Deep­en­ing US foot­print, As­traZeneca-part­nered French biotech In­nate shoots for $100M IPO

Fresh off of a 20th birth­day cel­e­bra­tion, French biotech In­nate Phar­ma filed for a US IPO worth up to $100 mil­lion. They de­tailed in their fil­ings a strat­e­gy to roll cash in­to pre­clin­i­cal work, ad­vanc­ing the tri­als for two drugs tar­get­ing blood can­cer and sol­id tu­mors and fur­ther test­ing the check­point in­hibitor mon­al­izum­ab, while al­so build­ing a com­mer­cial in­fra­struc­ture to mar­ket and cap­i­tal­ize on their trade­mark leukemia drug Lu­mox­i­ti.

Jen­nifer But­ler

The im­muno-on­col­o­gy biotech ac­quired its first big drug last year as it li­censed Lu­mox­i­ti from As­traZeneca. It’s the first FDA-ap­proved drug for hairy cell leukemia in 20 years. But, as they write in their F-1, al­though the com­pa­ny will be ful­ly re­spon­si­ble for mar­ket­ing the drug by 2020, they “cur­rent­ly have no sales, mar­ket­ing or com­mer­cial prod­uct dis­tri­b­u­tion or­ga­ni­za­tion and have no ex­pe­ri­ence in mar­ket­ing or man­ag­ing the man­u­fac­tur­ing of prod­ucts.”

Long­time As­traZeneca ex­ec Jen­nifer But­ler is now the head of In­nate’s US op­er­a­tions.

The com­pa­ny brought in €93 mil­lion last year (around $100 mil­lion), and €59 mil­lion in the first half of 2019 (about $65 mil­lion). They have re­ceived $550 mil­lion over the last 10 years in up­front pay­ments, mile­stone pay­ments and eq­ui­ty in­vest­ments through part­ner­ships with As­traZeneca and Sanofi and oth­ers, and they es­ti­mate they’re el­i­gi­ble for up to $5.5 bil­lion in var­i­ous pay­ments from such col­lab­o­ra­tions.

The three largest stock­hold­ers are No­vo Nordisk, Med­Im­mune (which is owned by As­traZeneca) and Bpifrance Par­tic­i­pa­tions, with co-founder Hervé Brail­ly hold­ing a 2.1% slice. No­vo ac­quired its 13.9% stake in ex­change for a new im­muno-on­col­o­gy tar­get af­ter a vaunt­ed In­nate leukemia ther­a­py flunked a Phase II tri­al. The biotech is cur­rent­ly list­ed on Eu­ronext Paris.

As of June 30, they had $220 mil­lion in cash, cash equiv­a­lents, short term in­vest­ments and non-cur­rent fi­nan­cial as­sets.

The com­pa­ny is work­ing on three class­es of prod­ucts: broad-spec­trum im­mune check­point in­hibitors, tu­mor anti­gen tar­get­ing, and sup­pres­sive fac­tors of the TME.

They are cur­rent­ly test­ing mon­al­izum­ab, their lead drug, in col­lab­o­ra­tion with As­traZeneca for sol­id tu­mors, in­clud­ing SC­CHN (head and neck) and CRC (col­orec­tal). They part­nered out that drug as part of the same deal that li­censed Lu­mox­i­ti to them, with As­traZeneca ex­er­cis­ing its $100 mil­lion for an op­tion on the drug, with an­oth­er $100 mil­lion pay­out at the first Phase III de­vel­op­ment and $825 mil­lion in po­ten­tial mile­stone mon­ey.

Pre­lim­i­nary da­ta from the lat­est 40-per­son ex­pan­sion to a Phase II tri­al showed a 27.5% re­sponse rate and one com­plete re­sponse. Fol­low-up da­ta are com­ing with­in the year.

As­traZeneca al­so agreed to fun­nel $20 mil­lion in­to four pre­clin­i­cal pro­grams, each po­ten­tial­ly worth $355 mil­lion, and pur­chased their 9.8% stake in In­nate for $72 mil­lion. In­nate paid $50 mil­lion for Lu­mox­i­ti.

This year, they al­so gained FDA fast-track sta­tus for the an­ti­body IPH4102 for treat­ment-re­sis­tant Sézary syn­drome, an ag­gres­sive form of lym­phoma, in ad­di­tion to or­phan drug des­ig­na­tions in the US and Eu­rope.

Lu­mox­i­ti was ap­proved un­der pri­or­i­ty re­view af­ter a Phase III tri­al demon­strat­ed a 75% re­sponse rate, with 30% of pa­tients re­spond­ing com­plete­ly. But there were less than 100 pa­tients and the drug was no­table among the half of all FDA-ap­proved treat­ments that were stamped based on a sin­gle tri­al in 2018.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Abbie Celniker (L) and Rob Sims (Flare)

A Third Rock-backed play­er charts a new course against tran­scrip­tion fac­tors. Do 'switch sites' hold the mag­ic sauce?

Long known for their role in guiding gene expression but considered “undruggable,” DNA binding transcription factors have long been a Holy Grail for drug developers. Now, a new startup from Third Rock Ventures thinks it could have the juice to get after transcription factors once and for all — and it all started with a “flare” of inspiration from an article out of an Oxford lab.

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