Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a pub­lic health cri­sis (think Ebo­la, Zi­ka) spurred by a rogue pathogen trig­gers a small-biotech ral­ly, as drug­mak­ers emerge from the wood­work with am­bi­tious plans to treat the mount­ing out­break. In most cas­es, that en­thu­si­asm nev­er quite de­liv­ers.

Things are no dif­fer­ent, as the coro­n­avirus out­break in Wuhan, Chi­na takes hold. There have been close to 300 con­firmed hu­man in­fec­tions in Chi­na, and at least four deaths. Coro­n­avirus­es are a large fam­i­ly of virus­es, which in­clude MERS and SARS. On Tues­day, the CDC re­port­ed the virus was de­tect­ed in a US trav­el­er re­turn­ing from Wuhan.

Shares of Mary­land-based vac­cine de­vel­op­er, No­vavax, which has seen a steady stream of set­backs with its RSV vac­cine and is cur­rent­ly in late-stage de­vel­op­ment with a flu vac­cine, saw its shares $NVAX cat­a­pult on Tues­day — clos­ing up more than 71% at $9.82. The com­pa­ny’s tech­nol­o­gy has al­so been used to de­vel­op ex­per­i­men­tal vac­cines for MERS and SARS.

In an email to End­points News on Wednes­day, the com­pa­ny said it ex­pects to de­vel­op a vac­cine can­di­date from the ge­net­ic se­quence of the Wuhan coro­n­avirus. The stock was down near­ly 16% at $8.25 on Wednes­day morn­ing, af­ter the drug­mak­er al­so dis­closed plans to sell $100 mil­lion worth of shares in a pub­lic of­fer­ing af­ter the mar­ket closed on Tues­day.

Mean­while, mR­NA-fo­cused Mod­er­na al­so un­veiled its plans on Wednes­day. The com­pa­ny is­sued a state­ment say­ing it is work­ing with NIH’s vac­cine re­search cen­ter on a po­ten­tial vac­cine re­sponse to the cur­rent pub­lic health emer­gency. Shares of the Cam­bridge, Mass­a­chu­sets-based de­vel­op­er $MR­NA — which pulled off a his­toric $604 mil­lion IPO in late 2018 — were up near­ly 9% at 22.80.

“Mar­kets tend to bot­tom with the peak in new cas­es and news flow,” JP Mor­gan an­a­lysts said, as cit­ed by Mar­ket­Watch. “A pos­i­tive bias is ap­pro­pri­ate on phar­ma stocks broad­ly and mak­ers of di­ag­nos­tic kits and pro­tec­tive equip­ment (like gloves).”

An­tho­ny Fau­ci NI­AID

Ther­a­peu­tics will like­ly make the cut be­fore vac­cines do, An­tho­ny Fau­ci, di­rec­tor of NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID), sug­gest­ed in an in­ter­view with Bio­Cen­tu­ry.

The agency plans to in­ves­ti­gate the ef­fi­ca­cy of ex­ist­ing an­tivi­rals and mon­o­clon­al an­ti­bod­ies, as well as de­vel­op a ther­a­py us­ing an­ti­bod­ies de­rived from blood drawn from a pa­tient di­ag­nosed in the state of Wash­ing­ton (the trav­el­er) to fight the Chi­na coro­n­avirus strain, he said in the re­port.

Oth­er biotech stocks al­so rose as new coro­n­avirus cas­es came to light.

Shares of a de­vel­op­er of nano-med­i­cines for vi­ral in­fec­tions, NanoVi­ri­cides, jumped more than 150% on Tues­day, but the shares $NNVC pared gains on Wednes­day, falling more than 52% to $4.07. Aethlon Med­ical $AEMD, a de­vice mak­er de­vel­op­ing a he­mo­p­u­ri­fi­er to com­bat vi­ral dis­eases, jumped more than 15% to $2.6. Shares of In­ovio Phar­ma­ceu­ti­cals $INO — which is work­ing on a MERS vac­cine — al­so ticked high­er on Tues­day, al­though the stock was in the red on Wednes­day. BioCryst Phar­ma­ceu­ti­cals, which is de­vel­op­ing a yel­low fever and Mar­burg virus drug that has shown ear­ly promise in coro­n­avirus­es, al­so saw its shares $BCRX rise about 5.5% to $3.09 on Wednes­day.

Max­im Ja­cobs, man­ag­ing ed­i­tor of in­vest­ment re­search firm Edi­son, sug­gest­ed the out­cry over coro­n­avirus­es was mis­placed.

Source: Twit­ter, 2020

Click on the im­age to see the full-sized ver­sion

Coro­n­avirus­es typ­i­cal­ly cir­cu­late among an­i­mals, such as camels, cats, and bats. Rarely, there is an­i­mal-to-per­son trans­mis­sion, as is sus­pect­ed in the Wuhan out­break. Many pa­tients af­flict­ed in Chi­na were linked to a large seafood and an­i­mal mar­ket, al­though there are cas­es where pa­tients were not ex­posed to the mar­ket at all, which sug­gests there is “lim­it­ed per­son-to-per­son spread…though it’s un­clear how eas­i­ly or sus­tain­ably this virus is spread­ing be­tween peo­ple,” the CDC said.

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.

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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.

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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.