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.

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 72,900+ biopharma pros reading Endpoints daily — and it's free.

Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.