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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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