Sorrento announces its main protein-based COVID-19 vaccine

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  • Immunization with a protein-based immunogen, DYAI-100, a receptor binding domain (RBD) of SARS-CoV-2, resulted in potent B cell immunity in preclinical studies, with strong serological recognition of the original SARS-CoV-2 virus and major variants of concern (Alpha, Beta, Gamma and Delta; “VOC”).
  • Sera from vaccinated mice demonstrated potent neutralization of viral infection with the original SARS-COV-2 and major VoCs, such as Beta and Delta, and to a lesser extent Gamma in vitro in a live virus challenge Vero-E6 cell model.
  • Sorrento and its collaborative partner, Dyadic International, Inc., are working together to complete the studies enabling the IND for submission of the IND for human vaccination trials worldwide.
  • A MultiValent RBD-based vaccine using SARS-CoV-2 RBDs and its major VoCs is under development to potentially serve as a universal vaccine and potentially a universal booster for other COVID-19 vaccines.

SAN DIEGO, August 19, 2021 (GLOBE NEWSWIRE) – Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), a clinical and commercial biopharmaceutical company developing new therapies to treat cancer, pain and COVID- 19, today released a preprinted publication, accessible at: https://www.biorxiv.org/content/10.1101/2021.08.17.456704v1.full.pdf. The publication details the preclinical vaccination studies of a new COVID-19 vaccine candidate based on proteins and to be developed, DYAI-100. The new RBD-based COVID-19 vaccine candidate has demonstrated in preclinical studies the potential to elicit potent neutralizing B-cell immune responses against the original strain of SARS-CoV-2 and its emerging variants, including Beta and Delta.

Generation of a protein-based vaccine candidate that offers protection against the original SARS-CoV-2 virus and emerging VoCs has proven difficult. The publication reports the protective neutralizing activities of sera from animals vaccinated against a broad spectrum of SARS-CoV-2 virus and its major VoCs by immunization with the recombinant Spike protein receptor (RBD) binding domain administered in conjunction with adjuvant of aluminum phosphate intramuscularly. Immunization of mice with an RBD protein vaccine with a simple aluminum phosphate adjuvant resulted in the production of IgG antibodies recognizing the Spike protein of the SARS-CoV-2 prototype as well as VoCs, such as Alpha (“Kingdom- Uni “), Beta (” South Africa “), Gamma (” Brazil / Japan “) and Delta (” India “). RBD protein immunization induced by activation of a Th1 polarization of CD4 positive T cells. In addition, immunization with the RBD protein produced IgG antibodies in vivo, which exhibited high neutralizing activity against live SARS-CoV-2 and highly transmissible VoCs, Beta and Delta, as well as Gamma to a lesser extent. Thus, DYAI-100 represents a promising COVID-19 vaccine candidate against COVID-19 that can potentially offer a wide range of protection against emerging COVs of the SARS-CoV-2 virus.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical-stage, antibody-focused biopharmaceutical company developing new therapies to treat cancer and COVID-19. Sorrento’s multimodal and multidimensional approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB ™ library”), immune therapies – clinical stage cells (“CAR-T”, “DAR-T ™”), antibody-drug conjugates (“ADC”) and clinical stage oncolytic virus (“Seprehvir ™”). Sorrento is also developing antiviral therapies and potential coronavirus vaccines, 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 is also demonstrated by our efforts to advance a first-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. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in patients with osteoarthritis. 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 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 DYAI-100 and its properties, including its induction of potent neutralizing activity against SARS-CoV-2 and its variants of concern, including Alpha, Beta, Gamma and Delta; the collaboration between Sorrento and Dyadic, including, but not limited to, the development of DYAI-100 and the completion of studies enabling IND for DYAI-100; the potential of DYAI-100 to serve as a universal vaccine and a universal booster for other COVID-19 vaccines; the ability of an RBD protein vaccine, including DYAI-100, to elicit strong immunity and produce IgG antibodies against SARS-CoV-2 and its variants of concern when administered intramuscularly in conjunction with an adjuvant, including an aluminum phosphate builder; and Sorrento’s expectation of obtaining the license rights for Dyadic’s DYAI-100. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, without limitation: risks relating to Sorrento’s technologies and prospects, including, but not limited to ‘to limit the risks associated with seeking regulatory approval for DYAI-100; clinical development risks, including risks related to the progress, timing, costs 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 will not meet all or part of the parameters of a clinical study and that the data generated from these studies may not support a regulatory submission or approval; the risks that the results of previous trials, studies and trials will not be reproduced in future studies and trials; risks associated with the manufacture and supply of pharmaceutical products; risks associated with using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic drug candidate strategies; risks associated with the global impact of COVID-19; and other risks which 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 fiscal 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 out 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 assume no obligation to update any forward-looking statements contained in this press release, unless the law requires it.

Media contact and investor relations
Alexis Nahama, DVM (SVP Business Development)
E-mail: [email protected]

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.


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