Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

Pres­i­dent Don­ald Trump com­ment­ed Mon­day morn­ing that Pfiz­er’s Covid-19 vac­cine can­di­date could be the first to win ap­proval by reg­u­la­tors.

Dur­ing an in­ter­view on a Fox News morn­ing show, the pres­i­dent said Pfiz­er was do­ing “very well” when asked which can­di­date could be ap­proved, ac­cord­ing to a Reuters re­port. He added that J&J could fol­low up af­ter­ward, say­ing “they’ll prob­a­bly be a lit­tle lat­er.”

In the in­ter­view, Trump re­it­er­at­ed his promise that a vac­cine would be avail­able by the end of Oc­to­ber, in an­oth­er break with pub­lic health of­fi­cials.

Vac­cine mak­ers have come un­der in­tense po­lit­i­cal pres­sure as the No­vem­ber pres­i­den­tial elec­tion draws near­er. Over the week­end, HHS sec­re­tary Alex Azar as­sert­ed broad au­thor­i­ty over the FDA’s abil­i­ty to con­duct rule mak­ing, putting ca­reer staff on no­tice that Azar’s sig­na­ture is re­quired.

Pfiz­er is cur­rent­ly one of three com­pa­nies con­duct­ing a Phase III for their Covid-19 vac­cine in the US, joined by Mod­er­na and As­traZeneca. Pfiz­er CEO Al­bert Bourla has pub­licly said that the com­pa­ny will know whether or not its can­di­date works by the end of Oc­to­ber, while Mod­er­na pres­i­dent Stephen Hoge claimed his out­fit will be sure of its can­di­date’s ef­fi­ca­cies by No­vem­ber.

The three com­pa­nies have pub­lished their Phase III tri­al pro­to­cols, a move nor­mal­ly re­served for the com­ple­tion of such stud­ies, af­ter much pres­sure say­ing that the pub­lic need­ed trans­paren­cy in or­der to as­sure the vac­cines would be safe and ef­fec­tive.

VBI to de­vel­op vac­cine ex­clu­sive­ly in Cana­da

VBI Vac­cines has a new cus­tomer, eh?

The Cam­bridge, MA-based biotech has an agree­ment with the gov­ern­ment of Cana­da to take po­ten­tial Covid-19 vac­cines through mid-stage tri­als by the first quar­ter of 2022, Reuters re­port­ed Mon­day. The tri­als will take place ex­clu­sive­ly in the coun­try, with Cana­da con­tribut­ing 75% of costs — good for a cool $42.2 mil­lion.

VBI said last month that it was in­ves­ti­gat­ing whether or not its VBI-2900 pro­gram could work for Covid-19 in col­lab­o­ra­tion with Cana­da’s Na­tion­al Re­search Coun­cil.

Known for its He­pati­tis B vac­cine re­search, VBI start­ed look­ing at a pan-coro­n­avirus ap­proach back in March, aim­ing to get a catch-all vac­cine for Covid-19, MERS and SARS. The com­pa­ny an­nounced last month that it would be­gin a Phase I/II tri­al by the end of the year.

Pre­clin­i­cal da­ta for its pro­gram showed four times as many neu­tral­iz­ing an­ti­bod­ies than the GMT of high-titer con­va­les­cent sera, which in­creased to 64 times high­er af­ter a sec­ond dose.

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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Shankar Musunuri, Ocugen CEO

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.

Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.

Covid-19 roundup: As Omi­cron spreads, African biotech re­port­ed­ly close to re­pro­duc­ing Mod­er­na's vac­cine, while WHO cre­ates pan­dem­ic pre­ven­tion body

The emergence of the Omicron variant over the holiday has reignited the focus on vaccine equity, and in its efforts to bring more shots to Africa, one South African biotech is reportedly close to reproducing Moderna’s mRNA shot.

Afrigen Biologics and Vaccines is speeding toward its pivotal trials, the Washington Post reported Sunday, though it’s doing so without Moderna’s recipe. The biotech reportedly has finished sequencing the Moderna vaccine and plans to soon compare its own recreation to Moderna’s jab.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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