Hemispherx Enhances Manufacturing Efficiency of Ampligen

Source: Hemispherx Biopharma, Inc.

New Technology Simplifies, Speeds Production of Immuno-Oncology Candidate

Hemispherx Biopharma, Inc. (NYSE American:HEB), has successfully tested a new chemical catalyst used in the manufacturing process of Ampligen®, a novel molecule currently being tested in combination therapy to potentially enhance the performance of checkpoint inhibitors, one of the fastest growing classes of immuno-oncology agents. 

Carol Smith, PhD, chief manufacturing officer, said “This development has a number of tangible benefits in terms of improved manufacturing efficiency and assured availability of a key manufacturing material. The new development can provide a consistent enzyme product, uninterrupted production of Ampligen®, and, in the long run, reduce production costs.”
The manufacture of Ampligen®, a double-stranded RNA, requires an enzyme which historically has been difficult to prepare. Recently, the gene coding for this enzyme was cloned and the production of the expressed enzyme is currently being scaled up for use in the manufacture of both RNA strands that are combined to form the Ampligen® molecule.

Hemispherx said that, during the scale up of the cloned enzyme, it has the equivalent of 18,000 vials of base product now ready for compound, fill and finish for projected distribution this year with an estimated value of $10.3 million.  Development of the new enzyme process is planned to facilitate production of the Ampligen® RNA strands for future needs.

Earlier this week, Hemispherx announced that a presentation will be made by Pawel Kalinski, MD, PhD, Rustum Family Professor for Molecular Therapeutic and Translational Research at Roswell Park Cancer Institute in Buffalo, NY on January 24 at the Immuno-Oncology Frontiers Conference in Miami, FL. detailing evidence of a favorable immuno-modulatory activity of Ampligen® on the tumor microenvironment, which may help convert cold tumors that are unresponsive to immunotherapy to tumors that will respond to immunotherapeutic drugs such as checkpoint inhibitors. 

About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.