Re­gen­eron to seek EUA for low­er dose of Covid-19 mAb cock­tail as new tri­al shows ma­jor drop in risk of hos­pi­tal­iza­tion or death

The suc­cess of mon­o­clon­al an­ti­body (mAb) cock­tails in keep­ing peo­ple with Covid-19 out of the hos­pi­tal con­tin­ued Tues­day, with Re­gen­eron an­nounc­ing that even a low­er-than-au­tho­rized dose of its com­bi­na­tion of mAbs re­duced hos­pi­tal­iza­tion or death by 70% in non-hos­pi­tal­ized Covid-19 pa­tients.

George Yan­copou­los

“We will rapid­ly dis­cuss the new da­ta with reg­u­la­to­ry au­thor­i­ties and re­quest that the 1,200 mg dose be added to the U.S. Emer­gency Use Au­tho­riza­tion, in or­der for the an­tic­i­pat­ed RE­GEN-COV sup­ply to be avail­able to treat even more pa­tients,” George Yan­copou­los, pres­i­dent and CSO of Re­gen­eron, said in a state­ment.

The place­bo-con­trolled tri­al of more than 4,500 peo­ple showed how casiriv­imab and imde­vimab re­duced the risk of hos­pi­tal­iza­tion or death by 70% for the 1,200 mg IV dose, and 71% for the au­tho­rized 2,400 mg IV ver­sion, when com­pared to place­bo, the com­pa­ny said.

In ad­di­tion, Re­gen­eron said a dose-rang­ing Phase II tri­al of 815 non-hos­pi­tal­ized Covid-19 pa­tients showed “sig­nif­i­cant and com­pa­ra­ble vi­ral re­duc­tions” for all dos­es test­ed of the mAb com­bo, in­clud­ing as low as 300 mg. A com­pa­ny spokesper­son said fur­ther dis­cus­sions with the FDA will be nec­es­sary to dis­cuss sub­cu­ta­neous ad­min­is­tra­tion, and “even low­er dose pos­si­bil­i­ties in the fu­ture.”

Walid Gel­lad

Walid Gel­lad, di­rec­tor of the Uni­ver­si­ty of Pitts­burgh Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing, who’s un­af­fil­i­at­ed with the re­sults, said that they show yet an­oth­er ex­am­ple of how ef­fec­tive these mAbs are for out­pa­tient use to re­duce hos­pi­tal­iza­tion.

“Com­pa­nies in a pan­dem­ic should be ap­plaud­ed for test­ing low­er dos­es, which will ex­tend sup­ply,” he added.

De­spite the pos­i­tive new da­ta, dos­es of the Re­gen­eron and Eli Lil­ly mAb cock­tails have been dif­fi­cult to come by and states have had to grap­ple with fig­ur­ing out new ways to ad­min­is­ter the in­fu­sions.

A Re­gen­eron spokesper­son said the com­pa­ny so far has de­liv­ered near­ly 300,000 dos­es to the US (al­though the gov­ern­ment’s web­site still says it’s dis­trib­uted about 150,000 as of ear­ly Feb­ru­ary). Be­gin­ning in April, Re­gen­eron will de­liv­er sup­plies of the mAb cock­tail un­der its sec­ond con­tract with the US gov­ern­ment, which will pro­vide 750,000 or more dos­es by mid-year.

“Most re­cent­ly we have said we ex­pect to pro­vide ap­prox­i­mate­ly 750,000 dos­es at the 2,400 mg dose lev­el by June 30, but now we an­tic­i­pate be­ing able to pro­vide more if the 1,200 mg dose is added to the EUA,” the spokesper­son added.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.