CELL AND GENE THERAPY, INDUSTRIAL IMPACT
The Center for Breakthrough Medicines | March 13, 2023
Nucleus Biologics and Stoic Bio have teamed up to form a supply agreement with the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization that aims to accelerate the development and manufacture of advanced therapies. Under the agreement, Nucleus Biologics will become CBM's selected supplier of cell culture media and other biological solutions, ensuring a consistent supply of this critical material with tighter quality control measures.
Nucleus Biologics' approach to cell culture media, which sees it as a critical raw material that can drive desired attributes of cells crucial to the success of cell and gene therapy research, is complementary to CBM's focus on transparency, technology, and end-to-end solutions. By working together, they hope to expedite cell and gene therapy breakthroughs.
In addition, CBM will be an early adopter of Stoic Bio's innovative family of point-of-use media makers, Krakatoa™, which allows scientists to manufacture their own media with 65% fewer CO2 emissions than conventional media. By demonstrating that developing and manufacturing lifesaving therapies doesn't have to come with a high environmental cost, CBM hopes to set an example for the industry.
With over 2,200 cell and gene therapies in development, collaborations like this one are needed to speed up the process of getting these therapies to the clinic and ultimately approved. The CBM, Stoic Bio and Nucleus Biologics collaboration aim to create a unique service offering that introduces a paradigm shift in development and manufacturing, showing how technology and sustainability can converge to make better therapies sustainably.
About The Center for Breakthrough Medicines
The Center for Breakthrough Medicines (CBM) is a CDMO focused on accelerating the development and manufacture of advanced therapies to save lives. It offers end-to-end solutions such as process development, manufacturing, and quality control for cell and gene therapies, gene editing, and immunotherapies. In addition, CBM collaborates with pharmaceutical companies, academic institutions, and healthcare providers to make advanced therapies more accessible while ensuring compliance with regulatory standards. The company also prioritizes sustainability by implementing green initiatives and sustainable technology and strives to positively impact the communities it operates in.
INDUSTRIAL IMPACT, MEDICAL
Prnewswire | April 27, 2023
LabCentral Ignite, a platform dedicated to advancing racial, gender and other representation and opportunity within the life sciences field, today launched IgniteVC in partnership with the Bioscience & Investor Inclusion Group (BIIG). BIIG is a grassroots effort driven by leaders from venture capital (VC) firms and startups. The new initiative aims to cultivate a highly inclusive life sciences venture capital community and support the growth of more diverse and inclusive portfolio companies from inception to success.
IgniteVC will provide VC firms and startups with practical tools, best practices, and a community of peers to advance their diversity, equity, and inclusion (DEI) goals. This new initiative will build upon years of work done by hundreds of leaders in BIIG, an unprecedented effort to promote DEI in life sciences innovation and investment.
"We are incredibly grateful for the time and expertise of the BIIG volunteers who have created a strong community and a set of unique resources that are now widely available. We look forward to welcoming them to our team as part of IgniteVC. Their hard work and dedication, along with the support of our sponsors, have been instrumental in launching IgniteVC," said Gretchen Cook-Anderson, LabCentral Ignite Executive Director.
Seed support for IgniteVC comes from founding sponsors Johnson & Johnson Innovation-JJDC, Inc., Mission BioCapital, and Third Rock Ventures. IgniteVC will be managed by LabCentral Ignite, which is set to hire a director this spring to lead VC community engagement, expansion, and planned global impact.
"The work that will be done by IgniteVC is critical to driving underrepresented groups into the life sciences sector as a viable career pathway," said Abbie Celniker, PhD, Partner at Third Rock Ventures. "By cultivating a more inclusive VC community and providing resources to support portfolio companies in implementing DEI best practices, IgniteVC is helping to create a more diverse and equitable life sciences ecosystem. We are proud to continue supporting this important work and look forward to seeing the impact it will have on our industry."
About LabCentral Ignite
The growing Ignite platform is dedicated to developing equity, inclusion, and opportunity within the life sciences field. Through a range of equity-driven programs and a growing member network of industry, startups, higher education, and nonprofits, Ignite connects underrepresented students, talent and innovators to academic, technical skills-building, mentoring, job placement, and board and leadership preparation opportunities that fuel biotech diversity and inclusively transform careers.
INDUSTRIAL IMPACT, DIAGNOSTICS
Vaxxinity, Inc. | March 21, 2023
Vaxxinity, Inc. a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, announced that the first subjects have been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart disease, by targeting proprotein convertase subtilisin/kexin type 9 serine protease (PCSK9). Heart disease remains the leading cause of death globally, claiming over 18 million lives per year, despite the existence of approved treatments that lower LDL.
“This is an exciting milestone for VXX-401 and Vaxxinity in our pursuit to vaccinate the world against heart disease with a preventative option that is convenient and accessible, addressing an unmet need to combat the leading global cause of death,” said Mei Mei Hu, Chief Executive Officer of Vaxxinity. “PCSK9 antibody therapies are well-tolerated and effective, but huge unmet patient need remains. In order to solve the problem of heart disease, the world needs a scalable, accessible technology that can reach the hundreds of millions, if not billions of people at risk. With an LDL-lowering vaccine we can potentially offer an option that’s cost-effective, safe, convenient, long-acting, and deployable.”
The multicenter Phase 1 dose-escalation trial aims to enroll 48 subjects aged 18 to 75 years, with LDL cholesterol between 2.59 and 4.89 mmol/L. The objectives of the trial are to evaluate safety, tolerability and immunogenicity (as measured by serum anti-PCSK9 antibody titers). Pharmacodynamics of the immune response will be measured by LDL cholesterol levels, an established model of PCSK9 inhibition in hypercholesterolemia.
“We’re excited to get this first-in-human trial of VXX-401 started. The concept of a vaccine for cholesterol could be a game-changer in cardiovascular health due to its potentially very broad reach and impact on human health,” said Professor Stephen Nicholls of Monash University and Victorian Heart Hospital in Australia. “Targeting PCSK9 with a monoclonal antibody is a proven and effective approach for lowering cholesterol and reducing the risk of heart attack and stroke. Despite the availability of statins and the approval of PCSK9-targeting medicines, there is still a need for new therapies. VXX-401 has the potential to extend the use of PCSK9 inhibition to the full population who could benefit.”
Earlier this month, Vaxxinity presented pre-clinical data at the American College of Cardiology/World Congress of Cardiology Annual Scientific Session demonstrating that VXX-401 induced robust anti-PCSK9 antibodies and durable LDL cholesterol lowering without affecting high-density lipoprotein (HDL) cholesterol levels, indicating that VXX-401 has the potential to be a safe and effective LDL lowering therapy. Data in non-human primate studies show that VXX-401 was well tolerated and provided durable and significant LDL reduction of 30% to 50% change from baseline. The data also demonstrate VXX-401’s immunogenicity: purified antibodies from immunized animals bound to human PCSK9 with high affinity, and exhibited a dose-dependent functional inhibition of PCSK9 in vitro. Additionally, Peripheral Blood Mononuclear Cells (PBMCs) collected prior to immunization did not release cytokines upon stimulation with various components of the vaccine, suggesting that VXX-401 may safely overcome immune tolerance.
VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform and is being developed for the treatment of hypercholesterolemia. The platform is designed to harness the immune system to convert the body into its own natural “drug factory,” stimulating the production of antibodies. VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 in order to lower LDL cholesterol.
Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.