Omega-backed start­up sells it­self qui­et­ly; Ab­b­Vie breaks out more Rin­voq da­ta; Re­vance gets FDA date for Botox ri­val

→ When it came in­to the lime­light with a $35 mil­lion Se­ries A fi­nanc­ing in 2018, At­ten­ua promised to re­pur­pose three oral neu­ronal nico­tinic re­cep­tor as­sets dis­card­ed by Cat­a­lyst Bio­sciences (which in turn got the drugs through a merg­er with Tar­ga­cept). But now that it’s wrapped a proof-of-con­cept tri­al of the lead drug in chron­ic cough, At­ten­ua is flip­ping the port­fo­lio to an­oth­er buy­er for yet an­oth­er use.

CO­DA Bio­ther­a­peu­tics has bought At­ten­ua and its clin­i­cal stage small mol­e­cule can­di­dates, which they say will serve to con­trol their chemo­ge­net­ic re­cep­tors de­signed to treat neu­ro­path­ic pain, fo­cal epilep­sy and oth­er neu­ro­log­ic dis­or­ders.

The South San Fran­cis­co biotech liked that At­ten­ua’s drugs come with “high-qual­i­ty drug de­vel­op­ment work al­ready com­plet­ed, one with a cur­rent­ly ac­tive IND,” CEO Michael Narachi said.

Ac­cord­ing to clin­i­cal­tri­als.gov At­ten­ua com­plet­ed its chron­ic cough study in May last year, where it com­pared bradan­i­cline to place­bo, but has not post­ed the re­sults pub­licly. “We un­der­stand that the Phase II study end­points were not met,” Narachi told End­points News via email.

Omega Funds, Abing­worth, Or­biMed and Red­mile Group in­vest­ed in At­ten­ua. The fi­nan­cial terms of the buy­out deal were not dis­closed.

Ab­b­Vie’s oral JAK in­hibitor Rin­voq, which is part­ly ex­pect­ed to fill the gi­ant Hu­mi­ra hole af­ter the megablock­buster falls off its patent cliff, has more pos­i­tive da­ta back­ing its use. The com­pa­ny on Wednes­day is­sued da­ta from a piv­otal study in pso­ri­at­ic arthri­tis pa­tients, months af­ter pub­lish­ing sim­i­lar­ly pos­i­tive re­sults from an­oth­er Phase III tri­al in the same pa­tient pop­u­la­tion. Rin­voq was ap­proved by the FDA in Au­gust for use in pa­tients with rheuma­toid arthri­tis, al­though the la­bel came with the dread­ed black box warn­ing that have plagued the class of drugs.

→  Co-founder Dan Browne may have stepped down in Oc­to­ber fol­low­ing a “mis­judg­ment in han­dling an em­ploy­ee mat­ter,” but Cal­i­for­nia-based Re­vance is go­ing full steam ahead with its Botox ri­val Dax­i­bot­u­linum­tox­i­nA for In­jec­tion (DAXI). The prod­uct has been ac­cept­ed for re­view by the FDA for use in frown lines, and the agency is ex­pect­ed to make its de­ci­sion by No­vem­ber 25. DAXI is po­si­tioned as a di­rect com­peti­tor to Al­ler­gan’s Botox fran­chise — a prod­uct that is ap­proved for 13 in­di­ca­tions and gen­er­at­ed close to $3.6 bil­lion in 2018, de­spite the emer­gence of ri­vals: Ipsen’s Dys­port (man­u­fac­tured by Gal­der­ma for cos­met­ic use), Merz Phar­ma’s Xeomin. An­oth­er com­peti­tor, Evo­lus, scored FDA ap­proval for its prod­uct, Jeu­veau, in Feb­ru­ary 2019.

→ Italy’s Chiesi, which has al­lied with Is­raeli biotech Pro­tal­ix to de­vel­op an en­zyme re­place­ment ther­a­py for Fab­ry dis­ease, is now carv­ing out a whole new di­vi­sion to fo­cus on rare and ul­tra-rare dis­eases. It will be head­quar­tered in Boston and con­duct R&D in lyso­so­mal stor­age dis­or­ders, as well as rare hema­tol­ogy and oph­thal­mol­o­gy dis­eases.

→ Tiny Tonix, whose ex­per­i­men­tal PTSD drug Ton­mya lost its break­through ther­a­py sta­tus, ceased en­roll­ment of a piv­otal study on Wednes­day af­ter an in­de­pen­dent mon­i­tor­ing pan­el rec­om­mend­ed stop­ping the tri­al due to fu­til­i­ty on the ba­sis that the drug like­ly does not work. Be­set with mul­ti­ple set­backs, Tonix has done every­thing in its pow­er to get Ton­mya across the fin­ish line, in­clud­ing chang­ing tri­al goal­posts and us­ing sub­set analy­ses to take the pro­gram for­ward. The drug will con­tin­ue to be test­ed in pa­tients with fi­bromyal­gia.

→ The Chi­nese tech gi­ant Ten­cent man­aged to riv­et at­ten­tion its way when the com­pa­ny tem­porar­i­ly post­ed an up­date on the coro­n­avirus epi­dem­ic that list­ed close to 25,000 deaths and more than 154,000 cas­es in Chi­na. The of­fi­cial num­ber of deaths is a bit more than 500. The con­glom­er­ate quick­ly re­vert­ed to the of­fi­cial num­bers once the re­port had been flagged by alarmed ob­servers.

Tai­wan News re­port­ed that the com­pa­ny may have in­ad­ver­tent­ly re­vealed the ac­tu­al fig­ures be­ing tracked, as op­posed to the num­bers Chi­na prefers. Ei­ther way, the re­port un­der­scores some lin­ger­ing doubts that the Chi­nese gov­ern­ment is not be­ing com­plete­ly up­front about the way it’s han­dled the brew­ing pan­dem­ic so far. The gov­ern­ment has about 60 mil­lion cit­i­zens un­der lock­down to try and help con­tain the spread of the Wuhan virus, which has se­vere­ly dis­rupt­ed the coun­try’s econ­o­my.

→ Fol­low­ing up on some promis­ing mid-stage da­ta out of ES­MO, Curis has con­vinced its part­ners at Au­ri­gene to fund and con­duct a Phase IIb/III study of CA-170 among pa­tients with non-squa­mous non-small cell lung can­cer (nsNSCLC). In ex­change Au­ri­gene, a sub­sidiary of In­dia’s Dr. Red­dy’s Labs, gets the rights to de­vel­op and com­mer­cial­ize the drug in all of Asia — adding to an ex­ist­ing agree­ment for In­dia and Rus­sia. De­signed to be used in com­bi­na­tion with chemora­di­a­tion, CA-170 is an oral drug that in­hibits both PD-L1 and VISTA.

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.”

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.

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.

News brief­ing: HHS chas­tis­es Eli Lil­ly for end­ing some dis­counts in a pan­dem­ic; Gilead to pay $97 mil­lion to set­tle kick­back al­le­ga­tions

Gilead agreed to pay $97 million to settle allegations that it illegally used a charity to pay thousands of Medicare patients’ co-payments for its pulmonary arterial hypertension drug Letairis.

The US government claimed that between June 2007 and December 2010, Gilead $GILD used the Caring Voice Coalition as a conduit to cover the costs of just its own drug. The alleged behavior goes against the False Claims Act.

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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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.