On November 29, 2021 GE Healthcare, the University of Cambridge and Cambridge University Hospitals reported that they have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that integrates cancer patient data from multiple sources into a single interface (Press release, GE Healthcare, NOV 29, 2021, View Source [SID1234596211]).

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Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

"Thanks to ever-improving technologies, we now generate increasing amounts of complex data for each patient with cancer. These include multiple imaging scans, digital pathology, genomic data, advanced blood tests and treatment information. Bringing all this data together to make precise and informed decisions for patients can be hard. We often do this inefficiently and miss important connections between the data," said Professor Richard Gilbertson, Director of the Cancer Research UK Cambridge Centre, and Head of the Department of Oncology at the University of Cambridge.

This new application would be designed using advanced software engineering and machine learning methods to integrate a variety of patient data including clinical, imaging and genomic data – from diagnosis through every stage of treatment – into one single location. The aim is to offer all medical teams involved in a patient’s cancer care – medical oncologists, clinical oncologists, surgeons, radiologists, pathologists, clinical nurse specialists and more – simultaneous access to the necessary data and information to allow the medical team to plan the best, most personalized treatment for each of their patients.

The application is expected to be evaluated for ovarian cancer initially in Cambridge and the goal is to evaluate it across the UK, and beyond. Ovarian cancer is often difficult to treat as most patients present with advanced disease. Although initially 70-80% of patients will respond well to chemotherapy, ultimately most develop chemotherapy resistance leading to treatment failure.1 The application may help clinicians have better visibility on how the patient respond to treatment, thus helping them more effectively identify when treatment may require adjustment. If the application is successfully developed, our vision is for it to be expanded for use in breast and kidney cancer patients.

"Healthcare professionals can struggle to easily find and interpret the many different types of patient data information they need to make the best clinical decisions," said Dr Ben Newton, GM Oncology at GE Healthcare. "Bringing these multiple data streams into a single interface could enable clinicians to make fast, informed and highly personalised treatment decisions throughout a patient’s cancer care pathway."

Two Addenbrooke’s cancer clinicians aiming to evaluate the application to help patients are consultant oncologist Prof. James Brenton, professor of Ovarian Cancer Medicine and a senior group leader at the Cancer Research UK Cambridge Institute; and consultant radiologist Prof. Evis Sala, professor of Oncological Imaging, University of Cambridge.

"Aggregating and analysing the substantial amounts of data available would help address an unmet need. Ovarian cancer is an important and complex disease with poor outcomes, and we believe this application would help us deal with its complexity. Eventually, we hope to be able to better understand the disease and therefore improve treatment and outcomes for patients," says Prof. Brenton, who co-leads the Mark Foundation Institute for Integrated Cancer Medicine (MFICM) at the University of Cambridge.

"If we can aggregate and integrate relevant data along the care pathway, and visualize the output, it may ultimately lead to clinicians making better-informed decisions and better care." adds Prof. Sala who also co-leads the MFICM at the University of Cambridge.

"The team aims to transform the delivery of cancer patient care by integrating multiple data streams together into a single platform that can be accessed simultaneously by clinicians, patients and multi-disciplinary teams (MDTs) from tertiary and regional hospitals."

The development work will be underpinned by GE Healthcare’s Edison platform to integrate data from diverse sources, such as electronic health records (EHR) and radiology information systems (RIS), imaging and other medical device data.

On November 29, 2021 Scorpion Therapeutics, Inc. ("Scorpion"), a next-generation oncology company pioneering Precision Oncology 2.0 to develop best- and first-in-class medicines for patients with cancer, reported its two lead programs, both targeting well-known, clinically validated, mutated oncogenes (Press release, Scorpion Therapeutics, NOV 29, 2021, View Source [SID1234596210]). The first program, STX-H1047-PI3Kα, targets the H1047X-mutant form of phosphoinositide 3-kinase alpha ("PI3Kα"), a cancer driver associated with a wide variety of solid tumors. The second program, STX-EGFR-EXON20, selectively targets exon 20 insertion mutations in epidermal growth factor receptor ("EGFR"), which drives non-small cell lung cancer ("NSCLC").

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"Scorpion was founded with a bold vision: to broaden the reach of precision oncology by developing exquisitely selective, optimized drug candidates with enhanced profiles, against high-impact targets, each with the potential to deliver transformational outcomes to patients, a strategy we call Precision Oncology 2.0," said Axel Hoos, M.D., Ph.D., CEO of Scorpion. "Today, we are excited to unveil our initial programs against mutant PI3Kα and EGFR Exon 20, two potentially best-in-class programs internally developed in less than two years, each with the opportunity to improve the treatment of certain patients living with solid tumors. We look forward to progressing these programs towards the clinic while continuing to advance our broader portfolio with urgency, including additional programs targeting historically "undruggable" or novel cancer targets."

The rapid discovery of both STX-H1047-PI3Kα and STX-EGFR-EXON20 was enabled by Scorpion’s fully integrated, fit-for-purpose drug-hunting platform, which integrates more than 20 years of cutting-edge advances across cancer biology, medicinal chemistry, and data sciences with the aim to redefine the frontier of precision medicine. Scorpion leverages its platform to address a wider array of targets with higher quality medicines than previously possible and to fill therapeutic white spaces of underserved patient populations. Scorpion is focused on three categories: (1) best-in-class molecules targeting validated oncogene targets; (2) first-in-class molecules for previously undruggable targets, including a number of transcription factors and validated synthetic lethal targets; and (3) first-in-class molecules for novel cancer target classes. The PI3Kα and EGFR programs fall into the first category.

STX-H1047-PI3Kα: PI3Kα is an established cancer target and one of the most highly mutated targets in cancer, particularly in solid tumors. The mutations at the H1047 residue represent the highest frequency of mutations in PI3Kα. More than 55,000 people in the United States annually are diagnosed with cancers driven by mutations at this residue. Approved therapies targeting PI3Kα are limited by inhibition of the normal, or wild-type, version of PI3Kα in healthy tissues, leading to significant metabolic side effects that hinder the ability of patients to tolerate these therapies, and by an inability to treat tumors that have progressed into the central nervous system.
Using its drug-hunting platform, Scorpion discovered a novel allosteric binding pocket that allows for specific targeting of the mutant over the wild-type form of PI3Kα with a small molecule. This may allow for maximal inhibition of the mutant protein in cancer cells compared to normal tissues, to avoid the off-target effects – such as metabolic dysfunction – that are associated with wild-type inhibition by commercially available options. STX-H1047-PI3Kα is designed to be a central nervous system-penetrant, oral pill. In preclinical studies, STX-H1047-PI3Kα has demonstrated exquisite in vitro selectivity and dose-dependent anti-tumor activity, without evidence of hyperglycemia in multiple model systems. Scorpion expects to submit an IND for STX-H1047-PIK3α in 2023.

STX-EGFR-EXON20: NSCLC is the most common form of lung cancer and EGFR mutations are one of the most common mutations in NSCLC. NSCLC tumors that express EGFR with Exon 20 insertion mutations have an incidence of approximately 3,400 patients per year in the United States. Commercially-available therapies for NSCLC patients with EGFR Exon 20 insertion mutations are limited by significant toxicities associated with the inhibition of wild-type EGFR protein in healthy tissues such as the skin and gut, leaving a significant unmet need for those patients.
Leveraging its discovery platform, Scorpion identified highly differentiated chemical matter that provides exquisitely selective inhibition of Exon 20 insertion mutations compared to the wild-type form of the protein. This may allow for maximal inhibition of the mutant protein in cancer cells compared to normal tissues, thereby reducing the toxicities – often gastrointestinal or skin-related – that lead to dose limitations or reductions with existing EGFR exon 20 inhibitors. STX-EGFR-EXON20 is designed as an oral pill, which in preclinical studies demonstrated best-in-class selectivity and dose-dependent anti-tumor activity in xenograft models at well-tolerated doses. Scorpion expects to submit an IND for STX-EGFR-EXON20 in 2023.

On November 29, 2021 Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer and pre|CISION platforms, reported that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for AVA6000 (Press release, Avacta, NOV 29, 2021, View Source [SID1234596209]). This will allow the Group to expand its Phase I clinical trial, ALS-6000-101, into clinical trial sites in the United States.

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AVA6000 is a novel form of doxorubicin that has been modified with Avacta’s pre|CISION platform to improve its safety and therapeutic index. Anthracyclines such as doxorubicin, a generic chemotherapy for which the market is expected to grow to $1.38bn by 20241, are widely used as part of standard of care in several tumour types, but their use is limited by cumulative toxicity. AVA6000 has been designed to limit cell penetration of the drug, and therefore its cell killing effect, until it is specifically activated by fibroblast activation protein α (FAP) which is in high concentration in many solid tumours compared with healthy tissues. The resulting reduced exposure of healthy tissues to active doxorubicin has the potential to significantly increase its therapeutic index by reducing the incidence of adverse effects, including cardiotoxicity and myelosuppression.

The FDA has completed its 30-day review of Avacta’s IND application, which was submitted ahead of schedule in October 2021, and has concluded that the Group may proceed with its proposed clinical investigation. This allows Avacta to enroll eligible patients into US clinical trial sites for the company’s Phase I multi-centre study, ALS-6000-101. As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 followed by completion of the dose expansion phase around mid-2023. Enrollment in US clinical trial sites is expected to begin in early 2022.

Dr. Alastair Smith, Chief Executive of Avacta Group, commented: "We are delighted to have received approval from the FDA to add clinical trial sites in the United States as part of the Phase I study for AVA6000. This is a major milestone in our development of pre|CISION chemotherapies and is testament to the performance of our clinical development team and the quality of the pre-clinical data for AVA6000.

Provided that the study shows that the pre|CISION technology is effective in reducing systemic toxicity of Doxorubicin, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISION chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 20272.

We now look forward to opening up clinical trial sites in the United States and additional clinical trial sites in the UK."

Neil Bell, Chief Development Officer of Avacta Life Sciences, commented: "We are excited to bring the first FAP-activated chemotherapeutic to the clinic in the US, which has the potential to meaningfully impact patients with difficult-to-treat tumours. The clearance of the AVA6000 IND by the FDA enables the opening of key US sites to support the ALS-6000-101 clinical trial which is currently recruiting patients across clinical sites in the UK."

On November 29, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company will participate in a fireside chat and host investor 1×1 meetings at the Piper Sandler 33rd Annual Virtual Healthcare Conference, which is being held November 29 – December 2 (Press release, EDAP TMS, NOV 29, 2021, View Source [SID1234596207]).

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EDAP will be participating in investor meetings on Tuesday, November 30.

A video replay of the fireside chat will be available on the Investors section of the EDAP website following the conclusion of the event.

On November 29, 2021 Vyant Bio, Inc. ("Vyant Bio", the "Company") (Nasdaq: VYNT), an emerging global drug discovery company, reported that it is rapidly identifying small and large molecule therapeutics to treat central nervous system (CNS) and oncology-related diseases (Press release, Vyant Bio, NOV 29, 2021, View Source [SID1234596206]). Today, Vyant Bio announced that it will be participating in The Benchmark Company Discovery One-on-One Investor Conference. The event is being held virtually on Thursday, December 2, 2021.

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Conference Date: December 2, 2021 (Thursday)
1:1 Availability: 8:00am-4pmET
Vyant Bio’s Chief Executive Officer, Jay Roberts, will be discussing key highlights from the Third Quarter 2021, the recent addition of Chief Scientific Officer – Dr. Robert Fremeau, and the business and strategic outlook for the remainder of 2021 and into 2022.

If you are an investor and would like to schedule a one-on-one meeting with Vyant Bio during the Discovery One-on-One Investor Conference, please contact your Benchmark representative.

Vyant Bio will also be available for virtual outside 1:1 meetings after The Benchmark Company Discovery One-on-One Investor Conference. Please contact Jennifer K. Zimmons, Ph.D. at [email protected] or +1 917.214.3514 for scheduling.