Re­gen­eron con­tin­ues reign atop the Covid treat­ment field with ex­pand­ed EUA for low­er dose sub­cu­ta­neous ver­sion of mAb cock­tail

The FDA on Fri­day au­tho­rized a new, low­er-dose ver­sion of Re­gen­eron’s Covid-19 mon­o­clon­al an­ti­body cock­tail for those with Covid-19 who are at high-risk of pro­gress­ing to hos­pi­tal­iza­tion.

The new dose is half the orig­i­nal­ly au­tho­rized dose, but the eas­i­er-to-ad­min­is­ter sub­cu­ta­neous ver­sion may not be the game-chang­er that ex­perts once en­vi­sioned. Re­gen­eron said in a state­ment that the com­bo “should be ad­min­is­tered by in­tra­venous (IV) in­fu­sion” and sub­cu­ta­neous in­jec­tions “are an al­ter­na­tive when IV in­fu­sion is not fea­si­ble and would lead to a de­lay in treat­ment.”

Re­gen­eron spokesper­son Alexan­dra Bowie al­so said the sub­cu­ta­neous ver­sion will still need to be giv­en in a health care set­ting (e.g. in­fu­sion cen­ter, hos­pi­tal, doc­tor’s of­fice) at this point, with one hour of ob­ser­va­tion re­quired af­ter­ward.

“The pre­sen­ta­tion (the co­for­mu­lat­ed vials which were al­so just au­tho­rized – this just means the casiriv­imab and imde­vimab an­ti­bod­ies are mixed to­geth­er now vs. in sep­a­rate vials) is the same for in­tra­venous in­fu­sion or sub­cu­ta­neous in­jec­tion,” Bowie added.

The ex­pand­ed EUA comes as Covid-19 vari­ants emerg­ing from In­dia and Brazil have dis­rupt­ed the de­liv­ery of some mAbs across the US, in­clud­ing two Eli Lil­ly prod­ucts, a com­bo of bam­lanivimab and ete­se­vimab, and bam­lanivimab alone, which had its EUA re­voked.

Re­gen­eron’s RE­GEN-COV (casiriv­imab and imde­vimab), fund­ed in part by BAR­DA, is cur­rent­ly the on­ly an­ti­body ther­a­py avail­able na­tion­wide, in­clud­ing eight states (Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon, Wash­ing­ton, Illi­nois and Mass­a­chu­setts) with high rates of those two vari­ants of con­cern.

Lat­er this sum­mer, Re­gen­eron ex­pects to sub­mit a full BLA for the com­bo treat­ment for the same in­di­ca­tion in non-hos­pi­tal­ized out­pa­tients with Covid-19. The eval­u­a­tion of RE­GEN-COV as a way to pre­vent Covid is al­so on­go­ing and the com­pa­ny said it sub­mit­ted da­ta to the FDA from a pos­i­tive Phase III tri­al on the pre­ven­tion of in­fec­tion among house­hold con­tacts of Covid-in­fect­ed in­di­vid­u­als.

As far as sup­plies, Re­gen­eron ex­pects to de­liv­er 1 mil­lion dos­es by the end of this month, and the US gov­ern­ment has pledged to pur­chase all dos­es of the mAb that are de­liv­ered by the end of this month, with the po­ten­tial for more through the end of Sep­tem­ber, up to a max­i­mum of 1.25 mil­lion dos­es.

That puts Re­gen­eron at an ad­van­tage over an­oth­er re­cent­ly au­tho­rized mAb from Vir and GSK, which are nav­i­gat­ing the open mar­ket with­out gov­ern­ment pur­chas­es. But Vir al­so says its sin­gle an­ti­body can neu­tral­ize each of the vari­ants sci­en­tists sus­pect are pro­lif­er­at­ing.

Ron­ny Gal

And all the mAbs on the mar­ket al­so now ben­e­fit from a widen­ing of who qual­i­fies to re­ceive them, as race or eth­nic­i­ty are now in­clud­ed by the FDA in the el­i­gi­bil­i­ty cri­te­ria.

Bern­stein biotech an­a­lyst Ron­ny Gal said in a note to in­vestors late last month that the pause of the Lil­ly com­bo treat­ment will like­ly push the mar­ket in Re­gen­eron’s fa­vor. He pre­dicts about $375 mil­lion in sales for the re­main­der of the year for Lil­ly, and about $1.6 bil­lion in the same pe­ri­od for Re­gen­eron.

As sup­plies are now plen­ti­ful, “it’s tough to see why any providers would take a chance on the Lil­ly com­bo,” he wrote. “We tip our hats to the Re­gen­eron team who em­pha­sized the im­por­tance tar­get­ing epi­topes less like­ly to mu­tate from the be­gin­ning and was will­ing to state this view pub­licly.”

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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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.

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.

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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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.”

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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