Off-the-shelf CAR-T and gene-editing player Precision Bio files $100M IPO

Nasdaq
Funds will be used for its CAR-Ts, in vivo genome editing platform and manufacturing scale-up. (Nasdaq)

Precision BioSciences is looking to raise up to $100 million in an IPO just a few months after raising $110 million in a series B and bagging a hepatitis B alliance with Gilead.

The Durham, North Carolina-based company said in its prospectus for the IPO that the additional cash would help it 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.

The CAR-T—called PBCAR0191 and partnered with French drugmaker Servier—has the same CD19 target as the FDA-approved CAR-Ts Yescarta from Gilead/Kite and Novartis’ Kymriah. However, it is based on cells from healthy donors rather than relying on cells harvested from patients, and Precision said that means it will “overcome the fundamental challenges of manufacturing that have limited the CAR-T field to date.”

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Additional spending will go into bringing more CAR-Ts into development, getting Precision’s in vivo gene correction platform ready for clinical trials and building a manufacturing facility, Precision said.

Precision is built around Arcus, a one-step genome editing platform that uses a synthetic mimic of the homing endonucleases found in nature to make insertions, deletions or other edits to DNA.

The biotech thinks 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. 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 Arcus gene-editing tech has already attracted the interest of Gilead, which signed up to a $445 million with Precision to apply it to the development of new therapies for hepatitis B virus and participated in the series B fundraising along with Servier.

The Gilead deal includes around $40 million in funding for the project over the next three years, and $3.7 million of that was booked in the last quarter of 2018, and should generate a candidate for clinical trials next year.

Meanwhile, Precision’s alliance with Servier dates back to 2016 and covers the development of PBCAR0191 and up to five other CAR-Ts. The alliance generated $105 million upfront and another $5.8 million apiece in 2017 and 2018.

All told, Precision has raised around $300 million to date, according to the prospectus, and made a net loss of $46 million last year. It plans to list on the Nasdaq under the DTIL symbol, and the IPO is being underwritten by J.P. Morgan, Goldman Sachs, Jefferies and Barclays.

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