Expanded Access Policy
About BioAtla
BioAtla Inc. (“BioAtla” or “us,”we,” “our”) is a clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors. Clinical trials form the foundation of our development programs. These trials are designed to assess the safety, tolerability and efficacy of investigational medicines. Participation in a clinical trial represents the best way, in a controlled setting, to gain access to an investigational medication. In some circumstances, a patient may not be able to participate in a clinical trial. Seeking use of an investigational medication under these circumstances is permitted by certain regulatory authorities, including the U.S. Food and Drug Administration (“FDA”), and commonly referred to as compassionate use or expanded access. Our policy is intended to comply with FDA requirements for any such use or access.
What is Expanded Access?
Expanded Access is a potential pathway for patients diagnosed with a serious and/or life-threatening disease or condition to gain access to an investigational product for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy options are available. In these instances, a patient’s treating physician can request an investigational product prior to regulatory approval, where allowed by local laws.
Who is Eligible for Expanded Access Programs?
BioAtla considers granting expanded access to investigational products when all of the following criteria are met:
- A patient is diagnosed with a serious and/or life-threatening disease or condition.
- There are no adequate standard or investigational therapies available.
- The patient is not eligible for or cannot participate in a BioAtla-sponsored study for the therapy being requested.
- There must be adequate data supporting use of the investigational medication in the treatment of the patient’s disease.
- Adequate supply exists to support both the ongoing clinical trials and expanded access, until and if a product becomes commercially available.
- Expanded access will not adversely impact the clinical development program or the regulatory approval process.
- The request must be made, unsolicited, by the patient’s treating physician.
- The treating physician must also agree to comply with the safety and monitoring requirements.
- Where appropriate demonstration of efficacy and safety may be required for continued treatment.
- Expanded access is permitted or approved in the country, region, and/or state where the investigational medicine will be administered.
- Any condition, in addition to those listed above, that in the opinion of BioAtla may preclude appropriate use of the investigational medicine, will be considered.
Available Expanded Access Program
Ozuriftamab Vedotin (CAB-ROR2-ADC) for treatment of patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck.
On July 22, 2024, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ozuriftamab vedotin, BioAtla’s conditionally and reversibly active ROR2 investigational antibody drug conjugate directed for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.
To learn more about this study: A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
How to Submit a Request
All requests must be submitted by a licensed physician on behalf of the patient.
If you are a patient and would like to obtain expanded access to investigational therapy, please contact your Healthcare Professional. Please submit request to EAP@bioatla.com
Requests will be acknowledged within 5 business days of receipt.