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.

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.