BA3182 / BioAtla - LARVOL DELTA

Dose-escalation for dual conditionally binding BA3182 (CAB-EpCAM x CAB-CD3-TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma (GlobeNewswire) - "The trial is currently ongoing and evaluating various dosing and treatment schedules with a readout expected in the first half of 2026. Additional readouts from the expansion portion of the study are expected later in 2026."

P1 data • Trial status • Solid Tumor

Results from a phase I dose escalation study of BA3182, a dual-conditionally active biologic (CAB) EpCAM x CD3 bispecific T cell engager in patients with treatment refractory metastatic adenocarcinoma (ESMO 2025) - P1 | "Conclusions BA3182, a CAB-EpCAM x CAB-CD3 T-cell engager that selectively binds to both EpCAM and CD3 in the acidic TME, is associated with preliminary evidence of anti-tumor activity with acceptable tolerability in humans. Dose escalation continues."

Clinical • Metastases • P1 data • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EPCAM

BioAtla Presents Promising Interim Data from its Phase 1 Trial with BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025 (GlobeNewswire) - "For those treated with BA3182 at doses of 0.6 mg and higher (N=24)​: 14 CRC patients: among 7 patients who had one scan, 5 achieved stable disease (SD) at 1st scan; 6 pancreatic cancer patients: 2 had SD at 1st scan, and 2 continued treatment beyond potential pseudo-progression; 2 cholangiocarcinoma patients: 1 achieved a cPR and 1 is pending first scan; 1 Adenoid Cystic Carcinoma (ACC) patient experienced SD; 1 patient with appendiceal cancer withdrew consent before 1st scan."

P1 data • Adenoid Cystic Carcinoma • Appendix Cancer • Cholangiocarcinoma • Colorectal Cancer • Pancreatic Cancer

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma. (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: BioAtla, Inc. | Trial completion date: Dec 2025 ➔ Sep 2028 | Trial primary completion date: Jun 2025 ➔ Sep 2028

Trial completion date • Trial primary completion date • Oncology

BioAtla Reports Second Quarter 2025 Financial Results and Highlights Recent Progress (BioAtla Press Release) - "Phase 1/2 dose-escalation for conditionally binding BA3182 (CAB-EpCAM x CAB-CD3 TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma: Phase 1 dose-escalation ongoing and on track for data readout 2H 2025....Cohort expansion data readout anticipated 1H 2026. ozuriftamab vedotin (Oz-V): Planned meeting with the FDA for guidance on proposed Phase 3 study in treatment-refractory, metastatic HPV+ OPSCC in 3Q 2025."

P1 data • Oncology

BioAtla Reports Second Quarter 2025 Financial Results and Highlights Recent Progress (BioAtla Press Release) - "Upcoming Presentations: Abstract accepted for presentation titled 'Results from a Phase 1 Dose Escalation Study of BA3182, a Dual-Conditionally Active Biologic (CAB) EpCAM x CD3 Bispecific T-cell Engager in Patients with Treatment Refractory Metastatic Adenocarcinoma' at the upcoming 2025 European Society for Medical Oncology (ESMO) Annual Meeting to be held in Berlin, Germany from October 17‒21, 2025."

P1 data • Oncology

BioAtla Announces Upcoming Oral Presentation at the 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting (GlobeNewswire) - "BioAtla...announced an oral presentation at the upcoming 2025 European Society for Medical Oncology (ESMO) TAT Asia Meeting....Oral Presentation Details: (i) Title: First-in-human phase I study of a dual-Conditionally Active Biologic (CAB) EpCAM x CD3 bispecific T-cell engager (TCE), BA3182, in patients with treatment refractory metastatic adenocarcinoma...; (ii) Presentation Number: 36O; (iii) Date and Time: July 18, 2025..."

P1 data • Solid Tumor

Preliminary results from a first-in-human phase I study of a dual-conditionally binding EpCAM x CD3 bispecific T-cell engager, BA3182, in pts with treatment refractory metastatic adenocarcinoma (ESMO-GI 2025) - P1 | "BA3182, an EpCAM x CD3 dual-conditionally binding T-cell engager that selectively binds at the acidic tumor cell membrane was associated with preliminary evidence of anti-tumor activity with acceptable tolerability. Dose escalation is currently ongoing at the 300 μg dose level."

Clinical • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • EPCAM

BioAtla Presents Data from Ongoing Dose Escalation of BA3182, Dual-Conditionally Binding EpCAM x CD3 Bispecific T-cell Engager, in Patients with Treatment Refractory Metastatic Adenocarcinoma at the 2025 European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress (GlobeNewswire) - P1 | N=168 | NCT05808634 | Sponsor: BioAtla, Inc. | "Patients (n=39) were heavily pretreated having received a median of 3 prior lines of therapy. Tumor types included a variety of adenocarcinomas including adenoid cystic carcinoma, breast, cholangiocarcinoma, colorectal, esophagus, gallbladder, lung, ovarian, and pancreas. Patients with colorectal carcinoma constituted 56% of enrolled patients....Compared with IV dosing, plasma BA3182 levels associated with SC dosing showed an improved profile (delayed and lower maximum concentration) with similar trough concentrations....Five patients achieved objective tumor size reductions: colorectal carcinoma (-8% and -10%), breast adenocarcinoma (-11%), cholangiocarcinoma (-13%), and non-small cell lung cancer (-25%). Prolonged progression-free intervals observed in 2 colorectal carcinoma pts: 11 months and 14 months. Dose escalation actively continues at 1.2 mg flat dosing; updated Phase 1 data are anticipated 2H2025."

P1 data • Adenoid Cystic Carcinoma • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gallbladder Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Pancreatic Cancer

Key Developments, Operational Updates and Upcoming Milestones (GlobeNewswire) - "Phase 1/2 dose-escalation for conditionally-binding BA3182 (CAB-EpCAM x CAB-CD3 TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma...Phase 1 dose escalation ongoing and on track for data readout mid-2025; Dosed first three patients at the 300 microgram treatment dose; Cohort expansion data readout anticipated 1H 2026"

P1 data • Trial status • Solid Tumor

Phase 1/2 dose-escalation for conditionally-binding BA3182 (CAB-EpCAM x CAB-CD3 TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma (GlobeNewswire) - P1 | N=168 | NCT05808634 | Sponsor: BioAtla, Inc. | "Phase 1 dose escalation ongoing and on track with data readout mid-2025, given encouraging continued ongoing dose escalation with increasing antitumor activity. Observed multiple patients with tumor reduction, including a colorectal cancer patient with stable disease for greater than one year. Maximally tolerated dose has not yet been reached. Currently dosing QW cohorts with priming dose and a 100 microgram ongoing treatment dose. Two of three patients have cleared this dose level and we anticipate dosing the 300 microgram cohort once the final patient clears the dose-limiting toxicity (DLT) period on April 8th....Cohort expansion data readout anticipated 1H 2026."

P1 data • Trial status • Solid Tumor

BioAtla, Inc. Announces Registered Direct Offering to Advance Two Mid-Stage Clinical Programs to Key Inflection Points (GlobeNewswire) - "The gross proceeds to the Company from the offering are expected to be approximately $9.2 million, before deducting expenses related to the offering payable by the Company. The Company intends to use the net proceeds to be received by it in the offering, along with its existing cash and cash equivalents, to fund its research and development efforts, including to reach several key inflection points for its mid-stage clinical T-Cell Engager (TCE) and Antibody Drug Conjugate (ADC) programs: BA3182 (CAB-EpCAM x CAB-CD3 TCE) Phase 1 dose escalation data (expected readout 2Q25) and Phase 2 expansion data (expected readout 1H26); and mecbotamab vedotin (CAB-AXL-ADC) Phase 2B data in mutated KRAS (mKRAS) non-small cell lung cancer (NSCLC) (expected readout 1H26), to support its partnering activities, and for working capital and other general corporate purposes."

Clinical data • Financing • Non Small Cell Lung Cancer • Solid Tumor

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma. (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: BioAtla, Inc. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2025 ➔ Jun 2025

Enrollment open • Metastases • Trial primary completion date • Oncology

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE (BA3182, NCT05808634): On track for full dataset readout of Phase 1 study in 2H 2024; Potential initiation of Phase 2 study in 2H 2024."

P1 data • Trial status • Oncology • Solid Tumor

BioAtla Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE (BA3182, NCT05808634): (i) Anticipate completion of Phase 1 with data readout in 2H 2024; (ii) Potential initiation of Phase 2 study in 2H 2024."

New P2 trial • P1 data • Trial status • Solid Tumor

BioAtla Reports Third Quarter 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 2 Trials of Ozuriftamab Vedotin, BA3021: All dosing to be completed before year-end 2023...Squamous Cell Carcinoma of Head and Neck (SCCHN): On track to complete all dosing regimens enrollment by year-end 2023....Phase 1/2 dose-escalation trial of CAB-CTLA-4, BA3071 basket trial: Phase 1 data readout and path forward at upcoming R&D Day on December 13....Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE, BA3182: Progressing Phase 1 study for the treatment of advanced adenocarcinoma; Anticipated completion of Phase 1 and data readout remains on track in 2024."

P1 data • Trial completion date • Trial status • Cervical Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

BioAtla Reports Second Quarter 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Key Developments, Operational Updates and Upcoming Milestones:...Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE (BA3182): (i) Enrolling Phase 1 study for the treatment of advanced adenocarcinoma; (ii) Anticipated completion of Phase 1 data readout remains on track in 2024."

Enrollment status • P1 data • Oncology • Solid Tumor

Phase 1 Study Evaluating BA3182 in Patients With Advanced Adenocarcinoma. (clinicaltrials.gov) - P1 | N=168 | Not yet recruiting | Sponsor: BioAtla, Inc.

Metastases • New P1 trial • Oncology

BioAtla Announces FDA Clearance of Investigational New Drug Application for BA3182, a CAB-EpCAMxCAB-CD3 Bispecific T-Cell Engager for the Treatment of Advanced Adenocarcinoma (GlobeNewswire) - "BioAtla, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate BA3182 (CAB-EpCAMxCAB-CD3 bispecific T-cell engager) for the treatment of advanced adenocarcinoma. BioAtla plans to initiate and advance a Phase 1 dose-escalation and expansion clinical study in 2023."

IND • New P1 trial • Oncology

BioAtla Provides Clinical Program Updates and Upcoming 2023 Milestones (GlobeNewswire) - "Phase 1/2 Dose-Escalation Trial of CAB-CTLA-4 (BA3071) Across Multiple Solid Tumor Types responsive to CTLA-4. Trial ongoing with two of three cohorts completed without any DLTs or SAEs reported...1H23: Phase 2 study of mecbotamab vedotin (BA3011, NCT03425279) in patients with AXL-positive NSCLC. Initiating preparations for discussions with the FDA regarding the potentially registrational part 2 of the study in AXL-positive NSCLC patients. Submission of Phase 2 part 1 interim data for presentation at ASCO. First patient dosed in Phase 2 part 2 study in AXL-positive UPS patients. Interim data in the Phase 2 part 1 ROR-2 positive NSCLC study CAB-EpCAM x CAB-CD3 TCE (BA3182) Phase 1 study initiation. 2H23: Phase 2 part 2 of the BA3011 study in NSCLC patients anticipated initiation. Interim data in the Phase 2 part 1 ROR-2 positive melanoma study. Interim data in the Phase 2 part 1 ROR-2 positive SCCHN study Phase 1 data and Phase 2 initiation in CAB-CTLA-4 (BA3071) study."

New P1 trial • P1 data • P2 data • Trial status • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Undifferentiated Pleomorphic Sarcoma

BioAtla Reports Third Quarter 2022 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 1/2 Dose-Escalation Trial of CAB-CTLA-4 (BA3071) Across Multiple Solid Tumor Types responsive to CTLA-4: Trial ongoing with first two cohorts completed without any DLTs or SAEs reported; third cohort (70mg) is on-going with DLT observation period anticipated to conclude by year end....On track for IND submission for CAB EpCAM x CAB-CD3 TCE (BA3182) by year end."

Enrollment status • IND • Oncology • Solid Tumor

BioAtla Reports Second Quarter 2022 Financial Results And Highlights Recent Progress (GlobeNewswire) - "Key Developments, Operational Updates and Upcoming Milestones: On track for IND filing for CAB EpCAM x CAB-CD3 bispecific antibody (BA3182) in 4Q22."

IND • Oncology