BioInvent International AB
The problem – one in three people will get cancer
One in three people will get cancer and, although treatments have improved, mortality in many forms of cancer is high and drug side effects are severe. The body’s immune system is one of the most effective weapons to fight cancer and development of immuno-oncology drugs directing the immune defense against cancer is expected to revolutionize the treatment. Researchers and pharmaceutical companies all around the world are now working intensely to find antibodies that can affect the target structures on tumor cells and in the immune system that inhibit or promote tumor development, without obstructing the normal functions of cells in the rest of the body.
The solution – a unique engine for developing immunooncology drugs
BioInvent International – established in 1983 – has a unique technology development engine that combines the n-CoDeR® antibody library, a clinically validated, highly functional and diverse source of 30 billion unique antibodies, and F.I.R.S.T.TM, a unique tool to identify antibodies that can affect target structures on tumor cells and in the immune system that inhibit or promote tumor development.
BioInvent uses its unique development engine to develop new proprietary drugs in oncology and also offers pharmaceutical and biotech companies to license their development capabilities. BioInvent has several decades of experience in cell line development, production optimisation and cGMP-certified manufacturing of antibodies for phase I – III clinical trials in the Lund facility.
An attractive pipeline and revenues from existing customers
With ieading expertise in immuno-oncology, BioInvent is wellpositioned to contribute to the ongoing revolution in cancer treatment.
During 2016, BioInvent will start clinical studies in three programs – all of which have potential to be developed and approved as orphan drugs and a faster development path to the market. All three trials are open-label; consequently, patient data can be continuously monitored during the studies.
BioInvent has entered into licensing agreements with seven global pharmaceutical companies who access the n-CoDeR® antibody library and, in some instances, collaborate with BioInvent to discover and develop optimal clinical candidates.
The future – building value with balanced risk
BioInvent’s proprietary drug assets have the potential to generate significant value growth as new data is generated and license agreements are entered into. In addition, the company has a preclinical pipeline focusing on regulatory T cells (Treg), tumor associated macrophages (TAM), and OX40 and 4-1BB coreceptors.
Good cost control, financial and operational support from nonprofit organizations – coupled with revenues from existing customers – allows the company to pursue a risk-balanced business model.
Multiple myeloma (BI-505)
BI-505 was primarily developed to treat multiple myeloma, a hematological disease that occurs in the patient’s bone marrow. BI-505 is a fully human antibody targeting ICAM-1, a protein on the surface of cancer cells. A favorable safety profile was documented in a phase I study in patients who were resistant to existing drugs and where there were also signs of a positive effect against the disease. The development strategy is focused on residual disease in combination with modern standard-of-care drugs in patients with multiple myeloma. A phase ll study in collaboration with Penn Medicine has been initiated to investigate if BI-505 can deepen the response after autologous stem cell transplantation. BI-505 has received Orphan Drug Designation for the multiple myeloma indication, both in the U.S. and EU.
Non-Hodgkin lymphoma and chronic lymphatic leukemia (BI-1206)
BI-1206 is a fully human antibody aimed at CD32b, an immunosuppressive protein that is overexpressed in patients with lymphoma. CD32b is involved in development of resistance to the market leading treatment in NHL and CLL – rituximab. Comprehensive preclinical studies suggest that by combining this treatment with BI-1206, a significantly better anti-tumour effect can be achieved. Planning is currently under way for a phase I/II study in patients with NHL and CLL. An application to start of the study was submitted to the UK Medicines Agency in April, 2016. The study will be executed and funded by a consortium headed by one of the world’s largest scientific non-profit organizations – Cancer Research UK. Alongside this clinical study, preclinical studies continue to demonstrate combination effects of BI-1206 in combination with other antibodies.
The U.S. FDA has approved an Investigational New Drug (IND) application prior to the start of a clinical phase I/II study of TB-403. The first safety evaluation portion of the study will include patients with medulloblastoma, neuroblastoma, Ewing’s sarcoma and alveolar rhabdomyosarcoma. The efficacy evaluation phase will include patients with medulloblastoma. Preclinical studies evaluating the effect of the antibody in models for neuroblastoma are ongoing, a type of tumor with many similarities to medulloblastoma. The clinical program is conducted in cooperation with Oncurious NV.