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Personalized delivery vector-based immunotherapy and uses thereof

A technology of immunotherapy and carrier, which is applied in the direction of carrier, nucleic acid carrier, gene therapy, etc., and can solve problems such as the difficulty of clarifying clinical benefits

Inactive Publication Date: 2018-03-27
ADVAXIS
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, using only one therapeutic immunotherapy approved by the FDA at the time of writing, it has proven difficult to demonstrate a clear clinical benefit associated with these treatments

Method used

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  • Personalized delivery vector-based immunotherapy and uses thereof
  • Personalized delivery vector-based immunotherapy and uses thereof
  • Personalized delivery vector-based immunotherapy and uses thereof

Examples

Experimental program
Comparison scheme
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preparation example Construction

[0701] Methods of making these fragments are known in the art. (See, eg, Harlow and Lane, Antibodies: A Laboratory Manual, Cold Spring Harbor Laboratory, New York, 1988, which is incorporated herein by reference).

[0702] In some embodiments, antibody fragments can be prepared by proteolysis of antibodies or by expression of DNA encoding the fragments in E. coli or mammalian cells (eg, Chinese hamster egg cell culture or other protein expression systems).

[0703] In some embodiments, antibody fragments can be obtained by pepsin or papain digestion of whole antibodies by conventional methods. For example, antibody fragments can be obtained as F(ab') by enzymatic cleavage of antibodies with pepsin. 2 The indicated 5S fragment was prepared. This fragment can be further cleaved using a thiol reducing agent, and optionally a capping group using a thiol group obtained from cleavage of the disulfide bond, to generate a 3.5S Fab' monovalent fragment. Alternatively, enzymatic clea...

example 1-2

[1085] cell line

[1086] C57BL / 6 syngeneic TC-1 tumors were immortalized with HPV-16 E6 and E7 and transformed with the c-Ha-ras oncogene. TC-1 provided by T.C. Wu (Johns Hopkins University School of Medicine, Baltimore, MD) are highly tumorigenic lung epithelial cells that express low levels of HPV-16 E6 and E7 and are transformed by the c-Ha-ras oncogene . Keep TC-1 at 37°C and 10% CO 2 Grow in RPMI 1640, 10% FCS, 2mM L-glutamine, 100U / ml penicillin, 100μg / ml streptomycin, 100μM non-essential amino acids, 1mM sodium pyruvate, 50 micromolar (mcM) 2-ME, 400 Micrograms (mcg) / mlG418 and 10% National Collection Type Culture-109 medium (National Collection Type Culture-109 medium). C3 are mouse embryonic cells from C57BL / 6 mice immortalized with the complete HPV 16 genome and transformed with pEJ-ras. EL-4 / E7 is thymoma EL-4 transduced with E7 retrovirus.

[1087] Listeria monocytogenes strains and reproduction

[1088] The Listeria strain used was Lm-LLO-E7, also referred ...

example 1

[1105] Example 1: LLO-antigen fusions induce anti-tumor immunity

[1106] result

[1107] The ability of Lm-E7 and Lm-LLO-E7 to affect the growth of TC-1 was compared. Subcutaneous tumors were established on the left flank of C57BL / 6 mice. Seven days later, the tumor had reached a palpable size (4-5mm). On days 7 and 14, mice were inoculated with 0.1 LD 50 Lm-E7, Lm-LLO-E7 or Lm-Gag and Lm-LLO-NP as controls. Lm-LLO-E7 induced complete regression of 75% of established TC-1 tumors, while tumor growth was controlled in the other 2 mice in the group ( image 3 ). In contrast, immunization with Lm-E7 and Lm-Gag did not induce tumor regression. The experiment was repeated several times, always with very similar results. In addition, Lm-LLO-E7 also obtained similar results under different immunization schemes. In another experiment, a single immunization was able to cure established 5 mm TC-1 tumors in mice.

[1108] In other experiments, similar results were obtained with ...

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Abstract

The invention provides a system of providing and creating personalized immunotherapeutic compositions for a subject having a disease or condition, including therapeutic immunotherapy delivery vectorsand methods of making the same comprising gene expression constructs expressing peptides associated with one or more neo-epitopes or peptides containing mutations that are specific to a subject's cancer or unhealthy tissue. A delivery vector of the invention includes bacterial vectors including Listeria bacterial vectors; or viral vectors, peptide immunotherapy vectors; or DNA immunotherapy vectors, comprising one or more fusion proteins comprising one or more peptides comprising one or more neo-epitopes present in disease-bearing biological samples obtained from the subject. This invention also provides methods of using the delivery vector for inducing an immune response against a disease or condition, including a tumor or cancer, or an infection, or an autoimmune disease or an organ transplant rejection in the subject.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Application No. 62 / 166,591, filed May 26, 2015, U.S. Application No. 62 / 174,692, filed June 12, 2015, and U.S. Application No. 62 / 218,936, filed September 15, 2015, Each of these applications is hereby incorporated by reference in its entirety for all purposes. [0003] References to Sequence Listings Submitted as Text Files via the EFS Network [0004] The sequence listing written in the file SEQLIST_ST25.txt is 488 kb, created on May 25, 2016, and is incorporated herein by reference. technical field [0005] The present invention provides a personalized immunotherapy composition comprising a therapeutic immunotherapy delivery vehicle for use in a subject with a disease or condition, and methods of making said composition comprising gene expression constructs The subject expresses a peptide associated with one or more neoepitopes or a peptide containing a mutation specific t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K48/00A61K38/16C07K14/195C12N15/74
CPCA61K48/00C07K14/195C12N2710/20034A61K39/0011A61K2039/523C12N15/62A61P31/04A61P31/12A61P33/00A61P35/00Y02A50/30A61K39/001193A61K39/001184A61K39/001176A61K39/001194A61K39/001119A61K39/001188A61K39/001191A61K39/00115A61K39/001106A61K39/001151A61K39/001157A61K39/001158A61K39/001164A61K39/001182A61K39/00119A61K39/001156A61K39/001153A61K39/001186C12Q1/6806C12Q2535/122C12Q2537/165A61K38/164A61K48/0008C12N15/74C12N2510/02C12N2800/101A61K39/02A61K2039/522A61K2039/585C07K2319/00C12N1/20C12N7/00C12Q1/6886
Inventor R·珀蒂K·佩里麦可·F·宾矽欧塔D·J·奥康纳
Owner ADVAXIS
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