City of Industry, CA – April 5, 2017 – Marina Biotech, Inc. (OTCQB: MRNA), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension and cancer, provided today a corporate update to investors, following the filing of its 10-K for the year ended December 31, 2016 with the SEC.
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.
Recent Clinical and Corporate Highlights:
- 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.
- Enhancing Marina’s executive management team with key hires:
- Seymour Fein appointed as Chief Medical Officer
- Larn Hwang, Ph.D. appointed as Chief Scientific Officer
- Mihir Munsif appointed as Chief Operating Officer
On March 31, 2017, the Company filed its 10-K with the SEC, which can be accessed on the Company’s website (click here).
About Marina Biotech
Marina Biotech is a biotechnology company focused on the development and commercialization of innovative therapeutics for disease intersections of arthritis, hypertension, and cancer. Our pipeline includes combination therapies of oligonucleotide-based therapeutics and small molecules. The Marina Biotech pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome). By its merger with IthenaPharma, Marina Biotech recently acquired IT-102/IT-103 – next generation celecoxib – which will be developed together with CEQ508 as a therapeutic enhancer for therapies against FAP and CRC. IT-102/IT-103 are also being developed for the treatment of combined arthritis/ hypertension and treatment of pain requiring high dose of celecoxib. Additional information about Marina Biotech is available at http://www.marinabio.com.
Marina Biotech Forward-Looking Statements
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Marina Biotech to successfully integrate its business operations with those of IthenaPharma; (ii) the ability of Marina Biotech to obtain funding to support its clinical development; (iii) the ability of Marina Biotech to attract and/or maintain manufacturing, research, development and commercialization partners; (iv) the ability of Marina Biotech and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (v) the ability of Marina Biotech and/or a partner to obtain required governmental approvals; and (vi) the ability of Marina Biotech and/or a partner to develop and commercialize products prior to, and that can compete favorably with those of, competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Marina Biotech’s most recent filings with the Securities and Exchange Commission. Marina Biotech assumes no obligation to update or supplement forward-looking statements because of subsequent events.