- 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 dose-limiting toxicity (DLT) observation period with 1 gram (14.2 mg/kg) in 2Q 2024 and initial Phase 2 monotherapy data readout on track for 2Q 2024 and in combination with pembrolizumab in 2H 2024; anticipate FDA meeting for first-line, metastatic or unresectable, BRAF-mutated melanoma potential registrational trial in 2H 2024
- Mecbotamab vedotin (CAB-AXL-ADC) initial 20 patients in Phase 2 potentially registrational study in undifferentiated pleomorphic sarcoma (UPS) enrolled; anticipate FDA meeting to discuss remaining portion of the trial in 2H 2024
- CAB-EpCAM x CAB-CD3 (BA3182) Phase 1 dose-escalation data readout and potential initiation of Phase 2 study expected in 2H 2024
- CAB-Nectin4-ADC (BA3361) FDA IND clearance in May
- Cash balance of
$80.6 million as ofMarch 31, 2024 is expected to fund operations into 2H 2025 - Management to host conference call and webcast today at
4:30 PM Eastern Time
“We have had a productive start to the year, highlighted by positive clinical responses and a manageable safety profile observed with our CAB Phase 2 assets, including ozuriftamab vedotin and evalstotug. In particular, we are encouraged to see multiple responses with single agent ozuriftamab vedotin in a difficult to treat head and neck cancer population with a median of 3 prior lines of therapy and intend to schedule a meeting with the FDA later this year for a potential randomized registrational trial in this indication,” said
Key Developments, Operational Updates and Upcoming Milestones
- Phase 2 Trials of ozuriftamab vedotin, CAB-ROR2-ADC in treatment-refractory SCCHN (NCT05271604) and treatment-refractory melanoma (NCT03504488)
- SCCHN patients (n=33) dosed at the 1.8 mg/kg 2Q3W (n=21) and Q2W (n=12) regimens; 29 evaluable patients (median 3 prior lines of treatment):
- To date, a total of 11 responses at the combined 2Q3W and Q2W dose regimens (5 confirmed, including 1 complete response)
- Among the 5 confirmed and 6 unconfirmed responders, the median number of prior treatments was 2 and 3, respectively, indicating that less heavily pretreated responders were generally more likely to receive confirmational scans
- Disease Control Rate (DCR) is 86%
- Anticipate FDA meeting in 2H 2024 for potential registrational trial in SCCHN
- Melanoma patients (n=29) dosed at the 1.8 mg/kg Q2W regimen (1 received 3 mg/kg Q3W in phase 1); 27 evaluable patients (median 2 prior lines of treatment).
- To date, a total of 5 responses (2 confirmed, including 1 complete response)
- DCR is 67%
- Ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals observed
- SCCHN patients (n=33) dosed at the 1.8 mg/kg 2Q3W (n=21) and Q2W (n=12) regimens; 29 evaluable patients (median 3 prior lines of treatment):
- Phase 1/2 dose-escalation trial of evalstotug, CAB-CTLA-4 (NCT05180799) across multiple solid tumor types responsive to CTLA-4
- Phase 1 study
- Meaningful antitumor activity at 350 mg dose in combination with PD-1 inhibitor; new PR reported in a patient with metastatic melanoma
- Evolving safety data are consistent with what was previously reported with low incidence of immune mediated adverse events
- 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
- Phase 1 study
- Phase 2 Trials of mecbotamab vedotin, CAB-AXL-ADC:
UPS (NCT03425279) ongoing potentially registrational trial- Completed enrollment of initial 20 patients at 1.8 mg/kg 2Q3W regimen with encouraging compliance and manageable safety
- Anticipate meeting with the FDA for guidance on the remaining portion of the potentially registrational trial in 2H 2024
- NSCLC (NCT04681131)
- Dosed 33 target-agnostic patients at the 1.8 mg/kg 2Q3W regimen across squamous and non-squamous patients
- Study remains 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)
- On track for full dataset readout of Phase 1 study in 2H 2024
- Potential initiation of Phase 2 study in 2H 2024
- Anti-Nectin-4-ADC (BA3361)
- FDA IND clearance
- BA3361 is the first CAB molecule containing one of BioAtla’s novel NextGen ADC glyco-linkers with highly improved stability and tumor specific payload release.
First Quarter 2024 Financial Results
Research and development (R&D) expenses were $18.9 million for the quarter ended March 31, 2024 compared to $21.7 million for the same quarter in 2023. The decrease of
General and administrative (G&A) expenses were $5.6 million for the quarter ended March 31, 2024 compared to $7.2 million for the same quarter in 2023. The
Net loss for the quarter ended March 31, 2024 was $23.2 million compared to a net loss of $27.5 million for the same quarter in 2023.
Net cash used in operating activities for the quarter ended
Cash and cash equivalents as of
First Quarter 2024 Conference Call and Webcast Details
The management of
https://viavid.webcasts.com/starthere.jsp?ei=1665384&tp_key=d63cb7a0e8. 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 13745807.
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, melanoma and breast. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including 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)
Evalstotug, 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. Evalstotug 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 glyco-linkers with highly improved stability and tumor specific payload release. BA3361 demonstrated 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, and reduced toxicity through CAB selectivity.
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; plans to form collaborations and other strategic partnerships for selected assets; 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; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations; and expectations regarding R&D expenses and cash burn. Forward-looking statements are based on
Internal Contact:
Richard Waldron
Chief Financial Officer
rwaldron@bioatla.com
858.356.8945
External Contact:
bmackle@lifesciadvisors.com
Unaudited Condensed Statements of Operations and Comprehensive Loss (in thousands, except share data) | ||||||||
Three Months Ended | ||||||||
2024 | 2023 | |||||||
Operating expenses: | ||||||||
Research and development expense | $ | 18,852 | $ | 21,697 | ||||
General and administrative expense | 5,605 | 7,233 | ||||||
Total operating expenses | 24,457 | 28,930 | ||||||
Loss from operations | (24,457 | ) | (28,930 | ) | ||||
Other income: | ||||||||
Interest income | 1,223 | 1,480 | ||||||
Other expense | — | (10 | ) | |||||
Total other income | 1,223 | 1,470 | ||||||
Net loss and comprehensive loss | $ | (23,234 | ) | $ | (27,460 | ) | ||
Net loss per common share, basic and diluted | $ | (0.48 | ) | $ | (0.58 | ) | ||
Weighted-average shares of common stock outstanding, basic and diluted | 48,087,460 | 47,578,418 |
Condensed Consolidated Balance Sheets Data (in thousands) | ||||||||
2024 | 2023 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 80,630 | $ | 111,471 | ||||
Total assets | 89,197 | 119,658 | ||||||
Total current liabilities | 19,260 | 28,344 | ||||||
Total liabilities | 39,481 | 48,986 | ||||||
Total stockholders’ equity | 49,716 | 70,672 | ||||||
Total liabilities and stockholders’ equity | 89,197 | 119,658 |
Source:
2024 GlobeNewswire, Inc., source