Pear Therapeutics president and CEO Corey McCann (Pear)

Pear Ther­a­peu­tics nabs $80M Se­ries D to com­mer­cial­ize three dig­i­tal ther­a­peu­tics

As the pan­dem­ic rages on, vir­tu­al care op­tions have in­vestors champ­ing at the bit. Boston-based Pear Ther­a­peu­tics is the lat­est to ben­e­fit, reel­ing in $80 mil­lion to com­mer­cial­ize its three pre­scrip­tion dig­i­tal ther­a­peu­tics.

The dig­i­tal ther­a­peu­tics um­brel­la en­com­pass­es tech­nol­o­gy like mo­bile apps and telemed­i­cine plat­forms de­signed to pre­vent, treat or man­age dis­ease. Some are used alone, while oth­ers are com­bined with med­ica­tion.

Pear’s re­SET, ap­proved in 2017, de­liv­ers cog­ni­tive be­hav­ioral ther­a­py to those with sub­stance abuse dis­or­der in out­pa­tients set­tings. Re­SET-O got ap­proval the fol­low­ing year for opi­oid use dis­or­der. And the biotech’s most re­cent OK came in March for an AI-pow­ered chron­ic in­som­nia ther­a­py called Som­ryst.

Som­ryst com­bines telemed­i­cine vis­its with dig­i­tal cog­ni­tive be­hav­ioral ther­a­py, de­liv­er­ing rec­om­men­da­tions — like when a pa­tient should sleep and rise — at the touch of a screen. In clin­i­cal stud­ies with more than 1,400 adults, the soft­ware re­duced the amount of time tak­en to fall asleep by 45%, and cut the amount of time spent awake at night by 52%, ac­cord­ing to Pear.

“We be­lieve pre­scrip­tion dig­i­tal ther­a­peu­tics are cre­at­ing a new cat­e­go­ry of med­i­cine,” Soft­Bank part­ner Kirthi­ga Red­dy said in a state­ment.

The re­cent Se­ries D — led by Soft­Bank Vi­sion Fund 2 — will be used to ac­cel­er­ate re­im­burse­ment cov­er­age and cre­ate a mar­ket ac­cess path­way for re­SET, re­SET-O and Som­ryst, Pear an­nounced. The in­fu­sion comes near­ly two years af­ter the biotech hooked a $64 mil­lion C round led by Temasek. They al­so chipped in to the Se­ries D, as well as 5AM Ven­tures, Ar­bore­tum Ven­tures, JAZZ Ven­ture Part­ners, No­var­tis, Crim­soNox, ED­BI, Forth Man­age­ment, Pi­lot House, Saris­sa Cap­i­tal, Shan­da Group, and QUAD In­vest­ment Man­age­ment.

“This over­sub­scribed round of fund­ing will al­low us to con­tin­ue to in­vest in the launch­es of our three com­mer­cial prod­ucts to ac­cel­er­ate rev­enue growth, which we in­tend to rein­vest in our ro­bust pipeline and plat­form,” Pear pres­i­dent and CEO Corey Mc­Cann said in a state­ment.

In ad­di­tion to its com­mer­cial prod­ucts, Pear is work­ing on oth­ers for ill­ness­es like schiz­o­phre­nia, PTSD and mi­graine dis­or­der.

No­var­tis paired with Pear back in March 2018 to work on the schiz­o­phre­nia and mul­ti­ple scle­ro­sis front. Its sub­sidiary San­doz joined forces with the start­up lat­er that year to launch re­SET. How­ev­er, San­doz pulled out of the deal in 2019, not long af­ter CEO Richard Fran­cis abrupt­ly re­signed. The move to sev­er ties with Pear rep­re­sent­ed a “re­in­forced fo­cus on and cap­i­tal al­lo­ca­tion for San­doz core busi­ness,” the com­pa­ny said at the time.

Pear isn’t the on­ly dig­i­tal­ly fo­cused biotech to catch in­vestors’ eyes this year. Med­able bagged a $91 mil­lion Se­ries C to build out its vir­tu­al clin­i­cal tri­al plat­form at the end of last month, and Sci­ence 37 closed a $40 mil­lion fund­ing round to do the same in Au­gust. Sci­ence 37’s round in­clud­ed in­vest­ments from No­var­tis, Am­gen and Sanofi Ven­tures.

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

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.

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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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.

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.

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.

Skin tu­mors in mice force Pro­tag­o­nist to halt lead pro­gram, crush­ing stock

Protagonist Therapeutics just can’t catch a break.

Six months after the Newark, CA-based biotech unveiled grand plans to launch its lead candidate for blood disorders into a Phase III trial, the FDA has slapped the program with a clinical hold. The halt — which applies to all trials involving the candidate, rusfertide — comes after skin tumors were discovered in mice treated with the drug, according to Protagonist.

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Chi­nese biotech Ever­est signs $550M+ li­cens­ing deal for BTK in­hibitors on heels of Covid-19 pact

Everest Medicines is on a roll with two licensing deals in one week.

The Shanghai-based biotech has paid Sinovent and SinoMab $12 million upfront for the rights to a BTK inhibitor for renal diseases, the company announced Thursday. The deal comes just days after Everest came away with rights to a Covid-19 vaccine in China, Taiwan, Singapore, Thailand and Indonesia.

Everest will pay Sinovent and SinoMab up to $549 million in milestone payments and royalties. The agreement includes tech transfer of Sinovent and SinoMab’s manufacturing process for the candidate, named XNW1011.