The goal of this clinical trial is to learn about TLPO cancer vaccine in cases of solid tumor malignancies. The main objectives it aims to learn about are:
What is the time to progression/recurrence of disease after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
What is the overall survival after vaccination with the autologous TLPO vaccine in multiple solid tumor malignancies?
What are the safety characteristics of autologous TLPO using standardized criteria (Common Terminology Criteria for Adverse Events v5.0)
Does TPLO generate an immune response?
Determine the presence, rate, and duration of any disease control response affected by TPLO.

Start Date29 Nov 2023

Sponsor / Collaborator

Elios Therapeutics LLC

[+1]

100 Clinical Results associated with Tumor lysate particle only vaccine (Orbis Health Solutions)

100 Translational Medicine associated with Tumor lysate particle only vaccine (Orbis Health Solutions)

100 Patents (Medical) associated with Tumor lysate particle only vaccine (Orbis Health Solutions)

Literatures (Medical) associated with Tumor lysate particle only vaccine (Orbis Health Solutions)

01 Jan 2024·Cancer Treatment and Research Communications

Tumor lysate particle only vaccine (TLPO) vs. Tumor lysate particle-loaded, dendritic cell vaccine (TLPLDC) to prevent recurrence in resected stage III/IV melanoma patients: Results of a phase I/IIa trial

Article

Author: Bohan, Phillip M Kemp ; Vreeland, Timothy J. ; Peoples, George E. ; Berger, Adam C ; Berger, Adam C. ; O'Shea, Anne E. ; Adams, Alexandra M ; McCarthy, Patrick M. ; Carpenter, Elizabeth L ; O'Shea, Anne E ; Valdera, Franklin A ; Sussman, Jeffrey J. ; Clifton, Guy T. ; Stojadinovic, Alex ; Hyngstrom, John ; Cindass, Jessica L ; Faries, Mark B. ; Hickerson, Annelies T ; Chick, Robert C. ; Adams, Alexandra M. ; Jakub, James W ; Shaheen, Montaser ; Faries, Mark B ; Hickerson, Annelies T. ; Valdera, Franklin A. ; Clifton, Guy T ; McCarthy, Patrick M ; Van Decar, Spencer G. ; Chick, Robert C ; Peoples, George E ; Vreeland, Timothy J ; Yu, Xianzhong ; Tiwari, Ankur ; Hale, Diane F ; Cindass, Jessica L. ; Jakub, James W. ; Carpenter, Elizabeth L. ; Van Decar, Spencer G ; Hale, Diane F. ; Wagner, Thomas ; Sussman, Jeffrey J

BACKGROUNDThe autologous tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from dendritic cells (DC) loaded ex vivo with autologous tumor lysate (TL). TLPLDC has been shown to decrease recurrence in resected Stage III/IV melanoma patients in a Phase IIb trial. The TL particle only (TLPO) vaccine is produced by loading of yeast cell wall particles with autologous TL and direct injection allowing for in vivo DC loading. We have compared the TLPO and TLPLDC vaccines in an embedded Phase I/IIa trial of a larger Phase IIb trial of the TLPLDC vaccine.METHODSPatients rendered clinically disease-free after surgery were randomized 2:1 to receive the TLPO or TLPLDC vaccine and followed for recurrence and death. Patients had scheduled intradermal inoculations at 0, 1, 2, 6, 12, and 18 months after enrollment. Kaplan-Meier and log-rank analysis were used to compare disease-free survival (DFS) and overall survival (OS) in an intention-to-treat (ITT) analysis.RESULTSSixty-three patients were randomized, 43 TLPO and 20 TLPLDC. Patients randomized to the TLPO arm were more likely to be female (37.2% vs. 10.0 %, p = 0.026), but otherwise no significant clinicopathological differences were identified. No differences in related adverse events (AE) were found between treatment arms. At a median follow-up of 20.5 months, the DFS (60.8% vs. 58.7 %, p = 0.714) and OS (94.6% vs. 93.8 %, p = 0.966) were equivalent between the TLPO and TLPLDC groups, respectively. No statistical differences were found in subgroup analyses between vaccine types, which accounted for receipt of immunotherapy and the use of G-CSF pre-blood draw.CONCLUSIONSIn a randomized, double-blind Phase I/IIa trial, there were no differences in DFS or OS in resected Stage III/IV melanoma patients receiving adjuvant TLPO versus TLPLDC vaccines. Given manufacturing advantages, further efficacy testing of TLPO is warranted in a Phase III trial.

01 Aug 2023·Journal for ImmunoTherapy of Cancer

Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis

Article

Author: Thomas, Katryna ; Van Decar, Spencer ; Hyngstrom, John ; Hale, Diane ; Yu, Xianzhong ; Vreeland, Timothy ; Kemp Bohan, Phillip ; Jakub, James ; Adams, Alexandra M ; Smolinsky, Todd ; Carpenter, Elizabeth Lee ; Hickerson, Annelies ; O'Shea, Anne E ; Cindass, Jessica ; Peoples, George E ; Valdera, Franklin A ; Faries, Mark ; Sussman, Jeffrey J ; Tiwari, Ankur ; McCarthy, Patrick ; Wagner, Thomas E ; Chick, Robert Connor ; Shaheen, Montaser F ; Berger, Adam C ; Clifton, Guy Travis

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is made by ex vivo priming matured autologous dendritic cells (DCs) with yeast cell wall particles (YCWPs) loaded with autologous tumor lysate (TL). The tumor lysate, particle only (TLPO) vaccine uses autologous TL-loaded YCWPs coated with silicate for in vivo DC loading. Here we report the 36-month prespecified analyses of this prospective, randomized, double-blind trial investigating the ability of the TLPO and TLPLDC (±granulocyte-colony stimulating factor (G-CSF)) vaccines to prevent melanoma recurrence in high-risk patients.MethodsPatients with clinically disease-free stage III/IV melanoma were randomized 2:1 initially to TLPLDC versus placebo (n=124) and subsequently TLPO versus TLPLDC (n=63). All patients were randomized and blinded; however, the placebo control arm was replaced in the second randomization scheme with another novel vaccine; some analyses in this paper therefore reflect a combination of the two randomization schemes. Patients receiving the TLPLDC vaccine were further divided by their method of DC harvest (with or without G-CSF pretreatment); this was not randomized. The use of standard of care checkpoint inhibitors was not stratified between groups. Safety was assessed and Kaplan-Meier and log-rank analyses compared disease-free (DFS) and overall survival (OS).ResultsAfter combining the two randomization processes, a total of 187 patients were allocated between treatment arms: placebo (n=41), TLPLDC (n=103), or TLPO (n=43). The allocation among arms created by the addition of patients from the two separate randomization schemes does not reflect concurrent randomization among all treatment arms. TLPLDC was further divided by use of G-CSF in DC harvest: no G-CSF (TLPLDC) (n=47) and with G-CSF (TLPLDC+G) (n=56). Median follow-up was 35.8 months. Only two patients experienced a related adverse event ≥grade 3, one each in the TLPLDC+G and placebo arms. DFS was 27.2% (placebo), 55.4% (TLPLDC), 22.9% (TLPLDC+G), and 60.9% (TLPO) (p<0.001). OS was 62.5% (placebo), 93.6% (TLPLDC), 57.7% (TLPLDC+G), and 94.6% (TLPO) (p=0.002).ConclusionsThe TLPO and TLPLDC (without G-CSF) vaccines were associated with improved DFS and OS in this clinical trial. Given production and manufacturing advantages, the efficacy of the TLPO vaccine will be confirmed in a phase 3 trial.Trial registration numberNCT02301611.

100 Deals associated with Tumor lysate particle only vaccine (Orbis Health Solutions)

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	US	LumaBridge LLCStartup	29 Nov 2023
Solid tumor	Phase 2	US	Elios Therapeutics LLC	29 Nov 2023

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