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.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

UK gov­ern­ment, pri­vate in­vestors dole out $340M+ to drug, di­ag­nos­tic man­u­fac­tur­ers

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.

Kourosh Davarpanah, Inato CEO

Big Phar­ma-part­nered clin­i­cal tri­al match­mak­er se­cures $20M to im­prove plat­form

A company with public links to Sanofi and Moderna has raised more money to expand its mission of improving diversity and enrollment in clinical trials.

Inato put the word out on Wednesday that it raised $20 million via an A2 round to advance its matching platform between pharma companies and potential clinical trial sites.

Inato CEO Kourosh Davarpanah told Endpoints News that with the $20 million in hand, it will pursue improvements to its diversity offerings, its focus on oncology and data collection.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”