Core Insights - Mersana Therapeutics has received an additional Fast Track designation from the FDA for XMT-1660, now known as emiltatug ledadotin (Emi-Le), targeting advanced or metastatic breast cancer patients with specific HER2 expression levels [1][2] - The Fast Track designation aims to expedite the development and review process for drugs addressing serious conditions and unmet medical needs [3] Company Overview - Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on developing antibody-drug conjugates (ADCs) for cancer treatment [5] - The company has proprietary platforms, Dolasynthen and Immunosynthen, which are generating a pipeline of product candidates [5] Product Development - The new Fast Track designation specifically targets patients with HER2 low or HER2-negative breast cancer, including triple-negative breast cancer (TNBC), who have previously received a topoisomerase-1 inhibitor ADC [2] - The FDA had previously granted Fast Track designation to Emi-Le for adult patients with advanced or metastatic recurrent TNBC [2] Clinical Trials - Initial clinical data from the ongoing Phase 1 trial of Emi-Le will be discussed in a conference call hosted by Mersana [4] - The company emphasizes the growing need for effective treatments for patients who are difficult to treat after standard therapies [3]

Company Updates - Mersana Therapeutics announced that the FDA granted an additional Fast Track designation to XMT-1660 for the treatment of advanced or metastatic breast cancer in patients with HER2 low or HER2-negative disease, including triple-negative breast cancer (TNBC), who have received a prior topoisomerase-1 inhibitor ADC [1][2] - The World Health Organization approved emiltatug ledadotin (Emi-Le) as the international nonproprietary name (INN) for XMT-1660 [1] - The company will host a conference call to discuss initial Phase 1 clinical data for Emi-Le, with a live webcast available on the Mersana website [4] Product Development - Emi-Le (XMT-1660) is a Dolasynthen ADC targeting B7-H4, part of Mersana's proprietary ADC platforms, which also include Immunosynthen ADCs like XMT-2056 targeting a novel HER2 epitope [5] - The FDA previously granted Fast Track designation to Emi-Le for the treatment of adult patients with advanced or metastatic recurrent TNBC [2] - Fast Track designation may provide benefits such as more frequent FDA communications, Accelerated Approval, Priority Review, or Rolling Review of a Biologics License Application (BLA) [3] Industry Insights - Topoisomerase-1 inhibitor ADCs are becoming the standard of care for metastatic TNBC and hormone-receptor positive breast cancer, with research indicating these patients are difficult to treat after initial therapy [3] - Mersana's focus on developing novel ADCs addresses the unmet medical need for new cancer treatment options, particularly for advanced or metastatic breast cancer [5]

Core Insights - Mersana Therapeutics announced positive initial clinical data for emiltatug ledadotin (Emi-Le), indicating a differentiated safety and tolerability profile, particularly in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor antibody-drug conjugates (ADCs) [1][2][4] Clinical Data Summary - The Phase 1 trial enrolled 130 heavily pretreated patients with advanced/metastatic TNBC and other cancers, with a median of 4.5 prior therapy lines [2] - Among patients with known B7-H4 tumor expression, approximately 44% had a tumor proportion score of 70% or higher, categorized as "B7-H4 high" [2] - Emi-Le demonstrated a confirmed objective response rate (ORR) of 23% in evaluable patients with B7-H4 high tumors at intermediate doses [3] - At higher doses above 76 mg/m, the ORR was 22%, with 78% of patients showing a ≥30% tumor reduction in target lesions [6] Safety and Tolerability - Emi-Le was generally well tolerated, with no Grade 4 or 5 treatment-related adverse events reported [2] - The most common treatment-related adverse events (TRAEs) included transient AST increase (38%), proteinuria (31%), nausea (29%), and fatigue (28%) [2] - TRAEs leading to discontinuation, dose reduction, and dose delay were observed in 2.3%, 9.2%, and 12.3% of patients, respectively [2] Future Milestones - Mersana plans to continue enrollment in the expansion cohort at a dose of 67.4 mg/m every four weeks in patients with TNBC who have received at least one prior topo-1 ADC [12] - The company aims to present additional Phase 1 clinical data and pharmacodynamic STING activation data related to its other ADC candidate, XMT-2056, in 2025 [7][12] Company Overview - Mersana Therapeutics is focused on developing novel ADCs, including Emi-Le targeting B7-H4 and XMT-2056 targeting a novel HER2 epitope [10] - The company is committed to addressing high unmet medical needs in cancer treatment through its proprietary platforms [10]

Mersana Therapeutics, Inc. (MRSN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 50%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.20, delivering a surprise of -11.11%.Over the last four quarters, the company has ...

Plan to announce initial clinical data for XMT-1660 at a company event by the end of 2024 Dose escalation advancing in Phase 1 clinical trial of XMT-2056 Conference call today at 8:00 a.m. ET CAMBRIDGE, Mass., Nov. 13, 2024 (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 provided a business update and report ...

CAMBRIDGE, Mass., Nov. 06, 2024 (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 it will provide business updates and report its financial results for the third quarter ended September 30, 2024 on Wednesday, November 13, 2024. The company will host a conference call and webcast at 8:00 a.m. Eas ...

Mersana Therapeutics, Inc. (MRSN) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.47 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -11.11%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.16, delivering a surprise of 11.11%. Over the last four quarters, the compan ...

Dose escalation advancing in Phase 1 clinical trials of both XMT-1660 and XMT-2056 Continue to expect to announce initial XMT-1660 clinical data and initiate expansion in the second half of 2024 Capital resources expected to support current operating plan commitments into 2026 Conference call today at 8:00 a.m. ET CAMBRIDGE, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibo ...

CAMBRIDGE, Mass., Aug. 06, 2024 (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 it will provide business updates and report its financial results for the second quarter ended June 30, 2024 on Tuesday, August 13, 2024. The company will host a conference call and webcast at 8:00 a.m. Eastern Tim ...

CAMBRIDGE, Mass., Aug. 06, 2024 (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 it will provide business updates and report its financial results for the second quarter ended June 30, 2024 on Tuesday, August 13, 2024. The company will host a conference call and webcast at 8:00 a.m. Eastern Tim ...