Lil­ly en­lists a long-in­cu­bat­ing RNA up­start in new $1.25B part­ner­ship

For near­ly a decade af­ter Im­pe­r­i­al Col­lege Lon­don pro­fes­sor Nagy Habib launched Mi­NA Ther­a­peu­tics around a new kind of RNA in 2008, the com­pa­ny made vir­tu­al­ly no an­nounce­ment: no ven­ture cap­i­tal raised, no col­lab­o­ra­tions signed. Now, it’s like a fire hose.

Robert Habib

On Tues­day, Mi­NA an­nounced a re­search col­lab­o­ra­tion with Eli Lil­ly worth up to $1.25 bil­lion: $25 mil­lion up­front and $245 mil­lion in mile­stones for each of five po­ten­tial tar­gets. The col­lab­o­ra­tors didn’t di­vulge what those tar­gets would be, but said they would come in Lil­ly’s “key ther­a­peu­tic ar­eas,” such as meta­bol­ic dis­eases and dis­eases of the cen­tral ner­vous sys­tem.

“It’s noth­ing odd they haven’t been work­ing on,” CEO Robert Habib, Nagy’s son, told End­points News.

The deal is the third and largest phar­ma col­lab­o­ra­tion Mi­NA has signed since the start of 2020, af­ter a re­search deal with As­traZeneca for an undis­closed sum and an up to $266 mil­lion neu­rol­o­gy-fo­cused part­ner­ship with Servi­er. They al­so grabbed their first ven­ture round in that span, rais­ing $30 mil­lion from the Is­raeli VC aMoon and oth­ers.

Nagy Habib

The flur­ry rep­re­sents the pay­off of over a decade of work on a tech­nol­o­gy Nagy Habib deemed small-ac­ti­vat­ing RNA. These strands func­tion sim­i­lar­ly to the small in­ter­fer­ing RNA that has turned Al­ny­lam in­to a $15 bil­lion com­pa­ny but in re­verse: In­stead of hi­jack­ing cel­lu­lar ma­chin­ery to turn the vol­ume down on a gene, they hi­jack it to turn the vol­ume way up.

The biotech first used saR­NAs for liv­er can­cer, Nagy Habib’s fo­cus as a re­searcher. They used saR­NA to turn up ex­pres­sion of cer­tain genes on the myeloid cells that clus­ter around and of­ten shield a tu­mor from the im­mune sys­tem. The idea was to re­pro­gram the cells from pro-tu­mor myeloid cells to tu­mor-eat­ing myeloid cells and boost the ef­fi­ca­cy of check­point ther­a­pies like Keytru­da. They showed (ear­ly) proof-of-con­cept da­ta at AS­CO last year.

Mi­NA thinks that saR­NA, like mR­NA and RNAi, can be used across a range of dis­eases and, with their new­found part­ners, they’re now work­ing to ex­pand the list. There’s al­so an old­er col­lab­o­ra­tion with Boehringer In­gel­heim on fi­brot­ic liv­er dis­eases, such as NASH.

In the Lil­ly deal, which they first be­gan ne­go­ti­at­ing at JPM 2020 be­fore the pan­dem­ic side­tracked every­thing, the In­di­anapo­lis phar­ma will se­lect the genes they want to am­pli­fy and Mi­NA will de­sign the RNA strands need­ed to do the trick.

“Where we start­ed is im­muno-on­col­o­gy but clear­ly we be­lieve this tech can be ap­plied across dif­fer­ent dis­ease ar­eas,” Robert Habib said. “It’s not lim­it­ed to any cell type.”

Cash from their part­ners has giv­en Mi­NA a good run­way, Habib said. Still, he added, they will look to raise an­oth­er ven­ture round in the next year.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Someit Sidhu, JATT

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

The SPAC train has slowed down since the extraordinarily high levels from late 2020 into early this year, but Tuesday saw the filing of a new blank-check company targeting the life sciences industry.

Jatt Acquisition submitted its SEC paperwork Tuesday, penciling in an estimated raise of $120 million as it sets its sights on a reverse merger partner. The SPAC is run by Someit Sidhu, a co-founder of Pathios Therapeutics, as well as CEO of Akaza Bioscience and Izana Bioscience. Sidhu will control about 97% of the blank-check company’s shares, per the S-1.

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Scientists have come up with the first evidence that Regeneron’s antibody cocktail, which has so far only been authorized for the outpatient setting, may reduce deaths of hospitalized Covid-19 patients — albeit only a subset.

The combination of casirivimab and imdevimab is the subject of the latest data cut from RECOVERY, the large-scale UK-based trial testing a variety of potential treatments. In total, 9,785 patients hospitalized with Covid-19 were enrolled in this arm of the study and were randomly assigned to receive either usual care plus the intravenous combo or usual care alone.

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”