Yuhan Corp and Sorrento Therapeutics Announce Completion of Phase 1 Clinical Study of Anti-PD-L1 Antibody IMC-001

In Clinical Studies News by Barbara Jacoby


From: apnews.com

Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced today that ImmuneOncia, a joint venture formed in September 2016, has completed the Phase 1 study of IMC-001 (also known as STI-3031), a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor.

This Phase 1 dose-escalation study, approved by the South Korean Ministry of Food and Drug Safety (MFDS) in February of 2018, enrolled subjects with locally-advanced or metastatic solid tumors at Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC). The Recommended Phase 2 Dose (RP2D) was determined to be successful with no observations of dose-limiting toxicities. More results of this study will be disseminated at upcoming conferences.

“Based on the results of the Phase 1 trial of IMC-001, we are planning on conducting a Phase 2 trial to evaluate its efficacy in rare cancers in the second half of this year,” stated Yun Jeong Song, CEO of ImmuneOncia. “Moreover, we greatly appreciate those who supported us and for their contributions as the company successfully completed a Phase 1 trial of IMC-001. In collaboration with various institutions, we will continue our research and development of IMC-001 as well as the additional checkpoint immune-oncology molecules in our pipeline.”

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, suppressing the inhibitory signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody. The clinical-grade material of IMC-001 was manufactured by Sorrento in its San Diego-based GMP antibody production facility.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento’s multimodal multipronged approach to fighting cancer is made possible by its’ extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”).

Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido®. Resiniferatoxin is completing a Phase 1b trial in terminal cancer patients. ZTlido was approved by US FDA on 02/28/18.

For more information visit www.sorrentotherapeutics.com

About Yuhan Corporation

Yuhan Corporation is a South Korea-based healthcare company founded in 1926. The company has positioned itself as one of the top pharmaceutical companies in terms of market cap and sales revenue in Korea. The core business consists of primary & specialty care, dietary supplements, household & animal care, and contract manufacturing of active pharmaceutical ingredients. It has several subsidiaries and a global presence in the form of joint ventures with Janssen (Belgium), the Clorox Company (USA), and Kimberly-Clark Corporation (USA). Yuhan (000100:KS) is a publicly-listed company traded on the Korea Stock Exchange.