WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD. This strategic move by 424 Capital aims to expedite positive clinical outcomes by enabling pharmaceutical and biotechnology organizations to focus on the research, development, and production of cutting-edge therapeutics in a compliant and effective manner.

Founded in 2001 by CEO Bill Robertson, VaLogic provides a comprehensive range of software and compliance services to the life science and biotechnology market. These services help organizations and facilities maintain GMP compliance and enact high standards while focusing on advancing life-saving therapeutics.

VaLogic offers advisory and facility design, full commissioning and qualification, cleanroom environmental monitoring, HEPA/cleanroom certifications, calibration, preventative maintenance, and a proprietary SaaS software called LogiPoint™ for continuous monitoring of critical facilities and equipment.

Richard Hughen’s thirty years of professional medical device experience spans three Fortune 500 and four start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up developing a novel continuous predictive respiratory monitoring device for the patient bedside and home. Ric was an investor and member of the executive team that built start-up CSA Medical, from a technology license (Navy) through product development, animal trials, clinical trials, five FDA clearances, CE mark, three rounds of funding ($50M), commercial growth and a 2019 sale to Steris. Ric was Managing Director of LearnWare, a life science focused e-learning start-up, which was successfully built and sold to a private equity fund.

He is currently a reviewer for the National Science Foundation’s SBIR/STTR program, an Entrepreneur in Residence for Johns Hopkins Tech Ventures and on the advisory board for George Mason University’s Bioengineering Alliance. He is founder of Life Science Planning, a strategic consultancy for life science companies with focus on fast paced start-up, early stage and emerging growth companies. Earlier in his career, Ric led various senior management, marketing, training and sales teams for Johnson & Johnson, BD, Abbott and Cordis. Ric holds MBA and BS degrees from The Pennsylvania State University. When not working, he is typically outside training for triathlon competition.

LEIDEN, the Netherlands, November 29, 2023 / B3C newswire / -- MIMETAS, a leader in human 3D disease modeling, and Yamaha Motor Co., Ltd., a developer of the CELL HANDLER™, announce a strategic joint marketing agreement aimed at advancing therapeutic development using human-relevant models throughout the early drug development pipeline. The collaboration combines MIMETAS’ comprehensive disease modeling and assay development expertise with Yamaha Motor's state-of-the-art CELL HANDLER, an automated system for selecting, picking and imaging spheroids, tissues and organoids.

Bas Trietsch, CTO of MIMETAS, emphasized the significance of this collaboration, stating, “Introducing patient-relevant 3D disease models into the drug development pipeline is key to developing new therapeutics for unsolved diseases. However, most of these models lack a vascular system and integrated immune cells, which are critical for studying disease processes and therapy efficacy. One of the primary challenges with complex biological models lies in the variability of growth rate and morphology, making high-throughput, robust assays challenging and time consuming. To address these challenges, state-of-the-art automation, such as the Yamaha Cell Handler, is critical.”  “By combining our technologies, we will improve the quality and robustness of tissue model applications in high-throughput,” said K. Matsuno, General Manager of Medical Device Business Division of Yamaha Motor.  “Together, we can make advanced 3D human disease models suitable for all stages of early drug development.”

ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE^® trial. RGX-202 is an investigational one-time AAV Therapeutic for Duchenne muscular dystrophy (Duchenne), using the NAV^® AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle-specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.

"Progressing to dose level 2 is an important milestone in our updated strategic plans and for accelerating the development of RGX-202," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "There is a large unmet need for new therapies for boys with Duchenne, and the market is capable of supporting multiple gene therapies. We believe RGX-202 has unique, differentiating features that support its potential to be a best-in-class product."

GAITHERSBURG, Md., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

BioHealth Innovation is thrilled to announce that our esteemed Entrepreneur-in-Residence, Kwame Ulmer, has been recognized by Quroba for his outstanding contributions to the MedTech industry. This recognition is a testament to Kwame's exceptional journey and his relentless pursuit of innovation in healthcare technology.

From Quroba's Post:

"This month, we're honored to shine the spotlight on a true industry luminary, our very own Kwame Ulmer.

With two decades of experience in evaluating medical technologies across both government and private sectors, Kwame's expertise is nothing short of exceptional.

COLUMBIA, Md. (November 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Social Impact Funds investment into NasaClip.

“Nosebleeds are common, and often don’t require medical intervention. In fact, with emergency treatment many patients end up walking out of the hospital later than anticipated and in more pain than when they entered,” said Dr. Elizabeth Clayborne, CEO and founder of NasaClip. “Thanks to TEDCO’s investment we can continue our efforts to provide a more timely, efficient and cost-effective solution for patients, allowing them to get treated from the comfort of their own homes.”

As the year 2023 comes to a close, CarrTech Corp has demonstrated remarkable progress and innovation in the biotechnology and medical device sectors. The company has achieved several milestones, engaged in significant collaborations, and is poised for further advancements in the coming year. Here are some of the key highlights from CarrTech Corp's journey over the past year:

GRAND RAPIDS, Mich., Nov. 27, 2023 /PRNewswire/ -- cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage medical device companies with innovative technologies, announced today that they have made a significant investment into Nanochon, a Washington, D.C.—based regenerative cartilage innovator.  

Nanochon develops solutions utilized by sports medicine physicians to treat active patients requiring cartilage restoration.  Nanochon's Chondrograft™ replaces lost or damaged cartilage and encourages new growth using an innovative material and 3D printed designs that are cost-effective and easy to deploy treatment options.

What is the dynamic synergy between pioneering science and transformative industry developments? Join us in this episode of BioTalk with Rich Bendis for a thought-provoking conversation about the work of Blackbird Laboratories. Our guest, Matt Tremblay, Ph.D., Chief Executive Officer of Blackbird Laboratories, sheds light on their role in fostering innovation within the vibrant BioHealth community of Baltimore and the wider BioHealth Capital Region.

Blackbird Laboratories recently launched with a significant $100 million founding grant from The Stephen and Renee Bisciotti Foundation. This significant investment aims to bridge the gap between academic research and industry innovation, catalyzing the development of innovative companies, groundbreaking technologies, and a thriving entrepreneurial ecosystem in Baltimore, Maryland. They provide crucial support, including capital, program management, and strategic scientific and business insights, to drive the growth of the BioHealth industry. Their team of seasoned life sciences professionals operates on a value-driven model, committed to reducing the risk of groundbreaking technology for commercialization, attracting crucial investments, nurturing start-ups, and cultivating meaningful public-private partnerships. Their vision is grounded in promoting a thriving ecosystem in Baltimore that will contribute significantly to the growth of the BioHealth sector in the region.

BETHESDA, Md., Nov. 24, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (“Gain” or the “Company”) (Nasdaq: GANX) today announced the closing of an underwritten public offering of 2,545,000 shares of its common stock and warrants to purchase up to an aggregate of 1,272,500 shares of its common stock at a combined public offering price of $2.005 per share and accompanying warrant, including 331,956 shares of common stock and warrants to purchase 165,978 shares of common stock issued pursuant to the full exercise by the underwriter of its over-allotment option. The public offering price for each set of two shares of common stock and accompanying warrant to purchase one share of common stock was $4.01 per set of securities, yielding an effective price of $2.00 per share and $0.01 per warrant. The warrants were sold at the rate of one warrant for every two shares of common stock. The warrants have an exercise price of $2.75 per share, are exercisable immediately, and will expire five years following the date of issuance.

Are you navigating the complex terrain of healthcare innovation? The National Institutes of Health (NIH) offers a powerful tool to guide your journey: the TABA Needs Assessment Report. This complimentary, unbiased report is a game-changer for companies in the critical Phase I of their projects.

What Does the Report Offer?

The TABA Needs Assessment Report is a comprehensive evaluation tool that scrutinizes four pivotal areas:

1. Intellectual Property and Market Entry: It assesses your project's intellectual property and potential barriers to entering the market.
2. Market Positioning: The report evaluates your project's standing in the competitive healthcare landscape.
3. Regulatory and Clinical Strategies: It reviews your plans in regulatory compliance, manufacturing, and clinical trials.
4. Business Model Analysis: The report delves into the profitability and sustainability of your business model.

LOWER GWYNEDD, Penn.--(BUSINESS WIRE)--ChromaTan, Inc., a bioprocess development company revolutionizing the 123-year-old traditional batch biopurification process through transformational next-generation biomanufacturing solutions, announced today that it has been selected as a BLUE KNIGHT™ company.

Are you ready to explore the transformative world of MedTech and its profound impact on healthcare? Join us in this episode of BioTalk with Rich Bendis as we dive deep into medical technology with an exceptional guest, Neal Piper, Founder & CEO of Luminoah, winner of the 8th Annual BioHealth Capital Region Crab Trap. Neal Piper is the visionary behind Luminoah, a cutting-edge MedTech company dedicated to enhancing the lives of enteral nutrition patients through innovative hardware and software systems. With a background steeped in healthcare, Neal's journey from Pfizer's Neuroscience Division to his role as President of the Global Health Fellows Alumni Business Network has uniquely positioned him to drive change in the industry. But what inspired Neal to create Luminoah? In 2019, his family received a cancer diagnosis for their 3-year-old son, leading to a new reality and a pressing need for a better nutritional feeding program. Neal recognized the challenges faced by patients and caregivers, from bulky equipment to limited data sharing with physicians. That's when Luminoah was born.

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Today, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the 17^th Director of the National Cancer Institute (NCI), the federal government’s principal agency for cancer research and training and the largest funder of cancer research in the world. Dr. W. Kimryn Rathmell is an accomplished physician-scientist and internationally recognized cancer expert who is well suited to lead the NCI during this critical time to achieve the goals the President set for the Biden Cancer Moonshot as part of his Unity Agenda. 
 
Statement from President Biden: “Dr. Rathmell is the talented and visionary leader the National Cancer Institute needs to drive us toward ending cancer as we know it.  Throughout her career, she has been committed to advancing discovery through scientific research, maintaining a steadfast commitment to caring for her patients, and demonstrating leadership in preparing the next generation of researchers. She embodies the promise of the Biden Cancer Moonshot and has spent her career driving toward the goals Jill and I set for the initiative, to improve outcomes and boost support for those facing a cancer diagnosis. The National Cancer Institute is central to the success of the Cancer Moonshot and Dr. Rathmell will lead the agency towards new ways to prevent, detect, and treat cancer and to ensure we reach more Americans with the tools we have to save and extend lives.”
 

MaxCyte continues supporting the advancement of novel therapeutics and looks to support education and advancement of mRNA medicines

ROCKVILLE, Md., Nov. 16, 2023 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced that it has joined the Alliance for mRNA Medicines (AMM), as a founding member. AMM is the leading global organization dedicated to advancing and advocating for mRNA and next-generation encoding RNA therapeutics and vaccines for the benefit of patients, public health and society. AMM’s mission is to propel the future of mRNA medicines, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists and other key stakeholders. MaxCyte is one of 31 founding members comprised of biotechnology, biopharma and life sciences companies and educational institutions. 

-- Arcellx to receive $200M equity investment at $61.68 per share and an $85 million upfront cash payment --

-- Kite exercises option to Arcellx's ARC-SparX program ACLX-001 in multiple myeloma --

-- The companies expand the scope of their existing collaboration for CART-ddBCMA to include lymphomas --

REDWOOD CITY, Calif. and SANTA MONICA, Calif., Nov. 15, 2023 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced that the companies have expanded their existing collaboration, which was originally announced in December 2022.

Kite has exercised its option to negotiate a license for Arcellx's ARC-SparX program, ACLX-001, in multiple myeloma, which is comprised of ARC-T cells and SparX proteins that target BCMA. The companies have also expanded the scope of the collaboration for Arcellx's CART-ddBCMA to include lymphomas.   

"Since entering into this strategic collaboration with Kite almost one year ago, we are thrilled with how the partnership is rapidly progressing and the alignment across our teams," said Rami Elghandour, Arcellx's Chairman and Chief Executive Officer. "Helping as many cancer patients as possible serves as the core of our collaboration. With the deep and durable responses demonstrated in our CART-ddBCMA Phase 1 trial in multiple myeloma, we believe that our novel synthetic binder, the D-Domain, underscores the potential to engineer a new class of CAR T therapies. We are excited to deepen our relationship with Kite as they continue to invest in our platform by exercising their rights to our ACLX-001 ARC-SparX program in multiple myeloma and increasing their investment in our company. With this additional investment from Kite, our strengthened cash position is anticipated to extend our runway into 2027, as we advance towards commercializing CART-ddBCMA. Additionally, as our partnership deepens, we continue to identify operational efficiencies and additional opportunities to collaborate which are also reflected in this agreement. Importantly, these efficiencies embody the trust developed with our Kite partners and do not alter the original agreement in principle or economics. We look forward to sharing data from our CART-ddBCMA Phase 1 trial at ASH in December."

WATERTOWN, Mass. and GAITHERSBURG, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Selecta Biosciences, Inc. (NASDAQ: SELB) (the Company) today announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases. In connection with the merger, Selecta announced a $60.25 million private financing led by Timothy A. Springer, Ph.D., member of the Selecta Board of Directors.

With the cash from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have over $110 million on hand to support the development of the Cartesian pipeline through the Phase 3 study of lead product candidate, Descartes-08, a potential first-in-class RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T) for the treatment of MG, as well as the advancement of additional RNA cell therapy programs.

Concurrent with the merger, the combined company has been renamed Cartesian Therapeutics, Inc. The Company’s Nasdaq ticker symbol will change to “RNAC” effective prior to the opening of trading tomorrow, November 14, 2023.

What are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI's SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI's efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

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• Apple: https://apple.co/40C6n0o
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Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI's vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

The hospital will advocate for the unique needs of children as part of nationwide network working to accelerate transformative health solutions

November 13, 2023 - Children’s National Hospital was selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H).

The Investor Catalyst Hub seeks to accelerate the commercialization of groundbreaking and accessible biomedical solutions. It uses an innovative hub-and-spoke model designed to reach a wide range of nonprofit organizations and Minority-Serving Institutions, with the aim of delivering scalable healthcare outcomes for all Americans.

“The needs of children often differ significantly from those of adults. This partnership reflects our commitment to advancing pediatric healthcare through innovation and making sure we’re addressing those needs effectively," said Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National. “Leveraging the strength of this hub-and-spoke model, we anticipate delivering transformative solutions to enhance the health and well-being of the patients and families we serve.”

ROCKVILLE, MARYLAND, November 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading organization dedicated to supporting and advancing the BioHealth industry, is pleased to announce the appointment of Dr. Eric S. Edwards, Co-founder and CEO of Phlow Corporation, to its Board of Directors. In addition, Donna J. Edmonds, CEO of BRAINBox Solutions, Inc., has been appointed as the new Vice Chair of the Board.

“We are incredibly excited to welcome Dr. Eric S. Edwards to our Board of Directors and to appoint Donna J. Edmonds as our new Vice Chair,” said Richard Bendis, BHI President and CEO. “Dr. Edwards' remarkable achievements in pharmaceutical innovation and his dedication to improving healthcare delivery are perfectly aligned with our mission at BHI. Similarly, Donna's extensive experience and proven leadership in the healthcare sector will be invaluable as we continue to drive forward our vision. Their appointments signify BHI's continued journey towards fostering a robust and dynamic BioHealth ecosystem in our region.”

Dr. Eric S. Edwards, currently the Co-founder and CEO of Phlow Corporation, brings a wealth of experience and innovation to BioHealth Innovation, Inc. (BHI). With a remarkable career spanning pharmaceuticals and healthcare, Dr. Edwards is at the forefront of securing the supply chain for critical essential medicines in America. His visionary leadership extends beyond Phlow, as he co-founded Kaléo, Inc., a pharmaceutical company dedicated to novel treatments for chronic and acute-care diseases.

The NHLBI is accepting applications for the I-Corps at NIH™ Program, which provides funding, mentoring, and networking opportunities to current Phase I SBIR/STTR awardees and Fast-Track awardees in the first phase of their award to help commercialize your promising biomedical technology. During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.   

Program benefits include:   

• Funding up to $55,000 to cover total program costs  
• Training from biotech sector experts  
• Expanding your professional network 
• Building the confidence and skills to create a comprehensive business model  
• Gaining years of entrepreneurial skills in a matter of week

All applications must be submitted through PAR-22-073 no later than November 15, 2023. Please note that the updated due dates for the FY2024 I-Corps at NIH™ cohorts may be found at NOT-OD-23-188. This cohort begins in March 2024. The sessions will be held virtually except for the in-person kickoff in Houston, TX, and the in-person closeout session in Bethesda, MD.

 For more information, contact Stephanie Davis, Small Business Program Coordinator (This email address is being protected from spambots. You need JavaScript enabled to view it.) or visit the I-Corps at NIH™ program website.  

US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on November 8 the third closing of its financing round, which secured investments from Sumitomo Mitsui Trust Bank, Limited, a new investor headquartered in Tokyo, and Mr. Robert G. Hisaoka, an existing investor in the US.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

GAITHERSBURG, Md., November 7, 2023 – Emergent (NYSE: EBS) has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the expansion of the indication for ACAM2000®, Smallpox (Vaccinia) Vaccine, Live to include immunization against mpox virus. The sBLA includes data from a well-controlled animal study in which ACAM2000® vaccine has been shown to be effective in protecting against mpox virus exposure.

“Community transmission of mpox continues to be a public health challenge in the U.S.,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Our sBLA submission for ACAM2000® reflects Emergent’s commitment to expanding our product capabilities and continuously support the U.S. government as we address emerging infectious diseases and strengthen future preparedness.”

Mpox, formerly called monkeypox, is a rare disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Mpox symptoms are similar to smallpox symptoms, but milder, and mpox is rarely fatal.¹ Since the start of last year, there have been more than 31,000 mpox cases in the U.S. and 55 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally.

BALTIMORE, MD, November 7, 2023 –Irazú Oncology, LLC, a biotechnology research company working to develop the next generation of cancer vaccines, and University of Maryland, Baltimore (UMB) are marking the one-year anniversary of their exclusive, worldwide license agreement and continuing partnership for the development of UMB’s novel immunotherapeutic vaccine technology. The Company, founded and led by Marco Chacón, PhD, is a UMB startup pursuing its plans to commercialize UMB’s technology as part of its oncology vaccine platform.

Irazú Oncology’s Membrane Vesicle Platform (MVP) technology utilizes nanosized outer membrane vesicles (OMVs) derived from attenuated bacteria to display and deliver tumor antigens to sites of immune response. The OMV vaccines are designed to stimulate the body’s own immune system to attack and destroy tumor cells. The Company’s lead vaccine candidate, IRZ-CRC-1, is a bivalent colorectal cancer vaccine that has shown excellent efficacy in colorectal cancer preclinical models.

A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.

Blackbird was founded at the start of this year with the backing of Baltimore Ravens owner Steve Bisciotti’s family foundation. So far, Blackbird has looked at about 80 to 100 proposals and funded five programs, Blackbird CEO Matt Tremblay told Endpoints News.

Baltimore has had a few notable biotech success stories, such as Thrive Earlier Detection (acquired by Exact Sciences in 2020) and Personal Genome Diagnostics (acquired by Labcrop in 20222), but Tremlay said he hopes to support a "Kendall Square-like phenomena." He's looking to back research ideas that ultimately become biotech startups based in Baltimore. 

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OXFORD, United Kingdom, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer will present data from its Phase 2 Hepatitis B trials of VTP-300 at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, November 10-14 in Boston, MA.

The company also announced today that it has changed its name to Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. The company expects to begin trading under its new name and ticker (Nasdaq: BRNS) effective as of November 7, 2023. As part of the rebranding, the company has also updated its website -- learn more at www.barinthusbio.com.

Are you curious about the world of transformative regenerative medicine and stem cell research? Are you eager to understand how Maryland champions researchers and companies in the field of stem cell and regenerative medicine? Do you want to learn more about the Maryland Stem Cell Research Fund (MSCRF)? Listen to the latest episode of BioTalk with Rich Bendis as he welcomes MSCRF Executive Director, Ruchika Nijhara, PhD.

In this enlightening episode, Dr. Nijhara, a forward-thinking leader driven by her passion for advancing scientific innovation, delves into the funding mechanisms that Maryland employs to support research and development at all stages and fosters collaboration and innovation.

• Partnership combines QIAGEN’s QIAseq panels, CLC LightSpeed, and QCI Interpret software to support Element’s AVITI System users in genomic analysis
• Collaboration to accelerate discovery, enhance cost efficiencies, and improve turnaround times for genomic applications in the scientific community
• QIAGEN to present performance data for universal QIAseq library preparation panels running on other sequencing platforms at ASHG Annual Meeting 2023 in Washington, DC

Venlo, the Netherlands, and San Diego, California, Nov. 02, 2023 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Element Biosciences, Inc. today announced a strategic partnership to offer comprehensive next-generation sequencing (NGS) workflows for the Element AVITI™ System, an innovative sequencing platform.

Element’s AVITI System is a versatile benchtop sequencer offering a combination of performance, cost, and flexibility for a wide range of NGS applications. For customers using the AVITI System, QIAGEN provides Sample to Insight NGS workflows with validated QIAseq panels and integrated bioinformatic solutions, including CLC LightSpeed and QCI Interpret software.

“The collaboration between QIAGEN and Element Biosciences delivers unprecedented insights across various genomic applications to our customers worldwide. Researchers are increasingly searching for complete solutions and workflows from sample to insight, and we are committed to advancing the field together by providing innovative technology and applications that help researchers accelerate discovery,” said Nitin Sood, Senior Vice President, Head of Life Sciences Business Area at QIAGEN.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the registration-phase TETON PPFstudy, which will evaluate nebulized Tyvaso® (treprostinil) Inhalation Solution in 698 adult patients with progressive pulmonary fibrosis (PPF). This is in addition to two separate ongoing registration-phase studies, TETON 1 and TETON 2, of nebulized Tyvaso in patients with another type of pulmonary fibrosis (PF) known as idiopathic pulmonary fibrosis (IPF).

By Alex Keown | October 31, 2023 - 

Addimmune, currently American Gene Technologies HIV-focused research, is expected to become a publicly traded company in early 2024 following a merger with 10X Capital Venture Acquisition Corp. III, a special purpose acquisition company (SPAC).

Following the merger with the SPAC company, Addimmune will use the raised funds to support its planned Phase Ib clinical trial assessing the company’s Gag-specific AGT103-T, a genetically modified cell product, CEO Jeff Galvin told BioBuzz. The merger announcement comes months after plans to separate the HIV business were shared by AGT.

Addimmune launched with the goal of building on the success of a Phase I study assessing AGT103-T as a potential therapeutic for HIV that could offer a functional cure of the disease. Trial data revealed that 100% of participants showed active immune responses to HIV after participants ceased taking their antiretroviral therapy. The data showed that several of the seven trial participants achieved significant viral suppression, which signals the possibility that AGT103-T has the potential to deliver a functional cure to HIV patients. The Phase I data was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement. 

Six new products that can be used to detect residual host cell genomic DNA (gDNA)

MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ -- Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.

"Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency and safety," said Amanda Cowley, General Counsel and SVP Legal, Strategy and People of USP. "With increased demands around the globe for new biological medicines on accelerated timelines, it's essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk."

ROCKVILLE, MARYLAND, October 30, 2023 – BioHealth Innovation Inc. (BHI) proudly welcomes Jon Nelson to its innovative team. Jon joins BHI as a Technical Writer and Program Manager, bringing an impressive nine years of research experience within the biological sciences, further enhancing BHI’s commitment to advancing healthcare technologies.

Jon’s journey in biological sciences began with the pursuit of his master’s degree in biology at the University of North Carolina at Greensboro. During this time, he worked with bioinformatics to predict epigenetic drug efficacy and leverage cutting-edge technology for groundbreaking solutions.

“We are excited to have Jon Nelson join our team. His extensive research experience and innovative mindset align perfectly with BHI’s mission to drive innovation and transformative healthcare solutions,” said Monique Bennett, BHI Life Science Business Strategist.

RICHMOND, Va., Oct. 30, 2023 /PRNewswire/ -- BRAINBox Solutions today announced initial investments into the company's Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.

"We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test," said Donna Edmonds, BRAINBox Solutions' CEO. "We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings." She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.

"The BRAINBox TBI test is the first to integrate physiologic and functional testing, an approach that is designed to maximize sensitivity and specificity, and provide objective criteria for the diagnosis and prognosis of acute traumatic encephalopathy, commonly known as concussion," said W. Frank Peacock, MD FACEP, FACC, FESC, the study's Principal Investigator and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.