- Socazolimab (anti-PD-L1 monoclonal antibody) was discovered by Sorrento from its fully human antibody G-MABMT library and under license from China Oncology Focus Limited (“COF”), a subsidiary of Lee’s Pharm, for the territories of Greater China.
- The COF has completed patient recruitment (498 patients) for a phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial of socazolimab plus chemotherapy in the first-line treatment of small-scale lung cancer. extended stage cells (“ES-SCLC”).
SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. ( SRNE, “Sorrento”) today announced that its licensing partner, China Oncology Focus Limited (“COF”), a subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”), has completed patient enrollment for a Phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial of socazolimab (anti-PD-L1 monoclonal antibody, formerly known as name ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”).
This clinical trial involves 54 centers and is led by Professor Shun Lu (陸舜) of Shanghai Chest Hospital (上海市胸科醫院). Clinical trial approval was granted by China National Medical Products Administration (“NMPA”) on March 1, 2021, and the first patient was enrolled on July 15, 2021. A total of 498 patients were enrolled in the study. An interim analysis should be carried out in April 2023.
Socazolimab is a licensed product from Sorrento for the People’s Republic of China, Hong Kong, Macao and Taiwan. To date, three Phase I clinical trials of socazolimab monotherapy have been completed: (1) recurrent or metastatic cervical cancer; (2) advanced urothelial carcinoma; and (3) high-grade osteosarcoma after adjuvant maintenance chemotherapy.
For recurrent or metastatic cervical cancer, a pivotal study was completed and Breakthrough Therapy designation was granted by the NMPA in February 2021, and a New Drug Application for this purpose was submitted and accepted by the NMPA Drug Evaluation Center for review in October 2021. Apart from monotherapies, several studies of Socazolimab plus chemotherapy are ongoing in advanced urothelial carcinoma (Phase Ib), SCLC-ES (Phase III), neoadjuvant treatment of carcinoma of the esophagus (Phase Ib+II), metastatic melanoma (Phase Ib) and resected bile duct cancer (Phase I).
About socazolimab
Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB™ library platform. Socazolimab has the following potential advantages over its competitors:
- The fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative generation of antigen-derived antibodies (ADA) in humans in studies to date.
- Potentially lower dose needed 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.
About ES-SCLC and Immunotherapy
The PD-L1 inhibitor atezolizumab, in combination with carboplatin and etoposide, has been approved by the NMPA as a first-line treatment for extensive-stage small cell lung cancer.
The treatment was a major milestone and the first new treatment for aggressive cancer in decades; it increased the median overall survival by 2 months and reduced the risk of death by 23% compared to chemotherapy alone in this pathological context. The advance was celebrated as a milestone. Durvalumab, another PD-L1 inhibitor, obtained New Drug Approval (NDA) in ES-SCLC in China earlier this month. No PD-1 inhibitor has been approved for this indication.
About China Oncology Focus Limited (COF)
COF is a subsidiary of Lee’s Pharm and a clinical development stage company focused on oncology. COF is currently developing several active ingredients, including Socazolimab (anti-PD-L1 antibody) in the pivotal clinical trial phase; Zotiraciclib, an oral multi-kinase inhibitor in phase I clinical trial for glioblastoma; Gimatecan, a topoisomerase I inhibitor for ovarian cancer; Pexa-vec (oncolytic virus) which is in a global phase Ib clinical trial for renal cell cancer. COF has built a pipeline of 10 assets through internal development and licensing. The diversity of its products creates a unique position for the company to use immuno-oncology as a core therapy in combination with in-house products and develop a potential paradigm-shifting treatment for cancer.
About Lee’s Pharm
Lee’s Pharm is a research-driven and market-driven biopharmaceutical company with more than 25 years in the pharmaceutical industry in China. The company is fully integrated with strong drug development, clinical development, regulatory, manufacturing, sales and marketing infrastructures based in mainland China with global outlook. The company has established extensive partnerships with over 20 international companies and currently markets over 25 proprietary, generic and licensed pharmaceutical products in Mainland China, Hong Kong, Macao and Taiwan. The Company focuses on several key disease areas such as cardiovascular disease, women’s health, pediatrics, rare diseases, oncology, dermatology and obstetrics, and has more than 40 products in various stages of development. from both in-house research and development as well as development, marketing and manufacturing licensing and rights from various US, European and Japanese companies. More information available at www.leespharm.com.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial-stage biopharmaceutical company developing novel therapies to treat cancer, pain (non-opioid treatments), autoimmune diseases and COVID-19. Sorrento’s multi-modal, multi-pronged approach to fighting cancer is enabled by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immunocellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”) and oncolytic viruses (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and coronavirus vaccines, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic testing solutions, including COVIMARK™.
Sorrento’s commitment to therapies that improve patients’ lives is also demonstrated by our efforts to advance a first-in-class, non-opioid pain management small molecule (TRPV1 agonist), resiniferatoxin (“RTX”) and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a new viscous gel formulation of a corticosteroid widely used for epidural injections to treat lumbosacral radicular pain, or sciatica, and to market ZTlido® (topical lidocaine system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a phase II trial in refractory pain associated with cancer and a phase II trial in patients with osteoarthritis. Positive final results from the CLEAR program of the pivotal Phase III trial for SEMDEXA™, its new non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.
For more information, visit www.sorrentotherapeutics.com
Forward-looking statements
This press release and all statements made for and during any presentation or meeting contain forward-looking statements relating 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. which could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Socazolimab; the therapeutic and clinical potential of Socazolimab; the potential safety and efficacy of socazolimab, including the potential efficacy of abivertinib against ES-SCLC; the planned schedule for the interim analysis of the phase III study; and the potential advantages of Socazolimab over its competitors. 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 relating to Sorrento’s technologies and prospects, including, but not to limit the risks related to the safety and efficacy of socazolimab; clinical development risks, including risks relating to the progress, timing, cost and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; the risks that the results of a clinical study may not meet any or all of the clinical study endpoints and that the data generated by such studies may not support a regulatory submission or approval; the risks that the results of prior tests, studies and trials will not be replicated in ongoing or future studies and trials; risks associated with the manufacture and supply of pharmaceutical products; the risks of using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in executing its product candidate strategies; risks related to the global impact of COVID-19; and other risks 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 fiscal year ended December 31, 2021 and subsequent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and Exchange Commission, including the risk factors set forth in those documents. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we undertake no obligation to update any forward-looking statements in this press release unless the law requires it.
Media and investor relations
Contact: Brian Cooley
E-mail: [email protected]
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are registered trademarks of Sorrento Therapeutics, Inc.
SEMDEXA™ (SP-102) is a registered trademark of Semnur Pharmaceuticals, Inc. Proprietary name review by the FDA is pending.
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