Positive Results in Phase III Trial for CIN in Breast Cancer Patients

 

Evive Biotech announced today that its Phase III study investigating F-627 to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients has met its primary and secondary endpoints.

F-627, also known as efbemalenograstim alpha, works by increasing the production of white blood cells. A low concentration of these cells is a common side effect of chemotherapy, and by increasing the number of them within the body, the immune system can be strengthened.

“F-627 has now shown positive results in its pivotal Phase III trial. We are excited that this trial has met its efficacy and safety endpoints as we believe that it has the potential to positively impact cancer treatment,” said Dr. William Daley, Evive’s Chief Medical Officer. “F-627 has proven that it is at least as efficacious and safe as Neulasta, which is the current standard of care. This successful trial result reinforces F-627’s potential to be a strong first line treatment, and an alternative for patients contraindicated or refractory to current treatment options. F-627’s fusion protein structure presents a unique alternative as it reduces the possibility of allergic reactions caused by PEGylation used in pegfilgrastim. It was also very encouraging to see that the treatment was well tolerated, with infection rates for those treated with F-627 lower than in the control arm of the trial which was more pronounced in certain patient subgroups.”

The Phase III study was a multi-center, randomized, single dose, double-blind, active-controlled trial that looked at F-627’s efficacy and safety. It also compared F-627 to Neulasta in the prophylactic treatment of chemotherapy-induced neutropenia in women with breast cancer receiving myelotoxic TC chemotherapy treatment. The study was conducted under a Special Protocol Assessment in agreement with the U.S. Food and Drug Administration (FDA).

“The successful completion of our global Phase III trial for F-627 is a validation of Evive’s platform, and the entire team’s commitment, dedication and belief in this product,” said Jacky Liu, CEO of Evive.

Evive has been involved in the fight against COVID-19 as well. Back in April, the company announced a partnership with Gauss, a developer of digital decision-support tools for the medical industry. Together, the businesses stated that they would be releasing Apollo, a free iOS app and WebApp designed to boost the safety and efficiency of drive-through screening and testing sites. Apollo helps people determine if they qualify for COVID-19 testing based on guidelines from the U.S. Centers of Disease Control and Prevention.

“The partnership with Gauss and launch of Apollo can help Evive achieve our goal of helping millions of people throughout the United States find testing centers,” said Evive CEO Prashant Srivastava. “With the work we do every day to guide people to relevant benefits that will support better health, integrating the Evive.Care public resource with Gauss’s free Apollo app is a perfect alignment of interests to benefit public health and fight COVID-19. We highly encourage everyone to share this app with your family and friends to empower them with the information they need to get tested.”

Apollo is also facilitating Stanford Medicine’s Department of Epidemiology and Population Health’s COVID-19 trial, titled “Apollo Study.” The trial uses a survey built into the Apollo app that will inform epidemiology and population health experts on the prevalence and characteristics of COVID-19.

“We embarked on Apollo because we felt strongly that our expertise in clinical-grade digital decision-support tools enables us to build a valuable tool for screening and triage of COVID-19,” said Siddarth Satish, founder and CEO of Gauss. “Apollo’s mobile pass makes contactless screening a reality to reduce potential points of exposure for frontline workers across America. Partnering with Evive helps us provide the critical connection between the public and testing centers to ensure testing occurs for those who need it.”