Oncotherapy Solutions, LLC
  
                         

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Focusing on scientific discovery and innovation in targeted therapy and immuno-oncology to save human lives: 

Cancer is the second most common cause of death in the US, exceeded only by heart disease.
 One of every four deaths in the United States is due to cancer.  The American Cancer Society estimates that in 2014, about 1,665,540 Americans were diagnosed with invasive cancer, and 585,720 Americans died of this disease.  The financial costs of cancer treatment are a burden to people diagnosed with cancer, their families, and society as a whole. The National Institutes of Health (NIH) estimates overall costs of cancer care in 2010 at $263.8 billion.  Currently used cancer drugs such as chemotherapeutic agents and monoclonal antibodies have limitations due to their toxicities and are ineffective against tumors with drug resistance.  Thus, there is an urgent need for more potent, targeted and safer cancer therapeutics.  Oncotherapy Solutions, a new biotechnology company is utilizing its previous expertise in preclinical drug development and delivery to design and test new pipeline of targeted, potent, stable and safer drug conjugates, kinase inhibitors and vaccines for the treatment of prostate, ovarian, breast, colon, pancreatic and lung cancers. 


The company currently has three preclinical programs:


The first program is focused on the development of novel, potent and safer drug conjugates carrying new chemotherapeutic agents.  We have completed proof of concept in-vitro preclinical studies of these drug conjugates on triple-negative breast, prostate and ovarian cancer cells.  We have also completed the efficacy
 in-vivo studies of our novel lead drug conjugate using MDA-MB-231 orthotopic triple-negative breast cancer mouse model.  The lead drug conjugate showed a dramatic and highly significant tumor growth inhibition in-vivo with no change in animal weight. The majority of treated mice had no detectable tumors (complete response) after 3 weekly injections of 1.6 mg/kg of our lead drug conjugate and we are currently conducting toxicology studies.  Further efficacy and toxicology studies on immuno-deficient mice bearing orthotopic human MDA-MB-231 triple-negative breast cancer showed that our drug conjugate is also effective with excellent safety profile at 2 weekly injections of 450 µg/kg.  In addition to the direct anti-tumor activity we are planning to investigate a potential immuno-stimulatory activity of our drug conjugates alone or in combination with immune checkpoint inhibitors in humanized SRG-SGM3 mice engrafted with human CD34+ hematopoietic stem cells and bearing MDA-MB-231 or BR1126 patient-derived triple-negative breast cancers.  Our goal is to complete the in-vivo preclinical studies of our lead drug conjugate on triple-negative breast, ovarian and prostate cancers as well as file IND applications and start clinical trials early 2019.  Our drug conjugate is highly targeted to cancer cells and safer than standard chemotherapy which suffers from high toxicity and low potency in drug-resistant cancers.  Our lead drug conjugate is also expected to be potent against other solid tumors including pancreatic, colon and lung cancers. 

The second program is dedicated to the development of novel multi-kinase inhibitors for the treatment of colon and breast cancers.  We are in the process of testing these novel kinase inhibitors as small molecule or targeted nanoparticle formulations in-vitro on breast and colon cancer cell lines.  Lead kinase inhibitor formulations will be further tested  in-vivo in animal models bearing human breast or colon cancer xenografts as well as Patient-derived tumors.
 
The third program is focused on the development of new immunotherapy small molecule drugs that will help patient's own immune system, namely cytotoxic T cells and natural killer cells to seek and destroy cancer cells that express specific antigens at their surface.  We are also seeking partnerships to develop immuno-oncology bispecific nanobodies for solid tumors. Our future plan is to screen well-designed small molecule drug candidates and humanized nanobodies for the treatment of pancreatic, lung, prostate and breast cancers. 
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