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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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