Ceres Nanosciences Receives 6 5M NIH Award

MANASSAS, Va. — September 2, 2020 — Ceres Nanosciences, a privately held company that makes innovative products to improve diagnostic testing, announced it has been awarded a contract from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative. The contract, for  $6.5 million, will support an expansion to increase the manufacturing capacity of Ceres’ Nanotrap® Virus Particles for COVID-19 tests.

 

Cartesian Therapeutics Initiates Clinical Trial of First RNA Engineered Cell Therapy for Acute Respiratory Distress Syndrome and COVID 19 Cartesian

Gaithersburg, MD, September 1, 2020 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer, autoimmune diseases and respiratory diseases, today announced that it has initiated a Phase 1/2 clinical trial of its lead RNA-engineered mesenchymal stem cell (MSC) therapy, Descartes-30, in patients with moderate-to-severe ARDS, including that caused by COVID-19. Based upon the company’s research and analysis, this program is understood to be the first RNA-engineered cell therapy to enter clinical development for ARDS and COVID-19. It is also the first cell therapy to specifically degrade NETs, webs of extracellular DNA and histones that entrap inflammatory cells, block alveoli and vessels, and drive the pathogenesis of ARDS and COVID-19.

 

MicroGem Logo

CHARLOTTESVILLE, Va., Sept. 2, 2020 /PRNewswire/ -- MicroGEM today announced it has been awarded up to $40.9 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company's molecular diagnostic test that provides rapid, sensitive and specific identification of SARS-CoV-2 and influenza types A and B at the point-of-need.

MicroGEM's COVID-19 saliva test provides laboratory-quality results in 15 minutes, allowing non-medical personnel to obtain rapid, on-site detection of COVID-19 without a laboratory. The system detects SARS-CoV-2 in saliva, simultaneously with influenza types A and B, using real-time reverse transcriptase RT-PCR. Based on patented enzymatic RNA extraction technology, the system is a simple approach to quickly detecting and managing infectious disease.

 

American Gene Technologies Developing Gene And Cell Therapies

HIV therapies, typically cocktails of antiviral drugs, have proven to be very successful in controlling HIV/AIDS. However, they are not a “cure,” which is a very lofty goal. American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

 

emergent biosolutions

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it is teaming up with the Boston Red Sox, Cincinnati Reds, Philadelphia Phillies, and Mothers Against Prescription Drug Abuse (MAPDA) to highlight the importance of potentially lifesaving overdose reversal medicines on International Overdose Awareness Day 2020. International Overdose Awareness Day is a global event held on August 31 each year that aims to raise awareness of overdose and reduce the stigma of drug-related deaths. Emergent, in collaboration with these teams and MAPDA, will address the importance of accessing overdose reversal medicines through special announcements, videos, and stadium presentations.

 

J J BARDA pick 7 startups to back in fight against COVID 19 and beyond FierceBiotech

As the world scrambles to develop diagnostics, treatments and vaccines for COVID-19, one big question looms: How will we face the next pandemic? Johnson & Johnson and the U.S. Biomedical Advanced Research and Development Authority (BARDA) are teaming up once again to answer that.

Through a joint effort dubbed Blue Knight, the duo aims to boost innovation and “amplify” scientific and technological advancements to prepare for potential health threats—starting with COVID-19. They've picked seven startups from J&J’s global JLABS network to participate. The startups will receive up to $500,000 in support, as well as mentorship from BARDA and J&J to help them navigate R&D challenges and regulatory pathways and get medicines and tools to patients and healthcare workers as soon as possible.

Image: Startups chosen for the program may participate at JLABS locations in Washington, D.C., New York, San Diego or Toronto. If they don't need a physical location or lab space, they may participate virtually. (Johnson & Johnson)

GSK

Microbiology Team Leader - https://jobs.gsk.com/en-gb/jobs/241125?lang=it-it (we also have a video of the line manager talking about the role, if you can add it to the newsletter)

New Product Development Director – Voltaren - https://jobs.gsk.com/en-gb/jobs/251039?lang=en-us&previousLocale=en-GB  (we also have a line manager's video)

Senior Process Engineer - https://jobs.gsk.com/en-gb/jobs/258078?lang=en-us&previousLocale=en-GB

Vaccitech and Oxford University announce landmark partnership with AstraZeneca for the development and large scale distribution of the COVID 19 vaccine candidate Vaccitech

Vaccitech Ltd, a clinical-stage biopharmaceutical company developing immunotherapies to treat and prevent infectious diseases and cancer, announces that the development of AstraZeneca’s AZD1222 vaccine has expanded into a Phase III clinical trial in the US to assess its safety, efficacy and immunogenicity. AZD1222 was co-invented by Vaccitech and Oxford University’s Jenner Institute.

The US Phase III trial, called D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

 

money

Advances in science and technology can drive the next generation of skincare innovations.  Today, cutting edge dermatological research and technologies hold the potential to revolutionize pore minimizing and anti-aging solutions. 

To that end, Johnson & Johnson Innovation, Johnson & Johnson Consumer Inc., and Alibaba’s TMALL announce the Skincare of the Future QuickFire Challenge, calling on innovators to submit products, services and technologies aiming to help consumers tackle the world’s toughest skincare challenges, with a specific focus on pore minimizing and anti-aging solution. 

 

NewImage

TruGenomix recently announced $1.8 million in financing in a seed round led by Sanford Health. The startup, a graduate of the Illumina Accelerator program and a Veteran Founder Initiative company, also announced matching funding from Viking Global, a partner of the Illumina Accelerator.

As a veteran-owned business, TruGenomix’s founding mission of improving the lives of U.S. military service members and veterans remains at its roots. With a vision of bringing behavioral health into the 21st century, TruGenomix is advancing the diagnosis of post-traumatic stress disorder (PTSD) through leveraging genomic and machine learning technologies.

Image: https://fi.co

NobelPharma Logo

ROCKVILLE, Md. — Recognizing the benefits of proximity to leading U.S. researchers, regulators and advocacy groups, Nobelpharma America, LLC has chosen Montgomery County, Maryland as the location for its first overseas subsidiary of Nobelpharma Co. Ltd., a company headquartered in Tokyo, Japan. Nobelpharma’s company mission is to contribute to society by providing critical but neglected pharmaceuticals and medical devices. 

Nobelpharma meets an essential patient need: it develops curative drugs and medical devices for diseases that often go overlooked because of the small number of patients. Examples include patients suffering from tuberous sclerosis complex (TSC) and adductor spasmodic dysphonia.    

 

coronavirus

Vaccitech officials say the company received a U.K. government grant to support research with its next-generation technology platform to protect against COVID-19. The grant is part of the UKRI-NIHR COVID-19 rapid response rolling call for proposals with potential to deliver public health impacts within 12 months.

Preclinical data indicate Vaccitech’s new platform induces antibody and cell-mediated immune responses when compared with the adenoviral platforms currently in vaccine trials for COVID-19, according to Bill Enright, Vaccitech CEO. The preclinical data informed the decision of UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR), and other funders, including the World Health Organization (WHO), to support Vaccitech’s research efforts, he added.

 

NewImage

ROCKVILLE, Md., Sept. 1, 2020 /PRNewswire/ -- Emmes today announced that Jonathan DeCarlo has been promoted to chief financial officer.  DeCarlo, who has served as vice president and controller, is replacing Brian Hochheimer, who is retiring after 15 years at Emmes.

Dr. Anne Lindblad, president and chief executive officer, said, "Jon has been a key player in Emmes' growth and success. His technical skills, high levels of integrity and honesty, and vision, have earned the trust and respect from all those with whom he works.  We are thrilled to have him as our new chief financial officer. I am extremely confident Emmes will be in excellent hands under Jon's leadership."   

 

Immunomic Therapeutics Logo

ROCKVILLE, Md. & SAN DIEGO–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that results from multiple ATTAC clinical studies of dendritic cell vaccines have been published online by American Association for Cancer Research (AACR) in an article titled, “Once, Twice, Three Times a Finding: Reproducibility of Dendritic Cell Vaccine Trials Targeting Cytomegalovirus in Glioblastoma.”

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma (GBM), with leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells.

 

Michele and Rich

Economic Alliance of Greater Baltimore (EAGB), President and CEO, Michele L. Whelley, joins BioTalk to discuss her career, the economic development environment in Baltimore, and how to create a greater sense of partnership between perceived competing regions.

Listen now via Apple https://apple.co/2DikZfg, Google https://bit.ly/2Exq5oD , Spotify https://spoti.fi/31GmIUV, TuneIn https://bit.ly/32FjGQ5, and YouTube Audio https://bit.ly/31IwGFl.

Michele L. Whelley, President & CEO, is an economic development professional who is well-known throughout the region’s business community, Whelley brings new energy and focus to marketing the region, ensuring that EAGB will continue to strengthen its marketing platform as a critical component of fostering and supporting a vibrant and growing economy throughout the Greater Baltimore region.  
 

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Don't miss your chance to be named the BioHealth Startup with the Most Commercial Potential at the BHCR Forum, win $10,000 and more!

CONSIDERATIONS:

  • Technical Feasibility and IP
  • Commercialization and Marketing Strategy
  • Leadership Team and Collaborations
  • Funding to Date and Financial Projections

CRITERIA:

  • Demonstrated Proof of Concept/MVP
  • Have received funding (dilutive/nondilutive)
  • Understand regulatory and reimbursement hurdles
  • A clear path to market and scalable

PREVIOUS WINNERS:

Sonavex

LifeSprout

Galen Robotics

Floreo

 

Applications due: 9/15

Finalists notified by: 10/2

Mandatory presenter coaching for finalists: 10/7

RE Biotech Games jtk delmarvagroup com Delmarva Group LLC Mail

Are you seeking an opportunity to engage your firm in a fun community-building activity?  Register one or more teams for the FRAXA Biotech Games.  The BioHealth Capital Region has been challenged by other clusters to demonstrate the greatest knowledge of biotech trivia. Proceeds benefit FRAXA Research Foundation, supporting Fragile X research projects at institutions around the world, including MIT, Harvard, Stanford and UCSD. Fragile X is the most common inherited cause of autism and intellectual disabilities.  BioHealth Innovation (BHI) is hosting the BioHealth Capital Region (Maryland, DC, and Virginia)’s participation in this exciting new event.   

Register one team or multiple teams this month to compete for the Cup in September!

 

 
OS Therapies Logo

CAMBRIDGE, Md. and LONDON, Aug. 26, 2020 (GLOBE NEWSWIRE) -- OS Therapies, and late-stage clinical research biotechnology company focused on Osteosarcoma and other solid tumors today announced the co-exclusive licensing of BlinkBio’s novel Si-Linker and Cassette Payload technologies, and exclusive licensing of the BlinkBio technology to target Folate Receptor Alpha (FRα) for tumors and other targeted diseases.

 

Novavax Logo

GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax’ COVID-19 vaccine.

“We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world.”

 

Arcellx Logo

GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Arcellx today announced the award of an EvansMDS Discovery Research Grant to Johns Hopkins University to support development of an Arcellx ARC-sparX therapy in the treatment of high-risk myelodysplastic syndromes (MDS). The collaborative effort, led by Amy E. DeZern, M.D., at the Johns Hopkins University School of Medicine, aims to advance development of ACLX-002, an immune cell therapy candidate directed at the therapeutic target CD123. The collaboration includes research to be conducted by Craig Jordan, Ph.D., of the University of Colorado School of Medicine, and materials and expertise to be contributed by Arcellx.

 

RegenXBio Logo

ROCKVILLE, Md., Aug. 25, 2020 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the clearance of the Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate the suprachoroidal delivery of RGX-314 in patients with diabetic retinopathy (DR). The IND is active, and REGENXBIO plans to begin dosing patients in a Phase II trial, ALTITUDE, in the second half of 2020.

 

Catalent Logo

(Reuters) - Catalent Inc said on Monday its Maryland facility would make the drug substance used in the COVID-19 vaccine being developed by AstraZeneca Plc and the University of Oxford, starting “late in the third quarter” this year.

The New Jersey-based company said the drug substance will be made at its commercial gene therapy manufacturing facility in Harmans.

Catalent would supply the so-called viral vector, which is a genetically modified harmless virus designed to trick the human body into producing certain parts of the coronavirus. These proteins, in turn, prompt the immune system to develop an arsenal for any real COVID-19 infections.

 

Qiagen Logo

Qiagen has announced plans to launch a new digital test for COVID-19 antibodies that can run multiple samples at once on a small portable device and deliver results in about 10 minutes. 

With a small digital hub and interchangeable testing stick system, the eHub was developed for use against the novel coronavirus in collaboration with Australian diagnostic developer Ellume. The device can process up to eight samples simultaneously, or up to 32 tests per hour, to detect the presence of IgA, IgM or IgG antibodies in plasma or serum.

 

emergent biosolutions

GAITHERSBURG, Md., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the company’s board of directors appointed Marvin L. White as a Class II director to serve on the board effective October 1, 2020, with an initial term expiring at the 2023 annual meeting of stockholders. Mr. White was also appointed as a member of both the Scientific Review Committee and Strategic Operations Committee of the board.

 

Catalent Logo

SOMERSET, N.J. – Aug 24, 2020 — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.

 

BHCR Forum Save the Date 08242020 pdf 1 page

This invitation-only event is free for executive level biotech leaders and is presented by the Association of University Research Parks, AstraZeneca, BioHealth Innovation, Children’s National Health System, Emergent BioSolutions, George Mason University, J.P. Morgan, Johns Hopkins University, Maryland Department of Commerce, Virginia Bio, and Wilson Sonsini Goodrich & Rosati, P.C.

Maryland, Virginia, and Washington, DC set the bar high for biotech innovation. So please join us for our 6th Annual BioHealth Capital Region Forum that will highlight the accomplishments of today and chart our successes of tomorrow.

We are excited to bring you an exceptional line up of speakers to this virtual event!

*Please note that attendees’ name might be recorded if participating in the chat function during the event.

From left, Secret Chord Laboratories founders Scott Miles, David Rosen and Robert Abelow will be participating in the third 757 Accelerate startup program. Due to the coronavirus pandemic, the program will be switching to operating virtually this year. (Courtesy photo)

Imagine being able to use science to choose the right music for an advertising campaign or being able to order food and groceries on a military base from a veteran-owned small business.

Hampton Roads startups are bringing these ideas and more to this year’s 757 Accelerate program. In the midst of a global pandemic, the region’s startup accelerator is moving its entire program online and implementing a new abridged program for three more area startups.

Image: From left, Secret Chord Laboratories founders Scott Miles, David Rosen and Robert Abelow will be participating in the third 757 Accelerate startup program. Due to the coronavirus pandemic, the program will be switching to operating virtually this year. (Courtesy photo)

Coronavirus has challenged the region's businesses to step up.
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Coronavirus made 2020 the year of the pivot.

But the D.C.-area ventures having real, direct impact on the Covid-19 crisis have done more than tweak their business models; they’re innovating, persevering and committing to getting us through the pandemic in one piece.

They’re laying groundwork and executing on plans to tackle the disease. They’re developing resources and launching initiatives to serve our communities, as we grapple with dangerous and disruptive ripple effects born from the public health emergency. They’re conducting research, donating dollars and delivering on their promises, all with one goal: to push through this period and make life easier in the interim, and thereafter.

Image: Coronavirus has challenged the region's businesses to step up. fpm - https://www.bizjournals.com

Peter Meath

In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has transformed the way people usually do business in the sector. 

Image: Peter Meath - https://medcitynews.com

Western lowland gorilla (Trisha Shears/FreeImages)

Humans are not the only species facing a potential threat from SARS-CoV-2, according to the results of a study by an international scientific team headed by researchers at the University of California, Davis (UC Davis). Using genomic analysis to compare the amino acids of a key part of the ACE2 protein that is used by SARS-CoV-2 to gain entry into human cells, with those of the ACE2 protein in more than 400 other animals, the team found it feasible that many different species, including some, like the Western lowland gorilla, which are highly endangered, could potentially be infected by the virus.

Image: Western lowland gorilla (Trisha Shears/FreeImages)

Silhouette Photography Of Boat On Water during Sunset Free Stock Photo

The United States aims to invest $765 million over the next 5 years in a dozen scientific centers dedicated to the study of artificial intelligence (AI) and quantum information science (QIS), such as quantum computing, the White House announced today. Numerous private tech companies such as IBM, Google, and Intel will also contribute to the twin pushes, which call for a total of more than $1 billion in research investment.

 

NIH Logo

The US National Institutes of Health (NIH) is one of the largest early stage life sciences investors, and funds over $1B in awards each year through its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programmes, according to NIH representatives who spoke at the “Key Role of NIH in the Product Development Pipeline” panel session at the Biotechnology Innovation Organization (BIO) Digital International Convention on 9 June.