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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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