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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Yanay Ofran (L) and Anat Binur (Ukko)

Leaps by Bay­er backs a pro­tein en­gi­neer­ing start­up tak­ing on Aim­mune — and Nestlé — in peanut al­ler­gy

Little capsules of peanut powder drove Nestlé’s $2.6 billion buyout of Aimmune. Now, with $40 million in new funding, a fledgling biotech is promising to bring a more sophisticated version of that protein therapy that can go much, much further.

Ukko’s goal is two-pronged — with the initial products spanning therapeutic and food — but it’s grounded in the same protein engineering platform, co-founder and CEO Anat Binur told Endpoints News.

As tar­get­ed ther­a­pies get ever more pre­cise, Deer­field un­veils $50M bet on an Har­vard pro­fes­sor's chem­istry in­sights

Behind the seemingly simple concept of targeted cancer therapies is the drug developer’s headache that the target is always changing. Each generation of kinase inhibitors may be ostensibly hitting the same oncogene, but in addition to blocking the wildtype oncogene, they must now also address the mutations that have developed along the way, spurring resistance to current drugs.

The more those target kinases evolve, too, the more they could resemble off-target kinases you don’t want to bind. So each iteration requires more selectivity — sometimes down to differences of a few atoms.

Vincent Sandanayaka (file photo)

UP­DAT­ED: Ex-MD An­der­son chief De­Pin­ho is help­ing launch an­oth­er biotech — and he's stick­ing with fa­mil­iar ground

Years after co-founding SINE-focused Karyopharm and stirring up controversy at MD Anderson, Ronald DePinho is helping uncloak a new biotech targeting solute carrier transporter proteins — and Karyopharm’s former head of chemistry is leading the charge.

Nirogy Therapeutics emerged from stealth mode on Tuesday with a $16.5 million Series A round and plans to hit the clinic by 2022. The financing should be enough to carry the startup’s lead program, a small molecule lactate transport inhibitor, through Phase I, CEO Vincent Sandanayaka said.

As­traZeneca scores new goal on the pipeline front, adding its first AI-gen­er­at­ed tar­get to the port­fo­lio

As more and more biopharmas develop artificial intelligence platforms, the drug discovery process is being reshaped to fit new goals on cutting down the prodigious amount of time, energy and money that go into a drug program. Now one of the most ambitious players in the drive to improve on ROI, AstraZeneca, is marking a milestone on that front by adding the first target generated by AI to its portfolio.

Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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