Craig Gibbs, Asher Bio CEO (Asher)

Ash­er Bio­ther­a­peu­tics joins search for a bet­ter IL-2 sans the tox­i­c­i­ties

Can IL-2 ther­a­pies — which can be pow­er­ful against can­cer but in­fa­mous for their tox­ic side ef­fects — be made in­her­ent­ly more spe­cif­ic? For Ash­er Bio­ther­a­peu­tics, that’s the $55 mil­lion ques­tion.

Ivana Djuret­ic and Andy Ye­ung left their jobs in can­cer im­munol­o­gy and pro­tein en­gi­neer­ing at Pfiz­er in 2019 to start Ash­er with the idea that they could im­prove the ef­fi­ca­cy of im­munother­a­pies. More specif­i­cal­ly, they want­ed to know if re­strict­ing the ac­tiv­i­ty of a cy­tokine to on­ly the cells that mat­ter would coun­ter­in­tu­itive­ly re­sult in bet­ter ther­a­peu­tics.

They de­cid­ed to start with IL-2, what Djuret­ic called “one of the most ex­cit­ing chal­lenges to­day.” And that work, she said, led them to an “aha mo­ment.”

Ivana Djuret­ic

“We sort of re­al­ized that we could … mod­u­late spe­cif­ic im­mune cell sub­sets in many con­texts, not on­ly IL-2, not on­ly CD8,” through a process called cis-tar­get­ing, Djuret­ic said. Cis-tar­get­ing is an en­gi­neer­ing ap­proach that works by re­quir­ing the si­mul­ta­ne­ous en­gage­ment of two re­cep­tors on the same im­mune cell for ac­ti­va­tion.

Djuret­ic and Ye­ung ran in­to Third Rock at an ear­ly 2020 meet­ing in Boston, and the rest is his­to­ry. Wash­ing­ton Uni­ver­si­ty pro­fes­sor Robert Schreiber and Nether­lands Can­cer In­sti­tute top sci­en­tist Ton Schu­mach­er, who were in­volved with Third Rock, hopped on board as co-founders. And on Tues­day morn­ing, the com­pa­ny un­veiled a $55 mil­lion Se­ries A to take its lead on­col­o­gy pro­gram, AB248, to the clin­ic next year.

Andy Ye­ung

“So a lot of peo­ple are try­ing to tar­get IL-2 spa­tial­ly to the site of the tu­mor, but it’s an in­her­ent­ly non­spe­cif­ic mol­e­cule. So we think there’s on­ly a lim­it­ed amount of speci­fici­ty we can get out of that,” CEO Craig Gibbs said. “What we’re try­ing to do is make IL-2 in­her­ent­ly spe­cif­ic, so it on­ly binds CD8+ T cells, which is the ones that we want, and not to T regs which are go­ing to be im­muno­sup­pres­sive, and not to NK cells which just cause tox­i­c­i­ty, and not to en­dothe­lial cells which cause vas­cu­lar leak.”

Gibbs left his job as CBO at Forty Sev­en to join Ash­er last sum­mer, af­ter the for­mer was bought by Gilead for near­ly $5 bil­lion. That Sep­tem­ber, he was “grat­i­fied” by some “re­al­ly stel­lar” da­ta from Schreiber’s lab. In vit­ro and mon­key stud­ies have shown a “much larg­er ex­pan­sion” of CD8 cells, with­out the ac­ti­va­tion of reg­u­la­to­ry T cells or NK cells, he said.

In ad­di­tion to on­col­o­gy, the Ash­er team be­lieves the plat­form could have ap­pli­ca­tions in au­toim­mu­ni­ty and in­fec­tious dis­ease.

The Se­ries A was led by Third Rock with par­tic­i­pa­tion from Box­er Cap­i­tal of Tavi­s­tock Group, In­vus, Y Com­bi­na­tor and MBC Bi­o­labs.

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).

Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether patients are immunocompromised or just don’t like needles, one fledgling Australian biotech says it has an alternative to Covid-19 vaccines that doesn’t involve a jab in the arm — and on Tuesday, it pulled in a fresh round of funding to take it into the clinic.

ENA Respiratory, which spun out of ENA Therapeutics last year, has pulled in nearly $24.7 million (AU $30 million) to advance its nasal spray for respiratory viral infections, the company said Tuesday.

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.

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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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.”

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.

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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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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