Mersana Therapeutics Outlines 2017 Milestones and 2018 Goals
“2017 was a year of exceptional execution as we positioned the company for achieving key clinical milestones in 2018 and beyond. Last year, we advanced two lead ADC product candidates, XMT-1522 and XMT-1536, into the clinic and supported our partner Takeda in selecting its first Dolaflexin-based ADC for initiation of IND enabling studies,” said Anna Protopapas, President and CEO,
Mersana’s pipeline includes two compounds in Phase 1 clinical trials: XMT-1522, a Dolaflexin ADC targeting HER2-expressing breast cancer, non-small cell lung cancer (NSCLC) and gastric cancer, and XMT-1536, a first-in-class Dolaflexin ADC targeting NaPi2b, a clinically validated ADC target broadly expressed in epithelial ovarian cancer and non-squamous NSCLC, as well as a number of other tumor types. Mersana is progressing both molecules in Phase 1 dose escalation studies. XMT-1522 has been administered to six dose cohorts with the sixth dose cohort currently in safety evaluation, and XMT-1536 has enrolled and cleared the first dose level. Mersana also has ongoing, robust research programs that the Company believes are positioned to deliver an additional investigational new drug (IND) every 12-24 months.
XMT-1522: a Dolaflexin ADC targeting HER2-expressing breast cancer, NSCLC and gastric cancers
- Initiated patient dosing for XMT-1522 and completed dosing of six cohorts in the dose escalation study. The maximum tolerated dose has not yet been established, as treatment related adverse events to date have generally been mild.
- Presented preclinical data on XMT-1522 at AACR 2017 that supported potential synergy with immune checkpoint inhibitors.
XMT-1536: a first-in-class Dolaflexin ADC targeting NaPi2b, a clinically validated ADC target broadly expressed in epithelial ovarian cancer and non-squamous NSCLC, as well as additional tumor types.
- Filed and received
FDAclearance of the IND for XMT-1536 in late October.
- The first dose level has been cleared and dose escalation continues.
- Presented XMT-1536 efficacy data in an ovarian mouse study at
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeuticsthat supported the potential for XMT-1536 to have broad activity in epithelial ovarian cancer.
- Developed and validated an immunohistochemistry assay for measuring NaPi2B protein levels to be integrated into the clinical development of XMT-1536.
- Supported partner Takeda in selecting its first Dolaflexin ADC for initiation of IND-enabling studies.
- Advanced Mersana’s discovery stage pipeline programs.
- Scaled up Dolaflexin.
- Strengthened ADC leadership position with the development of new proprietary platforms, including a novel DNA alkylating platform.
- Completed an initial public offering of 5 million shares of common stock for aggregate gross proceeds of
- Continued to attract top talent to support the advancement of its pipeline.
- Continue dose escalation study to establish Maximum Tolerated Dose (MTD).
- Select Recommended Phase 2 Dose (RP2D) and substantially enroll dose expansion cohorts.
- Present dose escalation data at a scientific conference.
- Continue dose escalation study to establish MTD. If MTD is established, select Phase 2 dose and initiate enrollment of expansion cohorts.
- Select the next ADC clinical candidate and disclose pre-clinical data at a scientific meeting.
- Disclose new proprietary platform technologies at a scientific meeting.
- Proactively evaluate potential for strategic collaborations that maximize the value of Mersana’s pipeline and platforms.
- Continue to recruit top talent and maintain a culture of scientific excellence, focused execution and patient needs.
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 management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include information concerning the Company’s business strategy and the design, progression and timing of its clinical trials. Forward-looking statements generally can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Forward-looking statements represent management’s beliefs and assumptions only as of the date of this press release. The Company’s 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 Company’s 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 of the Company’s product candidates and new platforms will take longer and/or cost more than planned and that the identification of new product candidates will take longer than planned, as well as those listed in the Company’s Quarterly Report on Form 10-Q filed on
Copies of the Company’s our Quarterly Report on Form 10-Q and our other SEC filings are available by visiting EDGAR on the SEC website at http://www.sec.gov.
Stern Investor Relations, Inc.
Source: Mersana Therapeutics, Inc.