The delta variant spreads much faster than other Covid-19 strains—and scientists may now know why.

People infected with the delta variant have more than 1,260 times the viral load—the concentration of viral particles in the body—than those with the original strain found in China, a group of scientists has reported in a preprint paper. A higher viral load can have many implications such as more severe disease. Its most significant contribution is to a virus’s higher transmissibility.

Image: https://qz.com

ROCKVILLE, Md. and CHESTERBROOK, Pa., July 26, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for immunologic, immuno-oncologic and rare genetic disorders, today announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate to severe Crohn's disease (CD). Crohn’s disease is a disorder affecting as many as 780,000 people in the United States.

Each quarter we bring you an update from our Johnson & Johnson Innovation – JLABS Portfolio of  ompanies across our 13 sites, from San Diego to Shanghai. Beyond news of our companies milestones, we also report on the diversity of our JLABS Portfolio leadership as we seek to reflect the patients we serve.

This past quarter JLABS @ Washington, DC opened its doors and welcomed the inaugural class of residents with areas of focus ranging from health equity to broad-spectrum antivirals. Housed at the new Children's National Research & Innovation Campus, JLABS @ Washington, DC also serves as the BLUE KNIGHT™ hub in collaboration with the Biomedical Advanced Research and Development Authority (BARDA). You can read more about our newest site in Fierce Biotech and you can always find our latest stats and companies via our JLABS Portfolio Navigator. Finally, don't forget to register to virtually join the JLABS @ Washington, DC Grand Opening celebration on September 22!

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it has appointed Steve Sang Young Park and Robert V. Ahlgren as new members to its Board of Directors, expanding the board to eight members.

“We are pleased to welcome Steve and Robert to Immunomic’s Board. Our scientific platform, financial acumen and growth strategies are strengthened by their wealth of knowledge and leadership experience,” commented Dr. William Hearl, CEO of ITI. “Each brings deep and diverse expertise across global financial markets and large healthcare companies that will be meaningful to us as we advance our immunotherapy pipeline and strategic vision.”

George Mason University bioengineering professor Michael Buschmann and a team of scientific collaborators have devised improved lipid nanoparticle  technologies to deliver mRNA that could make mRNA vaccines such as the COVID-19 vaccines less costly, with fewer side-effects and more available worldwide.

Image: Michael Buschmann (seated) and his team that includes (l to r) Aarthi Narayanan, Mikell Paige and Caroline Hoemann have developed improved technology that could help make COVID-19 vaccines better and more readily available. Not pictured: Pat Gillevet. Photo by Evan Cantwell/Creative Services 

A large interlaboratory study of adeno-associated virus (AAV), an important tool in gene therapy, will be led by USP and NIST in collaboration with NIIMBL.

Rockville, MD, July 27, 2021 —The United States Pharmacopeia (USP), the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) and The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) have announced a research collaboration to assess analytical methods and develop standards for adeno-associated virus (AAV), an important mechanism for delivering gene therapies.

AAVs are particularly useful for gene therapies because they are not known to cause human disease and cannot replicate on their own. AAV-based therapies are currently used to treat a type of inherited retinal dystrophy that causes blindness and spinal muscular atrophy in children, and treatments for many more diseases are currently being developed. However, to use AAVs most effectively, scientists need to accurately measure attributes related to their quality. These attributes include the purity of the AAV product and the relative number of virus particles that contain the full genetic payload.

GAITHERSBURG, Md., July 26, 2021 /PRNewswire/ -- MaxCyte, Inc., (LSE: MXCT) (LSE: MXCN), a leading provider of platform technologies for cell engineering, today announced the commencement of an underwritten offering of 12,000,000 shares of common stock (the "Offering") at an expected offering price between $11.50 and $13.50 per share. All shares to be sold in the Offering will be offered by MaxCyte. In addition, MaxCyte intends to grant the underwriters a 30-day option to purchase up to 1,800,000 additional shares of common stock.

Jeff Boyle, President of Ellume USA, joins Rich Bendis on BioTalk to chat about his history, their Flagship U.S. Manufacturing Facility in Frederick, MD, and why BioHealth Capital Region is a right fit for their company goals.

Listen now on Google https://bit.ly/3i0XFUO, Apple https://apple.co/2TDD1kg, Spotify https://spoti.fi/3kWwP1P, and TuneIn https://bit.ly/3BGPDrP

The US National Institutes of Health (NIH) are the largest public supporter of basic life science in the world.

With an FY2020 budget of $42 billion, most of their expenditures are university grants supporting either new discoveries or early-state clinical studies of promising treatments and diagnostic tests.

Since 1982, Congress has mandated that a fraction of the total annual NIH budget be put to work via grants or contracts to small life science and biotech companies rather than academic institutions.

Image: Photo by National Cancer Institute on Unsplash

German-based BioNTech has announced that it will soon be joining Montgomery County’s growing list of world-renowned international companies in the “Immunology Capital Next to the Nation’s Capital.” BioNTech is acquiring a Gaithersburg manufacturing facility and cell therapy research and development platform from Kite, a unit of Gilead Sciences, to support the development of BioNTech’s expanding pipeline of novel cell therapies.

The Endless Frontier bill, now incorporated into the U.S. Innovation and Competition Act, made progress in the U.S. Senate while parallel legislation in the House also advanced to create a Technology Directorate in the NSF. Congress and the Administration also advanced through the budget process and other Congressionally authorization bills billions of dollars to create new tech hubs, advanced manufacturing, increased tech transfer, test beds, and applied research. Collectively this is one of the largest investments in applied research and tech based economic development undertaken by the federal government.

You have invested the time, expertise, and financial resources to develop a therapy that changes patient lives for the better. After all of your hard work and dedication, how can you ensure your product reaches patients? What are the key commercialization considerations for healthcare innovators, large and small? Learn how to unlock product potential in this step-by-step guide to making the most of your commercialization investments.

Matan Companies breaks ground on Progress Labs at Riverside I The City-based project will feature 215,000 square feet of biomanufacturing-ready space -- including a 96,000 square foot existing building, which is available for immediate occupancy, as well as a 118,000 square foot expansion building, which will be delivered in June 2022.

ROCKVILLE, MD, July 15, 2021 /Globe Newswire/ -- American Gene Technologies (AGT) announced today that the Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV cure program without modification, after safety analysis of the participant’s data revealed no adverse effects from the treatment. AGT’s Phase 1 trial of AGT103-T, a new cell and gene therapy for HIV disease, is designed to induce durable viral suppression by delivering therapeutic genes to the recipient's immune cells. The cells are collected by leukapheresis, modified outside the body, then re-infused. Once infused, the cells are expected to durably suppress the virus at undetectable levels without the need for antiretroviral treatment.

Image: https://www.americangene.com

The extension follows a tumultuous time for the Gaithersburg company, making it unclear if the government would proceed with deals as normal.

The German firm hopes to expand its cancer treatments with the purchase.

Image: BioNTech is buying a Gaithersburg manufacturing facility on Clopper Road from Kite Pharma. GOOGLE STREET VIEW

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields. The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert”. Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

MAINZ, Germany & SANTA MONICA, Calif.–(BUSINESS WIRE)–BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Kite, a Gilead Company (Nasdaq: GILD, “Kite”) today announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, MD. The acquired Gaithersburg facility will provide production capacity to support clinical trials in the United States and will complement BioNTech’s existing cell therapy manufacturing facility in Idar-Oberstein, Germany. The facility will support the development of BioNTech’s expanding pipeline of novel cell therapies, including cancer product candidates based on its CAR-T Cell amplifying mRNA vaccine (CARVac) and NEOSTIM platforms as well as the newly acquired individualized neoantigen TCR program.

Image: https://biobuzz.io

Montgomery County is set to consider plans for the first phase of a five-building life sciences project in Rockville. 

An affiliate of life sciences giant Alexandria Real Estate Equities filed plans for a 200K SF research and development building as part of an 18-acre project on Darnestown Road. The Montgomery County Planning Board is scheduled to hear the plans on July 29. 

Image: Montgomery County Planning Department A rendering of the 200K SF lab building on Darnestown Road in Rockville.

The biomedical research ecosystem has delivered advances that not long ago would have been inconceivable, exemplified by highly effective COVID-19 vaccines developed by global partners and approved in less than a year. The United States stands at a moment of unprecedented scientific promise and is challenged to ask: What more can we do to accelerate the pace of break-throughs to transform medicine and health? Toward that end, President Biden recently proposed to create a new entity, the Advanced Research Projects Agency for Health (ARPA-H), within the National Institutes of Health (NIH) “to develop breakthroughs—to prevent, detect, and treat diseases like Alzheimer’s, diabetes, and cancer,” requesting $6.5 billion in the fiscal year 2022 budget.

Come join the Virginia Tech Corporate Research Center for Game Changer Week! Game Changer Week, set for August 23-27, 2021 will bring together industry disruptors, entrepreneurs, innovators, and researchers for a variety of online and in-person events. Events include webinars, happy hours, start-up mentoring, special guests, open houses, and more!

SUZHOU, China, and ROCKVILLE, Md., July 19, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the company has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of National Institutes of Health, under which they will collaborate on the non-clinical and clinical development of Ascentage Pharma's drug compound pelcitoclax.

The Data Safety and Monitoring Board has met and evaluated the safety data from the first participant treated with AGT103-T, our HIV-cure drug candidate. The participant experienced no significant adverse events, and the DSMB voted unanimously to "continue the study with no modification".

AGT is now a clinical-stage biotech company with initial safety data on a potential cure for a disease affecting over 1.2 million people in the U.S. and nearly 40 million people globally!

On a sweltering June morning, Novavax CEO and COVID vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland’s governor.

Erck was with Gov. Larry Hogan to announce Novavax’s global vaccine headquarters ― a Gaithersburg campus expected to house laboratories and more than 800 employees. Hogan called Novavax’s future “bright” and crowed that more than 71% of the state’s adults had received at least one shot.

Image: https://www.baltimoresun.com - From Video

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the U.S. Pharmacopeia (USP) since February 2014. USP is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements, and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 150 countries.

Image: Ronald Piervincenzi, CEO of U.S. Pharmacopeia

President Biden will nominate Laurie E. Locascio to lead the federal agency in charge of promoting innovation and technology, the National Institute of Standards and Technology.

Driving the news: Biden will name Locascio, currently vice president for research at the University of Maryland, as Undersecretary for Standards and Technology at the Department of Commerce.

Image: https://news.yahoo.com

GlaxoSmithKline (GSK) has plans to open an approximately $549m (£400m) biotechnology campus in Stevenage, UK, which would possibly create up to 5,000 skilled jobs in the coming five to ten years.

The plan for the new hub was developed in collaboration with Stevenage Bioscience Catalyst (SBC), the UK Government, Stevenage Borough Council and the Local Enterprise Partnership.

Image: GSK’s R&D site in Stevenage, UK. Credit: GSK / Flickr.

Venture capital totals for D.C. area companies got off to a strong start in 2021, and they’re continuing to rise with a new record high through the halfway point of the year.

In the second quarter of 2021, companies in the metro area collectively raised $1.27 billion across 72 deals, according to data from the PitchBook-NVCA Venture Monitor, a quarterly report produced by PitchBook and the National Venture Capital Association with support from Silicon Valley Bank.

Image: Venture capital. ((Photo by Flickr user, used via a Creative Commons license))

Until recently, biotech companies tended to be founded with a focus on a single technology or biological pathway. An early exemplar of this was Genentech, founded in 1976 on the promise of recombinant DNA to generate proteins relevant for human health.1 Proof of concept came with the production of the hormone somatostatin in 1977, and the company made its synthetic insulin breakthrough in 1978, alleviating the need to harvest the protein from animal pancreases.

The news: Johns Hopkins spinoff Bayesian Health has $15 million in VC backing to offer an AI-based clinical decision support platform designed to make health systems’ electronic health records (EHRs) more predictive.

Here’s how it works: The system analyzes EHR-collected patient data and sends providers real-time clinical signals when a critical moment is detected. It targets high-priority areas such as clinical deterioration, sepsis, pressure injury, and transitions of care.

FREDERICK, Md., July 15, 2021 /PRNewswire-PRWeb/ -- Beckham Gumbin Ventures (BGV), a commercial real estate investor and developer, is beginning construction on brand new R&D laboratory spec suites and amenities at Ballenger Bio (321 Ballenger Center Drive) in Frederick, Maryland. Ballenger Bio will offer several 3,000 to 7,000 SF R&D laboratory spec suites, with the ability to combine up to 37,000 SF of contiguous space on a single floor. Building such spec labs will allow for growing biotech companies to focus on their business as opposed to construction costs and timelines.

DNA-modified cells can behave unpredictably in the body and there is a risk that they could proliferate uncontrolled, cause severe toxicities, and even survive unchecked for months or years. Cartesian uses its platform technology to engineer RNA into cells, making time-controlled changes. The company is developing treatments for cancer, respiratory conditions, and autoimmune diseases such as myasthenia gravis. We spoke to Murat Kalayoglu, president and CEO of Cartesian, about its RNA-engineered cell therapies, how they work and how the company is pushing the use of cell therapies beyond cancer.

Image: https://globalgenes.org

If you are interested in pediatric medical device innovation or alternative solutions to surgery such as focused ultrasound, these two topics will merge at the Pediatric Device Innovators Forum, July 22, from 2 – 3:30 p.m. This free livestream event, hosted by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), features clinical, regulatory and reimbursement experts discussing the topic “Focused Ultrasound for Pediatric Indications.”

Image: https://medcitynews.com

Montgomery County, Maryland, home of the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and more than 480 life sciences companies, continues its momentum as a magnet for new life sciences development with a major surge in leasing and investment. With rising demand and just 5.2% availability for the county’s existing lab space, an additional 1.6 million square feet (SF) of lab space is in development—joining the current 10.6 million SF of total lab inventory already in Montgomery County. 

In May 2021, American Gene Technologies (AGT), a clinical-stage biotechnology company, announced the treatment of the first participant in its Phase I clinical trial to evaluate the safety of the cell and gene therapy product AGT103-T. Designated as the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), participants are infused once with their own CD4 T cells that were enriched, for cells capable of reacting to HIV, and genetically modified to resist infection. This is a first-in-human study for AGT103-T. The primary endpoint is safety; testing related to secondary endpoints evaluates responses to treatment including changes in the immune response to HIV. This video explains AGT's research and HIV cure program strategy.

https://www.youtube.com/watch?v=fiA2s7JCkJ8