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

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

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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 147,200+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.