Corey McCann, Pear Therapeutics CEO

The dig­i­tal health field con­tin­ues to boom as Soft­Bank-backed start­up hits uni­corn sta­tus in SPAC re­verse merg­er

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At the in­ter­sec­tion of med­i­cine and cut­ting-edge tech­nol­o­gy, the broad field of dig­i­tal health has seen boom­ing val­u­a­tions in re­cent months with some big-name in­vestors jump­ing in. Now, a com­pa­ny work­ing on soft­ware-based ther­a­peu­tics has leaped to uni­corn sta­tus and will take its show on the road to Nas­daq.

Pear Ther­a­peu­tics, a start­up de­vel­op­ing pre­scrip­tion dig­i­tal ther­a­peu­tics, will go pub­lic as part of a re­verse merg­er with a tech-fo­cused SPAC dubbed Thim­ble Point Ac­qui­si­tion Corp. that will val­ue the com­pa­ny at $1.6 bil­lion, the part­ners said Tues­day.

As part of the pact, Thim­ble Point will in­vest a to­tal of $400 mil­lion, with $276 mil­lion com­ing from the SPAC’s trust ac­count and the rest in PIPE fund­ing. The deal is ex­pect­ed to close in the sec­ond half of the year, and the new­co plans to trade un­der the tick­er $PEAR.

Pear cur­rent­ly sports three FDA-ap­proved PDTs, as they call them, which are stand­alone or com­ple­men­tary soft­ware prod­ucts that the biotech hopes to ex­tend in­to a range of ther­a­peu­tic ar­eas. The most re­cent prod­uct ap­proved was Som­ryst, a treat­ment for chron­ic in­som­nia that earned the FDA’s nod in March 2020.

In De­cem­ber, Pear closed an $80 mil­lion Se­ries D led by Japan’s Soft­Bank Vi­sion Fund 2. That round was ex­pand­ed to $100 mil­lion as an ad­di­tion­al in­vestor jumped on board in March.

On top of chron­ic in­som­nia, a mar­ket Pear es­ti­mates could hold around 30 mil­lion US pa­tients, the com­pa­ny’s two oth­er prod­ucts tar­get opi­oid ad­dic­tion, an­oth­er field that could in­clude as many as 20 mil­lion pa­tients, it said. On top of in­vest­ing more funds in­to com­mer­cial­iza­tion plans, Pear will look to build its pipeline, which in­cludes 14 in­ves­ti­ga­tion­al prod­ucts, the com­pa­ny said in a state­ment.

Elon Boms

“Thim­ble Point sought to col­lab­o­rate with a high-growth, tech-en­abled com­pa­ny with the po­ten­tial to dis­rupt large and es­tab­lished in­dus­tries,” the SPAC’s CEO, Elon Boms, said in a state­ment. “We chose to in­vest in Pear be­cause we be­lieve it has the op­por­tu­ni­ty to be­come the pri­ma­ry com­mer­cial plat­form through which pa­tients and pre­scribers ac­cess PDTs. Our growth cap­i­tal comes at an in­flec­tion point for Pear, as the team works to­wards ex­pect­ed near-term val­ue cre­ation mile­stones.”

Thim­ble Point went pub­lic back in Feb­ru­ary with a $240 mil­lion IPO and the goal “to fo­cus on high-growth soft­ware and tech­nol­o­gy-en­abled com­pa­nies that are dis­rupt­ing large and es­tab­lished in­dus­tries and mar­kets,” the blank-check com­pa­ny said in its prospec­tus. The team be­hind Thim­ble Point starts with Boms, the man­ag­ing di­rec­tor at the Pritzk­er Vlock Fam­i­ly Of­fice and co-founder and chair­man of Launch­Cap­i­tal.

Pear comes with the No­var­tis brand name at its back af­ter sign­ing a deal with the Swiss drug­mak­er in March 2018 to work on the schiz­o­phre­nia and mul­ti­ple scle­ro­sis front. No­var­tis gener­ics sub­sidiary San­doz al­so joined up to help launch opi­oid PDT re­SET in late 2018 but backed out af­ter re­jig­ging its port­fo­lio af­ter the de­par­ture of CEO Richard Fran­cis.

Pear is part of a wave of dig­i­tal health plat­forms that have earned mas­sive val­u­a­tions in re­cent months. Just last month, de­cen­tral­ized clin­i­cal tri­al play­er Sci­ence 37 went pub­lic as part of its own SPAC re­verse merg­er, earn­ing a val­u­a­tion at a lit­tle more than $1 bil­lion.

Mean­while, ge­net­ics test­ing com­pa­ny 23andMe went pub­lic back in Feb­ru­ary as part of a re­verse merg­er with a SPAC from bil­lion­aire Richard Bran­son. That deal val­ued the com­pa­ny at a whop­ping $3.5 bil­lion.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Mi­rati's KRAS drug looks like the fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed response rates grater than sotorasib solo  and as part of combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The best of the rest: High­lights from the be­low-the-fold pre­sen­ta­tions at #ES­MO21

This year’s ESMO Congress has had a major focus on Big Pharma drugs — most notably candidates from Merck and AstraZeneca — but there have also been updates from smaller biotechs with data looking to challenge the big-name drugmakers.

Today, we’re highlighting some of the data releases that flew under the radar at #ESMO21 — whether from early-stage drugs looking to make a mark or older stalwarts with interesting follow-up data.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.