Walking Fish to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to engineer novel B-cell based medicines for the treatment of serious diseases

ROCKVILLE, Md., May 04, 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 to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Walking Fish Therapeutics, Inc. a biotechnology company that is rapidly advancing B cell-based therapeutics.

Under the terms of the agreement, Walking Fish obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees, clinical milestone payments and sales-based payments.

ROCKVILLE, Md., May 04, 2023 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced the closing of its previously announced public offering of an aggregate of 4,495,825 shares of its common stock (or pre-funded warrants in lieu thereof) and common stock purchase warrants to purchase up to 4,495,825 shares of common stock at a combined public offering price of $0.7785 per share (or pre-funded warrant in lieu thereof) and accompanying warrant. The warrants have an exercise price of $0.7785 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants, and will expire five years from the date of stockholder approval.

BETHESDA, Md., May 03, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced that Innosuisse, the Swiss Innovation Agency, supports GT Gain Therapeutics SA with the amount of CHF 2.5 million (~$2.8 million) to develop GT-02287, Gain’s lead program for GBA1 Parkinson’s disease.

The Company’s Swiss Accelerator innovation project supported by Innosuisse entitled “Harnessing Structurally Targeted Allosteric Regulators to treat Parkinson’s Disease” includes clinical pharmacology and preclinical studies with the Company’s drug candidate GT-02287, which will be conducted as the lead program progresses through Phase 1 and Phase 2 clinical studies in GBA1 Parkinson’s disease.

GBA1 mutations are the major genetic risk factor for Parkinson’s disease and are associated with earlier onset of the disease, faster disease progression and increased rates of cognitive decline. Mutations of the GBA1 gene cause misfolding and dysfunction of the enzyme beta-glucocerebrosidase (GCase). Preclinical models of GT-02287 have shown the ability of this orally bioavailable and brain-penetrant molecule to target and bind to GCase, prevent its degradation and allow its transport to the lysosomes where the enzyme can carry out its biological function. Furthermore, the data from preclinical models demonstrate that enhancement of lysosomal GCase activity by GT-02287 protects against key pathological features of Parkinson’s disease, including alpha-synuclein related pathology and an increase in the survival of dopaminergic neurons. These findings support the potential of GT-02287 to slow or halt disease progression in GBA1 Parkinson’s disease.

• Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
• The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
• US launch is planned before the 2023/24 RSV season
  
  

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

Registration is Open for the 2023 Children’s National Innovation Day & Showcase

Date: May 31, 2023 Time: 10:00 am - 7:00 pm Location: Children’s National Research and Innovation Campus (CNRIC), Washington, DC Registration Link: Click here to register

The organizers of the 2023 Children’s National Innovation Day & Showcase are thrilled to announce that registration is now open for this premier event highlighting innovation in pediatric healthcare. The event will take place on May 31, 2023, at the Children’s National Research and Innovation Campus (CNRIC) in Washington, DC.

Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.

Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV's challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.

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Virginians have often sought experimental medical treatments outside the state — traveling to North Carolina, Boston or one of the Mayo Clinic’s locations. However, the Paul and Diane Manning Institute of Biotechnology at the University of Virginia aims to change that.

“We intend to tackle the biggest challenges in health care and to empower our researchers to make the life-changing breakthroughs that will transform care for people across Virginia and beyond,” says Dr. K. Craig Kent, CEO of UVA Health and executive vice president for health affairs at U.Va. “We’re on a cusp of a revolution in health care.”

Construction of the institute, which will be built in the 54-acre Fontaine Research Park adjacent to U.Va.’s Grounds, is set to be complete in 2026 or 2027. However, the university is forging ahead with hires, including about 100 scientists who will research potential treatments for diseases like diabetes and Alzheimer’s. Kent anticipates employing 1,000 to 1,400 people at the institute, which will include 30,000 to 40,000 square feet of lab space and a biomanufacturing facility.

Analysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers’ payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total.

Click here to read more from The Journal of Technology Transfer

GERMANTOWN, Md., April 25, 2023 (Newswire.com) - Seraxis Inc., a pre-clinical stage company with a best-in-class islet replacement therapy for insulin-dependent diabetes, today announced the presentation of results from an efficacy study of Synthetic Replacement Endocrine (SRE) pancreatic clusters. These data were presented by William Rust, PhD, Chief Executive Officer at Seraxis, as an oral podium presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation included an introduction to Seraxis' proprietary GMP process for manufacturing SRE clusters for nonclinical and clinical use.

Emmes collaborates with pharmaceutical companies as strategic partners, providing one-stop clinical trial services, reducing costs, and accelerating development.

SAN ANTONIO, TX. – April 25, 2023 – Frost & Sullivan researched the contract research organizations industry and, based on its analysis results, recognizes Emmes with the 2023 Global Competitive Strategy Leadership Award. Each year, Frost & Sullivan presents this award to the company that has leveraged competitive intelligence to successfully execute a strategy that results in stronger market share, competitive brand positioning, and customer satisfaction.

Emmes is a full-service, global Clinical Research Organization (CRO) committed to promoting public health and biopharmaceutical innovation. Its dedication to problem-solving, close collaboration with customers, and scientific excellence help its customers better understand complex research problems, generate higher-quality data, and enable better treatment options. The company has extensive therapeutic experience in common and rare diseases, which is backed up by specialized knowledge in biostatistics, biomedical data science and bioinformatics, and eClinical technologies.

The value of life-saving drugs for patients suffering from serious diseases is priceless. But the current economic environment is stifling the biopharmaceutical pipeline of up-and-coming clinical trials. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics and the visionary behind Jeeva eClinical Cloud, appreciates the significant innovations that emerging biotech companies bring to the pursuit of early clinical development of novel therapeutics. He recommends an active front-loading strategy to maximize operational efficiency of clinical trials

BioMADE Funding To Accelerate Capra Bioreactor Expansion and Technical Advancement, Aligning with New White House Bioeconomy Goals

MANASSAS, Va., April 24, 2023 (GLOBE NEWSWIRE) -- Capra Biosciences is scaling up their novel bioreactor technology to produce sustainable chemicals in Northern Virginia. This project was funded through a special BioMADE Project Call focused on advancing bioreactor design and development, thanks to support from Schmidt Futures. The expansion will jump start Virginia’s bioeconomy and place the state on the map for biochemical production.

The Manassas-based company uses a biofilm-forming microbe and its proprietary bioreactors to transform low-cost feedstocks, such as agricultural byproducts or food waste, into a variety of chemicals, including their first product, retinol.

“Our bioreactor platform is meant to handle small- or large-scale production of chemicals efficiently without a negative environmental impact,” said Dr. Andrew Magyar, Capra Biosciences’ chief technology officer. “We’ve already proved its potential on a smaller scale, and we’re excited to scale it for more chemicals and larger volumes. The new contract not only allows us to create a bigger facility, it also funds work with groundbreaking partners who will improve the efficiency and predictability of the bioreactors.”

JLABS is taking the lead in exploring new and innovative approaches to vaccinations with their upcoming event, "Breaking Dependencies on Seasonal Vaccines to Address Infectious Diseases." This forward-looking program is scheduled to take place on Wednesday, May 17, 2023, at JLABS in Washington, DC, from 11:00 AM to 2:00 PM.

The event aims to examine the potential of technology to break the dependence on annual or seasonal vaccinations and provide more durable and reliable solutions for preventing infectious diseases such as coronaviruses, influenza, and rhinoviruses. Through innovation, there is an opportunity to enhance the impact and acceptance of vaccinations, achieve more consistent and impactful outcomes, and limit the spread of infectious diseases across large populations, regardless of risk level.

Johns Hopkins University has launched a new, annual award to support promising business ventures developed by student entrepreneurs—and to encourage the creators of those startups to put down roots and grow in Baltimore.

The President's Venture Fellowship, by far the largest award for student entrepreneurship ever offered by the university, is open to any full-time Johns Hopkins student, undergraduate or graduate, who seeks to continue pursuing a business venture in Baltimore after graduation. Up to two winners will be selected annually to receive a $100,000 award, with the lead of each venture also receiving a $40,000 salary stipend.

After record years in 2020 and 2021, growth of the U.S. life sciences industry has returned to a more normal pace in 2023, although demand for lab/R&D space remains well above pre-pandemic levels. Life sciences employment reached a record high at the start of 2023, although the rate of growth slowed. The San Francisco Bay Area, Boston/Cambridge and Seattle were the fastest-growing markets last year.

Please see the reports below:

2023 U.S. Life Sciences Outlook

BioHealth Innovation is proud to announce that Rich Bendis, Founder and CEO, will be participating in the upcoming International APEC Dialogue on Strengthening the Resilience of the Medical Product Supply Chain in the Asia Pacific.

Rich Bendis will be sharing his expertise in Panel Session Four: "The U.S. Capital Region’s Role in Enabling Global Medicines Supply Chain Resilience." This session offers a unique opportunity to gain insights into building a robust and resilient medical supply chain on a global scale.

This important event, cosponsored by the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP), is aimed at accelerating efforts to strengthen medical product supply chains in the Asia Pacific region and beyond. Ensuring the resilience of these supply chains is a critical topic that impacts global health.

The program will take place on April 25 and 26, 2023, and will be a hybrid event, offering attendees the option to participate both in-person and virtually. The event will be held in conjunction with the USP Asia Pacific (APAC) Regional Chapter Meeting, which is scheduled for April 27, 2023.

Don't miss this opportunity to engage with experts and industry leaders in the field of medical supply chain resilience. Register now to attend in-person or virtually at the following link: https://cvent.me/2wVPXE

Discovering treatments for patients that currently have no available disease-modifying options is the priority of Gain Therapeutics. Specifically, there is a large unmet need for patients suffering from protein misfolding disorders that alter enzyme function.

What is Gain Therapeutics approach to drug discovery?

The pipeline begins with Gain’s agnostic discovery platform for Site-Directed Enzyme Enhancement Therapy (SEE-Tx). This is a computational platform, as opposed to an artificial intelligence (AI) system. This is preferable for multiple reasons. First, AI needs a large amount of data while SEE-Tx starts with a 3D protein structure to find novel binding sites within the protein. SEE-Tx can use the already published 3D protein structures solved by cryo-EM, or alternatively, the platform can utilize 3D structural predictions from the AlphaFold Database. After the platform identifies new binding sites on a previously undruggable protein, it can also compute the druggability of the identified allosteric binding site using quantitative predictions as opposed to discovery approaches using AI technology that cannot be interpreted. Importantly, any targeted sites will allow for protein function to be restored without interfering with the active sites of the enzyme and its substrate.

April 20, 2023 / By Katie Maney

Musculoskeletal injury (MSKI) is the most common form of medical injury experienced by Service members. Clinical interventions for MSKIs lack objective measures to determine their effectiveness, putting affected military personnel at risk of further damage if they return to duty  before fully recovering.

George Mason University bioengineer Dr. Parag Chitnis, an associate professor in the Department of Bioengineering and a member of the Institute for Biohealth Innovation (IBI), and his team are developing quantitative assessments that can both prevent and monitor MSKIs in Service members.

In partnership with Cephasonics Ultrasound, an ultrasound systems and technology company in California, and Infinite Biomedical Technologies, a biotechnology company in Maryland, the team has been selected by the United States Army Medical Research and Development Command to receive nearly $3M from the United States Department of Defense, awarded through the Medical Technology Enterprise Consortium (MTEC). The award will support the team’s development of wearable, compact, and hands-free ultrasound systems to assess rehabilitation and recovery from MSKIs through measurements of muscle structure and function during physical activity, with a specific focus on knee injuries.

“MTEC aims to facilitate prototype advancement in support of the Warfighters’ MSKI needs, “ said Dr. Lauren Palestrini, MTEC’s chief science officer. “We are excited to issue this award to the team at George Mason University and believe it has the potential to make great strides in military health and ultrasound research.”

Prior to this award, Dr. Chitnis and Dr. Siddhartha Sikdar, a professor in the Department of Bioengineering and a member of the IBI, formed the Training and Recovery Augmented with Ultrasound Myography and Assessment (TRAUMA) program. With funding from the Department of Defense’s Military Operational Medicine Research Program, TRAUMA’s goal is to develop ultrasound systems that can be used to evaluate MSKIs in dynamic settings. The award from MTEC enables the team to further advance their ongoing research.

Read more ...

Proposals are due May 1!

Grants for Technology Product Development Market-driven new technology and innovation leads to new products and new jobs. Creating jobs in innovative Maryland companies is what the Maryland Industrial Partnerships (MIPS) program has been doing for 32 years: bringing the inventive minds and extensive laboratory resources of the University System of Maryland (USM) to bear on creating the new products that feed the growth of Maryland businesses. Since the program’s inception in 1987, MIPS–enabled products have generated sales of $40 B.  MIPS is nationally recognized by the U.S. Small Business Administration as a model program for best practices in transferring technology and is a proven program that contributes significantly to job creation and high tech product development in Maryland.

Click here to learn more.