OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) (“OncBioMune” or the “Company”), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic prostate cancer vaccine immunotherapy and a CD71-targeted cancer therapy combining paclitaxel, gallium, and transferrin, or PGT, today announces the results of in vitro data for PGT in models of multi-drug resistant lung, pancreatic, and ovarian cancer.

The Company previously released results of initial in vitro proof-of-concept data for PGT in a multi-drug resistant ovarian cancer model.  Cell proliferation assays were performed under hypoxic conditions on an additional 6 human cancer cell lines, including:

• A549/Taxol, a multidrug-resistant lung cancer cell line that is a model for the study of drug resistance in lung cancer
• A2780/Taxol, a multidrug-resistant ovarian cancer cell line that is a model for the study of drug resistance in ovarian cancer
• MiaPaCa2, a pancreatic cancer cell line known to be resistant to paclitaxel when HIF1A (Hypoxia inducible factor 1a) is present
• Jurkat, a T-cell leukemia cell line
• U87, a human glioblastoma cell line
• NCI-H322m, a bronchioalveolar cell line

Cells were treated separately with varying concentrations of either the standard chemotherapy agent paclitaxel or PGT for 72 hours.  The IC50 (concentration of drug needed to inhibit the cell growth by 50%) was determined for paclitaxel and PGT, standardized by the concentration of paclitaxel.   The IC50s were calculated from growth inhibition curves.

The IC50 of the A549/Taxol cells for paclitaxel was 2.976 micromolar and the IC50 for PGT was 0.04882 micromolar. The IC50 of the A2780/Taxol cells for paclitaxel was 2.728 micromolar and the IC50 for PGT was 0.03861 micromolar. The IC50 of the MiaPaCa2 cells for paclitaxel was not converged, meaning it did not achieve enough cell killing to estimate the IC50, whereas the IC50 for PGT was 0.05176 micromolar.  For Jurkat, U87, and NCI-H322m, the IC50s for paclitaxel were 0.09534, 0.5677, and 0.4383, micromolar, respectively, whereas the IC50s for PGT were 0.01908, 0.0126, and 0.06934, respectively.

PGT is designed to deliver the chemotherapeutic agent paclitaxel to cancer cells over-expressing the transferrin receptor (aka CD71). Paclitaxel is currently FDA-approved in two forms: as solvent-based paclitaxel (sb-paclitaxel, Taxol®) and protein-based paclitaxel (nab-paclitaxel, ABRAXANE ®).

We believe PGT has a formulation similar to nab-paclitaxel by combining paclitaxel to the human protein transferrin, as opposed to albumin.  However, PGT has a function similar to antibody-drug conjugates (ADCs), in that it provides targeted drug delivery. This creates the potential to target the paclitaxel to CD71, which has been shown to be highly over-expressed on many different types of cancer cells.

“We are very excited about these most recent results.  Our data to date suggests that, in pre-clinical models, PGT is effective in 4 different cell line models of paclitaxel resistance across 3 separate types of cancer, namely ovarian, lung and pancreatic cancers.  Additionally, all of these tumor types are very commonly treated clinically with paclitaxel-based therapy.  Our observation of strong differential effect of PGT versus paclitaxel is very encouraging because it has the potential to address an area of high unmet need in a broad range of patients with refractory lung, ovarian and pancreatic cancers as well as other types of cancers that are treated with paclitaxel but become resistant to therapy.  Further, our recent data supports PGT’s apparent ability to evade the P-glycoprotein pump, or P-gp, which is a well characterized cell membrane-associated efflux pump that renders cells resistant to chemotherapy by pumping the drug out of the cell as some of these models are known high P-gp expressors” commented Dr. Brian Barnett, Chief Executive Officer at OncBioMune.

“We have secured funding to begin pilot animal experiments to evaluate PGT in an in vivomodel,” continued Dr. Barnett.  “Additionally, these cell line data are helping us refine our IND and Phase 1 plans. To that point, we are already working to secure funding for clinical trials and actively seeking partnerships. We expect that, once we start the IND process, we should be about 16 months from first human dose in Phase 1. Given this data and the potential mechanism of action, we are hopeful that our initial indication will focus on a patient population with metastatic disease that has failed previous paclitaxel-based therapy.  This population represents a group of patients with a high unmet medical need that we aspire to help.”

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About OncBioMune Pharmaceuticals, Inc.

OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, including a proprietary therapeutic cancer vaccine technology designed to stimulate the immune system to attack tumor cells without damaging healthy tissue and a CD71-targeted cancer therapy combining paclitaxel, gallium, and transferrin, or PGT. OncBioMune is headquartered in Baton Rouge, LA.

Forward-Looking Statements

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Contact:

OncBioMune Pharmaceuticals, Inc.
Brian Barnett, MD
Chief Executive Officer
[email protected]