NCBiotech News

Tune Therapeutics, an epigenome-editing company with origins at Duke University, has raised over $175 million in financing to advance a potential treatment for chronic hepatitis B and other diseases. The financing – among the largest ever for a North Carolina life science company – was led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation.

The first Clinical Outsourcing Group: CRO Summit was held in Raleigh on Dec. 3-4, 2024. The event brought together more than 200 attendees to explore opportunities for improving collaboration between sponsors and clinical research organizations (CROs).  

Tune Therapeutics, an epigenome-editing company based in Durham and Seattle, will be the first to initiate a human clinical trial for an epigenetic therapy for a common infectious disease. The company has received approval from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) to initiate a Phase 1b clinical trial for TUNE-401.

Research Triangle Park-based Opus Genetics, a clinical-stage gene therapy company devoted to treating inherited retinal diseases, has been acquired by a small ophthalmic biopharmaceutical firm with Durham operations, becoming North Carolina’s newest publicly traded life sciences company.

Jude Samulski calls genome editing “the next wave of technology to feed the world.”

Atsena Therapeutics, a Durham company developing gene therapies to treat genetic causes of blindness, has received another incentive from the U.S. Food and Drug Administration (FDA) to help boost the development of its leading product candidate.

California’s loss looks like North Carolina’s gain.

Astellas Gene Therapies is closing a production site in South San Francisco and transferring all of its projects to a biomanufacturing facility in Sanford, N.C.

The company, a unit of the global biopharmaceutical company Astellas Pharma of Tokyo, will consolidate its gene therapy production at a $100 million plant it opened in Sanford’s Central Carolina Enterprise Park in 2022.

Opus Genetics, a clinical-stage gene therapy company devoted to treating inherited retinal diseases, has been granted Rare Pediatric Disease designation by the U.S. Food and Drug Administration for one of its potential therapies. 

The Research Triangle Park-based company received the designation for OPGx-LCA5, an ocular gene therapy for treating patients with LCA5, a form of early-onset retinal degeneration that causes vision loss.

Durham-based Atsena Therapeutics, a gene therapy company focused on reversing or preventing blindness, has received an incentive from the U.S. Food and Drug Administration (FDA) for its leading product candidate.

The FDA granted Rare Pediatric Disease designation for ATSN-201, Atsena’s gene therapy product candidate for the treatment of X-linked retinoschisis (XLRS), a rare genetic disease that causes blindness.

Millions of consumers know Bayer as the aspirin company. Some even know it’s the Alka-Seltzer company. Investors know it as the German pharmaceutical, life sciences and agricultural giant that bought Monsanto in 2018.

Now Bayer is buying a bigger bite of plant technology developed by Pairwise, a North Carolina gene-based ag tech company, to expand its reach into the grocery food chain.

North Carolina-based Advanced Medicine Partners has announced a new financing agreement led by Deerfield Management, with additional support from ARCH Venture Partners and other investors. Once complete, this latest funding round of $32 million will bring the total direct investment in Advanced Medicine Partners to $60 million since its separation from Jaguar Gene Therapy.

The Foundation Fighting Blindness has awarded Opus Genetics, a Research Triangle Park drug development startup focused on inherited diseases of the retina, $1.7 million in funding to help advance two preclinical therapy candidates.

A Swiss contract research organization, Solvias, is establishing a cell- and gene-therapy (CGT) testing center in Morrisville, where it plans to employ more than 170 people by the end of 2025.

New research funded in part by the North Carolina Biotechnology Center shows that bioengineered platelets can be used to stop bleeding and enhance wound healing in animal models of trauma.

Two bioscience companies with operations in Durham are teaming up to discover new cancer therapies.

The collaboration between Boston-based Aktis Oncology and Indianapolis-based Eli Lilly and Company is aimed at developing radiopharmaceuticals for a range of solid tumors using Aktis’ novel mini-protein technology platform.