Medical
Frontage | January 02, 2024
Frontage Laboratories, Inc. announced that, through its wholly-owned subsidiary Frontage Europe S.r.l., it has completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (Accelera).
Accelera is a premier Contract Research Organization located in Nerviano, within the Lombardy region of Italy, part of the well-established NMS Group S.p.A. which has positioned itself as a global niche player in delivering discovery & preclinical studies and clinical bioanalysis to pharma and biotechnology companies, academic institutions, and other healthcare stakeholders.
"Today marks a very significant achievement in the 23-year history of Frontage Laboratories, as we establish a base of operations in continental Europe. Accelera has developed a tremendous reputation for high quality R&D services and we look forward to welcoming their Bioanalytical and Drug Metabolism & Pharmacokinetics teams to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "We envision this strategic acquisition as a first step in establishing Frontage's footprint in Europe, with the intent of adding other service areas in the continent. We believe both existing Frontage and Accelera clients stand to benefit greatly by leveraging Frontage's increasingly global platform. In addition, we are looking forward to partnering with the remaining Accelera business on exciting opportunities to service clients across our organizations."
According to Dr. Song Li, Founder and Chairman of Frontage: "It has been a long-standing goal of Frontage to expand our operations in Europe. We consider ourselves fortunate to capitalize on our outstanding relationship with the Accelera team, which has enabled us to bring our plans to fruition. We are very enthusiastic about working together as we further develop the Frontage platform in Europe, starting from a footprint in the Biopark in Nerviano Lombardy, where Accelera and Nerviano Medical Sciences Srl have already established a long-standing and efficient value chain. As always, our ongoing focus will remain on delivering the highest levels of quality, technology and expertise to our clients."
"We are thrilled to join forces with Frontage as part of this strategic acquisition that marks a significant milestone in Accelera's journey," said Luca Leone, CEO of Accelera. "Accelera has built a strong reputation for delivering high-quality R&D services through all phases of drug research and development with extensive experience in oncology. This unique occasion opens up new horizons for collaboration and growth. On one hand, we will further focus on offering top-notch In-vivo (end-to-end services) for multiple emerging modalities. At the same time, we look forward to exploring exciting opportunities to serve our clients across continents through our ongoing collaboration. This partnership reflects our commitment to advancing research and providing innovative solutions in the European market and beyond," said Luca Leone, CEO of Accelera S.r.l.
"Having Frontage as part of the growing partners operating from our Biopark is a landmark moment for us. In addition to the endless potential of the Accelera-Frontage collaboration, Nerviano Medical Sciences can leverage Frontage's world-class capabilities to drive breakthrough advancements in our drug discovery and development process. By uniting our strengths, we believe we can accelerate the pace of innovation and make a lasting difference in the field where all companies of this strong alliance operate and thrive here in Nerviano," said Hugues Dolgos, CEO of NMS Group S.p.A and Nerviano Medical Sciences Srl.V
About Frontage
Frontage Holdings Corp together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.
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Medical
Capricor Therapeutics | January 24, 2024
Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.
“We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.”
Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.”
About Capricor’s StealthX™ Vaccine
The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication.
About Capricor Therapeutics
Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.
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Medical
Vernal Biosciences | January 03, 2024
<p> Vernal Biosciences, a leading manufacturing and services company specializing in mRNA and lipid nanoparticle (LNP) formulation, proudly announces the additions of Sven Lee, Chief Commercial Officer, and Richard P. Hamel, Chief Financial Officer to its leadership team. Both distinguished leaders will strengthen Vernal’s position as a premier mRNA and LNP Contract Development and Manufacturing Organization (CDMO) while using their deep experience to deliver Vernal’s integrated mRNA manufacturing solutions to a growing marketplace.</p> <p> Chief Commercial Officer - Sven Lee</p> <p> Sven will lead the Commercial team, including business development, marketing, technical sales, and alliance management. His team will help customers define their manufacturing needs and provide creative solutions that leverage Vernal’s innovative technologies and manufacturing operations. Sven has a 30-year track record achieving remarkable business growth across the biotech and pharma sectors. Prior to joining Vernal, Sven was a Board Member and the Chief Commercial Officer at BioCina, an Australian based CDMO. Prior to BioCina, Sven spent six years as the Chief Business Officer of Abzena, a fully integrated, global biologics and bioconjugate CDMO. Sven has also held prominent roles in sales, marketing, and strategic planning at other CDMOs and life sciences companies including Global VP of Business Development at Catalent Biologics, Sr. Director of Global Business Development & Sales at TerumoBCT, Crucell (now Janssen), and Biogen.</p> <p> As Chief Commercial Officer, Lee says, “I am thrilled to be a part of a dynamic team specializing in high purity mRNA and LNP solutions for client partners in the rapidly advancing field of biotechnology of vaccines and therapeutic development for clinical trials and commercial use.”</p> <p> Chief Financial Officer – Richard P. Hamel</p> <p> Richard will be responsible for Vernal’s finance strategy and will lead the finance organization, including planning, treasury, tax and reporting, Richard is an accomplished financial executive with over 25 years of experience managing finance teams, improving business performance, and developing systems, processes, and procedures to streamline operations for high growth life science companies. Most recently, Richard was CFO at ReciBioPharm where he played a key role in integrating and managing several business units within ReciBioPharm. Prior to joining ReciBioPharm, he was CFO at United BioSource in Blue Bell, PA helping carve out the business from Express Scripts and building a stand-alone finance organization. Prior to joining United BioSource, Richard spent over seven years at inVentiv Health/Syneos in various financial roles of increasing responsibility including finance, shared services and treasury. Earlier in his career, Richard held a range of finance positions at ThermoFisher, AB Volvo, Kodak, Diageo and EY.</p> <p> As CFO, Richard will support Vernal Biosciences in achieving its ambitious goals and driving long-term success. “I am excited to join the Vernal team and apply my experience to further bolster the company’s already strong mRNA and LNP portfolio and further expand its unique capabilities,” said Hamel.</p> <p> CEO and Founder of Vernal Biosciences, Christian Cobaugh says, “On behalf of all Vernal employees and our investors, I am excited to welcome Sven and Rich to Vernal’s talented leadership team. Their collective experience and success that they bring to Vernal and our clients complements our expansion, including the recent addition of our GMP facilities and operations. Sven has spent most of his career helping customers find creative solutions in clinical manufacturing and Rich has successfully built and integrated several businesses in the life sciences sector, from early stage to global scale. Their additions to our team will help Vernal democratize access to high purity mRNA and LNPs for all stages of research and development.”</p> <p> <strong>About Vernal Biosciences</strong></p> <p> Vernal Biosciences is a leading CDMO specializing in mRNA and LNP manufacturing. Vernal provides comprehensive high purity platform manufacturing solutions for mRNA-based medicines and vaccines, from research to clinical development. Our dedicated team of experts, our platform solutions, and GMP facility show our commitment to our partners, enabling them to focus on accelerating their programs to clinical development to improve patient lives.</p>
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