OTCQB :
Joseph Ramelli, CEO of Marina Biotech, stated, “Since announcing Marina Biotech’s merger with IthenaPharma just six months ago, we have moved quickly to assemble an operational team and implement a strategy to advance our pipeline of combination therapies and novel oligotherapeutics. We are driven by our commitment to improve the lives of patients by delivering novel therapies that we believe will improve outcomes while reducing the undesirable side effects of many current therapies.”
“In the past several weeks, we announced preclinical and clinical data at several healthcare conferences for our two arthritis pain/hypertension drug candidates, IT-102 and IT-103. This data further supports the development of IT-102 and IT-103, not only for combined hypertensive/pain, but also for the treatment of cancers such as FAP and colorectal cancer. We also announced the signing of a definitive agreement with Windlas Healthcare to manufacture the IT-102 CTM batch for our pivotal phase III trial to be initiated in the first quarter of 2018.”
“We also announced findings of the START-FAP (Safety and Tolerability of an RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial at the Biotech Showcase 2017 and Society of Toxicology’s 56th Annual Meeting. START-FAP evaluated CEQ508, tkRNAi against beta-catenin, for the treatment of FAP and achieved primary and secondary end-points for safety and efficacy in knocking down beta-catenin in FAP patients. As the only oral delivery platform for oligotherapeutics, we are excited to continue to develop CEQ508 as a therapy for Familial Adenomatous Polyposis (FAP), as well as expansion of the platform to other indications.”
“In addition to developing our pipeline of therapeutics, we are positioned to effectively tap into the significant partnership opportunities for our SMARTICLES and tkRNAi delivery platforms. In early-February, we announced a licensing agreement with LipoMedics through which Marina Biotech could receive up to $90 million in success-based milestone payments. We have obtained another line of credit with Autotelic Inc. to further extend the runway for the commercialization of IT-102 and IT-103. With the additional line of credit, definitive manufacturing agreement and strong clinical data findings, Marina is poised for execution going forward and prepared to support near term commercialization of its pipeline,” concluded Mr. Ramelli.
Late Breaking poster for CEQ508 at the Society of Toxicology 56th Annual Meeting
The poster outlines a dose escalating Phase I trial conducted with daily, oral administration of CEQ508 over 28 days to FAP patients. The clinical results continue to prove that the Company’s proprietary tkRNAi delivery platform is a safe and effective oral delivery of siRNA.
Updated findings of the START-FAP trial at Biotech Showcase 2016
Marina provided updated findings of the START-FAP having achieved primary and secondary end-points for safety and efficacy in knocking down beta-catenin in FAP patients.
Retrospective patient level data for two late stage arthritis pain / hypertension drug candidates, IT-102 and IT-103
This is a retrospective study that uses two patient level data sources over a three-year period to demonstrate suppression of celecoxib drug induced edema by IT-102 and IT-103. The data were presented at the 7th International Conference on Fixed Combination in the Treatment of Hypertension, Dyslipidemia and Diabetes Mellitus in Cannes, France on March 2-5, 2017. These FDCs are being developed as next generation Celecoxib -- Celecoxib without Celecoxib drug-induced edema -- as inhibitor of the beta-catenin/COX-2 axis for the treatment of pain, arthritis, and cancers such as FAP and CRC.
Preclinical and clinical data supporting the use of IT-102 and IT-103 as novel anticancer agents
The synergy between celecoxib and lisinopril/olmesartan (IT-102/IT-103) along with its safety were presented at Endocrine Society Annual Meeting at Orange County Convention Center, Orlando, FL and the American Association for Cancer Research Annual Meeting in Washington, DC. IT-102 and IT-103 suppressed both the COX-2 tumor pathway and the vascular resistance of solid tumor to achieve suppression of tumor growth and metastasis.
License agreement for SMARTICLES
The Company entered into a license agreement with Lipomedics regarding its SMARTICLES platform for the delivery of nanoparticles, including small molecules, peptides, proteins and biologics. This is the first agreement in which SMARTICLES technologies have been licensed in connection with nanoparticles delivering small molecules, peptides, proteins and biologics. Under terms of the agreement, Marina could receive up to $90 million in success based milestones.
Manufacturing agreement for IT-102 FDC bi-layer tablet with Windlas Healthcare Limited
Marina selected Windlas Healthcare for the manufacturing of the FDC bi-layer tablets, a stringent FDA cGMP process, which Windlas has the expertise necessary to complete.
Secured line of credit in November 2016, and expanded the line in April 2017
Marina secured a $540,000 line of credit through its Chairman, Dr. Vuong Trieu. The Company has drawn down an aggregate of $250,000 under the line as of December 31, 2016. On April 4, 2017, Marina expanded the line of credit with Dr. Trieu for an additional $500,000.
Completed merger with IThenaPharma
Marina merged with IThenaPharma to advance its development and commercialization of combination products for pain, arthritis, hypertension, and cancer.
- Dr. Seymour Fein appointed as Chief Medical Officer
- Larn Hwang, Ph.D. appointed as Chief Scientific Officer
- Mihir Munsif appointed as Chief Operating Officer
Financial Update:
On March 31, 2017, the Company filed its 10-K with the SEC, which can be accessed on the Company’s website (click here).
