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

Rhea-AI Summary

Sorrento Therapeutics (SRNE) announced Phase 1 results for A166, a third-generation antibody drug conjugate targeting HER2-positive breast cancer. At the ASCO meeting, it was reported that A166 exhibited a 71.4% overall response rate (ORR) at a dosage of 6.0 mg/kg, surpassing its competitor DS-8201, which showed a 60.9% ORR at 5.4 mg/kg. The therapy also demonstrated a manageable safety profile with reduced hematological and gastrointestinal side effects. This development signals a promising advancement in treatment options for patients with HER2-positive breast cancer.

Positive

• A166 shows a high overall response rate of 71.4% at 6.0 mg/kg, outperforming DS-8201.
• Demonstrated manageable safety profile with lower acute toxicities compared to commercial products.

Negative

• None.

• 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, June 04, 2021 (GLOBE NEWSWIRE) -- 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:
CTR20181301
Citation:
J Clin Oncol 39, 2021 (suppl 15; abstr 1024)
DOI:
10.1200/JCO.2021.39.15_suppl.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.

For more information visit www.sorrentotherapeutics.com.

Forward-Looking Statements
This 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 safety profile and/or therapeutic efficacy of A166, including the demonstrated stability and/or reduction in acute toxicities as compared to commercial products; and the conduct of clinical trials of A166. 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 technologies and prospects with respect to A166, including, but not limited to risks related to 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 that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic antibody product candidate strategies; 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, 2020, 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 Relations Contact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

©2021 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What is A166 and its significance for Sorrento Therapeutics (SRNE)?

A166 is a third-generation antibody drug conjugate targeting HER2-positive breast cancer, showing higher efficacy than its competitor DS-8201.

What were the Phase 1 results for A166 presented at ASCO 2021?

The Phase 1 study revealed a 71.4% overall response rate at a dose of 6.0 mg/kg.

What advantages does A166 have over other HER2 treatments?

A166 has demonstrated a better safety profile and reduced toxicities compared to existing commercial products.

When were the A166 results announced?

The results were announced on June 4, 2021, ahead of the ASCO meeting on June 5-6, 2021.