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Combination of an agonist anti-PD-1 antibody with a GnRH agonist or antagonist to treat cancer

A PD-1, agonist technology, applied in the direction of antibodies, drug combinations, antibody medical components, etc., can solve problems such as immune-related side effects

Active Publication Date: 2020-09-29
DEBIOPHARM INTERNATIONAL SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As already mentioned before, such combination therapy produces severe immune-related side effects in a substantial proportion of patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1: Phase I (phase I) study Debio 8200-IMM-101

[0074] To evaluate combination therapies according to the present disclosure, a clinical trial was designed as an open-label, single-arm Phase I study (Debio 8200-IMM-101 ) of the safety and efficacy of the combination of triptorelin and nivolumab. Study population was male adult patients with refractory / relapsed locally advanced or metastatic histologically confirmed melanoma on a regimen containing anti-PD-1 / PD-L1 (antibody) progress. Screen potentially evaluable patients.

[0075] The study plans to enroll 15 evaluable patients. If any patient became unevaluable during the study, they were replaced.

[0076] The study included 3 to 12 treatment cycles (depending on individual response) of 28 days each. Patients received a 1-month formulation of triptorelin pamoate (i.m.) 3.75 mg intramuscularly (i.m.) on Day 1 of each 28-day cycle, and on Day 1 of each cycle. Receive nivolumab at 3 mg / kg body weight intrave...

Embodiment 2

[0086] Example 2: Results of Combination Therapy for Patient A

[0087] A 71-year-old (at screening on May 23, 2018) Caucasian male patient underwent left lobectomy on September 26, 2016 for melanoma metastases of unknown origin. On August 21, 2017, a PET-CT (positron emission tomography-computed tomography) biopsy detected a new melanoma metastasis in the pancreas. He was treated with the anti-PD-1 molecule pembrolizumab from September 27, 2017 until March 13, 2018 (last dose in cycle 9). On December 12, 2017, partial responses (PRs) were objectified. However, on March 30, 2018, PET-CT showed progression (PD) of the metastases. On May 23, 2018, the size of this unique pancreatic metastasis was 34mm on CT scan.

[0088] On June 12, 2018, the patient was enrolled in regimen Debio 8200-IMM-101 and received triptorelin (with the addition of the anti-androgen bicalutamide for 28 days) and the anti-PD-1 molecule nivolumab The first injection of monoclonal antibody.

[0089] As...

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PUM

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Abstract

The present disclosure relates to a novel method of treatment of a cancer patient in which the patient is subjected to both an inhibitor of an immune check point molecule, preferably "Programmed Death1 " (PD-1) or its ligand "programmed death ligand 1" (PD-L1), and a Gonadotropin-Releasing Hormone (GnRH, also known as LHRH or FSH-RH) agonist or antagonist.

Description

[0001] field of invention [0002] The present disclosure relates to a novel method of treating cancer patients, wherein the patient is subjected to an immune checkpoint molecule, preferably "programmed death 1" (PD-1) or its ligand "programmed death ligand 1" (PD-L1) Both inhibitors and gonadotropin-releasing hormone (GnRH, also known as LHRH or FSH-RH) agonists or antagonists. [0003] Background of the invention [0004] Typically, immune destruction of tumor cells is inefficient. It now appears that this is not because cancer patients do not have a significant repertoire of T cells capable of destroying their tumors, but because cells of the adaptive and innate immune systems are held in check or their activation or pathways for their effector functions. Useful in this inhibition are so-called immune checkpoint molecules. Over the past two decades, several such checkpoint molecules have been identified. A typical molecule of this type is cytotoxic T lymphocyte antigen 4...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K39/395C07K16/28A61P35/00A61K38/08
CPCA61K45/06A61K39/3955A61P35/00A61K2300/00C07K16/2818C07K2317/75A61K2039/876A61K38/09A61K31/427A61K31/47
Inventor 斐迪南·勒热纳布鲁诺·加维勒
Owner DEBIOPHARM INTERNATIONAL SA
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