Covid-19 af­flicts Eli Lil­ly’s share price and a KRAS drug gets tossed, but Jar­diance win salves the wound as an an­ti­body ef­fort ad­vances to PhII

Shares of Eli Lil­ly $LLY tum­bled close to 2% on Thurs­day in a tox­ic re­ac­tion to its mixed rev­enue per­for­mance in the face of the pan­dem­ic dur­ing Q2. But in­vestors found so­lace in a promis­ing Phase III read­out for Jar­diance, as their block­buster con­tin­ues to blaze a trail to much big­ger mar­kets.

Their SGLT2 in­hibitor beat out a place­bo in re­duc­ing the risk for the com­pos­ite of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion due to heart fail­ure, when added to stan­dard of care. The drug hit the pri­ma­ry end­point, added Lil­ly, not­ing that the full da­ta read­out will come at the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy (ESC) Con­gress at the end of Au­gust.

Swept out in the Q2 cleanup, though, was Lil­ly’s ear­ly stage KRAS G12C drug LY3499446. Af­ter Am­gen spurred hope for a big KRAS play, with a va­ri­ety of play­ers look­ing to make progress on a tar­get that has long been con­sid­ered un­drug­gable, added da­ta have dimmed hopes for broad ap­plic­a­bil­i­ty. And now Lil­ly, which has been steadi­ly re­work­ing its on­col­o­gy pipeline and brand un­der Loxo chief Josh Bilenker, wants out. The key is­sue was safe­ty.

Lil­ly’s state­ment to End­points News:

While we were ini­tial­ly ex­cit­ed to ex­plore the po­ten­tial of LY3499446, we saw un­ex­pect­ed tox­i­c­i­ty and de­cid­ed not to in­vest ad­di­tion­al time and re­sources in a pro­gram that may not be as clin­i­cal­ly and com­pet­i­tive­ly rel­e­vant as we hoped. We are tak­ing a very dis­ci­plined ap­proach to build­ing our pipeline and are sin­gu­lar­ly fo­cused on dis­cov­er­ing and de­vel­op­ing med­i­cines that we be­lieve will be tru­ly dif­fer­en­ti­at­ed and mat­ter to pa­tients.

The news on Jar­diance, one of their fastest grow­ing fran­chis­es at Lil­ly, will be sweet­er for in­vestors.

Vamil Di­van at Mizuho not­ed:

(I)t is clear to us that to­day’s news, com­bined with pos­i­tive news we have seen re­cent­ly from SGLT-2 in­hibitors in pa­tients with kid­ney dis­ease, is go­ing to open up large new mar­kets for the SGLT-2 class, with Jar­diance the clear mar­ket leader.

Oth­er drugs in the class, in­clud­ing Farx­i­ga from As­traZeneca, have been mak­ing their own ad­vances on the car­dio side of the med­ical equa­tion.

“The re­sults of the EM­PER­OR-Re­duced tri­al in­di­cate that SGLT2 in­hibitors have the po­ten­tial to be­come a new stan­dard of care for this dis­ease, which will be a mean­ing­ful ad­di­tion to cur­rent­ly es­tab­lished treat­ments,” not­ed Mil­ton Pack­er, chair of the ex­ec­u­tive com­mit­tee for the de­vel­op­ment pro­gram.

An­a­lysts have al­so been close­ly fol­low­ing Lil­ly’s an­ti­body de­vel­op­ment pro­gram for CoV555, part­nered with Ab­Cellera. In their Q2 state­ment, the com­pa­ny said they had com­plet­ed dos­ing in the first study and launched a Phase II tri­al, with da­ta ex­pect­ed in the fourth quar­ter.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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