Yishai Zohar, Gelesis CEO (Gelesis)

PureTech-backed Gele­sis wins biotech's lat­est SPAC deal, plan­ning to bring weight loss prod­uct to up to 150M Amer­i­cans

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The lat­est PureTech-found­ed biotech is head­ing to the New York Stock Ex­change, and it comes through a new SPAC re­verse merg­er.

De­vel­op­ing weight-man­age­ment pills that are on the cusp of a na­tion­al roll­out, Gele­sis will re­verse merge with Cap­star Spe­cial Pur­pose Ac­qui­si­tion Corp., the en­ti­ties an­nounced Mon­day morn­ing. The deal will give Gele­sis ac­cess to the $376 mil­lion raised from the SPAC, as well as an­oth­er $100 mil­lion in PIPE fund­ing.

The merg­er is ex­pect­ed to close be­fore the end of 2021 with Gele­sis earn­ing a pro for­ma im­plied val­ue of $1.3 bil­lion with the deal.

Gele­sis de­cid­ed to go with a SPAC rather than a more tra­di­tion­al IPO, CEO Yishai Zo­har told End­points News in an in­ter­view, be­cause it high­ly val­ued the SPAC team’s com­mer­cial ex­pe­ri­ence, which will aid in a rapid roll­out lat­er this year.

“What we thought was very ap­peal­ing for us is the idea that we will emerge with a SPAC that has a very strong con­sumer and com­mer­cial ex­per­tise,” Zo­har told End­points. “We re­al­ize that our la­bel is such that we need a very wide con­sumer ap­proach and strat­e­gy. We want­ed to build those ca­pa­bil­i­ties.”

That ex­per­tise comes from a syn­di­cate with a va­ri­ety of busi­ness ex­pe­ri­ence. Cap­star’s CEO is R. Steven Hicks, a Texas tele­com mag­nate whose for­mer com­pa­ny AMFM is the US’ largest ra­dio sta­tion op­er­a­tor with more than 450 sta­tions na­tion­wide. There’s al­so lead di­rec­tor Ro­dri­go de la Torre, the head of fi­nance and strat­e­gy for Taco Bell Glob­al since April 2019 who pre­vi­ous­ly served in a se­nior role at Piz­za Hut In­ter­na­tion­al.

Some of the SPAC cash is al­so slat­ed to ramp up man­u­fac­tur­ing of the pills, which are brand­ed un­der the name Plen­i­ty.

Gele­sis is the third PureTech en­ti­ty to go pub­lic af­ter Karuna Ther­a­peu­tics hit Nas­daq with a tra­di­tion­al IPO in 2019 and Vor Bio­phar­ma fol­lowed suit ear­li­er this year. Gele­sis’ SPAC raise, how­ev­er, dwarfs both of the pre­vi­ous to­tals: Karuna raised $89.2 mil­lion in its IPO and Vor pulled in $176.9 mil­lion.

The biotech is at­tempt­ing to make its mark on weight man­age­ment through the use of pills that mim­ic the feel­ing of eat­ing veg­eta­bles, Gele­sis said in an in­vestor call Mon­day morn­ing. With a reg­i­men to be tak­en pri­or to meals, Plen­i­ty ex­pands by ab­sorb­ing wa­ter and fills up to 25% of the stom­ach by vol­ume, mak­ing pa­tients feel fuller be­fore eat­ing.

Plen­i­ty has been cleared by the FDA as a de­vice, Zo­har not­ed, and the com­pa­ny says it’s re­ceived the broad­est la­bel of any weight main­te­nance treat­ment — in­di­vid­u­als with a BMI be­tween 25 and 40 are el­i­gi­ble for pre­scrip­tion. Fur­ther­more, he said, pa­tients do not need co­mor­bidi­ties to take Plen­i­ty, a key re­quire­ment for oth­er such drugs and de­vices al­ready on the mar­ket.

In the US alone, that ac­counts for about 150 mil­lion adults.

Gele­sis had ini­ti­at­ed a be­ta launch pro­gram in late 2020 that saw mem­ber­ship rise above 48,000 and is plan­ning full-scale na­tion­al com­mer­cial­iza­tion by the end of the year. For the be­ta, the pills were priced at $98 per 28-day sup­ply, with that fig­ure ex­pect­ed to re­main the same once Plen­i­ty up­scales, a Gele­sis spokesper­son told End­points in an email.

The biotech is not dis­clos­ing sales num­bers for the be­ta pro­gram, the spokesper­son added.

With the news of the deal, Gele­sis is tout­ing the safe­ty and ef­fi­ca­cy for the pills as well. In pre­vi­ous stud­ies com­plet­ed for the prod­uct, Zo­har says 59% of adults saw greater than 5% weight loss and 26% lost more than 10%. Com­pared to place­bo, Plen­i­ty dou­bled a pa­tient’s chances of los­ing at least 5% of their weight.

Plen­i­ty’s side ef­fect pro­file was sta­tis­ti­cal­ly no dif­fer­ent than place­bo, with no se­ri­ous ad­verse events.

One such pre­vi­ous tri­al, how­ev­er, said Plen­i­ty failed to demon­strate a 3% mean dif­fer­ence of weight loss be­tween the drug arm and the place­bo group, a fig­ure reg­u­la­tors typ­i­cal­ly have looked for in the past. But be­cause over­all risk pro­files were so low, and be­cause Plen­i­ty worked well for those who did re­spond, the FDA cleared the prod­uct with as broad a la­bel as it did, Zo­har said.

“The beau­ty of our ap­proach is be­cause of its fa­vor­able safe­ty and tol­er­a­bil­i­ty pro­file; there’s no harm for every­one to try and see if they’re a re­spon­der,” Zo­har said. “With weight loss, be­cause it’s such a het­ero­ge­neous prob­lem, it’s very usu­al that you don’t have one so­lu­tion that ap­plies for every­one.”

Gele­sis is pri­mar­i­ly go­ing to fo­cus on sell­ing Plen­i­ty in the US un­til the com­pa­ny has beefed up man­u­fac­tur­ing, though it al­so signed a part­ner­ship to mar­ket the prod­uct in Greater Chi­na, Zo­har said.

Af­ter hun­dreds of SPACs flood­ed the mar­ket late last year and in 2021’s first quar­ter, merg­ers start­ed to hit the gas ped­al once the cal­en­dar turned to spring. Over­all, SPACs have steered more than $15 bil­lion to the life sci­ences in­dus­try in 2021, ac­cord­ing to the End­points tal­ly.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

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

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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