FDA Grants Orphan Drug Designation Status to NeoImmuneTech’s Hyleukin-7 for Idiopathic CD4+ Lymphocytopenia Treatment

ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech,
Inc. (NIT), a T cell-focused therapeutics company, today announced
that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug
Designation (ODD) to Hyleukin-7^TM, a T cell amplifier, in
development for the treatment of Idiopathic CD4+ Lymphocytopenia (ICL).
Hyleukin-7 also received ODD from the European Medicines Agency in 2017,
and it is the first and only agent that has obtained ODD for ICL.

ICL was first defined in 1992 by the Centers for Disease Control and
Prevention, and is a rare disease in which patients present persistently
low CD4+ T lymphocyte counts without human immunodeficiency virus (HIV)
infection or any other cause of immunodeficiency.

“Patients with ICL frequently suffer from severe and recurrent
opportunistic infections and are at high risk for developing certain
types of cancer. Currently, no specific treatment for ICL exists. As
such, there is high medical need for therapies that can increase CD4+ T
cells in ICL patients,” said NgocDiep (Diep) Le, M.D., Ph.D., NIT’s
Executive Vice President and Chief Medical Officer. “We are delighted
that the FDA recognized the potential of Hyleukin-7 as an innovative and
transformative treatment for ICL and look forward to conducting a
clinical trial in this patient population.”

In the phase 1 trial in healthy subjects and multiple ongoing
dose-escalation trials in cancer patients, Hyleukin-7 showed a
well-tolerated safety profile and dose-dependent increases of CD4+ and
CD8+ T lymphocyte counts. NIT has been also actively conducting and
planning multiple proof-of-concept clinical trials to develop Hyleukin-7
as an immune-oncology (IO)-enabling drug in combination with other IO
therapeutics.

The FDA grants ODD status to medicines intended for the treatment,
diagnosis or prevention of rare diseases or disorders that affect fewer
than 200,000 people in the US. Receiving ODD may help to expedite and
reduce the cost of development, approval and commercialization of a
therapeutic agent.

About Hyleukin-7^TM
Hyleukin-7^TM (rhIL-7-hyFc,
NT-I7), an immuno-oncology agent, is a T cell growth factor composed of
a covalently linked homodimer of engineered Interleukin-7 (IL-7)
molecule, biologically fused with the proprietary long-acting platform –
hyFc™. IL-7 is known to be a critical factor for T cells homeostasis,
acting to increase both the number and functionality of T cells.
Hyleukin-7 amplifies and reinvigorates persistent T cell immunity in the
treatment of patients with cancer and lymphopenia, thus providing unique
opportunities for immuno-oncology (IO) combination strategies.
Hyleukin-7 is being developed as an “IO enabling” therapy to harness T
cell immunity in combination with current cancer treatments such as
anti-PD-(L)1 agents or chemo/radiotherapy as well as next generation IO
therapeutics.

About NeoImmuneTech, Inc.
NeoImmuneTech (NIT) is developing
T cell-focused therapeutics designed to prime, enhance and extend the
activity of current and future cancer therapies. Our lead product,
Hyleukin-7™, a T cell growth factor, has the potential to amplify and
prolong anti-tumor activity, which is pivotal to extending survival of
cancer patients. Hyleukin-7 is being studied in multiple clinical trials
in solid tumors, and being planned for testing in hematologic
malignancies, additional solid tumors and other immunology-focused
indications. www.neoimmunetech.com
NIT
is a U.S.-based company developing Hyleukin-7 for the U.S. and European
markets in collaboration with Korean-based Genexine.

Contacts

MacDougall
Shai Biran, Ph.D.
+1 781-235-3060
[email protected]