CELL AND GENE THERAPY
Intravacc | September 12, 2022
Intravacc, a world leader in translational research and development of preventive and therapeutic vaccines, today announced additional favorable preclinical and toxicology data for Avacc 10®, the company's SARS-CoV-2 intranasal candidate vaccine. These results demonstrate a reduction in upper respiratory tract viral load, broad cross protection against circulating variants of concern. and a good safety profile, allowing progression towards a phase I clinical study.
"Based on our additional pre-clinical data, Avacc 10® has the potential to reduce the spreading of the virus as well as providing broad protection against circulation variants. Combined with the favorable toxicological safety data, this puts us a good position for our Phase I clinical trial, which will commence in Q4 2022."
Dr. Jan Groen, Intravacc's Chairman & CEO
The first set of pre-clinical studies of Avacc 10®, published in Frontiers of Immunology in December 2021, demonstrated high levels of spike-binding immunoglobulin G (IgG) and A (IgA) antibodies in serum, and the nose and lungs after two intranasal vaccinations 3 weeks apart. Avacc 10® vaccinated hamsters challenged with SARS-CoV-2 were protected from weight loss and viral replication in the lungs and histopathology showed no lesions in lungs 7 days after challenge.
The objectives of the additional pre-clinical and toxicology study of Avacc 10® were to study the dosing, cross neutralization and safety of the intranasal vaccine. For the dosing study, mice were vaccinated intranasally with two doses of various concentrations of OMV and Spike protein. Three weeks after the last vaccination neutralizing antibodies against the SARS-CoV-2 Wuhan strain and variants of concern Delta, Gamma and Omicron were determined in the sera. High virus neutralizing antibody titers were detected against all the variant viruses. Syrian hamsters were used to study viral replication after challenge with SARS-CoV-2. A reduced viral load in throat and lungs and highly reduced lung lesions were observed in Avacc 10® vaccinated animals exposed to placebo vaccinated, challenged animals. Furthermore, delayed transmission of Avacc 10® vaccinated, challenged animals to placebo vaccinated animals was observed.
The purpose of the repeated dose toxicity study was to assess the safety and tolerability of Avacc 10® when administered through the intranasal route in New Zealand White Rabbits. Animals were vaccinated 3 times with Avacc 10® , and control animals with OMV only, or saline buffer. Toxicity was monitored until 2 weeks after the final vaccination. No clinical signs of toxicity nor morbidity/mortality were found in any of the groups, and no gross pathological changes were observed, demonstrating the safety of OMV based vaccine. All Avacc 10® vaccinated animals showed high IgG antibodies levels against Spike as well as virus neutralizing antibodies.
Based on the outcome of the Phase I trial, Intravacc will seek manufacturing and commercialization license partners.
About Intravacc's OMV platform technology
For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) - spherical particles with intrinsic adjuvant properties. The OMVs can be rigged with immunogenic peptides and/or proteins that stimulate effective adaptive immunity. The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens. Intravacc has also developed genetic tools to increase the yield of OMVs, reduce the toxicity and achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs.
Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. As an established independent CDMO with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology world-wide for many vaccines including polio-, measles-, DPT-, Hib- and influenza. Around 40% of childhood disease vaccines are based on Intravacc's know-how and proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, public health organizations biotech and pharmaceutical companies.
Sirona Biochem Corp. | November 24, 2022
Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence.
Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes.
Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039.
“We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.”
Dr. Howard Verrico, CEO
About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals
Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.
BioConsortia, Inc. | September 05, 2022
BioConsortia’s innovative microbial products and technical capabilities were on full display August 30th at its Davis, CA headquarters in an investor-focused Technology Showcase event. BioConsortia demonstrated rapid advancements in microbial product and pipeline developments for reducing nitrogen fertilizers, controlling soil pests and plant diseases for larger and better-quality crop yields, as well as protecting crops post-harvest to avoid food waste, while minimizing environmental impact and protecting our planet.
The Showcase event reintroduced CRIMSON™ fungicide and biostimulant ZAFFRE™, two products currently awaiting final registrations, and highlighted BioConsortia’s new fungicides, nematicides and nitrogen fixing products that are progressing through registration and commercialization and moving into evaluation with potential partners, as follows:
NO-NEM™ bionematicide advances: BioConsortia highlighted progress in bringing novel, safe and effective nematocidal microbes to market. Experts estimate global crop losses of $125 billion or 14% of crop value each year. Currently available chemical controls like methyl bromide, organophosphates and carbamates have an unacceptable level of toxicity to non-target organisms and are being withdrawn from use. NO-NEM is BioConsortia’s first nematicide product heading into full development phase. It has shown excellent performance against economically important pests in row crops, as well as fruits and vegetables, such as soybean cyst nematodes and root knot nematodes.
“Today we highlight the breadth of innovations developed to replace chemical crop inputs with superior microbe-based solutions for nitrogen fixing, disease control, nematode control, crop yields and post-harvest food safety. The recent progress of our pipeline – including some exciting technology breakthroughs - means we are ready to advance multiple major products into the commercialization phase with marketing partners.”
Marcus Meadows-Smith, CEO of BioConsortia
R&D Pipeline Expanded through Technical Innovation
Additions to BioConsortia’s R&D pipeline aim to leapfrog currently available microbial products, providing improved efficacy, increased shelf-stability, and reduced field use rates, as follows
Leveraging GenePro™ microbe editing platform for nitrogen-fixing breakthroughs: BioConsortia’s proprietary genomics and gene-editing platform, GenePro™, facilitates the discovery and engineering of a wide diversity of microbes faster and more efficiently. BioConsortia’s scientists affirmed GenePro has resulted in the discovery of novel genetic components driving nitrogen-fixation. BioConsortia’s proprietary bacterial strains fix nitrogen under conditions other N-fixing strains will not. This discovery validates the company’s position as a leader in microbe-derived alternatives for agriculture, has resulted in proprietary intellectual property, and will continue to drive our research focus.
Expanding library through AMS: BioConsortia’s patent-protected “AMS” - Advanced Microbial Selection™ platform uses evolutionary biology practices to find beneficial microbes that the plant has selected for specific gains. AMS underpins the breadth, depth, and success of BioConsortia’s product pipeline. The company announced the addition of more than 2000 rice diazotrophic microbial strains to its library, following a research program using AMS. This large addition to the library has greatly accelerated BioConsortia’s nitrogen-fixation project for rice, a crop with a paddy production model that represents a unique opportunity to impact the sustainability practices of both large and small growers of one of the world’s most fertilized crops.
Novel Bactericide Project: BioConsortia also introduced a new project focused on optimizing microbes for the production of metabolites active against bacterial disease. Project leaders highlighted early technological success within this project – again reliant on the GenePro platform, which focuses on utilizing novel tools to address evolving bacterial disease resistance and increasing bacterial pest pressure resulting from climatic challenges and global trade flows.
Novel Multi-spectrum Insecticide: Additionally, the company updated progress on a novel, developmental microbial active ingredient designed to deliver broad-spectrum control of both nematodes and critically important coleopteran and lepidopteran pests. The project aims to deliver a novel mode of action to support and extend crop trait lifecycles in the face of emerging insect resistance. Nematicide leads were originally characterized as strong root colonizers employing the company’s RhizoViz™ system, which uses proteins to visualize colonization robustness in different soils and environmental conditions. BioConsortia’s nematicide pipeline is now among the most expansive in agricultural research.
“BioConsortia’s pipeline progress highlights the strengths of the company’s R&D platform – unique in the industry in terms of discovery of plant-affiliated microbes and their optimization as solutions for agriculture,” said Dr. Hong Zhu, Senior VP of Research and Development at BioConsortia.
BioConsortia, Inc. develops superior microbial products that protect plants, enhance fertility, and increase yields while improving the sustainability of agriculture for our environment. Pioneering the use of directed selection within microbial communities, our patented Advanced Microbial Selection process and cutting-edge GenePro genomics and gene-engineering platform enable us to predict, design, and unleash the natural power of microbes.