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'We remain focused on strengthening our financial footing while containing costs to support our business objectives,' said
Program Highlights
Exclusive Rights to UltraCAR-T Targets, CD19 and BCMA, and IL-12 Gene Therapy
The Company amended its exclusive license agreement with
The Company regained exclusive rights to CD19 and B-cell maturation antigen (BCMA) targets to enable unencumbered development and commercialization of two validated targets utilizing the UltraCAR-T platform.
The Company 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 human papillomavirus (HPV)-associated cancers.
PRGN-2012 AdenoVerse Immunotherapy in RRP
PRGN-2012 is an investigational off-the-shelf (OTS) AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for the treatment of RRP. The
The Company announced positive Phase 1 dose escalation and expansion cohort data (N=15) in
The Company completed enrollment in the Phase 2 portion of the study (N=23) bringing the total number of enrolled patients to 35 at Dose Level 2. Patient follow up is ongoing.
The Company plans to outline the regulatory strategy as FDA discussions advance.
PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers
PRGN-2009 is an
The Company completed enrollment in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers. An abstract for the clinical data of the PRGN-2009 Phase 1 study (Abstract # 2628) titled, 'Phase I evaluation of PRGN-2009 alone and in combination with bintrafusp alfa in patients (pts) with recurrent/metastatic (R/M) HPV-associated cancers (HPV-C)' has been selected for presentation at the 2023
Enrollment was completed in the Phase 2 monotherapy arm with 20 evaluable patients in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients. An interim clinical data presentation from the Phase 2 monotherapy arm is expected in the second half of 2023.
PRGN-3006 UltraCAR-T in AML
PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a kill switch. The FDA granted orphan drug designation and fast track designation for PRGN-3006 UltraCAR-T for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML).
The Company completed the Phase 1 dose escalation study and announced positive data at the 64th
PRGN-3005 UltraCAR-T in Ovarian Cancer
PRGN-3005 UltraCAR-T is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a kill switch.
The Company completed enrollment in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm. An abstract for the clinical data of the PRGN-3005 Phase 1 dose escalation study (Abstract # 5590) titled, 'Phase 1/1b study of PRGN-3005 autologous UltraCAR-T cells manufactured overnight for infusion next day to advanced stage platinum resistant ovarian cancer patients' has been selected for presentation at the 2023 ASCO Annual Meeting on
The Company initiated a Phase 1b dose expansion trial of PRGN-3005. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b study. A Phase 1b clinical data presentation is expected in 2024.
PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors
PRGN-3007, based on the next generation of the UltraCAR-T platform, is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of PD-1 gene expression.
The Company announced dosing of the first patient in the Phase 1/1b dose escalation/dose expansion study of PRGN-3007 in advanced ROR1-positive (ROR1+) hematological and solid tumors. The target patient population for the Phase 1/1b study includes hematological cancers (chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL)) and solid tumors (triple negative breast cancer (TNBC)).
Next Generation UltraCAR-T Platform
The Company showcased advances in the UltraCAR-T platform with a preclinical data presentation for the next generation UltraCAR-T platform utilizing mesothelin (MSLN) CAR from
Financial Highlights
In
During the three months ended
Cash, cash equivalents, short-term and long-term investments and restricted cash totaled
Selling, general and administrative (SG&A) costs decreased by 15% for the three months ended
First Quarter 2023 Financial Results Compared to Prior Year Period
Research and development expenses increased
Total other income, net, increased
SG&A expenses decreased
Total revenues decreased
Loss from continuing operations was
Cautionary Statement Regarding Forward-Looking Statements
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Contact:
Tel: +1 (301) 556-9850
Email: investors@precigen.com
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