Sorrento Therapeutics Announces FDA Clearance of Its IND Application of Next Generation oHSV Oncolytic Virus STI-1386 for Patients With Relapsed and Refractory Solid Tumors

SAN DIEGO, Dec. 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the U.S. Food and Drug Administration (FDA) has granted clearance to proceed with a Phase 1b clinical trial using STI-1386, Seprehvec™, entitled “Dose Escalation Study of the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Patients with Relapsed or Refractory Solid Tumors.”

STI-1386, or Seprehvec, is a 2^nd generation oncolytic herpes simplex virus type 1 (oHSV) developed following the acquisition of Virttu Biologics by Sorrento in 2017 and produced in Sorrento’s GMP virus therapeutics manufacturing facility. The Seprehvec backbone is deleted of both RL1 gene copies, eliminating expression of the neurovirulence factor ICP34.5 and restricting virus proliferation to cells which are rapidly dividing, i.e., tumor cells. Seprehvec additionally expresses transgenes encoding an anti-PD-1 scFv-Fc isolated from the Sorrento G-MAB antibody library, a TGF beta receptor 2 decoy, and interleukin-12.

These transgene-encoded proteins secreted by Seprehvec-infected tumor cells are designed to act in a coordinated fashion to enhance immune-mediated tumor destruction by i) inhibiting the PD-1/PDL-1 immune checkpoint pathway, ii) diminishing the immunosuppressive effects of TGF beta in the tumor microenvironment, and iii) providing a localized IL-12 signal to activate and attract T cells and NK cells to the tumor.

“Seprehvec allows for locoregional immune stimulation at the tumor site while potentially minimizing the undesired effects that may accompany systemic immune stimulation. Our initial focus is to develop Seprehvec for treatment of sarcomas, pancreatic carcinomas, and hepatic metastases, with expansion to additional solid tumor indications in the future,” said Mike Royal, MD, JD, MBA, Chief Medical Officer of Sorrento.

Robert Allen, PhD, Senior Vice President of Antiviral and Oncolytic Immunotherapy Development, commented, “Seprehvec provides a unique means of simultaneously bringing multiple tumor-killing and tumor-suppressing elements to bear on solid tumors, which are notoriously hard to eradicate. Using this same approach, we are currently progressing additional oHSV candidates that mediate recruitment and activation of anti-tumor responses from specific subsets of immune cells. The virologists, cancer immunologists, and manufacturing scientists at Sorrento continue to leverage the breadth and quality of the G-MAB library, delivering best-in-class next-generation oHSVs, antibodies, and cellular immunotherapies to patients.”

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, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.

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 STI-1386 (Seprehvec); the therapeutic and clinical potential of STI-1386; the potential for STI-1386 to be used to treat sarcomas, pancreatic carcinomas, hepatic metastases and solid tumors; and additional oncolytic herpes simplex virus type 1 (oHSV) candidates under development for the treatment of cancers, including solid tumors. 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 STI 1386; 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 product candidates’ 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
Dorman Followwill
Email: [email protected]

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

G-MAB™, DAR-T™, SEPREHVEC™, SOFUSA™, COVI-AMG™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVITRACK™ 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.

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