Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
April 29, 2019

Genexine and NIT dose first patient in Hyleukin-7 and Keytruda trials

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).

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.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU