Precigen, Inc. - PGEN STOCK NEWS

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.

On September 8, 2020, Precigen (Nasdaq: PGEN) announced that Helen Sabzevari, PhD, President and CEO, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 10:30 AM ET. The event will be accessible via a live webcast through Precigen’s website. Precigen focuses on innovative gene and cell therapies to address serious diseases in immuno-oncology, autoimmune disorders, and infectious diseases, advancing its clinical pipeline toward commercialization.

Precigen, Inc. (Nasdaq: PGEN) announced the first patient has been dosed with PRGN-2009, an investigational OTS immunotherapy targeting HPV-associated solid tumors. The Phase I trial will evaluate the safety of PRGN-2009 as a monotherapy and in combination with bintrafusp alfa for recurrent or metastatic cancers. The study, facilitated through a CRADA with the National Cancer Institute, marks a significant step in developing new treatment options for patients. HPV-related cancers account for approximately 44,000 cases annually in the U.S., emphasizing the importance of this research.

Precigen, Inc. (PGEN) released its second quarter and first half financial results for 2020, reporting total revenues of $30.4 million for Q2 and $60.3 million for the first half. The net loss was $43.4 million in Q2 ($0.26 per share) and $73.3 million in the first half ($0.45 per share), affected by non-cash charges. Key developments included advancements in the UltraPorator device and ongoing clinical trials for therapies like UltraCAR-T and AG019, demonstrating promising safety and efficacy results.

Precigen ActoBio, a clinical-stage biotechnology firm, announced the successful completion of the primary endpoint in its Phase 1b study of AG019, focusing on safety and tolerability for early-onset type 1 diabetes. The study showed that AG019, an oral capsule, was well tolerated with no serious adverse events reported. Notably, 67% of patients exhibited a slower decline in C-peptide levels, indicating potential disease modification. The ongoing Phase 2a study will further evaluate AG019 in combination with teplizumab. This promising data supports continued development of AG019 in targeting type 1 diabetes.

Precigen Triple-Gene, a subsidiary of Precigen (Nasdaq: PGEN), has announced promising six-month follow-up data from its Phase I trial of INXN-4001, a multigenic gene therapy for heart failure. This therapy targets myocardial remodeling via retrograde coronary sinus infusion. The study met primary safety and feasibility endpoints, with no adverse events linked to the therapy. Additionally, 50% of evaluated patients showed improved quality of life and walking distance at follow-up. Final study results are expected in 12 months.

Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company, will release its second quarter and first half 2020 financial results on August 10, 2020, after market close. A conference call will follow at 4:30 PM ET to discuss these results along with a general business update. Precigen focuses on innovative gene and cell therapies targeting critical diseases, maintaining a preclinical and clinical pipeline. The company emphasizes its commitment to advancing precise, affordable biotherapeutics for various medical challenges.

Precigen announced preclinical data for its investigational PRGN-3005 UltraCAR-T aimed at treating advanced ovarian cancer, presented during the AACR Virtual Annual Meeting II. The data indicates that UltraCAR-T, generated through a rapid, non-viral process, shows superior efficacy and persistence compared to traditional CAR-T therapies. In preclinical trials, all treated mice became tumor-free after receiving PRGN-3005, and the treatment demonstrated durability upon tumor rechallenge. The FDA has approved the IND for a Phase I clinical trial that is currently underway.