On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

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AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."

On November 30, 2020 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY) reported that it has completed its conversion into an N.V., a public company under the laws of the Netherlands (naamloze vennootschap, "N.V.") effective from 28 November 2020 (Press release, Vivoryon Therapeutics, NOV 30, 2020, View Source [SID1234571935]). The Company will from that moment operate under the registered name Vivoryon Therapeutics N.V. and its statutory seat will be in Amsterdam, the Netherlands, while the administrative headquarters and the business operations will remain in Germany with locations in Halle (Saale) and Munich. The new legal form has no impact on the Company’s day-to-day operations.

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As a consequence of the conversion, the shareholders of Vivoryon Therapeutics AG will automatically become shareholders of Vivoryon Therapeutics N.V.. The shares will be trading under a new ISIN NL00150002Q7. The last trading date of the shares under the ISIN DE0007921835 and the first trading day of the shares under the new ISIN NL00150002Q7 will be announced as soon as possible by a press release . The central securities depository for the shares under ISIN NL00150002Q7 will be Euroclear Nederland (Nederlands Centraal Instituut voor Giraal Effectenverkeer B.V.). Trading in Vivoryon Therapeutics shares will not be affected by the conversion.

Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics N.V., commented: "This conversion into anN.V. reflects the continued international focus of Vivoryon Therapeutics. We are convinced that this corporate transformation will be a gateway to new international investors and may also provide access to additional capital markets, such as the US stock market via an ADR program or a full NASDAQ listing, even though there are currently no specific plans in this regard. We look forward to continuing to execute on our growth strategy with additional opportunities gained by this corporoate conversion."

On November 30, 2020 GENFIT (Nasdaq and Euronext: GNFT) a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, today announces that (Press release, Genfit, NOV 30, 2020, View Source [SID1234571969]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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•the reverse book building process for the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022 ("OCEANEs") achieved satisfactory results and ended on November 27, 2020 (COB) as planned;

•the Bond Purchase Agreements from investors having tendered their OCEANEs will be collected as quickly as possible and once the process is completed, GENFIT will communicate the final results of the partial buyback.

On November 30, 2020 Agilent Technologies Inc. (NYSE: A) reported the launch of the Biomarker Pathologist Training Program, a global initiative created to empower pathologists to score biomarkers accurately and confidently (Press release, Agilent, NOV 30, 2020, View Source [SID1234571992]). Developed by Agilent – a worldwide leader in developing and commercializing diagnostic products – this training program incorporates Agilent’s unique expertise in companion diagnostics and partnership with top pharmaceutical companies.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This program will allow pathologists to learn and practice scoring techniques, to gain the necessary confidence and competence to accurately score biomarker cases in their own laboratories. Combined with Agilent’s high-quality pathology staining solutions this training program will help ensure pathologists can score cases with high concordance."

Biomarker testing has profoundly influenced the practice of both pathology and oncology today. Targeted therapies have seen more than 30% increase from 2019, and more than 50% of targeted therapies currently in clinical trials are being co-developed with a predictive biomarker [1][2]. The Agilent Biomarker Pathologist Training Program will enable pathologists to gain confidence with scoring methodologies to enable the pursuit of the right treatment for patients.

"We are excited to successfully launch the Agilent Biomarker Pathologist Training Program to further support our efforts in the fight against cancer," said Simon Oestergaard, general manager and vice president of Pathology at Agilent. "This program will allow pathologists to learn and practice scoring techniques, to gain the necessary confidence and competence to accurately score biomarker cases in their own laboratories. Combined with Agilent’s high-quality pathology staining solutions this training program will help ensure pathologists can score cases with high concordance."

The program, which will initially be available in Europe and North America, followed by China and Asia, utilizes a digital platform, Pathcore Scholar, where attendees can navigate both standard and challenging cases. For Agilent products with approved indications, the training, supports Agilent biomarkers only and will provide strategies and best practices for delivering optimal scoring results, which will in turn improve patient outcomes. Training will be offered at different levels, from basic to advanced, and both in-person and remotely, to address individual training requirements.

On November 30, 2020 AP Biosciences reported In recent years, an increasing number of drugs have been granted breakthrough therapy designation in the United States, encouraging more companies to propose novel cancer treatment solutions (Press release, AP Biosciences, NOV 30, 2020, View Source [SID1234572009]). Currently, there are two companies in Taiwan that are accelerating the development of these therapies and provide innovative treatments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AP Biosciences’ target-dependent T-cell activating bi-specific antibodies

AP Biosciences (APBio) is a discovery-stage immunotherapeutic company developing mono- and bi-specific antibodies for various forms of treatment. One of the company’s major products, T-Cube bsAbs, involves bi-specific antibodies that lead T cells to cancer cells. They do so by bridging the T cells to unique antigens found on the surface of cancer cells, resulting in T cell activation which kills the cancer cells.

Unlike many current immune-therapeutic drugs (which activate the immune system to combat cancer cells while inducing a cytokine storm accompanied by strong side effects), APBio’s antibody drugs would benefit patients via improved specificity, leading to higher efficacy and a more favourable safety profile.

"T-Cube bi-specific antibodies activate cytotoxic and memory T cells upon binding to targeted cancer cells. In short, we’re creating better antibodies for better cures," explained Dr. Jeng Her, CEO of APBio. "In the near term, we see these treatments benefiting patients with liver, kidney, and lung cancers. Superiority in efficacy, safety, and cost is what makes our solutions unique and exciting to the medical community."

The strategy employed by APBio has attracted companies such as Innovent Biologics and Tasly Biopharmaceuticals to become development partners for several bi-specific antibodies. IBI302, a bi-specific antibody licensed to Innovent for the wet form of age-related macular degeneration (wet AMD), entered Phase I of clinical trials in April 2019. Further, APBio recently raised US$19.5 million in its series B funding round for the development of three in-house T-Cube antibodies, targeting human trials as early as Q4 2021.

LuminX provides cell GPS positioning in vivo

Most breakthrough therapy designations are granted to cell therapies. These therapies face great challenges in pre-market certification, owing to the difficulty of pre-clinical PK/PD data collection.

LuminX aims to accelerate and fine-tune cell therapies through better understanding of processes in the preclinical stage. With the help of an innovative cell-tracking method, live cells can be detected through fluorescence, thus making them easier to track for an extended period of time. This visibility helps scientists and researchers understand how therapeutic cells are distributed either in vivo or in vitro, how long they survive, and recognize what the cells’ eventual biological fate might be in a research or hospital setting.

According to Dr. Long-Jyun Su, CEO of LuminX, the company’s solution involves labelling cells with LuminX-tracking reagents that are non-toxic and non-genotoxic. The outcome sees labelled cells glow red for easy visual identification and remain potent long thereafter. The executive said that other techniques require 100, 1,000, or even 10,000 cells to elicit detection, whereas LuminX’s method only requires 10.

Dr. Su explained, "LuminX’s cell-tracking service is able to quantify the number of therapeutic cells in an individual organ, allowing us to obtain data on cell biodistribution and PK/PD. This means we’re able to study the movement of drugs through the animal model in the preclinical stage. Additionally for researchers and cell therapy companies, our tech will be a game-changer as it drastically cuts down the time and money otherwise needed for research and development."