The phase 1b/2a immuno-oncology trial will evaluate the combination of HyLeukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq), and will be led by NIT and the Immune Oncology Network (ION), a network of investigators from the foremost cancer centers and universities in North America that conducts multicenter trial of high priority immunotherapy agents. The purpose of this study is to evaluate safety and anti-tumor activity of HyLeukin-7 in combination with Tecentriq in approximately 70 patients with anti-PD-(L)1 naïve or refractory high-risk skin cancers. The planned multi-center open-label trial is anticipated to start in the second half of 2018 and will be conducted in the US and possibly additional countries.
"We are very excited to collaborate with Roche, a global leader in immuno-oncology, and with key opinion leaders from the ION, to advance the development of HyLeukin-7 and analyze its synergy with immune-checkpoint inhibitors," said NeoImmuneTech Chief Executive Officer Se Hwan Yang, Ph.D. "We believe that this combination regimen will deliver a strong dual effect over cancer by both increasing the numbers of T cells and eliminating cancer cells' escape route."
Patients with advanced high-risk skin cancers have poor prognosis and limited treatment options, as PD-(L)1 blockade fails to induce complete responses in most patients, especially those with low tumor infiltrating lymphocyte (TIL) counts. The trial aims to study HyLeukin-7's effect on the efficacy of Tecentriq by enhanced antitumor T-cell immunity and increased TIL count.
"HyLeukin-7 has shown in multiple studies to substantially increase the total body complement of T cells with little toxicity. HyLeukin-7 is designed to be effective when used in concert with a variety of different immunotherapy regimens, including the combination with anti-PD-(L)1 that is being tested in this trial," said Martin A. "Mac" Cheever, MD, Director of the Immune Oncology Network, which is based at Fred Hutchinson Cancer Research Center. He is also director of the National Cancer Institute's Cancer Immunotherapy Trials Network.
HyLeukin-7 (IL-7-hyFc, NT-I7) is a T cell amplifier, comprising 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, acting on increasing both the number and functionality of T cells. HyLeukin-7 could play a pivotal role in reconstitution and reinvigoration of T cell immunity for treatment of cancer patients, 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 many other cancer treatments, especially with anti-PD-(L)1 agents or chemo/radiotherapy. In a recent Phase I clinical trial in healthy volunteers, a single dose of HyLeukin-7 was safe and well tolerated and substantially increased the absolute lymphocyte counts (ALC) as well as the number of CD4/CD8 T cells without an increase in the number of regulatory T cells. NeoImmuneTech and Genexine are collaborating in three Phase 1b/2a clinical trials in advanced solid tumors and glioblastoma in the US and Korea.
TECENTRIQ® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Founded in 2014 as a spin-off company from Genexine, NeoImmuneTech (NIT) is focused on leading the development efforts for its flagship immunotherapy product, HyLeukin-7, in the US and EU. Based in Rockville, Maryland, NIT has the core competency of global clinical and business development with a strong scientific focus and a broad network of global leading R&D organizations. NIT is currently conducting Phase 1b/2a clinical trials of HyLeukin-7, aiming at developing not only the first-in-class treatment of lymphopenia but also a breakthrough cancer immunotherapy.
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has a robust pipeline of products in the clinical stage, e.g. HyLeukin-7, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed multinational phase II trials and is preparing to apply IND of US Phase III trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III. Founded in 1999, Genexine has over 140 employees, and half of them are scientists with MSc, or Ph.D. Genexine is located in Pangyo Techno Valley near Seoul, Korea with a branch office in New York.
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