To date, the anti-CD38 CAR-T cells have demonstrated specific activation through the CAR resulting in the production of cytokines and CAR-T proliferation. CD38-expressing multiple myeloma tumor cells were killed efficiently in vitro, and the CD38 CAR-T cells completely eradicated tumors in a xenograft mouse model of human multiple myeloma.
Importantly, TNK's anti-CD38 CAR-T cells selectively lysed target cells expressing high levels of CD38 while not killing cells with normal or low levels of CD38. This unique characteristic might allow for a better safety and efficacy profile in humans as well as enable a more effective manufacturing process of the anti-CD38 CAR-T cells.
The anti-CD123 CAR-T program is in development for the treatment of acute myeloid leukemia (AML). A proprietary anti-CD123 CAR was constructed based on a human fully anti-CD123 monoclonal antibody selected from Sorrento's G-MAB library. The anti-CD123 CAR-T cells were specifically activated through the CAR to produce cytokines and proliferate. To date, they have selectively lysed CD123-expressing AML tumor cells in vitro, and strongly suppressed the growth of established tumors in a xenograft mouse model of human AML.
"The strength of the preclinical data generated from these two CAR-T programs is very compelling. Given my experience in the field of multiple myeloma drug development, I am particularly excited to further develop the next generation of cellular therapies with our anti-CD38 CAR-T. CD38 has proven to be one of the most promising targets in myeloma treatment. Given its unique specificity profile, we believe our anti-CD38 CAR-T could have certain efficacy and safety advantages over current treatments with the potential to provide a functional cure in this disease. Similarly, our anti-CD123 CAR-T program has shown highly encouraging anti-tumor activity in preclinical studies and we are excited to further its development in the clinic," said Dr. Jerome Zeldis, Chief Medical Officer of Sorrento Therapeutics and President of TNK Therapeutics.
Dr. Zeldis added, "We look forward to concluding the preclinical development of these CAR-T programs and plan on submitting INDs in the first half of 2017. We expect first-in-human studies to commence shortly thereafter."
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for cancer, pain management, inflammation and autoimmune diseases. Sorrento's lead product candidates are clinical oncolytic virus and CAR-T therapies targeting solid tumors, late-stage pain medicine, as well as late-stage biosimilar and biobetter antibodies.
About TNK Therapeutics, Inc.
TNK Therapeutics is a subsidiary of Sorrento. TNK is focused on the development and commercialization of cellular therapies to address unmet medical needs in oncology. TNK technologies harness the adaptive and innate immune system by reprogramming immune cells to recognize and efficiently kill cancer cells. For these cellular immunotherapies, TNK's utilizes immune cells, including T cells and Natural Killer, or "NK", cells.
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. and its subsidiaries, including TNK Therapeutics, under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Sorrento's anti-CD38 and anti-CD123 CAR-T product candidates to treat multiple myeloma and acute myeloid leukemia respectively; expectations for Sorrento's and its subsidiaries' technologies and product candidates; and TNK's prospects. 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; risks related to pre-clinical and clinical studies of Sorrento's and it subsidiaries' product candidates; 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, 2015, as amended. 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.
Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
TNK™ and TNK Therapeutics™ are trademarks owned by TNK Therapeutics, Inc.
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