Oncotherapy Solutions, LLC


  Harnessing the power of targeted therapy and patient's immune system to treat drug-resistant solid tumors

5/20/2018: The National Cancer Institute has awarded Oncotherapy Solutions a Phase 1 SBIR grant to perform further oncology and immuno-oncology preclinical studies on its novel drug conjugate as monotherapy and as combination therapy for the treatment of Triple-Negative Breast Cancer (TNBC).  We are looking forward to the successful completion of the Phase 1 SBIR studies and the submission of Phase II and IIb SBIR grant applications to conduct further IND-enabling studies with the goal to start clinical trials in the near future.  Oncotherapy Solutions have also tested the novel drug conjugate alone or in combination therapy on Castration-Resistant Prostate Cancer (CRPC) in-vitro and found a direct synergistic anti-proliferative activity of the novel drug with another drug candidate.  We are looking forward to the conduct of immuno-oncology and oncology preclinical studies on CRPC upon availability of additional funds. Both TNBC and CRPC are resistant to current available therapies and thus Oncotherapy Solutions novel drug conjugate alone or in combination therapy is expected to provide patients suffering from these deadly cancers with targeted, highly effective and safer anti-cancer therapeutics.  Our novel drug conjugate is also potent against drug-resistant ovarian cancer cells and is expected to be effective against pancreatic and colon cancers which express high levels of the target biomarker.

7/18/2017:  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 its direct anti-tumor activity our drug conjugate is expected to have immuno-stimulatory activities through dendritic cell maturation and T cell activation in humanized NSG-SGM3 mice engrafted with human CD34+ hematopoietic stem cells and bearing MDA-MB-231 or BR1126 patient-derived triple-negative breast cancers.  We will soon initiate in-vivo immuno-oncology studies to elucidate the effect of our drug conjugate alone or in combination with immune checkpoint inhibitors on dendritic cells, cytotoxic CD8 T cells, T regulatory cells and natural killer cells in tumor tissue.  We are extremely excited about our future combination preclinical studies of targeted therapy and immuno-oncology drugs putting our company at the forefront of providing drug-resistant cancer patients with novel, effective, safer targeted therapies as compared to standard chemotherapy which is ineffective and highly toxic. Upon availability of additional funds we will test these targeted combination therapies on other solid tumors including prostate, ovarian, endometrial, pancreatic, colon and lung cancers. 

6/28/2016:  We are extremely delighted to announce that our lead drug conjugate showed a dramatic and highly significant tumor growth inhibition of triple-negative breast cancer using the MDA-MB-231 orthotopic mouse model.  The majority of treated mice had no detectable tumors (complete response) after 3 weekly injections of 1.6 mg/kg of the lead drug conjugate while animal weight remained unchanged.  We are looking forward to the completion of the efficacy and toxicology study. We will soon conduct additional in-vivo IND-enabling studies on triple-negative breast cancers with the goal to move very quickly to clinical trials  and seek Fast-Track FDA approval to help patients with triple-negative breast cancers.  

11/26/2015:  Additional in-vitro preclinical studies of our top drug conjugate showed higher stability, solubility and safety as well as potency in the low nanomolar doses on triple-negative breast cancer and drug-resistant ovarian cancer cells as compared to the competitor's product.  

9/6/2015: After extensive screening process we have selected a lead drug conjugate carrying a novel toxin that showed high efficacy in triple-negative and metastatic breast cancer cells as compared to competitor's drug conjugate. In addition, we found that our drug conjugate is much safer as it is effective only on cancer cells over-expressing the target biomarker while it has zero toxic effect on normal cells.  The lead drug conjugate was manufactured using simple, highly efficient, well-controlled and cost-effective conjugation chemistry.  

12/5/2014: We are in the process of testing our novel kinase inhibitors on drug-resistant breast and colon cancer cell lines 
in-vitro. We expect our kinase inhibitors to target multiple kinases responsible for cancer cell survival, proliferation and metastasis and be superior to the competition.  The selected lead kinase inhibitor will also be tested in combination with our targeted cytotoxic drug conjugates for possible synergistic effects. 

6/26/2014: Oncotherapy Solutions is pleased to announce that it was able with its partners to successfully manufacture drug conjugates carrying a highly potent cytotoxic payload.  The new drug conjugates caused a dramatic killing of ovarian cancer cells expressing the target biomarker in-vitro while the carrier molecule alone showed no effect whatsoever.  Our current goal is to introduce several modifications to the new drug conjugates in order to enhance their stability, specificity and potency against drug-resistant cancers in-vivo.  So far the company has been operating and conducting its research activities in a virtual status where all research projects and experimental protocols have been developed by Dr. Najib Lamharzi and all manufacturing and testing of drug candidates have been outsourced to contract research organizations.  The virtual business model allowed our company to operate on a small budget and save tremendous amounts of resources by working on carefully-designed research projects and through outsourcing.  Upon availability of additional adequate funds, we will be leasing laboratory space at Icogenex (our biotech incubator in Seattle WA) and perform the majority of our preclinical studies in-house according to a previous agreed upon arrangement.

1/7/2014: Oncotherapy Solutions attended the Bioconference on Cancer Research, Discovery and Therapeutics.  Dr. Lamharzi discussed with other scientists and clinicians from renowned institutions several subjects related to current cancer therapies and their limitations.  Oncotherapy solutions new anti-cancer drug conjugates address these limitations and are expected to be highly active and safer than current therapies.  

9/3/2013: We are delighted that our proof of concept preclinical studies showed that our targeted nanoconjugates are robust siRNA carriers to prostate cancer cells.  Our siRNA drug conjugates have several advantages including safety,  a straightforward and cost-effective manufacturing process as compared to other competing anti-cancer nanoparticles

3/8/2013: Oncotherapy Solutions LLC is currently conducting proof of concept preclinical studies of its novel and targeted siRNA delivery systems to prostate cancer cells in partnership with GenScript and Particle Technology Labs.  We have introduced several modifications to our siRNA delivery systems in order to decrease their particle size, increase their stability and enhance transfection efficiency.  We will soon be testing the new delivery systems on prostate cancer cells.

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