Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With con­cerns about the Delta vari­ant ris­ing and much of the world still in des­per­ate need of vac­cine dos­es, a Chi­nese biotech an­nounced Wednes­day that a new shot has shown pos­i­tive re­sults in a large tri­al against Covid-19, in­clud­ing new vari­ants.

Clover Bio­phar­ma­ceu­ti­cals an­nounced Wednes­day that its vac­cine can­di­date showed 79% ef­fi­ca­cy against the Delta vari­ant in a Phase II/III tri­al dubbed Spec­tra, and 67% ef­fec­tive against Covid-19 over­all.

The can­di­date, known as SCB-2019, met both the pri­ma­ry and sec­ondary ef­fi­ca­cy end­points in a study in which all of the strains were vari­ants from the orig­i­nal virus. The study showed 92% vac­cine ef­fi­ca­cy against the Gam­ma vari­ant, but just 59% ef­fi­ca­cy against Mu. The 30,000 par­tic­i­pants were all over the age of 18, and were in five coun­tries: Philip­pines, Brazil, Colom­bia, South Africa and Bel­gium.

The vac­cine showed 83% ef­fi­ca­cy against mod­er­ate-to-se­vere Covid-19. There were no caus­es of hos­pi­tal­iza­tion or death in the group, Clover said, and all three deaths in the tri­al were from the place­bo group.

Clover now plans to file for au­tho­riza­tion in Chi­na, Eu­rope and with the World Health Or­ga­ni­za­tion.

In a press re­lease, Clover CEO Joshua Liang said:

Spec­tra en­rolled par­tic­i­pants dur­ing a time when the world en­coun­tered the rapid spread of in­creas­ing­ly trans­mis­si­ble SARS-CoV-2 vari­ants and a takeover by Delta. Amidst this back­drop, we are pleased that SCB-2019 has suc­cess­ful­ly demon­strat­ed ef­fi­ca­cy against the glob­al­ly dom­i­nant Delta strain and oth­er con­cern­ing vari­ants. Based on our pi­o­neer­ing da­ta, we be­lieve that SCB-2019 could be uti­lized as an im­por­tant tool to com­bat this pan­dem­ic, and we re­main ded­i­cat­ed to ex­pe­dit­ing the avail­abil­i­ty and eq­ui­table ac­cess of our Covid-19 vac­cine can­di­date for glob­al dis­tri­b­u­tion.

Clover’s plat­form is dubbed Trimer-Tag and pro­duces co­va­lent­ly-trimer­ized fu­sion pro­teins. Its can­di­date, Covid-19 S-Trimer, re­sem­bles the vi­ral spike (S)-pro­tein found in the virus.

Though those fig­ures are be­low the ef­fi­ca­cy num­bers for mR­NA shots or the No­vavax vac­cine, biotech in­vestor Brad Lon­car not­ed it comes at a time when much of the world still des­per­ate­ly needs vac­cine dos­es.

The tri­al al­so found that the vac­cine sig­nif­i­cant­ly re­duced the risk of Covid-19 in peo­ple who have pre­vi­ous­ly been in­fect­ed with Covid-19. Near­ly 50% of par­tic­i­pants in the tri­al had pre­vi­ous­ly been in­fect­ed. The vac­cine showed a 64% re­duc­tion in risk of symp­to­matic in­fec­tion and a 79% re­duc­tion in symp­to­matic re­in­fec­tion from the Delta vari­ant.

Ear­li­er this month, Clover got the OK to man­u­fac­ture its can­di­date at a Changx­ing fa­cil­i­ty. The com­pa­ny says the fa­cil­i­ty has the ca­pa­bil­i­ty to pro­duce a bil­lion dos­es of anti­gens for the jab, which if grant­ed emer­gency use ap­proval, will be one of the first pro­tein-based Covid-19 vac­cines.

If all goes ac­cord­ing to plan, Clover an­tic­i­pates launch by the end of 2021. The com­pa­ny will sup­ply up to 414 mil­lion dos­es of the jab to Co­v­ax to dis­trib­ute through­out coun­tries in need of dos­es.

Clover has got­ten $328 mil­lion from CEPI to de­vel­op its vac­cine. Glax­o­SmithK­line put its trust in the com­pa­ny in Feb­ru­ary 2020, when it lent the com­pa­ny its ad­ju­vant sys­tem in fear of a pan­dem­ic that proved to be valid. The com­pa­ny boasts of one of the largest in-house com­mer­cial cGMP man­u­fac­tur­ing ca­pa­bil­i­ties in Chi­na, which puts it­self in a po­si­tion to quick­ly scale up pro­duc­tion when need­ed.

The com­pa­ny has six vac­cine can­di­dates that in its pipeline that use Trimer-Tag tech­nol­o­gy, which in­cludes an HIV/AIDS vac­cine and a flu vac­cine, and two on­col­o­gy can­di­dates.

About 18% of tri­al par­tic­i­pants had co-mor­bidi­ties for Covid-19, the com­pa­ny said.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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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 are 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 are 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.

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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.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

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.