MEDTECH, INDUSTRIAL IMPACT
INOVIO Pharmaceuticals, Inc. | February 01, 2023
On January 31, 2023, INOVIO, a leading biotechnology firm focused on the development and commercialization of DNA medicines to protect and treat people from cancer, HPV-associated diseases, and infectious diseases, announced a strategic reorganization to meet operational efficiency commitments and better position the company to deliver DNA medicines to patients.
Following the previously announced end of clinical development projects in late 2022, the restructuring is estimated to result in yearly savings of roughly $4.3 million and an 11% reduction in full-time personnel. These and other strategic initiatives divert resources needed to progress critical programs, such as INOVIO's product candidate INO-3107 for the treatment of Recurrent Respiratory Papillomatosis (RRP).
INOVIO anticipates a $1.1 million one-time restructuring charge in the first quarter of 2023. Its 2022 fourth-quarter and year-end financial results announcement, scheduled for March 2023, will provide more precise financial guidance.
INOVIO's lead initiatives include therapies for HPV-related disorders, such as INO-3107 for RRP and VGX-3100 for cervical high-grade squamous intraepithelial lesions (HSIL). In the first quarter of 2023, INOVIO is anticipated to release the results of its Phase 3 REVEAL2 study for VGX-3100 and the second cohort of its Phase 1/2 trial for INO-3107.
About INOVIO Pharmaceuticals, Inc.
Headquartered in Plymouth Meeting, PA, INOVIO Pharmaceuticals, Inc. is a biotechnology firm dedicated to bringing precisely designed DNA therapeutics to market in order to treat, cure, and protect individuals from infectious diseases, cancer, and HPV-related diseases. INOVIO's in-development DNA medications are delivered utilizing its investigational proprietary smart device, CELLECTRA®, to elicit immune responses against targeted pathogens and malignancies. Its DNA medicines platform and the proprietary smart device can target almost any DNA sequence. With 15 clinical studies in development, the company has the potential to save and protect lives throughout the world and fuel a new decade of DNA medicines.
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CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Bio-Techne Corporation | March 20, 2023
Bio-Techne Corporation announced it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities. The Catapult PAT consortium is the first initiative of this scale and functional expertise with member companies and organizations collaborating to develop cell and gene therapy-specific process analytical technologies.
The PAT initiative began in January 2021 with a series of experiments designed to monitor process parameters of an exemplar 8-day T-cell expansion bioprocess using primary T-cells. Data were gathered from five independent analyses to generate an extensive, world-first dataset. An analysis of multiple cytokine targets was conducted using high-plex Luminex® immunoassays and the precision multiplexing Ella™ platform from Bio-Techne. The automated workflow of the Ella platform proved to be particularly amenable to the efficiency, accuracy, and throughput demands inherent in a bioprocess manufacturing environment. With its robust performance in this project, the Cell and Gene Therapy Catapult plans to incorporate Ella™ into an existing CGT Catapult facility to further support scientists in the UK.
"As a leader in the forefront of innovative tools to measure cytokines, we are honored to be a part of the Catapult PAT initiative to help advance cell and gene therapy development," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "Bio-Techne remains excited about the potential of these advanced therapies to improve patient outcomes and treat a wide range of diseases that currently have very poor or ineffective treatments."
Established by Innovate UK, the Cell and Gene Therapy Catapult fosters collaborations between academia, industry, and healthcare providers to develop new technology and drive innovation. Catapult experts cover all aspects of advanced therapies, from research and development to clinical adoption and every step in between.
About Bio-Techne
Bio-Techne Corporation is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000employees worldwide.
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INDUSTRIAL IMPACT, MEDICAL
Kymanox | February 06, 2023
Kymanox, a leading life science-focused professional services firm, recently announced the acquisition of anteris medical GmbH and anteris helvetia AG (collectively anteris). Anteris specializes in assisting the commercialization and development of medical equipment, combination and in-vitro diagnostic products.
This acquisition enables both firms to achieve their common organizational goal of geographic expansion while enhancing their service capabilities by offering clients a greater range of highly specialized services. Customers who bring essential biologics, such as pharmaceuticals, cell and gene therapies (C>s) and biosimilars, medical devices, and drug/device combos to global markets will benefit significantly from the combined service offerings and office locations of the combined firms. In addition, by merging the technological, scientific, and regulatory expertise of both organizations, customers will actually benefit from this synergy to ensure FDA, EMA, Notified Bodies, and other health authorities' compliance and submission excellence.
Anteris, with its offices in Holzkirchen, Germany, and Küssnacht a.R., Switzerland, offers resource-efficient and innovative solutions for end-to-end development, technical documentation, and compliance to the life science and medical device sectors. Members of Anteris' technical, quality, and regulatory teams have decades of collective expertise in combination product and device development, with a focus on biosimilar development and registration, MDR, EU, CE marking, 510(k) submissions, and quality systems regulations across all key markets.
About Kymanox
Founded in 2004, Kymanox is a life science professional services firm that provides scientific, engineering, project management, quality, human factors, testing/CQV, QC, and regulatory assistance to firms in the biotechnology, pharmaceutical, medical device, and combination product sectors. It assists in getting products from the bench to the patient and distinguishes itself by providing a wide variety of technical services and products as well as comprehensive project implementation. The company offers its services to clients worldwide from its headquarters in Raleigh (RTP), North Carolina, as well as offices throughout the United States.
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