Biotherapeutics company Genexine and biotech firm NeoImmuneTech (NIT) have dosed the first patient in the combination trial of Hyleukin-7 with Merck’s Keytruda in patients with refractory or relapsed triple-negative breast cancer (TNBC).

Hyleukin-7TM, a homodimeric Interleukin-7 (IL-7) based growth factor for T cells, is engineered to serve as a stable factor for T cell production, maturation, expansion, trafficking, functioning, and survival, in various levels of T cell production.

Hyleukin-7, which is built on the hyFc platform technology, is designed to induce persistent and long-lasting anti-tumour T cell response, as it controls white blood cell production and peripheral homeostasis.

Keytruda is a type of immunotherapy that works by blocking the PD-1 pathway and to help prevent cancer cells from hiding.

“We believe Hyleukin-7 could deliver improvements for patients non-responsive to immunotherapy regimens by treating lymphopenia.”

In June 2018, the combination regimen trial was chosen as a grantee of joint R&D program supported by Korea Drug Development Fund.

The Korean Ministry of Food and Drug Safety had recently granted the authorisation to start the phase 1b/2 study, which is currently under recruitment in about ten clinical sites in Korea including Samsung Medical Center.

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Genexine senior vice-president, head of clinical division Jung Won Woo said: “This combination regimen trial of Hyleukin-7 and Keytruda is very meaningful, in that it attempts to treat advanced or metastatic TNBC patients who respond poorly to standard-of-care treatments.

“We believe Hyleukin-7 could deliver improvements for patients non-responsive to immunotherapy regimens by treating lymphopenia, which is commonly observed in TNBC patients, as well as amplifying tumor-infiltrating lymphocytes (TILs) that may enhance anti-tumor response.”

Hyleukin-7 is reported to have demonstrated a well-tolerated safety profile and dose-dependent increases of CD4+ and CD8+ T lymphocyte counts in a Phase I trial in healthy subjects and several ongoing dose-escalation trials in cancer patients.

Genexine and NIT have been undertaking and planning various proof-of-concept clinical trials to develop Hyleukin-7, a T cell amplifier as an immune-oncology-enabling drug in combination with other cancer therapeutics like immune checkpoint inhibitors and chemo/radiotherapies.