Expanded Access Policy

Expanded Access Policy

Expanded Access Policy

Coherent Biopharma is a clinical-stage biopharmaceutical company and dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. The company’s pipeline products are built on the proprietary bi-targeting drug conjugate (Bi-XDC) drug discovery platform.

Coherent Biopharma is committed to making investigational products, such as CBP-1008, and other appropriate pipeline products, available to seriously sick patients who have exhausted other treatment options. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Coherent Biopharma’s investigational products by contacting the Coherent Biopharma.

Expanded access (sometimes referred as compassionate use) is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. This Expanded Access Policy describes the requirements for Expanded Access to Coherent Biopharma investigational products to patients outside of a clinical study.

Scope

This policy applies to provision of access to a Coherent Biopharma investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.  This policy also applies that in case patients participate in one of our clinical studies, we may provide continued treatment for patients after their study treatment, or after the whole study, has completed.  

Policy Statements

Any use of a Coherent Biopharma investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Coherent Biopharma policies and procedures.  

In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Coherent Biopharma when it becomes available via the local healthcare system.  

Coherent Biopharma may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country.  

Consistent with U.S. FDA’s guidelines, expanded access may be appropriate when all the following apply:

  • Patient has a serious or immediately life-threatening disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

For more information about expanded access in the U.S., visit the FDA website at https://www.fda.gov/news-events/public-health-focus/expanded-access.

In addition to the patient eligibility requirements, the investigational product must meet the following criteria:  

  • The product is under investigation in one or more clinical studies.  
  • There is sufficient evidence to expect that the investigational product will have an acceptable safety profile for the intended patient population.  

The physician(s) attending to the patient(s) who is/are receiving an investigational product through Expanded Access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:

  • Any applicable country-specific legal and regulatory requirements related to providing an investigational product under Expanded Access.
  • Any Coherent Biopharma requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to RA@coherentbio.com