RRP is a rare condition characterised by the growth of benign tumours on and around the vocal cords. Credit: Andrey_Popov via Shutterstock.

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.

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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. 

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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. 

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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.”