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.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.