FDA fast-tracks personalized therapy for hard-to-treat-prostate cancer

A novel combination treatment for advanced prostate cancer has been granted Fast Track status by the FDA.  Depositphotos

The US Food and Drug Administration (FDA) has green-lit the fast-tracking of an innovative personalized treatment for advanced prostate cancer following a promising clinical trial where the cancer disappeared completely in almost 40% of participants.

Prostate cancer needs testosterone to grow. In metastatic castration-resistant prostate cancer (mCRPC), an advanced form of the disease, the cancer continues growing despite a reduction in testosterone brought about by chemical or surgical castration. As such, mCRPC has few treatment options and carries a high mortality rate.

So, the FDA’s grant of Fast Track designation to an innovative combination drug/device treatment for mCRPC developed by Florida-based biopharmaceutical company Syncromune Inc. is welcome news.

“We believe that Fast-Track designation for SYNC-T SV-102 will significantly aid our development goals for this therapy for men with difficult-to-treat prostate cancer,” said Charles Link, MD, Executive Chairman of Syncromune. “We look forward to initiating trials at multiple US sites later this year to expand our efforts to develop the SYNC-T SV-102 therapy.”

A Fast Track designation facilitates the development and expedites the review of drugs for serious conditions and is intended to address an unmet medical need. To quote the FDA, “The purpose is to get important new drugs to the patient earlier.”

SYNC-T takes advantage of prostate cancer’s immunologically ‘cold’ tumor microenvironment, meaning it’s not likely to trigger a strong immune response because cold tumors tend to be surrounded by cells that prevent T cells from attacking and killing the tumor cells. Cancer immunotherapies are designed to stimulate and strengthen the body’s antitumor immune response, but existing therapies struggle to overcome this cold microenvironment. In contrast, SYNC-T’s novel mechanism of action stimulates a body-wide antitumor immune response to mCRPC.

The first step involves inserting a probe directly into the primary or metastatic tumor using a process similar to that used routinely by urologists to take a prostate biopsy. Part of the tumor is frozen, causing its cells to fracture and release immune-stimulating neoantigens, tumor-specific antigens produced by mutated tumor cells. In effect, this process creates a personalized cancer vaccine within the patient’s body that switches on their immune system.

The next step is to infuse a drug called SV-102, comprised of a combination of pharmaceutical ingredients, into the ‘fractured’ area of the tumor. The combination approach activates cancer-fighting T cells to mount a body-wide attack on the primary tumor and its metastases.

A Phase 1 clinical trial of SYNC-T SV-102 showed that it was safe and effective. Fifteen subjects with mCRPC were enrolled. For most, the cancer had spread to their bones, and previous treatments had failed. They were treated with SYNC-T SV-102 therapy every four weeks for up to 12 cycles, and their response to treatment was evaluated every eight weeks. The overall response rate of the 13 subjects whose response was evaluated was 85%, with five complete responses and six partial responses. A ‘complete response’ is when all signs of cancer in the body disappear, and a ‘partial response’ means a decrease in tumor size or amount of cancer in the body.

The response rate to SYNC-T is notable given the advanced stage of the subjects’ cancer and that standard treatments typically produce a response rate of 20% to 40%.

“The Fast-Track designation for SYNC-T SV-102 therapy signifies another step forward in bringing our potentially groundbreaking therapy to patients who need it most,” said Eamonn Hobbs, CEO and co-founder of Syncromune.

Source: Syncromune


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