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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,300+ biopharma pros reading Endpoints daily — and it's free.

Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,300+ biopharma pros reading Endpoints daily — and it's free.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Atomwise co-founders Abe Heifets and Izhar Wallach (photo courtesy Atomwise)

Plot­ting to be the Bridge­Bio of AI, Atom­wise lands $123 mil­lion Se­ries B for hype-heavy plat­form

The PR-friendly, well-partnered AI biotech that’s provoked stern skepticism in some scientific corners is getting a boatload of new cash.

Atomwise has announced a $123 million Series B round led by Sanabil Investments — a subsidiary of the Saudi royal fund — and B Capital Group and joined by DCVC and Y Combinator, among others. The new round is nearly triple what Atomwise had raised prior and will go towards both scaling their molecule-hunting software and building the growing network of spinouts they’re launching to develop some of the molecules that software has turned up.

Bing Li, Debra Yu and Konstantin Poukalov, LianBio

Per­cep­tive births its first in-house start­up — and it's a Chi­na play

Perceptive Advisors is going to China.

The decision dates back two years, chief investment officer Adam Stone tells Endpoints News, when the firm began to figure out how it can, in hedge fund-speak, strategically increase its exposure to a growing biopharma market poised to be a key geographic area in the next several decades. It was a bit of a blindspot for Perceptive, he admits.

As “globalized scientist-investors, we just couldn’t afford to have that blindspot in place,” he says.

Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 87,300+ biopharma pros reading Endpoints daily — and it's free.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.