On October 5, 2021 GNS Healthcare (GNS), an artificial intelligence company creating in silico patients that simulate drug treatment at the individual patient level, reported a multi-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to leverage longitudinal multi-modal prostate cancer patient data and world class prostate cancer expertise with GNS’ Gemini in silico Prostate Cancer patient (Press release, Memorial Sloan-Kettering Cancer Center, OCT 5, 2021, View Source [SID1234590849]). The collaboration is one of four which MSK is undertaking through its new MSK Innovation Hub, a program that blends health tech innovators and MSK experts with the goal to speed the development of innovative products and businesses that have the potential to make a meaningful impact in the lives of people with cancer.

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This collaboration will address key questions for prostate cancer patients, including identifying subtypes of aggressive disease and discovering novel drug targets and drivers of patient response to an increasing array of therapeutics. These insights will enable the design of highly sophisticated clinical trials and generate evidence of comparative effectiveness between drugs and simulate treatment sequencing.

The work will build on the existing Gemini – The in silico Patient for Prostate Cancer developed in partnership with Tempus. Fueled by rich clinico-genomic data, specifically whole exome sequencing, RNAseq, patient treatment history, current treatments and associated lines of therapy and mortality, Gemini has already recapitulated known prognostic markers of overall survival and replicated the landmark Prostate Cancer Phase 3 LATITUDE Trial. Novel potential drivers of survival for metastatic castrate sensitive and castrate resistant prostate cancer patients have been discovered through Gemini’s hypothesis-free approach and will be validated and further understood through the collaboration with MSK.

"Collaborating with the MSK Innovation Hub will help to accelerate the discovery and development of new, more targeted and effective treatments for prostate cancer patients," said GNS CEO and Co-Founder, Colin Hill. "Simulating these in silico patient models allows us to understand what treatments work for which patients and why, improving clinical trial design and generating real-world evidence that maximizes the impact of drugs for patients. This has been a long road, but we are now at the point of being able to deliver true personalized treatments that work."

"The results generated from GNS’ transformative AI approach are compelling and I believe this ongoing collaboration will provide novel insights into prostate cancer that will directly improve patient care," said Howard I. Scher, MD, MSK medical oncologist and Head of the Biomarker Development Program.

MSK has institutional financial interests related to GNS associated with this collaboration.

On October 5, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has initiated the Observation of ResiduAl Cancer with Liquid biopsy Evaluation (ORACLE) study, a 1,000-patient prospective, observational, multi-center study designed to evaluate the performance of its Guardant Reveal liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types (Press release, Guardant Health, OCT 5, 2021, View Source [SID1234590848]).

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"For oncologists managing patients with early-stage cancer, there is a need for additional tools to help make informed decisions regarding risk for recurrence and benefit of adjuvant therapies, and avoid under- or over-treatment," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "This study is exciting because it will evaluate the first blood-only minimal residual disease (MRD) assay in additional tumor types, and set the stage to identify opportunities for this technology to improve patient care."

The study will analyze circulating tumor (ctDNA) status from blood samples of patients with early-stage cancer, using the Guardant Reveal test after the end of treatment, and during routine follow-up. Participants will be followed until distant recurrence, or up to five years. The ORACLE study adds to currently underway clinical studies (COBRA, ACT-3, PEGASUS) evaluating the performance of the Guardant Reveal blood test in patients with early-stage cancer.

"Initiating this study adds to the growing body of evidence that will support the expansion of the Guardant Reveal blood test from its first indication of early-stage colorectal cancer to multiple cancer types. We believe our blood-only test can be a powerful and streamlined decision-making tool for oncologists managing patients with early-stage cancers," said Helmy Eltoukhy, Guardant Health Co-CEO. "The ORACLE study exemplifies our commitment to further demonstrating the utility of our blood tests to improve long-term clinical outcomes."

The Guardant Reveal test is the first blood-only liquid biopsy test that detects residual and recurrent disease from a simple blood draw. The test detects ctDNA in blood after surgery, to identify patients with residual disease who may benefit most from adjuvant therapy, and to detect recurrence months earlier than current standard-of-care methods.1-6 The commercially available test achieves high sensitivity (91%)7 for detecting ctDNA by simultaneously interrogating both genomic alterations and methylation. The first indication of the test is colorectal cancer, with additional cancer types to follow.

More details about the ORACLE study can be found at NCT05059444.

On October 5, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that the Company will participate in the H.C. Wainwright Hepatitis B Virus (HBV) Conference on Wednesday, October 13, 2021 (Press release, Silverback Therapeutics, OCT 5, 2021, View Source [SID1234590847]).

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Laura Shawver, Ph.D., Silverback’s Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback’s President and Chief Scientific Officer, will participate in a fireside chat on Wednesday, October 13, 2021, at 10:30 a.m. ET (7:30 a.m. PT). The live webcast of the presentation will be available on Silverback’s investor relations website.

On October 5, 2021 Proscia, a leading provider of digital and computational pathology solutions, reported that it has released study results on new technology that leverages artificial intelligence (AI) to automatically detect melanoma, the deadliest form of skin cancer, with a high degree of accuracy (Press release, Proscia, OCT 5, 2021, View Source [SID1234590846]). The findings illustrate the promise of AI to deliver faster diagnoses, improve patient outcomes, and optimize laboratory economics in the routine practice of pathology.

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Proscia’s prospective study, conducted at Thomas Jefferson University and the University of Florida, demonstrated the real-world performance of the AI on an uncurated set of 1,422 sequential skin biopsies. The technology correctly identified invasive melanoma and melanoma in situ with a sensitivity of 93% and a specificity of 91%. It also classified basal cell carcinoma and squamous cell carcinoma with an AUC of .97 and .95, respectively, accounting for a combined 97% of all skin cancers. This study validated the results of a multi-site retrospective study of 12,784 images, which will be presented during the Computational Challenges in Digital Pathology Workshop at the 2021 International Conference on Computer Vision1.

"The performance of Proscia’s technology in detecting melanoma and other malignant skin diseases is impressive," said Dr. Kiran Motaparthi, Director of Dermatopathology and Clinical Associate Professor of Dermatology at the University of Florida. "This is an exciting development as pathologists increasingly look to unlock new sources of value from artificial intelligence."

In addition to the prospective and retrospective studies, Proscia is conducting additional research to demonstrate the potential benefits of AI in dermatopathology, including:

Delivering faster results to patients. AI that automatically identifies melanoma alerts the pathologist to these high-risk cases, flagging them for earlier diagnosis. As the volume of skin biopsies continues to rise amid a declining pathologist population, this detection could help to ensure that patients with the most clinically impactful diagnoses are prioritized so that they can begin treatment sooner.
Driving consistency in the diagnosis of difficult melanoma cases. In addition to being the most lethal skin disease, melanoma is among the most challenging to diagnose, leading to interobserver variability among pathologists2. The ability of AI to distinguish melanoma from benign mimickers could serve as an adjunctive aid to the pathologist, increasing diagnostic accuracy and improving patient outcomes.
Optimizing laboratory productivity to enhance profitability. More than 15 million skin biopsies are taken annually in the United States3, each of which may display one of hundreds of diagnoses. AI that classifies and distinguishes melanoma and non-melanoma skin cancer could enable laboratories to optimize case distribution among specialists and non-specialists, resulting in efficiency gains that make it possible to process more case volume and partially overcome the impact of declining reimbursements.
"Proscia’s technology represents a significant advancement in our work on skin pathology," said Julianna Ianni, Ph.D., Proscia’s Vice President of AI Research & Development. "Our AI not only identifies melanoma, a difficult diagnosis, but also accounts for the high degree of variation in disease to push the boundaries of deep learning in medicine. In doing so, it holds great promise to help pathologists deliver faster, more consistent diagnoses and improve patient outcomes."

The AI validated in the study expands upon the technology that powers Proscia’s DermAI application*. Available on the Concentriq digital pathology platform, DermAI provides an AI-based classification for every skin case to drive efficiency and quality gains. The application’s performance was demonstrated in one of pathology’s most comprehensive studies to date, and it continues to be validated and deployed as part of Proscia’s ongoing work in AI. The company is also collaborating with leading academic and commercial laboratories, including LabPON, Johns Hopkins School of Medicine, Unilabs, University Medical Center Utrecht, and University of California, San Francisco, to accelerate the adoption of AI in pathology.

To learn more about Proscia’s prospective study, join Julianna Ianni along with collaborators Dr. Kiran Motaparthi and Dr. Jason Lee for a webinar, "Automated Detection of Melanoma and Non-Melanoma Skin Cancer with Artificial Intelligence: Prospective Study & Real-World Impact," on November 9th at 1PM ET.

Related Resources

Product Spotlight: Proscia DermAI
Video: Leading dermatopathologists speak about DermAI
Discussion: Sean Grullon, Proscia’s Lead AI Scientist, on the retrospective study
Overview: Proscia’s platform + AI approach
*DermAI is available for research use only.

On October 5, 2021 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through a potentially best-in-class, computationally evolved IL-2 human antibody, reported the planned presentation of preclinical data on its lead investigational therapy, AU-007, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting (Press release, Aulos Bioscience, OCT 5, 2021, View Source [SID1234590845]). The SITC (Free SITC Whitepaper) meeting will run Nov. 10-14, 2021, in Washington D.C., as well as virtually.

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"We believe in the potential of our initial clinical candidate, AU-007, as a novel cancer treatment that could meaningfully impact the lives of patients with its highly differentiated approach to harnessing the power of IL-2 to eradicate solid tumors," said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. "We look forward to presenting preclinical data at the SITC (Free SITC Whitepaper) Annual Meeting and to initiating clinical testing in patients with cancer by year end."
Abstract ID

Poster Number and Title

Presenting Author

14867

704: The computationally designed human antibody, AU-007, mediates human immune activation by endogenous IL-2, while uniquely breaking the IL-2 auto-inhibitory loop and preventing Treg expansion

Yanay Ofran, Ph.D.

Biolojic Design and Aulos Bioscience

The poster will be presented in the Poster Hall at the Walter E. Washington Convention Center in Washington, D.C. Saturday, Nov. 13, 2021. It will also be available as an ePoster on display on the SITC (Free SITC Whitepaper) 2021 virtual meeting platform from 7 a.m. EST on Friday, Nov. 12, 2021, until the virtual meeting platform is closed on Jan. 9, 2022.

About AU-007
AU-007 is a computationally evolved, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages the body’s own IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2 secreted by T effector cells from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand effector cells. This prevents the negative feedback loop caused by other IL-2 based treatments and biases the immune system towards activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.