 CAMBRIDGE, Mass., Aug. 11, 2020 GLOBE NEWSWIRE -- Mersana Therapeutics, Inc. NASDAQ:MRSN, a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates ADCs targeting cancers in areas of high unmet medical need, today announced that the U.S. Food and Drug Administration FDA has granted Fast Track Designation for XMT-1536, for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or patients who have received four prior lines of systemic therapy regardless of platinum status. We are very encouraged by the FDAs decision to grant us Fast Track Designation for our lead program XMT-1536, which has shown very encouraging activity and tolerability in our Phase 1 study in ovarian cancer to date. We believe this recognition underscores the high unmet medical need for a treatment for patients with platinum-resistant ovarian cancer, said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. With this designation in hand, we plan to be able to quickly advance through the administrative steps of XMT-1536s development and bring forth a therapy for these patients as soon as possible.The FDAs Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application BLA.About XMT-1536 XMT-1536, a first-in-class ADC targeting the sodium-dependent phosphate transport protein NaPi2b, utilizes the Dolaflexin platform to deliver an average of 10-12 DolaLock payload molecules per antibody. The NaPi2b antigen is broadly expressed in ovarian cancer and non-small cell lung cancer NSCLC adenocarcinoma. XMT-1536 is in an ongoing Phase 1 proof-of-concept clinical trial in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov NCT03319628.About Mersana Therapeutics Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to rapidly develop novel ADCs with optimal efficacy, safety and tolerability to meaningfully improve the lives of people fighting cancer. Mersanas lead product candidate, XMT-1536, is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma. XMT-1592, Mersanas second ADC product candidate targeting NaPi2b-expressing tumors, was created using Mersanas customizable and homogeneous Dolasynthen platform and is in the dose escalation portion of a Phase 1 proof-of-concept clinical study. The Companys early stage programs include a B7-H4 targeting ADC, as well as a STING-agonist ADC developed using the Companys Immunosynthen platform. In addition, multiple partners are using Mersanas Dolaflexin platform to advance their ADC pipelines.Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws. These forward-looking statements are not statements of historical facts and are based on managements beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning the Companys business strategy and the design, progression and timing of its clinical trials. Forward-looking statements generally can be identified by terms such as aims, anticipates, believes, contemplates, continues, could, estimates, expects, goal, intends, may, on track, plans, possible, potential, predicts, projects, seeks, should, target, will, would or similar expressions and the negatives of those terms. Forward-looking statements represent managements beliefs and assumptions only as of the date of this press release. The Companys operations involve risks and uncertainties, many of which are outside its control, and any one of which, or combination of which, could materially affect its results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that may materially affect the Companys results of operations and whether these forward-looking statements prove to be correct include, among other things, that preclinical testing may not be predictive of the results or success of ongoing or later preclinical or clinical trials, that the development and testing of the Companys product candidates and new platforms will take longer andor cost more than planned, and that the identification of new product candidates will take longer than planned, as well as those listed in the Companys Annual Report on Form 10-K filed on February 28, 2020, with the Securities and Exchange Commission SEC, the Companys Quarterly Report on Form 10-Q filed on May 8, 2020, with the SEC and subsequent SEC filings. In addition, while we expect that the COVID-19 pandemic might adversely affect the Companys preclinical and clinical development efforts, business operations and financial results, the extent of the impact on the Companys operations and the value of and market for the Companys common stock will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, physical distancing and business closure requirements in the U.S. and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.Contact: Investor Media Contact Sarah Carmody, 617-844-8577 