NBE-Therapeutics Expanded Access Policy for NBE-002, a ROR1 targeting Antibody Drug Conjugate

NBE-Therapeutics Expanded Access Policy for NBE-002, a ROR1 targeting Antibody Drug Conjugate

NBE-Therapeutics is committed to developing best-in-class therapies to increase survival and improve quality of life for cancer patients worldwide. NBE-Therapeutics provides an opportunity for patients to receive its investigational medicinal products outside of ongoing clinical trials. Such access is called ‘expanded access’, and is regulated by the company’s Expanded Access Policy. Expanded access to the company products is established either via an EAP clinical trial protocol or on a case-by-case basis in accordance with recommendations and guidelines of appropriate local regulatory authorities. The access to NBE-Therapeutics’ product may be granted under the Expanded Access Policy only if the request fulfills all the following pre-requisites:

  • Comprehensive data on efficacy, safety, pharmacological and biological activity of the investigational medicinal product are available
  • Therapeutic dose(s) recommendations are available

Implementation on a case-by-case basis may be granted only when all of the following criteria are met:

  1. The request is made by the patient’s treating physician.
  2. The patient’s treating physician has a valid medical license and a relevant specialty board certification.
  3. The patient’s treating physician is willing and able to enter into an Expanded Access Agreement with NBE-Therapeutics.
  4. The patient’s treating physician is willing and able to comply with appropriate regulatory authority requirements and procedures foreseen for the use of investigational medicinal products under a relevant expanded access program. This may include approval of appropriate regulatory and ethics committees.
  5. The patient has a serious or life-threatening disease or condition for which there is no comparable or satisfactory alternative therapy, or the patient is no longer responsive to or no longer able to tolerate such alternative therapy.
  6. The patient does not qualify for participation in available clinical trials with the requested product, or enrollment in a clinical trial is not feasible (e.g., distance to a trial precludes access).
  7. The patient’s treating physician provides sufficient justification that the use of the product has reasonable possibility of being effective and safe, and that potential benefits outweigh potential risks associated with the investigational medicinal product administration. The request needs to be supported by relevant medical records of the patient.
  8. The patient provides, through the treating physician, informed consent for the use of NBE-Therapeutics’ investigational medicinal product under this Expanded Access Policy.
  9. The patient’s treating physician is willing and able to provide NBE-Therapeutics’ investigational medicinal product to the patient according to product-specific requirements defined by NBE-Therapeutics and to report any adverse events and other relevant medical data associated with the use of the product in the patient according to regulatory requirements.
  10. The access to NBE-Therapeutics’ product under the Expanded Access Policy does not obstruct or jeopardize the ongoing development program or regulatory marketing authorization of the product.
  11. NBE-Therapeutics is able to provide sufficient supply of the investigational medicinal product.

Additional medical criteria may be defined by NBE-Therapeutics in order to support patient’s safety and entry into this program.

Requests shall be made in writing and shall be sent to NBE-Therapeutics via email to: clinicaltrials@nbe-therapeutics.com. Neither submission nor consideration of the request is a guarantee or a promise that access will be granted. NBE-Therapeutics is committed to evaluate all requests in a fair and equitable manner, and will use its best efforts to acknowledge each submitted request within 7 business days from receipt of a fully completed request. NBE-Therapeutics is not obliged to provide reasons for refusal, if the access is denied. NBE-Therapeutics has the right to change the Expanded Access Policy at any time.

For more information about NBE-Therapeutics’ clinical trials, please visit: clinicaltrials.gov