Rachel Meyers (Marissa Fiorucci/Faze Medicines)

Faze Med­i­cines launch­es with $81M Se­ries A, Al­ny­lam vet head­ing sci­ence in play at bio­mol­e­c­u­lar con­den­sates

Once most­ly un­known to the larg­er sci­en­tif­ic world, the field of bio­mol­e­c­u­lar con­den­sates — cel­lu­lar struc­tures that could have big im­pli­ca­tions on neu­rode­gen­er­a­tive re­search — has seen a rush of in­vestor cash in the past two years. Now, a third biotech is tak­ing a swing at the field with a siz­able ini­tial fund­ing round to get go­ing.

Faze Med­i­cines, a Third Rock-backed biotech look­ing to de­vel­op med­i­cines tar­get­ing neu­rode­gen­er­a­tive dis­eases and po­ten­tial­ly even more ther­a­peu­tic ar­eas, launched Thurs­day with an $81 mil­lion Se­ries A round and Al­ny­lam vet­er­an Rachel Mey­ers head­ing up the sci­ence.

Found­ed by four in­ves­ti­ga­tors from the Howard Hugh­es Med­ical In­sti­tute in Mary­land — Roy Park­er, Mike Rosen, J. Paul Tay­lor and Ron Vale — Faze will cen­ter its sci­ence around bio­mol­e­c­u­lar con­den­sates, mem­brane­less com­part­ments in eu­kary­ot­ic cells that con­cen­trate pro­teins and nu­cle­ic acids and could play a role in RNA me­tab­o­lism and gene reg­u­la­tion.

Roy Park­er, Mike Rosen, J. Paul Tay­lor, Ron Vale (HH­MI)

Third Rock joins No­var­tis Ven­ture Fund, Eli Lil­ly, Ab­b­Vie Ven­tures, In­vus, Catalio Cap­i­tal Man­age­ment, Cas­din Cap­i­tal and Alexan­dria Ven­ture In­vest­ments on the round. Faze will run with a board of di­rec­tors led by biotech vet Charles Hom­cy, a Third Rock part­ner and clin­i­cal pro­fes­sor of med­i­cine at UCSF, as well as Bob Tep­per, an­oth­er Third Rock part­ner, and Lau­ra Brass of the No­var­tis Ven­ture Fund.

The com­pa­ny will al­so sport a stout sci­en­tif­ic ad­vi­so­ry board culled from lead­ers in drug dis­cov­ery and neu­rode­gen­er­a­tive re­search, in­clud­ing: Richard Chesworth, chief sci­en­tif­ic of­fi­cer at Kymera Ther­a­peu­tics; Jim Au­dia, a for­mer CSO at Con­stel­la­tion Phar­ma who is now an ex­ec­u­tive di­rec­tor at the Chica­go Bio­med­ical Con­sor­tium; and Mer­it Cud­kow­icz, chief at neu­rol­o­gy at Mass Gen­er­al; among oth­ers.

Mey­ers, who spent more than 13 years at Al­ny­lam head­ing re­search on the drug­mak­er’s RNAi-based ther­a­peu­tics, left the com­pa­ny back in 2016 to be a con­sul­tant in the Cam­bridge area. In 2018, she joined Third Rock as an en­tre­pre­neur-in-res­i­dence and was im­me­di­ate­ly keyed in to dis­cus­sions around the role of un­bound struc­tures in hu­man cells that could be im­pli­cat­ed in a range of puz­zle-box neu­rode­gen­er­a­tive dis­eases.

Those con­ver­sa­tions were tak­ing place in Third Rock’s halls, Mey­ers said, be­tween Hom­cy and Vale, al­so a UCSF pro­fes­sor. The dis­cus­sion orig­i­nal­ly cir­cled around the role of pro­tein con­cen­trat­ing RNA struc­tures in the cell that could be causal­ly re­lat­ed to re­peat ex­pan­sion dis­or­ders like ALS and my­oton­ic dy­s­tro­phy 1.

“That ini­tial con­ver­sa­tion led to in­ter­est in think­ing about how these RNA pro­tein struc­tures were in­volved in bi­ol­o­gy and in­volved in dis­ease,” Mey­ers said. “Ul­ti­mate­ly, we got ex­cit­ed about this no­tion of con­den­sates and start­ed ex­pand­ing this think­ing around re­peat RNAs to be­gin think­ing about the ways that RNA pro­tein struc­tures were in­volved in bi­ol­o­gy and dis­ease.”

Cary Pf­ef­fer

In the im­me­di­ate term, Faze’s team will fo­cus on those con­den­sates to de­vel­op mol­e­cules for neu­ro, but the goal­posts could even­tu­al­ly move in­to spaces like on­col­o­gy, vi­rol­o­gy and im­munol­o­gy as the sci­ence de­vel­ops, in­ter­im CEO and Third Rock part­ner Cary Pf­ef­fer told End­points News. That sort of clin­i­cal po­ten­tial is what helped bring Faze’s big-name in­vestors on board, Pf­ef­fer said, along­side Faze’s ear­ly in­vest­ment in its clin­i­cal plat­form.

“I think we can pre­dict that a few years from now, there will be al­most every in­di­ca­tion that is touched by the bi­ol­o­gy of bio­mol­e­c­u­lar con­den­sates so that sug­gests to us ac­cess points to many, many more dis­eases over time,” Mey­ers said. “What we’re ex­cit­ed about is the clues, and the ways dis­eases are con­nect­ed.”

Based in Cam­bridge, MA, the Faze team of 12 will work to “dri­ve to­ward de­vel­op­ment can­di­dates” as it looks for a lat­er en­try in­to the clin­ic, Pf­ef­fer said. The com­pa­ny will al­so keep build­ing its “prod­uct en­gine,” in­clud­ing the di­ag­nos­tic as­says used for prod­uct de­vel­op­ment. On­ly one pro­gram is cur­rent­ly in ac­tive de­vel­op­ment, but Pf­ef­fer said even more are ap­proach­ing that stage in the near team.

Pf­ef­fer — in what is a typ­i­cal process for Third Rock — will hold the in­ter­im CEO role un­til Faze hires a per­ma­nent re­place­ment. In terms of who the biotech could hire to the helm, Pf­ef­fer was mum.

“At the end of the day, great CEOs come in all stripes and col­ors,” Pf­ef­fer said. “There’s a lot of com­po­nents that go in­to it … we have a great track record of bring­ing on CEOs at our com­pa­ny, and that’s what we’re go­ing to do here.”

In set­ting up shop to chase bio­mol­e­c­u­lar con­den­sates, Faze will be run­ning along­side two re­cent en­tries in the space. In No­vem­ber, Nereid launched with a $50 mil­lion Se­ries A look­ing to chal­lenge Dew­point Ther­a­peu­tics, the first and on­ly biotech fo­cus­ing on bio­mol­e­c­u­lar con­den­sates be­fore Nereid’s en­try.

Dew­point it­self launched un­der the lead­er­ship of Po­laris Part­ners man­ag­ing part­ner Amir Nashat back in Jan­u­ary 2019 with $60 mil­lion and 15 staffers. That first-in-the-field launch came with some pret­ty big names on board, in­clud­ing ubiq­ui­tous MIT gi­ant Bob Langer and in­vestors in Sam­sara Bio­Cap­i­tal, 6 Di­men­sions Cap­i­tal, EcoR1 Cap­i­tal, Alexan­dria Ven­ture In­vest­ments, and Leaps by Bay­er.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to cor­rect an er­ror. The biotech com­pa­ny’s name is Faze Med­i­cines.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.