Chi­na re­searchers tout in vit­ro da­ta for Gilead­'s an­tivi­ral against Wuhan virus — which they are try­ing to patent

There’s no de­fin­i­tive proof yet that Gilead’s remde­sivir works as a treat­ment for 2019-nCov, but re­searchers in Chi­na clear­ly con­sid­er it promis­ing enough to have ap­plied for a patent on its use to com­bat the coro­n­avirus virus out­break stem­ming from Wuhan.

Amid world­wide vig­i­lance over what many fear is be­com­ing a pan­dem­ic, sci­en­tists from the Wuhan In­sti­tute of Vi­rol­o­gy and Na­tion­al En­gi­neer­ing Re­search Cen­ter for the Emer­gency Drug said they have test­ed a to­tal of sev­en drugs in vit­ro — and found remde­sivir and the malar­ia treat­ment chloro­quine most ef­fec­tive against the nov­el coro­n­avirus.

In a state­ment, the in­sti­tu­tions al­so dis­closed that they filed a patent ap­pli­ca­tion on Jan­u­ary 21, days be­fore Gilead first an­nounced it’s dust­ing off the nu­cle­o­side ana­log — which failed to make the cut as an Ebo­la drug — to test against the new virus.

While ex­perts have in­di­cat­ed that a patent is un­like­ly to be grant­ed, the move high­lights grow­ing con­fi­dence in remde­sivir in the midst of a glob­al race to hunt an­ti­bod­ies and ther­a­pies for 2019-nCoV, for which there is no ap­proved treat­ment. The high­ly con­ta­gious virus has killed more than 490, most­ly in Chi­na.

The up­date al­so comes as the FDA is­sued its first Emer­gency Use Au­tho­riza­tion (EUA) since the De­part­ment of Health and Hu­man Ser­vices de­clared a pub­lic health emer­gency in the US on Jan­u­ary 31. The EUA means that the 2019-nCoV di­ag­nos­tic pan­el that’s been in use at CDC labs can now be used at any CDC-qual­i­fied lab across the coun­try.

Gilead — which has been in a patent dis­pute with the US gov­ern­ment over its HIV fran­chise — didn’t an­swer di­rect­ly whether it knew about the patent fil­ing be­fore the an­nounce­ment or what it thought about the Chi­nese re­searchers’ grounds.

Gilead in­vent­ed remde­sivir and has patent­ed it in Chi­na, in­clud­ing fil­ing patent ap­pli­ca­tions for use on coro­n­avirus­es. We are aware of re­ports of the Wuhan In­sti­tute for Vi­rol­o­gy’s patent ap­pli­ca­tion. Our fo­cus at this time, is on rapid­ly de­ter­min­ing the po­ten­tial for remde­sivir as a treat­ment for 2019-nCoV and ac­cel­er­at­ing man­u­fac­tur­ing in an­tic­i­pa­tion of po­ten­tial fu­ture sup­ply needs.

Af­ter US doc­tors re­port­ed us­ing remde­sivir as part of the reg­i­men for the first do­mes­tic case of 2019-nCoV, Gilead said it’s work­ing with Chi­nese au­thor­i­ties to start a ran­dom­ized con­trolled tri­al.

Nine tri­als are al­ready un­der­way to eval­u­ate dif­fer­ent com­bi­na­tions of al­ready ap­proved an­tivi­rals and cor­ti­cos­teroids, Bio­Cen­tu­ry not­ed, in­clud­ing HIV drugs such as Ab­b­Vie’s Kale­tra/Alu­via and Gilead’s De­scovy.

Remde­sivir, on the oth­er hand, is an ex­per­i­men­tal com­pound that’s been test­ed in hu­man tri­als. In a Q4 earn­ings call, Gilead CEO Daniel O’Day in­di­cat­ed that it may be de­ployed as an emer­gency treat­ment. In re­sponse to a ques­tion about man­u­fac­tur­ing prepa­ra­tions in the event that they need to scale up pro­duc­tion quick­ly, he had this to re­port:

In terms of man­u­fac­tur­ing, our team has re­al­ly been work­ing night and day, it’s been very im­pres­sive to watch this team over the past cou­ple of weeks re­al­ly ramp up to the ex­tent that we can. Our ca­pac­i­ty is go­ing up every day. We’re look­ing at all the op­tions we have ex­pect­ing to be pre­pared for what may come.

Ob­vi­ous­ly we are wait­ing for da­ta, both in vit­ro and then in peo­ple to en­sure that the drug ac­tu­al­ly works. And it’s im­por­tant just for every­one to keep that in mind that this is still in­ves­ti­ga­tion­al and we are still wait­ing for more da­ta to know. But at risk, we are in­vest­ing pret­ty heav­i­ly to make sure that we’re pre­pared as best as we can.

Around the same time, some in vit­ro da­ta were be­ing pub­lished on Na­ture as a let­ter to the ed­i­tor.

“No­tably, two com­pounds remde­sivir (EC50 = 0.77 μM; CC50 > 100 μM; SI > 129.87) and chloro­quine (EC50 = 1.13 μM; CC50 > 100 μM, SI > 88.50) po­tent­ly blocked virus in­fec­tion at low-mi­cro­mo­lar con­cen­tra­tion and showed high SI,” they wrote.

Giv­en its po­ten­tial, the Wuhan In­sti­tute of Vi­rol­o­gy said in a state­ment, it’s ap­plied for a patent in Chi­na and plans to dis­trib­ute to oth­er coun­tries via the Patent Co­op­er­a­tion Treaty. But should “the rel­e­vant over­seas com­pa­ny” be will­ing to con­tribute to the out­break con­trol, they would tem­porar­i­ly sus­pend ex­er­cise of their patent rights.

But ex­perts in­ter­viewed by lo­cal me­dia point out that the ap­pli­ca­tion may not go through. Not on­ly does Gilead hold the foun­da­tion­al patent to the drug, but it al­so ap­plied for one to cov­er remde­sivir’s use in coro­n­avirus­es back in 2016 — which didn’t spec­i­fy but could ar­guably in­clude this new strain.

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.

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.

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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.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na chips in fur­ther on African vac­cine sup­ply — but ad­vo­cates are call­ing for even more

In a sign of its growing commitment to the continent, Moderna will supply up to 110 million doses of its Covid-19 vaccine to the African Union, the company announced Tuesday. And CEO Stéphane Bancel said it’s just the first step.

“We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions. We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world and we remain committed to helping to protect as many people as possible around the globe,” Bancel said in a statement.

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.

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Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioNTech’s first mRNA-based vaccine site in Africa will call Rwanda home, and construction is set to start in mid-2022, the company announced Tuesday at a public health forum.

The German company signed a memorandum of understanding, after a meeting between Rwanda’s Minister of Health, Daniel Ngamije, Senegal’s Minister of Foreign Affairs Aïssata Tall Sall, and senior BioNTech officials. Construction plans have been finalized, and assets have been ordered. The agreement will help bring end-to-end manufacturing to Africa, and as many as several hundred million doses of vaccines per year, though initial production will be more modest.

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.

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