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We are passionate in our commitment to improving and renewing people`s lives. Sesen Bio is a late-stage company devWe are passionate in our commitment to save and improve the lives of patients. Sesen Bio is a late-stage company developing fusion protein medicines for the treatment of patients with cancer. In February 2021, the FDA accepted for filing the Company`s BLA for Vicineum™, a potential best-in-class treatment for non-muscle invasive bladder cancer.eloping fusion protein medicines for people with cancer. Our fusion protein approach tethers a tumor-targeting antibody fragment to a protein cytotoxic payload to form a single protein molecule designed to selectively and broadly kill cancer cells while sparing healthy cells and to activate the body`s innate immune response system. The most advanced program in our pipeline is Vicinium™, a novel investigational anti-cancer treatment that has the potential to treat multiple cancers driven by overexpression of EpCAM, such as non-muscle invasive bladder (NMIBC) and squamous cell carcinoma of the head and neck (SCCHN). We are currently advancing Vicinium in a Phase 3 registration trial for the treatment of people with NMIBC who have been previously treated with bacillus Calmette-Guérin (BCG), with positive three-month efficacy results established and 12-month study results expected in mid-2019. Due to Vicinium`s potential to promote an anti-tumor immune response, we believe it holds promise as a combination treatment with immuno-oncology drugs, such as checkpoint inhibitors.
Microbion is a clinical stage biopharmaceutical company. Microbion is developing MBN-101 as the first product in the bismuth-thiol class for the treatment of resistant and difficult to treat infections. MBN-101 has broad spectrum, anti-bacterial efficacy against a broad range of pathogens, including multiple priority pathogens or “superbugs”. In addition to anti-bacterial efficacy, MBN-101 also has highly advantageous and product-differentiating capability to prevent and eradicate microbial biofilms. The dual action from this first in class product provides a novel clinical approach to treating infections. Their effectiveness against MRSA, MDR TB, CRE, VRE, and other antibiotic resistant pathogens highlights their potential to provide solutions to the dramatic and alarming increase in global antibiotic resistance.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body`s immune response. Celldex Therapeutics (NASDAQ: CLDX) was founded based on a fundamental scientific belief that harnessing the power of the immune system would break significant barriers in drug development for a host of devastating diseases. The Company`s pipeline is comprised of therapeutic antibodies, antibody drug conjugates, immune system modulators and vaccines that we believe have a higher probability of success because they are targeted to specific patient populations with high unmet medical need whose diseases express specific markers, including many underserved or completely un-served orphan indications. This has created a leading pipeline in immuno-oncology.
Kudo Biotechnology is a global CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has state-of the-art clinical GMP manufacturing facilities and labs in Boston, China & Singapore, making pDNA, mRNA and LNP. Kudo Bio differentiates by being a one-stop stop for all your mRNA manufacturing needs, by streamlining the process, removing bottlenecks and ensuring ease in your CMC. Our performance matches and surpasses industry-leading yields & efficiencies across all stages of the process. Our speed of 6.5 months from sequence to GMP mRNA-LNP exceeds industry platinum standards, and our quality is superior to competitors while maintaining full compliance with global regulatory requirements. Kudo Bio has a track record of accomplishing end-to-end GMP manufacturing with products entering the clinic, and successfully completing multiple batches of process validation after international technology transfer. We have an industry-leading manufacturing cGMP facility with capacity to make up to 50 GMP batches annually, with deep technology partnerships enabling access to scale-up expertise & production know-how. Finally a comprehensive quality management system with QA/QC capabilities which meet major regulatory agencies compliance requirements is paramount to delivering products to customers around the world.
Noveome Biotherapeutics, Inc. is a clinical stage company focused on breakthrough therapies for the regenerative repair of inflamed or damaged tissues.