evalstotug (BA3071) / BioAtla, BeiGene - LARVOL DELTA

Updated results from a phase 1 study of evalstotug (BA3071), an anti–CTLA-4 conditionally active biologic, with or without nivolumab, in advanced solid tumors (SITC 2024) - "Full Regular Abstract, Young Investigator Award (YIA), Immune Engineering Abstracts, and Late-breaking Abstract - Clinical Only (LBA) content will be embargoed until Nov. 5, 2024 at 8 a.m. CT / 9 a.m. ET"

Metastases • P1 data • Oncology • Solid Tumor

BioAtla Announces Upcoming Poster Presentation at the 39th Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "BioAtla...announced a poster presentation at the upcoming 39th Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held from November 8–10, 2024 at the George R. Brown Convention Center in Houston, TX."

P1 data • Solid Tumor

BA3021-002: A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - P2 | N=290 | Recruiting | Sponsor: BioAtla, Inc. | N=80 ➔ 290 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

BioAtla Announces Upcoming Oral Presentation at the Society for Melanoma Research 21st International Congress (GlobeNewswire) - "BioAtla, Inc...announced acceptance of an abstract for oral presentation at the upcoming Society for Melanoma Research 21st International Congress (SMR), being held from October 10–13, 2024, in New Orleans, LA."

Clinical data • Melanoma

Evalstotug (BA3071): a potent conditionally active biologic (CAB) anti-CTLA-4 antibody designed to enable high exposures, extended dosing, and reduced immune-mediated toxicity (SMR 2024) - No abstract available

Oncology

A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody (Currently Enrolling Patients With Nonsquamous or Recurrent NSCLC (Type IIB, IIIA, IV) (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: BioAtla, Inc. | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioAtla Highlighted Clinical Program and Pipeline Updates at Virtual R&D Day (GlobeNewswire) - P1/2 | N=320 | NCT05180799 | Sponsor: BioAtla, Inc. | "Phase 1 dose-escalation study evaluated evalstotug monotherapy followed by combination with nivolumab...3 out of 8 confirmed responses at the 350mg dose level...Only 2 out of 21 patients experienced grade 3 immune-related adverse events; no related grade 4 or 5 events. Initial Phase 2 monotherapy data readout with two scans in treatment-refractory solid tumors at 350mg (n=17) or 700mg (n=2)...to evaluate safety and immune-related adverse events; Low incidence (2/19) and severity of immune-related AEs observed, which is consistent with low incidence of immune-related adverse events in Phase 1; No grade 3/4 colitis, no grade 4/5 related treatment-emergent adverse events (TEAEs); Across 14 different tumor types enrolled to characterize safety, observed 10 patients with stable disease."

P1/2 data • Oncology • Solid Tumor

Phase 1 study of BA3071, an anti–CTLA-4 conditionally active biologic, in combination with nivolumab in advanced solid tumors. (ASCO 2024) - P1/2 | "Treatment with the novel, conditionally active anti–CTLA-4 agent BA3071, in combination with anti–PD-1 therapy (at doses higher than those currently approved for anti–CTLA-4/PD-1 therapy), yielded confirmed responses with a promising tolerability profile. Phase 1 dose escalation of BA3071 continues at 700 mg up to 1000 mg, and phase 2 monotherapy and combination therapy expansion cohorts are currently enrolling at a starting dose level of 350 mg. 1."

Combination therapy • Metastases • P1 data • Atrial Fibrillation • Cardiovascular • Cervical Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Hypertension • Lung Cancer • Metabolic Disorders • Oncology • Small Cell Lung Cancer • Solid Tumor • CD80 • CD86

BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - P1/2 | N=320 | NCT05180799 | Sponsor: BioAtla, Inc | "Three patients have tolerated their first 1-gram evalstotug infusion; clearing the DLT observation period is anticipated by early June; Evalstotug was generally well-tolerated with relatively low incidence and severity of immune-mediated AEs...Four patients experienced Grade 3 related treatment-emergent AEs...No Grade 4 or 5 related TEAEs were observed; Evalstotug demonstrated clinical benefit in heavily pre-treated patients (data cut as of April 30, 2024)...We continue to enroll in the Phase 2 first-line melanoma and mutated NSCLC combination cohorts at the 700 mg flat dose and we anticipate moving to the 1 gram flat dose in June following clearance of the DLT observation period and remain on track for monotherapy and combination data readouts later this year. We anticipate enabling a Phase 3 trial of evalstotug in first-line metastatic or unresectable BRAF-mutated melanoma in the second half of this year."

New P3 trial • P1 data • Trial status • Melanoma • Non Small Cell Lung Cancer

BioAtla Reports First Quarter 2024 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 1/2 dose-escalation trial of evalstotug: Phase 1 data to be presented at upcoming ASCO Annual Meeting in June; Anticipate clearing DLT observation period at 1 gram (14.2 mg/kg for 70 kg person) in 2Q 2024; Initial Phase 2 monotherapy data readout in approximately 20 patients with two scans in treatment-refractory solid tumors at 350 mg or 700 mg (5 or 10 mg/kg for 70 kg person, respectively) on track for 2Q 2024; Currently enrolling first-line melanoma and first-line NSCLC patients at 700 mg (10 mg/kg for 70 kg person) in combination with pembrolizumab and in combination with pembrolizumab plus chemotherapy, respectively; on track for data readout in 2H 2024; Anticipate FDA meeting in 2H 2024 for potential registrational trial in first-line, metastatic or unresectable, BRAF-mutated melanoma."

FDA event • P1 data • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BioAtla Announces Upcoming Poster Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "BioAtla...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."

P1 data • Solid Tumor

BioAtla Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Progress (GlobeNewswire) - "Phase 1/2 dose-escalation trial of Evalstotug, CAB-CTLA-4 (BA3071, NCT05180799) across multiple solid tumor types responsive to CTLA-4: (i) Phase 1 study: Cleared DLT observation period at 700 mg (10 mg/kg for 70 kg person); Enrolling dose cohort of 1000 mg (14.2 mg/kg for 70 kg person); on track to clear DLT period in 2Q 2024; (ii) Initial Phase 2 data readout in approximately 20 patients with two scans in treatment-refractory solid tumors at 350 mg or 700 mg (5 or 10 mg/kg for 70 kg person) treated with monotherapy anticipated in 2Q 2024; (iii) Currently enrolling first-line melanoma and NSCLC patients at the 350 mg or 700 mg (5 or 10 mg/kg for 70 kg person); anticipated data readout of BA3071 combination with pembrolizumab in 2H 2024."

P2 data • Trial status • Melanoma • Non Small Cell Lung Cancer

BioAtla Virtual R&D Day: BA3071 CAB-CTLA-4 Phase 1 Data Review in Multiple Solid Tumor Types (LifeSci Events) - "December 13, 2023, 10:00 AM EST, Join us for a Virtual R&D Day with BioAtla, featuring Omid Hamid, MD...who will review Phase 1 dose escalation trial results for BA3071, a novel conditionally and reversibly active antibody targeting CTLA-4. BA3071 is in Phase 2 development as a potential therapeutic for multiple solid tumor indications known to be responsive to CTLA-4 treatment in combination with a PD-1 blocking agent."

Live event • P1 data

A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: BioAtla, Inc. | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Oct 2023 ➔ Dec 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Urothelial Cancer

BioAtla Hosting Virtual R&D Day to Highlight BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types (GlobeNewswire) - "Preclinical data review of targeted, pH-dependent binding of BA3071 in the tumor microenvironment demonstrated complete tumor regression following BA3071 treatment. Exposure levels of BA3071 were similar to that of ipilimumab analog, with significantly less GI toxicity when combined with nivolumab in a non-human primate model."

Preclinical • Oncology • Solid Tumor

BioAtla Hosting Virtual R&D Day to Highlight BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types (GlobeNewswire) - P1/2 | N=320 | NCT05180799 | Sponsor: BioAtla, Inc. | "Across the 6 cohorts (n = 16 evaluable patients), best overall response observed with two confirmed responses (one complete response [CR] and one partial response [PR]); nine stable disease (SD)....More specifically, in the 350 mg cohort in combination with 240 mg nivolumab (n = 5), meaningful clinical benefit was observed in three patients, including 1 CR, 1 PR, and 1 SD....No grade 4 related treatment-emergent adverse events were observed among 18 treated patients....One DLT observed out of 3 patients who received 700 mg; further evaluation of 700 mg and potentially at 1000 mg is ongoing."

P1 data • Cutaneous Melanoma • Lung Cancer • Melanoma • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Uveal Melanoma

BioAtla to Host Virtual R&D Day to Review BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types on Wednesday, December 13, 2023 (GlobeNewswire) - "BioAtla, Inc...announced it will host a virtual R&D Day on Wednesday, December 13, 2023 at 10:00 AM ET....The event will feature Omid Hamid, MD...who will review Phase 1 dose escalation trial results for BA3071, a novel conditionally and reversibly active antibody targeting CTLA-4. BA3071 is in Phase 2 development as a potential therapeutic for multiple solid tumor indications known to be responsive to CTLA-4 treatment in combination with a PD-1 blocking agent."

P1 data • Oncology • 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 Provides Guidance on Near-Term Milestones and Plans to Announce Third Quarter 2023 Financial Results and Business Update on November 7, 2023 (GlobeNewswire) - "Submitted abstract on CAB-AXL-ADC, BA3011, in non-small cell lung cancer (NSCLC) to the IASLC 2023 North America Conference on Lung Cancer; KOL event planned for December 4, 2023, following conclusion of the IASLC conference; R&D day planned for December 13, 2023, to discuss BA3071 (CAB-CTLA-4) Phase 1/2 basket trial."

Clinical data • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

A Phase 1/2 Study of BA3071 (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: BioAtla, Inc. | N=36 ➔ 320

Combination therapy • Enrollment change • Metastases • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Urothelial Cancer

A Phase 1/2 Study of BA3071 (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: BioAtla, Inc. | Trial primary completion date: Jun 2023 ➔ Oct 2023

Combination therapy • Metastases • Trial primary completion date • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Urothelial Cancer

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

A Phase 1/2 Study of BA3071 (clinicaltrials.gov) - P1/2 | N=36 | Recruiting | Sponsor: BioAtla, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2023 ➔ Jun 2024 | Initiation date: Jan 2022 ➔ Aug 2022 | Trial primary completion date: Nov 2023 ➔ Jun 2023

Combination therapy • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Cervical Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Urothelial Cancer

BioAtla to Announce First Quarter 2022 Financial Results and Provide Business Highlights on May 4, 2022 (GlobeNewswire) - "BioAtla, Inc...announced that it plans to host a conference call and webcast on Wednesday, May 4, 2022 at 4:30 p.m. Eastern Time to discuss its financial results for the quarter ended March 31, 2022, and provide an interim topline data update from the mecbotamab vedotin (BA3011) Phase 2 study in sarcoma as well as an operational update on our ongoing clinical programs, including BA3011, ozuriftamab vedotin (BA3021) and CAB-CTLA-4 (BA3071)."

Clinical • P2 data • Oncology