With sparse R&D prospects, In­cyte bets $900M on Mor­phoSys' CAR-T ri­val taf­a­sita­m­ab

Hav­ing suf­fered a string of pipeline set­backs in re­cent years, In­cyte is rein­vig­o­rat­ing its R&D prospects with a pact to de­vel­op and mar­ket Mor­phoSys’ an­ti-CD19 an­ti­body taf­a­sita­m­ab, a drug be­ing primed as an al­lur­ing al­ter­na­tive to the ex­ist­ing CAR-T ther­a­pies Kym­ri­ah and Yescar­ta in pa­tients with a com­mon, treat­ment-re­sis­tant form of non-Hodgkin’s lym­phoma.

Un­der the deal, Mor­phoSys and In­cyte will co-com­mer­cial­ize taf­a­sita­m­ab in the Unit­ed States, while In­cyte has ex­clu­sive com­mer­cial­iza­tion rights out­side the re­gion. For these rights, In­cyte is giv­ing Mor­phoSys an up­front pay­ment of $750 mil­lion as well as mak­ing an eq­ui­ty in­vest­ment worth $150 mil­lion in the com­pa­ny. The Ger­man drug­mak­er is al­so el­i­gi­ble to re­ceive mile­stone pay­ments of up to $1.1 bil­lion, in ad­di­tion to roy­al­ties.

Mor­phoSys ex­pects the FDA to make its de­ci­sion on taf­a­sita­m­ab, or MOR208, for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL) by mid-2020.

The ap­pli­ca­tion to mar­ket the drug was based on da­ta that showed taf­a­sita­m­ab, in com­bi­na­tion with lenalido­mide, in­duced me­di­an pro­gres­sion-free sur­vival of 12.1 months, with a me­di­an du­ra­tion of re­sponse at 21.7 months. The over­all re­sponse rate among 80 pa­tients was 60%, with a for­mi­da­ble 43% com­plete re­sponse rate.

It will com­pete with No­var­tis’ Kym­ri­ah — which se­cured ap­proval for DL­B­CL in 2018 based on an over­all re­sponse rate of 50%, and a com­plete re­sponse rate of 32% in 68 evalu­able pa­tients — al­though its adop­tion has been plagued by man­u­fac­tur­ing prob­lems, mak­ing way for Gilead’s Yescar­ta to deep­er pen­e­trate the CAR-T mar­ket. Taf­a­sita­m­ab — which has been be­stowed with the FDA’s break­through ther­a­py sta­tus — is a gar­den va­ri­ety an­ti­body un­like the two CAR-T ther­a­pies, which re­quire an elab­o­rate per­son­al­ized man­u­fac­tur­ing process (cells are iso­lat­ed from the pa­tient, ma­nip­u­lat­ed in the lab by adding chimeric anti­gen re­cep­tors to di­rect T cells to snuff out can­cer cells and then re-in­fused in­to the pa­tient).

The two part­ners are al­so plan­ning to co-de­vel­op taf­a­sita­m­ab in oth­er DL­B­CL in­di­ca­tions, as well as fol­lic­u­lar lym­phoma (FL), mar­gin­al zone lym­phoma (MZL) and chron­ic lym­pho­cyt­ic leukemia (CLL).

In 2019, Mor­phoSys saw some top man­age­ment changes and some re­or­ga­ni­za­tion as the com­pa­ny pre­pared for taf­a­sita­m­ab’s loom­ing ap­proval. When the com­pa­ny’s 17-year vet­er­an Markus En­zel­berg­er de­part­ed from his post as chief sci­en­tif­ic of­fi­cer, the com­pa­ny’s re­search arm was merged in­to the de­vel­op­ment di­vi­sion un­der chief Malte Pe­ters. CEO Si­mon Mo­roney al­so un­veiled plans he would step aside — he was re­placed by Jean-Paul Kress, the for­mer CEO of Boston’s Syn­tim­mune, which was swal­lowed by Alex­ion.

The Mor­phoSys deal is key for In­cyte — ear­li­er this month the drug­mak­er’s ex­per­i­men­tal itac­i­tinib failed a piv­otal study, dubbed GRAV­I­TAS-301, in first-line acute graft vs host dis­ease.

“While itac­i­tinib did not rep­re­sent a ma­jor fun­da­men­tal dri­ver of val­ue in our mod­el, ~ $5/share, we be­lieve the fail­ure of GRAV­I­TAS-301, which fol­lows three pri­or high pro­file pipeline dis­ap­point­ments in four years (Jakafi in sol­id tu­mors, epaca­do­stat, and Olu­mi­ant), may lead some in­vestors to ques­tion the com­pa­ny’s abil­i­ty to con­sis­tent­ly gen­er­ate val­ue from R&D in­vest­ment,” SVB Leerink An­drew Berens wrote in a note in ear­ly Jan­u­ary.

In­cyte for years has leaned on its flag­ship JAK in­hibitor Jakafi, which se­cured about $1.2 bil­lion in sales in the first three quar­ters of 2019.

“We be­lieve this is a sol­id deal, as the tafa pro­file ap­pears to be the best-in-class CD19/CD20 for the treat­ment of R/R dif­fuse large B-cell lym­phoma (DL­B­CL), giv­en the to­tal­i­ty da­ta of ef­fi­ca­cy, safe­ty, and treat­ment con­ve­nience. While the deal could so­lid­i­fy IN­CY’s pipeline and fur­ther di­ver­si­fy rev­enue, we be­lieve the deal may dis­ap­point some in­vestors who are look­ing for a trans­for­ma­tive deal to strate­gi­cal­ly ex­tend the Jakafi in­tel­lec­tu­al prop­er­ty run­way be­yond 2027,” Berens wrote in a note on Mon­day.

“Giv­en the SVB Leerink’s es­ti­mate of taf­a­sita­m­ab’s world­wide peak sales of ~$1bn, we al­so think deal might not be suf­fi­cient to po­ten­tial­ly re­place Jakafi rev­enue for the long term. Al­so, due to the fi­nan­cial terms, it is un­clear to us when the com­pa­ny would be ca­pa­ble of do­ing a more trans­for­ma­tive deal.”

So­cial im­age: In­cyte, AP Im­ages

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.

J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,600+ biopharma pros reading Endpoints daily — and it's free.