Sorrento Receives FDA Clearance to Proceed With Clinical Trial for Anti-TROP-2 Antibody Drug Conjugate (TROP-2 ADC) for multiple solid tumors

Rhea-AI Summary

Sorrento Therapeutics (SRNE) announced that its partner, Escugen Biotechnology, has received FDA authorization to initiate clinical trials for ESG-401, an anti-TROP-2 ADC with drug payload SN38. This investigational therapy aims to address significant unmet medical needs in treating multiple solid tumors, particularly triple-negative breast cancer and urothelial carcinoma. The approval is a pivotal step in Sorrento's commitment to developing innovative cancer therapies and highlights the company's ongoing efforts in the oncology domain.

Positive

• FDA clearance for ESG-401 clinical trials enhances Sorrento's oncology portfolio.
• Potential to address unmet needs in treating solid tumors, including triple-negative breast cancer.

Negative

• Dependence on clinical trial outcomes poses risks for future regulatory approvals.
• Potential delays in clinical trials could impact the timeline for market entry.

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

SAN DIEGO, Oct. 13, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") previously announced that its partner Escugen Biotechnology Co, Ltd. (“Escugen”) and Sorrento’s subsidiary Levena (Suzhou) Biopharma Co., Ltd. (“Levena”) had 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. Today Sorrento announces that the US FDA has given clearance to proceed with clinical trials in cancer patients with relapsed or refractory solid tumors.

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 1B 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 ESG-401 the clinical potential of ESG-401; and the potential for ESG-401 to treat relapsed or refractory solid tumors, including triple-negative breast cancer and urothelial carcinoma; and Sorrento’s expected timing for filing a US IND. 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 and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting and receiving results of clinical trials for ESG-401; the viability and success of using ESG-401 for treatments in therapeutic areas, including relapsed or refractory solid tumors; 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 purpose of ESG-401 clinical trials initiated by SRNE?

ESG-401 aims to evaluate the safety and efficacy of the anti-TROP-2 ADC for treating relapsed or refractory solid tumors.

When did Sorrento Therapeutics receive FDA clearance for ESG-401?

Sorrento received FDA authorization for ESG-401 on October 13, 2021.

What cancers is ESG-401 targeting?

ESG-401 is targeting multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.

What are the next steps for Sorrento after receiving FDA authorization for ESG-401?

The next steps include initiating clinical trials and collecting data on the therapy's performance in patients.

What is the significance of FDA authorization for Sorrento (SRNE)?

FDA authorization represents a critical milestone in Sorrento's development of innovative cancer therapies and enhances investor confidence.