The Innovation Fund invests in the development of CYM-001, an innovative Bispecific Antibody to treat Metastatic castration- resistant Prostate Cancer (BAMPC)

September 13, 2023

The Innovation Fund has invested approximately DKK 12.3 million in a research project aimed at developing a biological drug candidate that represents a completely new concept in cancer treatment. The molecule, CYM-001, owned by Cymab ApS, is a bispecific antibody that stimulates the body’s own immune system to fight cancer cells.

In the past decade, immune therapy biologics, known as checkpoint inhibitors, have revolutionized cancer treatment. They are becoming more widely used, with an estimated global market of $22 billion in 2023. However, with the expansion of checkpoint inhibitors, it has become clear that there are limitations, and there are large patient groups who cannot benefit from the treatment as their tumors are non-immunogenic, as is the case with certain types of advanced-stage prostate cancer.

Non-immunogenic tumors in mCRPC are the initial target for CYM-001. Each year, about 1300 men in Denmark die from prostate cancer, with a mortality rate that has remained largely unchanged for decades (Association of The Nordic Cancer Registries). Both in Denmark and the USA, prostate cancer is the second most common cancer-related cause of death in men, surpassed only by lung cancer. Existing treatment options for late stages of prostate cancer are currently limited and are not curative for several patient subgroups, including mCRPC. Existing treatment options also often have severe side effects. Impotence and incontinence are frequent consequences, resulting in reduced quality of life for patients.

The goal of the project is initially to develop a treatment for non-immunogenic tumors within metastatic prostate cancer, but it is expected to be applicable to several cancer types. The project is based on experiences with approved drugs combined with new scientific discoveries. Laboratory testing of various molecular prototypes has been ongoing for the past two years.

The project will aim to achieve crucial preclinical and CMC development, as well as clarify the clinical development for CYM-001 into a product for the treatment of metastatic prostate cancer. CYM-001 has the potential to be the first product of a new class of biological drugs that increase the quantity and effectiveness of immune cells in the tumor and are thus effective for cancer treatment where existing immune therapy falls short.

The project is a collaboration between the University of Southern Denmark, Research Unit for Clinical Physiology and Nuclear Medicine, Bioneer A/S, and Cymab ApS. At the University of Southern Denmark, Mikael Palner, Head of the Preclinical Imaging Core Facility and Associate Professor, and Christina Baun, Radiographer, will be responsible for translational pharmacological studies to characterize CYM-001. At Bioneer A/S, Christian Clausen, CSO, and Alexandra Baer, R&D Manager Upstream Development Mammalian Cells, will be responsible for cell line and Master Cell Bank development of CYM-001. Together, the partners have extensive experience in drug development, from molecular design and preclinical testing to the development of production methods that enable clinical testing.

Johan Faber, CEO, Cymab ApS. “By both stimulating the body’s own immune cells and directing them directly towards the tumor, the treatment is expected to be effective against cancer types that are not responsive to existing immune therapy. This provides doctors with an entirely new tool in the fight against so-called non-immunogenic or ‘cold’ tumors, unlike today, where there are essentially no effective treatments. The original field of potential drug candidates has now been narrowed down to one, and the new investment from the Innovation Fund enables the crucial development towards the ultimate goal of bringing new treatment options to an area of cancer treatment where nothing currently exists. It’s fantastic.”

Hans Wandall, Prof. MD and Chairman, Cymab ApS.
”The lack of recruitment of the body’s immune cells in non-immunogenic tumors is observed in several other cancer types besides prostate cancer. By targeting the binding of the molecule to these cancer types, the concept has broad potential as a new treatment paradigm.”

Stine Kjellev, CSO, Cymab ApS.
We will be able to offer a better and more targeted treatment with fewer side effects for the types of cancer where the body’s own immune cells do not effectively collaborate with the existing treatment. Our therapy, which we call Targeted Immune Stimulation, abbreviated as TIMS, has the potential to ensure that the same revolutionary effect delivered by checkpoint inhibitors can now also be offered to patient groups with non-immunogenic tumors.”

Mikael Palner, Head of the Preclinical Imaging Core Facility and Associate Professor, University of Southern Denmark. “At the Research Unit for Clinical Physiology and Nuclear Medicine, we are at the forefront of diagnostics and are developing groundbreaking methods to improve patients’ quality of life. Therefore, it is truly exciting to be part of this project, which has the potential to revolutionize current treatment options and make a huge difference for the affected patients.”

Christian Clausen, CSO, Bioneer A/S. “Bioneer develops cell lines that can be used for the production of new biological drugs. We are working on new methods to improve cell lines to produce more efficiently, as well as to produce more complex proteins. We look forward to collaborating on this new type of prostate cancer treatment project.”

For more information on the project:
Christian Clausen, Chief Scientific Officer:

About Bioneer: Bioneer A/S is a Danish Research and Technology Organization (RTO) in the field of biomedicine and biotechnology. Bioneer A/S is a trusted strategic R&D partner to biotech and pharmaceutical companies worldwide creating customized research service solutions. As an extended R&D team and trusted strategic partner, we bring value with unique know-how and advanced technologies. With dedicated and highly skilled employees, state-of-the-art laboratory facilities, and a history of more than 40 years of operation, Bioneer A/S delivers innovative solutions to the Life Science industry, as a Danish government-approved RTO.

For more information on Bioneer’s Cell Line Development services:
Ryan Polito, Business Development Manager: