Meis­sa ob­tains $30M Se­ries A from Morn­ing­side to test syn­thet­ic bi­ol­o­gy ap­proach to 'elu­sive' RSV vac­cines

Morn­ing­side Ven­tures has writ­ten a $30 mil­lion check to fu­el an ear­ly-stage ex­plo­ration of a new kind of res­pi­ra­to­ry syn­cy­tial virus.

Mar­ty Moore

Meis­sa Vac­cines has cho­sen a field in which the most high-pro­file re­cent de­vel­op­ment might be the demise of Gates Foun­da­tion-backed No­vaVax, af­ter its can­di­date failed to pro­tect ei­ther in­fants or the el­der­ly from res­pi­ra­to­ry tract in­fec­tions caused by RSV. As­traZeneca has had more luck with an an­ti­body ap­proach, but oth­er dis­ap­point­ments abound.

“RSV vac­cines have been elu­sive,” CEO Mar­ty Moore told End­points News.

Af­ter years of re­search­ing child­hood in­fec­tions and vac­cines at Emory Uni­ver­si­ty, Moore be­lieves he has found a bet­ter way to make live-at­ten­u­at­ed RSV vac­cines — the on­ly type that has been test­ed in in­fants since the 1960s due to safe­ty con­cerns.

“The chal­lenge with gen­er­at­ing a live-at­ten­u­at­ed RSV vac­cine is that the nat­u­ral­ly cir­cu­lat­ing virus doesn’t pro­vide good enough im­mu­ni­ty. So, you can­not sim­ply weak­en the nat­ur­al virus and achieve a use­ful vac­cine strain,” he said. “What we have done unique­ly is re­code the virus genes to at­ten­u­ate in the host yet pro­vide pro­tec­tive im­mu­ni­ty.”

Rod­er­ick Tang

Moore and Rod­er­ick Tang — an As­traZeneca/Med­Im­mune vet who came on board as co-founder and CSO — have gen­er­at­ed enough Phase I/II clin­i­cal tri­al ma­te­r­i­al us­ing their new method in the past six months, run­ning on $3.4 mil­lion in seed fund­ing. The Se­ries A will al­low them to kick off hu­man test­ing and ad­vance oth­er vac­cine can­di­dates, which all fall square­ly in the res­pi­ra­to­ry space.

The IND is planned for Q1, with a Phase I read­out ex­pect­ed in the first half of 2020. Per their step­wise pro­to­col, Meis­sa will look to es­tab­lish safe­ty and im­muno­genic­i­ty in adults be­fore mov­ing on­to chil­dren and the el­der­ly.

“RSV is the num­ber one case of hos­pi­tal­iza­tion for chil­dren in the U.S. and caus­es high mor­tal­i­ty in the el­der­ly,” Moore not­ed. “Our vac­cine could be use­ful in both.”

Meis­sa will al­so beef up its se­mi-vir­tu­al team with the new fund­ing, adding six to 10 full-time em­ploy­ees and about as many con­sul­tants. The five cur­rent full-timers work out of JLABS in South San Fran­cis­co.

Isaac Cheng and Stephanie O’Brien of Morn­ing­side — who said the in­vest­ment aligns with their com­mit­ment to so­cial re­spon­si­bil­i­ty in glob­al health — will join the com­pa­ny’s board of di­rec­tors.

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.

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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.

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.”

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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.

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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.