ROCKVILLE, Md., Nov. 22, 2021 /PRNewswire/ --

• Potential one-time gene therapy for the treatment of Duchenne, includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV^® AAV8 vector
• Commercial-scale cGMP material to be used in clinical development
• Company on track to submit IND by end of 2021

REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne). RGX-202 is designed to deliver a novel, optimized microdystrophin transgene with a unique C-terminal domain and a muscle specific promoter to support targeted therapy for improved resistance to muscle damage associated with Duchenne. RGX-202 uses REGENXBIO's proprietary NAV^® AAV8 vector. 

In institutions and companies, investigators spent some two decades working on RNA-based drugs and vaccines before COVID-19 afforded many of them an opportunity to apply all that research into patients, with support from governments and regulators eager to fight the pandemic.

For two once obscure companies—Moderna, which went public in 2018, and BioNTech, which followed a year later—that opportunity has translated into multiple billions of dollars in new revenues. Not surprisingly as a result, both companies far outpace the other public companies ranked by GEN this year among top RNA-based biopharma companies.

The first cohort of the Techstars Equitech Accelerator is bringing global startups to Baltimore, and supporting companies already growing from a base in the city.

On Thursday, the accelerator announced the first 12-company cohort for the Baltimore-based program, kicking off the programming phase for one of the key initatives aimed at making the city a top-tier tech hub through the lens of equitech. This framework, coined and championed by UpSurge Baltimore, prioritizes supporting companies that are led by underrepresented founders, building diverse teams and developing solutions that aim to address systemic societal challenges.

Image: The Baltimore skyline. (Photo by Flicker user Phil! Gold)

BrainBox HeadSmart II Study Investigators Aim to Provide Clinicians with First-Ever Biomarkers and other Functional measurements for Acute Traumatic Encephalopathy (ATE.) A clinical trial of multi-modal diagnostic/prognostic test, already underway, is published in Frontiers in Neurology/NeuroTrauma.

Investigators in a major clinical trial of patients with mild traumatic brain injury (mTBI or concussion) describe for the first time objective diagnostic criteria, based on blood biomarkers and neurologic testing, for acute traumatic encephalopathy (ATE), the immediate physiologic consequence the injury.

Acute Traumatic Encephalopathy (ATE) represents the condition of an objective measure of TBI associated symptoms or dysfunction that occur as long as 90 days following an acute head injury, according to the investigators. It may be manifest by neuropsychiatric dysfunction, imaging pathology, or biomarker abnormalities in a patient presenting with a history consistent with TBI. Objective criteria for ATE have the potential to advance the understanding of mild TBI and significantly improve its subsequent clinical management.

COLUMBIA, Md., Nov. 17, 2021 /PRNewswire/ -- TEDCO, Maryland's economic engine for technology companies, announced today the findings of an independent study detailing the impact of TEDCO's six core programs to the state of Maryland.

Conducted by the University of Baltimore's Jacob France Institute, the study found that TEDCO provides significant value to the state's start-up community, supporting 10,433 Maryland jobs and more than $2.3 billion in statewide economic activity as of 2021.

Montgomery County announced that it has collaborated with M&T Bank to establish a Small Business Accelerator Program to aid minority business owners.

The Montgomery County Office of Human Rights and M&T Bank announced this week that they will partner to host a new 10-week business accelerator program to small businesses based in the county.

The program, set to begin January 11, 2022, will be free for participants and will feature business mentors, coaches and subject matter experts.

Image: https://conduitstreet.mdcounties.org - From Tweet

The University of Maryland secured its place among the nation’s top schools for entrepreneurship in new rankings that reflect its commitment to innovation education during the height of virtual learning amid the pandemic.

In the 2022 edition of the annual rankings, announced today by The Princeton Review and Entrepreneur magazine, UMD placed No. 10 for undergraduate entrepreneurship education across all institutions—its seventh consecutive year in the top 10 and 10th straight year in the top 25—and No. 4 among public universities. It was also listed at No. 24 for graduate entrepreneurship education. New this year, The Princeton Review ranked schools regionally, and UMD came in at No. 2 in the Northeast.

Image: MFA in performance alum Rob Jansen leads a workshop, "The Art of Presence: How to Warm Up for a Presentation," at the Startup UMD Suite in the Diamondback Garage. UMD's efforts to support entrepreneurs and innovators were recognized yesterday by The Princeton Review and Entrepreneur magazine. Photo by Emma Howells

PASADENA, Calif. and DURHAM, N.C., Nov. 16, 2021 /PRNewswire/ -- Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, agtech and technology campuses in AAA innovation cluster locations, today announced that it is advancing the revolution for complex integrated R&D and next-gen manufacturing in Research Triangle, N.C. through its strategic partnerships with top-tier emerging biotechnology companies, along with its acquisition of purpose-focused development sites in the region, to enable their increased control over the quality of their medicines, patient access, supply chains, and their intellectual property, critical processes and talent.  

Although women account for nearly half of entry-level jobs in the healthcare industry, female clinician-scientist executives continue to be sparse among healthcare leadership ranks. Less than a third of C-suite roles – approximately 26 percent – are filled by women and tend to focus on human resources or marketing, according to a recent analysis by Becker’s Hospital Review.

Image: Kolaleh Eskandanian, PhD, MBA, PMP, vice president and chief innovation officer at Children’s National Hospital, spoke on gender gaps in healthcare leadership during the 6th annual Health IT + Revenue Cycle Conference hosted by Becker’s Healthcare.

GERMANTOWN, Md., Nov. 16, 2021 /PRNewswire/ -- Maryland-based biotech company Deka Biosciences ("Deka") today announced that it has successfully closed a USD 20 Million Series A financing with a syndicate of life science investors led by Leaps by Bayer, the impact investment arm of Bayer AG, and new investor Lumira Ventures. Additional investors include O-Bio (Echo Investment Capital), Viva BioInnovator, and Alexandria Venture Investments.

Deka Biosciences 2021 Novel cytokine-based therapies have the potential to provide patients with innovative curative treatment options for cancer, autoimmune diseases, and many types of infectious diseases. Understanding the known function of each cytokine, Deka has developed Diakines™ – intentionally engineered therapeutic proteins that are designed to deliver clinically validated cytokines, coupled in combination in the Diakine™ structure, to diseased tissue. Deka has also combined this therapeutic platform with companion diagnostic assays that ensure delivery of each Diakine™ to patients that will benefit the most.

935 Prose is a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. It is positioned to recruit and retain the best-and-brightest scientific talent and will set a new standard for life science facilities. Located in the heart of North Bethesda’s nationally-acclaimed, metro-accessible, Pike & Rose mixed-use neighborhood.

Image: From PDF

ROCKVILLE, Md., Nov. 15, 2021 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients.

"This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treatments to patients around the world who are suffering from rare diseases and desperately awaiting new therapies," said Emmes Chief Executive Officer Dr. Christine Dingivan.

The first phase of TwinLabs, a life sciences complex in Rockville, Md., has been fully pre-leased, with four companies taking the entire 25,000 square feet of space, according to JLL, which is handling leasing for the property.

A joint venture between Bethesda, Md.-based GlenLine Investments and Singerman Real Estate of Chicago is redeveloping two buildings adjacent to the National Institute of Allergy and Infectious Diseases HQ into Class A lab space, after making major capital improvements. The duo acquired the 74,500-square-foot asset in 2020. 

Image: TWINLABS AT 5640 FISHERS LANE. PHOTO: JLL

In this riveting What’s Ahead conversation you’ll hear how Martine Rothblatt, creator of SiriusXM, left the communications field entirely to hunt for a cure for a rare, mortal disease with which her daughter was diagnosed. The pressure was intense, as patients usually died within two to three years of diagnosis. After immense effort—and setbacks—Rothblatt and her team came up with an effective treatment, which saved her daughter and thousands of others.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

Study results demonstrate first small molecule approach to significantly reduce phosphorylated and aggregated -synuclein and increase GCase protein levels with transport to the lysosomes in iPSC dopaminergic neurons

Results presented at Michael J. Fox Foundation's Therapeutic Development Webinar

BETHESDA, Md, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) ("Gain", or the "Company"), a biotechnology company directly addressing the urgent need for effective neurodegenerative therapies, today announced data from the Company's study conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds – GT-02287 and GT-02329 – for the treatment of Gaucher and GBA1 Parkinson's Disease, demonstrated highly statistically significant effects on all tested phenotypes representing a key breakthrough in the potential to treat neurodegenerative disorders characterized by misfolded proteins including Parkinson's Disease, Alzheimer's, Gaucher's Disease and Lewy Body Dementia. Study results were presented at The Michael J. Fox Foundation for Parkinson's Research's Innovating from Drug Discover to the Clinic: Novel Approaches to PD Therapeutic Development webinar.

BALTIMORE, Nov. 10, 2021 /PRNewswire/ -- South Duvall and Sagamore Ventures have announced a partnership to bring more than 100,000 square feet of biotech laboratory space to City Garage in Port Covington, Baltimore, over the next 10 years, with approximately 75,000 square feet being delivered in the next year, announced Scheer Partners, which brokered the transaction.

"Baltimore is home to many world class institutions, but there's been a true need for space built for research and development," said Matthew Brown, Director of Acquisitions, South Duvall. "City Garage and Port Covington will be the perfect place for the innovative life science community to grow in Baltimore."

ROCKVILLE, Md., Nov. 9, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. As previously announced on September 13, 2021, under the terms of the agreement, REGENXBIO will receive an upfront payment from AbbVie of $370 million with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones.

Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO will participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

VENLO, Netherlands & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its commitment to a science-based target of net-zero carbon emissions by 2050 in order to help limit global warming to 1.5˚C. This move supports the goals set out by the Paris Climate Agreement and marks an important milestone in QIAGEN’s sustainability efforts.

“Social and environmental responsibility are vital to our business. In pledging to become carbon neutral by 2050, we are taking these commitments to the next level and embedding environmental sustainability in everything we do.”

Tweet this QIAGEN’s ambition to reach net-zero by 2050 applies to its entire value chain and fulfills the criteria of the Science-Based Targets initiative (SBTi), a partnership between the non-profit disclosure specialist CDP, United Nations Global Compact (UNGC), World Resources Institute (WRI) and World Wide Fund for Nature (WWF).

The efforts to find a functional cure for HIV are speeding up for one Maryland company after the Data Safety and Monitoring Board found no serious, adverse events with the third patient, as was the case for the previous two, American Gene Technologies announced.

"One patient can be lucky. Two can be very lucky. Three is a trend, and so actually the Data Safety and Monitoring Board has decided that they will meet quarterly from now on. We don't need to check in with them between each patient, so that means we can greatly accelerate the clinical trial," said CEO and Founder of American Gene Technologies Jeff Galvin.

Ellington West, CEO & Co-founder of Sonavi Labs, joins BioTalk to discuss their building the startup, their medical device, and raising funds in the BioHealth Capital Region.

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The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC),  announced that it has awarded $1.9 million in grants to three life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 12 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

“We are excited to continue our mission of supporting collaborations and fostering economic growth in Virginia’s life sciences, enabling the Commonwealth to compete on a national and global scale,” said Mike Grisham, CEO, Virginia Catalyst. “The critical mass achieved by these collaborations provides Virginia with competitive advantages over other states and has resulted in significant outside capital being invested to finance the commercialization of Virginia’s innovations and create significant high-paying jobs for the Commonwealth.”

Richmond, VA, Oct. 13, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) today announced that CIT GAP Funds, the direct investment program of the Virginia Innovation Partnership Authority (VIPA) has invested in Charlottesville, Va.-based Cerillo. Cerillo designs innovative laboratory technologies that allow scientists to collect data more efficiently and researchers to amplify their impact on the world. Cerillo will use CIT’s funding to expand sales and marketing efforts and to continue expanding its business operations and product development teams, which will position the company for rapid growth.

Germantown, MD (November 4, 2021) – Deka Biosciences is pleased to announce the appointment of six new members to its Scientific Advisory Board: Aurélien Marabelle, MD, PhD (Gustave Roussy), Aung Naing, MD, FACP (MD Anderson Cancer Center), Abhishek Tripathi, MD (OU Health Stephenson Cancer Center), Khusru Asadullah, MD (The Charité – Universitätsmedizin Berlin, Dermatological Practice in Potsdam), Hans-Dieter Volk, MD (The Charité – Universitätsmedizin Berlin), and Florin Selaru, MD (John’s Hopkins University). 

“It is my honor to welcome such a highly esteemed group of world leaders and experts in regulation of the immune system to the company’s Scientific Advisory Board” said Dr. John Mumm, CEO, Deka Biosciences. “Each member will be invaluable to Deka as we continue to develop our Diakines into the next generation targeted cytokine platform that drive cures in both cancer and in patients suffering from autoinflammatory disease.”

The U.S. Department of Health and Human Services declared a Public Health Emergency (PHE) in response to the COVID-19 pandemic on January 31, 2020.

The Centers for Medicare & Medicaid Services followed by issuing waivers covering certain requirements that directly impact nurse aide training.  Legislators and regulators reacted by approving individual state waivers aligned with CMS’ guidance that aimed to ease the challenges of increasing the number of certified nurse aide caregivers. Some of the most significant challenges include the closure of or limited access to nurse aide testing facilities, a shortage of qualified nurse instructors and mandated quarantine protocols.   

November 2, 2021, Baltimore, MD – In a move to accommodate its continued fast growth, Early Charm – a company that creates, owns and operates ventures that convert science to revenue – announced today it is more than doubling its production and lab space at Baltimore's 1100 Wicomico building.

This significant expansion will occur adjacent to Early Charm's 3,200 square feet of current production and development space, bringing total production and development space to just under 7,000 square feet.

Image: https://www.earlycharm.com/

By Giacomo Bologna

November 03, 2021, Maryland is on track to top $2 billion worth of venture capital deals in 2021, its highest ever total.

The state had 34 deals totaling almost $400 million in the third quarter of the year, according to the most recent PitchBook-NVCA Venture Monitor report, which is released quarterly with support from Silicon Valley Bank and Affinity.

Through three quarters of 2021, Maryland has had 134 deals worth about $1.6 billion, the report said. This surpasses the entire amount of venture capital raised in 2020, when companies in Maryland raised about $1.26 billion.

PitchBook-NVCA Venture Monitor revised some figures it released earlier this year, but Greater Baltimore still appears headed for a record-breaking year. The area had 13 deals totaling $72 million in Q3, pushing its year-to-date total past $500 million. That's just shy of 2020's $524 million VC total for the entire year.

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Among the world’s largest nations, the U.S. has by far the highest rate of startup investment relative to population. Over the past year, venture investors put nearly $270 billion to work—averaging out to around $800 for every person in the country. 

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But among all countries, the U.S. ranks fourth in per capita startup investment. The No. 1 and No. 2 slots go to Singapore and Israel, two smaller countries that punch well above their weight class for tech-driven entrepreneurship.

Image: https://news.crunchbase.com

Rockville, Md. — Thus far in 2021, a record pace for initial public offerings (IPO), private investment and venture capital deals has been set in Montgomery County. Over $18 billion of investment across 76 companies and 87 separate transactions have been made in the first three quarters of the year from January 1 through September 30. The companies receiving funding span major industries from life sciences and health tech to quantum and media.

Image: https://thinkmoco.com

Since the start of the COVID-19 pandemic, the response from public health agencies, regulators, researchers, and industry has been dominated by the development of vaccines. As of October 14, McGill University’s McGill COVID19 Vaccine Tracker listed 153 vaccines in clinical development, of which 23 had been approved or authorized for emergency use in at least one country.

In the United States, the FDA has approved one COVID-19 vaccine (Pfizer/BioNTech’s Comirnaty) and authorized for emergency use two others (Moderna’s Moderna COVID-19 Vaccine and Johnson & Johnson’s Janssen COVID-19 Vaccine). Beyond the United States, most approvals and authorizations have been granted to those vaccines and others developed by AstraZeneca/University of Oxford (122 countries), Sinopharm (65), Sinovac Biotech (40), Russia’s Gamaleya Research Institute (16), and CanSino Biologics (9).

GAITHERSBURG, MD, November 2, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has entered into an agreement with the Antibacterial Resistance Leadership Group (ARLG) to support a multi-center Phase 1b/2, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. 

ARLG consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. Created in 2013, ARLG is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. It is facilitated by the Duke Clinical Research Institute and works under the leadership of an executive committee, four component centers, and two Principal Investigators: Vance Fowler, MD, of Duke University, and Henry "Chip" Chambers, MD, of University of California, San Francisco. The NIAID is the Sponsor of this study.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

BALTIMORE, MD, OCT. 29, 2021 – The University of Maryland BioPark (UM BioPark) today announced that JuneBrain Inc., a telehealth device company that empowers ophthalmology and neurology communities, joined the UM BioPark as its newest tenant. JuneBrain, a Maryland-based company, is located in the BioPark’s innovation space in the Lion Brothers Building on Hollins Street.

“We are delighted to welcome JuneBrain to our tenant community,” said Jane Shaab, executive director of the UM BioPark. “The BioPark is an ideal fit for emerging technology companies seeking pre-built space to grow. By fostering unique opportunities and connections, we provide a supportive environment that helps companies thrive at any stage in their development.”

Amritha Jaishankar, PhD, Executive Director, Maryland Stem Cell Research Fund (MSCRF), joins BioTalk to discuss her career, investing in Maryland, and accelerating cures.

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