Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

De­spite hav­ing al­ready re­ceived an emer­gency use au­tho­riza­tion for its Covid-19 an­ti­body in non-hos­pi­tal­ized pa­tients last No­vem­ber, Re­gen­eron con­tin­ued to con­duct tri­als to eval­u­ate the cock­tail’s ef­fec­tive­ness. Now, the big biotech has re­ceived some good news from their IDMC.

George Yan­copou­los

On the IDMC’s rec­om­men­da­tion, Re­gen­eron will be shut­ting down en­roll­ment in the place­bo group of a Phase III out­pa­tient tri­al for their REGN-COV pro­gram — a mix of casiriv­imab with imde­vimab — af­ter in­ves­ti­ga­tors found “clear clin­i­cal ef­fi­ca­cy” in both dos­es com­pared to the con­trol, the com­pa­ny an­nounced Thurs­day. CSO George Yan­copou­los al­so said in a state­ment that the cock­tail can neu­tral­ize emerg­ing strains of the nov­el coro­n­avirus.

“Our cock­tail ap­proach us­ing two func­tion­al­ly-in­de­pen­dent an­ti­bod­ies safe­guards against vari­ants that may im­pact po­ten­cy to a sin­gle an­ti­body,” Yan­copou­los said.

Re­gen­eron still does not have ac­cess to the un­blind­ed da­ta, in­clud­ing the rel­a­tive treat­ment ben­e­fit of the 1,200mg and 2,400mg dos­es, and said they will re­lease re­sults next month. Re­searchers will con­tin­ue en­rolling pa­tients at both dosage lev­els.

This is not the on­ly tri­al Re­gen­eron is con­duct­ing for its ex­per­i­men­tal ther­a­py. Last month, the com­pa­ny re­leased in­ter­im da­ta from a sep­a­rate tri­al look­ing at whether it could pre­vent symp­to­matic in­fec­tions from oc­cur­ring in peo­ple ex­posed through a fam­i­ly con­nec­tion.

Those da­ta showed that ze­ro in­fec­tions man­i­fest­ed among 186 peo­ple treat­ed in the treat­ment arm, com­pared to eight of 223 in­fec­tions oc­cur­ring in the place­bo group. Ad­di­tion­al­ly, when adding asymp­to­matic in­fec­tions, there were 23 cas­es among the place­bo pa­tients com­pared to 10 in the cock­tail arm.

In that study, re­searchers al­so not­ed sig­nif­i­cant­ly low­er peak vi­ral loads and short­er pe­ri­ods of vi­ral load­ing for the drug arm. Full da­ta are ex­pect­ed ear­ly in the sec­ond quar­ter.

Fol­low­ing an EUA for the cock­tail last No­vem­ber, the US has been rapid­ly buy­ing up sup­ply of the ther­a­py. Last month, Re­gen­eron scored a $2.625 bil­lion sup­ply deal with the gov­ern­ment. The biotech’s best-case sce­nario for sup­ply is to de­liv­er 1.25 mil­lion dos­es by the end of June, but that may de­pend on the FDA’s stance on the low­er dose — cur­rent­ly, on­ly the 2,400mg cock­tail dose is au­tho­rized.

If reg­u­la­tors don’t soon ex­pand the EUA to cov­er the low­er-dose reg­i­men, which is still be­ing test­ed for the same pop­u­la­tion of non-hos­pi­tal­ized, mild to mod­er­ate Covid-19 pa­tients at high risk of pro­gres­sion, Re­gen­eron will on­ly be able to sup­ply around 750,000 fin­ished dos­es by that time.

In the com­pa­ny’s piv­otal out­pa­tient tri­al, on­ly the high­er dose helped new­ly di­ag­nosed pa­tients achieve sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tions in virus lev­els and re­quire few­er med­ical vis­its. The cock­tail is not au­tho­rized for hos­pi­tal­ized pa­tients or pa­tients re­quir­ing sup­ple­men­tal oxy­gen, ei­ther due to Covid-19 or those with a high-risk co­mor­bid­i­ty.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.