• 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.

Happy New Year! Maryland is coming off of a busy and successful year of business attraction and expansion. Continue reading to see the companies that committed to Maryland in the 4th quarter of 2022.

Our momentum continues into 2023, with many exciting new projects on the horizon. We look forward to connecting with industry colleagues at events this spring, and as always, we’re standing by to help you make your next project a success.

Total research spending at American universities reached nearly $90 billion in 2021,1 2 and university licensing revenue has climbed to almost $3 billion a year.3 From robotics to agriculture to medicine, useful discoveries constantly emerge from academic labs. Yet policymakers often fail to recognize the critical role of intellectual property in driving all that spending, income, and innovation. Standing up for strong IP rights must be a priority for American universities.

Click here to read the full PDF Briefing.

GAITHERSBURG, Md., January 12, 2023--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc., (APT) a clinical-stage biotechnology company advancing the APT phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the first patient has been dosed in the PHAGE clinical trial, evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or "phage," therapy is safe and able to reduce the amount of bacteria in the lungs of volunteers. The trial is being conducted by the Antibacterial Resistance Leadership Group (ARLG) which consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. ARLG is funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The investigational phage therapeutic, WRAIR-PAM-CF1, was developed by the Walter Reed Army Institute of Research (WRAIR) and is licensed to and manufactured by APT. The trial is expected to enroll a total of 72 patients at multiple sites across the country.

Image: Photo: Business Wire

COLUMBIA, Md. (January 10, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a new collaboration between TEDCO’s Maryland Innovation Initiative (MII) and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The MII Pop-up Event will take place on February 8 at HJF home office in Bethesda, Md., including the signing of the Memorandum of Understanding (MOU) and speakers from MII, TEDCO and HJF leadership.

“We’re very proud of MII’s successful track record when it comes to both collaboration and outcomes,” said Dr. Arti Santhanam, executive director of MII. “This MOU gives us the opportunity to expand on that success in partnership with the dedicated team at HJF. Together, we anticipate advancing new business creation with crucial military medical applications.”

The Maryland Industrial Partnerships (MIPS) program offers grants for projects that team Maryland-based companies with University System of Maryland faculty to develop technology products and processes.

Join us for a free webinar to learn how MIPS can help advance your technology-based products by leveraging the facilities, resources, and expertise within Maryland’s public universities to create new products and opportunities!

Next webinar:
Thursday, January 19, 2023, at 1 p.m.
online via Zoom

Click to register

Mentia is honored to be selected for the inaugural Artificial Intelligence and Technology Collaboratory #A2Collective #johnshopkinsuniversity The National Institutes of Health Full story at https://lnkd.in/g6ewtb9W

There are now more Americans aged 65 and older than at any other point in history, and that number is expected to rise, according to the National Institute on Aging (NIA). With longer lifespans come challenges like Alzheimer’s, which about one in nine Americans aged 65 or older have.

The a2 Pilot Awards were created to encourage the development of tech for the elderly. Funded by the NIA with $40 million over the next five years, the awards announced today the first cohort of 33 projects selected for funding. The majority use artificial intelligence or machine learning tech, and 40% are led by women.

Deployed military personnel frequently face numerous health and safety hazards as part of their daily activities in service to their nation. Among many dangers is the possibility of encountering hemorrhagic fever viruses (HFVs), a group of highly infectious pathogens such as the Ebola virus. Many of these diseases do not currently have effective therapeutics and can be prevalent in areas where service members are deployed, putting them at risk of exposure.

George Mason University infectious disease researcher Aarthi Narayanan has partnered with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and Cyclica, a biotechnology company based in Canada, to identify potential broad-spectrum therapeutics for illnesses triggered by HFVs and similar pathogens.

Biopharmaceutical company Kite Pharma will expand its footprint in Frederick County with a new warehouse that will bring 100 new jobs to the area, the company announced Tuesday.

Kite, a Los Angeles-based subsidiary of Gilead Sciences (NASDAQ: GILD), will build an approximately 70,000-square-foot raw materials warehouse to support its global cell therapy manufacturing network. The company's CAR T-cell therapy uses a person's own immune system to recognize, attack and destroy certain types of cancer with a one-time, individualized treatment.

Today, College Park, Maryland quantum leader IonQ announced its first-ever acquisition.

The DMV company acquired the operating assets of Entangled Networks, a Toronto, Canada-based startup founded in 2021. Entangled Networks specialized in enabling computing for multiple quantum processors, including those that are distributed. Through the deal, the Entangled team will become the staff of IonQ Canada, the quantum pioneer’s first outpost in the country.

Image: IonQ's Kai Hudek in the lab. (Courtesy photo)

To kick off the new year, The Galien Foundation is delighted to share with you highlights from the 2022 Prix Galien Awards Ceremony and recognize the incredible achievements of the Medalists  of the Prix Galien Golden Jubilee and the Prix Galien USA.

Kite , a global biopharmaceutical company, is adding 100 new jobs and expanding its cell therapy manufacturing operations in Frederick County.

A Gilead company, Kite is planning to construct a 70,000 square-foot warehouse adjacent to its current facility in the Urbana Corporate Center, which will help expand its global manufacturing network. The company originally announced its entry into Maryland back in 2019 , helping form the largest dedicated in-house cell therapy manufacturing network in the world. The company expects to employ more than 500 full-time staff between its two facilities by the end of 2026.

Linshom Medical raising $3M series A to launch respiratory monitor

Ellicott City startup Linshom Medical is looking to raise a $3 million round as it works to develop a medical device that catches the warning signs of a respiratory crisis.

CEO Richard Hughen plans to use the series A raise, as well as a $2.4 million grant from the National Institutes of Health, to fund a study to prove the company’s respiratory monitor is effective at detecting breathing issues. The company previously raised $1.5 million in convertible notes. Linshom has raised $1 million of its $3 million series A goal so far, with support from the Maryland Momentum Fund, the Maryland Technology Development Corp. and other investors.

Once the studies are complete, the three-person company is planning to do a soft launch in a few hospital systems late this year.

· Global biopharmaceutical company focusing on metabolic and digestive diseases

· Proceeds to fund clinical and business development

ROCKVILLE, MD and SHENZHEN, CHINA,January 5, 2023— HighTide Therapeutics Inc. (“HighTide”), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund.

On September 30, 2022, the SBIR and STTR Extension Act of 2022 (the Act) was enacted, reauthorizing the SBIR and STTR programs until September 30, 2025. The Act makes several significant changes related to national security risks and foreign influence in the programs. The changes include agency implementation of due diligence procedures, new offeror disclosure and ongoing contractor reporting requirements, and new award eligibility requirements, with an offeror’s or contractor’s omissions or misstatements resulting in repayment of the entire award amount, among other changes to the programs.

WALTHAM, Mass., Jan. 09, 2023 (GLOBE NEWSWIRE) -- CinCor Pharma, Inc. (NASDAQ: CINC) today announced that it has entered into a definitive agreement with AstraZeneca under which AstraZeneca has agreed to acquire CinCor.

Marc de Garidel, Chief Executive Officer at CinCor, said: "We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved. CinCor is committed to ensuring a smooth transition of the development responsibilities to AstraZeneca once the acquisition is consummated. Thank you to all who have played, and will continue to play, essential roles in developing and evaluating baxdrostat as a potential novel treatment for cardiorenal diseases."

The transition will take place in late January.

Image: Stanley Erck is retiring as CEO of Gaithersburg vaccine maker Novavax. EMAN MOHAMMED

Today we announced an agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension.

The acquisition will strengthen our cardiorenal pipeline, where there is a high unmet medical need.

This acquisition is expected to close in first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Additional important information can be found here: https://know.az/3IvkzkQ

Jan 9 (Reuters) - Life sciences firm Qiagen said on Monday it has acquired DNA-biometrics firm Verogen in a $150-million cash deal, strengthening its forensics portfolio.

The deal builds on the companies' existing partnership from 2021, under which Qiagen has the rights to distribute some of Verogen's products such as its next-generation gene sequencing panels and genetic code analyzing technology GEDmatch.

Scientists and researchers have made remarkable breakthroughs in basic science to better understand the complex pathology of many diseases today. Some of that progress is through utilizing technology to uncover new insights, and some of the progress is through the incalculable capacity of the human mind to analyze problems and find solutions. With all that knowledge and all the effort put in, however, human biology and disease pathology continue to be surprising. Every day researchers continue to make profound discoveries in basic science that create new possibilities in fighting disease.

First awarded in 2016, the International Biomedical Research Alliance’s Innovation Award recognizes novel solutions in biology or medicine and acknowledges discoveries of unusual importance, application, or magnitude that make use of new or unusual methods, paradigms, or approaches to solve important problems in biology or medicine. Once again, this year, the Innovation Award was generously sponsored by BioHealth Innovation Inc. This award was presented to Sooraj Achar, an NIH-Oxford D.Phil. Scholar in the Class of 2020 who is mentored by Dr. Gregoire Altan-Bonnet at the National Cancer Institute (NCI/NIH) and Prof. Mike Dustin at the University of Oxford.

Image: https://biomedalliance.org

GAITHERSBURG, Md., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an indefinite-delivery, indefinite-quantity procurement contract with a maximum value up to $379.6 million to supply RSDL® (Reactive Skin Decontamination Lotion Kit) for use by all branches of the U.S. military. Emergent's Canadian Subsidiary will serve as the sole subcontractor to deploy RSDL® to the U.S. Department of Defense (DoD) through a new contract award to the Canadian Commercial Corporation (CCC). The new contract has a base year, which began in December 2022, and four single year option renewals.

"Emergent has a 25-year history of developing and supplying medical countermeasures (MCM) for the U.S. and other governments around the world," said Paul Williams, senior vice president, government MCM at Emergent. "RSDL® has been a routine part of the U.S. warfighters armamentarium for 13 years. This new contract award demonstrates the unique capabilities of our core MCM business to continue to meet the needs and deliver on the requirements for chemical and biological preparedness of public and military forces, which is an important part of our mission to help protect and enhance life."

Maryland, with its six million plus residents, may not be the biggest state, but even before the creation of the United States, the colony’s location in the mid-Atlantic was key to its economic prosperity.

While the state’s central location on the Eastern seaboard is still vital for companies like Amazon and its massive Baltimore-area shipping enterprise, the proximity to another center, the federal capital, provides Maryland with its most important source of large employers.

Image: https://www.heraldmailmedia.com

Cast your mind back to 2020, if you can bear it. As the year progressed, so did the impact of covid-19. We were warned that wearing face coverings, disinfecting everything we touched, and keeping away from other people were some of the only ways we could protect ourselves from the potentially fatal disease.

Thankfully, a more effective form of protection was in the works. Scientists were developing all-new vaccines at rapid speed. The virus behind covid-19 was sequenced in January, and clinical trials of vaccines using messenger RNA started in March. By the end of the year, the US Food and Drug Administration issued emergency-use authorization for these vaccines, and vaccination efforts took off.

Image: STEPHANIE ARNETT/MITTR; ENVATO

SHANGHAI, Jan. 4, 2023 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics' proprietary technology platforms.

Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.