NeoImmuneTech Announces that the FDA has Allowed the Center for Cancer Research, National Cancer Institute to Proceed with an Investigational New Drug Application to Initiate a Clinical Trial for Hyleukin-7™ with Vaccines in Elderly Cancer Survivors

ROCKVILLE, Md.–(BUSINESS WIRE)–NeoImmuneTech,
Inc. (NIT), a T cell-focused immunotherapeutics company, today
announced that the U.S. Food and Drug Administration (FDA) has allowed
the Center for Cancer Research, National Cancer Institute to proceed
with an Investigational New Drug application (IND) application for
Hyleukin-7™, a long acting T cell amplifier, to begin a clinical trial
aiming to enhance the immune reconstitution and vaccine responses in
elderly cancer survivors following chemotherapy.

The study’s principal investigator, Ronald Gress, M.D., Chief,
Experimental Transplantation & Immunology Branch, Center for Cancer
Research, National Cancer Institute (NCI), National Institutes of Health
commented. “Our previous study with IL-7 in humans showed restoration of
polyclonality in T cell populations; the question now is whether the
restored clonality has functional benefit in response to antigen
challenge.”

Elderly cancer survivors are vulnerable to vaccine-preventable diseases
and are known to have poor anti-vaccine-specific immune responses.
Effective prevention of communicable diseases is important for cancer
survivorship, especially in the elderly population. The cytokine
Interleukin-7 (IL-7) may play a role in immune reconstitution and immune
enhancement in various circumstances of immune insufficiency in older
individuals following chemotherapy. This phase 1/1b study will test
whether Hyleukin-7, a long acting human IL-7, can enhance specific
immune responses to selected vaccines in older subjects following
chemotherapy.

“As we continue to explore the potential of Hyleukin-7 in oncology and
other therapeutic areas, including infectious disease, NIT and the
world-renowned experts at the NCI are very encouraged by the strong
scientific rationale supporting the combination of Hyleukin-7 with
various vaccines to enhance immune responses,” said NgocDiep Le, M.D.,
Ph.D., NIT’s Executive VP and Chief Medical Officer. “Our mission at NIT
is to develop innovative therapeutic options to ultimately improve the
survival and quality of life for cancer patients. Through an in-depth
analysis of Hyleukin-7’s function on specific T cell subsets, both in
quantitative and qualitative aspects in this clinical trial, we will be
able to assess the potential of using Hyleukin-7 in combination with
various vaccines in Infectious Disease and Oncology.”

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
cancer therapeutics such as immune checkpoint inhibitors or
chemo/radiotherapies.

About Hyleukin-7™
Hyleukin-7™ (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 immunotherapeutics 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]