Covid-19 roundup: CanSi­no sub­mits vac­cine to Chi­nese reg­u­la­tors; As­traZeneca says an­ti­bod­ies show ear­ly ef­fi­ca­cy against new vari­ants — re­port

CanSi­no says their sin­gle-dose Covid-19 vac­cine is 65.28% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 cas­es, and they’ve of­fi­cial­ly filed for au­tho­riza­tion with Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

The vac­cine was 90.07% ef­fec­tive at pre­vent­ing se­vere dis­ease 28 days af­ter the sin­gle dose, ac­cord­ing to a state­ment re­port­ed by lo­cal me­dia. Ef­fi­ca­cy rates were slight­ly high­er 14 days af­ter the sin­gle dose, at 68.83% for symp­to­matic dis­ease and  95.47% for se­vere dis­ease.

The re­sults come from a mul­ti­cen­ter Phase III tri­al that took place in Pak­istan, Mex­i­co, Rus­sia, Chile and Ar­genti­na. To date, 40,000 vol­un­teers have been vac­ci­nat­ed, CanSi­no said.

Chi­na’s gov­ern­ment be­gan al­low­ing its mil­i­tary to use the ade­n­ovi­ral vec­tor-based vac­cine back in June, mak­ing it the first vac­cine ap­proved for lim­it­ed hu­man use. It was al­so Chi­na’s first vac­cine to en­ter hu­man test­ing.

Fac­ing con­cerns that the can­di­date had lim­it­ed ef­fi­ca­cy, CanSi­no en­tered a Phase I tri­al in Chi­na study­ing the ef­fi­ca­cy of a two-dose reg­i­men in Sep­tem­ber. That tri­al, which is ac­tive but no longer re­cruit­ing, en­rolled 149 par­tic­i­pants ac­cord­ing to reg­is­tra­tion records.

As­traZeneca says its an­ti­bod­ies show ear­ly ef­fi­ca­cy against new vari­ants — re­port

Ear­ly tests sug­gest that As­traZeneca’s mon­o­clon­al an­ti­body cock­tail ap­pears to be ef­fec­tive against emerg­ing vari­ants, the phar­ma’s head of mi­cro­bial sci­ences, Mark Ess­er, told Bloomberg. 

Ess­er said the an­ti­bod­ies showed promise against two strains first de­tect­ed in the UK and South Africa, Bloomberg’s Suzi Ring re­port­ed. In to­tal, As­traZeneca is run­ning five late-stage tri­als eval­u­at­ing the an­ti­bod­ies for pre­ven­tion and treat­ment — though Ess­er says the com­pa­ny is strug­gling with en­roll­ment as peo­ple drop out to get vac­ci­nat­ed.

AZD7442 en­tered an in­ter­na­tion­al Phase III tri­al back in No­vem­ber, with a tar­get of 5,000 par­tic­i­pants. So far, As­traZeneca has re­cruit­ed 3,000 vol­un­teers, Bloomberg re­port­ed.

Pro­phy­lac­tic treat­ments like the one As­traZeneca is de­vel­op­ing could prove use­ful for those with weak­er im­mune sys­tems, or those who don’t re­spond well to a vac­cine. AZD7442 is a com­bi­na­tion of two mon­o­clon­al an­ti­bod­ies that is de­signed to be in­ject­ed in­to the mus­cle.

Mene Pan­ga­los

“These have been en­gi­neered specif­i­cal­ly to have what we call a long half-life, (so) we think they will con­fer pro­tec­tion for (at least) six, but more like­ly clos­er to 12 months,” Mene Pan­ga­los, As­traZeneca’s ex­ec­u­tive vice pres­i­dent of bio­phar­ma­ceu­ti­cals R&D, said in No­vem­ber, per Reuters.

Eli Lil­ly clinched the first emer­gency use au­tho­riza­tion for a Covid-19 an­ti­body back in No­vem­ber, and racked up an­oth­er EUA ear­li­er this month for the use of its two-drug an­ti­body cock­tail in re­cent­ly di­ag­nosed pa­tients with mild to mod­er­ate dis­ease.

The news comes about a week af­ter the WHO ap­proved As­traZeneca and Ox­ford’s Covid-19 vac­cine. The As­traZeneca shot makes up the vast ma­jor­i­ty of CO­V­AX vac­cines, with more than 330 mil­lion dos­es sched­uled for de­liv­ery start­ing in late Feb­ru­ary.

NIH launch­es new ini­tia­tive study­ing Covid long-haulers

As a grow­ing num­ber of Covid-19 pa­tients re­port symp­toms that just won’t go away, the NIH has launched a new ini­tia­tive to un­der­stand the long-term ef­fects of the virus.

Large num­bers of pa­tients con­tin­ue to ex­pe­ri­ence a “con­stel­la­tion” of symp­toms af­ter re­cov­er­ing from the ini­tial stages of Covid-19, from “brain fog” to short­ness of breath, ac­cord­ing to the NIH. The symp­toms, dubbed “Long Covid,” can per­sist for months. And in some cas­es, new symp­toms arise over time.

Fran­cis Collins

“We do not know yet the mag­ni­tude of the prob­lem, but giv­en the num­ber of in­di­vid­u­als of all ages who have been or will be in­fect­ed with SARS-CoV-2, the coro­n­avirus that caus­es COVID-19, the pub­lic health im­pact could be pro­found,” NIH di­rec­tor Fran­cis Collins said in a state­ment.

With the help of $1.15 bil­lion from Con­gress over the next four years, the NIH is launch­ing the Post-Acute Se­que­lae of SARS-CoV-2 in­fec­tion (PASC) Ini­tia­tive in the hopes of ad­dress­ing key ques­tions, in­clud­ing what caus­es the pro­longed symp­toms and why some peo­ple are more vul­ner­a­ble than oth­ers.

The ini­tia­tive’s cen­tral pro­gram, the SARS-CoV-2 Re­cov­ery Co­hort, will fo­cus main­ly on char­ac­ter­iz­ing the long-term ef­fects and the tra­jec­to­ry of symp­toms over time. An­oth­er com­ple­men­tary study will source da­ta from health records and data­bas­es to un­der­stand how many peo­ple are af­fect­ed and what con­tributes to re­cov­ery. A sec­ond one will eval­u­ate in­jury to the brain and oth­er or­gans.

“Through this ini­tia­tive, we aim to learn more about how SARS-CoV-2 may lead to such wide­spread and last­ing symp­toms, and to de­vel­op ways to treat or pre­vent these con­di­tions,” Collins said. “We be­lieve that the in­sight we gain from this re­search will al­so en­hance our knowl­edge of the ba­sic bi­ol­o­gy of how hu­mans re­cov­er from in­fec­tion, and im­prove our un­der­stand­ing of oth­er chron­ic post-vi­ral syn­dromes and au­toim­mune dis­eases, as well as oth­er dis­eases with sim­i­lar symp­toms.”

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

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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UP­DAT­ED: Pfiz­er hits the brakes on their piv­otal tri­al for a BC­MA/CD3 bis­pe­cif­ic on safe­ty con­cerns while FDA road­block is hold­ing up Duchenne MD PhI­II

Pfizer’s ambitious plan to take a Phase II study of its BCMA CD3-targeted bispecific antibody elranatamab (PF-06863135) and run it through to an accelerated approval has derailed.

The pharma giant said in a release this morning that they have halted enrollment for their MagnetisMM-3 study after researchers tracked three cases of peripheral neuropathy in the ongoing Phase I. They are now sharing info with the FDA as they explore the red safety flag.

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Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month after announcing their variant-specific Covid-19 vaccine boosters showed promising results in mice, Moderna says it now has some human data to back it up.

Volunteers given a booster shot about six to eight months after receiving their second dose saw increased antibody levels against SARS-CoV-2 and two variants of concern: B.1.351, which was first identified in South Africa, and P.1, first identified in Brazil, the company said on Wednesday.

FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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Cynthia Butitta (L) and Joe Jimenez

Is that an­oth­er IPO in the mak­ing? Ex-No­var­tis CEO Joe Jimenez and a lead Kite play­er take up new posts at an off-the-shelf ri­val to 2 pi­o­neer­ing drugs

Right on the heels of taking on a $160 million crossover round in a likely leap to Nasdaq, Century Therapeutics CEO Lalo Flores is now pushing ahead with the high-profile ex-Novartis chief Joe Jimenez as chairman.

Jimenez’s greatest fame at Novartis was earned for one of its weakest products, as their pioneering personalized CAR-T Kymriah won the honors for the first such drug to make it to the market. Now a host of players, including Century, are barreling in behind the frontrunners with allogeneic rivals that can be created for off-the-shelf use.

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An em­ploy­ee com­plaint at Eli Lil­ly's Branch­burg plant al­leges al­tered qual­i­ty con­trol docs amid FDA probe — re­port

Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.

An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.

Joe Wiley, Amryt CEO

A biotech with a yen for pricey rare dis­ease drugs — and bar­gain base­ment shop­ping — adopts an­oth­er or­phan in lat­est M&A pact

After making it through a long, painful haul to get past a CRL and on to an FDA approval last summer, little Chiasma has found a buyer.

Amryt $AMYT, a company known for its appetite for acquiring expensive drugs for rare diseases at bargain prices, snagged Chiasma and its acromegaly drug Mycapssa (octreotide) capsules in an all-stock deal — with an exchange of 0.396 shares of Amryt for every share of Chiasma.