T cell amplifier + immunotherapy! Nit cooperates with MSD to evaluate the efficacy of hyeukin-7 and keytruda in the treatment of relapsed / refractory advanced solid tumors!

December 13, 2019 / BIOON / -- neoimmunotech (NIT) is a clinical stage biopharmaceutical company focusing on the development of T-cell therapy Recently, the company announced that it has signed a clinical cooperation agreement with Merck & Co to evaluate the T-cell amplifier hyleukin-7 (rhil-7-hyfc) in a "basket" study among patients with relapsed / refractory (R / R) advanced solid tumors, Nt-i7) was used in combination with keytruda (Coretta, common name: pembrolizumab, mAb) 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 with checkpoint inhibitor (CPI) and untreated with CPI The results of this study will be used for further clinical development of this combination in selected tumor types In April of this year, the first clinical study (nct03752723) to evaluate the combination of hyleukin-7 and keytruda in the treatment of refractory or recurrent triple negative breast cancer (TNBC) was conducted 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: "although immunotherapy has become a new model of cancer treatment, most patients do not respond For those tumors that are considered to be unresponsive to CPI, such as colorectal cancer and pancreatic cancer with msi-s, the response to single drug CPI has been very low Since immunotherapy relies heavily on the antitumor activity of T cells, the ability of hyleukin-7 to increase multiple T cell subsets may enhance the breadth and depth of CPI responses such as keytruda " Dr se Hwan Yang, CO president and CEO of nit, said: "we are pleased to work with MSD to provide new treatment options for patients whose tumors have no response to CPI or have progressed after CPI treatment This combination program can open the door for expanding the application of immunotherapy in these patients and ultimately improve clinical results " 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.) Source: phase 1B / 2A study will evaluate the safety and efficiency of the combination of hyleukin-7 Gamma (NT-I7) and KEYTRUDA® (pembrolizumab) in patients with Relapsed/Refractory Advanced Solid Tumors