UP­DAT­ED — Covid-19 roundup: WHO all but con­firms virus not man-made; Neu­roRx, Re­lief say they don't know if IV treat­ment works

The WHO has been work­ing on trac­ing the ori­gins of the Covid-19 pan­dem­ic in re­cent weeks, send­ing a field team to Wuhan, Chi­na, to in­ves­ti­gate. And Tues­day morn­ing, they all but ruled out the pos­si­bil­i­ty that the virus was man-made.

Re­searchers with the or­ga­ni­za­tion said the nov­el coro­n­avirus stem­ming from the re­sult of a lab ac­ci­dent was “ex­treme­ly un­like­ly,” con­firm­ing what most health ex­perts had said since it first emerged in late 2019. The ev­i­dence con­tin­ues to point to­ward the virus spread­ing from an­i­mals to hu­mans.

“All the work that has been done on the virus and try­ing to iden­ti­fy its ori­gin con­tin­ue to point to­ward a nat­ur­al reser­voir,” lead sci­en­tist Pe­ter Ben Em­barek said at a news con­fer­ence, per a New York Times re­port.

In speak­ing with re­porters, Em­barek swat­ted down the lab ac­ci­dent the­o­ry that had been pro­mot­ed at times by for­mer Pres­i­dent Don­ald Trump’s ad­min­is­tra­tion, among oth­ers. “It was very un­like­ly that any­thing could es­cape from such a place,” he said, not­ing the heavy safe­ty pro­to­cols.

The WHO mis­sion comes af­ter months of crit­i­cism that the or­ga­ni­za­tion has gone out of its way to de­fer to the Chi­nese gov­ern­ment in its as­sess­ments of the pan­dem­ic. Chi­na had been re­luc­tant to al­low the sci­en­tists in­to the coun­try but ul­ti­mate­ly ac­qui­esced last month, let­ting the group of 14 con­duct their in­ves­ti­ga­tion.

The coun­try al­so used Tues­day’s news con­fer­ence to con­tin­ue as­sert­ing that the virus first ap­peared else­where, a the­o­ry that many health ex­perts dis­miss. WHO sci­en­tists have said they will in­ves­ti­gate these claims while al­so call­ing for more re­search in­to an­i­mals sold at a mar­ket in Wuhan where some of the first cas­es were re­port­ed.

Ef­fi­ca­cy for se­vere Covid-19 treat­ment still TBD, Neu­roRx and Re­lief say

Neu­roRx and Re­lief Ther­a­peu­tics have teamed up on de­vel­op­ing in­haled and IV for­mu­la­tions of an ex­per­i­men­tal drug for se­vere Covid-19 cas­es, and on Tues­day re­vealed that the ju­ry is still out on whether or not the IV pro­gram works as in­tend­ed.

The pair said they are still work­ing to de­ter­mine whether or not the can­di­date, dubbed Zye­sa­mi, met the pri­ma­ry end­point of re­cov­ery from res­pi­ra­to­ry fail­ure with­in 28 days in a Phase IIb/III study. Pa­tients are be­ing fol­lowed through 60 days.

The pair al­so re­vealed key sec­ondary end­point da­ta, in­clud­ing that re­searchers did not see dif­fer­ences in sur­vival ben­e­fit af­ter four weeks. Neu­roRx and Re­lief ap­peared to blame that on over­all ICU care im­prov­ing, say­ing in a re­lease “With the im­prove­ment in sur­vival since the start of the pan­dem­ic, dif­fer­ences in sur­vival were not seen at day 28.”

In­vestors in Re­lief were ap­par­ent­ly not pleased, send­ing shares of the Swiss pen­ny stock down more than 30%.

138 pa­tients out of a to­tal of 203 sur­vived in that time­frame, with 91 of those tak­ing Zye­sa­mi and 47 on stan­dard of care. Pa­tients were ran­dom­ized in­to the drug arm at a 2-to-1 ra­tio.

The com­pa­nies at­tempt­ed to high­light a small pos­i­tive in an­oth­er sec­ondary end­point, though, not­ing that pa­tients who were treat­ed with Zye­sa­mi on top of the max­i­mal stan­dard of care ben­e­fit­ed over place­bo. They mea­sured this out­put us­ing time to dis­charge from the hos­pi­tal, say­ing that in six of eight evalu­able cas­es pa­tients saw a three-day me­di­an dif­fer­ence in hos­pi­tal stay.

But by the com­pa­nies’ own ad­mis­sion, that find­ing may not end up mean­ing any­thing.

“The sec­ondary end­point da­ta re­port­ed to­day should not cre­ate an ex­pec­ta­tion that the pri­ma­ry end­point will be met over­all or for any sub­group,” the com­pa­nies said.

End­points News sent out a re­quest for com­ment on the news, and re­ceived this in an emailed re­sponse from CEO Jonathan Javitt:

“The end­point da­ta we re­port­ed are sta­tis­ti­cal­ly-sig­nif­i­cant and clin­i­cal­ly mean­ing­ful to doc­tors, pa­tients, and fam­i­lies. Re­duced hos­pi­tal stay has been a key ba­sis for reg­u­la­to­ry de­ter­mi­na­tions dur­ing the COVID pan­dem­ic and the re­duced hos­pi­tal stay seen in this pop­u­la­tion was shown in a pop­u­la­tion that lacks ef­fec­tive ther­a­pies. These da­ta are there­fore ma­te­r­i­al.”

The can­di­date it­self is a for­mu­la­tion of va­soac­tive in­testi­nal polypep­tide, which is known to be high­ly con­cen­trat­ed in the lungs. Though Tues­day’s re­sults come from the IV ver­sion of the pro­gram, the in­haled for­mu­la is cur­rent­ly in a Phase II/III study.

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

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Re­gen­eron halts place­bo en­roll­ment in Covid-19 cock­tail tri­al af­ter IDMC finds 'clear' ef­fi­ca­cy — but there are no da­ta yet

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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