Working to address key unmet needs across a number of cancer types

Despite many recent advances in cancer treatments with breakthrough therapies, a large proportion of patients unfortunately develop resistance to their current treatment and are in need of new options. We at ORIC are committed to addressing this unmet medical need.
Our commitment includes conducting clinical trials with our investigational medicines to demonstrate their safety and efficacy. Data from these clinical trials ultimately could support regulatory approval, allowing these medicines to become available for the benefit of many cancer patients.
Patients who choose to participate in clinical trials play a critical role in the development of these and other new medicines. If you are interested in gaining access to our investigational medicines, we encourage you to speak with your physician about the possibility of enrolling in a clinical trial.

CLINICAL TRIALS NOW ENROLLING

ORIC-533, ORIC-114, and ORIC-944 are investigational drug candidates and have not been approved for marketing by the US FDA or other regulatory authorities.

EXPANDED ACCESS POLICY

ORIC Pharmaceuticals, Inc. (ORIC) is committed to developing innovative therapies for cancer and is currently in the early stages of clinical development.

In general, all new drug therapies must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they can become commercially available for use by doctors to treat patients. Investigational therapies that have not been approved by FDA may, or may not, be effective as a treatment, and the use of such investigational products may cause unexpected serious side effects. Currently, before our investigational therapies are approved by regulatory authorities, they can be accessed only through participation in our clinical trials, that is, only by patients who meet the clinical trial criteria and are enrolled in a clinical trial.

Wherever possible, we encourage patients who qualify for participation in a clinical trial to participate in that trial, which offers the best opportunity for patients to access an investigational product before regulatory approval.

However, in rare cases, where patients may not qualify for a particular clinical trial and have exhausted all available treatment options, ORIC may consider providing access to one of its investigational products outside of an ORIC-sponsored clinical trial to a limited number of doctors who are treating patients with an immediately life-threatening condition or serious disease or condition through a process called expanded access, also known as compassionate use.

Requests for expanded access are evaluated on a case-by-case basis, and only when a request is submitted by a doctor. Making an expanded access decision is complex and includes considering a number of factors, including, but not limited to, the patient’s circumstances and scientific and medical information available for the investigational product at the time of the request.

While ORIC aims to promptly consider all requests for expanded access from doctors who are treating a patient who does not meet the criteria for ORIC’s clinical trials, we must ensure that expanded access can be provided in a fair manner that complies with current regulations and guidelines, including upholding ethical principles, promoting good, and minimizing potential risks to patients, including, but not limited to, the following threshold factors:

• The investigational product is currently in clinical development and is currently being studied in humans for a particular use.
• The patient must have a serious disease or condition, or whose life is immediately threatened by their disease or condition, with no viable treatment options.
• Patient enrollment in an ORIC-sponsored clinical trial is not possible because the patient does not meet the criteria for participation.
• There must be sufficient evidence that the potential benefit to the patient justifies the potential risks of treatment with the investigational product, based on all currently available information for the investigational product.
• Granting expanded access for the requested use must not interfere with ORIC’s clinical trials that could support an investigational product’s clinical development or regulatory approval, including having sufficient supplies of the investigational product.
• The patient receiving expanded access is located in the US and will be treated by a US-licensed physician in the US.

Requesting Expanded Access:

We encourage patients to first discuss with their treating physicians about their eligibility for a clinical trial. If a treating physician believes expanded access may be the only available option for a patient, the physician may submit an inquiry or a formal request for expanded access on behalf of the patient to ORIC by email to clinical@oricpharma.com. This will allow the treating physician to work with ORIC’s clinical team to determine the best course of action.

ORIC will acknowledge receipt of an expanded access inquiry or a request from a US-licensed physician within five (5) business days of receipt. Submitting a request or receiving ORIC’s acknowledgement of receipt of a request does not guarantee that expanded access will be granted. A request for expanded access can only be considered if the patient’s treating physician provides the required patient medical information and is fully committed to and is supportive of the requested treatment, including submitting a single patient Emergency Investigational New Drug (E-IND) application to the FDA and being fully responsible for patient care.

If a request to provide an investigational drug is granted by ORIC, the FDA must grant final approval before ORIC can supply the investigational product to the requesting physician.

Physicians located in the United States may find additional information regarding expanded access to investigational products by visiting the FDA websites: Expanded Access: Information for Physicians and Project Facilitate (expanded access requests for investigational oncology products).

ORIC is not currently able to provide expanded access outside of the United States.