Oncotherapy Solutions, LLC


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

10/3/2019: We have successfully completed our Phase I SBIR grant studies and looking forward to Phase II SBIR grant studies.  Our new lead drug conjugate showed a dramatic tumor growth inhibition of multiple triple-negative breast cancer models.  A single intravenous injection of 1.5 mg/kg animal weight of the new lead drug conjugate caused a 100% tumor growth inhibition of HCC1806 TNBC model with the majority of mice showing complete response.  Toxicology studies showed no effect on animal weight, white blood cells or normal organs suggesting the safety of our new drug conjugate.  In addition to its direct antitumor activity we expect our lead drug conjugate to exert an immune-mediated activity in TNBC.  We are looking forward to perform detailed immuno-oncology studies on our new drug conjugate alone or in combination regimen, especially the effect on intratumoral immunosuppressive cells namely T regulatory cells (Tregs), M2 macrophages and myeloid derived suppressor cells (MDSCs) as well as on cytotoxic CD8 T cells and natural killer cells.  We will further perform safety pharmacology of our lead drug conjugate in cynomolgus monkey with the goal to submit IND application to the FDA and start clinical trials upon availability of additional funds.

5/20/2018: The National Cancer Institute has awarded Oncotherapy Solutions a Phase I 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 I 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.  Our novel drug conjugate is also potent against drug-resistant ovarian cancer cells and is expected to be effective against prostate, endometrial and pancreatic cancers which express high levels of the target biomarker.

7/18/2017: Oncotherapy Solutions has submitted a Phase I SBIR grant to the NCI and proposed to initiate additional in-vivo oncology studies of its drug conjugate in triple-negative breast cancer.   

6/28/2016:  We are extremely delighted to announce that our initial 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 initial drug conjugate while animal weight remained unchanged.  We are looking forward to the completion of the efficacy and toxicology study. 

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.  

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.

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