Fast biotech: Gilead hands $200M to com­pu­ta­tion­al wiz Nim­bus as it speeds in­to PhII NASH tri­al

Nim­bus CEO Don Nichol­son

When Nim­bus Ther­a­peu­tics CEO Don Nichol­son struc­tured his $1.2 bil­lion li­cens­ing deal with Gilead $GILD ear­li­er this year, he built it with the Big Biotech’s rep for fo­cus, sci­ence and clin­i­cal speed in mind.

It paid off. Fast.

To­day, Cam­bridge, MA-based Nim­bus is re­veal­ing that it grabbed a $200 mil­lion mile­stone from Gilead for its ear­ly-stage NASH drug, just 6 months af­ter nab­bing a $400 mil­lion up­front pay­ment. The pay­out now gives them $600 mil­lion this year, half of that $1.2 bil­lion deal to­tal that Gilead signed off on.

“It’s a great drug for a com­pa­ny that re­al­ly needs a pipeline,” Nichol­son tells me about his new part­ners at Gilead. “Once they sink their teeth in­to some­thing, they go af­ter it ham­mer and tong.”

Nichol­son says the pay­out is a di­rect ben­e­fit of his de­ci­sion to over­look an­oth­er of­fer for more mon­ey — no, he’s not say­ing which com­pa­ny was left at the deal ta­ble — to fa­vor a part­ner that demon­strat­ed with hep C that it will move heav­en and earth to push rapid­ly through the clin­ic. What he al­so can’t say is ex­act­ly what the mile­stone pay­ment is for, though it seems rea­son­able to as­sume on my end that it might have some­thing to do with the quick ramp up for a mid-stage clin­i­cal pro­gram.

Work­ing with a com­pu­ta­tion­al chem­istry plat­form that has at­tract­ed the back­ing of Mi­crosoft mogul Bill Gates, Nim­bus built a pro­gram for a drug that tar­gets an en­zyme called Acetyl-CoA car­boxy­lase, or ACC, in­volved in the cre­ation of en­doge­nous fat­ty acids and the reg­u­la­tion of be­ta-ox­i­da­tion, de­scribed as the process by which fat­ty acids are bro­ken down at a cel­lu­lar lev­el.

Tack­ling ACC, if it works as planned, should pre­vent the buildup of lipids in the liv­er and break down the ones al­ready present, re­duc­ing the fi­bro­sis that is char­ac­ter­is­tic of the fat­ty liv­er dis­ease. For Gilead, it’s al­so a can­di­date for the kind of com­bi­na­tion ap­proach­es that they fa­vor in look­ing to com­mand a mar­ket like NASH.

Now with $600 mil­lion in hand from the sale of a sub­sidiary, all hands on deck at Nim­bus have switched to work­ing on pre­clin­i­cal ef­forts, with lead ef­forts un­der­way for Tyk2 and STING.

The Gilead deal came along at a per­fect time, adds the CEO. In late 2015, Nim­bus was work­ing on an S-1. Then the IPO mar­ket chilled over — par­tic­u­lar­ly for ear­ly-stage, high-risk biotechs. Now he has the cash to re­ward in­vestors as well as em­ploy­ees while stock­pil­ing enough cash to pay for years of run­way.

Says Nichol­son: “It gave us an aw­ful lot of fi­nan­cial op­tions.”

And the biotech can hang on to the S-1 for a bet­ter mo­ment on the mar­ket.

In cer­tain cir­cles among the scribes that cov­er biotech, biobucks have a faint scent of the dis­rep­utable. The cash awards of­fered for de­vel­op­ment and com­mer­cial mile­stones can be writ­ten off as un­at­tain­able stacks of Mo­nop­oly mon­ey, of­ten use­ful on­ly in the realm of fan­ta­sy — Lep­rechaun gold found in the pot at the end of every rain­bow.

But Nim­bus Ther­a­peu­tics of­fers us an ex­am­ple of how wrong that view can be.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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