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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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