calotatug ginistinag (XMT-2056) / Mersana, GSK - LARVOL DELTA

Mersana Therapeutics Provides Business Update and Announces First Quarter 2024 Financial Results (GlobeNewswire) - "XMT-2056: The company plans to advance dose escalation in this trial in 2024."

Trial status • Oncology • Solid Tumor

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 (clinicaltrials.gov) - P1 | N=162 | Recruiting | Sponsor: Mersana Therapeutics | Suspended ➔ Recruiting | Trial completion date: Nov 2025 ➔ Apr 2027 | Trial primary completion date: Nov 2025 ➔ Apr 2027

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Provides Business Update and Announces Fourth Quarter and Full Year 2023 Financial Results (GlobeNewswire) - "At the European Society of Gynaecological Oncology (ESGO) 2024 Congress from March 7-10, 2024 in Barcelona, Spain, clinical data will be presented for Mersana’s two discontinued NaPi2b ADC product candidates: XMT-1536 (UpRi), which was developed using the company’s first-generation Dolaflexin ADC platform, and XMT-1592, which was developed using the company’s next-generation Dolasynthen ADC platform....The decline in R&D expenses was primarily related to reduced manufacturing and clinical costs related to UpRi and XMT-2056 and manufacturing costs for the company’s Dolasynthen platform, partially offset by increased clinical costs related to XMT-1660."

Clinical data • Commercial • Oncology • Solid Tumor

Mersana Therapeutics Announces Business Updates, Expected 2024 Milestones and Upcoming Presentation at the 42nd Annual J.P. Morgan Healthcare Conference (GlobeNewswire) - "XMT-1660: Mersana continues to advance its Phase 1 clinical trial of XMT-1660, the company’s lead Dolasynthen ADC candidate targeting B7-H4...Mersana plans to initiate tumor-specific expansion cohorts in the second quarter of 2024 and share initial dose escalation and backfill cohort data in mid-2024...XMT-2056: Mersana is restarting its Phase 1 clinical trial of XMT-2056...The company plans to advance dose escalation in 2024....In the first half of 2024, Mersana expects to present data at multiple scientific meetings demonstrating Dolasynthen’s differentiation from first-generation cytotoxic ADC platforms. The presentations will include clinical data from two discontinued ADC candidates, XMT-1592 and XMT-1536 (UpRi)."

Clinical data • P1 data • Trial status • Oncology • Solid Tumor

Mersana Therapeutics Provides Business Update and Announces Third Quarter 2023 Financial Results (GlobeNewswire) - ".Additionally, we are now preparing to resume enrollment in our Phase 1 clinical trial of XMT-2056, a novel HER2-directed STING-agonist ADC product candidate....Advance XMT-1660 and Mersana’s Dolasynthen Platform: Mersana expects to complete the dose escalation portion of this Phase 1 clinical trial by the end of 2023 and initiate the dose expansion portion of the trial in 2024."

Trial status • Oncology • Solid Tumor

Mersana Therapeutics Announces FDA has Lifted Clinical Hold on Phase 1 Clinical Trial of XMT-2056 (GlobeNewswire) - "Mersana Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the company’s Phase 1 clinical trial of XMT-2056....'We have lowered the starting dose in our Phase 1 dose escalation design. We are pleased to have aligned with FDA on the path forward....The multicenter Phase 1 open-label trial is investigating XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers."

FDA event • Breast Cancer • Colorectal Cancer • Gastric Cancer • Non Small Cell Lung Cancer

Tumor-Targeted Activation of the STING Pathway with Immunosynthen ADCs (PEGS 2023) - "XMT-2056 is a HER2-targeted Immunosynthen ADC that binds a novel HER2 epitope and has entered clinical development. The mechanistic translational studies presented could guide clinical development."

Oncology • HER-2 • STING

XMT-2056, a HER2-targeted STING agonist antibody-drug conjugate, exhibits ADCC function that synergizes with STING pathway activation and contributes to anti-tumor responses (AACR 2023) - "The ADCC activity of HT-19 was comparable to that of trastuzumab in NK cell co-cultures. Collectively, our data reveal a synergy between ADCC function and STING pathway induction both mediated by XMT-2056, which enhances the cancer cell-killing activity of FcγRIII+ cells. This additional mechanism of action of XMT-2056 can potentially impact the overall anti-tumor immune responses in tumors infiltrated by FcγRIII+ cells."

Oncology • GZMB • HER-2 • IFNG • NCAM1

"Did anyone ask @marc_drcell about the clinical results of XMT-2056, or was discussion only on preclin? #AACR23 @AACR" (@GooseData)

Clinical • Oncology

"Wow! #AACR23! Over 100 posters on best target #Her2. Many are promising ADCs like Xmt-2056 and innovative intrinsic TI payloads like Eribulin. What is everyone most excited to see?!?! 👀" (@GooseData)

Oncology

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 (clinicaltrials.gov) - P1 | N=171 | Suspended | Sponsor: Mersana Therapeutics | Recruiting ➔ Suspended

Metastases • Trial suspension • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Announces Clinical Hold on XMT-2056 Phase 1 Clinical Trial (GlobeNewswire) - "Mersana Therapeutics, Inc...announced that the Phase 1 trial of XMT-2056 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). This action follows the company’s communication to FDA that Mersana was voluntarily suspending the trial due to a recent Grade 5 (fatal) serious adverse event (SAE) that was deemed to be related to XMT-2056. The SAE and its cause remain under investigation."

Trial suspension • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Announces Initiation of Phase 1 Trial of XMT-2056 in HER2-Expressing Tumors (GlobeNewswire) - "Mersana Therapeutics...announced the initiation of patient dosing in its Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen product candidate....XMT-2056 is a systemically administered Immunosynthen STING agonist ADC that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells to provide the potential to treat patients with HER2-high or -low tumors as monotherapy or in combination with standard-of-care agents....The multicenter Phase 1 open-label trial will investigate XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers."

Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • HER-2

Mersana Therapeutics Provides Business Update and Announces Strategic Objectives and Expected Milestones (GlobeNewswire) - "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."

Trial status • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • Triple Negative Breast Cancer

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: Mersana Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2022 ➔ Dec 2022

Enrollment open • Trial initiation date • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Provides Business Update and Announces Third Quarter 2022 Financial Results (GlobeNewswire) - "Strategic Goals, Recent Developments and Anticipated Milestones - Build Upifitamab Rilsodotin (UpRi), a First-in-Class NaPi2b-Targeting ADC, into a Foundational Medicine in Ovarian Cancer...Nearing Completion of Dose Escalation in UPGRADE-A Trial: The dose escalation portion of UPGRADE-A, the company’s Phase 1/2 trial of UpRi in combination with carboplatin, is now nearly complete. The company expects to enter the dose expansion portion of UPGRADE-A in the first quarter of 2023 and plans to present data from the trial in the second half of 2023. Build a Pipeline of Highly Impactful Cancer Medicines....Readying for Initiation of XMT-2056 Phase 1 Trial...The company expects to initiate a multicenter Phase 1 open-label trial of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2, including breast, gastric, colorectal and non-small-cell lung cancers later in the fourth quarter of 2022."

P1/2 data • Trial status • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gynecologic Cancers • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Beyond Cytotoxic ADCs & Immunogenic Cell Death: Advancing ADCs Fully Into Immuno-oncology (ADC-USA 2022) - "SynopsisDesign and optimization of the Immunosynthen STING agonist ADC platformExtensive characterization of the pre-clinical profile of XMT-2056, a novel, Her-2 targeted Immunosynthen ADCTranslational Research demonstrating the mechanism of an Immnosynthen ADC and its ability to activate the STING pathway in tumor cells and tumor-resident immune cells to deliver a “1-2 punch”"

Immunogenic cell death • Oncology • HER-2

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 (clinicaltrials.gov) - P1 | N=144 | Not yet recruiting | Sponsor: Mersana Therapeutics

New P1 trial • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Announces Option Agreement with GSK for the Co-Development and Commercialization of XMT-2056, an Immunosynthen ADC Targeting HER2 (GlobeNewswire) - "Mersana Therapeutics...announced a global collaboration that provides GSK plc...an exclusive option to co-develop and commercialize XMT-2056, an Immunosynthen ADC that targets a novel epitope of HER2. XMT-2056 is designed to activate the innate immune system through STING signaling in both tumor-resident immune cells and in tumor cells."

Licensing / partnership • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Mersana Therapeutics Announces FDA Grant of Orphan Drug Designation to XMT-2056 for the Treatment of Gastric Cancer (GlobeNewswire) - "Mersana Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer....Mersana plans to initiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing tumors, such as breast, gastric and non-small-cell lung cancers, in mid-2022."

New P1 trial • Orphan drug • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

XMT-2056, a HER2-targeted Immunosynthen STING-agonist antibody-drug conjugate, binds a novel epitope of HER2 and shows increased anti-tumor activity in combination with trastuzumab and pertuzumab (AACR 2022) - "To this end, administration of an XMT-2056 surrogate ADC in combination with an anti-PD1 agent improved anti-tumor activity in a ratHER2-engineered EMT-6 syngeneic mouse model. Together these data support the potential of XMT-2056 both as a monotherapy and in combination with other HER2 targeted agents as well as checkpoint inhibitors."

Combination therapy • IO biomarker • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Mersana Therapeutics to Present Preclinical Data on XMT-1660, XMT-2056 and the Immunosynthen Platform at AACR Annual Meeting (GlobeNewswire) - "Mersana Therapeutics...announced that it will present three posters highlighting data for XMT-1660, XMT-2056, and the Immunosynthen ADC platform at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022 to be held in New Orleans, Louisiana from April 8-13, 2022....The data show that a single dose of XMT-1660 has anti-tumor activity in both triple-negative breast cancer (TNBC)...Mersana expects a Phase 1 clinical trial for XMT-1660 to start in mid-2022....The preclinical data presented show that XMT-2056 demonstrates robust anti-tumor activity as a monotherapy in both HER2-high and HER2-low expressing models....Mersana expects to initiate a Phase 1 clinical trial of XMT-2056 in mid-2022."

New P1 trial • Preclinical • Breast Cancer • Oncology • Solid Tumor

Mersana Therapeutics Announces 2022 Strategic Priorities and Milestones (GlobeNewswire) - "XMT-1592, a first Dolasynthen ADC targeting NaPi2b, is currently in a Phase 1 trial, with dose exploration expected to be complete in the second half of 2022....XMT-1660, a first-in-class Dolasynthen ADC targeting B7-H4, is expected to initiate a Phase 1 dose escalation trial in mid-2022....XMT-2056, a first-in-class HER2-targeted Immunosynthen STING-agonist ADC, is expected to initiate a Phase 1 dose escalation trial in mid-2022....The Company plans to disclose two new development candidates, XMT-2068 and XMT-2175, during the first half of 2022....The Company will review these corporate updates and milestones during its upcoming presentation at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 pm ET."

Clinical • New P1 trial • Trial completion date • Oncology

Mersana Therapeutics Announces Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "Investigational New Drug (IND)-enabling studies of XMT-1660 ongoing with Phase 1 studies expected to start in early 2022; The Company plans to initiate a Phase 1 study of XMT-2056 in early 2022; Mersana plans to present a poster entitled, 'STING-agonist ADCs targeting tumor-associated antigens coordinate immune-mediated killing of antigen-negative cancer cells,' at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) during the live poster display session available from November 12 – 13, 2021."

New P1 trial • Oncology

Mersana Therapeutics Announces Target and Presents New Preclinical Data for XMT-2056, First Immunosynthen STING-Agonist ADC, at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Mersana Therapeutics...announced that XMT-2056, its first Immunosynthen STING-agonist ADC candidate, targets a novel epitope of human epidermal growth factor receptor 2 (HER2) and presented new preclinical data during a plenary session at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics (Triple Meeting)....XMT-2056 showed excellent in vivo efficacy as a single agent in a SKOV3 HER2 high model and this efficacy is further enhanced by combining XMT-2056 with a 3 mg/kg dose of trastuzumab."

Preclinical • Oncology • Solid Tumor