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National Post
6 days ago
- Business
- National Post
BeOne Medicines Unveils Promising Clinical Data for Two Novel Breast Cancer Therapies at ASCO 2025
Article content Article content Data underscore strength of emerging breast cancer pipeline as part of BeOne's global transformation with next wave of innovation Article content SAN CARLOS, Calif. — BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced new clinical data from its emerging breast cancer pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Poster presentations feature preliminary results of the dose escalation studies of two investigational molecules: BG-C9074, a novel B7-H4-targeting antibody-drug conjugate (ADC) in patients with advanced solid tumors, including breast cancer, and BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), in HR+/HER2- breast cancer patients with prior CDK4/6i exposure. Article content 'Presenting the first clinical data for two novel breast cancer candidates at ASCO 2025 marks a pivotal moment for BeOne,' said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. 'These early results highlight the strong potential of our B7-H4-targeting ADC and CDK2 inhibitor to address critical gaps in breast cancer treatment. Alongside our advancing CDK4 inhibitor, they represent just the beginning of a pipeline built on targeted, biology-driven innovation. As we debut our new identity as BeOne, this milestone reflects the momentum behind our science and our commitment to delivering impactful therapies to cancer patients worldwide.' Article content BeOne is advancing a robust pipeline of differentiated investigational medicines for breast cancer that may both effectively combat the disease and potentially improve quality of life for patients receiving treatment. Article content BeOne presented initial results of the ongoing first-in-human, Phase 1a dose escalation study of BG-C9074 monotherapy in 78 patients with advanced solid tumors, of which more than a quarter were breast cancer patients. BG-C9074, an investigational topoisomerase I inhibitor ADC that targets the B7-H4 protein, which is broadly expressed in breast and gynecologic cancers, is designed with an innovative drug linker to deliver a potent cancer-killing drug directly to the cancer cells. Article content With limited follow-up among the 56 efficacy-evaluable patients, preliminary clinical responses were observed at multiple dose levels across various tumor types without selection for B7-H4 expression in these heavily pretreated patients. Confirmed overall response rate (ORR) was 16.1% (9/56; 95% CI: 7.6%–28.3%), with 9 confirmed partial responses; unconfirmed ORR was 25.0% (14/56; 14.4%-38.4%) (n=14 partial responses). Confirmed disease control rate (DCR) was 73.2% (59.7%-84.2%) and confirmed clinical benefit rate (CBR) was 17.9% (8.9%-30.4%). Pharmacokinetics (PK) were observed to be approximately dose-proportional across dose levels. Article content BG-C9074 showed a manageable safety and tolerability profile in patients with B7-H4 advanced solid tumors, including breast cancer. There were 5 dose-limiting toxicities (DLTs) reported among 3 dose levels, all related to treatment: grade 3 fatigue (n=1); grade 3 febrile neutropenia (n=2); and grade 4 platelet count decreased (n=2). The most common treatment-emergent adverse events (TEAEs) were nausea, fatigue, and neutropenia*. The most common grade ≥3 TEAEs were neutropenia and thrombocytopenia†. There were no TEAEs leading to treatment discontinuation or death. Article content Dose-escalation data from the first-in-human, Phase 1a study of a novel CDK2 inhibitor, BG-68501, were presented as a poster today. BG-68501 is designed to address elevated CDK2 activity as well as cyclin E1-driven upregulation, two key resistance mechanisms that often limit the effectiveness of CDK4/6 inhibitors in treating HR+/HER2- breast cancer. CDK inhibitors target checkpoint proteins that control cell division to stop the growth of cancer cells. Article content A total of 57 enrolled patients with advanced solid tumors, including 19 patients with HR+/HER2- metastatic breast cancer, received BG-68501 as monotherapy or in combination with fulvestrant in escalating dose cohorts (all received prior CDK4/6i). Article content Of the 37 efficacy-evaluable patients (all with monotherapy), unconfirmed overall response rate (ORR) was 5.4% (2/37; 95% CI: 0.7%–18.2%). Two extensively pretreated patients (5.4%) experienced unconfirmed partial response (PR), 15 patients (40.5%) had stable disease (SD), 15 patients (40.5%) had progressive disease (PD), and 5 patients (13.5%) were not evaluable/not assessed. Of the 2 patients with PR, both were breast cancer patients, and one was ongoing with treatment at the time of data cutoff, while the other had discontinued treatment. Unconfirmed clinical benefit rate (CBR) was 8.1% (3/37; 95% CI: 1.7%-21.9%) and unconfirmed disease control rate (DCR) was 45.9% (17/37; 95% CI: 29.5%-63.1%). BG-68501 demonstrated a linear PK profile consistent with preclinical data and signs of pharmacodynamic responses. Article content BG-68501 demonstrated a manageable safety and tolerability profile, with no DLTs observed to date during dose escalation. The most common TEAEs were vomiting, nausea, and fatigue, and TEAEs leading to treatment discontinuation occurred in 4 patients (7%) across all dose levels. There were no TEAEs leading to death. Article content The data support continued development of BG-68501 as a next-line option for tumors with CDK2 dependency. ( NCT06257264) Article content For additional information about our presence at the 2025 ASCO Annual Meeting, please visit our meeting hub: Article content BeOne will host an investor R&D Day on June 26 at 8:30 am ET covering its deep and broad global innovation pipeline and platforms, as well as the Company's vision, differentiated capabilities, and value creation drivers. A live webcast will be accessible from the investors section of BeOne's website at or An archived replay will be available for 90 days following the event. Article content BeOne is advancing a robust portfolio of investigational medicines for breast cancer, including three molecules in clinical development – two cyclin-dependent kinase (CDK) inhibitors, BGB-43395, a CDK4 inhibitor, and BG-68501, a CDK2 inhibitor, and an antibody-drug conjugate (ADC), BG-C9074. BeOne also plans to evaluate the potential of BCL2 inhibition in breast cancer, with next-generation BCL2 inhibitor, BGB-21447, expected to begin clinical testing in solid tumor indications soon. Multispecific antibodies and targeted protein degraders with potential applications in breast cancer are among the preclinical assets being developed. Article content About Breast Cancer Article content Breast cancer accounts for close to one in four cancer cases and one in six cancer deaths in women worldwide. 1 Globally, breast cancer is the second most common cancer and the fourth highest cause of cancer mortality as well as the leading cause of cancer death in women. 1 More than 2.3 million patients were diagnosed with breast cancer in 2022, and over 666,000 deaths were reported globally. 1 Approximately two-thirds of breast cancer cases are the HR+/HER2- subtype. 2 Article content About BeOne Article content BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. Article content This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential of BeOne's B7-H4-targeting ADC and CDK2 inhibitor to address critical gaps in breast cancer treatment; the ability of BeOne to deliver impactful therapies to cancer patients worldwide; the ability of BeOne's pipeline to effectively combat breast cancer and improve quality of life for patients; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. Article content *Neutropenia was defined by a custom MedDRA basket with neutropenia and neutrophil count decrease preferred terms. Article content †Thrombocytopenia was defined by a custom MedDRA basket with thrombocytopenia and platelet count decreased preferred terms. Article content Article content Article content Article content Article content Contacts Article content Article content Article content
Yahoo
16-05-2025
- Business
- Yahoo
Mersana Therapeutics Inc (MRSN) Q1 2025 Earnings Call Highlights: Strategic Restructuring and ...
Cash and Cash Equivalents: $102.3 million at the end of Q1 2025. Net Cash Used in Operating Activities: $29.3 million for Q1 2025. Collaboration Revenue: $2.8 million for Q1 2025, down from $9.2 million in Q1 2024. Research and Development Expenses: $18.3 million for Q1 2025, compared to $18.7 million in Q1 2024. General and Administrative Expenses: $8.9 million for Q1 2025, down from $11.6 million in Q1 2024. Net Loss: $24.1 million for Q1 2025, compared to $19.3 million in Q1 2024. Warning! GuruFocus has detected 5 Warning Signs with MRSN. Release Date: May 15, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Mersana Therapeutics Inc (NASDAQ:MRSN) has implemented a strategic restructuring plan to extend its cash runway into mid-2026, allowing for continued development of its key product, Emi-Le. The company reported promising clinical data for Emi-Le, particularly in patients with B7-H4 high tumors, showing an objective response rate (ORR) of 29% and a median progression-free survival (PFS) of 16 weeks. Enrollment in the expansion cohort for Emi-Le has progressed rapidly, indicating strong interest and potential for further clinical success. Mersana Therapeutics Inc (NASDAQ:MRSN) has adopted new proteinuria management guidelines, which are expected to improve treatment tolerability and maintain dose intensity. The company has a solid financial position with $102.3 million in cash and cash equivalents, supporting its operations into mid-2026 without relying on future milestone payments or collaborations. Mersana Therapeutics Inc (NASDAQ:MRSN) has reduced its workforce by about 55% and eliminated internal pipeline development efforts, which may impact future innovation and development capabilities. The company's collaboration revenue decreased significantly from $9.2 million in Q1 2024 to $2.8 million in Q1 2025, reflecting reduced revenue from partnerships with J&J and Merck KGaA. Despite restructuring efforts, Mersana reported a net loss of $24.1 million for Q1 2025, an increase from the $19.3 million net loss in the same period of 2024. The focus on breast cancer in clinical development may limit the exploration of Emi-Le's potential in other tumor types, as expansion efforts in ovarian and endometrial cancers have been deprioritized. The company faces challenges in managing proteinuria, a side effect of Emi-Le, which requires careful mitigation strategies to avoid treatment delays and maintain efficacy. Q: Can you expand on the high dose, especially regarding safety and the updated protocol? Will this be included in the ASCO update? A: Brian Deschuytner, CFO and COO, explained that the data shared at ASCO will be based on escalation and backfill only, not expansion. The 44.5 mg/m dose is distinct and higher than the 67.4 mg/m dose, ensuring meaningful exposure. The 44.5 mg/m dose showed effectiveness in tumor reduction, but proteinuria management is crucial to maintain treatment without interruptions. Q: How might the ASCENT 3 and ASCENT 4 studies impact your clinical development plans in the post topo setting? A: Brian Deschuytner noted that the earlier use of topo-1 ADCs could expand the post topo-1 patient pool, where Mersana's Emi-Le has shown activity. This development is positive for patients and the opportunity size Mersana is pursuing. Q: Could you comment on the types of patients who showed responses at the intermediate dose? Also, how effective have the proteinuria management strategies been? A: Martin Huber, CEO, stated that the two additional responses were in ACC 1 patients. The proteinuria management strategies are not expected to eliminate proteinuria but aim to manage its consequences. The company is confident in these efforts and will share more details in the second half of the year. Q: Are there additional dosing regimens being evaluated beyond the current ones in expansion? What can we expect from the upcoming ASCO presentation? A: Brian Deschuytner confirmed that the current two doses are the focus for expansion, with no plans for additional regimens. The ASCO presentation will focus on backfill and escalation data, not expansion data. Q: Could you provide more color on a potential pivotal study and the cutoff for B7-H4 expression? A: Martin Huber discussed the benefits of a randomized trial over a single-arm trial, including global filing opportunities and avoiding confirmatory trials. The B7-H4 expression cutoff is being refined in expansion, but 40-50% of patients are expected to be positive. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
