Sorrento’s License Partner, Lee’s Pharmaceutical Announces NDA Filing Acceptance by NMPA for Anti-PD-L1 Antibody Socazolimab for Treatment of Recurrent or Metastatic Cervical Cancer

Rhea-AI Summary

Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced that its license partner, China Oncology Focus Limited (COF), has submitted a NDA for its anti-PD-L1 antibody, socazolimab, for treating recurrent or metastatic cervical cancer. The application has been accepted by the China National Medical Products Administration (NMPA). Socazolimab, which received breakthrough designation in February 2021, could become the first approved fully human antibody from Sorrento's G-MAB™ library. This antibody shows potential advantages, including minimal immunogenicity and a dual mechanism of action.

Positive

• Submission of NDA for socazolimab accepted by China NMPA.
• Potential first approved fully human antibody from Sorrento's G-MAB™ library.
• Socazolimab shows minimal immunogenicity and requires potentially lower dosing.

Negative

• None.

• Socazolimab is an anti-PD-L1 antibody licensed from Sorrento for the Greater China Territory by Lee’s Pharma.
• China National Medical Products Administration (NMPA) accepted the filing of socazolimab for the cervical cancer indication.

SAN DIEGO, Nov. 01, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that its license partner, China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharma, HKEX: 950) has submitted a NDA (new drug application) for the anti-PD-L1 antibody, socazolimab, licensed from Sorrento to COF for the greater China territory to treat recurrent or metastatic cervical cancer. The NDA application has been accepted by China NMPA.

In February 2021, Sorrento and Lee’s Pharma announced that socazolimab had been granted breakthrough designation by the NMPA. If approved by NMPA, this will be the first approved fully human antibody discovered and isolated from Sorrento’s proprietary G-MAB™ library. “This is a major step forward that demonstrates the power of discovery and development engines at Sorrento for producing proprietary biopharmaceuticals for unmet medical needs,” said Dr. Henry Ji, Chairman and CEO of Sorrento.

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB™ library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

• Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
• Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
• Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.
  

The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

About Lee's Pharmaceutical Holdings Limited

Lee’s Pharma is a research-driven and market-oriented biopharmaceutical company with more than 25 years of operation in the pharmaceutical industry in Greater China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Greater China with global perspectives. The Company has established extensive partnerships with over 20 international companies and currently markets 23 proprietary and licensed-in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease areas such as cardiovascular, woman health, pediatrics, rare diseases, oncology, dermatology, obstetrics and urology, and has more than 40 products under different development stages stemming from both internal research and development as well as from the licensing, development, commercialization and manufacturing rights from various United States, European and Japanese companies. Lee’s Pharma is also involved in the area of ophthalmology through its investment in Zhaoke Ophthalmology Limited, an associated company of the Group.

For more information visit www.leespharm.com.

About China Oncology Focus Limited

China Oncology Focus Limited (COF) is a subsidiary of Lee’s Pharma and a clinical development stage company focused in oncology with emphasis in immune oncology. COF is currently developing several assets, including socazolimab (anti-PD-L1 antibody) in pivotal clinical trial stage; Zotiraciclib, an oral multi-kinase inhibitor in Phase I clinical trial for glioblastoma; Gimatecan, a topoisomerase I inhibitor in Phase I clinical trial for ovarian cancer and in Phase Ib/II clinical trial for small cell lung cancer in China; Pexa-vec (oncolytic virus) which is in global Phase Ib clinical trial for renal cell cancer. COF has built a pipeline of 10 assets through internal development and in-licensing. The diversity of its products creates a unique position for the company to use immune oncology as backbone therapy in combination with in-house products and develop potential paradigm-shifting treatment for cancer.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease 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”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™, COVISHIELD™, 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 socazolimab; and the potential efficacy and safety profile of a Socazolimab product candidate in patients with recurrent or metastatic cervical cancer. 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, including, but not limited to risks related to seeking regulatory approval for socazolimab; 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™, 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 the news about Sorrento Therapeutics and socazolimab?

Sorrento Therapeutics announced that its license partner, China Oncology Focus Limited, submitted a new drug application for socazolimab to treat cervical cancer, which has been accepted by the China NMPA.

What is the significance of the NDA submission for socazolimab?

The NDA submission for socazolimab is significant as it could lead to the first approval of a fully human antibody developed from Sorrento's proprietary G-MAB™ library.

What advantages does socazolimab have compared to other treatments?

Socazolimab may offer advantages such as minimal immunogenicity and potentially lower doses needed for efficacy compared to other anti-PD-L1 antibodies.

When was the breakthrough designation for socazolimab granted?

The breakthrough designation for socazolimab was granted by the China NMPA in February 2021.