FDA News

FDA grants fast track designation to RM-1929 for HNSCC

The FDA granted breakthrough therapy designation to RM-1929 for the treatment of patients with locoregional recurrent head and neck squamous cell carcinoma who have failed two prior therapies, according to a press release from the therapy’s manufacturer.

RM-1929 (Aspyrian Therapeutics) — a conjugate of cetuximab (Erbitux, Eli Lilly) and IRDye 700DX (Li-Cor Biosciences) — targets epidermal growth factor receptors.

The FDA based this designation on interim results from a phase 2 study of RM-1929.

Results showed improvements in overall response rate, PFS and OS compared with standard of care treatments.

“These data support the potential for RM-1929 to control this disease while preserving normal healthy tissues in the head and neck area that are so critical to maintaining the patient’s quality of life and we look forward to initiating the pivotal clinical trials,” Merrill Biel, MD, PhD, chief medical officer of Aspyrian, said in the release.

“We are delighted that the FDA granted fast track designation to RM-1929 for the treatment of patients with recurrent head and neck cancer, illustrating their recognition of the large unmet medical need for this severe disease. Based on the interim phase 2 data, we believe that RM-1929 as a single agent has the potential to offer effective treatment options for patients who have failed all existing therapies, providing the opportunity to treat with curative intent” Miguel Garcia-Guzman, president and CEO of Aspyrian, said in the release. “In addition, based on our preclinical and clinical data, we expect that RM-1929-mediated tumor destruction may serve to trigger innate and adaptive anticancer immune responses that have the potential to enhance the destruction of the patient’s cancer.”

Aspyrian plans to begin a global pivotal study of RM-1929, alone and in combination with immunomodulators, for the treatment of recurrent head and neck cancer.

The FDA granted breakthrough therapy designation to RM-1929 for the treatment of patients with locoregional recurrent head and neck squamous cell carcinoma who have failed two prior therapies, according to a press release from the therapy’s manufacturer.

RM-1929 (Aspyrian Therapeutics) — a conjugate of cetuximab (Erbitux, Eli Lilly) and IRDye 700DX (Li-Cor Biosciences) — targets epidermal growth factor receptors.

The FDA based this designation on interim results from a phase 2 study of RM-1929.

Results showed improvements in overall response rate, PFS and OS compared with standard of care treatments.

“These data support the potential for RM-1929 to control this disease while preserving normal healthy tissues in the head and neck area that are so critical to maintaining the patient’s quality of life and we look forward to initiating the pivotal clinical trials,” Merrill Biel, MD, PhD, chief medical officer of Aspyrian, said in the release.

“We are delighted that the FDA granted fast track designation to RM-1929 for the treatment of patients with recurrent head and neck cancer, illustrating their recognition of the large unmet medical need for this severe disease. Based on the interim phase 2 data, we believe that RM-1929 as a single agent has the potential to offer effective treatment options for patients who have failed all existing therapies, providing the opportunity to treat with curative intent” Miguel Garcia-Guzman, president and CEO of Aspyrian, said in the release. “In addition, based on our preclinical and clinical data, we expect that RM-1929-mediated tumor destruction may serve to trigger innate and adaptive anticancer immune responses that have the potential to enhance the destruction of the patient’s cancer.”

Aspyrian plans to begin a global pivotal study of RM-1929, alone and in combination with immunomodulators, for the treatment of recurrent head and neck cancer.