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.

On October 15, 2021 Pepper Bio, the world’s first transomics drug discovery company, reported the company emerges from stealth to leverage its proprietary transomics — including phosphoproteomics — data translation technology to discover new drugs, rediscover new uses for existing therapeutics, and rescue drugs that may be on a course toward failing (Press release, Pepper Bio, OCT 15, 2021, View Source [SID1234638709]).

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Drug discovery is often a bad bet for pharma. Pepper Bio significantly reduces that risk.
Currently, the successful development of a new therapy is estimated to cost around $2.6 billion on average and last over a decade through a variety of failed and successful trials. Because of the high cost and risks involved, many diseases will go untreated because of their low expected return on investment in drugs that may work. With hundreds of thousands of therapeutics candidates being evaluated each year, 86 percent of clinical trials of drug candidates fail to earn FDA approval, according to a new study from the MIT Sloan School of Management. More than 30 percent of drugs entering Phase II clinical trials fail to progress, and 58 percent of drugs fail in Phase III. These end-stage studies commonly cost upward of hundreds of millions of dollars for manufacturing, clinical trial design, implementation, and data analysis.

"From my experience as a drug development strategist, many therapeutic programs were killed simply because they would have cost too much with an inadequate return on investment," said Jon Hu, co-founder and CEO, Pepper Bio. "These are very difficult decisions because they are made with the understanding that many people who may benefit from these potential new drugs would never have that opportunity. We founded Pepper Bio in order to significantly improve the volume, quality, and accuracy of the data analysis used to evaluate opportunities for novel new therapeutics. We empower our drug discovery partners with a much higher level of informed confidence. Ultimately, our work will result in many more drug development initiatives going forward to help people around the world struggling with diseases that are left untreated today."

A first in drug discovery, Pepper Bio and their partners make significantly more informed strategic decisions by relying on more accurately analyzed data. This allows them to develop therapeutics that treat diseases at their root cause, have less toxicity and higher response rates with patients exhibiting fewer symptoms. Already, Pepper Bio has demonstrated proof of concept of the company’s proprietary platform across three therapeutic areas: Neurodegenerative, Oncology, and Inflammatory.

Pepper Bio’s proprietary capability to translate multiple levels of complex transomic data unlocks a new level of sophistication in drug discovery, much like Waze leverages multiple layers of data to direct travelers on the optimal and safe road to their destination. Pepper Bio identifies how and why novel drug candidates may or may not be effective in specific patient populations and diseases, directing drug discovery initiatives toward the most promising disease targets and patients who will be helped most with reduced side effects.

The success of Pepper Bio is rooted in the company’s proprietary capacity to access and analyze transomic data leveraging three pillars of the field: Global (1), comprehensive data from the entire biological system are analyzed to determine functional (2) characteristics of intercellular biologic activity. Multiple omic layers, including phosphoproteomics, the layer at the top of the biotech stack, are analyzed. By analyzing all layers combined, Pepper Bio empowers drug developers to identify and reach accurate, much more informed causal (3) inferences.

"Pepper Bio is working to ensure that the right therapeutics and combinations of drugs are developed in a precise, effective, efficient, and safe manner. Our proprietary capacity to translate complex transomic data into meaningful, evidence-based guidance for drug discovery programs significantly improves the likelihood of success for clinical trials. This promises to conserve many millions of dollars that may otherwise be funneled into traditional methods of research and development," said Samantha Dale Strasser, Ph.D., Co-Founder and Chief Scientific Officer, Pepper Bio.

The industry moving towards transomics is inevitable and Pepper Bio is leading the way." said Omri Amirav Drory, General Partner at NFX, an investor in Pepper Bio. NFX was an early backer of biotech companies such as Mammoth Biosciences and c2i genomics.

CEO Jon Hu is experienced in pharmaceutical research and development (Shire Pharmaceuticals), corporate strategic consulting (Bain & Company), and venture capital (Guild Capital). Hu earned his Bachelor’s degrees in biomedical engineering and economics, and earned his MBA from Harvard Business School. CSO Samantha Dale Strasser, Ph.D., developed the foundation of Peppe Bio’s technology during her time as a National Science Foundation Graduate Research Fellow at the Massachusetts Institute of Technology, where she earned her Doctorate in Electrical Engineering and Computer Science. She earned her Master’s Degree in M.Phil in Physics at the University of Cambridge as a Churchill Scholar and her Bachelor’s degrees in Biomedical Engineering and Applied Mathematics from Northwestern University.

Mr. Hu and Dr. Strasser are joined by Christopher Nicholson, Ph.D., Head of Biology, and Caitlin Brown, Ph.D., Head of Business Development. Dr. Nicholson earned his doctorate from Newcastle University and was a Senior Research Fellow at Harvard Medical School and MGH. Dr. Brown earned her doctorate from Brown University.

Pepper Bio announced its scientific and strategic advisory board members today: Douglas Lauffenberger, Ph.D., Professor, MIT; Founder, Biological Engineering, MIT.; Dean Felsher, MD, Ph.D., Professor, Oncology, Stanford; Director, Translational Research, Stanford. Imran Nasrullah, JD, VP & Head, Open Innovation Center, North America – East, Bayer; Former Director, Strategic Partnering & Business Development & Licensing, Boehringer-Ingelheim. Tom Rush, Ph.D., Chief R&D Officer, Variant Bio; Former US Lead, Functional Genomics, GlaxoSmithKline. Jerome Windsor, PharmD, SVP, Corporate Development & Product Strategy, GNS Healthcare; Former VP, Strategy & Business Development, Median Technologies. Peter Hornbeck, Ph.D., Director, Cell Signaling Technology; Founder, PhosphoSitePlus.