Af­ter No­var­tis left, Boehringer bets up to $500M on the field of pre­scrip­tion smart­phone apps

Boehringer In­gel­heim wants in on dig­i­tal ther­a­peu­tics.

The Ger­man phar­ma signed an up to $500 mil­lion col­lab­o­ra­tion with Click Ther­a­peu­tics, one of a hand­ful of ma­jor com­pa­nies de­vel­op­ing pre­scrip­tion com­put­er and smart­phone ap­pli­ca­tions for var­i­ous neu­ro­log­i­cal or men­tal dis­or­ders. They join a small list of phar­mas that have de­cid­ed to test the wa­ters in the emerg­ing field.

Un­der the deal, Boehringer and Click will co-de­vel­op a dig­i­tal ther­a­peu­tic for schiz­o­phre­nia, known as CT-155. It’s a com­ple­men­tary ef­fort to Boehringer’s more tra­di­tion­al schiz­o­phre­nia work. The com­pa­ny has con­cen­trat­ed their neu­ro­science ef­forts there since 2018, when a Phase II fail­ure blew up their late-stage Alzheimer’s ef­forts.

Cor­nelia Dorner-Ciossek

“CT-155 is an ex­cel­lent ad­di­tion to our CNS pipeline port­fo­lio; it re­flects our pa­tient cen­tric ap­proach and trans­lates ev­i­dence show­ing how be­hav­ioral mod­i­fi­ca­tion can in­duce pos­i­tive neu­ronal changes in­to a wide­ly ac­ces­si­ble so­lu­tion,” Cor­nelia Dorner-Ciossek, Boehringer’s head of CNS dis­ease re­search, said in a state­ment.

Boehringer is at least the third Big Phar­ma to dip their toes in­to dig­i­tal ther­a­peu­tics. Sanofi Ven­tures — the French gi­ant’s in­vest­ment arm — led a $17 mil­lion fund­ing round for Click in 2018, the same year Mer­ck’s ven­ture arm con­tributed to the video game ther­a­peu­tics com­pa­ny Ak­ili’s $55 mil­lion Se­ries C. No­var­tis al­so signed a part­ner­ship that year with Pear Ther­a­peu­tics to com­mer­cial­ize Pear’s FDA-au­tho­rized app for sub­stance abuse, al­though they pulled out of the part­ner­ship just one year lat­er.

Boehringer’s new deal marks one of the first ma­jor de­vel­op­ment part­ner­ships be­tween a large phar­ma com­pa­ny and a dig­i­tal ther­a­peu­tic.

Click has al­ready de­vel­oped a com­mer­cial app for smok­ing ces­sa­tion called Click­o­tine. Click­o­tine, like the oth­er apps Click has in de­vel­op­ment for in­som­nia, mi­graine and ma­jor de­pres­sive dis­or­der, among oth­ers, us­es a va­ri­ety of smart­phone-based fea­tures to try to ad­just peo­ple’s be­hav­ior. In Click­o­tine’s case, that in­volves “per­son­al­ized cur­ricu­lums” that of­fer users live coach­ing, guid­ed breath­ing, and per­son­al an­a­lyt­ics. That app, though, while backed by a non-con­trolled study, did not have to be FDA-ap­proved as oth­er apps will.

Click has re­leased lit­tle about CT-155 — its de­scrip­tion on their web­site reads sim­ply “con­fi­den­tial” — but in the­o­ry it could be used along­side ex­ist­ing schiz­o­phre­nia drugs and, even­tu­al­ly, along­side the schiz­o­phre­nia meds Boehringer now has in its pipeline. Two such com­pounds are now in Phase II.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

#ES­MO20: As­traZeneca aims to spur PRO­found shift in prostate can­cer treat­ment with Lyn­parza OS da­ta

AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit.

But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut.

The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga. Patients on Lynparza lived a median of 19.1 months, compared to 14.7 months for the anti-androgen therapies (p = 0.0175).

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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