INOVIO | September 28, 2020
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed. This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial.
CellCarta | May 23, 2022
CellCarta, a leading global provider of precision medicine laboratory services, announced today the acquisition of the commercial rights to the antibody panels and assays from Precision Assays, a leader in next-generation targeted proteomics testing solutions. A spin-off from Fred Hutchinson Cancer Center ("Fred Hutch"), Precision Assays develops and deploys high-end multiplex quantitative immuno-MRM mass spectrophotometry-based assays for its pharmaceutical and biotech industry clients.
The acquisition from Precision Assays of its large spectrum of targeted mass spectrometry assays characterized according to the National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) Tier 2 guidelines greatly expands CellCarta's capabilities in off-the-shelf multiplex protein quantification offerings ready for deployment in immuno-oncology clinical and pre-clinical studies.
Precision Assays' large portfolio of robust assays characterized according to CPTAC guidelines and its established proof of concept data will enable CellCarta to confidently support its clients' exploratory studies and therapeutic development strategies, offering them key solutions to address important clinical challenges and move their immuno-oncology programs forward. Given CellCarta's expertise in protein quantitation, these immuno-MRM panels can further be validated to support secondary and primary clinical endpoints."
Lorella Di Donato, Chief Operating Officer of CellCarta, Immunology and Proteomics Divisions.
Based on technology licensed from Fred Hutch, Precision Assays' platform is uniquely positioned to fully capture the unique advantages of multiplex protein quantification using targeted mass spectrometry. Founder Dr. Amanda Paulovich, a professor in the Clinical Research Division at Fred Hutch who holds the Aven Foundation Endowed Chair, is an internationally recognized pioneer in targeted mass spectrometry and a clinically trained oncologist. Dr. Paulovich has set best-in-class standards to support precision medicine studies in cancer-specific protein expression analysis in a variety of matrices from FFPE cancer tissue biopsies to clinical serum-based samples. Precision Assays is one of the few CROs to offer large and immuno-oncology relevant multiplex off-the-shelf panels and is at the forefront of targeted-mass spec proteomics-based research.
As a global CRO with expertise in targeted mass spectrometry and specializing in biomarker testing to support precision medicine, CellCarta is an ideal partner to deploy and industrialize our platform to support discovery, translational and clinical research, especially in precision medicine and immuno-oncology."
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 11 facilities located in Canada, USA, Belgium, Australia, and China.
Kane Biotech Inc. | February 11, 2022
Kane Biotech Inc. announces that it has signed collaboration agreements with Dr. James Doub, MD, Assistant Professor of Medicine, University of Maryland School of Medicine’s Institute of Human Virology, and the University of Texas Medical Branch (UTMB) to study the use of DispersinB® with Prosthetic Joint Infection (PJI) patients. The group is securing funding from the National Institutes of Health (NIH) for pre-clinical work to be done by Josh Wenke, a Professor in the Department of Orthopedic Surgery and Rehabilitation at UTMB.
PJI’s are one of the most serious complications of joint replacement surgery. Conservative estimates are that approximately 1–2% of all prostheses will become infected over the life of the implant . The financial burden of treating these infections is staggering. It is estimated that they will cost the US healthcare system $1.62 billion in 2020 . In addition, patients have significant morbidity and mortality as a direct result of our current medical and surgical management to treat these infections . In one study, the five-year mortality for prosthetic joint infections is over 20% .
“These collaborations are of utmost importance given our shared strategies for managing complex musculoskeletal infections and finding cures for the debilitating morbidity associated with PJI. We are highly optimistic of advancing this field scientifically and clinically for the benefit of patients across the globe”
Marc Edwards, CEO of Kane Biotech
“The Institute of Human Virology has been testing the use of bacteriophage therapeutics in treating recalcitrant PJIs with some early signals of success,” explained Dr. Doub, who is also Director of Infectious Diseases Ambulatory Practice at the University of Maryland Medicine Center. “However, DispersinB®, has properties that bacteriophages do not have which include superior application as a preventative therapeutic, broader spectrum of activity, and a much easier regulatory (FDA) path.” Dr. Doub is a consultant for Kane Biotech.
Dr. Nanda Yakandawala, Vice President of Research and Development at Kane, in collaboration with Dr. Doub and Josh Wenke, Ph. D, recently submitted a R-21 grant application to NIH to fund pre-clinical work to be performed by Dr. Wenke.
About University of Texas Medical Department
Established in 1891 as the University of Texas Medical Department, UTMB was the nation's first public medical school and hospital under unified leadership and has evolved into a modern academic health science center with multiple campus locations and almost 1,000 faculty members educating approximately 3,500 students. Since the beginning, UTMB has been at the forefront of medical research, with researchers studying the viruses common to a sub-tropical island climate. Today, our world-renowned investigators generate a portfolio exceeding $160 million, and work in state-of-the-art laboratories developing diagnostic tools, cures and vaccines to benefit the global community.
About Kane Biotech
Kane Biotech is a biotechnology company engaged in the research, development, and commercialization of technologies and products that prevent and remove microbial biofilms. The company has a portfolio of biotechnologies, intellectual property (81 patents and patents pending, trade secrets, and trademarks) and products developed by the company's own biofilm research expertise and acquired from leading research institutions. StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactiv+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc.