San Diego, CA (Press Release) – Sorrento Therapeutics, Inc. (NASDAQ:SRNE) and Celularity Inc announced today that the com­pa­nies have started screen­ing patients for its leading CD38 chi­meric an­ti­gen re­cep­tor (CAR) T cell ther­apy drug devel­op­ment pro­gram, fol­low­ing FDA review allowing clin­i­cal trial initiation.

The com­pa­nies’ CD38 CAR-T pro­gram is their most ad­vanced pro­gram targeting this dif­fi­cult-to-treat con­di­tion. This trial is cur­rently the only active US-based clin­i­cal trial targeting CD38 using a CAR-T cell ther­apy.

The first inves­ti­ga­tional site at Roger Williams Medical Center, RI, is actively engaged in the clin­i­cal study execution, with addi­tional sites to be in­cluded.

“Our CD38 CAR-T pro­gram has now officially entered clin­i­cal stage and will be treating patients as well as collecting valuable data in the upcoming months. This rep­re­sents a major mile­stone for Sorrento and Celularity that clearly dem­onstrates our keen focus on ad­vanc­ing our thera­peutics assets as well as our ability to deliver on the timelines we pre­vi­ously communicated,” stated Dr. Henry Ji, Chairman and CEO of Sorrento before adding, “we ex­pec­t to share initial clin­i­cal data from this study as soon as it becomes avail­able.”

“We are extremely pleased that we can begin this study in our ongoing efforts to im­prove treat­ment options for this and other serious diseases. Celularity, created through the con­tri­bu­tions from Celgene Corpo­ra­tion, United Therapeutics, Human Longevity Inc., and founding strategic partner Sorrento, is uniquely positioned to combine its plat­form cellular tech­nology with the vast tool set accessible from Sorrento,” said Dr. Robert Hariri, Chairman and CEO of Celularity. “Celularity is build­ing a deep pipe­line of immuno­therapeutic prod­ucts from our pro­pri­e­tary placental cells in­­clud­ing ‘off-the-shelf’ CAR-T and CAR-NK cell ther­a­pies,” added Dr. Hariri.

Utilizing avail­able cGMP manu­fac­tur­ing, Sorrento and Celularity esti­mate they can produce up to 300 patient treat­ments per year. These existing capacities easily cover the needs of the Phase 1 clin­i­cal study and would be sufficient to meet the require­ments for sub­se­quent ad­vanced pivotal clin­i­cal studies.

Full details about the study avail­able on www.clinicaltrials.gov

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”), 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 IB trial in terminal cancer patients. ZTlido was approved by the FDA on 02/28/18.

For more in­­for­ma­tion visit www.sorrentotherapeutics.com

About Celularity, Inc.

Celularity, headquartered in Warren, New Jersey, is a private bio­technology com­pany with pro­pri­e­tary, leading-edge tech­nology and Intellectual Property to harness the power of the placenta. Their medicine asset portfolio consists of more than 200 issued or pending patents as well as pre-clinical and clin­i­cal assets in­­clud­ing CAR constructs for allogeneic CAR-T/NK prod­ucts, licenses of 100+ immuno­therapy assets, and commercial stage bio-sourcing and functional regeneration businesses. For more in­­for­ma­tion, please visit www.celularity.com. Follow Celularity on Social Media: @Celularity.

Forward-Looking Statements

This press release con­tains 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 devel­op­ments of and prospects for Sorrento's and its sub­sid­i­aries’ and affiliates’ prod­ucts and tech­nolo­gies, in­­clud­ing their re­spec­tive­ anti­body and CAR-T prod­ucts and tech­nolo­gies; Sorrento's ability to leverage the expertise of its employees, sub­sid­i­aries, affiliates and partners to assist the com­pany in the execution of its strategies; out­come of the data from any clin­i­cal trial; Sorrento's M&A and licensing strategy; Sorrento's and its partners’ abilities to accelerate the devel­op­ment of any lead pro­grams in the clinic; the timing of ex­pec­ted clin­i­cal devel­op­ment pro­grams and clin­i­cal trials and FDA sub­missions; Sorrento’s and its sub­sid­i­aries’ abilities top supply drug prod­uct; and ex­pec­ta­tions for Sorrento's and its sub­sid­i­aries', affiliates’ and joint ventures’ tech­nolo­gies and 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, its sub­sid­i­aries', affiliates’ and partners’ tech­nolo­gies and prospects; 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 related to seeking regu­la­tory approvals and conducting clin­i­cal trials; risks of supplying drug prod­uct; and other matters that are described in Sorrento's Annual Report on Form 10-K for the year ended December 31, 2017, 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.

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.

Source: Sorrento.