Tim Miller, Forge Biologics CEO

Forge Bi­o­log­ics con­tin­ues its hot streak with $90M round to boost gene ther­a­py man­u­fac­tur­ing ser­vices

Over the past two years, the Ohio-based gene ther­a­py man­u­fac­tur­er Forge Bi­o­log­ics has man­aged to get a large amount of cap­i­tal to scale up its AAV pro­duc­tion ca­pa­bil­i­ties. And as the field con­tin­ues to grow, the com­pa­ny looks to grow along with it.

The com­pa­ny an­nounced Mon­day that it has raised $90 mil­lion in a Se­ries C fund­ing round, bring­ing the to­tal amount raised so far to $330 mil­lion. In an in­ter­view with End­points News, Forge Bi­o­log­ics CEO Tim Miller said that the round it­self took on­ly a few months to put to­geth­er as firms had ap­proached Forge to par­tic­i­pate.

As for what the round is go­ing to­ward, Miller told End­points that the fund­ing raise is meant to help ac­cel­er­ate ad­di­tion­al client of­fer­ings. Miller said that as reg­u­la­to­ry bod­ies be­come more strin­gent on how they look at gene ther­a­py prod­ucts, the com­pa­ny is help­ing to try to ad­dress that by putting in an au­to­mat­ed fill along with oth­er el­e­ments the com­pa­ny is plan­ning to put in on the front end of its AAV man­u­fac­tur­ing process.

Miller al­so said that funds are al­so ear­marked for adding pro­pri­etary tech­nol­o­gy that the com­pa­ny has been work­ing on as well as boost­ing Forge’s man­u­fac­tur­ing sys­tems and cell line de­vel­op­ment. The com­pa­ny will add more 5,000-liter biore­ac­tors to sup­port its AAV clients.

“There are al­most 400 ac­tive clin­i­cal tri­als in gene ther­a­py right now. And AAV is still the ma­jor­i­ty of vec­tor for gene ther­a­peu­tic ap­proach­es,” Miller told End­points. “So, for us, it’s about ex­pand­ing in­to those 5000-liter biore­ac­tors, those of the largest biore­ac­tors in the in­dus­try for sus­pen­sion-based growth. And, you know, as we ramp those up in 2023, it’s re­al­ly ex­cit­ing to see that there are groups that are al­ready look­ing at us­ing those for their larg­er pa­tient pop­u­la­tions.”

He al­so added that Forge is plan­ning to hire ag­gres­sive­ly on the back of the raise. With the com­pa­ny sit­ting at a head­count of around 250, Miller plans to add an­oth­er 50 to 75 em­ploy­ees in the next 12 months to help meet de­mand.

Forge’s 200,000 square-foot space in Colum­bus, OH, along with its 20 GMP suites, en­ables the com­pa­ny to ex­pand in­ter­nal­ly and to meet de­mand when need­ed so any more phys­i­cal build­outs are not in the cards cur­rent­ly.

In terms of any po­ten­tial fu­ture fund­ing or an IPO, Miller said that the com­pa­ny is cur­rent­ly bring­ing in rev­enue, al­low­ing the com­pa­ny to be more strate­gic with tak­ing on new rounds of fund­ing.

In 2020, the com­pa­ny re­ceived a $40 mil­lion Se­ries A from the PXV Fund. In 2021, the com­pa­ny got an even big­ger boost as it racked up a $120 mil­lion Se­ries B.

The Colum­bus area has al­so been grow­ing for biotech man­u­fac­tur­ing as Am­gen broke ground on a $365 mil­lion plant in New Al­bany, OH last year. In May, Am­pli­fy­Bio re­ceived $150 mil­lion to es­tab­lish a new 350,000 square-foot fa­cil­i­ty.

The round for Forge was led by Dri­ve Cap­i­tal and Ais­ling Cap­i­tal, along with a strate­gic in­vestor who was not dis­closed.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

SPACs might be slowly creeping back.

Monday evening, Estrella Biopharma said it was going public via a SPAC deal with TradeUP Acquisition Corp. The deal is set to close in the first half of 2023, and if all goes as planned, the public version of Estrella — dubbed Estrella Immunopharma — will be worth around $398.5 million.

The Bay Area biotech will also get around $45.4 million in cash, and TradeUp stockholders will get around 15% stock in the public biotech.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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