On April 3, 2023 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the amendment of its exclusive license agreement with Alaunos Therapeutics, Inc. (Alaunos) (Press release, Precigen, APR 3, 2023, View Source [SID1234629767]).

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With this amendment, Precigen has the unique ability to utilize the clinically validated UltraCAR-T platform for unencumbered development and commercialization of two proven CAR-T targets, CD19 and B-cell maturation antigen (BCMA). These targets enhance Precigen’s UltraCAR-T library approach, which is designed to transform the personalized cell therapy landscape for cancer patients through the development and validation of a library of non-viral plasmids to target various hematological and solid tumor-associated antigens. Enabled by the design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator system, Precigen is working to empower cancer centers to deliver personalized, autologous CAR-T treatment with overnight manufacturing for cancer patients. The addition of CD19 and BCMA targets positions Precigen as a front runner in the CAR-T space.

Precigen also regained exclusive rights to its interleukin (IL)-12 gene therapy, including application through the off-the-shelf AdenoVerse immunotherapy platform, paving the way for potential future treatments in oncology given the important role of IL-12 cytokines in targeting many types of tumors such as HPV-associated cancers. Precigen maintains the right to pursue non-neoantigen T-cell receptors (TCRs). As part of the amendment, all milestone payments and royalties between the parties have been eliminated.

"We are excited to regain exclusive rights and have full autonomy over UltraCAR-T development and commercialization with the potential to bring cost-effective UltraCAR-T therapies using two validated targets to cancer patients. We believe rapidly progressing CD19 and BCMA toward the clinic, on our own or through strategic partnerships, will bolster our current UltraCAR-T clinical program, which currently includes the MUC16 targeted PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer, CD33 targeted PRGN-3006 UltraCAR-T in adult patients with relapsed or recurred acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and ROR1 targeted PRGN-3007 UltraCAR-T in patients with advanced hematologic and solid tumor malignancies," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are also pleased to regain the right to include IL-12 gene therapy for implementation through our AdenoVerse platform to address oncology indications, including HPV-associated cancers."

Further details on the terms of the transaction are available within Precigen’s report on 8-K filed with the SEC.

The Company will host a conference call on Tuesday, April 4, 2023 at 8:30 AM ET to provide business and clinical updates related to recent announcements. The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061 (International) and providing the participant access code 0835947. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call. Event details can be found on Precigen’s website in the Events & Presentations section.