ProNAi said today it has shut down a research site in Plymouth, MI, that supported development of its failed cancer candidate PNT2258 and its underlying DNAi platform.

James Smith, ProNAi’s vp of corporate affairs, told GEN the shutdown reflected the end of the PNT2258 development program, which resulted in the elimination of “around 10” staffers.

“We don’t anticipate any further reduction in staff,” Smith said.

The closing was disclosed within a press release, as well as a quarterly regulatory filing of second-quarter results that said ProNAi implemented PNT2258-related staff reductions in the United States and Canada.

The company had 52 employees as of December 31, 2015, of which 33 were engaged in R&D activities, according to its 10-K annual filing for 2015.

ProNAi said it incurred a one-time $2.8 million restructuring charge toward estimated close-out expenses for PNT2258.

The restructuring comes two months after the company revealed in June that PNT2258 showed only modest efficacy in the Phase II Wolverine trial, assessing the candidate in 61 patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

ProNAi immediately suspended development of PNT2258 in DLBCL, after interim results showed a response rate of 8.1% overall and 15.8% in a subgroup of 19 patients with a performance status of 0-1, who were exposed to one to three prior systemic regimens and received at least eight doses of PNT2258 within 35 days of starting therapy. No response was seen in 10 patients with a performance status of 2 and/or four or more prior lines of therapy enrolled before the eligibility criteria were amended, nor in eight additional patients enrolled after the April 25 data cutoff date for the interim analysis.

PNT2258 won the FDA’s Orphan Drug Designation for DLBCL in March, and earlier received a similar designation from the European Commission.

ProNai has shifted its R&D focus to advancing PNT141, a selective, oral small-molecule inhibitor of the Cdc7 kinase. According to ProNAi, PNT141 is a key regulator of both DNA replication and DNA damage response, making it a compelling emerging target for the potential treatment of a broad range of tumor types.

“We’re in the process of building a pipeline. We want to have multiple products under development, and we want to be adequately staffed to support a robust and broad pipeline of oncology products,” Smith said.

ProNAi said it finished the second quarter with a net loss of $12.9 million compared to a net loss of $15.2 million for Q2 2015. The company reported $130.6 million in cash and cash equivalents, down from $150.2 million on December 31, 2015.

[This report has been updated to include comment from ProNAi].








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