Søren Bregenholt describes his professional career and how it led to him become the Chief Executive Officer at Alligator Bioscience, a research-based biotechnology company developing antibody-based pharmaceuticals for cancer treatment. He explains how the company specialises in the development of tumour-directed immunotherapies, in particular agonistic mono- and bispecific antibodies. During the podcast Søren shares his knowledge and experience about the options currently available for treatments and the work Alligator are doing in developing other drug options. Watch the podcast to find out more.
Alligator Bioscience announces that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. US 11,873,348 covering ATOR-4066, a Neo-X-Prime™ next generation bispecific antibody targeting CD40 and CEACAM5, in the treatment of cancer.
The patent, titled ”Novel peptides”, provides ATOR-4066 with protection regarding methods of treating cancer and/or a tumour using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule.
The patent is the first patent of the ATOR-4066 intellectual property portfolio which is expected to strengthen as more patents are filed and granted. Its accelerated application was part of the Cancer Immunotherapy Pilot program, which provided a fast-track review for cancer immunotherapy-related patent applications in the U.S.
“By simultaneously targeting CD40 and a tumor associated antigen, ATOR-4066 has demonstrated superior anti-tumor immunity, and we see medical opportunities for this first-in-class preclinical asset in , multiple cancer indications, targeting both cold and hot tumor types “ said Søren Bregenholt, CEO of Alligator Bioscience. “The granting of this patent is an important step in the ongoing development of ATOR-4066 and we place great emphasis on the protection of our intellectual property as a key component of our drug development program and our overall business strategy.”
ATOR-4066 was developed by Alligator’s proprietary Neo-X-Prime™ platform that generates bispecific conditional antibody agonists able to significantly boost dendritic cells and T-cell activation by connecting them to tumor debris.
ATOR-4066 is a new type of drug for cancer that works by stimulating the immune system to attack the tumour cells. It is a bispecific antibody, which means that it can bind to two different molecules at the same time. One of these molecules is CD40, which is found on immune cells and helps them to become more active. The other molecule is CEACAM5, which is found on tumour cells and tumour-derived particles. By connecting CD40 and CEACAM5, ATOR-4066 can bring the immune cells and the tumour cells closer together, and make the immune cells recognize and destroy the tumour cells more effectively. ATOR-4066 is made by Alligator Bioscience, a company from Sweden that specializes in developing drugs that use the immune system to fight cancer. ATOR-4066 is still in the early stages of testing, but it has shown promising results in laboratory and animal studies. ATOR-4066 is the first drug that uses Alligator’s Neo-X-Prime™ technology, which is designed to create a strong and specific immune response against each tumour. ATOR-4066 has also received a patent in the U.S. for its way of treating cancer using a bispecific antibody with certain features. This patent will help protect the rights and interests of Alligator Bioscience and support the further development of ATOR-4066.
Neo-X-Prime™ is a technology that creates bispecific antibodies that target CD40 and a tumour-associated antigen (TAA). CD40 is a molecule that activates immune cells, such as dendritic cells (DCs), and TAA is a molecule that is expressed by tumour cells or tumour-derived particles. By binding to both CD40 and TAA, the bispecific antibodies can link the DCs and the tumour material and make the DCs take up and present parts of the tumour cells to other immune cells. These parts are called neoantigens, and they are unique to each tumour. By presenting the neoantigens, the DCs can trigger a powerful and personalized immune response against the tumour. This technology aims to overcome the resistance to some drugs that block the signals that prevent the immune system from attacking the tumour, such as PD-1.
The reimbursement of cancer therapeutics is a complex and dynamic process that depends on various factors, such as the type of drug, the indication, the evidence of clinical benefit, the cost-effectiveness, the budget impact, and the negotiation between the manufacturers and the payers.
In general, the USA has a more decentralized and market-based system of reimbursement, where different payers (such as Medicare, Medicaid, private insurers, etc.) have different criteria and methods for determining the coverage and price of cancer drugs. The USA also tends to have higher prices and faster access to new cancer drugs than most European countries.
In contrast, the EU has a more centralized and regulated system of reimbursement, where the European Medicines Agency (EMA) evaluates the quality, safety, and efficacy of new cancer drugs, and then each member state decides on the pricing and reimbursement based on their own national policies and priorities. The EU also tends to have lower prices and more stringent assessments of the value and affordability of new cancer drugs than the USA.
Therefore, the answer to your question may vary depending on the specific drug, indication, and payer involved. However, based on the available evidence, that getting a cancer therapeutic reimbursed in the USA is easier than the EU in terms of the number of drugs available, the time to market, and the level of reimbursement. However, this may also come at the expense of higher costs and lower equity for patients and health systems