Agenus Prophage (Heat-Shock Protein Peptide Complex-96) Vaccine

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Drug Name Agenus Prophage (Heat-Shock Protein Peptide Complex-96) Vaccine
Overview Agenus Prophage (Heat-Shock Protein Peptide Complex-96) Vaccine is currently in Phase II clinical trials for treating recurrent heavily pretreated glioblastoma multiforme and newly diagnosed glioblastoma, showing promising results with median survival times of approximately 9.8 months for recurrent cases and 23.8 months when combined with the Stupp protocol for newly diagnosed cases. While not yet FDA-approved, the vaccine could enhance progression-free survival, reflecting a novel immunotherapy approach aimed at improving outcomes in a challenging disease with limited treatment options.
FDA Approval In clinical trials; not yet FDA-approved
Used for Recurrent heavily pretreated glioblastoma multiforme (GBM) and newly diagnosed GBM
Clinical Trial Phase Phase II
Clinical Trial Explanation Not specified
Common Side Effects Not explicitly detailed; similar immunotherapy treatments often include flu-like symptoms, injection site reactions, fatigue
OS without Historical controls suggest a median survival time of 6 months for recurrent GBM
OS with Median survival of 42.6 weeks (~9.8 months) in recurrent GBM; Median survival of 23.8 months in newly diagnosed GBM when combined with the Stupp protocol
PFS without Typically less than 7 months for newly diagnosed GBM under standard treatment
PFS with 17.8 months for newly diagnosed GBM, possibly the longest PFS seen in a phase II trial for GBM
Usefulness Rating 4
Usefulness Explanation The vaccine shows promise, especially in extending progression-free survival in newly diagnosed GBM. It offers a novel approach by leveraging the patient's immune system, potentially improving outcomes in a disease with few effective treatments.
Toxicity Level 2
Toxicity Explanation While specific side effects are not detailed, similar vaccines have been associated with manageable side effects like flu-like symptoms, suggesting a relatively low toxicity level.


Links: https://delta.larvol.com/Products/?ProductId=2a41421b-2069-4661-ab62-7631bc4eb36d, https://synapse.patsnap.com/drug/9269a1e8dda548e9babb2434396151ed

From Ben Williams Book: A variation in the use of dendritic cells first subjected tumor tissue to a heat-shock treatment to elevate the expression of heat-shock proteins, which were extracted from the blood and incubated with dendritic cells from individual patients. In a clinical trial (163) conducted at UCSF and Columbia for patients with recurrent heavily pretreated tumors, the vaccine produced a median survival of 42.6 weeks (about 9.8 months), which compares favorably to the 6-month survival time for historical controls, and is comparable to the 9-11 months when Avastin is used with patients with recurrent tumors.

A subsequent news release from Agenus, Inc, a biotech company sponsoring the research, reported the results of phase II clinical trial in which the heat-shock dendritic vaccine was combined with the standard Stupp protocol (164). Median progression-free survival was 17.8 months and median survival was 23.8 months. This median progression-free survival of 17.8 months is perhaps the longest PFS yet seen in any substantially sized phase 2 trial for newly diagnosed glioblastoma.

Follow-up data (reference 339, abstract 2011) presented at the ASCO 2015 conference revealed that patients with high PD-L1 expression (the ligand for the PD-1 immune checkpoint on the surface of immune cells which is the target for the therapeutic antibodies nivolumab and pembrolizumab) had a median survival of 18 months, while those with low expression of PD-L1 had a median survival of 44.7 months. This finding suggests that efficacy of the heat shock protein peptide vaccine could be greatly improved by co-administration of PD-1 antibodies such as nivolumab or pembrolizumab.Property "Has original text" (as page type) with input value "A variation in the use of dendritic cells first subjected tumor tissue to a heat-shock</br>treatment to elevate the expression of heat-shock proteins, which were extracted from the</br>blood and incubated with dendritic cells from individual patients. In a clinical trial (163)</br>conducted at UCSF and Columbia for patients with recurrent heavily pretreated tumors,</br>the vaccine produced a median survival of 42.6 weeks (about 9.8 months), which</br>compares favorably to the 6-month survival time for historical controls, and is</br>comparable to the 9-11 months when Avastin is used with patients with recurrent tumors.</br></br>A subsequent news release from Agenus, Inc, a biotech company sponsoring the research,</br>reported the results of phase II clinical trial in which the heat-shock dendritic vaccine was</br>combined with the standard Stupp protocol (164). Median progression-free survival was</br>17.8 months and median survival was 23.8 months. This median progression-free</br>survival of 17.8 months is perhaps the longest PFS yet seen in any</br>substantially sized phase 2 trial for newly diagnosed glioblastoma.</br></br>Follow-up data (reference 339, abstract 2011) presented at the ASCO 2015 conference</br>revealed that patients with high PD-L1 expression (the ligand for the PD-1 immune</br>checkpoint on the surface of immune cells which is the target for the therapeutic</br>antibodies nivolumab and pembrolizumab) had a median survival of 18 months, while</br>those with low expression of PD-L1 had a median survival of 44.7 months. This finding</br>suggests that efficacy of the heat shock protein peptide vaccine could be greatly improved</br>by co-administration of PD-1 antibodies such as nivolumab or pembrolizumab." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.

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