J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spin­out is gar­ner­ing even more in­vest­ment and space even af­ter on­ly be­ing around for about a year.

Am­pli­fy­Bio, a CRO and R&D biotech, has re­ceived a nine-fig­ure in­vest­ment to ex­pand its fa­cil­i­ties to a sec­ond lo­ca­tion in New Al­bany, a sub­urb of the state cap­i­tal of Colum­bus.

The com­pa­ny is re­ceiv­ing an in­vest­ment of around $150 mil­lion to es­tab­lish a new 350,000-square-foot fa­cil­i­ty. With this in­vest­ment, the com­pa­ny is al­so ex­pect­ed to cre­ate over 200 new jobs both at its new lo­ca­tion and at an ex­ist­ing lo­ca­tion in West Jef­fer­son, an­oth­er Colum­bus sub­urb. That lo­ca­tion, which has 220,000-square-feet of space for the young biotech, is the head­quar­ters for non­prof­it Bat­telle, which spun out Am­pli­fy­Bio last year.

Since then, the biotech has raised $200 mil­lion, which so far has been fo­cused on safe­ty, ef­fi­ca­cy and tox­i­col­o­gy test­ing drug can­di­dates, but cell and gene ther­a­pies are in the cards, as well. The com­pa­ny will be look­ing to hire re­search and de­vel­op­ment po­si­tions through­out the rest of the year, with its new lo­ca­tion hav­ing 130 new em­ploy­ees.

Ac­cord­ing to Am­pli­fy­Bio, its ex­pan­sion is meant to meet the in­creas­ing mar­ket de­mand for ad­vanced ther­a­pies, in­clud­ing cell and gene ther­a­py prod­ucts. The com­pa­ny’s ex­ist­ing lo­ca­tion in West Jef­fer­son con­tains a 30-acre cam­pus and cur­rent­ly em­ploys 155 peo­ple. The new in­vest­ment will see the cre­ation of 99 new jobs at that lo­ca­tion, in ad­di­tion to 32 new cor­po­rate jobs that will be added at a lo­ca­tion yet to be de­ter­mined.

Ac­cord­ing to the gov­er­nor’s of­fice, the new po­si­tions will gen­er­ate $24.1 mil­lion in new an­nu­al pay­roll and re­tain $7.8 mil­lion in ex­ist­ing pay­roll. The Ohio Tax Cred­it Au­thor­i­ty al­so ap­proved a 2.143%, 10-year Job Cre­ation Tax Cred­it for this project.

We are ex­cit­ed to ex­pand our pres­ence in the Colum­bus re­gion, and specif­i­cal­ly New Al­bany. We be­lieve that our in­no­va­tion plat­form is a per­fect fit for the col­lab­o­ra­tive en­vi­ron­ment that I first no­ticed when I came to Ohio,” said Am­pli­fy­Bio CEO and pres­i­dent J. Kel­ly Gan­jei in a state­ment.

The in­vestor base that launched the com­pa­ny, be­sides Bat­telle, in­clud­ed Con­necti­cut-based Viking Glob­al In­vestors, New York-based Cas­din Cap­i­tal and Cincin­nati-based Narya Cap­i­tal. Ac­cord­ing to the com­pa­ny, the in­vestor base has not changed and will be back­ing the ex­pan­sion project.

Colum­bus has been at­tract­ing some at­ten­tion from biotech in­vestors and large phar­ma com­pa­nies, in­clud­ing Forge Bi­o­log­ic, which raised a $120 mil­lion se­ries B in 2021 to bring on­line a 175,000-square-foot fa­cil­i­ty to man­u­fac­ture AAV gene ther­a­pies. Am­gen al­so broke ground on a $365 mil­lion man­u­fac­tur­ing fa­cil­i­ty in New Al­bany last year.

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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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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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.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

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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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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Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.