News

• Company has initiated Phase I/II AFFINITY DUCHENNE™ trial of RGX-202
• Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne
• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
• RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO’s proprietary NAV® AAV8 vector

ROCKVILLE, Md., Jan. 23, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne muscular dystrophy (Duchenne) is now active and recruiting patients. RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO’s proprietary NAV® AAV8 vector.

AFFINITY DUCHENNE is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

The University of Virginia will build a biotechnology institute funded with a $100 million donation from Charlottesville investor Paul Manning and his wife, Diane, the university announced Friday.

Along with the Mannings’ gift, U.Va. will contribute $150 million, and the state has allocated $50 million in initial investments for the institute in its 2022-24 budget, according to the announcement.

Image: Paul Manning. Photo courtesy the University of Virginia

Ahead of his swearing-in on Wednesday, Gov.-elect Wes Moore’s Cabinet is nearly complete. Moore announced his picks for nine additional cabinet positions on Tuesday, filling out key roles including the heads of the departments of Housing, Environment, Planning and Commerce.

The latest appointments include two Maryland mayors — Jake Day of Salisbury and Emily Keller of Hagerstown — meaning a change of leadership elsewhere in the state.

Image: The Great Seal of the State of Maryland on the front of the Maryland State House. Photo by Danielle E. Gaines.

On December 19, 2022, the Department of Defense (“DOD”) issued a proposed rule seeking to amend the Defense Federal Acquisition Regulation Supplement (“DFARS”) to implement the data rights portions of recent Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, which emphasizes the need to protect the intellectual property interests of small businesses. In addition to addressing the small business directives, the proposed rule seeks to update markings requirements related to (1) small business data rights and (2) concerns raised by the Federal Circuit’s decision in The Boeing Co. v. Secretary of the Air Force, 983 F.3d 1321 (Fed. Cir. 2020).

Federal innovation and entrepreneurship initiatives would receive substantial new funding under the text of the omnibus spending bill shared on the morning of Dec. 20 by the Senate Committee on Appropriations. The legislation, which totals $1.7 trillion and covers both regular FY 2023 appropriations and supplement funding, provides a total of $1.8 billion for programs authorized by this year’s CHIPS and Science Act and increases funding for multiple long-standing efforts — including each of the SSTI Innovation Advocacy Council’s priority programs. The legislation is expected to pass Congress this week, before the current funding agreement expires on Dec. 23.

Organizations across the globe are pivoting their workplace technology strategy and many employers are grappling with big questions about which tools are needed to create a thriving hybrid environment in 2023.

Based on a JLL survey of over 1,000 companies worldwide, a vast majority expect to make significant changes to their tech stack over the next three years. Download the infographic highlighting the workplace technologies that were consistently mentioned by employers as top priorities and discover why those technologies are prioritized and how they change workplace.

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The region’s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Image: https://biobuzz.io/

A new year means new opportunities to grow your business. If you’re one of the millions of resolution makers who are using the new year to take their ventures to new heights, Maryland SBDC has the expertise to turn your goals into gains.

Whether your goal is to start a business, grow a business, or just learn something new, Maryland SBDC will jump-start your year with no-cost confidential, one-on-one consulting and low-cost training on topics ranging from business planning and financing to marketing and more.

Norfolk biotech company Embody has racked up a bevy of accomplishments since it was founded in 2014 with just two employees.

It has attracted millions of dollars in grant funding from the Department of Defense, and millions more from local and national stakeholders. Last April, the company announced plans to spend $5 million to expand its lab space by 10,000 feet and add 92 new jobs.

And now a bigger milestone can be added to the list: Embody’s sale to a major sports medicine company.

Zimmer Biomet, a Fortune 500 medical technology company based in Warsaw, Indiana, has signed a deal to acquire Embody for $155 million at closing and an additional $120 million subject to achieving other milestones over a three-year period.

Sanofi has thrown its financial weight behind its venture capital unit, making a $750 million, multi-year commitment to enable the financier to build on a year in which it backed 10 companies globally.

Sanofi Ventures is a well-established player in the biotech VC space, with its roots dating back to the formation of Sanofi-Genzyme BioVentures in 2011 and beyond that to the establishment of Genzyme Ventures a decade earlier. But Sanofi has largely stayed in the shadows, leaving its venture unit to build out a portfolio without publicly disclosing the details of how it supports the fund.