In­cyte grabs a new PD-1 check­point drug in $900M deal with Macro­Gen­ics

In­cyte $IN­CY has just inked a $900 mil­lion deal to grab glob­al rights to an ear­ly-stage PD-1 check­point now be­ing de­vel­oped at Macro­Gen­ics.

Hervé Hop­penot

The two com­pa­nies an­nounced Wednes­day morn­ing that In­cyte will pay $150 mil­lion in a cash up­front for the de­vel­op­ment and com­mer­cial­iza­tion rights to MGA012, with Macro­Gen­ics hang­ing on to rights for run­ning com­bi­na­tion stud­ies us­ing their pipeline can­cer drug as­sets.

The deal in­cludes $420 mil­lion in de­vel­op­ment mile­stones along with $330 mil­lion for com­mer­cial goals. Roy­al­ties will stretch from 15% to 24%.

In­vestors liked it, dri­ving up Macro­Gen­ics’ shares $MGNX by 18% in the mid-af­ter­noon.

The PD-1 ther­a­py is cur­rent­ly in Phase I be­ing test­ed as a monother­a­py in four dif­fer­ent tu­mor types. And the first da­ta cut from the dose es­ca­la­tion study is due to go pub­lic in a cou­ple of weeks at the SITC meet­ing in Wash­ing­ton, DC.

“We do see the unique­ness of the deal in com­mer­cial­iz­ing the com­bi­na­tion prod­ucts,” says Macro­Gen­ics CEO Scott Koenig. This way the PD-1 can be a “back­bone” ther­a­py at both com­pa­nies, the two ex­ecs add, go­ing in­to a broad set of com­bi­na­tion tri­als with re­searchers at In­cyte and Macro­Gen­ics pur­su­ing their in­di­vid­ual ob­jec­tives — with­out get­ting in each oth­er’s way.

In­cyte is wide­ly viewed as the leader in the IDO1 field now, with piv­otal da­ta com­ing up for epaca­do­stat. Al­ready part­nered with Mer­ck and Bris­tol-My­ers Squibb in com­bi­na­tion tri­als us­ing their check­points, In­cyte clear­ly sees val­ue in hav­ing their own PD-1 to use for com­bos.

The deal comes two years af­ter In­cyte grabbed a pact with Chi­na’s Jiang­su Hen­grui Med­i­cine for an an­ti-PD-1 drug dubbed SHR-1210. In ex­change for $25 mil­lion up­front and a heav­i­ly back end­ed $770 mil­lion pack­age of mile­stones — in­clud­ing a $150 mil­lion bonus if the treat­ment can prove its su­pe­ri­or­i­ty — In­cyte CEO Herve Hop­penot got all glob­al rights out­side of Chi­na and re­lat­ed ter­ri­to­ries.

That drug, Hop­penot tells me to­day, was linked to a unique and mild side ef­fect — grade 1 and 2 he­man­giomas, small, non-can­cer­ous vas­cu­lar skin growths — that made it un­ap­peal­ing for com­bi­na­tion work in a high­ly com­pet­i­tive field, forc­ing the switch to Macro­Gen­ics as a new part­ner.

Koenig adds that Macro­Gen­ics is scal­ing up new man­u­fac­tur­ing ca­pa­bil­i­ty that they will use to sup­ply the PD-1, of­fer­ing an­oth­er com­mer­cial ad­van­tage for the biotech.

“An­ti-PD-1 ther­a­py is be­com­ing a main­stay of can­cer treat­ment across mul­ti­ple tu­mor types, and we be­lieve the ad­di­tion of MGA012 to our clin­i­cal pipeline is im­por­tant to ful­fill­ing our long-term de­vel­op­ment strat­e­gy in im­muno-on­col­o­gy. This col­lab­o­ra­tion with Macro­Gen­ics will al­low us to rapid­ly ex­plore the po­ten­tial clin­i­cal ben­e­fit of de­vel­op­ing MGA012 as a monother­a­py and al­so com­bin­ing an­ti-PD-1 ther­a­py with sev­er­al of our ex­ist­ing port­fo­lio as­sets,” said Steven Stein, chief med­ical of­fi­cer of In­cyte.

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.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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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.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Eric Shaff (Seres)

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

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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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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Robert Gould, Fulcrum Therapeutics CEO

Ful­crum stum­bles in PhII of old GSK drug, send­ing shares tum­bling

Investors are selling off shares of Fulcrum Therapeutics $FULC after their lead drug failed in a Phase II trial.

The company, founded three years ago on new research techniques such as CRISPR screening, isolated a gene called DUX4 they believed to have a central role in facioscapulohumeral muscular dystrophy, where patients’ muscle dies and is replaced by fat. And to target it, they licensed a GlaxoSmithKline drug that had failed as a cardio drug.

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Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Lig­and scoops up Pfenex for up to $516M, adding pro­teins to their an­ti­body chick­ens and de­liv­ery tech

The technology hunting folks over at Ligand Pharmaceuticals have picked up a new one from across town, for a significant price.

Ligand has acquired fellow San Diego-based biotech Pfenex and their protein expression platform for $438 million cash, plus $78 million in contingent value agreements should an undisclosed milestone be hit before the end of next year.  The deal pays $12 per share, or $4.34 more than what Pfenex had been trading at before the announcement.