Introducing BCS-C01, a new treatment that engages the body's own immune system to treat diseases driven by chronic inflammation and unwanted cell proliferation.
BCS-C01 dampens chronic and overly robust inflammatory responses by enabling T cell recognition of antigen, resulting in a specific immune response and a selective reduction of unwanted, pro-inflammatory cells. The mechanism of action behind BCS-C01's activity provides a novel means to treat various forms of chronic inflammatory disease, including some autoimmune and neurodegenerative diseases, and some cancers.
BCS-C01 has been computationally designed to function effectively in the context of virtually everyone’s immune system to help focus a more effective immune response in very broad patient populations.
Because BCS-C01 was designed to facilitate a smooth transition from an acute, generalized inflammatory response to an effective, specific response, it provides a fundamental strategy for multiple conditions where "run-away" inflammation is a problem.
Chronic Inflammatory Diseases: BCS-C01 targets excess,
pro-inflammatory B cells, reducing an unwanted inflammatory immune response associated with chronic inflammation.
Neurodegenerative Diseases: BCS-C01 engages the immune system’s anti-inflammatory mechanisms, reducing unwanted inflammation associated with various brain-related syndromes, including traumatic brain injury.
Cancer: BCS-C01 facilitates presentation of antigens to T cells, helping to focus the T cell on the tumor cell as an effective anti-tumoral response.
BCell Solutions, Inc., is a Colorado Public Benefit Corporation on a mission to develop BCS-C01, a novel, transformative new drug therapy for the treatment of diseases driven by chronic inflammation and unwanted cell proliferation.
Following 30 years of University-based research dedicated to exploration of the nuances of the body’s immune system, our Chief Scientific Officer discovered, synthesized, and patented a new peptide, BCS-C01, which enables T cell recognition of antigen, triggering the transition from general, innate inflammatory response to specific, targeted adaptive immune response, assisting the body's immune system to effectively fight a broad range of serious diseases, especially those where unwanted inflammation is a key problem.
BCell Solutions has obtained a license from the University of Colorado for BCS-C01 and is aggressively pursuing its development for the treatment of various forms of chronic inflammatory diseases, including autoimmune and neurodegenerative diseases, and some cancers. BCell Solutions has also expanded BCS-C01 into a new BCS family of immunotherapies, establishing a pipeline of new immunotherapy products that target an additional mechanism that promotes a successful transition from chronic inflammation to a specific immune response.
An injury or infection results in two phases of an immune response: the first phase is known as an innate immune response and the second, an adaptive immune response. The first phase happens quickly and is characterized by inflammation and expansion of cellular players that “gear up” to a more selective attack that occurs during the second phase, adaptive immunity, that is specific and targeted to clear the infection or damage.
Chronic inflammatory diseases occur due to a failure to properly modulate pro-inflammatory cells during innate immune responses, or in transition from innate to adaptive immune responses, and in the case of autoimmune diseases, the immune system attacks the body’s own cells. Chronic inflammatory diseases sometimes occur following an injury or infection, perhaps resulting from collateral damage from either the innate response or perhaps from an adaptive response or possibly a failure to control the inflammation in the transition from innate to adaptive immunity.
Certain molecular patterns are displayed on all cell surfaces; some of these patterns are unique to each individual, thus allowing the immune system to distinguish self from non-self cells and healthy from infected or damaged cells. An important group of these molecular patterns are known as the Major Histocompatibility Complex Class II ("MHCII") molecules. MHCII is an important immune system component that flags other immune cells, such as T cells, to recognize the antigens that are pocketed into the antigen binding groove of MHCII for presentation to T cells. T cell recognition of the antigenic peptide is an important component of the transition between inflammation and an adaptive immune response. An appropriate transition can result in the death of unwanted cells, thereby eliminating threats from many viruses and pathogens.
During the initial inflammatory phase following infection or insult, the self-peptide CLIP (Class II-associated invariant chain peptide) can be pocketed into the antigen binding groove of MHCII receptors, and can prevent T cells from recognizing antigens and MHCII molecules and from causing the death of antigen-presenting cells. CLIP can prolong the activity of pro-inflammatory cells and, when CLIP “sticks around” too long, can lead to chronic inflammation, a key feature of many chronic diseases.
BCS-C01, the first of our patented peptides in the BCS family of immunotherapies, possesses unique binding characteristics that successfully compete with CLIP to occupy cell surface MHCII receptors. Thus, BCS-C01 eliminates CLIP’s ability to protect unwanted pro-inflammatory cells from immune system mediated cell death, reversing the destructive inflammatory process. As BCS-C01 is narrow in its targeting of only CLIP-positive cells, it avoids drawbacks characteristic of current, broad-based B cell depletion therapies. BCS-C01 was computationally derived to function in the MHCII molecules from every individual, optimizing BCS-C01's effectiveness for a very broad and diverse range of patients.
Current therapies that combat chronic inflammatory diseases tend to be non-specific in targeting inflammation. For example, current total B cell depletion therapies eliminate virtually all B cells, potentially compromising the patient's ability to fight infection, whereas BCS-C01 selectively eliminates only those cells that are pro-inflammatory.
Cancer is characterized by the proliferation or accumulation of “bad” cells, and cancer growth is enabled by the body’s failure to recognize and kill cancer cells using "normal" cell death signal machinery used routinely by the body to respond to common pathogens, viruses, or damaged cells. So, much like treatment of chronic inflammatory diseases, treatment of cancer involves the immune system's proper identification of unwanted antigens, such as tumor-associated antigens, and engagement of the immune system to fight unwanted cancer cells just as the body fights unwanted viruses and pathogens.
Similar to the mechanism that promotes chronic inflammation via the survival of unwanted, pro-inflammatory B cells, cancer cells survive by avoiding immune system recognition. As with chronic inflammatory diseases, a cancer cell's avoidance of an immune response can result from the presence of the "self" peptide CLIP in the cancer cell's MHCII receptor. The presence of CLIP in the MHCII receptor of a cancer cell effectively camouflages the cancer cell as a "self" cell, protecting the cancer cell from recognition and destruction by T cells.
Treatment with our patented BCS-C01 immunotherapy "competes out" CLIP from the MHCII signaling mechanism of some cancer cells, re-establishing "normal" antigen presentation and restoring the ability of T cells to identify and kill unwanted cancer cells as if they were the equivalent of a typical infected or damaged cell.
A major advantage of BCS-C01 over other immunotherapies in the treatment of cancer is the narrow targeting of BCS-C01 to CLIP expression, helping to focus the T cell on unwanted, CLIP-positive cells, rather than the broader population of properly functioning antigen presenting cells. As a result, BCS-C01 therapy will not trigger excessive T cell activation, or otherwise weaken or suppress the patient's desired immune response mechanisms.
An injury causes an innate immune response that is characterized by inflammation and expansion of cellular players that “gear up” to a more selective attack that occurs during the second phase, adaptive immunity. An example of this type of response occurs after traumatic brain injury ("TBI"). Our work, and the work of others, has shown that TBI causes an expansion of pro-inflammatory cells. In our model of TBI in animals, treatment with BCS-C01 immediately after the injury prevents the inflammation that would normally cause severe symptoms after brain trauma, including neurodegeneration. While this work is in its early stages, BCS-C01 and the BCS family of immunotherapies offer great promise for treating the syndromes that occur after brain trauma or other diseases where brain inflammation and neurodegeneration cause pathology.
BCell Solutions, Inc., is built upon decades of collaboration between and among our Founders and leading scientists and entrepreneurs around the world. The list of scientific collaborators and research institutions involved, directly and indirectly, in our findings and discoveries is long, and spans many decades of passionate research and exploration to unlock the nuances of the human immune system.
BCell Solutions is directed by a diverse management team:
Dr. M. Karen Newell Rogers, a Founder and our Chief Scientific Officer, is a world-renowned immunologist, researcher, and inventor. Several of her patented inventions serve as keystones of our work at BCell Solutions, and she directs our scientific research and development portfolio. Karen has held significant research posts at various Universities and has collaborated over the last 30 years with leading immunologists, scientists and physicians around the globe. Karen is now on a full-time mission at BCell Solutions, Inc., to move her BCS-C01 peptide, and the BCS family of immunotherapies, forward to clinical trial and full commercialization.
Dr. Ian Askill, a Founder and our Chief Operating Officer, is responsible for day to day research and development activities of BCell Solutions. Ian is a highly qualified scientist as well as an accomplished entrepreneur. He has previously founded a successful biotech start-up and also has significant experience in the pharmaceutical and bioscience fields.
Bernard "Chip" Landman III, a Founder and our Chief Executive Officer, is responsible for overall corporate management and strategic development activities. In addition to his legal training, Chip has a diverse range of skills developed from his various entrepreneurial, manufacturing, public sector and regulatory experiences.
Our Chief Scientific Officer, Dr. M. Karen Newell Rogers, has devoted the last 30 years to researching immune system function, and its many nuances. Dr. Newell Rogers is a world-renowned immunologist who holds numerous patents in various fields of immunology. Several of
Dr. Newell Rogers' patents were filed during her tenures at the University of Colorado and Texas A&M University, and subsequently licensed to BCell Solutions, Inc., for commercialization. BCS-C01, a patented peptide-based drug therapy, is included in BCell Solutions' IP portfolio. BCell Solutions has also developed and has "patents pending" for an expanded BCS family of immunotherapies, creating a pipeline of new immunotherapies that target an additional mechanism of action that promotes a successful transition from chronic inflammation to a specific immune response.
BCell Solutions' IP portfolio is maintained and safeguarded by the law firm of Wolf, Greenfield & Sacks, P.C., in Boston, one of the world’s premier intellectual property firms.
BCell Solutions is engaged in multiple proof of principle/proof of concept studies to validate the use of our BCS-C01 drug therapy, and our pipeline of BCS immunotherapies, for the treatment of various forms of chronic inflammatory diseases, including autoimmune and neurodegenerative disease, and some cancers.
BCell Solutions is actively engaged in pre-clinical studies to validate and advance our existing data on the use of BCS-C01, and our BCS family of immunotherapies, for the treatment of many forms of chronic inflammatory disease, including multiple sclerosis, traumatic brain injury, Alzheimer’s, Crohn's, Type 1 diabetes, transplant rejection,
Lyme, sepsis, preeclampsia, PANS, myasthenia gravis, and multiple forms of cancer, including melanoma, glioblastoma multiforme, pancreatic, leukemia and others.