News

CEL-SCI Corporation Completes Commercial-Scale Buildout of Multikine Manufacturing Facility

CEL-SCI Corporation announced it has completed the expansion of its existing dedicated Multikine* (Leukocyte Interleukin, Injection) cGMP manufacturing facility. The expansion was undertaken in anticipation of filing a Biologics License Application (BLA) which, if approved, will allow Multikine produced in the facility to be commercially distributed. The construction, which began in 2020, expanded the facility and added various upgrades to ensure it will be in compliance with all requirements of the FDA’s Current Good Manufacturing Practice (GMP) regulations. The facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it is licensed. The renovations also anticipate that additional personnel will be required to staff a second manufacturing shift to meet the eventual market demand for Multikine. Following an $11 million investment to increase production, CEL-SCI staff recently moved back into the renovated facility.

“We are now validating the facility and will begin preparing our facility license application for Multikine. We continue to hire and train additional personnel required to efficiently operate the manufacturing facility in compliance with all federal and state requirements,” stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported topline results in June 2021 from its landmark pivotal Phase 3 study of Multikine as a neoadjuvant treatment of advanced primary previously untreated head and neck cancer, which is believed to be the largest study in the world for this indication.

To learn more click here.

Recent News

11/19/2021

Study aiming to define acute traumatic encephalopathy (ATE) published by leading neurology journal

BrainBox HeadSmart II Study Investigators Aim to Provide Clinicians with First-Ever Biomarkers and other Functional measurements for Acute Traumatic Encephalopathy (ATE.) A clinical trial of multi-modal diagnostic/prognostic test, already underway, is published in Frontiers in Neurology/NeuroTrauma. Investigators in a major clinical trial of patients with mild traumatic brain injury (mTBI or concussion) describe for the

11/17/2021

Euclid Systems Names Key Leadership Hires and Announces Major Facility Expansion

Euclid Systems Corporation, a global leader in advanced orthokeratology and proactive myopia management, today announced two exceptional additions to its leadership team as well as the expansion of its manufacturing facility in Sterling, Virginia. The changes come at a time when Euclid’s next-generation of Ortho-K lens, Euclid MAX, is helping to combat the battle against

11/16/2021

HemoShear Therapeutics Identifies Second Novel Target to Treat NASH Through Successful Collaboration with Takeda

HemoShear Therapeutics, Inc. announced today that a second target identified utilizing the company’s REVEAL-Tx™ human disease modeling platform has been selected by Takeda Pharmaceutical Company Limited (“Takeda”) for further drug discovery activities for nonalcoholic steatohepatitis (NASH). This marks the successful completion of HemoShear’s exclusive collaboration with Takeda to discover novel targets and develop therapeutics for