ACE-MABTM is a proprietary bi-specific fusion protein that binds to the spike protein of coronaviruses, including SARS-CoV-2 and SARS-CoV, which is expected to block SARS-CoV-2 from binding and infecting respiratory epithelial cells or ACE2-expressing cells to interrupt the viral life cycle
ACE-MAB is in the cGMP cell line development stage by our strategic partner, Mabpharm Limited, and could be ready for large-scale production in Mabpharm’s 30,000 m2 cGMP facilities in China for human clinical trials and commercialization upon receipt of requisite regulatory approvalsSorrento has been granted an exclusive license to develop and commercialize the ACE-MAB product candidate in the North American and European marketsSAN DIEGO, March 24, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced it has entered into an exclusive license agreement with China-based antibody biopharmaceutical company, Mabpharm Limited (Hong Kong Stock Exchange: 2181HK, “Mabpharm”), for the clinical development and commercialization of the ACE-MAB fusion protein (Sorrento’s product code name STI-4920 and Mabpharm’s product code name CMAB020) for the potential treatment of COVID-19, the disease caused by the SARS-CoV-2 virus. Mabpharm has generated a fusion protein (CMAB020) that binds to the spike protein of the SARS-CoV-2 virus.Designed as a bi-specific fusion protein, ACE-MAB has two functional arms. One arm (Ab) is a fully human antibody that targets the spike protein of SARS-CoV-2 with high affinity. The other arm (TR) is a truncated ACE2 protein that binds to a different epitope of the spike protein. The ACE-MAB fusion protein could also block the receptor binding domain (RBD) with CD147 to mitigate lung inflammation and cytokine storm. The dual-arm design could be a unique advancement, potentially providing binding to the SARS-CoV-2 virus that is sufficient to prevent the virus from invading normal human cells. ACE-MAB retains the ACE2 enzymatic function, which could provide benefits such as reduced vasoconstriction and increased blood flow to infected lung tissue. The ACE2 arm competes with RBD binding to respiratory epithelial or other cells. It should preserve the ACE2 enzymatic activity, which is important in maintaining normal blood pressure and healthy blood flow into patients with infected lung tissue, which would include patients with advanced COVID-19 disease.Under the exclusive license agreement, Sorrento will focus on the development and commercialization of ACE-MAB in the North American and European markets, while Mabpharm retains rights in the rest of the world, including the China and Japan markets.“The license of the ACE-MAB fusion protein from our partner Mabpharm provides Sorrento with yet another potential therapeutic agent to combat COVID-19,” stated Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics. “Since the breakout of COVID-19, Sorrento has built a broad product candidate pipeline for the potential vaccination and treatment of COVID-19. We are looking forward to further evaluating the safety and efficacy in IND-enabling preclinical studies and clinical trials and making these potentially Life-Saving medicines available to the vast population affected by the COVID-19 pandemic.”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”, “DAR-T”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir®”). Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. Resiniferatoxin is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was approved by the FDA on February 28, 2018.For more information visit www.sorrentotherapeutics.comAbout Mabpharm LimitedMabpharm is a leading biopharmaceutical company in China, focusing on the development and production of new drugs and biosimilars for the treatment of cancer and autoimmune diseases. Mabpharm is committed to bringing high-quality and affordable innovative biopharmaceuticals to the market through an efficient research and development system and low-cost pharmaceutical production capabilities, and fully utilizes its rich research and development experience to develop a variety of therapeutic products.Mabpharm has strong internal research, preclinical and clinical development capabilities, with a special focus on the development and manufacturing of monoclonal antibodies. The members of Mabpharm’s core R & D team have more than 16 years of experience in this field. Mabpharm’s 30,000 m2 production facilities in Taizhou and Shanghai are one of the largest antibody drug production facilities in China by capacity.Forward-Looking StatementsThis press release and any statements made for and during any presentation or meeting contain 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 potential therapeutic benefits of ACE-MAB in treating the SARS-CoV-2 virus and COVID-19 disease; ACE-MAB’s ability to treat and prevent coronaviruses; regulatory approvals of ACE-MAB, the readiness of Mabpharm Limited’s cGMP facilities for large-scale production of ACE-MAB for human clinical trials and commercialization; the safety and efficacy of ACE-MAB; the completion of IND-enabling preclinical studies and clinical trials of ACE-MAB; the development and commercialization of ACE-MAB for individuals affected by the COVID-19 disease; Sorrento’s pipeline of product candidates for the potential vaccination and treatment of COVID-19; and Sorrento’s potential position in the anti-viral immunity industry. 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 and its subsidiaries’, affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting pre-clinical trials and seeking IND regulatory approval for ACE-MAB; conducting and receiving results of clinical trials for ACE-MAB; the clinical and commercial success of the treatment of the SARS-CoV-2 virus infections using ACE-MAB; the viability and success of using ACE-MAB for treatments in anti-viral therapeutic areas, including coronaviruses; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results 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 of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its ACE-MAB strategies; risks related to Sorrento’s debt obligations; risks related to the global impact of COVID-19; and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2019, 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.Media and Investor RelationsAlexis Nahama, DVM (SVP Corporate Development)Telephone: 1.858.203.4120Email: [email protected]Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ACE-MAB™ and G-MAB™ are trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
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.
All other trademarks are the property of their respective owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
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