FDA Grants HSB-1216 Orphan Drug Designation for Small Cell Lung Cancer

Hillstream BioPharma announced that it has been granted FDA orphan drug designation (ODD) for HSB-1216 for the treatment of small cell lung cancer (SCLC).^1-2

About QUATRAMER salinomycin

QUATRAMER salinomycin is a new formulation of a drug for the treatment of small cell lung cancer.¹ HSB-1216 uses salinomycin, a strong cancer stem cell inhibitor, and the special medication delivery technology is called QUATRAMER.

QUATRAMER is a nanoparticle delivery platform. This unique technology allows for the targeted delivery of the medication directly into the cell. It uses small molecules, peptides, genes, other macromolecules and biologics to get the medication into the tumor cells. This minimizes the exposure of the drug to normal tissues.^1-2

Randy Milby, the Chief Executive Officer of Hillstream released a statement on the treatment of small cell lung cancer. He said using HSB-1216 can slow the growth of cancer stem cells. This drug may offer a complementary approach, one that works well with other small cell lung cancer therapies to inhibit cancer stem cells.^1-2

Small cell lung cancer

Around 10-15 percent of lung cancers are small cell. It is an aggressive cancer that grows quickly. It begins in the lungs around or near the bronchi, the pathways to the lungs. It can invade surrounding tissues and metastasize (or spread) to other areas of the body.¹

Over the past few years, there have been a number of new treatment options for those living with small cell lung cancer. HSB-1216 is the latest to join this growing list.^1-2

How does HSB-1216 work?

Salinomycin is a drug that kills cancer stem cells. It works by a process called ferroptosis. This is a kind of programmed cell death where iron is hidden in the lysosomes of cells. Encapsulating the salinomycin appears to increase a person’s ability to tolerate the drug.²

The technology used in the QUATRAMER salinomycin has the effect of concentrating the medicine within the tumor. It inhibits the growth of lung cancer cells. The QUATRAMER encapsulation may increase people’s ability to tolerate salinomycin.¹

What does "orphan drug designation" mean?

The FDA can grant orphan drug designation to novel drugs and biologics 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 allows the companies that make these rate drugs to qualify for various benefits. These include tax credits for qualified clinical trials and seven years of exclusive marketing rights after FDA approval.^1-3

The prescribing information is not yet available from the FDA.