Francis Collins, NIH director (Sean Zanni/Patrick McMullan via Getty Images)

NIH kicks off Covid-19 vac­cine, mon­o­clon­al an­ti­body re­search net­work

The NIH to­day an­nounced the kick­off of a na­tion­al clin­i­cal tri­als net­work to test vac­cines and oth­er treat­ments that could pre­vent in­fec­tion with SARS-CoV-2, the virus that caus­es in­fec­tion with Covid-19.

The net­work has been es­tab­lished by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) through the merg­er of four pre­vi­ous­ly ex­ist­ing clin­i­cal tri­als net­works that fo­cused on HIV/AIDS.

Alex Azar HHS

“Start­ing this sum­mer, this new net­work will lever­age ex­ist­ing in­fra­struc­ture and en­gage com­mu­ni­ties to se­cure the thou­sands of vol­un­teers need­ed for late-stage clin­i­cal tri­als of promis­ing vac­cines,” said Health and Hu­man Ser­vices Sec­re­tary Alex Azar.

The net­work, dubbed the Covid-19 Pre­ven­tion Tri­als Net­work (COVPN), is a func­tion­al unit of Op­er­a­tion Warp Speed, the fed­er­al part­ner­ship fo­cused on speed­ing the de­vel­op­ment and de­liv­ery of COVID-19 di­ag­nos­tics, ther­a­peu­tics and vac­cines.

Vac­cine test­ing is to be led by Lar­ry Corey of Fred Hutchin­son Can­cer Re­search Cen­ter (Seat­tle), and Kath­leen Neuzil of the Uni­ver­si­ty of Mary­land (Col­lege Park). The vac­cine arm of COVPN will use a har­mo­nized pro­to­col that per­mits cross-tri­al analy­sis, with more than 100 US and in­ter­na­tion­al tri­al sites be­ing planned.

Mod­er­na’s mR­NA-1273 vac­cine, which was de­vel­oped joint­ly with NI­AID, is ex­pect­ed to be test­ed in the first phase 3 clin­i­cal tri­al con­duct­ed through COVPN, with a start date ex­pect­ed this sum­mer.

Mon­o­clon­al an­ti­body test­ing will be an­oth­er COVPN fo­cus; this arm will be led by My­ron Co­hen of the Uni­ver­si­ty of North Car­oli­na (Chapel Hill) and Emory Uni­ver­si­ty’s David Stevens.

The COVPN web­site fea­tures a se­cure, be­spoke da­ta col­lec­tion plat­form that al­lows in­di­vid­u­als to en­roll in a rolling clin­i­cal tri­al par­tic­i­pant reg­istry from which po­ten­tial study par­tic­i­pants can be con­tact­ed and screened for study par­tic­i­pa­tion.

The hub of op­er­a­tions will be at Fred Hutchin­son Can­cer Re­search Cen­ter, where staff will over­see a com­mu­ni­ty en­gage­ment frame­work de­signed to achieve quick re­cruit­ment of large num­bers of re­search vol­un­teers.

“Each of the Phase 3 clin­i­cal tri­als that the COVPN will con­duct will re­quire thou­sands of vol­un­teers,” said NIH Di­rec­tor Fran­cis Collins. “Com­mu­ni­ty en­gage­ment, par­tic­u­lar­ly with the com­mu­ni­ties most vul­ner­a­ble to COVID-19’s se­vere out­comes, will be crit­i­cal to the suc­cess of this re­search en­deav­or.”

“Hav­ing a safe and ef­fec­tive med­ical coun­ter­mea­sure to pre­vent COVID-19 would en­able us to not on­ly save lives but al­so help end the glob­al pan­dem­ic,” said NI­AID Di­rec­tor An­tho­ny Fau­ci. “Cen­tral­iz­ing our clin­i­cal re­search ef­forts in­to a sin­gle tri­als net­work will ex­pand the re­sources and ex­per­tise need­ed to ef­fi­cient­ly iden­ti­fy safe and ef­fec­tive vac­cines and oth­er pre­ven­tion strate­gies against COVID-19.”

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Andrew Cuomo, AP

Covid-19 roundup: Con­va­les­cent plas­ma flops in UK tri­al; New York Gov. An­drew Cuo­mo seeks to pur­chase vac­cines di­rect­ly from Pfiz­er

The UK’s RECOVERY trial is no longer recruiting patients for the convalescent plasma arm after an independent data monitoring committee found no significant improvement in mortality — another nail in the coffin for President Donald Trump’s so-called “historic breakthrough” treatment.

The RECOVERY trial spans several potential Covid-19 treatments, including  Regeneron’s antibody cocktail, and the anti-inflammatories colchicine and tocilizumab. But convalescent plasma missed its primary endpoint in a preliminary analysis, and the DMC “saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup,” according to a report by the trial’s co-chairs, Peter Horby and Martin Landray.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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News brief­ing: Beam bags a $260M pri­vate place­ment; mi­Ra­gen re­brands to Virid­i­an Ther­a­peu­tics

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

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