On November 12, 2021 NOXXON Pharma N.V. (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that interim data from the ongoing Phase 1/2 GLORIA trial in brain cancer will be presented by Dr. Frank Giordano in an oral presentation at the Society for Neuro-Oncology (SNO) Annual Meeting (Press release, NOXXON, NOV 12, 2021, View Source [SID1234595294]). The meeting will take place in Boston, Massachusetts, USA from November 18 to 21, 2021.

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Dr. Frank Giordano, lead investigator of the GLORIA study, commented: "For many years, I have been focused on optimizing radiation therapy of brain cancers to offer patients more effective treatments that do not come at the costs of higher toxicity. The clinical data obtained to date from the combination of NOX-A12 with radiotherapy, that I will be presenting at the SNO, show a mild toxicity profile and at the same time encouraging efficacy. I am very much looking forward to seeing the results of six months of therapy of patients in the high-dose cohort in Q1 2022. To gather further data, we have also expanded the study to evaluate additional treatment combinations of NOX-A12 and radiotherapy."

The oral presentation entitled "CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial" will present and discuss the results of the proof-of-concept study on CXCL12 inhibition during and after radiotherapy of brain cancer. Patients enrolled are all newly diagnosed with MGMT promoter unmethylated glioblastoma (GBM), that do not respond to standard of care chemotherapy (temozolomide). Advanced MRI and multiplexed immunofluorescence of treated patient samples suggest efficacy of combined radiotherapy and CXCL12 inhibition in unmethylated GBM. In addition, outcomes of patients treated with NOX-A12 and radiotherapy will be compared to a matched historical cohort of patients who received standard of care. More information about the GLORIA study (NCT04121455) can be found at ClinicalTrials.gov.

Details of the oral presentation are as follows:

Title: CXCL12 inhibition in MGMT unmethylated glioblastoma – results of an early proof-of-concept assessment in the multicentric phase I/II GLORIA trial (NCT04121455)
Abstract: download
Session Title: Abstract Session: Clinical Trials I
Session Date: Friday, November 19, 2021
Presentation Time: 05:00 p.m. EST // 11:00 p.m. CET
Presenter: Dr. Frank Giordano, Director and Chairman of the Department of Radiation Oncology at the University Hospital Bonn, Germany
Registration: To register to the event, please click here.

The NOXXON team will attend the conference in person. A copy of the presentation will be made available on the NOXXON website at the time of Dr. Giordano’s presentation.

On November 12, 2021 Dr Olga Kondrashova from the Medical Genomics Lab at QIMR Berghofer reported that it has been awarded a $650,740 Investigator grant from the National Health and Medical Research Council (Press release, QIMR Berghofer Medical Research Institute, NOV 12, 2021, View Source [SID1234595267]).

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Dr Kondrashova will use genomic technologies to study molecular portraits of cancers including ovarian and breast cancers with faulty DNA repair to better understand how to prevent drug resistance and treat each cancer most effectively.

This important work linking cancer genomics with patient treatment responses aims to improve cancer survival rates.

We are very grateful to the National Health and Medical Research Council for supporting our cancer genomics research initiatives.

On November 11, 2021 Aix Inc. (hereinafter referred to as Aix), a company that develops and provides big data-based marketing solutions, and Portrai Inc. (hereinafter referred to as Portrai), a spatial transcriptomics and AI-based new drug analysis company, reported the companies have formed a partnership with an eye toward entering the Japanese market (Press release, Portrai, NOV 11, 2021, View Source [SID1234651827]).

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aix Co., Ltd. has entered into a business partnership with Portrai, a Korean spatial transcriptomics-based artificial intelligence (AI) new drug analysis company, in order to contribute to and smoothly enter the Japanese AI new drug development market.

Portrai was founded by four active doctors, centered around Seoul National University Hospital and a professor at Seoul National University in Korea. When developing new drugs, Portrai has the technology to explore complex cellular and molecular mechanisms related to drugs under development by comparing images of drug distribution within tissues with spatial transcriptomics data. Spatial transcriptomics technology is a technology that can grasp the positional information of each cell in the tissue section space and perform gene expression profiling for each cell. In new drug development research, it is a cutting-edge biotechnology that can be widely applied to drug treatment mechanisms, drug efficacy prediction, etc.

Portrai’s "PortraiDRUG" technology combines spatial transcriptomics analysis with biomolecular imaging technology to integrate the fine distribution location of drugs in lesions and genetic information obtained from spatial transcriptomics analysis. In addition, it is possible to analyze actual drug-induced changes in expression and signaling systems at the cellular level, making it an effective method for evaluating treatment responses when developing new drugs that require huge budgets.

"PortraiTME" technology introduces AI as an image analysis method in addition to spatial transcriptomics technology, and is useful as a platform for analyzing the detailed environment of various cancer cells, including cell types, and developing biomarkers.

The two companies have agreed to share their business experience in Japan and Korea, including knowledge related to AI and local patenting processes, and to jointly promote the provision of technology in Japan and the construction of an AI service model. The two companies signed an MOU on November 7th this year and plan to collaborate on surveying needs for new drug AI analysis services, localizing new drug AI analysis services in Japan, and managing related patents in the Japanese region.

Protrai’s CEO Lee (specialist physician) said he hopes to demonstrate his track record in proving the company’s superiority and commercialization potential in the Japanese market through the lineup of Portrait TARGET (technology for discovering molecular targets for new drugs), Portrai MOA (technology for exploring drug mechanisms), and Portrai DRUG (technology for evaluating drug distribution and value), which are currently under development.

Our company’s CEO Min said of the significance of this partnership, "We want to continue to strengthen our AI bio business, which we expect to be a growth area within AI, and continue to produce results in order to establish ourselves as a specialized bridge company in the field of AI-based solution services in Japan and Korea."

On November 11, 2021 Shanghai De Novo Pharmatech reported achievement of important First-in-Human milestone in China in phase I Trials with the novel investigational STING agonist DN015089 (Press release, De Novo Pharmatech, NOV 11, 2021, View Source;NewsCateID=38&CateID=38 [SID1234649251]). This Phase Ia/Ib open-label, multi-center study is designed to investigate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary antitumor activity of DN015089 monotherapy in Chinese patients with advanced solid tumors (CTR20212462).

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On November 11, 2021 HanX Biopharmaceuticals reported PCT patent "Method for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life" has been officially authorized by the Japan Patent Office (Press release, HanX Biopharmaceuticals, NOV 11, 2021, View Source [SID1234647314]).

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The present invention discloses a platform technology for improving the binding affinity of IgG antibodies to FcRn and prolonging their serum half-life. This technology can effectively improve the binding affinity of IgG antibodies to FcRn and prolong their serum half-life. Moreover, the binding affinity of the modified IgG antibodies to the corresponding antigen will not be reduced. Based on this patented technology, Hans Bio has independently developed a number of long-acting monoclonal antibody and bispecific antibody projects, including the long-acting anti-human PD-1 monoclonal antibody HX008.

HX008 (also known as "Putelimab") is a humanized anti-PD-1 monoclonal antibody developed by Hans Biotech and its former subsidiary Taizhou Hanzhong Biotech. It uses FcRn modification technology for differentiated design, and transforms the Fc of IgG4 to extend the half-life, reduce the number of dosing, reduce treatment costs, and improve patient drug compliance. The results of Phase I clinical trials show that the half-life of the product is 17-23 days for a single dose, and the half-life can reach 18-38 days after stabilization. Hans Biotech led the pharmaceutical evaluation, preclinical research and development, and early clinical research of the HX008 project. In 2018, Lepu Biotech acquired the controlling stake of Taizhou Hanzhong and obtained the right to market and sell the product.

So far, HX008 has conducted multiple Phase II and Phase III clinical trials. Two of the registration clinical trials: advanced melanoma and multiple advanced solid tumors with MSI-H/dMMR, have been submitted to the NMPA for marketing.