Phase 2 Study to Start Later 2020
SEOUL, South Korea and SAN DIEGO, March 11, 2019 (GLOBE NEWSWIRE) -- Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics, Inc. (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 (KS) is a publicly-listed company traded on the Korea Stock Exchange.
This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward looking statements include statements regarding the developments of and prospects for IMC-001 (PD-L1 antibody); Sorrento's products and technologies, including its antibody products and technologies; outcome of the data from clinical trials for IMC-001 (PD-L1 antibody); Sorrento's joint venture and licensing strategies; Sorrento's and its partners’ abilities to accelerate the development of any lead programs in the clinic; and expectations for Sorrento's and its subsidiaries’ and partners’ technologies and product candidates. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's, its subsidiaries' and partners’ technologies and prospects; risks that IMC-001 (PD-L1 antibody) may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks related to seeking regulatory approvals and conducting clinical trials; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2017, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
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Contact: Alexis Nahama, DVM
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ZTlido® and G-MAB™ are trademarks owned by Scilex Pharmaceuticals Inc. and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
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