Resilience | February 20, 2023
National Resilience, Inc. (Resilience), a manufacturing company with a technology-focused mission to improve access to complex medications, recently announced a 10-year biomanufacturing partnership with a top pharmaceutical company for its portfolio of services in process and analytical development, drug substance manufacturing, and drug product manufacturing. The extensive agreement covers prospective biologic, vaccine, nucleic acid, cell, and gene therapy manufacturing.
Resilience’s recently acquired facility in Cincinnati, Ohio, is its worldwide center of excellence to produce commercial medicinal products, and will deliver the first product as stipulated under the agreement. The development of complicated pharmaceuticals, such as cell and gene therapies, has not kept up with the rate of scientific advancements that are supporting them. Resilience brings together exceptional minds in science and engineering to bridge this gap with access to state-of-the-art technology.
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience, said, “The partnership announced today is a major milestone for Resilience.” He further added, “We are grateful to have this opportunity to work with our partner to deliver important, life-saving medicines to patients. We understand the trust placed with us to manufacture the medicine with the highest quality, regulatory compliance, and reliability. We are committed to maintaining a responsible manufacturing operation that exceeds the expectations of our partners and enables us to make a meaningful impact on global healthcare.”
(Source – Business Wire)
With the addition of this alliance to its expanding commercial portfolio, the company anticipates generating record revenues in 2023.
Resilience is a technology-focused biomanufacturing startup. The company intends to increase access to sophisticated medications. The firm is establishing a long-term network of cutting-edge, all-inclusive manufacturing solutions to guarantee that the therapies of today and the future may be produced efficiently, securely, and at scale. Resilience aims to continuously develop the science of biopharmaceutical manufacture and development, so their partners concentrate on the discoveries that enhance patients' lives and safeguard biopharmaceutical supply chains from future disruptions.
INDUSTRIAL IMPACT, MEDICAL
Celularity | January 17, 2023
Celularity Inc., a biotechnology firm based in the United States that develops placental-derived allogenic cell treatments and biomaterials, and CH Trading Group LLC, an international import, export, and trading corporation, have agreed to an exclusive territorial distribution agreement.
CH Trading Group will serve as the exclusive territorial distributor for halal-certified products previously announced by Celularity in over 100 countries. The product distribution agreement for halal-certified products by Celularity provides a five-year minimum accumulated purchase commitment of US $225 million.
CEO of CH Trading Group, Sayed Zayan, said, “Based on market demand for Celularity’s commercial biomaterial products, we believe there is a billion-dollar commercial opportunity across the Middle East and North Africa Islamic markets.” He also added, “We are excited to be in a position to expand access to these important medicines and wellness products to more people across the region through our exclusive territories distributor agreement with Celularity.”
(Source – Business Wire)
“According to Emergent Research's most recent analysis, the global regenerative medicine market was valued at $9.80 billion in 2021 and is predicted to expand at a CAGR of 15.9%, reaching $37.10 billion in 2030.”
Under the agreement, CH Trading Group will distribute products to more than 100 countries that are members of or affiliated with the following intergovernmental organizations (‘Islamic Markets’)
The Gulf Cooperation Council: Consists of Bahrain, Oman, Kuwait, Qatar, Saudi Arabia, and the UAE.
The Organization of Islamic Cooperation: It spans four continents and includes 57 member nations
The African Union: Includes 55 member countries
Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder, said, “Our partnership with the CH Group represents another critical milestone towards bringing our innovative halal-certified—under globally recognized Circle H International Inc. standards – regenerative biomaterial products to treat degenerative disease across Islamic Markets.”
(Source – Business Wire)
Headquartered in Florham Park, N.J., Celularity is a clinical-stage biotechnology firm paving the way for the future of cellular medicine by offering off-the-shelf allogeneic placenta-derived cellular therapeutics with unmatched scale, quality, and affordability. With its novel approach to cell therapy, the company can unlock the unique therapeutic potential of the postpartum placenta. In addition, through the placenta, nature’s immunotherapy engine, the firm is driving the next generation of cellular medicine using placenta-derived T cells, NK cells, and pluripotent stem cells to address unmet and underserved clinical needs in cancer, infectious, and degenerative diseases.
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.