Sorrento to Provide Corporate Update, Including DAR-T Cell Therapy Advances, at LEERINK Global Healthcare Conference

SAN DIEGO, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), announced today that Dr. Henry Ji, Chairman and CEO, will present at the 9th Annual LEERINK Partners Global Healthcare Conference (Lotte New York Palace Hotel, New York) on Thursday Feb 27 at 11:00-11:25 AM (Presentation Room Adams).

Key updates:

• Both RTX Phase 1b Cancer Pain and Phase 1b Osteoarthritis (OA) Knee Pain studies have completed initial enrollment with preliminary positive results: no dose limiting toxicities observed and significant efficacy signal confirmed.
• Allogeneic “Off-the-Shelf” Dimeric Antigen Receptor-T (DAR-T) cell therapy products targeting hematologic cancer targets (BCMA, CD38, CD20, CD123) and solid tumor targets (GD2, CEA, EGFR, and many others) have been successfully produced.
• Proprietary DAR construct for coronavirus targeting, including COVID-19, has been successfully generated; COVID-19 targeting DAR-T cells and DAR-NK cells will be produced next in Sorrento’s cGMP facilities (San Diego) as part of the IND-enabling package necessary to promptly initiate human clinical studies.

DAR-T specific developments:

Sorrento’s proprietary DAR structure offers potential advantages over the conventional CAR (chimeric antigen receptor) structure by:

• increasing specificity and functionality of the DAR-T cells as compared to CAR-T cells due to higher inherent stability of the Fab fragment used in the DAR
• potentially reducing the clinical dose due to increased functional activity (preclinical data)

In addition to the proprietary DAR structure, Sorrento’s proprietary non-viral knockout-knockin (KOKI) manufacturing approach offers several potential benefits over virus-based transduction currently used for CAR-T therapies:

• site-specific integration of transgenes into pre-selected loci in the T cell genome
• enhanced clonal expansion of the DAR-T cells
• streamlined method for transgene construct production without the need for laborious and time-consuming virus production, release and validation processes, resulting in a shorter research and development timelines for IND-enabling activities. 

Combining those approaches, the allogeneic DAR-T products could potentially have the following major advantages over current autologous CAR-T therapy technologies:

• off-the-shelf availability allowing for immediate patient access to allogeneic cell therapies (by using healthy donor cells instead of modifying a patients’ own cells)
• significantly improved cost of goods (by making much greater patient-doses in each manufacturing run)
• easier execution of global trials and international market access due to established shipping logistics and distribution processes (drug like product)

Beyond targeting cancer related indications, which is the primary focus of Sorrento’s immuno-oncology business, Sorrento believes it can apply its KOKI DAR-T platform against pandemic infectious pathogens, including but not limited to coronaviruses, HBV, HIV, malaria, measles and fungi.

The potential spread of the COVID-19 coronavirus from Wuhan, China is only one example of how quickly a local infection can become a pandemic. Sorrento’s agile KOKI DAR-T and DAR-NK cell therapy platforms, coupled with in-house cGMP manufacturing facilities, should allow for emergency adoptive T cell and innate NK cell therapies being produced rapidly for clinical testing.

COVID_DAR_001 has been added to the Sorrento development pipeline and allocated internal priority both to demonstrate the maturity, agility and development readiness of the proprietary platform and to address an emergency and potentially critical patient need in the upcoming months.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), development stage DAR-T cell therapies, intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir^®”). 

Sorrento's commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido^®. Resiniferatoxin is completing a Phase 1b trial for intractable pain associated with cancer and a Phase 1b trial in osteoarthritis (OA) patients.  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 and its subsidiaries' technologies and product candidates, including, but, not limited to, resiniferatoxin (RTX) and DAR-T, the clinical potential of RTX, potential advantages of Sorrento’s DAR-T program and NK and CAR gene editing technologies, potential benefits of the KOKI manufacturing approach, potential advantages of allogeneic DAR-T products over current autologous CAR-T therapy and potential applications for the KOKI DAR-T and DAR-NK platforms.  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' technologies and prospects, including, but not limited to, RTX, DAR-T, KOKI and DAR-NK; risks related to seeking regulatory approvals and conducting and obtaining results of clinical trials, including, but not limited to, the Phase 1b studies and any prior RTX studies in animals; costs associated with clinical trials, the clinical and commercial success of RTX; the viability and success of using RTX for treatments in certain therapeutic areas, including for the treatment of intractable pain associated with cancer, Sorrento’s DAR-T, KOKI and DAR-NK programs and drug products; risks related to seeking regulatory approvals and conducting clinical trials 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, 2018, 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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Contact: Alexis Nahama, SVP Corp Development

Telephone: 1.858.203.4120

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

ZTlido^® and G-MAB™ are trademarks owned by Scilex Pharmaceuticals, Inc. and Sorrento, respectively.

Seprehvir^®, is a registered trademark of Virttu Biologics Limited, a wholly owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.

All other trademarks are the property of their respective owners. 

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