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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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