Sorrento Announces That Its Subsidiary Levena and Its Partner Escugen Have Received Clearance to Begin Clinical Trials With Anti-TROP-2 Antibody Drug Conjugate For Multiple Solid Tumors

  • Anti-TROP-2 coupled to SN38 (a DNA polymerase inhibitor) (ESG-401) has received approval to begin clinical trials.
  • ESG-401 addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.

SAN DIEGO, CA, USA I July 21, 2021 I Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. (“Levena”) have received an approval letter from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Application for Clinical Trial (Acceptance No. CXSL2101069) of Recombinant Humanized Anti-Trop2 Mab-SN38 Conjugate.

The TROP-2 ADC (ESG-401) was jointly developed by Shanghai-based Escugen and Levena, and the two companies jointly own the domestic and international patents for this ADC and share global rights for the product.

ESG-401 has potentially distinct differentiating advantages over its competitors in terms of safety, effectiveness and process robustness. Using an innovative, highly stable and cleavable linker, this ADC demonstrated in a series of preclinical studies that it releases very little free toxin during circulation, highly enriches in tumor tissues and rapidly endocytoses, thereby effectively killing tumor cells and inhibiting tumor growth. In the preclinical studies, ESG-401 demonstrated excellent safety, with no off-target or off-tumor toxicity observed in those high-dose, repetitively administered non-human primates. Additionally, ESG-401 showed significant antitumor activity in a variety of tumor models expressing TROP-2, with a low effective dosage and long inhibition time on tumor growth. ESG-401 potentially addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.

Sorrento intends to file a US IND for this ESG-401 before the end of the year.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. 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™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

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 SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

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SOURCE: Sorrento Therapeutics

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