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BioAtla's Mecbotamab Vedotin (Mec-V), an AXL-targeting ADC, Demonstrates a Median Overall Survival (OS) of 21.5 months in Subtypes of Refractory Soft Tissue Sarcomas
Globenewswire· 2025-11-07 14:00
Core Insights - BioAtla, Inc. presented clinical data showing that Mecbotamab Vedotin (Mec-V) achieved a median overall survival (OS) of 21.5 months in patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma, compared to approximately 12 months with approved agents [1][4][7] - The safety profile of Mec-V, both as a monotherapy and in combination with anti-PD-1 antibody, was manageable and consistent with its mechanism of selectively targeting the tumor microenvironment [1][2][4] Clinical Trial Details - In a Phase 2 clinical trial, 79 patients with advanced soft tissue sarcomas were treated with Mec-V, either as monotherapy (n=54) or in combination with anti-PD-1 antibody (n=25) [3] - A focused efficacy analysis was conducted on a subset of 44 patients who had treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma [3] Efficacy and Safety Data - The median OS was 21.5 months across all patients, with 22.9 months in the combination arm and 18.4 months in the monotherapy arm [7] - The 12-month OS rate was 73%, significantly higher than the approximately 50% historically reported for approved agents in similar populations [7] - The disease control rate (DCR) was 52% across all patients, with two patients achieving partial responses [7] - Adverse events were generally low-grade and manageable, with no treatment-related deaths reported [7] Presentation Information - The data was presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting the potential of Mec-V to extend survival in patients with limited treatment options [1][6]
BioAtla’s Mecbotamab Vedotin (Mec-V), an AXL-targeting ADC, Demonstrates a Median Overall Survival (OS) of 21.5 months in Subtypes of Refractory Soft Tissue Sarcomas
Globenewswire· 2025-11-07 14:00
Core Insights - BioAtla, Inc. presented clinical data showing that Mecbotamab Vedotin (Mec-V) achieved a median overall survival (OS) of 21.5 months in patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma, significantly higher than the approximately 12 months observed with approved agents [1][4][7] - The safety profile of Mec-V, both as a monotherapy and in combination with anti-PD-1 antibody, was manageable and consistent with its mechanism of selectively targeting the tumor microenvironment [1][2][4] Clinical Trial Details - In a Phase 2 clinical trial, 79 patients with advanced soft tissue sarcomas were treated with Mec-V, either as monotherapy (n=54) or in combination with anti-PD-1 antibody (n=25) [3] - A focused efficacy analysis was conducted on a subset of 44 patients who had treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma [3] Efficacy and Safety Data - The median OS was 21.5 months across all patients, with 22.9 months in the combination therapy arm and 18.4 months in the monotherapy arm [7] - The 12-month OS rate was 73%, compared to approximately 50% historically reported for similar populations treated with approved agents [7] - The disease control rate (DCR) was 52% across all patients, with two patients achieving partial responses [7] - Adverse events were generally low-grade and manageable, with no treatment-related deaths reported [7] Presentation Information - The data was presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, highlighting the potential of Mec-V to extend survival in patients with limited treatment options [1][6]
BioAtla Presents Compelling Mechanistic Rationale for Targeting ROR2 with Ozuriftamab Vedotin (Oz-V) in Oropharyngeal Squamous Cell Carcinoma (OPSCC) at the Annual Conference of the International Papillomavirus Society
Globenewswire· 2025-10-23 12:00
Core Insights - BioAtla, Inc. is presenting clinical data on its investigational antibody-drug conjugate, ozuriftamab vedotin (Oz-V), at the International Papillomavirus Society Conference, focusing on its application in treating advanced HPV+ oropharyngeal squamous cell carcinoma (OPSCC) [1][2] Company Overview - BioAtla is a global clinical-stage biotechnology company based in San Diego, California, and Beijing, China, specializing in the development of Conditionally Active Biologic (CAB) antibody therapeutics [6] - The company utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting and greater efficacy with lower toxicity [6] Product Details - Ozuriftamab vedotin (Oz-V) targets ROR2, a receptor tyrosine kinase overexpressed in various solid tumors, including OPSCC, driven by HPV infection [4] - In a Phase 2 trial, Oz-V demonstrated an overall response rate (ORR) of 45% and a disease control rate (DCR) of 100% in refractory patients, with a median overall survival (OS) of 11.6 months [4] - The FDA has granted Fast Track Designation to Oz-V for treating recurrent or metastatic squamous cell carcinoma of the head and neck [4] Market Opportunity - The global market opportunity for second-line and beyond OPSCC is over $1 billion, while for first-line HPV+ tumors, it is potentially over $7 billion [5] - OPSCC is rapidly increasing, with HPV infections accounting for approximately 80% of cases in the United States [5]
BioAtla Presents Promising Interim Data from its Phase 1 Trial with BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025
Globenewswire· 2025-10-20 12:00
Core Insights - BioAtla, Inc. announced preliminary clinical data from a Phase 1 study of BA3182, a bispecific T-cell engager targeting EpCAM and CD3, at the ESMO Congress 2025, highlighting its potential for treating treatment-refractory metastatic adenocarcinoma [1][3] Group 1: Clinical Data and Efficacy - BA3182 shows a manageable safety profile with preliminary evidence of antitumor activity [4] - Prolonged tumor control observed with increasing doses of BA3182, including a confirmed partial response at 0.6 mg in a patient with intrahepatic cholangiocarcinoma without progression for over 6 months [6] - Among patients treated at doses of 0.6 mg and higher, there was a higher rate of stable disease and prolonged treatment intervals compared to those receiving lower doses [13] Group 2: Safety Profile - Adverse events were generally transient and manageable, with only 2 cases of cytokine release syndrome reported [6] - No treatment-related deaths occurred, and only one patient discontinued treatment due to an adverse event [6] - Safety profile supports continued dose escalation, with the maximally tolerated dose not yet defined [6] Group 3: Technology and Mechanism - BA3182 is designed to selectively bind within the acidic tumor microenvironment, reducing on-target, off-tumor toxicity associated with traditional antibodies [2][9] - The CAB technology utilized by BioAtla activates only in diseased microenvironments, aiming for more selective targeting and lower toxicity compared to conventional therapies [10] Group 4: Market Potential - BA3182 has the potential to serve over one million patients globally, indicating a significant market opportunity for BioAtla [3]
BioAtla to Announce Second Quarter 2025 Financial Results and Provide Business Highlights on August 7, 2025
GlobeNewswire News Room· 2025-08-04 12:00
Core Viewpoint - BioAtla, Inc. is set to discuss its financial results for Q2 2025 and provide business highlights during a conference call on August 7, 2025 [1][2] Company Overview - BioAtla is a global clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] - The company operates in San Diego, California, and Beijing, China, through a partnership with BioDuro-Sundia for preclinical development services [3] - BioAtla utilizes its proprietary CAB platform technology to create novel monoclonal and bispecific antibodies, aiming for selective targeting, greater efficacy, lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3] - The company holds extensive patent coverage with over 780 active patent matters, including more than 500 issued patents, covering methods of making, screening, and manufacturing CAB product candidates [3] Product Development - BioAtla's first dual CAB bispecific T-cell engager antibody, BA3182, is in Phase 1 development, targeting EpCAM, which is commonly expressed in adenocarcinomas [3] - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin (CAB-AXL-ADC) and ozuriftamab vedotin (CAB-ROR2-ADC) [3] - The Phase 2 CAB-CTLA-4 antibody, evalstotug, is designed to reduce systemic toxicity and enable safer combination therapies with checkpoint inhibitors like anti-PD-1 antibody [3]
BioAtla Announces Poster Presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting
Globenewswire· 2025-04-24 12:00
Core Insights - BioAtla, Inc. is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) antibody therapeutics for solid tumors [1][3] Presentation Details - BioAtla will present two preclinical posters at the 2025 American Association for Cancer Research (AACR) conference in Chicago from April 25–30, 2025 [1][2] - The first poster discusses novel senolytic targets and CAB-based drug conjugates for eliminating senescence-associated secretory phenotype cells [2] - The second poster highlights BA3361, a tumor-selective CAB anti-Nectin4 antibody-drug conjugate that enhances therapeutic efficacy in pancreatic cancer [2] Company Overview - BioAtla operates in San Diego, California, and Beijing, China, utilizing its proprietary CAB platform technology to develop monoclonal and bispecific antibodies [3] - The CAB technology aims for selective targeting, greater efficacy with lower toxicity, and cost-efficient manufacturing compared to traditional antibodies [3] - The company holds over 780 active patent matters, with more than 500 issued patents covering its CAB technology and products [3][4] Technology Highlights - The CAB anti-Nectin4-ADC shows differentiated preclinical activity with superior efficacy compared to enfortumab vedotin in various cancer models [4] - CAB technology offers a new generation of biologics with an increased safety margin and therapeutic index, targeting senescence-related cells in cancer and age-related diseases [4]