On April 5, 2018 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) and Celularity Inc. reported 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 (Press release, Sorrento Therapeutics, APR 5, 2018, View Source [SID1234525804]).
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Phase 1, Open-Label, Dose-Escalation, Pharmacokinetic, and Pharmacodynamic Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma (www.clinicaltrials.gov : NCT03464916). IND filing completed. Study cleared for patient enrollment.
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