The FDA has granted Quick Monitor designation to the most cancers vaccine GLSI-100 for sufferers with HLA-A*02-positive and HER2-positive breast most cancers.
The U.S. Meals and Drug Administration (FDA) has granted quick observe designation to the most cancers vaccine GLSI-100 for sufferers with HLA-A*02-positive and HER2-positive breast most cancers.
The event, based mostly on findings from the section 3 FLAMINGO-01 medical trial evaluating the immunotherapy GLSI-100 to forestall breast most cancers recurrences, was introduced in a information launch issued by clinical-stage biopharmaceutical firm Greenwich LifeSciences, Inc.
The designation, in line with the information launch, states that “GLSI-100 for the remedy of sufferers with HLA-A*02 genotype and HER2-positive breast most cancers who’ve accomplished remedy with normal of care HER2/neu focused remedy to enhance invasive breast most cancers free survival meets the factors for quick observe designation.”
Quick observe, because the FDA explains on its web site, is a course of designed to facilitate the event and expedite the evaluation of medication to deal with severe situations and fill an unmet medical want.
“Greenwich is happy that the FDA sees the potential of GLSI-100 to alter essential medical outcomes on this inhabitants of breast most cancers sufferers. We proceed to work earnestly to gather knowledge to help a BLA submitting demonstrating this profit,” acknowledged Dr. Jaye Thompson, vice chairman of medical and regulatory affairs, within the information launch.
CEO Snehal Patel commented within the information launch: “We’re excited to have acquired quick observe designation. The FDA evaluation of our quick observe utility included a evaluation of the potential of GLSI-100 as a brand new drug to deal with severe situations and to fill unmet medical want. By displaying the potential of GLSI-100 to forestall metastatic breast most cancers recurrence within the affected person inhabitants that we’re finding out, we had been in a position to estimate the potential lives that may very well be saved. The corporate plans to proceed discussions with the FDA, and doubtlessly the European regulatory authorities, to discover extra methods to make GP2 and GLSI-100 accessible to bigger populations.”
Findings from the FLAMINGO-01 trial
Therapy with GLSI-100 has demonstrated an elevated immune response over time in sufferers with HER2-positive breast most cancers following surgical procedure, in line with preliminary immune response knowledge from the section 3 FLAMINGO-01 trial, as CURE beforehand reported.
Knowledge from the trial confirmed that GLSI-100 is creating an immune response over time, with the remedy creating seen pores and skin response on the injection website — a optimistic signal {that a} affected person’s immune system is responding to remedy. Furthermore, sufferers on each the HLA-A*02 — which is a genetic marker that helps the immune system acknowledge illnesses — and non-HLA-A*02 arms skilled an immune response which elevated over time from baseline by way of the fourth to sixth month.
FLAMINGO-01, the corporate detailed within the information launch, is a section 3 medical trial inspecting the protection and effectiveness of GLSI-100 in sufferers with HER2-positive breast most cancers who had residual illness or high-risk pathologic full response at surgical procedure and who’ve accomplished each neoadjuvant and postoperative adjuvant Herceptin (trastuzumab)-based remedy.
The trial, which remains to be recruiting members, plans to finally enroll 750 sufferers and is estimated to be accomplished in December 2026, in line with its itemizing on clinicaltrials.gov.
GLSI-100, as outlined by the Nationwide Most cancers Institute on its web site, is a most cancers peptide vaccine that comprises the epitope GP2, a 9 amino acid peptide which can induce a cytotoxic T-lymphocyte (CTL)-mediated immune response in opposition to tumor cells expressing the HER2/neu antigen, which can end result within the inhibition of proliferation of HER2/neu-expressing tumor cells.
The possible, randomized, double-blinded, placebo-controlled, multi-center trial entails sufferers receiving six intradermal injections over the primary six months of remedy after which 5 booster intradermal injections spaced six months aside, the Nationwide Most cancers Institute explains on its web site.
References
- “Greenwich LifeSciences’ GLSI-100 Granted US FDA Quick Monitor Designation,” information launch, Sept. 10, 2025; https://investor.greenwichlifesciences.com/news-events/press-releases/element/102/us-fda-fast-track-designation
- “Quick Monitor,” FDA; https://www.fda.gov/sufferers/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
- “Investigative Agent Elicits Responses in Part 3 Breast Most cancers Trial,” CURE, April 3, 2025; https://www.curetoday.com/view/investigative-agent-elicits-responses-in-phase-3-breast-cancer-trial
- “Part 3 Research to Consider the Efficacy and Security of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Constructive Topics (FLAMINGO-01);’ https://clinicaltrials.gov/examine/NCT05232916
- “HER2/neu peptide vaccine GLSI-100,” Nationwide Most cancers Institute; https://www.most cancers.gov/publications/dictionaries/cancer-drug/def/her2-neu-peptide-vaccine-glsi-100
- “Part 3 Research to Consider the Efficacy and Security of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Constructive Topics,” Nationwide Most cancers Institute; https://www.most cancers.gov/analysis/take part/clinical-trials-search/v?id=NCI-2022-03768&r=1
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