Sorrento Receives FDA Authorization to Start Phase 1 Clinical Trial of Proprietary, "Off-the-Shelf", Allogeneic anti-CD38 DAR-T (Dimeric Antigen Receptor-T) Cell Therapy to Treat Relapsed or Refractory Multiple Myeloma

• First allogeneic, off-the-shelf anti-CD38 DAR-T cell therapy cleared for Phase 1 clinical trial in Relapsed or Refractory Multiple Myeloma.
• CD38 DAR-T is the first allogeneic, off-the-shelf clinical-stage cellular therapy product candidate based on Sorrento’s proprietary Dimeric Antigen Receptor (DAR) – T cell platform.
• DAR-T product candidates enabled by Sorrento’s proprietary KOKI technology offer potential advantages over conventional Chimeric Antigen Receptor (CAR) – T cell therapies, including improved target specificity and functionality, which may reduce potential undesirable side effects and toxicity.
• Sorrento has built a product pipeline of over a dozen potential DAR-T cell product candidates targeting hematologic and solid tumors using its proprietary KOKI engineering and manufacturing approach, paving the way for the rapid advancement of DAR-T product candidates into clinical testing.

SAN DIEGO, Aug. 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that the FDA has authorized Sorrento’s IND application for the Phase 1 clinical testing of its allogeneic anti-CD38 Dimeric Antigen Receptor (DAR) - T Cell therapy for relapsed or refractory multiple myeloma. The proprietary CD38 DAR-T cell therapy candidate demonstrated strong cytotoxic activity in preclinical studies. DAR-T product candidates are produced using Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology, which potentially allows for improved specificity, stability and potency, and enables an off-the-shelf treatment approach, thereby eliminating the need for patients to undergo leukapheresis and undesirable treatment delays to perform cell harvesting, manufacturing and release prior to treatment for each individual cancer patient.

Sorrento’s KOKI-enabled DAR-T platform uses DAR-modified T cells from a normal healthy donor which are engineered to be specific to the cell surface marker of interest, in this case CD38, a clinically validated antigen in myeloma, to target tumor cells. The combination of KOKI and DAR-T technologies offers potential advantages over conventional CAR-T therapies, including removing the ability for DAR-expressing T cells to illicit undesired immune reaction to the cancer patient, thereby reducing or eliminating the possibility of graft versus host disease (GvHD) following treatment. Additionally, once DAR-T cells are manufactured, they can be stored at the clinic site, allowing patients to be screened and treated within days. This is compared to existing approved CAR-T therapies, which typically require 6-8 weeks of screening, cell production and qualification before a patient can receive treatment. Because of this timeframe, it is not unusual for cancer patients to no longer be eligible for CAR-T treatment due to disease progression. Also, autologous CAR-T cells pose several manufacturing challenges, including issues that relate to quality control and single-lot-release, and often do not meet the release criteria following the manufacturing process. DAR-T technology is designed to potentially provide a significant advancement to the timeliness and potency of treatments for patient populations who have already undergone multiple rounds of chemotherapy and are suffering from persistent disease.

DAR-T technology is readily adaptable to dozens of cancer targets and Sorrento has developed a preclinical product pipeline with specific fully human antibodies discovered from Sorrento’s G-MAB™ library. Sorrento expects to file additional IND applications now that the first DAR-T Phase 1 trial has been cleared to proceed by the FDA.

“This FDA clearance of our first allogeneic DAR-T cell therapy is a seminal event for our cutting-edge KOKI and DAR-T technologies,” said Henry Ji, Ph.D., Chairman and CEO of Sorrento. “We foresee the first “Off-the-Shelf" DAR-T trial will open the door to numerous other DAR-T cell therapies for other indications to follow.”

About the DAR-T™ Platform

Sorrento’s DAR-T technology is a proprietary, next-generation cell therapy platform that offers potential advantages over conventional Chimeric Antigen Receptor (CAR) T cell therapy:

• The proprietary DAR construct utilizes a natural antibody Fab (antigen-binding fragment) structure instead of an artificial scFv (single-chain variable fragment) sequence.
• Preclinical in vitro and in vivo studies have demonstrated that DAR-T cells provide better target specificity and functionality, due to higher inherent stability of the Fab and stronger affinity of DAR vs. CAR receptors on the T cell surface.
• DAR-T cells may reduce potential undesirable side effects, such as CAR-T induced cytokine release syndrome (CRS) and graft-versus-host disease (GvHD).
  
  

About KOKI™ Technology

Sorrento’s proprietary, non-viral knockout-knockin (KOKI) technology provides DAR-T cells with several potential benefits over virus-based transduction currently used for CAR-T therapies:

• “Off-the-Shelf": DAR-T cells are cryo-preserved engineered T cells designed to be delivered to patients on-demand without delays in treatment due to the lengthy and individualized manufacturing process for CAR-T.
• “Allogeneic”: DAR-T cells are produced from pre-screened healthy volunteers; while autologous CAR-T cells are patient-specific and made from and for individual cancer patients.
• “Mass Production”: DAR-T cell manufacturing is scalable (potentially hundreds to thousands of doses per manufacturing run) and can meet high demand while autologous CAR-T cell therapy requires a single-lot-release process that can only be performed one patient at a time.
  
  

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers 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”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, 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 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.

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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 the expectations for Sorrento's technologies and product candidates, including, but, not limited to, Sorrento’s anti-CD38 DAR-T clinical candidate; the clinical potential of DAR-T; potential advantages of Sorrento’s DAR-T and KOKI technologies, including allogeneic and off-the-shelf capabilities, and scalable production of DAR-T cells; potential benefits of the KOKI manufacturing approach; potential advantages of allogeneic DAR-T products over current autologous CAR-T therapy, including the reduction of potential undesirable side effects; potential applications for the DAR-T platform; the development of additional DAR-T programs based on antibodies from Sorrento’s G-MAB antibody library; and Sorrento’s expected timing for filing new IND applications for DAR-T product candidates. 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 its CD38 DAR-T therapeutic candidate; 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.

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G-MAB™, DAR-T™, KOKI™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

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