OBSERVER File Photo Pictured is the ImmunityBio production facility on Route 5 in Dunkirk.

A monumental achievement for ImmunityBio, Inc. occurred earlier this week, leaving the door open for potential major benefits to the Dunkirk community.

On Monday, the Food and Drug Administration officially approved ANKTIVA, a treatment for unresponsive non-muscle invasive bladder cancer. ANKTIVA is expected to be available in the U.S. by the middle of May.

“The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.

The development is a major step for ImmunityBio, who has recently taken over the former Athenex plant off Route 5 in Dunkirk. ImmunityBio began leasing the property in February 2022, with major layoffs to employees upon its arrival.

ImmunityBio’s 2022 year-end report to the SEC stated, “In September 2022, we initiated a workforce reduction at the Dunkirk facility as a result of upcoming construction at the project, which we believe may take approximately 12 to 18 months.

We believe this facility will provide us with a state-of-the-art biotech production center that will substantially expand and diversify our existing manufacturing capacity in the U.S. and the ability to scale production across all of our key platforms.”

ANKTIVA received Breakthrough Therapy Designation and approval from the FDA based on the safety and efficacy outcome of complete responses and duration of complete responses throughout trials that evaluated 77 patients. The patients received ANKTIVA with Bacillus Calmette-Guérin (BCG) treatments for up to 37 months. The status of tumors evaluated were assessed with cystoscopy and urine cytology and will continue for up to five years after each patient began their participation in the trial.

The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. These prolonged duration of complete response results beyond 24 months with ANKTIVA and BCG exceed the benchmark for the magnitude of meaningful clinical results suggested by a panel of experts at the IBCG.

“We are pleased that treatment with ANKTIVA now exceeds the clinically meaningful benchmarks established by the IBCG in 2016 for durable complete response,” said Roger Buckley of the International Bladder Cancer Group. “We look forward to the global availability of ANKTIVA to potentially reduce the need for cystectomy in many patients worldwide with NMIBC.”

Bladder cancer is the 10th most commonly diagnosed cancer globally. The American Cancer Society estimates there will be 83,190 new cases and 16,840 deaths from bladder cancer in 2024 in the United States. At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer, wherein the cancer is found only on the inner layer of the bladder wall. The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of Bacillus Calmette-Guerin (BCG).

“A new immunotherapy that builds upon our knowledge and experience with BCG as an immune stimulant is exciting to see,” said Ashish Kamat, M.D., MBBS, an Endowed Professor of Urologic Oncology and Cancer Research at University of Texas MD Anderson Cancer Center. “While patients have had limited options in the past after failure of BCG, nogapendekin alfa inbakicept-pmln, with its reported safety and efficacy, now offers them yet another choice in their quest to avoid a radical cystectomy. This is a big win for NMIBC patients everywhere.”

ANKTIVA has been studied in more than 700 patients in multiple Phase 1 and 2 trials in both liquid and solid tumors. In addition to trials in NMIBC, it is currently being studied in trials for non-small-cell lung cancer, colorectal cancer, non-Hodgkin’s lymphoma, glioblastoma, solid tumors, and HIV. Future studies are planned for platinum-resistant ovarian cancer and acute myeloid leukemia.

“(The) approval of ANKTIVA for patients with NMIBC marks an important milestone in our quest to develop cancer vaccines, and preventative vaccines for patients with genetic predisposition to developing cancer such as in Lynch syndrome,” said Soon-Shiong. “We believe that by orchestrating the innate and adaptive immune system and driving long-term complete remission, AKTIVA has the potential to play a key role as the immunotherapy beyond checkpoints in multiple tumor types in the years to come.”