T cell amplifier + immunotherapy! Hyeukin-7 combined with keytruda in the treatment of advanced solid tumors "basket" study was approved by the US FDA!

January 29, 2020 / BIOON / -- neoimmunotech (NIT) is a clinical stage biopharmaceutical company focusing on the development of T-cell therapy Recently, the company announced that the U.S Food and Drug Administration (FDA) has approved its T-cell amplifier hyleukin-7 (rhil-7-hyfc, nt-i7) and mosadon anti PD-1 therapy keytruda (coreda, common name: pembrolizumab, pabolizumab) for the treatment of relapsed / refractory (R / R) advanced solid tumors The ind approval will allow neoimmunetech to launch a phase Ib / IIA "basket" study to evaluate the combination therapy for patients with advanced R / R solid tumors who have received checkpoint inhibitor treatment (CPI treated) and who have not received checkpoint inhibitor treatment (CPI initial treatment) The purpose of this phase Ib / IIA study was to establish a recommended regimen and to explore the preliminary antitumor activity of the combination regimen in patients with R / R tumors treated by CPI and those initially treated by CPI The results of this study will be used for further clinical development of this combination in selected tumor types In April 2019, the first patient was treated in a clinical study (nct03752723) to evaluate the combination of hyleukin-7 and keytruda in the treatment of refractory or recurrent triple negative breast cancer (TNBC) In the phase I study in healthy subjects and multiple continuous dose increasing studies in cancer patients, hyleukin-7 showed good tolerability and safety characteristics, and increased the CD4 + and CD8 + T lymphocyte count in a dose-dependent manner At present, nit company is also actively carrying out and planning a number of concept validation clinical research, using the development of hyleukin-7 as a drug to start other immunooncology drugs (IO) Dr Ngoc DIEP Le, executive vice president and chief medical officer of nit, said: "we are working hard to develop a safe and effective immunotherapy for patients with advanced solid tumors of R / R, including those who do not respond to the single drug treatment of CPI This approval of ind marks the next step towards the goal of combining hyleukin-7 with advanced cancer therapies such as keytruda " The mechanism of action of hyleukin-7 (photo source: neoimmunotech company) hyleukin-7 is a new immunooncology preparation, which is a T-cell growth factor, composed of engineered interleukin-7 (IL-7) covalently linked homodimer, and fused with the proprietary long-term platform hyfc IL-7 is an important factor of T cell homeostasis, which can increase the number and function of T cells In the treatment of cancer and lymphocytopenia patients, hyleukin-7 can enhance and restore sustained T-cell immunity, thus providing a unique opportunity for the combination of immunooncology (IO) strategies The top of hyleukin-7 is its effect part, which is a stable form of IL-7 As a therapeutic protein, IL-7 has poor structural stability and low production efficiency, which is an inherent technical barrier to commercialization Using advanced protein engineering technology, neoimmunotech has created a stable and more effective form of IL-7 Based on the hyfc platform technology, the base of hyleukin-7 hybridized the engineered IL-7 with the fragments of IgD and igg4fc as non cytolytic and non immunogenic vectors to construct a long-term fusion protein Hyfc technology can prolong the half-life, minimize the loss of biological activity of candidate drugs, and prevent the cell killing effect caused by the reaction of ADCC and CDC Hyleukin-7 is a T cell growth factor based on IL-7 It aims to promote the production, maturation, expansion, transportation, function and survival of T cells at multiple levels of T cell production as a stable and lasting factor The ultimate goal is to induce a lasting anti-tumor T cell response Hyleukin-7 is designed to increase the number of new and memory T cells, enhance the function of T cells, and expand the diversity of T cell receptor (TCR), so that T cells respond to pressure dominant epitopes In addition, hyleukin-7 can enhance T cell homing and tumor invasion by increasing homing chemokine activity and antagonizing various inhibition networks At present, hyleukin-7 is being developed as an "IO enabling" therapy, which combines T-cell immunity with current cancer therapies (such as Pd - (L) 1 immunosuppressive checkpoint inhibitors, chemotherapy / radiotherapy, next-generation IO therapy, etc.) Original source: neimumunetech received U.S FDA clearance of ind application for phase 1B / 2A study of hyleukin-7? (nt-i7) and keytruda? (pembrolizumab) in relapsed / refactory advanced solid tumors