- CAB-CTLA-4 (BA3071) Phase 1 study cleared dose-limiting toxicity (DLT) observation period with 700 mg (10 mg/kg); initial Phase 2 monotherapy data readout anticipated in 2Q 2024 and in combination with pembrolizumab in 2H 2024
- CAB-ROR2 (BA3021) Phase 2 melanoma and squamous cell carcinoma of the head and neck (SCCHN) clinical trials fully enrolled; on track for data readouts in 2Q 2024
- CAB-AXL (BA3011) Phase 2 potentially registrational study in undifferentiated pleomorphic sarcoma (UPS) on track for enrollment completion of approximately 20 patients in April with anticipated FDA meeting for guidance on the remaining portion of the potentially registrational trial in 2H 2024
- CAB-EpCAM x CAB-CD3 (BA3182) Phase 1 dose-escalation study on track with full data readout anticipated in 2H 2024; potential initiation of Phase 2 study in 2H 2024
- Cash balance of
$111.5 million at year-end 2023 is expected to fund operations into 2H 2025 - Management to host conference call and webcast today at
4:30 PM Eastern Time
“BioAtla continued to make considerable progress in 2023 across both of our CAB-ADC clinical trials targeting multiple tumor types, as well as advancing our CAB-CTLA-4 clinical asset, BA3071, with recent clearance of the DLT observation period at the 10 mg/kg dosing cohort,” said
Key Developments, Operational Updates and Upcoming Milestones
- Phase 1/2 dose-escalation trial of Evalstotug, CAB-CTLA-4 (BA3071, NCT05180799) across multiple solid tumor types responsive to CTLA-4
- 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
- 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
- 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
- Phase 1 study
- Phase 2 Trials of Ozuriftamab Vedotin, CAB-ROR2-ADC, (BA3021) in treatment-refractory melanoma (NCT03504488) and treatment-refractory SCCHN (NCT05271604)
- Melanoma patients (n=28) dosed at the Q2W regimen; anticipate two plus scans in April
- SCCHN patients dosed at Q2W or 2Q3W regimens (n=12 and 20, respectively); anticipate two plus scans in May
- Data readouts for both indications anticipated in May
- Phase 2 Trials of Mecbotamab Vedotin, CAB-AXL-ADC, (BA3011):
UPS (NCT03425279) ongoing potentially registrational trial- On track to complete enrollment of approximately 20 patients in April
- Anticipate FDA meeting for guidance on the remaining portion of the registration trial in 2H 2024
- Bone and soft tissue sarcomas (NCT03425279)
- Data presented as oral presentation at ESMO Sarcoma and Rare Cancers on
March 14 - Promising monotherapy disease control rate among 43% of patients with treatment-refractory sarcomas (n=87)
- Osteosarcoma: two partial responses observed out of 11 efficacy-evaluable patients with observed PFS at 12 weeks of 45.5%
- Manageable safety profile with no new safety signals reported, no Grade 3 peripheral neuropathy
- Data presented as oral presentation at ESMO Sarcoma and Rare Cancers on
- NSCLC (NCT04681131)
- Enrolled 33 target-agnostic patients at the 2Q3W regimen across squamous and non-squamous patients
- Study is on track to evaluate initial clinical benefit in the target-agnostic non-squamous EGFR wild-type patient population in 2Q 2024
- Phase 1/2 dose-escalation for CAB-EpCAM x CAB-CD3 TCE (BA3182, NCT05808634)
- Anticipate completion of Phase 1 with data readout in 2H 2024
- Potential initiation of Phase 2 study in 2H 2024
- Anti-Nectin-4-ADC (BA3361)
- In vitro and in vivo characterization of a novel NextGen linker system yields differentiated anti-Nectin-4-ADC
- Data to be presented at upcoming AACR Annual Meeting in April:
- Complete tumor regression observed in several cell line derived xenograft models
- Superior efficacy to an enfortumab vedotin analogue in a patient-derived xenograft pancreatic cancer model
- Demonstrated influence of linker technology on specific cancer models and reduced toxicity through CAB selectivity
- IND submission anticipated in 2Q 2024
Presentations
- Oral presentation titled “Results from a Phase 2 part 1 trial of mecbotamab vedotin (BA3011), a CAB-AXL-ADC, in patients with advanced refractory sarcoma” at
ESMO Sarcoma and Rare Cancers Congress March 2024 - Trial in Progress poster titled “Phase 1 study of BA3182, a conditionally active bispecific anti-EpCAM x CD3 antibody, in patients with advanced adenocarcinoma” presented at SITC Spring Scientific Meeting
March 2024 - Five preclinical abstracts accepted for poster presentations at the upcoming
American Association for Cancer Research (AACR) 2024 Annual Meeting, titled:- “Using a novel NextGen linker system to generate a Conditionally Active Biologic (CAB) anti-Nectin4-ADC demonstrates improved efficacy in pancreatic PDX cancer models and improved tolerability and toxicity profile in non-human primates”
- “Novel conditionally active tetravalent B7-H3 x CD3 T-cell engager targeting solid tumors”
- “Novel Conditionally Active Biologic (CAB) tetravalent T-cell engagers targeting solid tumors”
- “Targeting novel senescence markers by Conditionally Active Biologics eliminates senescence-associated secretory phenotype in in vitro and in vivo models”
- “Development of a humanized anti-IL-22 antibody for cancer and inflammation therapy”
- Late-breaking abstract titled “Novel Conditionally Active Biologic (CAB) tetravalent T-cell engagers targeting solid tumors” accepted for presentation at the upcoming AACR Annual Meeting
April 2024 and will be published online in Proceedings of the AACR - Online article published in mABs
March 2024 (https://doi.org/10.1080/19420862.2024.2322562), titled “A novel Conditional Active Biologic anti-EpCAM x anti-CD3 bispecific antibody with synergistic tumor selectivity for cancer immunotherapy”
Fourth Quarter and Full Year 2023 Financial Results
Research and development (R&D) expenses were $22.7 million for the quarter ended December 31, 2023 compared to $21.9 million for the same quarter in 2022. The increase of
General and administrative (G&A) expenses were $5.9 million for the quarter ended December 31, 2023 compared to $6.7 million for the same quarter in 2022. The
Net loss for the quarter ended December 31, 2023 was $26.9 million compared to a net loss of $27.6 million for the same quarter in 2022.
Net cash used in operating activities for the full year ended
Cash and cash equivalents as of
Fourth Quarter and Full Year 2023 Conference Call and Webcast Details
The management of
https://viavid.webcasts.com/starthere.jsp?ei=1653291&tp_key=ca14db6fd2. The conference call can be accessed by dialing toll-free (877) 425-9470 or (201) 389-0878 (international). The passcode for the conference call is 13744024.
A replay of the webcast and slides with topline interim clinical data referenced on the call will be available through “Events & Presentations” in the Investors section of the company’s website after the conclusion of the presentation and will be archived on the
About Mecbotamab Vedotin (BA3011)
Mecbotamab vedotin, CAB-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including the treatment of soft tissue and bone sarcoma and non-small cell lung cancer (NSCLC) patients who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies. The Office of
About Ozuriftamab Vedotin (BA3021)
Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a receptor tyrosine kinase that is overexpressed across many different solid tumors including lung, head and neck and melanoma. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including the treatment of NSCLC patients who have previously progressed on PD-1/L1, EGFR or ALK inhibitor therapies, melanoma patients who have previously progressed on PD-1/L1 therapy and SCCHN patients who have previously progressed on PD-1/L1 therapies with or without platinum chemotherapy.
About Evalstotug (BA3071)
BA3071, is a CAB anti-CTLA-4 antibody that is being developed as an immuno-oncology agent with the goal of delivering efficacy at least comparable to the approved anti-CTLA-4 antibodies, but with lower toxicities due to the CAB's tumor microenvironment-restricted activity. This may enable safer anti-CTLA-4 antibody combination therapies, such as with anti-PD-1 antibody checkpoint inhibitors, and potentially broaden the patient population tolerant to combination therapy and deliver greater efficacy. Like our other CAB candidates, this Phase 2 clinical asset is designed to be conditionally and reversibly active in the tumor microenvironment. BA3071 is being developed as a potential therapeutic for multiple solid tumor indications that are known to be responsive to CTLA-4 treatment in combination with a PD-1 blocking agent.
About BA3182
About BA3361
BA3361, CAB-Nectin4-ADC, is a conditionally and reversibly active antibody drug conjugate directed against Nectin4, a cell-cell adhesion molecule overexpressed in multiple human malignancies. The Nectin4-binding domains of BA3361 have been optimized for binding under tumor microenvironment (TME) conditions and reduced binding under normal physiological conditions. BA3361 is the first molecule containing one of BioAtla’s novel NextGen ADC linkers with highly improved stability and tumor specific payload release. BA3361 showed superior activity in patient-derived pancreatic cancer xenograft models.
About
Forward-looking statements
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding our business plans and prospects and whether our clinical trials will support registration; achievement of milestones; results, conduct, progress and timing of our research and development programs and clinical trials; expectations with respect to enrollment and dosing in our clinical trials, plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; plans to form strategic partnerships for selected assets; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations; and expected R&D expenses. Forward-looking statements are based on
Internal Contact:
Chief Financial Officer
rwaldron@bioatla.com
858.356.8945
External Contact:
bmackle@lifesciadvisors.com
Unaudited Statements of Operations and Comprehensive Loss | ||||||||||||||||
(in thousands) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development expense | $ | 22,674 | $ | 21,874 | $ | 103,731 | $ | 79,347 | ||||||||
General and administrative expense | 5,862 | 6,686 | 25,956 | 28,793 | ||||||||||||
Total operating expenses | 28,536 | 28,560 | 129,687 | (108,140 | ) | |||||||||||
Loss from operations | (28,536 | ) | (28,560 | ) | (129,687 | ) | (108,140 | ) | ||||||||
Other income: | ||||||||||||||||
Interest income | 1,638 | 1,047 | 6,312 | 1,648 | ||||||||||||
Other income (expense) | (27 | ) | (30 | ) | (87 | ) | 10 | |||||||||
Total other income | 1,611 | 1,017 | 6,225 | 1,658 | ||||||||||||
Net loss and comprehensive loss | $ | (26,925 | ) | $ | (27,543 | ) | $ | (123,462 | ) | $ | (106,482 | ) |
Balance Sheet Data | ||||||||
(in thousands) | ||||||||
2023 | 2022 | |||||||
(Unaudited) | ||||||||
Cash and cash equivalents | $ | 111,471 | $ | 215,507 | ||||
Total assets | 119,658 | 225,736 | ||||||
Total current liabilities | 28,344 | 23,131 | ||||||
Total liabilities | 48,986 | 45,397 | ||||||
Total stockholders’ equity | 70,672 | 180,339 | ||||||
Total liabilities and stockholders’ equity | 119,658 | 225,736 |
Source:
2024 GlobeNewswire, Inc., source