Precigen, Inc. reports developments as a commercial-stage biopharmaceutical company advancing precision medicines for difficult-to-treat diseases. Its news centers on PAPZIMEOS (zopapogene imadenovec-drba), an FDA-approved therapy for adults with recurrent respiratory papillomatosis, including commercialization, access, reimbursement, medical-publication updates, and adoption by treating physicians.
Company updates also cover financial results, business presentations, and pipeline activity across immuno-oncology, autoimmune disorders, and infectious diseases. Precigen’s recurring technology references include the AdenoVerse immunotherapy platform, UltraCAR-T programs, and related manufacturing capabilities used to support its precision-medicine portfolio.
On January 5, 2021, Precigen (Nasdaq: PGEN) announced FDA clearance for its IND application to start a Phase I clinical trial for PRGN-2012, an investigational immunotherapy for recurrent respiratory papillomatosis (RRP), a rare disease caused by HPV types 6 and 11. This trial aims to evaluate the safety and tolerability of PRGN-2012, which utilizes Precigen's proprietary gorilla adenovector technology. The study will enroll 12 patients to assess the treatment's efficacy following surgical removal of the disease. Precigen's collaboration with the NCI aims to address unmet medical needs in RRP patients.
Precigen (Nasdaq: PGEN) held a virtual R&D event on Dec. 15, 2020, showcasing significant advancements in its clinical pipeline. Key updates include:
- PRGN-3005 UltraCAR-T: First clinical data reported with promising results in ovarian cancer showing 50% tumor regression among patients.
- PRGN-3006 UltraCAR-T: Positive data in acute myeloid leukemia (AML) with effective treatment responses.
- AG019 ActoBiotics: Demonstrated safety and potential in stabilizing C-peptide levels in Type 1 diabetes patients.
These results mark critical milestones for the company, indicating progress in innovative gene and cell therapies.
Precigen, a biopharmaceutical company (Nasdaq: PGEN), announced a virtual event on December 15, 2020, at 11:00 AM ET, to update stakeholders on its clinical pipeline. The event will feature data from key programs, including PRGN-3005 and PRGN-3006 UltraCAR-T, as well as AG019 ActoBiotics. Executives and leading investigators will participate, presenting advancements in the company's innovative gene and cell therapies targeting serious diseases. Registration is available via the investor relations website.
Precigen announced new data from its PRGN-3006 UltraCAR-T® phase 1/1b study for treating relapsed or refractory acute myeloid leukemia (AML) at the 62nd ASH Annual Meeting. The study shows promising results, with six patients treated and no dose-limiting toxicities reported. A 100% manufacturing success rate using their proprietary process was achieved. The UltraCAR-T cells demonstrated encouraging expansion and persistence in patients, with one case study showing robust cell activity seven months post-infusion. These advancements suggest a potential improvement over existing CAR-T therapies.
On November 16, 2020, Precigen (Nasdaq: PGEN) announced the successful dosing of the first patients with UltraCAR-T cells made using its proprietary UltraPorator system, which aims to revolutionize the manufacturing of personalized cancer therapies. The patients participated in two Phase 1 clinical trials: PRGN-3005 for advanced ovarian cancer and PRGN-3006 for relapsed acute myeloid leukemia. This innovation streamlines manufacturing, allowing for rapid cell production within medical facilities and timely patient treatment.
Precigen, Inc. (Nasdaq: PGEN) reported third quarter 2020 revenues of $23.6 million, up 29% from $18.3 million in Q3 2019. The net loss narrowed to $29.5 million or $(0.18) per share, improving from $49.1 million or $(0.32) per share a year prior. Year-to-date revenues reached $83.8 million, a 14% increase from $73.7 million in 2019. Key achievements included FDA clearance for the UltraPorator system, dosing the first patient in the PRGN-2009 trial, and advancing UltraCAR-T therapies for ovarian cancer and AML.
Precigen, a biopharmaceutical company, will release its third quarter 2020 financial results on November 9, 2020. The company focuses on developing gene and cell therapies for various diseases, including cancer and autoimmune disorders. In early December, Precigen plans to host a call to update stakeholders on its clinical pipeline. The firm emphasizes its commitment to precision medicine and aims to innovate in affordable biotherapeutics. Investors should stay tuned for financial performance insights and clinical progress in the upcoming announcements.
Precigen, Inc. (Nasdaq: PGEN) has appointed Gaurav Vij as the new head of business development. Mr. Vij, with over 18 years of experience, will focus on accelerating strategic partnerships and enhancing the company’s pipeline programs. His prior experience includes significant roles at Gilead Sciences, Amgen, and Shire Pharmaceuticals, with a strong emphasis on oncology. This appointment aligns with Precigen's strategy to maximize value through partnerships and foster innovation in gene and cell therapies.
Precigen (Nasdaq: PGEN) has received FDA clearance for its UltraPorator system, designed for rapid manufacturing of UltraCAR-T therapies. This system enables efficient clinical trial manufacturing for PRGN-3005 and PRGN-3006, targeting ovarian cancer and acute myeloid leukemia, respectively. The technology transfer is now complete, allowing personalized therapy delivery to patients. The UltraPorator significantly reduces processing time and contamination risks compared to traditional methods, enhancing the scalability of CAR-T therapy production. This advancement aims to transform patient access to critical cancer treatments.
On October 9, 2020, Precigen (Nasdaq: PGEN) announced that Merck KGaA, Darmstadt, Germany, increased its ownership from 11.6% to 14.8% by converting a $25 million convertible note. This move positions Merck as Precigen's second-largest shareholder. The agreement includes the reassignment of CAR-T development rights, allowing Precigen to regain autonomy over its proprietary CAR-T technology in exchange for $150 million in stock and the convertible note. Two UltraCAR-T therapies are currently in Phase 1 trials against ovarian cancer and AML.