SynDevRx is a clinical-stage biotechnology company focused on developing treatments that address a serious and unmet medical need: cancers that are sensitive to dysregulated metabolic hormones. It is well established that obesity and diabetes increase the risks for developing cancer, but new research shows that these same risk factors also promote cancer and increase its lethality. Our approach combines standard of care therapies with our lead drug evexomostat (SDX-7320) to improve the tumor micro-environment by correcting the systemic metabolic hormones and key angiogenic factors that promote cancer progression and metastasis. We are the first company to target this significant yet underfunded area of research in drug development – an area called ‘metabo-oncology’.

SynDevRx has completed a Phase 1 study and is conducting 2 Phase 2 clinical studies – the first in post-menopausal HR+, Her2- metastatic breast cancer patients with the PIK3CA mutation in combination with standard of care treatment (Piqray(R) and fulvestrant). The second clinical study is in patients with triple-negative breast cancer (TNBC) and an HbA1c >5.5 or a BMI >30.
Information regarding our clinical trials can be accessed at www.clinicaltrials.gov.

In addition to our clinical trials, SynDevRx has an Expanded Access Policy for evexomostat (SDX-7320) for eligible patients in the U.S. Expanded Access refers to the use of an investigational drug by an individual patient outside of a clinical trial to prevent or treat a serious condition when the patient is unable to obtain the investigational drug under an IND (e.g., when a patient is not eligible for a clinical study or a clinical study is not recruiting or has been completed). To qualify for the SynDevRx Expanded Access Program, the patient’s physician must determine that probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition. Expanded access is different from a clinical trial where the primary purpose is to collect extensive safety and efficacy data to support submission of an application to the U.S. Food and Drug Administration (FDA) to market a drug.

Physicians seeking additional information regarding Expanded Access for evexomostat (SDX-7320) should submit a request via expandedaccess@syndevrx.com (telephone number 1-617-401-3110). SynDevRx considers providing access to our investigational drug evexomostat (SDX-7320) on a case-by-case basis, dependent on available drug supplies, the physician’s determination as to whether the potential benefit to the patient justifies the potential risks, and company resources. A requesting oncologist/physician should expect to receive a response acknowledging receipt of a request within 5 business days after a completed request has been received.
The request for access to a SynDevRx investigational medicine can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment.

In accordance with the 21st Century Cures Act, this policy may be revised at any time. Should you have additional questions, please reach out to your oncologist/physician.