Prima BioMed is a globally active biotechnology company headquartered in Sydney, Australia. Developing novel immunotherapeutic products for cancer and autoimmune diseases, Prima is dedicated to leveraging its current technology and expertise to offer innovative treatment options for patients and to maximize value to shareholders. Prima’s main pipeline of products, covering the LAG-3 mechanism of controlling immune responses, now has a number of trials under development or being progressed by partners. Prima’s lead product IMP321 is under clinical development for the future application in a range of cancer therapies. Prima’s newest product candidate IMP761 is under preclinical development with the potential to be applied in autoimmune diseases. Prima’s autologous dendritic cell-based product tested in clinical trials for ovarian cancer patients has been licensed to Sydys Inc. in the US and to Neopharm in Israel.
Prima’s business focus is to leverage its current technology platform and expertise to develop immunotherapeutic products for patients.
Prima's lead product is IMP321, a T cell immunostimulatory factor under development for applications in chemoimmunotherapy and immune-immuno combinatory therapy in a range of different cancers. Clinical studies are ongoing and show safety and tolerability.
Prima’s newest product candidate is IMP761, which is an antibody against highly active immune cells in autoimmune diseases. IMP761 is under preclinical development.
The company's foundation product CVac™ was transferred to Sydys Inc. in May 2016. CVac is a dendritic cell product tested in clinical trials for ovarian cancer.
Our corporate mission is to strive to become a leader in cancer immunotherapy. This process is driven by the development of high value, immunotherapeutic products, capitalizing on Prima’s innovation to date and the capacity for further innovation which leverages our experience and know-how.
Prima BioMed was originally created as a mining company (Prima Resources) in Australia in 1987, and was first publicly traded in 1988 on the Australian Stock Exchange. The corporate focus changed radically in 2001 with the acquisition of the rights to develop technologies from the Austin Research Institute (now the Burnet Institute), including CVac™, an immunotherapeutic product.
On 2 October 2014, Prima announced the acquisition of Immutep SA (Immutep), a private French biotechnology company.The transaction was formalized at the Annual General Meeting of shareholders on 14 November 2014 and completed 17 December 2014. Immutep is now the French subsidiary of Prima Biomed.
Prima BioMed’s corporate headquarters are in Sydney, Australia. Additional offices and local subsidiaries are located in Germany and France.
The LAG-3 pathway has an impact on controlling immune responses. LAG-3 is an important immuno-oncology target leading to a growing interest in research and development by scientific laboratories and pharmaceutical industry within last years. With its potential synergistic function with PD-1 and PD-L1 – another immune checkpoint inhibitor – LAG-3 is a very promising target in cancer and autoimmune disease therapies.
Prima’s products are as follows:
- IMP321 is the lead Immutep product and under clinical development. It is a recombinant protein that may be used as monotherapy, as an adjuvant, in chemoimmunotherapy or in combinatory immunotherapy. IMP321 works by binding to a receptor on antigen presenting cells (APC's) such as dendritic cells to activate them. The APC's are important for showing cancer antigens to T cells and switching them on to remove these cancer cells. So, this technology has potential to push the patient’s own immune system to fight against cancer cells.
- IMP731 is a depleting anti-LAG-3 antibody. It depletes T cells in autoimmune disease leading to long term immunosuppression. A derivate of IMP731 is being developed by GSK.
- IMP701 is an antagonist antibody that binds to a receptor on suppressive T cells to block their inhibitory signal. It is being developed by Novartis (CoStim).
- IMP761 is Prima’s newest product candidate and believed to be the first agonist anti-LAG-3 monoclonal antibody. It is under preclinical development with the potential to decrease the massive number of autoreactive CD8+ T cells in autoimmune diseases.
IMP321 is under clinical development in a Phase IIb chemoimmunotherapy trial in metastatic breast cancer and in a Phase I trial in combination with Keytruda in melanoma. The partnered products including the depleting and the antagonist LAG-3 antibodies have commenced Phase I trials. The newest product candidate IMP761 is under preclinical development.
CVac™ has been transferred to US based Sydys Corporation for further clinical development. It is a dendritic cell-based therapeutic that has been studied in global clinical trials as a maintenance therapy for epithelial ovarian cancer and resected pancreatic cancer.
Prima BioMed operates as a global company, and therefore, R&D has been performed across many continents. Clinical research has been conducted in Australia and Europe for patients who are in first line remission and in numerous countries in Europe for patients in whom the cancer has recurred and are in second remission.
With its subsidiary Immutep, Prima has a laboratory facility in Paris where the newest product candidate IMP761 was developed.
Prima's current development strategy is to focus on its LAG-3 programs as LAG-3 is one of the main checkpoint inhibitors and a very promising immune-oncology target.
Prima will continue to develop IMP321, an immune activator in Phase IIb for metastatic breast cancer through its AIPAC trial (clinicaltrials.gov identifier NCT 02614833). As an immuno-immuno combinatory treatment, IMP321 is applied in combination with PD-1 inhibitor known as Keytruda® in a phase I trial called TACTI-mel (clinicaltrials.gov identifier NCT 02676869).
In line with the LAG-3 strategy, Prima developed the newest product candidate IMP761 as the first agonist antibody of LAG-3 with the potential to be applied in autoimmune diseases. As IMP761 is early stage, in 2017 Prima will focus on preclinical development, including in vivo efficacy model studies, to better understand its potential applications.
The depleting antibody as well as the antagonist antibody will continue to be developed by GSK and Novartis.
Prima continues to lead the way in researching and developing novel LAG-3 targeting technologies.
Q6: What is the novelty of IMP761?
IMP761 is believed to be the first agonist antibody of LAG-3. It has been developed as new early stage product candidate, a humanised IgG4 monoclonal antibody. A new patent has been filed to provide protection for this antibody. It is mechanistically distinct from any of the known LAG-3 antibodies. Until now, therapeutic antibodies with agonistic properties have not been described for any of the three major immune checkpoints, CTLA-4, PD-1 or LAG-3. IMP761 promises the first opportunity for fine tuning of the immune response to an immune checkpoint target. This singular biological activity of IMP761 could benefit patients suffering from certain autoimmune diseases by temporarily switching off activated LAG-3+ T cells that are damaging tissue or creating inflammatory responses.
Prima BioMed has partnerships with Eddingpharm, GlaxoSmithKline and Novartis (Costim).
The LAG-3 technology has a number of academic collaborations in progress for clinical studies of IMP321. In addition, via the partnership with Eddingpharm, the Shanghai-based WuXi Apptech are manufacturing clinical grade IMP321 for the studies.
Prima has completed a licensing deal with US based biotechnology company Sydys Corporation for the CVac technology.
For the LAG-3 technology, there are 12 patent families covering the pipeline of products. Three families are licensed from Merck Serono and provide protection for the LAG-3 gene and antibodies. One family is co-owned with the French National Health and Medical Research Institute known as INSERM. This patent has been licensed to GSK.
The remaining patents are fully owned by Prima and will provide broad and lengthy protection for the development of existing and new LAG-3 technologies.
Q2: Can you please explain what your licensed patents are about?
For the LAG-3 patents, we have numerous patents that cover the LAG-3 gene, protein and antibodies. There are a multitude of method of composition and method of use claims.
There are claims covering modifications to the original gene sequence to allow generation of IMP321 and other LAG-3 derivatives. There are method of use claims covering the use of various LAG-3 reagents to treat autoimmunity and cancer and to cover different dosages. There is potential to use various LAG-3 products in different situations including with cell therapies, with or as antibodies, as an adjuvant, in combination therapies and so on.