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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Bay­er plots a ma­jor facelift at Berke­ley cam­pus, un­cork­ing a 30-year, $1.2B plan to dri­ve cell and gene ther­a­pies

Bayer first set roots in Berkeley back in 1974, when it was still operating as Miles Labs. The site has pumped out three hemophilia A treatments for distribution worldwide; but now, as the pharma continues its cell and gene therapy push, it has something bigger in mind.

Bayer is planning a 30-year revamp at the campus, which includes 918,000 square feet in new buildings and double the jobs, according to a report by the Bay Area Council Economic Institute.

LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lymphoma Society has tapped 5 new early-stage projects to back with up to $10 million each in fresh investments. The 5 biotechs are:

— Caribou, headed by Rachel Haurwitz and co-founded by Jennifer Doudna, is working on next-gen, off-the-shelf CAR-Ts to replace the patient-derived cells now in use.

— The LLS supported NexImmune’s IPO, helping fund its work on nanoparticles that can gin up an immune response directed at cancer cells. The biotech has 2 projects now in Phase I trials.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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