Hemispherx Announces Data Presentation on the Potential for Ampligen to Improve Cancer Outcomes with Checkpoint Inhibitors

MIAMI, Jan. 25, 2018 -- Hemispherx Biopharma, Inc. (NYSE American:HEB), focused on pharmaceutical research, announced that Pawel Kalinski, MD, vice chairman for translational research and professor of oncology at Roswell Park Cancer Institute, presented data yesterday detailing the role of combination Ampligen® therapy in making the microenvironment of solid tumors more responsive to immuno-oncology agents such as checkpoint inhibitors.

Pawel Kalinski, MD, presenting at the Immuno-Oncology Frontiers 2018 Conference

The presentation, titled “Sensitizing Cold Tumors to Immunotherapy: Selectivity and Specificity of Systemic and Local Approaches”, took place January 24, 2018 at the Immuno-Oncology Frontiers Conference in Miami, FL.

“Increasing the presence of cytotoxic (killer) T cells while reducing suppressive regulator T cells in the tumor microenvironment is critically important to better outcomes with PD-1 blockers such as checkpoint inhibitors, and other immune therapies of solid tumors,” Dr. Kalinski stated. “We found that Ampligen, a selective activator of the TLR3 pathway, in combination with alpha interferon and COX-2 inhibitors uniformly induces the attraction of killer T cells into the tumor lesions of multiple human cancer types, rather than healthy tissue, while at the same time eliminating undesirable Treg cells and local production of other suppressive factors such as interleukin-10”.

The research found that the combinational regimen promotes accumulation of killer T cells in the tumor microenvironment and shows strong therapeutic synergy with checkpoint inhibitors such as anti-PD-1/PD-L1 agents in mouse models of ovarian and colorectal cancers. 

Dr. Kalinski reported that early-stage on-going clinical trials in ovarian and colorectal cancers in combination with Ampligen® are in support of his earlier work.  Additionally, it further explores the safety and effectiveness of promoting killer T cell accumulation and modulating the PD-1/PD-L1/PD-L2 system in the tumor microenvironment of human cancers.

Thomas Equels, CEO of Hemispherx, attended the conference and commented on Dr. Kalinski’s presentation. “We are deeply grateful for the pioneering work done at University of Pittsburgh Cancer Institute and Roswell Park Cancer Institute which supports this breakthrough research indicating an important potential future role for Ampligen (rintatolimod) as a superior TLR immune system amplifier in oncology combination therapies. Because of our company’s pioneering work in both AIDS/HIV and ME/CFS we have approximately 100,000 doses of Ampligen administered IV in humans. No other TLR agonist has such a ‘ready-made’ safety profile with the potential to facilitate rapid deployment in oncology.”

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.

Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release.  We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

A photo accompanying this announcement is available at  http://www.globenewswire.com/NewsRoom/AttachmentNg/462f0df7-b2d4-4a77-8152-b3b84da81b26.

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Phone Number: 800-778-4042
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