FDA Grants Fast Track Designation to Vergent Bioscience’s Novel Agent for Visualizing Solid Tumors During Lung Cancer Surgeries

Image Credit: Adobe Stock Images/Sebastian Kaulitzki

The FDA has granted Fast Track designation to Vergent Bioscience’s VGT-309, an injectable tumor-targeted fluorescent imaging agent designed to aid surgeons in visualizing tumors, lymph nodes, and positive surgical margins during lung cancer surgeries. According to the company, the decision by the FDA was based on positive safety, tolerance, and enhanced tumor visualization results in lung cancer patients.¹

“Receiving Fast Track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said John Santini, PhD, president, CEO, Vergent Bioscience, in a press release. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”

The open label Phase II efficacy study (NCT05400226) evaluated the safety and efficacy of VGT-309 in identifying cancer in up to 40 subjects undergoing lung cancer surgery.² The primary efficacy endpoint was the proportion of patients with at least one clinically significant event, which were defined as localization of lesions not found by standard surgical techniques, identification of synchronous and occult cancers, and identification of inadequate surgical margin.³

“The expanded use of minimally invasive surgery, including robotic-assisted technologies, for lung cancer has created a significant and growing need for better visualization during these surgeries, which can be curative when lung cancer is diagnosed early enough and all tumor tissue is removed,” said Santini, in a press release. “We are pleased that data from our clinical program continue to suggest VGT-309 may help overcome existing challenges to tumor visualization and thereby optimize surgical outcomes for physicians and patients.”

Results demonstrated clinically significant outcomes in 42.5% of trial participants. Moving forward, Vergent has officially completed enrollment for the Phase II VISUALIZE study, which evaluated the efficacy and safety of VGT-309 in patients undergoing surgery for proven or suspected cancer in the lung. This year, the company intends to begin enrollment in the Phase III confirmatory, multicenter VISUALIZE-2 study.¹

According to the American Cancer Society (ACS), lung cancer is the second most common form of cancer for both men and women in the United States. In men, prostate cancer is more common while in women, breast cancer is more common. Last year, it was estimated that there were 234,580 new cases of lung cancer diagnosed and around 125,070 deaths. In most cases, lung cancer occurs in patients over 65 years of age, with a median diagnosis age of 70 years. However, a small number of people under 45 years of age have been diagnosed with it as well.

The ACS also stated that lung cancer is the leading cause of cancer deaths in the United States, accounting for every one in five cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined. The chances of a man developing lung cancer during his lifetime is one in 16. For a woman, the chances are one in 17. These numbers include both people who smoke and those who don’t smoke. For people who smoke, the risk is much higher, while for those who don't, the risk is lower.⁴

References

1. Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery. BusinessWire. January 7, 2025. Accessed January 7, 2025. https://www.businesswire.com/news/home/20250107433815/en

2. Phase 2 Study of VGT-309 in Lung Cancer. Clinicaltrials.gov. Accessed January 7, 2025. https://clinicaltrials.gov/study/NCT05400226

3. Vergent Bioscience Data Published in The Annals of Thoracic Surgery Demonstrate VGT-309 May Help Surgeons Visualize Tumor Tissue in the Lung During Surgery. Vergent. July 18, 2024. Accessed January 7, 2025. https://www.vergentbio.com/press-releases/vergent-bioscience-data-published-in-the-annals-of-thoracic-surgery-demonstrate-vgt-309-may-help-surgeons-visualize-tumor-tissue-in-the-lung-during-surgery

4. Key Statistics for Lung Cancer. American Cancer Society. Accessed January 7, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html