FDA Grants Fast Track Designation to REM-001 Therapy for Cutaneous mBC

Fast track designation has been granted to REM-001 therapy for patients with cutaneous metastatic breast cancer based on positive data from 4 phase 2/3 studies.

The FDA has granted fast track designation to REM-001 therapy for the treatment of patients with cutaneous metastatic breast cancer (mBC), according to Kintara Therapeutics, Inc.1

"The receipt of fast track designation represents an important regulatory milestone for our REM-001 therapy program," said Robert E. Hoffman, president and chief executive officer of Kintara Therapeutics, Inc, in the press release. "We believe this designation is a key component of our future clinical and regulatory strategy as we continue to seek funding, in particular grants, to restart REM-001 clinical development as soon as possible."

REM-001 therapy is a photodynamic therapy which consists of the laser light source, the light delivery device, and the REM-001 drug product. This platform shows potential for the treatment of patients with localized cutaneous, or visceral tumors as well as in other potential indications.

Previously, there have been 4 phase 2/3 studies which evaluated REM-001. In these studies, patients with cutaneous mBC were enrolled who had received prior chemotherapy and/or failed radiation therapy.2

In these trials, REM-001 therapy was able to reduce or eliminate a large number of cutaneous mBC tumors. To-date, researchers have found that among 148 patients who were enrolled in these phase 2/3 trials, approximately 80% of cutaneous mBC evaluable lesions treated with REM-001 led to complete responses. This indicates that follow-up clinical assessments showed no visible evidence of the tumor remaining.

There is also an existing robust safety database of approximately 1,100 patients across multiple indications.

As more is developed regarding REM-001 therapy, experts hope the platform can be of use as a key element in an immunotherapy regimen for the treatment of patients with cutaneous cancers, including mBC.

Next, the company is preparing for a future phase 3 study which will further assess the effects of REM-001 therapy for this patient population.

"This designation from the FDA emphasizes the important unmet medical need for safe and effective therapeutic options to address cutaneous mBC. We have extensive data in hand to support the advancement of this clinical program and look forward to the continued investigation of our drug candidate in the next study as planned," added Dennis Brown, PhD, chief scientific officer of Kintara, in the press release.

Kintara Therapeutics granted fast track designation from FDA for REM-001 for cutaneous metastatic breast cancer. News release. Kintara Therapeutics, Inc. November 28, 2022. Accessed November 29, 2022. https://prn.to/3XK4WeD
Cutaneous metastatic breast cancer (CMBC). Kintara Therapeutics, Inc. Accessed November 29, 2022. https://bit.ly/3Uc87IN