Tim Miller, Forge Biologics CEO (Forge)

Forge Bi­o­log­ics bags $120M round as it looks to scale AAV man­u­fac­tur­ing for Krabbe dis­ease treat­ment

In less than a year, Forge Bi­o­log­ics has grown its staff size from just four em­ploy­ees to more than 75, a sure sign of rapid growth from the Chris Garabe­di­an-launched start up. Here’s an­oth­er sign: the $120 mil­lion Se­ries B fi­nanc­ing round the com­pa­ny just an­nounced.

The gene ther­a­py CD­MO se­cured fund­ing from RA Cap­i­tal Man­age­ment, and par­tic­i­pa­tion from Per­cep­tive Ad­vi­sors, Sur­vey­or Cap­i­tal, Oc­ta­gon Cap­i­tal and Mar­shall Wace.

The funds will help bring on­line a 175,000-square-foot fa­cil­i­ty to man­u­fac­ture AAV gene ther­a­pies in Colum­bus, OH, that will add eight times as much space to speed up the man­u­fac­tur­ing process.

“We’re here to ba­si­cal­ly pro­vide more ac­cess to these life-sav­ing life-chang­ing gene ther­a­pies,” CEO Tim Miller said in an in­ter­view with End­points News. “When you want to play on the glob­al stage for a dis­ease, this is how you build it.”

The suc­cess of AAV-de­liv­ered drugs has ex­haust­ed man­u­fac­tur­ing ca­pac­i­ties around the world. In a state­ment, Matthew Ham­mond, prin­ci­pal at RA Cap­i­tal, said that this fi­nanc­ing could help ad­dress the ca­pac­i­ty short­age.

“We are con­fi­dent that Forge’s ex­pe­ri­enced team will be­come the trust­ed part­ner of in­no­v­a­tive ther­a­peu­tics com­pa­nies, work­ing col­lab­o­ra­tive­ly with clients to suc­cess­ful­ly de­liv­er AAV man­u­fac­tur­ing so­lu­tions,” he said.

With­in its own pipeline, the com­pa­ny is re­search­ing AAV in com­bi­na­tion with um­bil­i­cal cord bone mar­row (UCBT) trans­plants as a treat­ment for Krabbe dis­ease. The ge­net­ic dis­or­der de­stroys pro­tec­tive coat­ing of nerve cells in the brain and through­out the ner­vous sys­tem, and of­ten re­sults in the pa­tient’s death by the age of 2.

The treat­ment us­es a vi­ral gene trans­fer af­ter a bone mar­row trans­plant, which solves for a num­ber of pe­riph­er­al deficits that de­vel­op af­ter the stan­dard of care.

Forge took home $40 mil­lion in Se­ries A fund­ing back in Ju­ly 2020, the eighth biotech in­vest­ed in by the PXV Fund. What sets the com­pa­ny apart, Miller said, is that while some com­pa­nies are in the busi­ness of rais­ing boat­loads of cash to do all sorts of gene and cell ther­a­py man­u­fac­tur­ing, Forge is just fo­cused on AAV man­u­fac­tur­ing. That’s what many gene ther­a­py com­pa­nies who have had suc­cess­ful tri­als — like the reti­nal dy­s­tro­phy treat­ment Lux­tur­na and spinal mus­cu­lar at­ro­phy treat­ment Zol­gens­ma — have used.

“One of the dif­fer­en­tia­tors is that we have mul­ti­ple of­fer­ings, things that es­pe­cial­ly start­up clients need to have to be suc­cess­ful,” Miller said. “We of­fer reg­u­la­to­ry sup­port for ear­li­er stage pro­grams and we al­so of­fer re­search-grade pro­duc­tion which is some­thing a lot of oth­er com­pa­nies don’t do.”

As a part of the fi­nanc­ing, Ham­mond and Fred Cal­lori of the al­ready-in­vest­ed Per­cep­tive Xon­toge­ny Ven­ture Fund will join the board of di­rec­tors. That board cur­rent­ly con­sists of Miller, Garabe­di­an and Dri­ve Cap­i­tal part­ner Mol­ly Bonakdar­pour.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.