TAMPA, Fla. (WFLA) – Tampa company Morphogenesis has received a “fast track” designation for its skin cancer vaccination from the United States Food and Drug Administration.
Morphogenesis is a clinical-stage biotechnology company that specializes in development of cell and gene therapy products to treat diseases such as cancer. It announced on Tuesday that its lead clinical-stage candidate, a drug called IFx-Hu2.0, will be fast tracked by the FDA to treat patients with advanced skin cancer.
The drug will treat patients with advanced cutaneous melanoma who have not responded to other therapies and medication.
“This is a therapeutic cancer vaccine, so it’s not preventative that we normally think of for an infectious disease. So this is actually a therapy to treat many different types of cancer,” Morphogenesis CEO Patricia Lawman told 8 On Your Side’s Daisy Ruth in August of 2019.
According to the FDA, speeding up the availability of drugs such as IFx-Hu2.0, are in everyone’s interest, especially when the drugs are “the first available treatment or if the drug has advantages over existing treatments.” The purpose is to, of course, get important new drugs to a patient earlier.
The FDA has a variety of conditions for a drug or treatment to be fast tracked, mainly, if it shows advantages over therapy already available.
As explained by Lawman, IFx-Hu2.0 brings the intelligence of the body’s immune system down on a skin cancer patient’s tumor, creating a “beacon,” for the immune system to target and fight.
The treatment is a shot just like a normal vaccine that is injected right into a tumor. Lawman said it takes approximately 30 seconds to complete, compared to a patient sitting in a chemotherapy infusion bed for hours.
The vaccine entered phase one of clinical trials after completing its first in-human phase at the end of January.
“Fast track designation for IFx-Hu2.0 signifies the FDA’s recognition that patients suffering from this life-threatening disease remain in dire need of effective treatment options, even with all the therapies that are being developed for melanoma. IFx-Hu2.0 holds promise to effectively treat these patients,” Morphogenesis President Dr. Michael J.P. Lawman said.
The company is committed to developing and expediting the review of the drug to make IFx-Hu2.0 eligible for accelerated approval and priority review if certain criteria are met.
In February, Lawman told 8 On Your Side Morphogenesis could soon be receiving a grant to begin research on a cervical cancer treatment for underprivileged women, but no update was given on that process.