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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.