The primary focus of Vaccicure in 2017 has been reinitiating manufacturing activities and producing Good Manufacturing Practice (GMP)-compliant batches of PAS for future clinical trials and marketing registration purposes. The first 15-g demonstration test batch utilizing starting materials from the existing inventory was produced as planned in July of 2016. In the third and fourth quarter of 2016 the demonstration batch underwent significant quality and analytical release testing. These tests have been completed and the final batch records and certification documentation were received indicating that the demonstration batch passed all testing.
Vaccicure intended to utilize raw materials from Cancer Advances existing raw materials inventory in the clinical and marketing manufacturing batch however when the raw materials inventory was evaluated in April 2016 the peptide, linker and diphtheria toxoid were deemed unsuitable for use by the contract manufacturer’s Qualified Person. These materials were produced prior to current regulatory guidelines pertaining to minimizing the risk of transmissible spongiform encephalopathy or bovine spongiform encephalopathy transmission. As a result, Vaccicure had to seek new peptide, linker and diphtheria toxoid from qualified suppliers that are compliant with current regulatory and quality guidelines. During the period June 2016 through March 2017 Vaccicure identified, evaluated and audited several different vendors qualified to provide these materials. In the second quarter of 2017 contracts were negotiated and entered into with three companies to obtain sufficient raw materials to produce the clinical batch of drug conjugate scheduled for manufacture in 2017. These raw materials were received in the second quarter of 2017 and we are awaiting a confirmed manufacturing date to manufacture the clinical batch of PAS. Subject to funding, this date is expected to be in the first quarter of 2018 and subsequent testing and analysis of the clinical batch will be completed before the end of the third quarter of 2018.
Other activities include:
We are scheduling a follow up meeting with the FDA in the third or fourth quarter of 2018 to update the FDA on the manufacturing results and determine what other steps need to be taken to receive market approval.
Further study and analysis of PAS has indicated that PAS could be an effective therapy in combination with other therapies that have not demonstrated the results in pancreatic cancer as a stand-alone or monotherapy. As such we have filed a provisional patent that covers the combination of PAS with these monotherapies. These patents have been completed and were filed in the third quarter of 2017.
We are having multiple conversations and meetings with potential Pharma partners to update them on PAS and inquire about a commercialization partnership where PAS would be part of a combination therapy with their drug that is either not approved for pancreatic or gastric cancer or a drug that did not produce the expected results as a stand-alone therapy. As a result of these meetings, one Big Pharma Company has expressed interest in a co-development/licensing arrangement. Further discussion with this Company is scheduled for the first or second quarter of 2018.
We have had several meetings with a medium sized Pharma Company in China who is interested in a licensing agreement for the PAS product in China. Discussions are positive and will continue in the first half of 2018.
We are constantly reviewing the market and the clinical development pipeline for other pancreatic cancer therapies currently in clinical trial or that have been granted market approval with the FDA. We also attend medical conferences throughout the year and remain diligent on staying current of new therapies for pancreatic cancer. We do not have any knowledge of any drug that has been granted market approval or is near market approval as a first line pancreatic cancer therapy since 2014.
The development program is proceeding reasonably to schedule as set out in the Vaccicure Information Memorandum.
Forward Looking Statements: This document contains forward-looking statements made pursuant to the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, and in accordance with UK practice. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and the reader should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the clinical development of PAS by Vaccicure and Cancer Advances, the potential timing and outcomes of clinical studies of PAS undertaken in the future; the ability of Vaccicure and Cancer Advances to timely source adequate supply of its development products from third party manufacturers on whom they each depends; the limited cash reserves available to Vaccicure and Cancer Advances, and their ability to obtain additional capital on acceptable terms, or at all; their ability to successfully progress, partner or complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the ability of Vaccicure and Cancer Advances to protect its intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the PAS products; and other factors listed under “Risk Factors” in the Information Memorandum of Vaccicure and filings with the Securities and Exchange Commission of Cancer Advances and its parent companies.