CEL-SCI To Build Manufacturing Site

CEL-SCI Corp. has signed a letter of intent with BioProperties, Inc., a privately held real estate firm specialized in the biomedical sector, to acquire and build out a cGMP drug manufacturing facility for CEL-SCI’s cancer product Multikine. CEL-SCI was recently given the green light by the FDA to start a Phase III clinical trial of head & neck cancer patients with Multikine.

This manufacturing facility is an integral part of moving Multikine into the Phase III clinical trial and later commercialization, according to a company statement. The commitment, subject to a final contract, is for $15 million. The facility is expected to cost about $12 – 14 million, to be paid through a long-term lease agreement.

According to Stan Wendzel, managing director of BioProperties, Inc., “We are very excited to be providing a facility to CEL- SCI that will allow them to complete the Phase III trials for Multikine and ultimately bring this important product to market.”

Geert Kersten, chief executive officer of CEL-SCI, added, “This facility represents a huge step forward for our company. We will be able to produce our drug Multikine in our own cGMP facility for Phase III trials as well as for sale once marketing approval is granted. From a regulatory perspective and for the control of the manufacturing process, this is the most prudent way for CEL-SCI to proceed. An additional benefit of having this facility is that, during the Phase III study, it may also be used for contract manufacturing work with other biotech companies and/or the U.S. government, since it will contain a clean cold-fill suite. The ability to aseptically fill in the cold is rapidly becoming very important for many bio-defense and other biologic drugs, and is aimed at avoiding the large biological activity losses seen in these products when cold aseptic fill is not available.”