No­var­tis inks a $2.5B bis­pe­cif­ic can­cer drug de­vel­op­ment al­liance with Xen­cor

No­var­tis is jump­ing on board Xen­cor’s grow­ing bis­pe­cif­ic on­col­o­gy plat­form. The phar­ma gi­ant is pay­ing $150 mil­lion up­front for a tick­et to ride, be­gin­ning at the pre­clin­i­cal stage of de­vel­op­ment. And No­var­tis ($NVS) is promis­ing up to $2.4 bil­lion in mile­stones as it paves the way for a ma­jor new al­liance for Jay Brad­ner’s No­var­tis In­sti­tutes for Bio­Med­ical Re­search in Cam­bridge, MA.

The phar­ma gi­ant an­nounced the pact with the Mon­rovia, CA-based biotech ear­ly Tues­day. In re­turn No­var­tis gains ex-U.S. rights on two pre­clin­i­cal pro­grams — the AML drug XmAb14045 and XmAb13676 for B-cell ma­lig­nan­cies, both head­ed to the clin­ic lat­er this year — as well as non-ex­clu­sive use of the tech for up to 10 more pro­grams.

In ad­di­tion to shar­ing de­vel­op­ment costs, Xen­cor has an opt-in on co-com­mer­cial­iz­ing one of the phar­ma gi­ant’s drugs de­vel­oped from an ex­clu­sive use of the tech on four undis­closed tar­gets.

No­var­tis marks the lat­est in a string of heavy­weight part­ners for Xen­cor. Am­gen paid $45 mil­lion up­front to part­ner last fall in a $1.7 bil­lion deal, fol­low­ing the likes of Mer­ck, No­vo Nordisk, J&J, Boehringer and Alex­ion.

No­var­tis is an ag­gres­sive play­er in the on­col­o­gy are­na. It moved de­ci­sive­ly to al­ly it­self with in­ves­ti­ga­tors at the Uni­ver­si­ty of Penn­syl­va­nia on CAR-T and swift­ly moved from in­vestor to part­ner with In­tel­lia on gene edit­ing tech. Gen­er­al­ly cir­cum­spect about what it will pay in any deal, the com­pa­ny has sig­naled time and again that it will fork over what it needs to to get the tech that it wants. In this case the com­pa­nies didn’t an­nounce the up­side on the hefty mile­stone pack­age, but Xen­cor in­clud­ed the num­ber in its SEC fil­ing.

Xen­cor is by no means alone in bis­pecifics, but the biotech says it’s sep­a­rate from the pack.

“What dis­tin­guish­es us is plug-and-play sim­plic­i­ty,” Xen­cor CEO Bassil Dahiy­at tells me in an email.  “Mak­ing a bis­pe­cif­ic is just as easy as mak­ing a reg­u­lar an­ti­body can­di­date. And the man­u­fac­tur­ing is stan­dard Ab man­u­fac­tur­ing with stan­dard process­es and great yields. Half-life is long like an an­ti­body. And we’ve tuned their po­ten­cy so they can bring T-cell killing against tu­mors while be­ing tol­er­at­ed, com­pared to the de­gree of tox seen with ear­li­er plat­forms. We make it faster and sim­pler to do bis­pecifics and to give them to pa­tients.”

Bassil Dahiy­at, Xen­cor CEO

Xen­cor’s lead in-house drug is the mid-stage bis­pe­cif­ic XmAb5871, which tar­gets CD-19 and the FcγRI­Ib re­cep­tor to block B cell ac­ti­va­tion with­out elim­i­nat­ing them. That kind of dou­ble team work could dis­tin­guish it from oth­er au­toim­mune drugs. And the biotech has been at work test­ing it for rheuma­toid arthri­tis.

In to­day’s deal, No­var­tis is fol­low­ing up with a pact that puts it in the lab with a group of Xen­cor sci­en­tists who have spent years re­fin­ing a bis­pe­cif­ic an­ti­body ap­proach to can­cer ther­a­py. While one seg­ment of the an­ti­body binds to a tu­mor cell, the Fc re­gion flags an im­mune re­sponse, re­cruit­ing T cells to the tar­get. And that’s a field that No­var­tis has been spe­cial­iz­ing in.

Can­cer R&D has al­so been chang­ing dra­mat­i­cal­ly in re­cent years, com­press­ing years of Phase I-through-Phase III work in­to one rel­a­tive­ly quick lunge for ac­cel­er­at­ed ap­provals of the most promis­ing pro­grams. Chang­ing that time­line has made it pos­si­ble to do big-mon­ey up fronts for new can­cer drugs.

“The crit­i­cal as­pect of this deal is we kept full U.S. com­mer­cial­iza­tion rights and 50/50 world­wide de­vel­op­ment with No­var­tis,” notes Dahiy­at. “So their cap­i­tal and the up­front/mile­stones, com­bined with their ex­per­tise and scale, will help us in our am­bi­tions to one day be a com­mer­cial com­pa­ny, if a lot of steps in be­tween go well! This deal is a great help and we made sure not to li­cense away our fu­ture.  No­var­tis is an ex­cel­lent part­ner be­cause they can de­rive a lot of val­ue of these pro­grams and the re­search pro­grams of theirs that we en­able.”

Xen­cor has just over 60 em­ploy­ees now and ex­pects to add an­oth­er 15 to 20 in the next 12 months, pri­mar­i­ly to con­tin­ue to scale up clin­i­cal de­vel­op­ment ca­pa­bil­i­ty.

Tower Bridge in London [Shutterstock]

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Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

Deborah Dunsire. Lundbeck

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A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

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We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Scott Gottlieb, AP Images

Scott Got­tlieb has a new board po­si­tion to add to the re­sume — and this one is fo­cused on a fa­vorite sub­ject

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He’ll be joining the advisory board of FasterCures, a think tank which former junk bond king Michael Milken set up to help drive more drugs to the market, looking to accelerate drug R&D. That’s a subject close to the heart of Gottlieb, who blazed a trail at the FDA focused on hustling up the process. That helped endear him to the industry, making him one of the most popular commissioners in FDA history.

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Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

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CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

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The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

Lisa M. DeAngelis, MSKCC

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His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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