Florida-based biopharmaceutical company Hemispherx BioPharma (NYSEAMERICAN:HEB) has been awarded a Buy rating and a $0.75 price target by Edward Woo, an analyst with Ascendiant Capital Markets, which kicked off coverage of the stock.
In a note to investors Monday, Woo writes that Hemispherx has made significant advances with its oncology program for its therapy Ampligen, which is being evaluated as an immuno-oncology agent for the treatment of multiple types of cancer.
In collaboration with prominent cancer research centers in the US, clinical trials are underway to test that the combination of Ampligen with checkpoint blockade therapies will improve clinical tumor responses, time to progression and survival rates.
While Hemispherx operates in a “highly competitive environment,” such concerns are outweighed by Ampligen’s growth prospects and valuation, writes Woo.
“Though we acknowledge that Hemispherx’s oncology drugs still have long development roads left (approximately 2 years), we believe the [approximately] billion dollar market potentials present a high reward for the risks,” Woo wrote.
Hemispherx’s second product is Alferon N Injection, which is FDA-approved for the treatment of genital warts, a sexually-transmitted disease. But its commercialization is on hold as Hemispherx focuses on Ampligen as an immuno-oncology treatment and to address the symptoms of chronic fatigue syndrome (CFS).
Woo has tagged Hemispherx with a $0.75 12-month price target on the view that the valuation “appropriately balances out the company’s high risks with the company’s high-growth prospects and large upside opportunities.”
On top of the ongoing cancer studies, Ampligen is also being assessed as a treatment for chronic fatigue syndrome. It is already approved for this treatment in Argentina and is available through a US Food and Drug Administration-authorized expanded access program.
The FDA, however, has thus far declined to approve the new drug application for Ampligen for the treatment of chronic fatigue syndrome, pending its request for additional clinical trials and data.
All in on Ampligen
Hemispherx CEO Thomas K Equels elaborated in a letter to shareholders earlier this month about how Hemispherx is making great strides in using its therapy Ampligen as an immuno-oncology agent to fight multiple types of cancer.
The company is currently supporting the evaluation of Ampligen’s use in fighting eight solid tumors (urothelial carcinoma, renal cell carcinoma, melanoma, triple-negative breast, colorectal, ovarian, non-small cell lung and pancreatic carcinomas) as part of six separate clinical studies at major research institutions, Equels said.
The goal of the various studies, which are being carried out at the University of Pittsburgh Medical Center, the University of Nebraska Medical Center and Roswell Park Comprehensive Cancer Center, is to test the hypothesis that the combination of Ampligen with checkpoint inhibitors will “improve clinical tumor responses.”
Checkpoint inhibitors are powerful immune-therapy drugs that block proteins that restrain the body’s immune system from fighting cancer.
Especially encouraging was that clinical proof of concept findings using an Ampligen cocktail to fight colorectal cancer demonstrated a more favorable ratio of killer T-cells, which attack cancer cells, to regulatory T-cells in the tumor microenvironment.
“In collaboration with major cancer research centers in the US and around the world, we have been making tremendous progress and strongly believe in the future of our cancer-fighting efforts,” wrote Equels.
“It is important that you have the opportunity to see what these top experts in immune-oncology have to say about their recent successes with Ampligen and its importance as a promising agent for advance in oncology. Progress in oncology provides a clear opportunity for commercial success for Hemispherx,” he added.
Hemispherx added 8.4% to close at $0.23 Wednesday.
Contact Ellen Kelleher at [email protected]