On October 15, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases (Press release, Applied BioMath, OCT 15, 2021, View Source [SID1234591308]). BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily.

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"We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms," said Margaret Jackson, D.Phil., Founder and CEO of BYOMass. "We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis.

"We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "We look forward to collaborating with BYOMass and helping them decide next steps for this project."

On October 15, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered an agreement with PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology (Press release, Hoffmann-La Roche, OCT 15, 2021, View Source [SID1234591281]). Under the development and distribution agreement, the companies will jointly develop an embedded image analysis workflow for pathologists. This workflow will allow PathAI image analysis algorithms to be accessed within NAVIFY Digital Pathology, the cloud version of Roche’s uPath enterprise software. This collaboration is now possible through Roche’s Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche’s growing menu of AI-based image analysis tools.

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This agreement with PathAI is among the first to expand digital tools through the Roche open environment, and is one of the first for PathAI to distribute its AI-powered solutions via a third party platform.

"Working together, Roche and PathAI will bring the latest leading technologies to pathologists through our digital pathology solution. Expanded access to a menu of high medical value digital diagnostic tools will further ensure that patients are accurately diagnosed and receive the most effective treatment available," said Thomas Schinecker, CEO Roche Diagnostics.

Roche will initially distribute PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, spanning multiple cancer types. The combined innovation will expand support for healthcare companies’ companion diagnostic and drug development programs.

"This collaboration brings together all of the components required to deliver and commercialise a differentiated AI-based digital pathology medical device including assay, scanner, image management system and algorithm. We believe this partnership will unlock the potential for digital pathology in the companion diagnostics setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," said Dr. Andy Beck, CEO of PathAI.

About Roche Digital Pathology
As the leading provider of pathology lab solutions, Roche is delivering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms.

Whole slide imaging combined with modern artificial intelligence (AI)-based image analysis tools have the potential to transform the practice of pathology. The use of AI and deep learning methods to interpret whole slide images in digital pathology enables pathologists to derive novel and meaningful diagnostic insights from tissue samples. AI-based image analysis automates quantitative tasks and enables fast, repeatable evaluation of information-rich tissue images that are sometimes difficult to interpret manually. AI-based image analysis uncovers aspects that are invisible to the human eye and reduces the risk of human error. Patients, whose tissue samples are analysed using AI-based image analysis, can benefit from a faster and more accurate diagnosis. The insights gained from these analyses can help pathologists determine the best treatment option for cancer patients.

Roche offers two deployment options for its uPath software: an on-premise solution and a cloud solution, marketed as NAVIFY Digital Pathology. The VENTANA DP 200 slide scanner and Roche uPath enterprise software are CE-IVD marked for in-vitro diagnostic use and are available in the U.S. for research use only (RUO). Image analysis algorithms developed by third-party entities and their utilisation are the responsibility of the third party provider.

On October 15, 2021 Antengene reported that The 36th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2021) will take place in Washington, D.C., United States, on November 10-14, 2021 (Press release, Antengene, OCT 15, 2021, View Source [SID1234591309]). The SITC (Free SITC Whitepaper)’s annual meeting is the world’s largest gathering in the field of immuno-oncology. The event is dedicated to promoting exchanges and collaborations in the field in order to improve treatment outcomes for cancer patients. At this year’s event, Antengene will release data of its PD-L1/4-1BB bispecific antibody, ATG-101, and its ERK1/2 inhibitor, ATG-017, in poster presentations both online and offline.

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Details of those poster presentations are as follows:

Abstract Number: 227
Title: A computational semi-mechanistic pharmacology model of ATG-101, a PD-L1/4-1BB bispecific antibody for treatment of solid tumors and NHL
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. David C. Flowers, Applied BioMath, LLC
First Author: Dr. David C. Flowers, Applied BioMath, LLC

Abstract Number: 608
Title: Synergistic effect of the combination of ATG-017, an ERK1/2 inhibitor, and immune checkpoint inhibitor in preclinical cancer models
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. Bing Hou, Antengene Corporation Limited
First Author: Dr. Peng Chen, Antengene Corporation Limited

Abstract Number: 893
Title: ATG-101, a novel PD-L1/4-1BB bispecific antibody, augments anti-tumor immunity through immune checkpoint inhibition and PDL1-directed 4-1BB activation
Time: 7:00-17:00 EST, November 12-14, 2021
Presenter: Dr. Bing Hou, Antengene Corporation Limited
First Author: Dr. Hui Yuwen, Antengene Corporation Limited

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of multiple kinds of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking the binding of PD-L1/PD-1 and inducing 4-1BB stimulation. In PD-L1 over-expressed cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, thus potentially enhancing therapeutic efficacy, whilst mitigating risk of hepatoxicity. Antengene is currently conducting a Phase I study of ATG-101 in Australia for the treatment of patients with metastatic/advanced solid tumors and non-Hodgkin lymphoma.

About ATG-017

ATG-017 (AZD0364) is a potent and selective small molecule extracellular signal-regulated kinases 1 and 2 (ERK1/2) inhibitor. ERK1/2 are related protein-serine/threonine kinases that function as terminal kinases in the RAS-MAPK signal transduction cascade. This cascade regulates a large variety of cellular processes, including proliferation. The RAS-MAPK pathway is dysregulated in more than 30% of human cancers with the most frequent alterations being observed in RAS or BRAF genes across multiple tumor types. An ERK inhibitor enables the targeting of both RAS and BRAF mutant diseases. In nonclinical pharmacology studies, ATG-017 has demonstrated potent inhibition of ERK1/2 enzyme activity and tumor growth in vitro and in vivo. At present, Antengene is conducting a Phase I study of ATG-017 in Australia for the treatment of patients with advanced solid tumors and hematologic malignancies.

On October 15, 2021 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s amivantamab, a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy (Press release, Genmab, OCT 15, 2021, View Source [SID1234591282]). In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

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"Following the U.S. FDA approval of RYBREVANT earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For more information related to Janssen’s CHMP opinion for amivantamab, click here.

On October 15, 2021 Geron Corporation (Nasdaq: GERN) reported that it will host a virtual investor event on November 9 at 4:00 p.m. ET. Topics to be covered at the event, include (Press release, Geron, OCT 15, 2021, View Source [SID1234591283]):

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The unmet medical needs in lower risk myelodysplastic syndromes and refractory myelofibrosis and the disease modification potential of imetelstat, Geron’s first-in-class telomerase inhibitor.
Expansion opportunities for imetelstat into new indications and in combination with other drugs.
A live physician panel discussion and question-and-answer session with:
Dr. Swaminathan Iyer, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Dr. John Mascarenhas, Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
Prof. Uwe Platzbecker, Director, Clinic and Policlinic for Hematology, Cell Therapy and Hemostaseology, University Hospital, Leipzig, Germany
A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.