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Marina, ProNAi partner in exclusive license agreement
BOTHELL, Wash.—Marina Biotech, Inc., formerly known as MDRNA Inc., and ProNAi Therapeutics, Inc. have announced an exclusive license agreement for the development and commercialization of DNAi-based therapeutics that will utilize Marina Biotech's novel SMARTICLES liposomal delivery technology.
Under the terms of the agreement, ProNAi will be solely responsible for developing and commercializing any products that result from the partnership. Marina Biotech stands to receive up to $14 million for each gene target in total upfront, clinical and commercialization milestone payments, and is also eligible for royalties on sales. For its part, ProNAi has the option to select any number of additional gene targets. Additional details were not disclosed.
"We are extremely pleased to have entered into a relationship with a company like ProNAi that is developing a first-in-class nucleic acid therapeutic," J. Michael French, President and CEO of Marina Biotech, said in a press release. "In addition, we are excited to see the continued advancement of oligonucleotide-based therapeutics using our SMARTICLES technology. Besides advancements within our own internal research programs, we have now been able to establish two license agreements broadening the application of the SMARTICLES technology to the systemic administration of both single- and double-stranded oligonucleotide therapeutics. We look forward to the rapid advancement of ProNAi Therapeutics' clinical pipeline and the opportunity to bring novel therapeutics to patients in need."
ProNAi is currently conducting an open-label, single arm, Phase I dose-escalation study of PNT2258 in patients with advanced solid tumors. The compound is ProNAi's first drug candidate from its DNAi drug platform. In the study, patients will receive PNT2258 as an intravenous infusion once daily for five consecutive days of every 21-day cycle.
"We are pleased that twenty-two patients have been dosed with PNT2258 in our Phase I clinical trial in advanced solid tumor patients to evaluate safety and tolerability, maximum tolerated dose, pharmacokinetics and pharmacodynamics. PNT2258 is our first DNAi oligonucleotide targeted against the anti-apoptotic bcl-2 oncogene and encapsulated in Marina's SMARTICLES technology," Charles L. Bisgaier, Ph.D., President and CEO of ProNAi Therapeutics, said in press release. "This novel delivery technology offers protection for the DNAi oligonucleotide during systemic administration with good circulation times and extrahepatic tumor exposure.
"DNAi are short single-strand unmodified oligonucleotides designed to silence genes by interfering with DNA. The DNAi silencing approach is differentiated from that of RNAi, antisense or miRNA in that it targets genomic sequences within the non-coding region of DNA disrupting transcription," Bisgaier continued. "The progress and delivery validation in the clinic this past year on the novel DNAi-SMARTICLES formulation gives us confidence to bring forward more first-in-class drug candidates alone or with partners. ProNAi is now positioned to advance additional cancer therapies from its pre-clinical leads targeting other oncogenes such as c-myc and k-ras while also exploring other disease targets in areas such as inflammation and genetics diseases."
SOURCE: Marina Biotech press release