FDA Grants Orphan Drug Designation to QXL138AM for Pancreatic Cancers

Orphan drug designation has been granted to QXL138AM for the treatment of patients with pancreatic cancers.

The FDA granted an orphan drug designation to QXL138AM, a first in class masked Immunocytokine (MIC), for the treatment of patients with pancreatic cancers, according to Nammi Therapeutics, Inc.1

QXL138AM is made of a CD138-targeted antibody which is fused with Interferon alpha (IFN) and masked with a tumor-selectively releasable peptide. Once bound to the tumor cell, proteases on the surface of the cell leave the mask off the IFNα and allow it to bind to its receptor. When activated, the IFNAR complex induces direct killing of the pancreatic tumor cells and activates innate and adaptive anti-tumor immunity.

QXL138AM works to address the issue of toxicity in patients with pancreatic cancer.

The antibody in which the drug is made of, CD138, is expressed in various solid tumor indications as well as multiple myeloma. Some of these solid tumor indications include pancreatic, breast, colon, hepatic, ovarian, urothelial, and head and neck cancers.

Earlier this month, QXL138AM received an orphan drug designation for the treatment of patients with multiple myeloma.2

While IFNα-based therapeutics have demonstrated anti-tumor activity in clinical studies, they are not frequently used because of the significant toxicities seen with them. Because of this, QXL138AM aims to directly combat the toxicity issue in both patients with multiple myeloma and pancreatic cancer.

An investigational new drug (IND) application is expected to be filed by Nammi with the FDA to allow initiation of clinical studies this year.

References:
  1. Nammi therapeutics granted FDA orphan drug designation for QXL138AM for the treatment of pancreatic cancer. News release. Nammi Therapeutics, Inc. June 16, 2022. Accessed June 20, 2022. https://prn.to/3N73ImX
  2. Nammi therapeutics granted FDA orphan drug designation for QXL138AM for the treatment of multiple myeloma. News release. Nammi Therapeutics, Inc. June 13, 2022. Accessed June 20, 2022. https://prn.to/3y5Qx1q