Biopharmaceutical company OncoSec Medical (OTC:ONCS) Tuesday announced it has entered into an exclusive manufacturing agreement with DNA plasmid services business VGXI Inc (VGXI) for the production of its cancer immunotherapy.
The company said the exclusive agreement is significant as it uses VGXI's patented DNA plasmid manufacturing process to produce the drug, called interleukin-12 plasmid DNA (DNA IL-12).
Financial terms of the agreement were not disclosed.
OncoSec said the deal also leverages VGXI's expertise for large-scale process development and clinical manufacturing for DNA IL-12 for use in OncoSec's OMS ElectroImmunotherapy program.
OMS ElectroImmunotherapy is currently being developed for the treatment of three rare skin cancer indications - metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.
Phase II studies for two of these indications have already begun.
The locally administered and potentially systemic ElectroImmunotherapy program uses the OMS system to deliver the DNA-based immunotherapy, known as DNA IL-12.
The OMS electroporation system has proven to enhance cellular uptake, effectively treating cancerous cells while sparing surrounding healthy tissue cutting through the toxic side effects of current available treatment options like chemotherapy and radiation.
"We are pleased to enter this agreement with VGXI as we look beyond our on-going phase II trials and begin planning for pivotal trials and projected future commercialization of OMS ElectroImmunotherapy," said president and CEO Punit Dhillon.
"VGXI was selected for its manufacturing activities based upon its ability to produce to commercial specifications and its leadership position in cGMP [current good manufacturing practice] manufacturing of plasmid DNA for clinical use.
"In addition, the facility meets [Food and Drug Administration] FDA cGMP compliance standards for manufacturing of biopharmaceutical products."
VGXI provides DNA plasmid manufacturing and development services for DNA vaccine and gene therapy research.
"We are delighted to be chosen by OncoSec as the manufacturing partner for DNA IL-12 and we look forward to leveraging our expertise in this plasmid DNA production to support OncoSec in further executing its clinical development strategies for OMS ElectroImmunotherapy," said VP of operations at VGXI, Dorothy Peterson.
OncoSec is currently developing advanced-stage OMS ElectroOncology therapies to treat solid tumors and metastatic disease.
OncoSec uses its OMS electroporation delivery system that applies short electric pulses to cells, causing the opening of pores in the cell membrane, and allowing for the efficient and safe delivery of immunotherapy or chemotherapy agents to treat a range of solid tumour cancers.
At the end of May, the company provided an update to shareholders, reviewing the key developments of OncoSec so far this year.
In a financial update, the company said it recently raised $7.75 million through a public offering to continue clinical development programs. The financing was underwritten by Rodman & Renshaw.
OncoSec currently has more than $6.5 million in cash reserves to fund operations, which it said should be sufficient to complete current studies.
The company also noted that it has initiated and enrolled several patients in a phase II study for the treatment of metastatic melanoma, called OMS-I100.
The study is being led by the University of California in San Francisco, with additional sites at the John Wayne Cancer Institute in Santa Monica and Lakeland Comprehensive Cancer Center in Florida. OncoSec expects to report interim clinical data before year end.
In addition, the cancer therapy company has started its phase II study for the treatment of Merkel cell carcinoma, called OMS-I110. Merkel cell carcinoma is a rare and highly aggressive form of skin cancer with a 40 percent mortality rate and about 1,500 new cases each year.
The OMS-I110 study is being led by the University of Washington and the Fred Hutchinson Cancer Center in Seattle, with the company expecting to report interim clinical data before year-end.
OncoSec said it is also aiming to initiate and begin enrolling patients for its phase II cutaneous T-cell lymphoma (CTCL) study, called OMS-I120, by year-end. This study will be led by the University of California, and will include multiple centers across the US.
The company also plans to present the preliminary data from phase III recurrent head and neck cancer studies at the 5th International Head and Neck Cancer Conference taking place July 21-25.
OncoSec said it has been developing a strategy focused on creating regional partnerships or establishing a global partner to develop the market potential for its OMS ElectroChemotherapy option in Europe, Asia and other emerging markets.