Introducing KEN1, a new treatment mechanism that engages the body's own immune system to treat diseases driven by chronic inflammation and unwanted cell proliferation.
KEN1 dampens chronic and overly robust inflammatory responses by selectively reducing the number of unwanted cells that help drive excess inflammation, allowing an effective innate and acquired immune response to various forms of autoimmune disease, neurodegenerative disease, and cancer.
KEN1 has been computationally designed to function effectively in the context of virtually everyone’s immune response genes to help focus a more effective immune response.
Autoimmune Disease: KEN1 downregulates excessive B cell proliferation, reducing an unwanted inflammatory immune response associated with autoimmune disease.
Neurodegenerative Disease: KEN1 engages the immune system’s anti-inflammatory mechanisms, reducing unwanted inflammation associated with various brain-related syndromes, including traumatic brain injury.
Cancer: KEN1 facilitates presentation of antigens to T cells, helping to focus an immune response to unwanted cancer cells.
BCell Solutions, Inc., is a Colorado Public Benefit Corporation on a mission to develop KEN1, a novel, transformative new drug therapy for the treatment of diseases driven by chronic inflammation and unwanted cell proliferation, including various forms of autoimmune disease, neurodegenerative disease, and cancer.
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, KEN1, which resolves an important immune system signaling defect, facilitating a “normal” immune system response mechanism that allows the body's immune system to effectively fight a broad range of pernicious and deadly diseases.
BCell Solutions has obtained a license from the University of Colorado for KEN1 and is aggressively pursuing its development for the treatment of various forms of autoimmune disease, neurodegenerative disease, and cancer.
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.
Autoimmune diseases occur when the immune system attacks the body’s own cells. Autoimmune disease sometimes occurs 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 antigens that are pocketed into the antigen binding groove of MHCII for presentation to T cells. T cell recognition of the antigenic peptide 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 on MHCII receptors, and can prevent T cells from recognizing antigens and the 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 autoimmune diseases.
Current therapies that combat autoimmune disorders tend to be non-specific in targeting inflammation. For example, B cell depleting drugs deplete virtually all B cells, potentially compromising the patient's ability to fight infection.
KEN1, our patented peptide, possesses unique binding characteristics that can compete with CLIP to occupy external MHCII receptors. Thus, KEN1 can eliminate CLIP’s ability to protect unwanted pro-inflammatory cells from immune system mediated cell death/destruction and can reverse the destructive inflammatory process associated with autoimmune disease. As KEN1 is narrow in its targeting of CLIP, it avoids drawbacks characteristic of current, broad-based B cell depletion therapies. KEN1 was computationally-derived to function in the MHCII molecules from every individual, optimizing KEN1’s effectiveness for a very broad and diverse range of patients.
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 autoimmune diseases, treatment of cancer involves the immune system's proper identification of unwanted cancer cells, and engagement of the immune system to fight unwanted cancer cells just as the body fights unwanted viruses and pathogens.
Similar to the autoimmune disease mechanism, cancer cells proliferate as a result of immune system signal interference with the MHCII receptor. As with autoimmune disease, this signal interference can result from the presence of the "self" peptide CLIP in the MHCII receptor, that effectively camouflages the cancerous cell as a "self" cell, protecting the cancerous cell from recognition by the immune system, and protecting the cancerous cell from T cell activation that could result in recognition and destruction of the cancer cell.
Treatment with our patented KEN1 drug therapy displaces CLIP from the MHCII signaling mechanism, re-establishing "normal" antigen presentation and restoring the immune system's ability to identify and kill unwanted cancer cells as if they were the equivalent of a typical infected or damaged cell.
A major advantage of KEN1 in the treatment of cancer over other immunotherapies is the narrow targeting of KEN1 to CLIP-positive MHCII cells, focusing T cell activation only against unwanted, CLIP-positive cells, rather than the broader population of properly functioning B cells. As a result, KEN1 therapy will not impair proper B cell function, 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 KEN1 immediately after the injury prevents the neurodegeneration that would normally cause severe symptoms after brain trauma. While this work is in its early stages, KEN1 could offer great promise for treating the syndromes that occur after brain trauma or other diseases where neurodegeneration causes pathology.
Although a new Company, the "deep roots" of BCell Solutions, Inc., result from decades of collaboration between and among our Founders and leading scientists and entrepreneurs around the world. The time and dedication of a very diverse team is the platform upon which we have built our Public Benefit Corporation, recently formed to launch and implement our BioMoonshot to commercialize KEN1. The list of scientific collaborators and research institutions involved, directly and indirectly, in our BioMoonshot is long, and spans many decades of passionate research and exploration to unlock the nuances of the human immune system. In addition to the historical and on-going contributions of our various colleagues in the scientific and business communities, the BCell Solutions BioMoonshot 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 patented KEN1 peptide drug 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 tenure at the University of Colorado (Issued Patent Numbers 8,557,764 and 8,957,031) and Texas A&M University (Provisional Application Number 62/559,499), and this IP has been licensed to BCell Solutions, Inc., for commercialization. KEN1, a patented peptide-based drug therapy, is included in BCell Solutions' IP portfolio.
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 KEN1 drug therapy in the treatment of various forms of autoimmune disease, neurodegenerative disease, and cancer.
BCell Solutions is actively engaged in a pre-clinical study validating and advancing our existing data on the use of KEN1 as a co-therapy with existing immune checkpoint inhibitor (ICI) drugs in the treatment of melanoma. BCell Solutions is also aggressively pursuing parallel and stacked research and development on KEN1 as a potential therapy for the treatment of many other serious diseases and conditions, 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 glioblastoma multiforme, pancreatic, leukemia and others.