Sorrento Therapeutics And ViralClear Enter Into Agreement To Explore Combination Antibody Plus Antiviral Therapy Against COVID-19

Sorrento to initiate testing with a selection of its agents in combination with ViralClear's anti-viral compound for possible synergistic anti-viral effect against SARS-CoV-2 in the preclinical model of Golden Syrian hamster.
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  • Sorrento to initiate testing with a selection of its agents in combination with ViralClear's anti-viral compound for possible synergistic anti-viral effect against SARS-CoV-2 in the preclinical model of Golden Syrian hamster. 
  • ViralClear to contribute its oral antiviral Merimepodib (IMPDH inhibitor) which is currently in a Phase 2 trial in combination with remdesivir to treat COVID-19. 
  • Sorrento to initially make available STI-1400 neutralizing antibody candidate for testing.             

WESTPORT, Conn., Sept. 30, 2020 (GLOBE NEWSWIRE) -- ViralClear Pharmaceuticals, Inc. (Nasdaq BSGM) and Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced the companies are exploring the synergistic potential of small molecules and antibodies combination therapies against COVID-19.

In general, multi-modal approaches are considered the most likely to succeed anti-viral strategies. Even with highly effective stand-alone therapies, a synergistic combination can be pursued to help reduce the effective dose needed of each individual agent and aim to ensure maximum effect.

The agreement between ViralClear Pharmaceuticals, Inc. (Parent company BioSig Technologies, Inc. Nasdaq:BSGM) and Sorrento Therapeutics will allow for testing of merimepodib with neutralizing antibodies in the Golden Syrian hamster model of COVID-19.

The study will look for synergy at the effective doses between the two drugs already in human clinical trials and will try to specifically demonstrate that the combined benefits in strengthening and accelerating viral clearance exceed what each drug could deliver by itself.

Pending the outcome of these studies, the results might be presented to the FDA to support the initiation of a human clinical trial of the drug combination.

About ViralClear Pharmaceuticals and Merimepodib BioSig's Technologies, Inc (Nasdaq: BSGM subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is seeking to develop a novel pharmaceutical called merimepodib to treat patients with COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against SARS-CoV-2 in cell cultures. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials (7 in phase 1 and 5 in phase 2) with over 400 subjects and patients and an extensive preclinical safety package was completed. A manuscript titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue Remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro", was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.

About Sorrento Therapeutics, Inc.  Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. 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"), clinical stage immuno-cellular therapies ("CAR-T", "DAR-T"), antibody-drug conjugates ("ADCs"), and clinical stage oncolytic virus ("Seprehvir ®", "Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™, COVI-GUARD™, COVI-SHIELD™ and T-VIVA-19™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

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 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.  ZTlido ® was approved by the FDA on February 28, 2018.

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Forward-Looking StatementsThis 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 the potency and potential blocking capabilities of STI-1499 and STI-2020 and the impact on SARS-CoV-2; the preclinical testing of STI-1499 and STI-2020; the safety and efficacy of STI-1499 and STI-2020; the expectation of the commencement of any pivotal trials for STI-1499 and STI-2020; the predictive value of the animal model used in preclinical studies; the human equivalent dose of STI-1499 and STI-2020 that may be required; the expected method of administration of STI-2020 and the expected dosage amount and rate thereof; the potential applications for STI-1499 and STI-2020; the potential of having a low efficacious dose; the potentially faster or efficient manufacturing speed, availability and potential lower cost for STI-2020; the strategic prioritization of an IND submission for STI-2020; and Sorrento's potential position in the antiviral industry. 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 preclinical studies and seeking IND regulatory approval for STI-2020; conducting and receiving results of clinical trials for STI-1499 and STI-2020; the clinical and commercial success of STI-1499 and STI-2020 against preventing and treating SARS-CoV-2 virus infections; the viability and success of STI-1499 and STI-2020 in anti-viral therapeutic areas, including coronaviruses; 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 the company in the execution of its COVID-19 therapeutic 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, 2019, 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.

Contact Alexis Nahama, DVM (SVP Corporate Development)Email:

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.G-MAB™, COVI-GUARD TM, COVI-SHIELD™, COVIDTRAP™, T-VIVA-19™, COVI-MAB™, ACE-MAB TM, COVI-TRACK™, COVI-STIX™ and COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.

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