Gates vets at Ad­ju­vant back Coda­genix's soft­ware-dri­ven ap­proach to re­cod­ing RSV, flu, on­colyt­ic virus­es and more

Soft­ware is eat­ing the way we make vac­cines, and it has earned Farm­ing­dale, NY-based biotech $20 mil­lion for a plat­form tech the­o­ret­i­cal­ly ap­plic­a­ble to any virus — from in­fluen­za to on­colyt­ic virus­es tar­get­ed at can­cer.

Ad­ju­vant Cap­i­tal, the group of Gates Foun­da­tion vet­er­ans out to test a VC mod­el for glob­al health, led the Se­ries B for Coda­genix. Ex­ist­ing back­ers Eu­clid­ean Cap­i­tal and Top­spin Part­ners al­so re­turned for more.

Robert Cole­man

As sci­en­tists ex­pand their toolk­it for tin­ker­ing with virus­es, it’s be­come pos­si­ble for vac­cine mak­ers to al­so lend the ex­per­tise to the vast on­col­o­gy mar­ket. Ad­ju­vant is al­so an in­vestor in Themis, a Mer­ck-part­nered Aus­tri­an biotech ap­ply­ing its measles virus vac­cine vec­tor tech­nol­o­gy in both chikun­gun­ya and can­cer.

Coda­genix’s ap­proach cen­ters around a com­put­er-based al­go­rithm that in­tro­duces hun­dreds of silent mu­ta­tions in­to the vi­ral genome in sil­i­co such that they would use codon pairs un­der­rep­re­sent­ed in hu­man cells. The win­ning genome can then be syn­the­sized from scratch and trans­fect­ed in­to hu­man cells and test­ed. They call this a “de-op­ti­miz­ing” process dis­tinct from the tra­di­tion­al way of at­ten­u­at­ing live virus­es.

“With RSV, the biggest chal­lenge, in our view, to con­struct a live-at­ten­u­at­ed vac­cine has been the ge­net­ic sta­bil­i­ty, mean­ing pre­vi­ous can­di­dates would re­vert to vir­u­lence dur­ing clin­i­cal test­ing as these first-gen­er­a­tion vac­cine can­di­dates have on­ly a hand­ful of mu­ta­tions,” CEO Robert Cole­man wrote in an email to End­points News. “Our vac­cine, on the oth­er hand, has hun­dreds of silent mu­ta­tions that make it prac­ti­cal­ly im­pos­si­ble to re­vert.”

One oth­er ad­van­tage of this is speed — cru­cial in the time-rac­ing game of vac­cine mak­ing. In an out­break, once Coda­genix se­cures the strain’s dig­i­tal se­quence, it can gen­er­ate a full-length “de-op­ti­mized” genome with­in 3 to 5 days, and then syn­the­size it, test it in cell lines and then in non-hu­man pri­mates, and have a vac­cine can­di­date ready for clin­i­cal man­u­fac­tur­ing by day 48.

“(E)spe­cial­ly in light of the re­cent coro­n­avirus out­break, our plat­form has the po­ten­tial for very rapid gen­er­a­tion of live-at­ten­u­at­ed vac­cine can­di­dates – giv­en our abil­i­ty to re-code their genomes dig­i­tal­ly and in turn re­cov­er at­ten­u­at­ed vac­cine strains from this syn­thet­ic DNA,” Cole­man said. “With that broad palette in mind, we hope that the plat­form will be of use in re­spond­ing to pub­lic health emer­gen­cies caused by emer­gent virus­es and as well as help to solve un­met needs like RSV and dengue.”

The biotech plans to tack­le some chal­leng­ing tar­gets such as H1N1 uni­ver­sal in­fluen­za, res­pi­ra­to­ry syn­cy­tial virus (RSV), Zi­ka, dengue and H7N9 in­fluen­za. Out­side of the lead pro­gram, which is in Phase I, the rest are still in pre­clin­i­cal stages.

Stef­fen Mueller

All are mass in­di­ca­tions that have been chal­leng­ing to crack. No­vaVax’s RSV vac­cine, backed by the Gates Foun­da­tion, fa­mous­ly floun­dered in Phase III; trou­bles with Sanofi’s dengue vac­cine caused a pub­lic health scan­dal for the French phar­ma gi­ant. But small­er play­ers such as Meis­sa have al­so emerged with brighter promis­es.

As for us­ing on­colyt­ic virus­es for sol­id tu­mors, Coda­genix be­lieves the pre­vi­ous gen­er­a­tion of de­vel­op­ers have adopt­ed an “un­nec­es­sar­i­ly com­plex strat­e­gy” — aug­ment­ing the virus by growth fac­tors and im­mune stim­u­la­tors. Their syn­thet­ic virus, based on a nat­ur­al im­muno­gen, doesn’t re­quire a trans­gene.

“We like to say our ap­proach is el­e­gant in its sim­plic­i­ty,” Cole­man said.

The Se­ries B cash will al­low it to push the RSV and TNBC can­di­dates in­to Phase I, launch two new vac­cine pro­grams, as well as ad­vanc­ing the in­fluen­za vac­cine.

Stef­fen Mueller, the CSO, co-found­ed Coda­genix with Cole­man in 2012 based on re­search on out Eckard Wim­mer’s lab at Stony Brook Uni­ver­si­ty.

Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Q32 Bio grabs $60M to kick off hu­man stud­ies for next-gen com­ple­ment drugs — with some Covid-19 tweaks along the way

For a company that launched in the early months of the pandemic, Q32 Bio had its fair share of run-ins with the new normals under Covid-19.

The original plan, for instance, was to conduct first-in-human studies of the IL-7 receptor antibody it licensed from Bristol Myers Squibb in the Netherlands. But they realized shortly after that while the country was beginning to open up clinical trials, there were additional restrictions on drugs that tampered with immunological mechanisms.

Konstantin Poukalov

Per­cep­tive re­cruits A-list in­vestors to back its in-house Chi­na start­up with a mam­moth $310M raise

It took two years for Perceptive Advisors to conceive and boot up LianBio, its big bet on a new kind of in-licensing model for China, seeding it with enough cash to set up two anchoring deals with MyoKardia and BridgeBio. The result was a startup that was all ready to go, reaping $310 million just a little over two months after official launch.

Homegrown Chinese biotechs — many of them boasting of US ties and execs with overseas credentials — have been raking in mega-venture rounds in 2020, both from influential local backers and overseas VC firms that have been loading up new cash. As with IPOs, the deal flow might be slower but the amounts are often more staggering. LianBio’s latest round, unusually, is branded both a Series A and crossover.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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