Autologous tumor vaccines and methods

a tumor vaccine and autologous technology, applied in the field of autologous tumor vaccines, can solve the problems of significant underestimate of the degree of intra- and inter-tumor heterogeneity, hampered antigen discovery, and cancer immunologists have not adequately trained the immune system of patients to recognize abundant foreign substances, etc., to achieve elimination of tumorigenicity, minimizing cytotoxicity, and preserving cell viability

Inactive Publication Date: 2015-04-02
VACCINOGEN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023]The method of autologous vaccine manufacture may further comprise treatment of the harvested tumor, before dissociation, with a disinfectant solution at a concentration and for a duration that provides anti-microbial activity while minimizing cytotoxicity. In another aspect, the method includes characterizing the antigenic profile of the harvested cells via DNA or RNA sequencing, flow cytometric analysis, or proteomic analysis to ensure that the heterogeneity of the patient's tumor has been preserved.
[0024]In yet another aspect, the method further comprises applying a dose of gamma radiation to the harvested cells in an amount sufficient to inactivate microorganisms, eliminate tumorigenicity, and preserve the viability of the cells to obtain sterile, non-tumorigenic, and immunogenic tumor cells.
[0025]The present invention further provides methods for eliciting an immune response to prevent the recurrence of metastases in a cancer patient in need, comprising: excisi

Problems solved by technology

Unfortunately, when most cancers (melanoma, breast, etc) have progressed to 3.5 grams, tumor burden is often systemic, immunosuppressive, and consequently not susceptible to previous treatment modalities.
In addition, previous studies significantly underestimated the degree of intra- and inter-

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Acquisition of Patient Primary Tumor Cells

[0063]Pre-production involves the acquisition of the source material (tumors) for the manufacture of an autologous vaccine and, therefore, includes all of the handling of the tumor outside the vaccine production facility. This typically comprises the surgical tumor resection, the dissection, pathological processing, and transport of the tumor to the manufacturing facility. Operating room and pathology personnel should be trained in accordance with specific protocols concerning collection and tumor processing. After resection of the tumor-containing colon specimen, the resected colon is placed in a sterile bag or basin. The resected colon will be processed within the operating suite. The resected colon is cut open, and washed in accordance with the standard operating procedure. The pathologist performs the dissection of the tumor after which the tumor is prepared for transport to the production facility. For transport, the tumor may be put in...

example 2

DTH Response Measurements

[0087]A phase I / II study (ASI-2002-01) was conducted to evaluate the safety and immunogenicity of the current (non-propagated), sterile, autologous tumor cell vaccines admixed with BCG in patients with stage II / III primary adenocarcinoma of the colon. Additionally, this study intended to demonstrate the immune response to the sterile vaccine formulation is equivalent to that of the non-sterile formulation used in previous clinical trials.

[0088]To meet the primary endpoint (DTH response measured at 48 hours after the third vaccine, which excluded BCG), a patient was considered to have a positive response to the vaccine if he / she achieved an induration of at least 5 mm. Local, regional, and systemic adverse events were monitored after each vaccine injection and full safety evaluation including physical examination, performance status, complete blood count with differential, blood chemistries, CEA, and urinalysis was conducted 3 and 6 months after surgery and 9...

example 3

ONCOVAX® Identity Assay

[0092]This Example describes methods for identifying the percentage of CD66 positive tumor cells, after propagation in nude mice, that are also 88BV59 positive by flow cytometry.

[0093]Materials and Equipment

[0094]MATERIALS: test tube 12×75 mm blue, pipet tip sterile 100 μl with filter, pipet tip sterile 1000 μl with filter, OncoVAX® identity 5EX-IgG antibody, OncoVAX® identity 5EX-88BV59 antibody, OncoVAX® identity CD66-PE antibody, fixation / permeabilization solution kit, HB (1×) without Phenol Red; 500 ml, and purified water

[0095]EQUIPMENT: Beckman Coulter FC500 flow cytometer, Eppendorf model 5415D centrifuge, refrigerator GKx 7080, digital timer, adjustable volume pipettors.

[0096]Procedure:

[0097]Sample Preparation

[0098]For each specimen a set of two (2) tubes is prepared. The tubes are labeled with IgG3 or 88BV59. The sample to be analyzed is identified (SUB / PRD). The first tube contains human 5-EX IgG3 and anti CD66-PE; the second contains 5-EX 88V59 and a...

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Abstract

Autologous anti-cancer vaccines and methods of manufacture and treatment are provided, including expansion of individual patient-derived tumor cells in an immune-compromised animal(s) to attain, quantitatively and qualitatively, sufficient material for efficacious vaccine production and utilization, to elicit an immune response against micrometastases and/or recurrence in the individual patient following tumor excision.

Description

PRIORITY CLAIM[0001]This application claims priority from U.S. Provisional Patent Application Ser. No. 61 / 883,501 filed Sep. 27, 2013, the disclosure of which is incorporated herein in its entirety.FIELD OF THE INVENTION[0002]The present invention relates to autologous cancer vaccines and methods for generating and utilizing injectable vaccine doses containing immunogenic, and metabolically-active, but non-tumorigenic, cells for personalized therapy.BACKGROUND OF THE INVENTION[0003]A 2007 review by Finke et al., Vaccine 2007; 25 (Suppl 2):B97-109; PMID:17916465, distinguished active immunotherapy “cancer vaccines” as a separate entity from passive immunotherapy, which employs immune stimulatory agents or monoclonal antibodies. This analysis indicated that it is important to use the intended study population to assess the proportion of tumors that express the target of choice and the proportion of cells within each tumor that express it. The authors were focused on appropriate antige...

Claims

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Application Information

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IPC IPC(8): A61K39/00A61K45/06C12N13/00A61K35/00
CPCA61K39/0011A61K35/13A61K2039/572C12N13/00A61K2039/5152A61K45/06A61K41/17A61P35/00A61P35/04A61P37/04A61K2039/80A61K9/0019
Inventor HANNA, JR., MICHAEL G.
Owner VACCINOGEN
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