The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021

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Af­ter a slow cou­ple of weeks, the biotech IPO mar­ket is heat­ing back up with four more com­pa­nies hit­ting Nas­daq.

In­stil Bio, Con­nect Bio­phar­ma, Finch Ther­a­peu­tics and Gain Ther­a­peu­tics are this week’s win­ners, with the fear­some four­some all mak­ing their pub­lic de­buts Thurs­day or Fri­day. In­stil led the way with a heav­i­ly up­sized $320 mil­lion raise, mark­ing the sec­ond-biggest IPO raise of 2021 be­hind Sana, and Con­nect and Finch al­so pulled in nine-fig­ure fund­ing.

By the End­points News tal­ly, there have been 22 com­pa­nies to com­plete their IPO rais­es so far in 2021. The group has com­bined to raise about $3.81 bil­lion.

In terms of ac­tiv­i­ty, noth­ing will like­ly top the first week of Feb­ru­ary any­time soon when 10 — yes, 10 — biotechs made the pub­lic leap. But this week’s four de­buts mark the sec­ond-busiest IPO week of the year.

With $320M megaraise, In­stil seeks to make its mark in the TIL space

In­stil had orig­i­nal­ly pen­ciled $100 mil­lion in­to their S-1, but it soon be­came ap­par­ent they had a much high­er raise in mind.

Ear­li­er this week, the Dal­las com­pa­ny up­sized its es­ti­mate to $250 mil­lion and in­creased its po­ten­tial range from $17-$19 to $19-20 per share. They ul­ti­mate­ly priced at $20, the high end of the new range, and pulled in the $320 mil­lion raise.

Pre-IPO, In­stil $TIL had raised $380 mil­lion in ven­ture fund­ing.

In­stil 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. But they’re all-in on their tech plat­form, and be­lieve they have the prop­er man­u­fac­tur­ing ca­pa­bil­i­ties to boot.

The com­pa­ny plans to sub­mit its first IND to the FDA lat­er this year and head straight in­to a Phase II tri­al for melanoma with its lead TIL can­di­date, ITIL-168. In­stil is hope­ful that could lead to a sub­mis­sion for ap­proval some­time in 2023.

But giv­en the CMC is­sues that seem to trip up every gene ther­a­py play­er nowa­days, In­stil like­ly faces a long road ahead.

Con­nect looks to si­dle up to the com­pe­ti­tion — and Dupix­ent is up first

Con­nect Bio­phar­ma came up with the sec­ond-high­est raise of this week’s group, net­ting $191 mil­lion in their IPO haul.

The fig­ure is slight­ly high­er than the terms they set out late last week, when Con­nect $CNTB es­ti­mat­ed $150 mil­lion in a $15 to $17 share range. Ul­ti­mate­ly, the Chi­nese com­pa­ny priced at the high end of that spec­trum: $17.

Con­nect’s IPO comes af­ter the old pals from a uni­ver­si­ty in Guangzhou, Chi­na who found­ed the biotech se­cured a $115 mil­lion Se­ries C last Au­gust. As they tran­si­tion to be­com­ing a pub­lic com­pa­ny, they come with a pipeline of im­mune mod­u­la­tors.

Their port­fo­lio is led by an an­ti-IL-4Ra an­ti­body that they hope can treat in­flam­ma­to­ry al­ler­gic dis­eas­es such as atopic der­mati­tis, asth­ma, and chron­ic rhi­nos­i­nusi­tis with nasal polyps — mar­kets that have seen big in­vest­ment from world’s biggest phar­ma com­pa­nies. Con­nect’s lead ex­per­i­men­tal drug hits the same tar­get as Re­gen­eron and Sanofi’s Dupix­ent.

How will their pro­gram match up? All eyes are on a Phase IIb tri­al ex­pect­ed to read out topline da­ta in the sec­ond half of 2021. Con­nect be­lieves the as­says they used in drug dis­cov­ery could make them a best-in-class con­ten­der.

Finch hopes to move past the strug­gles of the mi­cro­bio­me field

Finch Ther­a­peu­tics al­so raised more mon­ey than orig­i­nal­ly es­ti­mat­ed. Af­ter pen­cil­ing $100 mil­lion in­to their S-1, Finch re­turned from the IPO well with a $128 mil­lion raise.

They al­so priced at the high end of their range, de­but­ing on the mar­ket Fri­day at $17 per share. The pub­lic de­but comes rough­ly six months af­ter its $90 mil­lion Se­ries C round.

Born from the ash­es of an im­plo­sion at Seres Ther­a­peu­tics that cloud­ed the mi­cro­bio­me field in 2017, Finch $FNCH is fo­cus­ing its re­search on an oral ther­a­py pro­gram that can de­liv­er a com­plete mi­cro­bio­me to the gut. The can­di­date, CP101, is be­ing test­ed in pa­tients with a C. dif­fi­cile in­fec­tion and has so far re­turned pos­i­tive re­sults for re­cur­rence-free bac­te­ria clear­an­ce.

A sec­ond tri­al for the pro­gram is ex­pect­ed to be­gin not long af­ter the IPO, with topline da­ta ex­pect­ed some­time in 2023. The study will like­ly have a sim­i­lar de­sign and size to the ear­li­er tri­al. Among 206 pa­tients, pa­tients giv­en CP101 had a 74.5% chance of re­cur­rence-free bac­te­ria clear­ance ver­sus 61.5% on the place­bo arm.

The com­pound it­self is a cap­sule made of freeze-dried stool sam­ples from healthy donors. The biotech is al­so plan­ning oth­er clin­i­cal stud­ies in chron­ic he­pati­tis B, in­flam­ma­to­ry bow­el dis­ease and autism spec­trum dis­or­der.

Gain goes pub­lic with pro­tein mis­fold­ing pro­grams

Gain pulls up the rear this week, suc­cess­ful­ly rais­ing the $40 mil­lion they orig­i­nal­ly out­lined in their S-1. The biotech priced at the mid­point of its range, de­but­ing Thurs­day at $11 per share.

Gain $GANX fo­cus­es on pro­tein mis­fold­ing, with an ini­tial goal of treat­ing lyso­so­mal stor­age dis­or­ders. They have ex­clu­sive­ly in-li­censed a pro­pri­etary plat­form to ac­com­plish this, and are tar­get­ing the GLB1 gene to cre­ate ther­a­pies for GM1 gan­gliosi­do­sis and the GBA1 Gauch­er’s dis­ease and Parkin­son’s.

As de­scribed in their SEC pa­per­work, the biotech is plan­ning to di­rect its IPO funds to­ward these can­di­dates, hope­ful­ly push­ing them in­to Phase I/II tri­als for their re­spec­tive in­di­ca­tions. Gain emerged from stealth last Ju­ly with a $10 mil­lion Se­ries B round, us­ing that fundraise to set up two IND-en­abling stud­ies.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

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Another week, another horde of biotechs is doing the Nasdaq dance.

This week saw four companies file their SEC paperwork ahead of expected debuts, another hit Nasdaq on Friday and a sixth formally withdrew its bid to go public. Aerovate Therapeutics, Ocean Biomedical and Acumen Pharmaceuticals all penciled in initial raises of $100 million, while Dermata Therapeutics is estimating a modest $18 million raise.

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Keiichi Fukuda, Heartseed CEO

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ap­proach to treat­ing heart fail­ure

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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