BioAtla(BCAB)

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BioAtla Highlighted Clinical Program and Pipeline Updates at Virtual R&D Day
Newsfilter· 2024-07-25 21:39
Clinical benefit observed among non-small cell lung cancer (NSCLC) patients harboring mutant KRAS (mKRAS) variants in the Phase 2 mecbotamab vedotin (CAB-AXL-ADC) study; AXL tumoral expression highly associated with multiple mKRAS variants Evalstotug (CAB-CTLA-4 antibody) as a monotherapy and in combination with PD-1 continues to provide promising anti-tumor activity with a differentiated safety profile associated with a low incidence of immune-related adverse events SAN DIEGO, July 25, 2024 (GLOBE NEWSWIRE ...
BioAtla Highlighted Clinical Program and Pipeline Updates at Virtual R&D Day
GlobeNewswire News Room· 2024-07-25 21:39
Core Insights - BioAtla, Inc. presented promising clinical data for its antibody drug conjugate mecbotamab vedotin and anti-CTLA-4 antibody evalstotug during a virtual R&D Day, highlighting their potential in treating solid tumors, particularly in patients with KRAS mutations [1][2][3] Group 1: Mecbotamab Vedotin - Mecbotamab vedotin (CAB-AXL-ADC) shows clinical benefit in non-small cell lung cancer (NSCLC) patients with mutant KRAS variants, with confirmed responses observed in heavily pretreated patients [2][3] - AXL expression of ≥1% is correlated with clinical benefit in patients who have undergone a median of three prior lines of therapy [3] - Initial clinical benefits were noted across various KRAS mutation variants, including G12A, G12C, and G12V, supporting a trend towards improved overall survival compared to KRAS wildtype [3] Group 2: Evalstotug - Evalstotug (CAB-CTLA-4 antibody) demonstrates promising anti-tumor activity as a monotherapy and in combination with PD-1, with a low incidence of immune-related adverse events [1][2] - In a Phase 1/2 trial, 3 out of 8 patients at the 350mg dose level showed confirmed responses, with patients receiving a mean of 7.2 doses compared to lower averages for other CTLA-4 inhibitors [3][4] - Only 2 out of 21 patients experienced grade 3 immune-related adverse events, indicating a manageable safety profile [3][4] Group 3: Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing conditionally active biologic (CAB) therapeutics for solid tumors, with operations in San Diego and Beijing [9][10] - The company has two first-in-class CAB programs in Phase 2 clinical testing: mecbotamab vedotin and ozuriftamab vedotin, along with a CAB-CTLA-4 antibody designed to reduce systemic toxicity [10]
BioAtla Granted FDA Fast Track Designation for Ozuriftamab Vedotin (CAB-ROR2-ADC) for Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Newsfilter· 2024-07-23 12:00
Core Insights - BioAtla, Inc. has received Fast Track Designation from the FDA for ozuriftamab vedotin, an antibody drug conjugate targeting ROR2, aimed at treating recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) [1][2] - The company is preparing to meet with the FDA in the second half of 2024 to discuss plans for a potential registrational trial [1][2] Group 1: Clinical Development - Ozuriftamab vedotin has demonstrated promising clinical activity in treatment-refractory SCCHN patients, with a median of 3 prior lines of therapy [2] - The drug maintains a manageable safety profile with no new safety signals reported [2] - The Fast Track Designation allows for expedited development and review processes, including potential priority review during the Biologics License Application (BLA) submission [2] Group 2: Product and Technology Overview - Ozuriftamab vedotin is a conditionally and reversibly active antibody drug conjugate that targets ROR2, a receptor associated with poor prognosis in various solid tumors [3] - The drug is part of a broader pipeline targeting multiple solid tumor indications, including SCCHN patients who have progressed on PD-1/L1 therapies [3] - BioAtla utilizes its proprietary Conditionally Active Biologics (CAB) technology to develop therapeutics that aim for selective targeting and greater efficacy with lower toxicity [4] Group 3: Company Background - BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and Beijing, China [4] - The company has over 750 active patent matters, with more than 500 issued patents covering its CAB technology and products [4] - BioAtla is currently advancing two first-in-class CAB programs in Phase 2 clinical testing, including mecbotamab vedotin and ozuriftamab vedotin [4]
BioAtla to Participate in the Jefferies Global Healthcare Conference
globenewswire.com· 2024-05-29 12:00
SAN DIEGO, May 29, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that the Company’s management will participate in a fireside chat and one-on-one investor meetings at the Jefferies Global Healthcare Conference, to be held in New York, NY June 4–6, 2024. Format: Fireside chat and scheduled one-on-one investor meetings ...
BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
globenewswire.com· 2024-05-23 21:05
Core Insights - BioAtla, Inc. announced promising data for evalstotug, a novel anti-CTLA-4 antibody, showing prolonged progression-free survival (PFS) of over 10 months in refractory patients [2][3] - The company is on track to complete Phase 1 dose-escalation studies and anticipates initiating a Phase 3 trial for evalstotug in the second half of 2024 [1][2] Group 1: Clinical Data and Efficacy - Evalstotug demonstrated confirmed responses in patients, with a disease control rate of 52% and three patients remaining without progression for over 1 year [4] - In a Phase 1 study, patients treated with 350 mg of evalstotug received a mean of 7.2 doses, indicating good tolerability and no dose reductions [3] - The drug was well-tolerated, with only four patients experiencing Grade 3 treatment-emergent adverse events (TEAEs) and no Grade 4 or 5 TEAEs observed [3] Group 2: Development Plans - The company is currently enrolling patients in Phase 2 studies for first-line melanoma and mutated non-small cell lung cancer (NSCLC) combination cohorts, with plans to transition to a 1 gram flat dose in June [2][3] - A Phase 3 trial for evalstotug in first-line metastatic, unresectable BRAF-mutated melanoma is expected to start in the second half of 2024 following a planned FDA meeting [1][2] Group 3: Company Overview - BioAtla is a clinical-stage biotechnology company focused on developing Conditionally Active Biologic (CAB) therapeutics for solid tumors, with a proprietary technology aimed at reducing systemic toxicity while enhancing efficacy [5][6] - The company has extensive patent coverage for its CAB technology, with over 765 active patent matters, indicating a strong intellectual property position [6]
BioAtla(BCAB) - 2024 Q1 - Earnings Call Transcript
2024-05-15 00:35
BioAtla, Inc. (NASDAQ:BCAB) Q1 2024 Earnings Conference Call May 14, 2024 4:30 PM ET Company Participants Bruce Mackle – LifeSci Advisors Jay Short – Chairman, Chief Executive Officer and Co-Founder Eric Sievers – Chief Medical Officer Sheri Lydick – Chief Commercial Officer Richard Waldron – Chief Financial Officer Conference Call Participants Brian Cheng – JPMorgan Dev Prasad – Jefferies Kaveri Pohlman – BTIG Arthur He – H.C. Wainwright Tony Butler – EF Hutton Operator Greetings and welcome to the BioAtla ...
BioAtla(BCAB) - 2024 Q1 - Quarterly Report
2024-05-14 21:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Common Stock, $0.0001 par value per share BCAB The Nasdaq Global Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39787 | --- | --- | --- | --- | --- | --- | --- | --- | - ...
BioAtla(BCAB) - 2024 Q1 - Quarterly Results
2024-05-14 20:05
BIOATLA REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS – Ozuriftamab vedotin (CAB-ROR2-ADC) Phase 2 data in squamous cell carcinoma of the head and neck (SCCHN) showed multiple confirmed responses and manageable safety profile; anticipate FDA meeting for SCCHN potential registrational trial in 2H 2024 – Evalstotug (CTLA-4 antibody) Phase 1 study progressing well, anticipate clearing doselimiting toxicity (DLT) observation period with 1 gram (14.2 mg/kg) in 2Q 2024 and initial Ph ...
BioAtla Announces Upcoming Poster Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
Newsfilter· 2024-04-24 20:35
SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- BioAtla, Inc. (NASDAQ:BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024. Presentation Details: Title: Pha ...
BioAtla(BCAB) - 2023 Q4 - Earnings Call Transcript
2024-03-26 23:21
BioAtla, Inc. (NASDAQ:BCAB) Q4 2023 Earnings Conference Call March 26, 2024 4:30 PM ET Company Participants Bruce Mackle - Investor Relations, LifeSci Advisors Jay Short - Chairman, Chief Executive Officer and Co-Founder Richard Waldron - Chief Financial Officer Sheri Lydick - Chief Commercial Officer Eric Sievers - Chief Medical Officer Conference Call Participants Dev Prasad - Jefferies Kaveri Pohlman - BTIG Arthur He - H.C. Wainwright Reni Benjamin - Citizens JMP Securities Operator Greetings and welcome ...