BOTHELL, Wash.—Marina Biotech, Inc., formerly known as MDRNAInc., and ProNAi Therapeutics, Inc. have announced an exclusive licenseagreement for the development and commercialization of DNAi-based therapeuticsthat will utilize Marina Biotech's novel SMARTICLES liposomal deliverytechnology.
Under the terms of the agreement, ProNAi will be solelyresponsible for developing and commercializing any products that result fromthe partnership. Marina Biotech stands to receive up to $14 million for eachgene target in total upfront, clinical and commercialization milestonepayments, and is also eligible for royalties on sales. For its part, ProNAi hasthe option to select any number of additional gene targets. Additional detailswere not disclosed.
"We are extremely pleased to have entered into arelationship with a company like ProNAi that is developing a first-in-classnucleic acid therapeutic," J. Michael French, President and CEO of MarinaBiotech, said in a press release. "In addition, we are excited to see thecontinued advancement of oligonucleotide-based therapeutics using ourSMARTICLES technology. Besides advancements within our own internal researchprograms, we have now been able to establish two license agreements broadeningthe application of the SMARTICLES technology to the systemic administration ofboth single- and double-stranded oligonucleotide therapeutics. We look forwardto the rapid advancement of ProNAi Therapeutics' clinical pipeline and theopportunity 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 solidtumors. The compound is ProNAi's first drug candidate from its DNAi drugplatform. In the study, patients will receive PNT2258 as an intravenousinfusion once daily for five consecutive days of every 21-day cycle.
"We are pleased that twenty-two patients have beendosed with PNT2258 in our Phase I clinical trial in advanced solid tumorpatients to evaluate safety and tolerability, maximum tolerated dose,pharmacokinetics and pharmacodynamics. PNT2258 is our first DNAioligonucleotide targeted against the anti-apoptotic bcl-2 oncogene andencapsulated in Marina's SMARTICLES technology," Charles L. Bisgaier, Ph.D.,President and CEO of ProNAi Therapeutics, said in press release. "This noveldelivery technology offers protection for the DNAi oligonucleotide duringsystemic administration with good circulation times and extrahepatic tumorexposure.
"DNAi are short single-strand unmodified oligonucleotidesdesigned to silence genes by interfering with DNA. The DNAi silencing approachis differentiated from that of RNAi, antisense or miRNA in that it targetsgenomic sequences within the non-coding region of DNA disruptingtranscription," Bisgaier continued. "The progress and delivery validation inthe clinic this past year on the novel DNAi-SMARTICLES formulation gives usconfidence to bring forward more first-in-class drug candidates alone or withpartners. ProNAi is now positioned to advance additional cancer therapies fromits pre-clinical leads targeting other oncogenes such as c-myc and k-ras whilealso exploring other disease targets in areas such as inflammation and geneticsdiseases."
SOURCE: Marina Biotech press release
