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.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $1 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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Covid-19 roundup: Ab­bott prof­its soar on test­ing kits; As­traZeneca could soon re­sume US vac­cine tri­als

Abbott Laboratories, one of the companies at the forefront of Covid-19 testing, is seeing big windfalls as a result of the pandemic.

The company reported its third-quarter results Wednesday morning, noting that overall profit went up 26.9% over the same period in 2019 as well as 28.2% in the first nine months of 2020 compared to that timeframe last year. Abbott’s Covid-19 tests drove the profits after seeing strong demand and helped the company beat quarterly estimates.

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CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.