Strategic business alliance with Portrai, a spatial transcriptomics and AI-based new drug analysis company, to enter the Japanese new drug development support market

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."

SHH De Novo Completed Dosing of First Patient in China in Phase I Clinical Study for STING agonist DN015089

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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HanxBio’s Patent on FcRn Affinity is granted by Japanese Patent Office, and HX008 monoclonal antibody using this technology is included in NMPA priority review

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.

PharmaMar signs a licensing and commercialization agreement with Lotus Pharmaceutical for lurbinectedin in Taiwan

On November 11, 2021 PharmaMar S.A. (MSE:PHM) reported a licensing agreement with Lotus Pharmaceutical CO., LTD. (TWSE:1795) to commercialize the anticancer drug lurbinectedin in Taiwan (Press release, PharmaMar, NOV 11, 2021, View Source [SID1234596675]).

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Under the terms of the license and commercialization agreement, PharmaMar will receive a non-disclosed upfront payment and will be eligible for additional remunerations, including regulatory and sales milestone payments. PharmaMar will retain production rights and will sell the product to Lotus for its clinical and commercial use.

Lotus will pursue the marketing approval in Taiwan and have the right to market the product exclusively upon approval.

Lurbinectedin was granted accelerated approval by FDA (Food and Drug Administration) for the treatment of metastatic Small Cell Lung Cancer in 2020. In addition, in 2021, lurbinectedin has received marketing approval in the United Arab Emirates, Canada, Australia and Singapore.

According to Luis Mora, General Manager of PharmaMar’s Oncology and Virology Business Units:

"We are very pleased to sign this new agreement with Lotus, which will allow, if approved, to bring lurbinectedin to all appropriate patients in Taiwan."

Petar Vazharov, Chief Executive Officer of Lotus, said:

"Lung cancer has been among the top cause of death in Taiwan for decades. We are very honored to have this opportunity partnering with PharmaMar to offer the patients in Taiwan access to innovative drug, which is aligned with our key focused therapeutic area."

Biodesix to Present at the Canaccord Genuity Virtual MedTech

On November 11, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported Scott Hutton, Chief Executive Officer of Biodesix, will present in a fireside chat at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum being held virtually November 18, 2021 (Press release, Biodesix, NOV 11, 2021, View Source [SID1234595884]).

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Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum
Date: Thursday, November 18, 2021
Time: 4:30 PM ET

The fireside chat will be webcast live and available for replay under "News & Events" in the Investors section of the Company’s website at www.biodesix.com.