Lil­ly, In­cyte-al­lied Chi­nese drug­mak­er In­novent bags Roche as part­ner in deal that could yield bil­lions

Chi­na’s bi­o­log­ic pow­er­house In­novent has snagged an­oth­er il­lus­tri­ous part­ner: Roche.

The com­pa­ny — which made its pub­lic de­but on Hong Kong Stock Ex­change in 2018 rais­ing a whop­ping $421 mil­lion — is al­ready col­lab­o­rat­ing with a host of key bio­phar­ma and aca­d­e­m­ic groups such as Eli Lil­ly, In­cyte and the MD An­der­son Can­cer Cen­ter. Now, In­novent has inked a deal with Roche that grants it ac­cess to the Swiss drug­mak­er’s bis­pe­cif­ic an­ti­body and CAR-T tech­nol­o­gy.

Har­ness­ing these plat­forms, In­novent is tasked with dis­cov­er­ing, de­vel­op­ing and com­mer­cial­iz­ing bis­pe­cif­ic an­ti­bod­ies and cell ther­a­pies for use in hema­to­log­i­cal and sol­id can­cers. Roche will have the op­tion right to li­cense each prod­uct for ex-Chi­na de­vel­op­ment and com­mer­cial­iza­tion. If those op­tions are ex­er­cised, the 1896-found­ed drug­mak­er will be on the hook for $140 mil­lion, plus ad­di­tion­al mile­stone pay­ments up to $1.96 bil­lion if the drugs are suc­cess­ful­ly de­vel­oped and com­mer­cial­ized. In­novent will al­so be el­i­gi­ble for roy­al­ties over and above that meaty fig­ure.

Roche, the world’s biggest di­ag­nos­tic mak­er, has a large on­col­o­gy port­fo­lio — 6 out of 10 of its topselling drugs last year were can­cer ther­a­pies, in­clud­ing its old­er Avastin and Her­ceptin ther­a­pies as well as new­er of­fer­ings such as Tecen­triq and Kad­cy­la. Roche has been carv­ing out niche ap­provals for its block­buster check­point in­hibitor Tecen­triq, as it plays catch up the mar­ket-lead­ing drugs from Mer­ck and Bris­tol My­ers Squibb. But its plan to con­sol­i­date its po­si­tion in the field rests on its sec­ond-gen­er­a­tion check­point in­hibitor. The com­pa­ny’s an­ti-TIG­IT mol­e­cule tiragolum­ab, which is track­ing ahead of its ri­vals, should give the com­pa­ny an edge over ex­ist­ing ther­a­pies, al­though so far, da­ta have been mixed.

In­novent, mean­while, was the first drug­mak­er to get a home­grown Chi­nese check­point in­hibitor across the fin­ish line in the coun­try — in late 2018, the Lil­ly-part­nered PD-1 agent Tyvyt (sin­til­imab) scored ap­proval for pa­tients with re­lapsed/re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma. The com­pa­ny is a promi­nent mem­ber of a pack of Chi­nese biotech firms that have mush­roomed to cater to the sky­rock­et­ing rates of can­cer in the re­gion and have lured mil­lions in ven­ture fund­ing and pub­lic list­ings.

The Suzhou-based com­pa­ny has a brim­ming pipeline with 23 ex­per­i­men­tal ther­a­pies un­der in­ves­ti­ga­tion for use in a raft of dis­eases, in­clud­ing can­cer, meta­bol­ic and au­toim­mune dis­or­ders. Last year, Lil­ly ex­pand­ed its part­ner­ship with In­novent by out-li­cens­ing a slice of its di­a­betes pipeline, a fran­chise that has pro­duced the In­di­anapo­lis-based drug­mak­er’s best­selling drugs Trulic­i­ty and Hu­ma­log. In late 2018, In­novent part­ed with $40 mil­lion in cash for Chi­na rights to three ex­per­i­men­tal In­cyte drugs un­der de­vel­op­ment for dif­fer­ent can­cers and graft ver­sus host dis­ease.

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA’s work­load buck­les un­der the strain, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,600+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan (AP Images)

Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,600+ biopharma pros reading Endpoints daily — and it's free.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Image credit: AP

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,600+ biopharma pros reading Endpoints daily — and it's free.