Fri, Jan 14, 2022  

New Cooperative Agreement to Aid in the Development of Therapeutics and Vaccines, Improve Access to Medication  

The Institute for Bioscience and Biotechnology Research (IBBR) announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology (NIST) headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino (NIST). This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges.  

IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines.  This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers.  

It takes more than a great idea to accomplish a great project. Our research and experience have convinced us that many worthy projects wither or are never launched because neither academic laboratories, start-up firms nor government facilities can support them.

This applies particularly to projects that would produce public goods, such as data sets or tools, that could make research faster and easier. Few research-enabling projects will be commercially viable enough to attract venture capital.

Image: Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

Cartesian Therapeutics is developing non-permanent cell therapies that can be used soon after diagnosis and address a wide range of diseases beyond cancer. The biotech’s approach to cell engineering relies upon RNA rather than DNA to effect changes within the cells.

The benefit, Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D. told BioSpace, is that “our RNA approach, compared to a traditional DNA modification, offers an order of magnitude greater control over the therapeutic product and what happens when those cells are in the body.” A high level of control is important if cell therapy is to be used in the treatment of either front-line cancer or in indications where the choice isn’t between life and death.

Image: Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D./Courtesy Cartesian Therapeutics  

-- Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine granted approval in South Korea

GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, today announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.

"Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine."

January 10, 2022 by Ronald Piervincenzi  

The COVID-19 pandemic made the last year both an extraordinary and challenging time to work in health care. Development, distribution and administration of new vaccines, treatments and preventatives moved at a pace never before experienced. Pharmacists and other health care practitioners were called to the front lines of a mass vaccination effort, working to balance safety, speed and a plethora of daily demands in caring for patients and working to save countless lives. Manufacturers, regulators, pharmacists and other care providers demonstrated how cross-sector collaboration could rapidly transform cutting-edge innovation into the new standard of care, including an expanding scope of practice for many pharmacists.  

Under pressure of the COVID-19 pandemic, multitudes of clinical trials of new medications and treatments have moved to a decentralized model, bringing them to the patients rather than having patients come to a central trial site such as an urban medical center.(1) At the same time, recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.(2) “This,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “is not an acceptable situation. The extent to which patients comprehend the consent they grant is essential to the ethical conduct of medical research.”

Image: http://www.prweb.com

ROCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ --

• ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada
• Pivotal trials expected to support BLA submission for RGX-314 in 2024

REGENXBIO Inc. (Nasdaq: RGNX) today announced the initiation of ASCENTTM, the second of two Phase III pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD). ASCENT, the first trial to be initiated by REGENXBIO under the eye care collaboration with AbbVie, is currently active and screening patients. RGX-314 is being investigated as a potential  one-time gene therapy for the treatment of wet AMD.

A Biologics License Application (BLA) is expected to be submitted to the United States Food and Drug Administration (FDA) in 2024 based on two pivotal trials, ASCENT and the ongoing ATMOSPHERE trial.

Leiden, May 27, 2021 - MIMETAS, the global leader in human-relevant organ-on-a-chip models, has just opened their Phenotypic Screening Center. The center facilitates large-scale screening campaigns on Organ-on-a-Chip models, a powerful technology that improves the human physiological relevance of cultured tissues by utilizing microfluidic techniques. In contrast to other Organ-on-a-Chip platforms, the MIMETAS OrganoPlate® technology offers the scalability and the throughput needed for drug discovery studies.

Image: https://www.mimetas.com

Isaac Newton apocryphally discovered his second law – the one about gravity – after an apple fell on his head. Much experimentation and data analysis later, he realised there was a fundamental relationship between force, mass and acceleration. He formulated a theory to describe that relationship – one that could be expressed as an equation, F=ma – and used it to predict the behaviour of objects other than apples. His predictions turned out to be right (if not always precise enough for those who came later).

- Partnership aims to drive innovation and clinical development of novel therapeutics for cancer treatment -

ROCKVILLE, Md.--(BUSINESS WIRE)--Hibiscus BioVentures, a firm committed to building patient-focused companies around transformative technologies, today announced it has entered into a partnership agreement with the Detroit-based Barbara Ann Karmanos Cancer Institute (Karmanos). This partnership between Hibiscus’ venture studio, Hibiscus BioTechnology, and Karmanos seeks to leverage the combined resources of the two organizations to develop innovative therapeutics for the treatment of cancer. Karmanos is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country.

The U.S. Economic Development Administration announced last month the winners of $500,000 planning grants to 60 jurisdictions across the country for the $1 billion Build Back Better Regional Challenge. Winners of Phase 2 Build Back Better will be eligible for federal grants of up to $100M to create new science and technology parks and districts, accelerators, and other technology infrastructure across the country.

Funding for the technology infrastructure must go to a nonprofit, such as a university, but the nonprofit will need the commercial real estate industry to design, build and manage this technology infrastructure.

The District of Columbia/Maryland/Virginia (DMV) region submitted some very good bids, including ones in quantum technology, biotechnology, advanced manufacturing, and other topics but only Howard County for cyber security, Richmond, Virginia in bio manufacturing, and rural Southwest Virginia in transportation logistics won planning grants.

GAITHERSBURG, Md., Jan. 05, 2022 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced the formation of its Autoimmune and Infectious Disease Scientific Advisory Board (AI & ID SAB). The AI & ID SAB is comprised of distinguished academic and industry leaders in the fields of autoimmune and infectious diseases, translational research, immunology and T cell biology.

“As we continue to advance our AIM nanotechnology platform, we are grateful to have the input and guidance of these established experts,” said Jerry Zeldis, NexImmune’s EVP of R&D. “Their combined experience in autoimmune and infectious diseases, translational science and clinical development will help make informed decisions as we expand our pipeline and explore new therapeutic areas.”

ROCKVILLE, Maryland – January 6, 2022 South Duvall today announced that it has submitted construction plans for permit to bring 45,000 square feet of lab space to 1450 Research Boulevard in Rockville, MD. South Duvall will renovate the façade, create new building amenities and common areas, and install brand-new mechanical, electrical, and plumbing systems. Three move-in ready lab spec suites ranging from 2,800 square feet to 3,700 square feet range are expected to deliver by the fourth quarter of 2022 with two full floors of roughly 15,000 square feet available for tenant fit out now. Leasing will be handled by Scheer Partners. “The submission of construction plans for our lab conversion of 1450 Research Boulevard begins our timeline to deliver much needed lab space to the I-270 corridor in 2022,” said Matthew Brown, director of acquisitions, South Duvall. “Our design team took lessons we have learned from other similar projects and developed an exciting plan to deliver a unique, best-in-class lab building.”  

DUBLIN--(BUSINESS WIRE)--Jan. 6, 2022-- Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. to be the first tenant at the Alexandria Center® at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will serve as the company’s primary East Coast research and development and technical operations hub. Construction at the 192,000-square-foot site is underway and Horizon expects to start work on interior improvements in 2023. Additional terms of the agreement were not disclosed.

ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ --

• Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector 
• Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose 
• cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202
• REGENXBIO expects to initiate trial in the first half of 2022

REGENXBIO Inc. (Nasdaq: RGNX) today announced the clearance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to evaluate RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne) in a first-in-human clinical trial. RGX-202 is designed to deliver a transgene for a novel microdystrophin 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. REGENXBIO plans to initiate the trial in the first half of 2022.

Maryland biotech company Zalgen Labs has moved to Frederick, illustrating the magnetism of the biotech hub for leaders like its own Dr. Luis Branco who want to capitalize on the new sense of collaboration the pandemic has brought about in life sciences companies in the region.

The move to Frederick puts Zalgen closer to the epicenter of what’s known as BioHealth Capital Region (BHCR) that encompasses Maryland, Virginia and DC. Frederick alone is home to over 80 biotech companies, according to the county’s Office of Economic Development.

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

Click here to read more via BioBuzz.

On this snowy start to 2022, I wanted to share with you two interviews with AHEAD100 Chief Scientist Dr. James Crowe that occurred over the last week on CNBC and Bloomberg TV. Each piece is a powerful continuation of our work to build awareness and support for the work of the Global Pandemic Prevention and Biodefense Center and lead initiative, AHEAD100 — and together, they garnered more than 100 million impressions, representing more than $1 million in advertising value equivalent.

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.

Download the Full Job Description.

Global health tech companies are queueing up for one of the world’s largest in-person events of the New Year- CES 2022. The global health tech event would showcase innovative ideas from over 2200+ exhibitors between 5 and 8 January in Las Vegas. CES 2022 will go forward as an important innovation for world health and safety, mobility and solving problems will be exhibited. Furthermore, thousands of smaller and medium-sized companies rely on CES for their business.

Image: https://aithority.com

Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against

Omicron (B.1.1.529) and other variants

Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose

Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January

Company to host investor conference call today from 4:30 – 5:00 pm ET

GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.

The University System of Maryland (USM) retained the Jacob France Institute of the University of Baltimore to prepare this update of the prior 2012 The Economic Impact of the University System of Maryland: A Fiscal Perspective FY2011 report. This analysis uses the Human Capital Approach to assess the system’s economic impact and State of Maryland’s return on its investment by assessing the incremental earnings impacts associated with four cohorts of USM graduates and the current impacts of out-of-state spending attracted to Maryland by the USM. The key findings of this analysis are as follows:

On Thursday, Governor Larry Hogan announced three key appointments in Maryland.

Former Maryland Secretary of Commerce Mike Gill has been named secretary of the Maryland Department of Commerce, succeeding Secretary Kelly Schulz.

Gill is chairman of Columbia-based Evergreen Advisors, which was his role prior to serving as Maryland’s secretary of commerce from 2015 to 2019. He has four decades of experience in business, which includes founding Hoyt Capital, an investment and advisory firm serving startups and growth companies. He served as a member of the University System of Maryland Board of Regents from 2004 to 2009.

Image: Photo of Maryland flag at Annapolis State House (WBFF)

Investment into biotech and health care boomed during the pandemic as thousands of venture capital firms turned their attention to breakthrough artificial intelligence, cancer-detection technology, mental health treatments, digital doctor visits, diagnostics and more. 

But two of those investment firms have emerged as major leaders, not only in the number of biotech funding rounds led, but also in overall dollars invested into the industry. Boston-based RA Capital Management and New York-based OrbiMed ranked first and second, respectively, on the two lists compiled using Crunchbase data. 

Image: https://news.crunchbase.com

Total research and development (R and D) expenditures at American colleges and universities topped $86 billion in Fiscal Year 2020, according to the most recent Higher Education Research and Development (HERD) Survey, released by the National Science Foundation (NSF) on Monday. The total represents an increase of $2.7 billion (3.3%) over FY 2019.

By Holden Wilen - Reporter December 23, 2021, 01:35pm EST Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.  

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.  

Pharmacy Times interviewed Ronald T. Piervincenzi, PhD, the CEO of US Pharmacopeia (USP), on reflections from 2021 and predictions for 2022.

The discussion is the seventh in a video series collaboration between Pharmacy Times and USP that highlights USP’s work to support the pharmacist and discussed USP’s perspective on timely and topical issues in the field.

Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.

Image: Personal Genome Diagnostics, or PGDx, which is based in Canton, is getting bought by life sciences giant Labcorp. Carley Milligan

As the omicron variant became the dominant strain in the U.S. this week, health care providers are left with fewer options to treat positive COVID-19 patients as most of the existing treatments have been found to be less effective in fighting off the new variant.

Up until recently, the U.S. Department of Health and Human Services (HHS) had been distributing three types of COVID-19 antibody treatments, Regeneron monoclonal antibodies, Eli Lilly’s antibody treatments and GlaxoSmithKline’s sotrovimab monoclonal antibody.

Please join us in welcoming our two newest members of the CLS Board of Directors!

• Vasiliki Anest,Ph.D: serves as Chief Innovation Officer for USC Norris Comprehensive Cancer Center

• Kwame Ulmer: is a venture partner at Wavemaker Three-Sixty Health

Their experience and backgrounds will be invaluable in supporting CLS’s goals to empower the life sciences ecosystem.

Image: https://www.linkedin.com/feed/update/urn:li:activity:6877654463474143232/

ROCKVILLE, MD. (PRWEB) DECEMBER 21, 2021 Data from the First Three Patients Shows Critical Efficacy Markers of the HIV Cure Cell Therapy: Engraftment, Persistence, and Maintained HIV-clearing Functionality of Infused Cells

American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached two important milestones for its HIV cure program.  

All three patients achieved engraftment of the genetically modified cell product, AGT103-T, and avoided rejection of the infused cells. In addition, patient samples were challenged to determine if their HIV-specific response remained active. All three products demonstrated an active response. These two studies confirm that the patients retained an appropriate concentration of the product and indicate AGT103-T should be able to create an effective immune response against HIV in the absence of antiretroviral treatment (ART).  

Located in the heart of Maryland’s Shady Grove Life Sciences Center, 9603 Medical Center Drive has efficient access to all points in Montgomery County via Route 355 and I-270 and is minutes to the Intercounty Connector (Route 200), which connects I-270 to I-95.

Click here for more information.

Since the beginning of the global pandemic, capital has flowed into the BioCapital Health Region. Billions of dollars from Operation Warp Speed, as well as private venture firms, have poured in to support startups, as well as companies focused on pandemic responses.

Image: Image / Pixabay  

Company's Third Major Acquisition Expands European Presence in Germany; Adds New Electronic Data Capture Tool to Enhance Real World Evidence Research

ROCKVILLE, Md., Dec. 21, 2021 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Institut Dr. Schauerte, a CRO headquartered in Munich, Germany.  Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies.  It has conducted more than 400 studies across a range of therapeutic areas. 

Three Johns Hopkins faculty members are among 164 creators or co-developers elected as fellows of the National Academy of Inventors, a distinction that recognizes the people behind the outstanding inventions that have made a difference for society. They join the more than 4,000 current fellows of the academy, which features members of more than 250 institutions worldwide.