ProNAi Therapeutics, Inc. (NASDAQ:DNAI) on Tuesday revealed its Wolverine Phase 2 trial of PNT2258 for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) interim results.
According to Nick Glover, ProNAi Therapeutics President and CEO, the interim results do not demonstrate enough evidence that shall sustain the development of PNT2258. In line with this, the company has decided to suspend the drug development until further steps have been determined.
Consequently, ProNAi Therapeutics is shifting its focus on PNT141, its licensed Cdc7 inhibitor. Moreover, the company is also planning to diversify its oncology drug pipeline as it secures new assets.
PNT2258 is a clinical-stage drug generally based on DNA interference (DNAi), an all-new therapeutic approach.
The Wolverine Phase 2 trial is ProNAi Therapeutics’ multicenter, single-arm, open-label study, seeking to assess the efficacy of PNT2258 monotherapy among r/r DLBCL patients. Under the study, 120 mg/m2 of PNT2258 is administered as a four-hour IV infusion on the first five days of a 21-day program cycle.
As of April 25, PNT2258 demonstrated an overall response rate (ORR) of 8.10% among 37 subjects.
Aside from r/r DLBCL, the drug is also being tested in the Brighton study for Richter’s Transformation patients. However, four out of the five enrolled subjects have already discontinued the trial. The remaining subject has undergone two complete cycles already but no responses have yet been recorded.
Dr. Barbara Klencke, ProNAi Therapeutics Chief Development Officer, elaborated that the company carefully executed the experiments. However, both diseases are extremely challenging to treat and as a result, PNT2258 did not exhibit the necessary treatment potentials. Given the disappointing results, all studies under the DNAi platform are temporarily on hold.
Q1 Financial Results
ProNAi Therapeutics revealed its first quarter results recently as well. Its cash and cash equivalents for the period are seen at 140.88 million, which is significantly up from the 34.10 million seen during the same quarter last year. Net income for the quarter came in at -10.54 million compared to last year’s -11.46 million. This signifies an 8.03% growth year-over-year. However, the company did not record its revenues for the past 12 months.