Delving into the Latest Updates on Oncophage, NewVac adjuvanted(Agenus, Inc.) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Endoplasmin (human tumor rejection antigen 1), Heat shock protein-peptide complex-96 vaccine, Vitespen

+ [8]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Renal Cell Carcinoma

Inactive Indication

Follicular LymphomaGlioblastoma MultiformeGliosarcoma+ [9]

Originator Organization

Agenus, Inc.

Active Organization

Agenus, Inc.

Inactive Organization

Chemrar Pharma

License Organization

NewVac LLC

Agenus, Inc.

Drug Highest PhaseApproved

First Approval Date

Russia (08 Apr 2008),

Renal Cell Carcinoma

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 616720719

Source: *****

Background:
Glioblastoma (GBM) refers to a specific kind of brain cancer called glioblastoma. The standard treatment for GBM is radiation plus temozolomide, an oral chemotherapy drug. Pembrolizumab is an immune therapy that is now used to treat other cancers. The addition of pembrolizumab to the standard treatment of radiation and temozolomide has been shown to be well tolerated. Researchers want to see if adding a vaccine made from the person's own tumor will improve the effect of the pembrolizumab. The vaccine which is developed from fresh tumor taken at the time of surgery is called heat shock protein peptide complex-96 (HSPPC-96).
Objectives:
To see if the adding of pembrolizumab and HSPPC-96 improves the standard treatment for glioblastoma.
Eligibility:
Adults at least 18 years old with glioblastoma.
Design:
Participants will be screened with typical cancer tests:
Brain scan
Medical history
Blood and urine tests
Questions about quality of life and symptoms
These tests will be repeated throughout the study.
Participants will have surgery to remove their tumor. A tissue sample from the tumor will be sent to a lab. A vaccine will be made from it.
Some participants will get pembrolizumab and vaccine. Some will get pembrolizumab and placebo. Participants will not know which they get.
Participants will get radiation for 6 weeks.
Participants will take temozolomide by mouth before each treatment.
Participants will get pembrolizumab by intravenous (IV) for 30 minutes 3 times over the radiation cycle.
Participants will keep taking the 2 drugs every few weeks for about a year. Some may take pembrolizumab for an additional year.
Most participants will get the vaccine or placebo after radiation. They will get it 5 times over 6 weeks. Some participants will continue to get the vaccine every few weeks for 1 or 2 years.
Participants will repeat the screening tests when they stop study treatment. They will also have follow-up phone calls.

Start Date21 Sep 2017

Sponsor / Collaborator

National Cancer Institute

NCT02722512

/ TerminatedPhase 1IIT

A Phase I and Feasibility Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Pediatric Patients With Newly Diagnosed Intracranial High Grade Glioma and Recurrent Resectable Intracranial High Grade Glioma and Ependymoma

The purpose of this study is to determine whether Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine is an feasible and safe treatment for pediatric patients with newly-diagnosed High-Grade Gliomas or recurrent, resectable High-Grade Gliomas and Ependymomas.

Start Date01 Jul 2016

Sponsor / Collaborator

Ann & Robert H. Lurie Children's Hospital of Chicago

[+1]

NCT02452281

/ WithdrawnPhase 1/2IIT

Phase I-II Pilot Study to Evaluate the Immune-mediated Effects of an Autologous Tumor-derived Heat Shock Protein-peptide Complex 96 (HSPPC-96) Combined With Ipilimumab in Patients With Therapeutically Unresectable Stage III or Stage IV Malignant Melanoma

The purpose of this research study is to see if the combination of HSPPC-96 and ipilimumab is safe and effective in the treatment of advanced melanoma. HSPPC-96 is an investigational vaccine created from tissue from the patient's tumor. The vaccine is designed to capture the cancer's "fingerprint." Injection of the vaccine may cause the patient's immune system to recognize and attack any cells with the specific cancer fingerprint. Ipilimumab is a drug approved by the FDA for the treatment of metastatic melanoma that boosts immune response.

Start Date01 Dec 2015

Sponsor / Collaborator

University of Texas Health Science Center at Houston

[+1]

100 Clinical Results associated with Oncophage, NewVac adjuvanted(Agenus, Inc.)

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100 Translational Medicine associated with Oncophage, NewVac adjuvanted(Agenus, Inc.)

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100 Patents (Medical) associated with Oncophage, NewVac adjuvanted(Agenus, Inc.)

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43

Literatures (Medical) associated with Oncophage, NewVac adjuvanted(Agenus, Inc.)

01 Jan 2020·OncoimmunologyQ2 · MEDICINE

T cell receptor repertoire as a prognosis marker for heat shock protein peptide complex-96 vaccine trial against newly diagnosed glioblastoma

Q2 · MEDICINE

ArticleOA

Author: Alexander, Peter B. ; Wang, Liuyang ; Ji, Nan ; Zhang, Yang ; Wu, Haiyang ; Mudgal, Poorva ; Huang, Na ; Li, Qi-Jing ; Gao, Zhixian

Glioblastoma multiforme (GBM) is the most common primary malignant brain tumor in adults with a dismal prognosis. We previously reported that vaccination with heat shock protein peptide complex-96 (HSPPC-96) improves survival in patients with newly diagnosed GBM (NCT02122822). Especially for patients with a strong antitumor immune response after vaccination, a durable survival benefit can be achieved. Here, we conducted T cell receptor (TCR) sequencing to retrospectively examine the TCR repertoires of tumor-infiltrating lymphocytes in long-term survivors (LTS) and short-term survivors (STS). We found that LTS exhibit lower TCR repertoire diversity compared with STS, indicating the prevalence of dominant TCR clones in LTS tumors. Accordingly, the LTS group showed increased inter-patient similarity, especially among high-frequency TCR clones, implying some of these dominant clones are shared among LTS. Indeed, we discovered four TCR clones significantly enriched in the LTS group: the presence of these clones has predictive value for stratifying patients prior to vaccination. Together, these findings uncover a group of preexisting TCR clones shared in LTS that can be utilized as candidate biomarkers to select GBM patients most likely to durably respond to HSPPC-96 treatment.

17 May 2018·JCI insightQ1 · MEDICINE

Heat shock protein peptide complex-96 vaccination for newly diagnosed glioblastoma: a phase I, single-arm trial

Q1 · MEDICINE

ArticleOA

Author: Zhang, Yang ; Hao, Shuyu ; Xie, Jian ; Liu, Yunpeng ; Ji, Nan ; Wang, Yi ; Gao, Zhixian

BACKGROUND:

Heat shock protein peptide complex-96 (HSPPC-96) triggers adaptive and innate antitumor immune responses. The safety and efficacy of HSPPC-96 vaccination was examined in patients with newly diagnosed glioblastoma multiforme (GBM).

METHODS:

In this open-label, single-arm, phase I study, adult patients were vaccinated with HSPPC-96 in combination with the standard treatment for newly diagnosed GBM after surgical resection. Primary endpoints were frequency of adverse events and progression-free survival (PFS) at 6 months. Secondary endpoints included overall survival (OS), PFS, and tumor-specific immune response (TSIR).

RESULTS:

A total of 20 patients with newly diagnosed GBM were enrolled from September 2013 to February 2015. No grade 3 or 4 vaccine-related adverse events were noted. After a median follow-up of 42.3 months, PFS was 89.5% (95% CI, 66.9%-98.7%) at 6 months, median PFS was 11.0 months (95% CI, 8.2-13.8), and median OS was 31.4 months (95% CI, 14.9-47.9). TSIR was significantly increased by 2.3-fold (95% CI, 1.7-3.2) after vaccination. Median OS for patients with high TSIR after vaccination was >40.5 months (95% CI, incalculable) as compared with 14.6 months (95% CI, 7.0-22.2) for patients with low TSIR after vaccination (hazard ratio, 0.25; 95% CI, 0.071-0.90; P = 0.034). A multivariate Cox regression model revealed TSIR after vaccination as a primary independent predicator for survival.

CONCLUSION:

The HSPPC-96 vaccination, combined with the standard therapy, is a safe and effective strategy for treatment of newly diagnosed GBM patients. TSIR after vaccination would be a good indicator predicting the vaccine efficacy.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02122822.

FUNDING:

National Key Technology Research and Development Program of the Ministry of Science and Technology of China (2014BAI04B01, 2014BAI04B02), Beijing Natural Science Foundation (7164253), Beijing Talents Fund (2014000021469G257), and Shenzhen Science and Technology Innovation Committee (JSGG20170413151359491).

01 Jun 2017·Breast cancer research and treatmentQ2 · MEDICINE

Efficacy and safety of nab-paclitaxel 125 mg/m2 and nab-paclitaxel 150 mg/m2 compared to paclitaxel in early high-risk breast cancer. Results from the neoadjuvant randomized GeparSepto study (GBG 69)

Q2 · MEDICINE

Article

Author: Aktas, Bahriye ; Warm, Mathias ; Schmatloch, Sabine ; Just, Marianne ; Gerber, Bernd ; Nekljudova, Valentina ; von Minckwitz, Gunter ; Wiebringhaus, Hermann ; Costa, Serban Dan ; Untch, Michael ; Kümmel, Sherko ; Jackisch, Christian ; Paepke, Stefan ; Hackmann, John ; Denkert, Carsten ; Furlanetto, Jenny ; Schneeweiss, Andreas ; Hanusch, Claus ; Blohmer, Jens Uwe ; Loibl, Sibylle ; Clemens, Michael

PURPOSE:

The GeparSepto study demonstrated that the use of nab-paclitaxel instead of paclitaxel prior to anthracycline-based chemotherapy could lead to a significantly increased pCR rate, especially in the triple negative subpopulation. We report efficacy and safety for patients treated with two different doses of nab-paclitaxel in comparison to weekly solvent-formulated paclitaxel.

METHODS:

Patients were treated for 12 weeks with either intravenous nab-paclitaxel 150 mg/m² (nP150) weekly, after study amendment 125 mg/m² (nP125) weekly or solvent-based paclitaxel 80 mg/m² (P80) weekly followed by epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² on day 1 for four 3-week cycles.

RESULTS:

229 patients received nP150, 377 nP125. Baseline characteristics were fairly balanced between these two sequential cohorts as well as compared to 601 patients receiving P80 except for hormone receptor status, HER2 status, and Ki67. Taxane treatment was discontinued in 26.8% (nP150), 16.6% (nP125), and 13.3% of (P80) patients, respectively. Median relative total dose intensity (mRTDI) based on 125 mg/m² for nP was 103% with nP150, 95% with nP125, 99% with P80 before and 98% with P80 after the amendment. PSN grade 3-4 was observed in 14.5% of patients with nP150, 8.1% of patients with nP125 (p = 0.018), and 2.7% of patients with P80. Overall pCR before the amendment was 33.6% after nP150 and 23.5% after P80 (OR 1.65 [95% CI 1.10-2.50]; p = 0.022); pCR after the amendment was 41.4% after nP125, and 32.4% after P80 (1.48 [95% CI 1.10-1.99]; p = 0.013).

CONCLUSIONS:

Nab-paclitaxel 125 mg/m² was associated with a better safety profile and compliance without compromising the efficacy compared to nab-paclitaxel 150 mg/m².

100 Deals associated with Oncophage, NewVac adjuvanted(Agenus, Inc.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06400

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	Russia	Agenus, Inc.	08 Apr 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis	Phase 3	United States	Agenus, Inc.	29 May 2001
Locally Advanced Renal Cell Carcinoma	Phase 3	United States	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Austria	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Belgium	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Canada	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	France	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Israel	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Norway	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Poland	Agenus, Inc.	01 Jun 2000
Locally Advanced Renal Cell Carcinoma	Phase 3	Spain	Agenus, Inc.	01 Jun 2000

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Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01147536 (CTgov)	Phase 2	Renal Cell Carcinoma	12	HSPPC-96	auibyamomt(nirbbmyopd) = vazzldxlpp dwbsnkyymi (vtrvulhjfe, zauzbjiqna - skqetvtdsp) View more	-	03 Jun 2021
NCT00293423 (CTgov)	Phase 1/2	Recurrent Glioma \| Recurrent Malignant Glioma	96	Standard Surgical Resection+HSPPC-96 (Phase 1: Vaccine)	wotbrynlxj = cmjoamreln otlhuihlmd (yuxznsfguq, yjtuihklfr - oihqiduuws) View more	-	13 May 2021
NCT00293423 (CTgov)	Phase 1/2	Recurrent Glioma \| Recurrent Malignant Glioma	96	Standard Surgical Resection+HSPPC-96 (Phase 2: Vaccine)	iwcddaofmk(ujqcbkssck) = qvtqtqwidx jmxrocqpgr (knheqdsrwd, qcmdivijkc - debqvottbg) View more	-	13 May 2021
NCT00905060 (HeatShock, CTgov)	Phase 2	Glioblastoma Multiforme	70	Standard Surgical Resection+Temozolomide+HSPPC-96	ydcrhzlner = fddoxtymun ccpcpswqgi (gkolymsdqt, xmozouhdof - qfeuxrkfue) View more	-	24 Mar 2021
NCT01814813 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	90	Bevacizumab+HSPPC-96 (Arm 1, HSPPC-96 + Concomitant Bevacizumab)	eonvtztyom(tgbxqosutz) = xljnwfbrtm abyspgcbkg (ungymmcpew, nbqayakgaf - bzcqcouduc) View more	-	12 Jun 2019
NCT01814813 (CTgov)	Phase 2	Gliosarcoma \| Recurrent Glioblastoma	90	Bevacizumab+HSPPC-96 (Arm 2, HSPPC-96 With Bevacizumab at Progression)	eonvtztyom(tgbxqosutz) = gaifptlesc abyspgcbkg (ungymmcpew, ygjmehfxas - vswvwwquln) View more	-	12 Jun 2019
NCT00905060 (ASCO2015)	Phase 2	Glioblastoma	46	Autologous heat shock protein peptide vaccine	ddzwbxsilq(wnipuvkvmw) = regdwfkmco jvpbrgdypr (pjtlldnewv )	-	20 May 2015
NCT00293423 (Pubmed \| Neuro Oncol)	Phase 2	Recurrent Glioblastoma	41	Heat-shock protein peptide complex-96 vaccine	speyvvqdqb(sxdmzjcecg) = sgwywzzhml clmddpywpw (erzbnsshzl, 34.7 - 50.5)	-	01 Jan 2014
ASCO2011	Phase 2	Recurrent Glioblastoma	33	Autologous heat shock protein vaccine (HSPPC-96) (HSPPC-96)	kytfzgmbfc(kmjruzjbqu) = kwviumpgva ibzfpuffxp (loxuabjifk )	Positive	20 May 2011
ASCO2008	Phase 2	Lung Cancer	14	HSPPC-96	vaxnymirot(kdpphxcyvz) = twdvrxvfvb ucfznfqndt (siyqnexcxp )	-	20 May 2008
ASCO2006	Phase 3	Malignant melanoma stage IV	322	Vitespen	gmrpnzgzqs(sxtrsylezd) = wbwssvczzm fsosrpptgs (bkkpenwqbz ) View more	-	20 Jun 2006
ASCO2006	Phase 3	Malignant melanoma stage IV	322	Physician's choice (PC)	gmrpnzgzqs(sxtrsylezd) = kysbpkqvya fsosrpptgs (bkkpenwqbz ) View more	-	20 Jun 2006
ASCO2004	Phase 2	Malignant melanoma stage IV	28	HSPPC-96	iwsctdscoq(svxypporjb) = tfppixbypq gtzjlthsed (waqxomiksp ) View more	-	15 Jul 2004