Sorrento’s and Yuhan’s Joint Venture, ImmuneOncia, receives Approval to begin clinical trial of Anti-PD-L1 Monoclonal Antibody in South Korea

San Diego, California, UNITED STATES

SEOUL, South Korea and SAN DIEGO, Feb. 05, 2018 (GLOBE NEWSWIRE) -- Effective February 5th, 2018, Yuhan Corporation (KRX:000100.KS) (Yuhan) and Sorrento Therapeutics, Inc. (Nasdaq:SRNE) (Sorrento) announce that the South Korean Ministry of Food and Drug Safety (MFDS) has approved ImmuneOncia Therapeutics’ (51% Yuhan/49% Sorrento joint venture formed in March 2016) IND for the initiation of clinical trials for Sorrento-discovered anti-PD-L1 monoclonal antibody STI-A1015 (IMC-001), which is exclusively licensed to ImmuneOncia for select regional markets by Sorrento. 

Yuhan had initially contributed more than $10M to the formation of ImmuneOncia and towards the development of IMC-001, with a commitment of additional funding for clinical development of IMC-001. Sorrento contributed its antibody STI-A1015 (IMC-001) and two other antibodies, as well as cGMP manufacturing and regulatory expertise support for the data submission package for the IND.

The clinical Phase 1 studies will enroll patients suffering from solid tumors at two clinical sites in South Korea, namely, Seoul National University Hospital (SNUH) and Samsung Medical Center (SMC).

"We are proud to announce the acceptance of the IND by MFDS for our anti-PD-L1 antibody IMC-001. Throughout the IND-enabling activities, our team has worked collaboratively with our Sorrento colleagues to generate a high-quality submission package that was very well received by MFDS”, said Dr. Kwang Ho Cheong, CEO of ImmuneOncia Therapeutics.

“Yuhan is proud of this outstanding achievement by Dr. Cheong and the ImmuneOncia team. Together with our friends and partners from Sorrento, we created ImmuneOncia to develop important immunotherapies for cancer patients in South Korea and worldwide. Through our investment in ImmuneOncia, Yuhan has become a true biopharmaceutical company. We look forward to the future success of IMC-001 and the other antibody programs in ImmuneOncia’s pipeline”, said Mr. Jung Hee Lee, CEO and President of Yuhan Corporation.

“We are very pleased with the progress made by our joint venture in the past year. We believe this is additional validation of our antibody technology as well as our in-house cGMP antibody manufacturing and development capabilities. Notably, Sorrento has retained the rights for STI-A1015 (IMC-001) in many major markets, including the EU, Japan and the US, and we intend to leverage ImmuneOncia’s clinical work to support our clinical development in these territories where we retain rights to STI-A1015 (IMC-001). We also think the success of ImmuneOncia further highlights our ability to create shareholder value through productive strategic partnerships,” added Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics.

ImmuneOncia is exploring being publicly-listed on the South Korea Stock Exchange (KSEX) in 2019, which could result in additional sources of non-dilutive capital for Sorrento.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/PDL1 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 potentially further strengthening the anti-tumor effect of the antibody.

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 is in regulatory review following NDA re-submission.

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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 a number of 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.

Forward-Looking Statements

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 (STI-1015); Sorrento's products and technologies, including its antibody products and technologies;  Sorrento's ability to leverage the expertise of its employees, subsidiaries, affiliates, joint ventures and partners to assist the company in the execution of its strategies; outcome of the data from any clinical trial, including any clinical trial for IMC-001 (STI-A1015); Sorrento's M&A and licensing strategy; 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', affiliates’ and joint ventures’ 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', affiliates’, joint ventures’ and partners’ technologies and prospects; risks that IMC-001 (STI-A1015) 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, 2016, 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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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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