Sorrento Announces Positive Results From Its License Partner, Kelun, on a Phase I Study of Safety and Pharmacokinetics of A166, a Novel HER2 ADC for Advanced HER2 Positive Breast Cancers

  • A166 (ASCO Abstract #1024) is a third generation antibody drug conjugate (ADC) against HER2-positive breast cancer with Levena’s proprietary tubulin inhibitor Duo-5 toxin, cleavable linker and site-specific K-Lock™ conjugation chemistry.
  • In this Phase 1 Study, A166 demonstrated a manageable safety profile and high stability in circulation with much lower acute hematological and gastrointestinal toxicities compared to commercial products.
  • A166 has also demonstrated promising antitumor activity with clinically meaningful responses in heavily pretreated subjects with HER2-positive breast cancer. At a dose of 6.0 mg/kg, A166 demonstrated an 71.4% ORR as compared to 60.9% ORR from its major competitor DS-8201 at 5.4 mg/kg.

SAN DIEGO, CA, USA I June 04, 2021 I Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun”), a license and development partner, will present posters at this year’s American Society of Clinical Oncology (ASCO) meeting to be held June 5-6, 2021, releasing Phase 1 data for its HER2-ADC, A166. To generate this site-specific third generation antibody drug conjugate (ADC), Kelun partnered with Levena Biopharma, a wholly owned subsidiary of Sorrento, which provided the patent-protected technologies for the generation and production of A166, including (1) a proprietary small molecule toxin, Duostatin-5, a tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology and (3) an enzymatically cleavable linker. Compared to its commercial competitors, A166 demonstrated a better safety profile in the initial study and potentially better efficacy, as shown in the overall response rate (ORR) of 71.4% (A166) at 6.0 mg/kg vs DS-8201, which has an ORR of 60.9% (DS-8201) at 5.4 mg/kg.

Clinical Trial Information:

Clinical Trial Registry Number:
J Clin Oncol 39, 2021 (suppl 15; abstr 1024)

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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