Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

Whether pa­tients are im­muno­com­pro­mised or just don’t like nee­dles, one fledg­ling Aus­tralian biotech says it has an al­ter­na­tive to Covid-19 vac­cines that doesn’t in­volve a jab in the arm — and on Tues­day, it pulled in a fresh round of fund­ing to take it in­to the clin­ic.

ENA Res­pi­ra­to­ry, which spun out of ENA Ther­a­peu­tics last year, has pulled in near­ly $24.7 mil­lion (AU $30 mil­lion) to ad­vance its nasal spray for res­pi­ra­to­ry vi­ral in­fec­tions, the com­pa­ny said Tues­day.

The fund­ing, trig­gered by mile­stones, was led by Aus­tralian in­vestors Bran­don Cap­i­tal Part­ners and Min­deroo Foun­da­tion, with Uniseed chim­ing in.

ENA’s lead can­di­date, IN­NA-051, is a small mol­e­cule that tar­gets the TLR2/6 re­cep­tors on air­way ep­ithe­lial cells to boost the body’s nat­ur­al im­mune re­sponse to virus­es. It’s set to en­ter the clin­ic “in the com­ing weeks,” ac­cord­ing to the ENA.

Christophe De­mai­son

“Along­side vac­cines, there is a need for com­ple­men­tary ap­proach­es to help pro­tect the most vul­ner­a­ble peo­ple and al­so pro­vide pro­tec­tion against emerg­ing vari­ants,” co-founder and CEO Christophe De­mai­son said in a state­ment.

He sees the spray as es­pe­cial­ly use­ful for peo­ple who are el­der­ly or im­muno­com­pro­mised, and can’t mount a suf­fi­cient re­sponse to cur­rent­ly avail­able vac­cines. It would be self-ad­min­is­tered once or twice a week, ei­ther be­fore or short­ly af­ter ex­po­sure. And be­cause it’s not virus-spe­cif­ic, ENA be­lieves IN­NA-051 could ward off oth­er ill­ness­es like the flu and com­mon cold, as well as emerg­ing Covid-19 vari­ants.

Back in De­cem­ber, ENA pub­lished re­sults in EBio­Med­i­cine show­ing that a group of fer­rets treat­ed with IN­NA-051 in a chal­lenge study saw re­duced vi­ral repli­ca­tion of up to 96%.

“If hu­mans re­spond in a sim­i­lar way, the ben­e­fits of treat­ment are two-fold,” De­mai­son said at the time. “In­di­vid­u­als ex­posed to the virus would most like­ly rapid­ly elim­i­nate it, with the treat­ment en­sur­ing that the dis­ease does not progress be­yond mild symp­toms. This is par­tic­u­lar­ly rel­e­vant to vul­ner­a­ble mem­bers of the com­mu­ni­ty. In ad­di­tion, the ra­pid­i­ty of this re­sponse means that the in­fect­ed in­di­vid­u­als are un­like­ly to pass it on, mean­ing a swift halt to com­mu­ni­ty trans­mis­sion.”

In ad­di­tion to the fund­ing, ENA is tap­ping Glax­o­SmithK­line vet Ruth Tal-Singer to its board of di­rec­tors. While she’s cur­rent­ly pres­i­dent and CSO of the non­prof­it COPD Foun­da­tion, Tal-Singer once held a va­ri­ety of se­nior roles at the phar­ma, in­clud­ing VP of med­ical in­no­va­tion and VP of res­pi­ra­to­ry R&D.

Nasal sprays have gained in­creas­ing in­ter­est as an al­ter­na­tive for those who can’t ben­e­fit from vac­cines in the last year. Back in No­vem­ber, gene ther­a­py pi­o­neer James Wil­son and his col­leagues at the Uni­ver­si­ty of Penn­syl­va­nia inked a pact with Re­gen­eron to see if they could com­bine the biotech’s Covid-19 an­ti­body cock­tail with a nasal spray-based AAV de­liv­ery plat­form. And back in March, GV led a $47 mil­lion round to fund Ley­den Labs’ mis­sion to de­vel­op a nasal spray that could pro­tect peo­ple from a whole range of virus­es for a few days.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Anthony Sun, Zentalis and Zentera CEO (Zentalis)

With clin­i­cal tri­als lined up for Zen­tal­is drugs, Chi­na's Zen­tera sets its sights on more deal­mak­ing and an IPO

As Zentalis geared up for an AACR presentation of early data on its WEE1 inhibitor earlier this year, its Chinese joint venture Zentera wasn’t idle, either.

Zentera, which has headquarters in Shanghai, had already nabbed clearance to start clinical trials in China for three of the parent company’s drugs. In May — just a month after Zentalis touted three “exceptional responses” out of 55 patients for their shared lead drug, ZN-c3 — it got a fourth CTA approval.

Thomas Soloway, T-knife CEO

What hap­pens when you give a mouse a hu­man self-anti­gen? In­vestors bet $110M to find out

T-knife Therapeutics launched last August on a mission to isolate T cell receptors not from human donors, but from mice. Now, with a new CEO and a candidate bound for the clinic, the Versant-backed company is reloading with a fresh $110 million.

“What we are trying to do for the field of TCR therapy and solid tumor therapy is very analogous to what the murine platforms have done in antibody development,” CEO Thomas Soloway told Endpoints News. 

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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