Russian president Vladimir Putin in a video conference meeting at his Moscow residence, Oct. 14, 2020. Putin says a second Covid-19 vaccine has been approved after the US was dubious of the first. (Alexei Druzhinin, Sputnik, Kremlin Pool Photo via AP)

Covid-19 roundup: Rus­sia ap­proves sec­ond vac­cine, Putin says; Ad­vo­ca­cy groups ask WTO to waive patent rights

Rus­sia has ap­proved a sec­ond Covid-19 vac­cine, pres­i­dent Vladimir Putin an­nounced Wednes­day. Like its first, the coun­try’s new vac­cine did not un­der­go large-scale tri­als be­fore ap­proval.

Putin said that the vac­cine comes from the Siber­ian biotech Vec­tor State Vi­rol­o­gy and Biotech­nol­o­gy Cen­ter, al­so a for­mer So­vi­et bioweapons re­search lab, ac­cord­ing to the Wall Street Jour­nal. The in­sti­tu­tion plans to be­gin a 40,000-pa­tient tri­al soon.

So far, Russ­ian health of­fi­cials have not elab­o­rat­ed on the vac­cine’s ear­ly tri­al re­sults nor its ap­proval process, per the Moscow Times. The vac­cine us­es pep­tide-based anti­gens to train the body’s im­mune sys­tem to fight the virus, the coun­try’s patent of­fice pre­vi­ous­ly said. Deputy prime min­is­ter Tatyana Go­liko­va added dur­ing the an­nounce­ment that a third Russ­ian vac­cine could come some­time in De­cem­ber.

Rus­sia be­came the first coun­try to ap­prove a Covid-19 vac­cine in Au­gust with its Sput­nik V pro­gram, but drew heavy crit­i­cism from sci­en­tists in oth­er coun­tries af­ter Rus­sia grant­ed the ap­proval with­out a Phase III tri­al. The orig­i­nal an­nounce­ment, as well as Rus­sia’s of­fer to col­lab­o­rate on fu­ture tri­als, drew par­tic­u­lar scorn in the US with one of­fi­cial say­ing at the time, “There’s no way in hell the US tries this on mon­keys, let alone peo­ple.”

The coun­try has since re­leased some da­ta from ear­ly clin­i­cal tri­als from the shot, but none of the stud­ies so far have been deemed suf­fi­cient to sup­port au­tho­riza­tion else­where. Moscow has since reached deals with Brazil, In­dia and Mex­i­co to sell dos­es of Sput­nik V.

Near­ly 400 ad­vo­ca­cy groups ask WTO to waive Covid-re­lat­ed patent rights

A coali­tion of ad­vo­ca­cy groups across the globe band­ed to­geth­er Wednes­day to ask the World Trade Or­ga­ni­za­tion to waive some patent rights for Covid-19 vac­cines and treat­ments to al­low eas­i­er ac­cess for de­vel­op­ing coun­tries.

About 400 groups signed on to the let­ter in sup­port of a pro­pos­al from In­dia and South Africa ear­li­er this month. The waiv­er would lift some rules for patents, in­dus­tri­al de­signs, copy­rights, and pro­tec­tion of trade se­crets in or­der to en­sure a “glob­al so­lu­tion” to the pan­dem­ic. The WTO is meet­ing this week.

Wednes­day’s let­ter ex­press­es con­cern that some of the rich­est coun­tries have en­tered in­to se­cre­tive pacts with phar­ma­ceu­ti­cal com­pa­nies that have pre­vent­ed less wealthy na­tions from see­ing mean­ing­ful ac­cess to Covid-19 treat­ments. The or­ga­ni­za­tions specif­i­cal­ly point to the world­wide short­age of Gilead’s remde­sivir, which they note was de­vel­oped with some pub­lic funds, as a re­sult from places like the US and UK buy­ing up most of the sup­ply.

They al­so wrote that while As­traZeneca has pledged to pro­duce its vac­cine can­di­date at cost dur­ing the pan­dem­ic, the com­pa­ny has the abil­i­ty to uni­lat­er­al­ly de­clare the pan­dem­ic over and start gen­er­at­ing a prof­it.

The let­ter reads, in part:

These re­stric­tive busi­ness strate­gies have di­rect­ly trans­lat­ed in­to ex­or­bi­tant pric­ing and prof­i­teer­ing. With en­tire health sys­tems al­ready over­whelmed by COVID-19 and with gov­ern­ments fac­ing a loom­ing eco­nom­ic cri­sis, the health bud­gets of many coun­tries sim­ply can­not sus­tain high­ly priced COVID-19 med­ical prod­ucts. These re­al­i­ties will al­so hin­der pro­duc­tion by any com­pe­tent man­u­fac­tur­er and im­pede the full free­dom to col­lab­o­rate, in de­vel­op­ing, pro­duc­ing, im­port­ing and ex­port­ing the need­ed med­ical prod­ucts.

At the cen­ter of the dis­pute is a WTO agree­ment known as the Trade-Re­lat­ed As­pects of In­tel­lec­tu­al Prop­er­ty Rights, or TRIPS. Go­ing in­to ef­fect orig­i­nal­ly in 1995, TRIPS was amend­ed in 2001 to al­low some patent rights to be sus­pend­ed in the name of pub­lic health by way of man­u­fac­tur­ing low­er-cost gener­ics.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,100+ biopharma pros reading Endpoints daily — and it's free.

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.