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Bihaptenized autologous vaccines and uses thereof

A hapten and autologous technology, applied in the direction of vaccines, multivalent vaccines, cancer antigen components, etc., can solve the problem of initial tumor insensitivity tumors

Pending Publication Date: 2021-08-17
BIOVAXYS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although these checkpoint therapies have been somewhat effective, issues remain of initial tumor insensitivity, acquired resistance, or previously responsive tumors becoming checkpoint therapy resistant

Method used

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  • Bihaptenized autologous vaccines and uses thereof
  • Bihaptenized autologous vaccines and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] Example 1. Preparation of autologous double haptenized tumor vaccine

[0163] Processing Fresh Tumor Samples

[0164] Freshly excised tumor samples were placed in sterile disposable containers with approximately 150 ml of Hank's Balanced Salt Solution (HBSS) containing 20 μg / ml gentamicin. Tumor samples were stored at 4°C until further processing. Samples were never stored for more than about 96 hours before initiating further processing.

[0165] In a biosafety cabinet, tumor tissue is minced and then mechanically dissociated to generate a tumor cell suspension. Tumor cell suspensions were counted, aliquoted into sterile cryovials, frozen in a controlled rate freezer, and stored in liquid nitrogen.

[0166] double haptenization

[0167] Cells were thawed and washed with HBSS. Cells were then irradiated to a total dose of 2500 cGy of gamma rays. Next, the inactivated cells were divided into two equal aliquots: the first aliquot was modified with DNP by a 30 min ...

Embodiment 2

[0170] Example 2. Personalized Diagnostic Tests

[0171] Personalized diagnostic testing includes evaluation of delayed-type hypersensitivity (DTH) responses to autologous personalized tumor vaccines and comparison with negative controls.

[0172] Diagnosis is individualized because the reagent that elicits a DTH response is an autologous individualized tumor vaccine manufactured using the patient's own tumor tissue.

[0173] On the side of the patient's arm, an area of ​​skin is selected for diagnostic testing. This area is called the test area. Intradermal injections usually contain Hank's Balanced Salt Solution and a negative control of human serum albumin to form vesicles. In the adjacent area, intradermally inject approximately 3 × 10 6Autologous individualized tumor vaccine of individual cells to form small vesicles.

[0174] After approximately 48 hours, the test area was visually inspected and the diameters of induration, wheal, and erythema of the positive contr...

Embodiment 3

[0178] Example 3. Typical co-administration schedule

[0179] The table below shows an exemplary administration schedule for a dual haptenized vaccine and an immune checkpoint inhibitor, in this example Keytruda™ (pembrolizumab).

[0180] events and timing describe week 1, day 1 First dual haptenized vaccine administered without adjuvant Week 1, Day 7 Cyclophosphamide 300 mg / m via rapid IV infusion 2

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Abstract

In some embodiments, methods of treating cancer, including metastatic cancers, cancers that are resistant to immune checkpoint inhibitor therapy, and cancers that do not respond to immune checkpoint inhibitor therapy or have acquired resistance to immune checkpoint inhibitor therapy are disclosed.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 735,381, filed September 24, 2018, and U.S. Provisional Patent Application No. 62 / 746,066, filed October 16, 2018, which are hereby Entirely incorporated by reference. technical field [0003] The invention described herein relates generally to methods of treating metastatic cancer, and more particularly, but not exclusively, to the use of autologous vaccines in combination with other treatments. Background technique [0004] Immunotherapy protocols using unmodified, whole tumor cells prepared from patient-derived tumors have been extensively described in the literature (see, e.g., Berd et al., Cancer Research 1986;46:2572-2577; Hoover et al., Cancer 1985; 55:1236-1243; and US Patent No. 5,484,596 to Hanna et al.). Alternative vaccine compositions based on the destruction of cells, including, for example, tumor cell membranes have als...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12N5/09C07K14/705A61K35/13
CPCC07K14/705C07K14/70575A61K35/13A61P35/04C07K16/2818A61K39/39541A61K39/0011A61K2039/55594A61K2039/6012A61K2039/70A61K2039/5152A61K2039/545A61K2300/00
Inventor D·伯德
Owner BIOVAXYS LLC
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