Our technology is a novel Mode of Action using micelles with an immune stimulating small molecule drug. This approach show a strong activation and migration of immune cells into tumor tissue a few hours after treatment. Initially the micelles activate neutrophils that migrate into tumor tissue leading to tumor cell killing. Subsequently other immune cells are recruited to the tumor tissue and eventually stimulate tumor antigen specific responses leading to a long lasting immune memory response and complete remission of tumors.
This approach is a novel approach to use a small molecule TLR7 agonist compatible with a micelle formulation termed MBS8; an approach not previously seen for TLR stimulation.
Key benefits of the MonTa Biosciences’ technology are:
- Novel Mode of Action to recruit antitumor immune cells to the tumor tissue
- MBS8 micelles allow administration of immune stimulating drugs with reduced cytokine production with favourable safety profile
- MBS8 can be administered using the intravenous route which is a major advantage for doctors and patients
- MBS8 is a micellar formulation of a small molecule TLR7 agonist which has undergone GMP scale up production
- TLR7 is a well validated target in cancer therapy with the Aldara cream used for topical cancer
- MBS8 show superior anti-tumor activity in monotherapy to many approved therapies
- Combination with Immune Checkpoint Inhibitors, radiotherapy and chemotherapy show complete remission in preclinical models
- The CMC package for MBS8 is strong with 3 y stability and streamlined GMP production
Todays challenges in cancer treatment
The major challenge for cancer treatment today is to improve treatment and survival of patients with advanced, recurrent and metastatic disease.
The total number of patients expected to die in 2024 from cancer exceeds 500.000 in the US alone, and more then 7 million people Worldwide. More than 90 % of cancer deaths today is caused by metastatic disease.
In particular lung and pancreatic cancer patients are diagnosed late and often with metastatic disease, resulting in less than 10 % of these patients alive after 5 years. Also cancers with good 5 year survival rates like colon cancer, colorectal cancer, breast and prostate cancer are difficult to treat if the disease has progressed to the metastatic stage.
Our technology provides a solution to this challenge. We have demonstrated the ability of our technology to raise an immune memory response that is effective in treatment of metastatic disease.
Cancer is the leading cause of death worldwide, accounting for more than 8 million deaths annually, and this number is projected to continue rising, with an estimated 13 million deaths in 2030. In the western world one out of three will get cancer during their lifetime, and more than one third of these patients will die from their disease. During the last decade, the 5 year survival has improved markedly for most cancers, and today there is more than 80 % chance of surviving breast, ovarian, prostate and colon cancer.
The most efficient treatment of cancer today is surgery, but often the tumor is localized at in-operable sites or has spread to distant sites called metastasis. Other treatment types includes radiotherapy, chemotherapy, small molecule drugs or therapeutic antibodies.
A major improvement in cancer treatment for the last 5 years has been the approval of immune checkpoint inhibitors (ICI) that prevent the tumor from suppressing the immune system once it attacks the tumor. The ICIs have demonstrated good effect in certain patients, but it is clear that to improve patient outcome even further, additional combination treatment is warranted.
The technology by MonTa Biosciences is a type of immunotherapy to complement both ICI treatment, but also a number of other treatments approved today.
Cancer Immunotherapy relies on use of the patients own immune system to fight cancer. It is now clear that one step in the process of cancer development involves loss of efficient immune control, leading to tumor immune escape mechanisms with subsequent uncontrolled tumor progression.
Immunotherapeutic strategies that are now clinically used includes:
- Checkpoint inhibitors blocking the PD-1/PD-L1 synapse is expanding their use for many different cancers “Immune Checkpoint Inhibitors“
- CAR-T-cell technologies.
- Therapeutic antibodies e.g. Avastin®, Rituxan® Erbitux® and Herceptin®. These drugs are among the top 10 selling anti-cancer drugs today with annual sales approaching 5 billion US$.
We have Composition of Matter Worldwide exclusive rights to a novel TLR7 agonist and the formulation MBS8, which is a potent stimulator of the innate immune system. Both the API and our Drug Product has been scaled in production and GMP produced in three batches so far, all showing 3 years stability at 4C.