­ket. CP101, a cap­sule made of freeze-dried stool sam­ples from healthy donors, has hit the mark on re­cur­rence-free bac­te­ria clear­ance for pa­tients with a C. dif­fi­cile in­fec­tion — re­sults that Smith, co-founder and CEO at Finch, said came at a turn­ing point for the field. Af­ter some ear­ly fail­ures and im­plo­sions, sci­en­tists may have found the right way to pack all the ben­e­fits of a fe­cal mi­cro­bio­ta trans­plant (FMT) in­to a pill and skip the cum­ber­some pro­ce­dure.

A sec­ond, con­fir­ma­to­ry tri­al is ex­pect­ed to be­gin not long af­ter Finch lands on Nas­daq and should read out in 2023.

The biotech is al­so plan­ning oth­er clin­i­cal stud­ies in chron­ic he­pati­tis B, in­flam­ma­to­ry bow­el dis­ease and autism spec­trum dis­or­der — the lat­ter in­volv­ing dif­fer­ent pills with se­lect strains of mi­crobes in­stead of all of them.

They will be do­ing it with some as­sets pur­chased from Open­Bio­me, in­clud­ing the bi­o­log­i­cal sam­ples ac­crued over the years and tech­nol­o­gy so that they can “in­ter­nal­ize some of func­tions for which we have pre­vi­ous­ly re­lied on Open­Bio­me,” ac­cord­ing to a fil­ing. The whole deal will cost around $5 mil­lion.

Con­nect Bio­phar­ma wants to take on Dupix­ent

Found­ed by two old pals whose friend­ship traces back to a uni­ver­si­ty in Guangzhou, Chi­na, Con­nect Bio­phar­ma had snagged $115 mil­lion from a slate of mar­quee in­vestors back in Au­gust.

RA Cap­i­tal Man­age­ment led the Se­ries C while Lil­ly Asia Ven­tures, Box­er Cap­i­tal and HBM Health­care In­vest­ments, Qim­ing and Ad­van­tech chimed in.

The main draw? A pipeline of im­mune mod­u­la­tors, led by an an­ti-IL-4Ra an­ti­body, that can treat in­flam­ma­to­ry al­ler­gic dis­eases such as atopic der­mati­tis, asth­ma, and chron­ic rhi­nos­i­nusi­tis with nasal polyps. These are big in­di­ca­tions chased by some of the top names in the glob­al bio­phar­ma world — in fact, the lead drug hits the same tar­get as Re­gen­eron and Sanofi’s Dupix­ent — but Con­nect be­lieves the as­says they used in drug dis­cov­ery could make them a best-in-class con­tender.

The big re­veal will come in the sec­ond half of 2021, when topline Phase IIb re­sults are due.

In­stil Bio seeks a spot among emerg­ing TIL play­ers

By div­ing in­to tu­mor-in­fil­trat­ing lym­pho­cytes, In­stil Bio faces some high-pro­file com­pe­ti­tion not just with TIL play­ers like Io­vance, Adap­ti­m­mune and PACT Phar­ma but al­so CAR-T and TCR-T cell ther­a­py de­vel­op­ers like Gilead’s Kite and Bris­tol My­ers Squibb’s Juno.

Yet the Dal­las-based biotech is all-in on the tech plat­form — in­clud­ing the man­u­fac­tur­ing know-how — it first in-li­censed then ac­quired from Im­meta­cyte, a Uni­ver­si­ty of Man­ches­ter spin­out that’s been run­ning a com­pas­sion­ate use pro­gram at a UK hos­pi­tal for eight years.

Since its found­ing in 2018, it’s raised $380 mil­lion of ven­ture fund­ing to get here.

The plan now is to sub­mit an IND to the FDA — its first — and jump straight in­to a Phase II tri­al for melanoma lat­er this year, which In­stil hopes can sup­port a BLA sub­mis­sion as ear­ly as 2023.

Giv­en how fre­quent­ly CMC is­sues trip up cell and gene ther­a­pies these days, though, there’s like­ly a long way to go for its in-house man­u­fac­tur­ing crew.

An un­der-the-radar RNA play­er of­fers some de­liv­ery so­lu­tions

Found­ed and led by CRO vet Michael Dud­ley, Boston-based Transcode Ther­a­peu­tics is fo­cused on de­liv­er­ing RNA drugs to where they are need­ed to kill can­cer.

And they are am­bi­tious.

The lead can­di­date is de­signed to treat metasta­t­ic can­cer, mean­ing tu­mors in the breast, pan­creas, ovary, colon or even the brain.

“To date, re­search in­to RNA ef­fi­ca­cy has been lim­it­ed due to three de­liv­ery-re­lat­ed chal­lenges: pro­tect­ing the RNA from be­ing dis­man­tled by the im­mune sys­tem; main­tain­ing sta­bil­i­ty so the mol­e­cule has time to do its job; and pen­e­trat­ing the tar­get­ed or­gans and cells,” the S-1 read. “Our strat­e­gy seeks to over­come these de­liv­ery chal­lenges by re­pur­pos­ing a par­ti­cle used ex­ten­sive­ly in hu­mans for imag­ing pur­pos­es to de­liv­er syn­thet­ic RNA mol­e­cules (called oligonu­cleotides) to can­cer cells.”

Fore­site wants one more blank check at its dis­pos­al

Hav­ing com­plet­ed the merg­er for its first SPAC and raised $175 mil­lion for a sec­ond, Fore­site has made it clear that it views SPACs as an ex­ten­sion of its ven­ture in­vest­ing busi­ness.

“Hav­ing that as an op­tion for an en­tre­pre­neur that is with­in the Fore­site fam­i­ly, we think it’s a nice op­tion,” man­ag­ing di­rec­tor Michael Rome told End­points News re­cent­ly. “So re­al­ly we view the SPAC as sort of a — some­thing we can of­fer a com­pa­ny.”

On the hunt for com­pa­nies de­ploy­ing tech to solve biotech prob­lems, they can get quite spe­cif­ic with the kind of tar­gets to merge with, as the $216 mil­lion deal with Gem­i­ni Ther­a­peu­tics showed.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.