HEB Hemispherx Biopharma Inc New

Hemispherx Biopharma Inc. (NYSE American: HEB) issued its quarterly update on the progress of its ongoing clinical trials evaluating Ampligen’s ability to reprogram tumor microenvironments and increase the effectiveness of existing cancer immunotherapies, such as checkpoint blockade therapies. This second update follows the company’s first quarterly Ampligen update on March 13.

The company has five ongoing immuno-oncology clinical trials, four planned clinical trials and an active Early Access Program (EAP). The most recent addition to the ongoing group is a clinical study in the treatment of prostate cancer, where FDA authorization has been received.

“Thus far, we have had steady and consistent clinical progress in immuno-oncology. I believe this is critical to creating long-term stockholder value, as success in any one of our trials has the potential to be a strong driver of the market,” said Hemispherx CEO Thomas K. Equels. “Especially significant are the larger clinical trials, such as our Phase 2 recurrent ovarian cancer trial. I believe that third parties’ fronting of trial costs shows that it’s not just Hemispherx that believes in Ampligen, but that major cancer research centers, public grantors and private grantors also see the potential of Ampligen as a combination therapy.”

Experiments from the University of Pittsburgh Medical Center and the Roswell Park Comprehensive Cancer Center have demonstrated in animal and human tumor explant studies that Ampligen, a TLR3 restricted and targeted immune modulator, can facilitate the transformation of “cold” solid tumor microenvironments into “hot” tumor microenvironments, making them potentially responsive to checkpoint inhibitors.

“These ongoing clinical trials put that proposition to the test and, if favorable, I believe that they make a place for Ampligen at the immuno-oncology table,” said Equels. “Which, of course, should create great opportunities for Hemispherx.”

CLINICAL DEVELOPMENT OVERVIEW

Ongoing clinical trials:

Recurrent Ovarian Cancer — A 45-patient, Phase 2, investigator-sponsored clinical trial combining Ampligen, cisplatin and pembrolizumab. University of Pittsburgh Medical Center. Dr. R. Edwards, PI. Treatment of the first patient has commenced, effective 6/11/19.

See: https://clinicaltrials.gov/ct2/show/NCT03734692

Colorectal Cancer Metastatic to the Liver — A 12-patient, Phase 2a clinical study combining Ampligen, Intron A and celecoxib. Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Seven subjects have so far been enrolled and completed treatment. The additional five have not yet been identified. Data expected in 2020.

See: https://clinicaltrials.gov/ct2/show/NCT03403634

Metastatic Triple Negative Breast Cancer — A 6-patient, open label study combining Ampligen, Intron A, celecoxib and pembrolizumab. Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI. Two patients have been enrolled and both are in early treatment.

See: https://clinicaltrials.gov/ct2/show/NCT03599453

Recurrent Ovarian Cancer — A Phase 1 / 2 study of intraperitoneal chemo-immunotherapy in recurrent ovarian cancer. University of Pittsburgh Medical Center. Dr. R. Edwards, PI. Eleven of 12 patients in Phase 1 have been enrolled; 10 have completed treatment and 1 is undergoing treatment and evaluation. An interim report from Dr. Edwards’ team was received and his team is drafting a manuscript on the biological and clinical outcomes from the Phase 1 portion of the trial.

See: https://clinicaltrials.gov/ct2/show/NCT02432378

Prostate Cancer — A 60-patient Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without Intron A compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Roswell Park Comprehensive Cancer Center. Dr. G. Chatta, PI. IRB and FDA approval to proceed received; pending internal tasks before the study can be opened, with the goal of the end of June.

See: https://clinicaltrials.gov/ct2/show/NCT03899987

Expanded Access Program:

Pancreatic Cancer — An Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands for pancreatic cancer at Erasmus Medical Center has been ongoing for two years. The team at Erasmus is making progress under the supervision of Prof. Casper van Eijck, MD, a world-renowned specialist in this dread malignancy, and Diba Latifi, MD. The Dutch government has approved and extended the therapeutic program for an additional year. Early progress was reported in a published abstract from Erasmus. The abstract was part of a larger original report covering a variety of medical topics, which can be found at https://www.pancreasclub.com/wp-content/uploads/2018/06/Poster-Abstracts.pdf. The last two patients planned to be enrolled for a planned paper are nearing the end of treatment. The paper analyzing the data is expected in 2020.

Clinical trials planned for initiation in 2019:

1. Phase 2 study that will evaluate Ampligen in combination with pembrolizumab in refractory metastatic colorectal carcinoma at Roswell Park Comprehensive Cancer Center. Dr. P. Boland, PI. Roswell Park is reviewing the budget and preparing it for institutional submission.
2. Phase 2 study of advanced urothelial (bladder), melanoma and renal cell carcinoma, resistant to checkpoint blockade, that will evaluate Ampligen in combination with a checkpoint blockade therapy at Roswell Park Comprehensive Cancer Center. Dr. M. Opyrchal, PI. Protocol design currently being finalized. Hemispherx Biopharma signed a clinical trial agreement with Roswell Park Comprehensive Cancer Center to study Ampligen in combination with checkpoint inhibitors in a Phase 2a study in urothelial carcinoma, renal cell carcinoma and melanoma. This Phase 2a study will be led by Mateusz Opyrchal, MD, PhD, Assistant Professor of Medicine and Associate Director of the Early Phase Clinical Trial Program at Roswell Park, in collaboration with Dr. Kalinski. Hemispherx is awaiting the study protocol, which is under review at Roswell Park.
3. First-line therapy for non-small cell lung cancer with SOC chemotherapy that will evaluate Ampligen in combination with pembrolizumab at University of Nebraska Medical Center. Dr. V. Ernani, PI. Study design and budget being developed. However, we now anticipate an extended delay, as other studies with funding have moved ahead of the Ampligen project.
4. Phase 2 study in advanced pancreatic cancer using checkpoint blockade plus Ampligen at University of Nebraska Medical Center. Dr. K. Klute, PI. Protocol and budget being developed. Based upon success in the initial animal studies, an additional round of more extensive and comprehensive pre-clinical animal pancreatic cancer studies are being conducted at University of Nebraska to reconfirm results, test additional PC tumor types, examine anti-PD-1 in addition to the prior anti-PD-L1 analysis, then fine tune the focus of the proposed future pancreatic cancer clinical trial and reduce the chances of error in clinical trial design. This information will also be used to formulate proposed future combination therapy clinical activity in the Kingdom of the Netherlands.

About Hemispherx Biopharma Hemispherx Biopharma, Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed pre-clinical studies and clinical trials, Hemispherx believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen® already conducted include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma. These and other potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system.

Cautionary StatementSome of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, 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. Among other things, no assurance can be given as to whether the ongoing or planned trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities of the Cancer Centers sponsoring these trials. 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.

Contacts:

Hemispherx Biopharma, Inc.Phone: 800-778-4042Email: IR@hemispherx.net

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LHA Investor RelationsMiriam Weber MillerSenior Vice PresidentPhone: +1-212-838-3777Email: mmiller@lhai.com