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.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

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

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Janet Woodcock, CDER chief (AP Images)

More Warp Speed con­tracts com­ing, vac­cine pro­duc­tion to be­gin in 4-6 weeks — of­fi­cials

Operation Warp Speed has already handed out 4 of what they once said would be 3-5 major contracts to develop Covid-19 vaccines, but administration officials indicated Monday that more would be on their way.

“The slate is not closed,”  a senior HHS official said on a call with reporters. “We’ve invested in four … but the slate is not closed.”

At the same time, the official indicated that Warp Speed would continue to focus on three technologies: mRNA, viral vectors and protein subunits. That leaves the door open for a wide range of platforms, notably including both of Merck’s vaccine candidates — one of which has already received BARDA funding — and one of Sanofi’s candidates. It appears to preclude, though, the potential for Inovio and Vaxart, among certain other small developers that have hyped their ties to the Trump administration, to be included.