PRGN-2009

Precigen's stock slid more than 12% on Wednesday after it announced a restructuring that includes laying off over a fifth of its staff and suspending multiple CAR-T clinical programmes. The shake-up comes as the biotech redirects efforts towards PRGN-2012, an off-the-shelf AdenoVerse gene therapy currently in Phase II for recurrent respiratory papillomatosis (RRP)."We are on track toward our goal of submitting a rolling [biologics licence application] for PRGN-2012 in the second half of this year," stated CEO Helen Sabzevari. Precigen has already initiated patient enrollment in a confirmatory clinical trial for PRGN-2012 and is eyeing a possible 2025 launch.Beyond the staffing cuts, the company is pausing all UltraCAR-T clinical programmes except for PRGN-3006 in acute myeloid leukaemia (AML), which has completed enrollment in its Phase Ib trial. Suspended CAR-T programmes include PRGN-3005, which was being evaluated in ovarian cancer, and PRGN-3007 for haematological and solid tumours. Both were in Phase I.Precigen says it will "minimise UltraCAR-T spend and focus on strategic partnerships to further advance" these projects. All preclinical programmes will be paused as well."These prioritisation steps enhance our ability to rapidly prepare for 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," Sabzevari remarked.Precigen also said it is closing its Belgium-based ActoBio subsidiary and eliminating all associated personnel. The company will continue Phase II trials for PRGN-2009 in collaboration with the National Cancer Institute (NCI), but pause enrollment at non-NCI clinical sites. PRGN-2009 is an off-the-shelf adenovirus-based immunotherapy targeting cancers caused by HPV16 or HPV18.The AdenoVerse platform uses proprietary gorilla adenovectors for gene delivery of therapeutic effectors, immunomodulators and vaccine antigens. Gene therapies derived from the platform have generated "high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration," according to the firm.Earlier this week, the company said it was launching a $30-million public stock offering, with an option for underwriters to buy an extra $4.5 million in shares within 30 days.

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. 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. See Also: Takeda’s ADZYNMA gains EU approval for cTTP treatment Amneal’s CREXONT gains FDA approval for Parkinson’s treatment 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.”