Hillstream BioPharma Granted Orphan Drug Designation for HSB-1216 (QUATRAMER Salinomycin) for Treatment of Small Cell Lung Cancer (SCLC)
January 6, 2020
Positive pre-clinical data with an emerging validated mechanism of action, Ferroptosis
HSB-1216 is a novel therapeutic using the QUARTRAMER formulation of a potent anti-Ferroptotic compounds, Salinomycin
Chester, New Jersey, January 6, 2020 – Hillstream BioPharma Inc. (“Hillstream”) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to salinomycin based on nonclinical pharmacology data from HSB-1216 (QUATRAMER salinomycin), a new chemical entity for the treatment of small cell lung cancer. The ODD designation provides seven years of market exclusivity post approval for the HSB-1216.
“We are very excited and pleased that HSB-1216 received orphan designation from the FDA,” stated Randy Milby, Hillstream’s Chief Executive Officer. “Now is an exciting time for the development of medicines for small cell lung cancer. We believe treatment with HSB-1216 may represent a complementary approach to other potential therapies by inhibiting cancer stem cells.”
About HSB-1216 (QUATRAMER Salinomycin)
HSB-1216 is a novel formulation of salinomycin, a potent cancer stem cell inhibitor, encapsulated within QUATRAMER delivery technology. Salinomycin kills cancer stem cells by ferroptosis when iron is sequestered in the lysosomes. Salinomycin was identified as the most potent cancer stem cell (CSC) inhibitor known to-date by who or include reference. CSC represent an elusive population of tumor stem cells that are believed to reproduce and sustain cancer. HSB-1216 has shown strong effect on eliminating CSCs. The QUATRAMER salinomycin concentrates within the tumor and is a highly efficacious inhibitor of lung cancer cells. The encapsulation within the QUATRAMER enables may increase tolerability to salinomycin.
About Small Cell Lung Cancer
Lung cancer is a leading cause of cancer-related mortality in the United States with small cell lung cancer (SCLC) accounting for about 10%-15% of all lung cancer diagnoses and has a five-year survival rate of 6% all Surveillance, Epidemiology and End Results (SEER)stages combined.
About Orphan Drug Designation
The FDA, through its Office of Orphan Products Development, grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan drug designation provides a drug developer with certain benefits and incentives, including seven-year period of US market exclusivity from the date of marketing authorization, waiver of FDA user fees, and tax credits for clinical research.
About Hillstream BioPharma Inc.
Hillstream BioPharma Inc. (“Hillstream”) is a development-stage company advancing improved therapies for patients with cancer via a unique QUATRAMER nanoparticle delivery platform. This unique technology enables intranuclear and intracellular delivery of small molecules, peptides, genes, other macromolecules and biologics to the tumor cello, while significantly minimizing exposure to normal tissues. Hillstream’s competitive advantage is to enhance the safety and efficacy of oncology therapies by encapsulating them in its proprietary polymeric injectable suspension comprised of FDA-recognized inactive ingredients. Encapsulation ensures delivery within the tumor cells and prevents free drug levels in circulation that can cause toxicity.. For more information, please visit tharimmune.com.
Forward Looking Statements
This press release includes forward-looking statements including, but not limited to, statements related to the development of drug candidates, our operations and business strategy, our expected financial results, and corporate updates. The forward-looking statements contained in this press release are based on management’s current expectations and are subject to substantial risks, uncertainty and changes in circumstances. Actual results may differ materially from those expressed by these expectations due to risks and uncertainties, including, among others, those related to our ability to obtain additional capital on favorable terms to us, or at all, including, without limitation, to fund our current and future preclinical studies and clinical trials and the success, timing and cost of our drug development program and our ongoing or future preclinical studies and clinical trials, including, without limitation, the possibility of unfavorable new clinical and preclinical data and additional analyses of existing data, as well as the risks that prior clinical and preclinical results may not be replicated. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to review or update any forward-looking statement except as may be required by applicable law.
Hillstream BioPharma Inc.
President & CEO
Hillstream Biopharma Inc.
Tel: +1 302.743.2995
Jennifer K. Zimmons, Ph.D.
Zimmons International Communications
Tel: +1 917.214.3514