Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

Bioreg­num Opin­ion Col­umn by John Car­roll

You don’t go more than 40 years in biotech with­out ever get­ting a prod­uct to mar­ket un­less you can learn the art of writ­ing a pro­mo­tion­al press re­lease. And In­ovio cap­tures the prize in bait­ing the hook.

Tues­day morn­ing In­ovio, which has been strug­gling to get its Covid-19 vac­cine lined up for mass man­u­fac­tur­ing, put out a re­lease that touched on vir­tu­al­ly every hot but­ton in pan­dem­ic PR.

There was, first and fore­most, an in­ter­im snap­shot of ef­fi­ca­cy from their Phase I pro­gram for INO-4800.

Analy­ses to date have shown that 94% (34 out of 36 to­tal tri­al par­tic­i­pants) demon­strat­ed over­all im­muno­log­i­cal re­sponse rates based on pre­lim­i­nary da­ta as­sess­ing hu­moral (bind­ing and neu­tral­iz­ing) and T cell im­mune re­spons­es.

Mod­er­na was crit­i­cized for its de­ci­sion to sketch ini­tial an­ti­body re­spons­es — which it said were at or above the lev­el need­ed to guard against the pan­dem­ic at 2 dos­es over var­i­ous times. But it pro­vid­ed a trea­sure of in­for­ma­tion com­pared to In­ovio’s bare­bones ex­pla­na­tion. The full da­ta set, In­ovio says, will be pub­lished lat­er in a peer-re­viewed jour­nal. In the mean­time, they’re large­ly leav­ing the da­ta read­out to the read­er to de­ci­pher.

Al­so dan­gling bait to day traders:

A Phase II/III study should be set to go this sum­mer, if reg­u­la­tors sign off. Plus, Op­er­a­tion Warp Speed — the pres­i­dent’s ini­tia­tive at achiev­ing a vac­cine roll­out, around the elec­tion — is in­clud­ing 4800 in a non-hu­man pri­mate study. And then there was the trusty mouse study, in which their vac­cine pre­vent­ed vi­ral repli­ca­tion in ro­dent lungs af­ter the tiny crea­tures were chal­lenged with SARS-CoV-2.

Usu­al­ly, that sort of re­lease de­liv­ers a pow­er­ful — if tem­po­rary — surge in the share price. But this morn­ing, Wall Street proved skep­ti­cal.

In­ovio’s stock price slid 11% as some ex­pe­ri­enced ob­servers called them out.

In­ovio’s at­tempt to break out of the pack seemed to large­ly back­fire this morn­ing. When you’re in a race in­volv­ing As­traZeneca, Pfiz­er, Mod­er­na, a host of Chi­nese com­pa­nies, and many, many more, it seems the usu­al bait doesn’t work so well.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.