US-based cell and gene therapy biotech Precigen will reduce its workforce by 20% and pause several programmes to focus on the potential commercialisation of its PRGN-2012 gene therapy for recurrent respiratory papillomatosis (RRP).
The company also announced that it will try to raise $30m in a public stock offering. It plans to give the option to buy up to $4.5m more in shares over the next 30 days. This move comes alongside a cost reduction strategy, which aims to streamline resources and focus on advancing PRGN-2012.
As of June 2024, Precigen reported having $19.5m in cash. The funds from the offering and cost reduction strategies will support the company’s efforts to prepare PRGN-2012 for a potential market launch next year, with a rolling biologics licence application (BLA) submission expected in the latter half of 2024.
This strategic shift involves the suspension of various clinical and preclinical programmes, except for the PRGN-2009 trials for certain cancers, and the PRGN-3006 programme for acute myeloid leukaemia (AML). The company also plans to shut down its Belgium-based ActoBio subsidiary and pause all preclinical activities.
PRGN-2009 is being investigated in several Phase II studies, including in trials for recurrent/metastatic cervical cancer (NCT06157151) and newly diagnosed HPV-associated oropharyngeal cancer (NCT06223568) that are sponsored by the National Cancer Institute (NCI). However, enrolment for PRGN-2009 at non-NCI clinical sites will be paused. A Phase Ib trial of Its chimeric antigen receptor-T (CAR-T) therapy PRGN-3006 has completed enrolment for AML (NCT03927261), and Precigen plans to meet with the US Food and Drug Administration (FDA) to discuss the next steps.
If everything goes to plan, PRGN-2012 will be Precigen’s first candidate to be approved. RRP is a rare condition characterised by the growth of benign tumours or papillomas in the respiratory tract. The condition is caused by human papillomavirus type 6 (HPV) or HPV type 11 (HPV 11), causing breathing difficulties. Based on the Gorilla Adenovector technology of the company’s AdenoVerse platform, PRGN-2012 can induce immune responses against HPV 6 or HPV 11-infected cells.
According to GlobalData’s Pharma Intelligence Center, global sales of PRGN-2012 are forecast to reach $826m in 2030.
GlobalData is the parent company of Pharmaceutical Technology.
In the announcement accompanying the strategic move, Precigen’s CEO Helen Sabzevari said: “These prioritisation steps enhance our ability to rapidly prepare for the potential commercialisation of PRGN-2012, which, if approved, we believe has the safety, efficacy, and route of administration profile to be the first and best-in-class therapy for RRP patients.”
