Forbion European Acquisition has entered a definitive business combination agreement with biotechnology company enGene to create a combined biotechnology company to develop next-generation non-viral, locally administered gene therapies.

The combined company will be named enGene Holdings and its common shares are expected to be listed on the Nasdaq.

Funding for the deal includes $20m from the existing investment of Forbion Growth in FEAC Class A shares, along with PIPE investment, other private investment and a non-redemption commitment of almost $115m.

This financing is supported by Forbion Growth with participation from new institutional and existing investors Lumira Ventures, Fonds de solidarité FTQ and Forbion Ventures III.

Other investors include Investissement Québec, Omega Funds, Cowen Healthcare Investments, CTI Life Sciences Fund III, Northleaf Capital Partners, BVF Partners and Vivo Capital.

The proposed transaction will conclude in the second half of 2023.

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enGene CEO Jason Hanson said: “Our mission at enGene is to broaden the reach of gene therapy by creating safe, locally deliverable, non-viral therapies while freeing physicians from the onerous handling procedures typically required by viral-based gene therapy products.

“The proposed business combination with FEAC will enable us to build on the favourable safety and promising preliminary efficacy data from the Phase I portion of our Phase I/II LEGEND clinical trial of intravesical detalimogene voraplasmid, which we believe has the potential to set a new bar for organ-sparing NMIBC [non-muscle invasive bladder cancer] treatments and serve as the cornerstone of a multi-indication franchise.”

Net proceeds from the transaction are expected to be used to finance the clinical development of enGene’s lead product, intravesical detalimogene voraplasmid (EG-70).

The therapy is currently being developed to treat Bacillus Calmette-Guérin (BCG)-resistant NMIBC with carcinoma-in-situ.

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