Stephen Yoder, Pieris Pharmaceuticals CEO

Covid-19 roundup: Pieris to in­ves­ti­gate treat­ment of long Covid with Bavar­i­an grant mon­ey; A roller­coast­er year ends in FDA OK for re­pur­posed Covid drug

An­oth­er res­pi­ra­to­ry drug is be­ing de­vel­oped for the treat­ment of Covid-19.

Pieris Phar­ma­ceu­ti­cals an­nounced Fri­day that the in­haled CT­GF in­hibitor PRS-220, orig­i­nal­ly be­ing de­vel­oped for the treat­ment of id­io­path­ic pul­monary fi­bro­sis, re­ceived a grant from the Bavar­i­an Min­istry of Eco­nom­ic Af­fairs to de­vel­op that same agent to treat “long Covid.”

CT­GF is a pro­tein in the ex­tra­cel­lu­lar ma­trix, and a dri­ver of fi­brot­ic tis­sue re­mod­el­ing that comes from the wound heal­ing process. IPF af­fects more than 3 mil­lion peo­ple in the world, and 130,000 in the US, Pieris said in its re­lease. The av­er­age sur­vival time for a pa­tient di­ag­nosed with IBF is two to five years.

“The crit­i­cal func­tion of CT­GF in fi­bro­sis, as well as its in­duced ex­pres­sion up­on tis­sue in­jury and fi­brot­ic re­mod­el­ing, ren­der it a com­pelling in­ter­ven­tion for PASC-PF,” the re­lease said. “Per­sis­tent symp­toms fol­low­ing se­vere COVID-19 have been re­port­ed by dif­fer­ent stud­ies in more than one third of hos­pi­tal­ized pa­tients.”

Right now, there’s no ap­proved treat­ment for post-acute se­que­lae of SARS-CoV-2 in­fec­tion, the of­fi­cial name of long Covid.

The grant will sup­port Phase I clin­i­cal de­vel­op­ment and good man­u­fac­tur­ing prac­tice man­u­fac­tur­ing, Pieris said in the re­lease. Pre­clin­i­cal da­ta is ex­pect­ed to be pre­sent­ed lat­er in 2021.

“The health con­se­quences of the COVID-19 pan­dem­ic will af­fect our health sys­tem for a long time to come. Bavaria’s biotech and phar­ma­ceu­ti­cal com­pa­nies are at the fore­front of de­vel­op­ing new ther­a­pies to com­bat the ef­fects of this virus,” Hu­ber Ai­wanger from the Bavar­i­an Min­is­ter of Eco­nom­ic Af­fairs said in the re­lease. “Through the strate­gic grants of the Bavar­i­an Min­istry of Eco­nom­ic Af­fairs, we are pro­vid­ing fi­nan­cial sup­port for par­tic­u­lar­ly in­no­v­a­tive ther­a­peu­tic re­search projects.”

In May, Pieris Phar­ma­ceu­ti­cals added a deal with Genen­tech worth $20 mil­lion up­front, four years af­ter strik­ing an up to $2 bil­lion res­pi­ra­to­ry part­ner­ship with As­traZeneca.

Pfiz­er’s rheuma­toid arthri­tis drug to­fac­i­tinib has al­so been test­ed in pa­tients with Covid-19.

Last week, Pfiz­er an­nounced that the drug re­duced the risk of death and res­pi­ra­to­ry fail­ure in hos­pi­tal­ized pa­tients through 28 days, ac­cord­ing to da­ta pub­lished in the New Eng­land Jour­nal of Med­i­cine. — Josh Sul­li­van

A roller­coast­er year ends in FDA OK for re­pur­posed Covid drug

Near­ly a year af­ter Roche an­nounced their IL-6 drug Actem­ra failed to help hos­pi­tal­ized Covid-19 pa­tients in a large tri­al, the FDA has giv­en the mol­e­cule an emer­gency use au­tho­riza­tion to treat hos­pi­tal­ized Covid-19 pa­tients.

The EUA caps near­ly 18 months of head-spin­ning news for the rheuma­toid arthri­tis drug; dis­tressed doc­tors turned to it in the ear­ly months of the pan­dem­ic, pre­scrib­ing it off-la­bel for pa­tients who had no oth­er op­tions, on­ly to learn when tri­al da­ta came out last sum­mer that it like­ly had lit­tle ef­fect. Then, in the win­ter, more da­ta emerged, mak­ing a left-for-dead drug look strange­ly alive.

The FDA’s de­ci­sion is like­ly based large­ly on two large stud­ies. In Feb­ru­ary, the UK’s na­tion­wide Re­cov­ery tri­al an­nounced that, across just over 2,000 pa­tients, Actem­ra re­duced the num­ber of deaths com­pared to place­bo by 4 per­cent­age points. Lat­er that month, the in­ter­na­tion­al aca­d­e­m­ic-run REMAP-CAP tri­al, us­ing a more com­plex sta­tis­ti­cal analy­sis, pub­lished da­ta sim­i­lar­ly show­ing that treat­ing hos­pi­tal­ized pa­tients with Actem­ra or Sanofi’s IL-6 Roche drug re­duced the risk of dy­ing. (They made the first su­pe­ri­or­i­ty an­nounce­ment in No­vem­ber.)

Al­though the de­ci­sion comes af­ter the pan­dem­ic has died down in much of the US, the drug could still pro­vide a key tool as a new vari­ant and slow vac­ci­na­tion rates dri­ve hos­pi­tal­iza­tions in ar­eas such as Mis­souri. Al­though its ben­e­fits are rel­a­tive­ly mod­est, it is on­ly the sec­ond drug — af­ter the gener­ic steroid dex­am­etha­sone — shown to im­prove sur­vival for all hos­pi­tal­ized pa­tients in large, con­trolled stud­ies.

The move al­so points again to the piv­otal role large, aca­d­e­m­ic or gov­ern­ment-led stud­ies have played in the pan­dem­ic, col­lect­ing da­ta — and ul­ti­mate­ly an­swers — from a far greater num­ber of pa­tients than the in­dus­try-led tri­als that dom­i­nate in the US. The Re­cov­ery tri­al al­so gave the world the first da­ta show­ing dex­am­etha­sone could boost sur­vival, that Re­gen­eron’s an­ti­body cock­tail could boost sur­vival for a sub­set of hos­pi­tal­ized pa­tients, and some of the first da­ta sug­gest­ing hy­drox­y­chloro­quine doesn’t work in that set­ting. — Ja­son Mast

Two Chi­nese vac­cines ap­pear less ef­fec­tive against Delta vari­ant

More bad news on the Delta vari­ant: Two ma­jor Chi­nese-pro­duced vac­cines, from Sino­vac and Sinopharm, ap­pear less ef­fec­tive in lab stud­ies against the new strain but still of­fer some pro­tec­tion, Reuters re­port­ed.

The news, re­layed by a Chi­nese dis­ease con­trol re­searcher to state me­dia, comes as lit­tle sur­prise. Da­ta from the UK al­ready sug­gest­ed the new vari­ant can evade some of the an­ti­bod­ies pro­duced by Pfiz­er’s vac­cine.

But where­as Pfiz­er’s vac­cine was ef­fec­tive enough that a slight downtick had lit­tle im­pact — it was still 88% af­ter two dos­es — the Sinopharm and Sino­vac vac­cines were less ef­fec­tive to be­gin. The lat­ter on­ly of­fered about 50% pro­tec­tion.

The Chi­nese dis­ease con­trol re­searcher said the shots still of­fered pro­tec­tion against the vari­ant, but didn’t clar­i­fy what de­gree of pro­tec­tion. He said, how­ev­er, that dur­ing a re­cent out­break in three cities in Guang­dong province, none of those hos­pi­tal­ized had been vac­ci­nat­ed. — Ja­son Mast

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

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

Credit: Shutterstock

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

Fenlai Tan still gets chills thinking about the darkest day of his life.

Three out of eight lung cancer patients who received a tyrosine kinase inhibitor developed by his company, Betta Pharma, died in the span of a month. Tan, the chief medical officer, was summoned to Peking Union Medical College Hospital, where the head of the clinical trial department told him that the trial investigators would be conducting an autopsy to see if the patients had died of the disease — they were all very sick by the time they enrolled — or of interstitial lung disease, a deadly side effect tied to the TKI class that’s been reported in Japan.

An­gion's or­gan dam­age drug strikes out again, this time in high-risk kid­ney trans­plant pa­tients

After flopping a test in Covid-19 earlier this year, Angion’s lead organ damage drug has now hit the skids again in kidney transplant patients.

Angion and partner Vifor Pharma’s ANG-3777 failed to beat out placebo in terms of improving eGFR, a measure of kidney function, in patients who had received a deceased donor kidney transplant and were at high risk of developing what is known as delayed graft function, according to Phase III results released Tuesday.

(Photo courtesy Pfizer)

FDA's vac­cine ad­comm votes al­most unan­i­mous­ly in fa­vor of Pfiz­er's Covid-19 vac­cine for younger chil­dren

The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday voted 17-0, with one panelist abstaining, that the benefits of the Pfizer-BioNTech Covid-19 vaccine outweigh the risks for children between the ages of five and 12.

The vote will likely trigger a process that could allow the shots to begin rolling out as early as next week.

The vaccine, which is one-third of the adult Pfizer dose, proved to be about 90% effective in a placebo-controlled trial in which about 1,500 kids in this age range received the vaccine, and only about 12% of those receiving the vaccine had any adverse event. All serious adverse events in the trial were unrelated to the vaccine.

An image of Alzheimer's brain tissue. The red show gingipains, a protein from P. gingivalis, intermixing with neurons (yellow) and glial cells (green)

An Alzheimer's dark­horse fails its first big tri­al, but of­fers hope for a long-over­looked hy­poth­e­sis

Three years ago, Cortexyme emerged out of obscurity with some big-name backers and an unorthodox approach to treating Alzheimer’s.

They moved their drug into a pivotal study the next year, offering one of the first major tests for a hypothesis that has fluttered on the outskirts of Alzheimer’s research for decades: that, in many cases, the disease is driven by infectious agents — the havoc they wreak in the brain and the inflammation the body uses to try to fend them off. And that quashing the infection could slow patients’ cognitive decline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis dumps AveX­is pro­gram for Rett syn­drome af­ter fail­ing re­peat round of pre­clin­i­cal test­ing

Say goodbye to AVXS-201.

The Rett syndrome gene therapy drug made by AveXis — the biotech that was bought, kept separate, then renamed and finally absorbed by Novartis into its R&D division — has been dropped by the biopharma.

In Novartis’ third quarter financial report, the pharma had found that preclinical data did not support development of the gene therapy into IND-enabling trials and beyond. The announcement comes a year after Novartis told the Rett Society how excited it was by the drug — and its potential benefits and uses.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

Peter Nell, Mammoth Biosciences CBO

UP­DAT­ED: Jen­nifer Doud­na spin­out inks a Mam­moth CRISPR deal with Ver­tex worth near­ly $700M

When a company gets its start in gene editing pioneer Jennifer Doudna’s lab, it’s bound to make headlines. But three years in, the fanfare still hasn’t died down for Mammoth Biosciences. Now, the Brisbane, CA-based company is cheering on its first major R&D pact.

Mammoth unveiled a nearly $700 million deal with Vertex on Tuesday morning, good for the development of in vivo gene therapies for two mystery diseases. The stars of the show are Mammoth’s ultra-small CRISPR systems, including two Cas enzymes licensed from Doudna’s lab over the past couple years, Cas14 and Casɸ.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

FDA is much worse than its reg­u­la­to­ry peers at proac­tive­ly dis­clos­ing da­ta, re­searchers find

The European Medicines Agency and Health Canada continue to outpace the FDA when it comes to proactively releasing data on drugs and biologics the agency has reviewed, leading to further questions of why the American agency can’t be more transparent.

In a study published recently in the Journal of Law, Medicine, & Ethics, Yale and other academic lawyers and researchers found that between 2016 and April 2021, the EMA proactively released data for 123 unique medical products, while Health Canada proactively released data for 73 unique medical products between 2019 and April 2021. What’s more, the EMA and Health Canada didn’t proactively release the same data on the same drugs. In stark contrast, the FDA in 2018 only proactively disclosed data supporting one drug that was approved that year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,800+ biopharma pros reading Endpoints daily — and it's free.