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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.