| Wednesday | ||||
Mersana Therapeutics… Mersana Therapeutics announced that patient dosing is underway in the expansion portion of its UPGRADE-A clinical trial of UpRi in combination with carboplatin in platinum-sensitive ovarian cancer. UpRi is Mersana's first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload designed to enable a high drug-to-antibody ratio and controlled bystander effect. "While the combination of carboplatin and paclitaxel has historically served as the standard of care in early lines of therapy for platinum-sensitive ovarian cancer, it is limited by distinct tolerability and side effect challenges that can include severe neutropenia, peripheral neuropathy and alopecia," said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. "With UPGRADE-A, we are investigating the potential benefits of replacing paclitaxel with UpRi in the induction phase of treatment and then continuing UpRi as maintenance monotherapy. We are pleased to enter this exciting new phase of the trial." Mersana expects to report interim data from UPGRADE-A in the second half of 2023. | ||||
| Over a week ago | ||||
Mersana Therapeutics… Mersana Therapeutics announced the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company's lead Immunosynthen product candidate. "We believe this trial will give us important insights into XMT-2056's tolerability and clinical activity profile across a range of solid tumors while also helping to demonstrate the differentiated nature of our Immunosynthen platform, which is designed to take ADCs beyond the cytotoxic realm by enabling innate immune activation," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "Given the preclinical activity XMT-2056 has demonstrated as a monotherapy and in combination with multiple agents, including standard-of-care HER2 therapies, we believe XMT-2056 may offer a differentiated and highly complementary therapeutic approach. We are excited to have candidates derived from all three of our ADC platforms in active clinical trials, demonstrating our continued innovation and leadership within the ADC space." | ||||
Institutional investors…
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Citi analyst Ashiq… Citi analyst Ashiq Mubarack initiated coverage of Mersana Therapeutics with a Buy rating and $12 price target. He believes topline registrational data from the UPLIFT Phase 2 study evaluating upifitamab rilsodotin in platinum-resistant ovarian cancer, or PROC, will be "a catalyst of significant debate" over the next roughly six months, Mubarack tells investors. While he acknowledges the readout will be binary, he thinks investors are underappreciating UPLIFT's probability of success. If UPLIFT is positive, he thinks shares could trade up to 100% above current levels given such a result will leave Mersana with "a clear pathway to an accelerated approval filing" by year end, the analyst added. | ||||
Mersana Therapeutics… Mersana Therapeutics provided a business update and announced strategic objectives and expected milestones for 2023. "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." Strategic Objective: Establish UpRi as a Foundational Medicine in Ovarian Cancer - Expected Milestones: Report top-line data from UPLIFT in mid-2023; Assuming positive data, submit a biologics license application to the U.S. Food and Drug Administration 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; and 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 - 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 - Expected Milestones: Pursue impactful new collaborations; Execute against existing collaboration agreements;. | ||||
| Over a month ago | ||||
Check out this evening's…
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Mersana Therapeutics… Mersana Therapeutics (MRSN) announced a research collaboration and commercial license agreement with a subsidiary of Merck KGaA (MKKGY) to discover novel Immunosynthen ADCs directed against up to two targets. Immunosynthen, Mersana's proprietary STING-agonist ADC platform, is designed to generate systemically administered ADCs that locally activate STING signaling in both tumor-resident immune cells and in antigen-expressing tumor cells. "Building on our deep expertise in the ADC space, we are focused on the discovery of next-generation state-of-the-art ADC drugs," said Paul Lyne, Head of Research Unit, Oncology, Merck KGaA, Darmstadt, Germany. "An approach that can directly target the tumor microenvironment with an immunomodulatory ADC has the potential to bring the benefits of this immunotherapy to a broader group of patients. This collaboration with Mersana to design novel immunostimulatory ADCs that can harness the potential of the STING pathway is an ideal complement to our innovation." Under the terms of the agreement, Mersana will develop novel ADC product candidates against up to two targets utilizing its Immunosynthen platform to conjugate proprietary antibodies from Merck KGaA, Darmstadt, Germany. Mersana will be responsible for certain discovery activities, as well as limited preclinical manufacturing and supply obligations, which will be reimbursed by Merck KGaA, Darmstadt, Germany. Merck KGaA, Darmstadt, Germany will be solely responsible for in vitro and in vivo characterization, other preclinical work, and all clinical development and potential commercialization activities relating to any resulting product candidates. Mersana will receive an upfront payment of $30M. Mersana is also eligible to receive reimbursement of certain costs, up to $800M in potential regulatory, development and commercial milestone payments, and tiered royalties up to the low double-digit percentages on worldwide net sales of any approved ADCs developed under the agreement. | ||||
Mersana Therapeutics… Mersana Therapeutics announced that the European Commission, E.C., has designated upifitamab rilsodotin, UpRi, as an orphan medicinal product for the treatment of ovarian cancer. UpRi is Mersana's first-in-class NaPi2b-targeting ADC with a novel scaffold-linker-payload that is designed to enable a high drug-to-antibody ratio and controlled bystander effect. "Receiving this orphan designation in the European Union is an important regulatory milestone for Mersana as we seek to expedite UpRi's global development," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "This designation reinforces the unmet needs that patients with ovarian cancer continue to face today. We look forward to advancing our ongoing clinical trials, which aim to establish UpRi as a foundational medicine in ovarian cancer." | ||||
Truist analyst Asthika… Truist analyst Asthika Goonewarden initiated coverage of Mersana Therapeutics with a Buy rating and $12 price target. While the company is a newer entrant to the antibody drug conjugate space, it has several proprietary components that he finds "very attractive and differentiating", the analyst tells investors in a research note. Goonewarden adds that given a pivotal study for their lead candidate UpRi being underway, along with two new ADCs entering the clinic, he expects mid-2023 and the second half of 2023 to be "quite active" for Mersana Therapeutics. | ||||
Truist analyst Asthika… Truist analyst Asthika Goonewarden initiated coverage of Mersana Therapeutics with a Buy rating and $12 price target. | ||||
