Phase 1 Investigational Drug for Rare Blood Cancers

Mark Frohlich, MD, CEO of Indapta Therapeutics, discusses the Phase 1 clinical trial for investigational drug candidate IDP-023, to treat patients with rare blood cancers.

Non-Hodgkin lymphoma (NHL) is a group of malignant cancers originating from the lymphoid tissues, mainly the lymph nodes. These tumors may result due to chromosomal translocation, various toxins, infections, and chronic inflammation. NHL comprises various subtypes, each with different epidemiologies, etiologies, immunophenotypic, genetic, clinical features, and response to therapy. The treatment of NHL varies greatly, depending on tumor stage, grade, type of lymphoma, and various patient factors.

Multiple myeloma is a form of cancer that occurs due to abnormal and uncontrolled growth of plasma cells in the bone marrow. When present, the most common symptom is anemia, which can be associated with fatigue and shortness of breath. Other features of the condition may include multiple infections; abnormal bleeding; bone pain; weak and/or easily broken bones; and numbness and/or weakness of the arms and legs. The exact underlying cause of multiple myeloma is currently unknown.

Acute myeloid leukemia (AML) is a cancer that affects the blood and bone marrow. It is often an aggressive form of cancer. The signs and symptoms of AML vary but may include easy bruising; bone pain or tenderness; fatigue; fever; frequent nosebleeds; bleeding from the gums; shortness of breath; and/or weight loss. AML is one of the most common types of leukemia among adults and is rarely diagnosed in people under age 40. There are many potential causes of AML such as certain blood disorders, inherited syndromes, environmental exposures, and drug exposures; however, most people who develop AML have no identifiable risk factor.

IDP-023 is a g-NK cell therapy with mechanisms including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells. NK, or “natural killer” cells area type of white blood cell known to kill cancer cells. This drug has demonstrated higher potency and durability in antitumor activity in combination with cancer targeting monoclonal antibodies when compared to typical NK cells. An ongoing Phase 1 trial is currently enrolling patients with NHL, multiple myeloma, and AML. To learn more, visit Clinical Trials.
Dr. Frohlich also describes the company’s plans to enter the autoimmune space, with plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for a clinical trial with IDP-023 in multiple sclerosis.

Chapters:
Intro 00:00
Current Management for Blood Cancers 1:00
IDP-023 Overview 2:34
Phase 1 Clinical Trial 4:01
Fast Track Designation 5:21
Moving Into the Autoimmune Space 6:23