On January 6, 2023 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, reported a business update and announced strategic objectives and expected milestones for 2023 (Press release, Mersana Therapeutics, JAN 6, 2023, View Source [SID1234625972]).
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"Following a year of tremendous accomplishment in 2022, we are now approaching top-line data from our first registrational trial of UpRi, which we believe will provide an opportunity to further demonstrate Mersana’s increasing role as an ADC leader," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "The data we expect to report from our UPLIFT clinical trial in mid-2023 will represent the most significant milestone to date in our effort to establish UpRi as a foundational medicine for patients with ovarian cancer. Assuming positive data, we plan to target the submission of a BLA around the end of 2023 and prepare for a potential U.S. commercial launch in 2024. We will also continue to advance our UP-NEXT and UPGRADE-A trials of UpRi in earlier lines of treatment."
"Beyond UpRi, our efforts to expand the reach of all three of our fully-scaled ADC platforms, each supported by substantial data, will remain a central theme in 2023," continued Ms. Protopapas. "We will work aggressively to progress our two next-generation ADCs, XMT-1660 and XMT-2056, in Phase 1 trials and establish proof-of concept. Additionally, exploring new collaborations will remain a core component of our strategy as we seek to build upon Mersana’s recent business development successes."
Strategic Objective: Establish UpRi as a Foundational Medicine in Ovarian Cancer
2022 Accomplishments
Completed enrollment in UPLIFT, the company’s single-arm registrational trial of UpRi in platinum-resistant ovarian cancer
Initiated Phase 3 UP-NEXT clinical trial of UpRi as a maintenance monotherapy in recurrent platinum-sensitive ovarian cancer
Neared completion of dose escalation in Phase 1 UPGRADE-A trial of UpRi in combination with carboplatin in platinum-sensitive ovarian cancer
Announced that the European Commission has designated UpRi as an orphan medicinal product for the treatment of ovarian cancer
Expected Milestones
Report top-line data from UPLIFT in mid-2023
Assuming positive data, submit a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) around the end of 2023
Prepare for potential U.S. accelerated approval and commercial launch in 2024
Significantly advance enrollment of UP-NEXT in 2023
Initiate dose expansion portion of UPGRADE-A in the first quarter of 2023 and report interim data from UPGRADE-A in the second half of 2023
Strategic Objective: Advance Clinical-Stage Pipeline
2022 Accomplishments
XMT-1660: Initiated multicenter Phase 1 clinical trial in patients with previously treated breast, endometrial and ovarian cancers
XMT-1660: Announced Fast Track designation for the treatment of adult patients with advanced or metastatic triple-negative breast cancer
XMT-2056: Announced FDA orphan drug designation for the treatment of gastric cancer
Expected Milestones
XMT-1660: Complete dose escalation portion of Phase 1 clinical trial in 2023
XMT-2056: Initiate Phase 1 clinical trial in the first quarter of 2023
Strategic Objective: Position Mersana as the ADC Partner-of-Choice
2022 Accomplishments
Entered into the following agreements that collectively provided Mersana with $170 million in upfront payments and an opportunity for more than $3 billion in milestones, plus royalties:
An Immunosynthen research collaboration and license agreement with Merck KGaA, Darmstadt, Germany for two targets, which includes a $30 million upfront payment to Mersana and the potential for up to $800 million in total potential milestones, plus tiered royalties up to the low double-digits on net sales
A collaboration, option and license agreement with GlaxoSmithKline plc (GSK) for the co-development and commercialization of XMT-2056, which provided Mersana with a $100 million upfront option purchase fee and the potential to receive up to $1.36 billion in the form of an additional option exercise fee and milestone payments, plus an option for Mersana to retain a U.S. profit share and tiered royalties on net sales outside of the United States or to receive tiered royalties up to the mid-twenties on global net sales
A Dolasynthen research collaboration and license agreement with Janssen Biotech, Inc. for three targets, which provided Mersana with a $40 million upfront payment and the potential to receive over $1 billion in total potential milestones, plus tiered royalties up to the low double-digits on net sales
Expected Milestones
Pursue impactful new collaborations
Execute against existing collaboration agreements
Financial Update
Mersana estimates that its cash, cash equivalents and marketable securities as of December 31, 2022 were approximately $280 million. This figure is preliminary and unaudited. The company expects to report its audited cash, cash equivalents and marketable securities, as well as other information necessary for a complete understanding of its financial position, in its Annual Report on Form 10-K for the year ended December 31, 2022. The company expects that its available funds, together with the $30 million upfront payment due from Merck KGaA, Darmstadt, Germany under the collaboration and license agreement referenced above, will be sufficient to support its operating plan commitments into the second half of 2024.