An antiviral gel may prevent genital herpes in women

In a paper recently published in the Journal of Infectious Diseases, researchers examined the effect of vaginal tenofovir 1 percent gel use on the risk of acquiring herpes simplex virus type 2, or HSV-2. The study was conducted through a secondary analysis of data from the VOICE study, the primary results of which were published in 2015. According to the Centers for Disease Control and Prevention, more than one in six Americans ages 14 to 49 are infected with genital herpes. HSV-2 infection is the most common cause of genital herpes and also enhances the risk of acquiring and transmitting HIV. No vaccine currently exists for HSV-2. "Women are especially susceptible to infection because it is more easily transmitted from an infected man to his female sex partner than vice versa," said corresponding author Jeanne Marrazzo, M.D., director of the Division of Infectious Diseases at the University of Alabama at Birmingham. "A product that protects against HSV-2 could have an important public health impact." Of the 566 HSV-2-negative participants, Marrazzo and her colleagues found that overall use of vaginal tenofovir 1 percent gel was associated with a 40 percent reduction of HSV-2 acquisition. Over the follow-up period, 92 new cases of HSV-2 occurred, with 77 in women with no plasma tenofovir detected and 15 with plasma tenofovir. Tenofovir measured in plasma was used as a measure of gel use.

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Vernal Biosciences Announces Strategic Leadership Appointments to Drive Growth in mRNA and LNP Formulation

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&rsquo;s position as a premier mRNA and LNP Contract Development and Manufacturing Organization (CDMO) while using their deep experience to deliver Vernal&rsquo;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&rsquo;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 &amp; Sales at TerumoBCT, Crucell (now Janssen), and Biogen.</p> <p> As Chief Commercial Officer, Lee says, &ldquo;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.&rdquo;</p> <p> Chief Financial Officer &ndash; Richard P. Hamel</p> <p> Richard will be responsible for Vernal&rsquo;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. &ldquo;I am excited to join the Vernal team and apply my experience to further bolster the company&rsquo;s already strong mRNA and LNP portfolio and further expand its unique capabilities,&rdquo; said Hamel.</p> <p> CEO and Founder of Vernal Biosciences, Christian Cobaugh says, &ldquo;On behalf of all Vernal employees and our investors, I am excited to welcome Sven and Rich to Vernal&rsquo;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.&rdquo;</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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Personalis and ClearNote Health Announce Partnership to Advance Epigenomic Technology

Personalis, Inc. | February 05, 2024

Personalis, Inc. a leader in advanced genomics for cancer, and ClearNote Health, Inc., a pioneer in epigenomic technologies, today unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform. “We have built a unique pharma channel based on our industry-leading tissue and MRD assays and ClearNote Health’s blood-based epigenomic approach is complementary to our offering as it helps our customers deepen their understanding of a patient’s response to immunotherapies,” said Chris Hall, CEO and President of Personalis. “Commercial partnerships such as this broaden our portfolio and are expected to appeal to a wide range of biopharma customers and accelerate our revenue growth.” Echoing this sentiment, Dave Mullarkey, CEO of ClearNote Health, remarked, “Partnering with Personalis presents an excellent opportunity to bring our 5hmC technology to the forefront of cancer research. This alliance is a testament to the synergy between our two companies, enabling us to expand our reach and significantly impact the biopharmaceutical industry. Together, we can accelerate the development of personalized therapies and make a real difference in the lives of patients.” ClearNote Health’s Epigenomics Platform represents a groundbreaking advance in cancer detection, offering real-time insights into disease-specific pathways. By tracking changes in 5hmC levels coupled with artificial intelligence-based analytical methods, the platform can detect cancer earlier, monitor disease progression, understand mechanisms of resistance, and identify promising drug targets and biomarkers. These insights are invaluable for optimizing drug development programs and delivering more effective treatments to patients. The Epigenomics Platform identifies changes in gene activation and gene regulation by labeling specific changes in the 5hmC landscape from plasma-derived cell-free DNA. This rich biological information, as part of clinical trials, enables the monitoring of cancer therapies in real time and contributes to an understanding of drug resistance mechanisms. The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry. About ClearNote Heath, Inc. ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health’s first commercially available test is the Avantect™ Pancreatic Cancer Test, which detects the presence of pancreatic cancer signals in patients at high risk of the disease, including those recently diagnosed with Type 2 diabetes. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

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Virica Expands Bioprocessing Capabilities with Carleton University Partnership

Virica Biotech | January 17, 2024

Virica Biotech Inc. (“Virica”), a leading developer of cell enhancers for scaling of viral vector as well as cell and gene therapy manufacturing will expand its bioprocessing services through a partnership with Carleton University. Slated to open this spring, Virica’s new facility at the university multiplies the Company’s capacity to provide high throughput virology services for customers looking to optimize production of their cell and gene therapies. “Carleton’s new Health Sciences Building provides us with greater access to modern infrastructure and analytical expertise,” said Jean Simon Diallo, Ph.D., CEO of Virica Biotech. “Their state-of-the-art analytical research facilities and world-class researchers across multiple disciplines open the door to exciting opportunities for partnering with Carleton University as we continue to invest to meet customer demand.” “We are very pleased to welcome Virica Biotech to the Carleton campus,” said Rafik Goubran, Ph.D., Vice-President (Research and International) and Chancellor’s Professor, Carleton University. “This multi-year, multi-million-dollar research and infrastructure partnership will help drive innovation and talent development in the Ottawa region for the creation and manufacturing of advanced therapies.” This partnership expands on Carleton’s history of supporting Ottawa biotechnology companies. The new open concept facility will include high throughput equipment to accelerate Virica’s bioprocess development and optimizations. In addition to expanded modern infrastructure, this new location enables the development and recruitment of world-class talent with experiential learning and training opportunities for Carleton students. Through this partnership, Carleton will coordinate the establishment of a scholarship fund designed to empower graduate students from traditionally underrepresented groups in science. About Virica Biotech Virica develops cell enhancers for viral vectors that improve the yield and quality of vaccines and cell and gene therapies, allowing developers to economically deploy their products at scale. Virica’s Viral Sensitizer (VSE™) platform reduces production inefficiencies caused by anti-viral defenses in manufacturing cells. Purpose formulated VSE combinations substantially increase manufacturing yields and reduce the cost of goods for a range of life-changing products, including vaccines, gene therapies, and cell therapies. About Carleton University Carleton University is a dynamic, research-intensive institution that engages in partnerships to address the world’s most pressing challenges. The university’s corporate collaborations bring together world-class companies, researchers and a new generation of talent with over 30,000 students to deliver innovations and results that are driving a more prosperous, sustainable future.

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