Genome editing firm, Precision BioSciences has filed for an initial public offering (IPO) seeking to raise $100 million, which it wants to use to advance its pipeline.
The money raised from the IPO is expected to help complete a phase 1/2a trial of lead off-the-shelf or allogeneic CAR-T targeting CD19 in non-Hodgkin’s lymphoma, which is due to get underway in the first half of this year. This comes as the U.S. Food and Drug Administration (FDA), in November, accepted the company’s investigational new drug (IND), application for its first gene-edited allogeneic CAR-T cell candidate targeting CD19.
“We believe this trial will be the first clinical investigation of an allogeneic CAR-T therapy for non-Hodgkin lymphoma. We believe our proprietary, one-step engineering process for producing allogeneic CAR-T cells at large scale in a cost-effective manner will enable us to overcome the fundamental challenges of manufacturing that have limited the CAR-T field to date,” Precision, a spin out of Duke University, said in its prospectus for the IPO.
In its pipeline, Precision also has CAR-T therapies targeting CD20, BCMA and CLEC12A in preclinical development. It plans to submit an IND to FDA for the CD20-targeting therapy in the fourth quarter of this year. With the cash at hand, the company is also hoping to submit INDs for the other two programs next year.
Precision’s technology is based on its ARCUS tech platform, which has been described as a fully synthetic enzyme, much like a homing endonuclease. ARCUS is an improvement on nature, with high specificity that can be customized to recognize a DNA sequence inside any target gene.
“We leverage ARCUS in the development of our product candidates, which are designed to treat human diseases and create healthy and sustainable food and agricultural solutions. We believe the versatility and breadth of ARCUS support our ability to develop products across the spectrum of biotechnology,” Precision said.
In simple terms, Precision’s technology is touted as a one-step engineering process that is considered simpler and more effective in completing the gene editing process, ultimately leading to reduced costs.
According to the FierceBiotech website, Precision believes that its approach is more specific than competing gene-editing technologies like CRISPR, TALEN and zinc finger nucleases with a lower risk of off-target activity and will open up new opportunities in CAR-T as well as gene-modifying therapies.
Underwriters for the IPO are J.P. Morgan, Goldman Sachs, Jefferies and Barclays.
Last year, Precision, published a paper in Nature Biotechnology that it thinks is the first peer-reviewed report of in vivo genome editing in nonhuman primates. The paper was published in collaboration with researchers from the Perelman School of Medicine at the University of Pennsylvania.
The ARCUS platform has already attracted the interest of Gilead Sciences, which is working on developing a hepatitis B treatment by collaborating on gene therapies aimed at eliminating viral infections in vivo by using Precision BioSciences’ genome editing platform. Under this collaboration, Precision will receive up to $445 million in milestone payments, plus tiered royalties following commercialization.
The decision to go for the IPO comes almost nine months after Precision raised $110 million in an oversubscribed Series B financing round.
At the time, the Durham North Carolina firm said it would use the money to continue developing its ARCUS genome editing platform in the areas of immuno-oncology, genetic disease, and food. It also had plans to advance both its lead in vivo gene therapy program into IND-enabling studies and its flagship food program into field trials.
Matt Kane, Precision’s Chief Executive Officer, said the financing “provides us with a strong foundation from which we can advance our translational genome editing programs in multiple sectors.”
The financing round was led by ArrowMark Partners and joined by new investors Franklin Templeton Investments, Cowen Healthcare Investments, Brace Pharma Capital, Pontifax AgTech, OCV Partners, Adage Capital Management, Cormorant Asset Management, Gilead Sciences, Vivo Capital, Alexandria Venture Investments, Ridgeback Capital, Agent Capital, and entities affiliated with Leerink Partners. Others who participated in the financing round were existing investors venBio, F-Prime, RA Capital Management, Amgen Ventures, Osage University Partners, DUMAC, and the Longevity Fund.