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Exscientia and GT Apeiron Therapeutics Enter Oncology Joint Venture

On July 21, 2021 Exscientia, an AI-driven pharmatech company with a mission to revolutionise how drugs are discovered, and GT Apeiron Therapeutics （Apeiron）, a Shanghai based company focused on novel oncology drugs, reported a strategic research and development collaboration agreement (Press release, Exscientia, JUL 21, 2021, View Source [SID1234585035]). The collaboration will leverage the patient-centric AI-first capabilities of Exscientia to accelerate the discovery of multiple small molecule therapeutic drug candidates designed to selectively treat aberrant cell cycle driven cancers and build a pipeline of CDK novel therapies. All pipeline products will be equally owned and Exscientia holds an equity stake in Apeiron.

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This expanded collaboration follows the successful design of multiple selective CDK7 compounds. The potent, highly selective, non-covalent CDK7 compounds have demonstrated consistent tumour responses in xenograft models as well as exceptional pharmacokinetics. In addition, using live primary tissue samples from ovarian cancer patients, the CDK7 inhibitors showed both enhanced tumour cell cytotoxicity as well as selectivity over immune cells in the same microenvironment.

"Based on what they have already achieved, Exscientia is clearly the leader in AI-driven drug discovery, and we have witnessed this first-hand in our collaboration so far," stated Dr. Mingxi Li, President of GT Apeiron Therapeutics. "We have been incredibly impressed by the combined power of the AI design and use of patient data to optimize and select molecules that are more likely to give positive effects in the clinic. This joint venture is a significant step in building GT Apeiron’s valuable and robust pipeline of CDK inhibitor drugs and substantially accelerates our early-stage output and progression towards being a clinical stage biotech company."

"We are driven to bring drugs to market that make a difference for patients," says Andrew Hopkins, chief executive officer of Exscientia. "Apeiron bring a focus and an expertise on the biological basis of multiple cancers and helps us to create better drugs for better outcomes in the clinic and beyond. This collaboration has already proven to be capable of delivering potential drug candidates with promising patient-relevant data, and we look forward to extending that into a portfolio of multiple clinical assets."

Omniscient Neurotechnology Launches Quicktome™ Brain Mapping Platform for Neurosurgery After Regulatory Clearance in United States, Canada and Australia

On July 21, 2021 Omniscient Neurotechnology ("o8t"), a pioneering brain mapping software company, reported that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Quicktome, a digital brain mapping platform that allows neurosurgeons to visualize and understand a patient’s brain networks prior to performing life-changing brain surgery (Press release, Omniscient Neurotechnology, JUL 21, 2021, View Source [SID1234585033]). This announcement occurs on Glioblastoma Awareness Day, a day dedicated to increasing public understanding of the most common, complex, treatment-resistant, and deadliest type of brain cancer.

In addition to FDA clearance in the United States, Quicktome has also received Health Canada approval as well as regulatory clearance by the Therapeutic Goods Administration (TGA) of Australia.

Quicktome is a neurosurgical planning software which incorporates "connectomics", the field of understanding brain connectivity, into routine neurosurgical planning. Critically, by visualizing networks that are responsible for complex functions such as language, movement, and cognition, Quicktome assists neurosurgeons in making more informed decisions and reduces surgical uncertainty.

Utilizing cloud computing for large-volume data processing, and intuitive browser-based interfaces, Quicktome aims to streamline the process for neurosurgeons. The digital platform furthermore enables multidisciplinary collaboration in hospitals, and greater insight on a patient before and during surgery.

"We are thrilled to receive regulatory clearance for Quicktome. This is the first digital mapping platform designed to incorporate brain connectome data for neurosurgeons to improve patient outcomes," said Stephen Scheeler, CEO, Omniscient Neurotechnology. "Until now, the tools that neurosurgeons have relied on have been no match for the brain’s complexity. Quicktome breaks information down into actionable insights to inform the impact each incision will have on the patient. Since its authorization, physicians are already relying on this technology to guide surgical planning. This is a significant milestone for Omniscient and, more importantly, begins a new era for neurosurgery for patients and physicians."

"I wish I had technology like this when I started practicing," said Dr. Michael Sughrue, Chief Medical Officer, Omniscient Neurotechnology, a neurosurgeon who has completed over 3,000 brain tumor removals. "When I learnt about connectomics, I realized the biggest impact I could make to the field of neurosurgery was to make Quicktome a routine source of insight for all neurosurgeons. With this ground-breaking technology, our hope is for a better quality of life for patients and families after brain surgery."

"Omniscient is the first to harness the power of brain connectomics for use in neurosurgery," said Stephane Doyen, Chief Data Officer at Omniscient Neurotechnology. "Big data is changing everything we know about the brain. Modern neuroscience has shown that we are our brain networks, which control everything from movement to speech. Understanding how the brain is connected and what these connections mean will drastically help us better deliver healthcare, starting with neurosurgery."

Immunomic’s Academic Collaborator Dr. John Sampson Recognized as “World Expert” in Glioblastoma as Part of Glioblastoma Awareness Day

On July 21, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that its’ academic collaborator, Dr. John Sampson of Duke University’s Department of Neurosurgery, has been recognized as a World Expert in Glioblastoma by Expertscape, an online resource that identifies the world’s top experts in all medical fields (Press release, Immunomic Therapeutics, JUL 21, 2021, View Source [SID1234585032]). The publication recognized the top 0.1% of scholars writing about glioblastoma over the past ten years, a level they label as "World Expert". Dr. Sampson’s recognition as a World Expert in glioblastoma is part of Glioblastoma Awareness Day, which is being celebrated today, Wednesday, July 21, 2021.

"Dr. Sampson’s contributions to advancing the research in glioblastoma is widely known in our scientific community and we are excited that his significant impact is being recognized on a global level by Expertscape," commented Dr. William Hearl, CEO of ITI. "This recognition is especially important today, on Glioblastoma Awareness Day, where we honor the patients, families, and care givers who have faced this complex and deadly type of brain cancer. We look forward to continuing to collaborate with Dr. Sampson to advance our glioblastoma immunotherapy program, ITI-1000, through Phase 2 and toward patients in need."

RefleXion Expands Commercial Reach With Sale to Texas Cancer Center

On July 21, 2021 RefleXion Medical, Inc., a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality that will one day treat all stages of cancer, reported the sale of its RefleXion X1 machine to The Center for Cancer and Blood Disorders, a free-standing cancer treatment center with 15 locations throughout northern Texas (Press release, RefleXion Medical, JUL 21, 2021, View Source [SID1234585031]).

"We are thrilled to bring the promise of biology-guided radiotherapy to the Dallas-Fort Worth Metroplex," said Barry Russo, CEO of The Center for Cancer and Blood Disorders. "We have a long history of offering our patients the latest advances in cancer therapies, clinical trials and cancer research, and BgRT continues this convention. The multi-modality nature of the X1 will allow us to eventually offer advanced radiotherapy for all stages of solid tumor cancers, even in cancers where it has been traditionally infeasible to do so."

The RefleXion X1 machine is cleared for clinical use in stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), intensity modulated radiotherapy (IMRT), and forms of conventional radiotherapy indicated for early-stage cancers, or palliative relief of symptoms for later-stage cancers. BgRT, currently under development, is designed to treat both early and late-stage cancers.

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide radiotherapy. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct radiotherapy to each tumor and destroy it, even in moving tumors.

"We are gratified by the commitment and enthusiasm of the clinicians at The Center for Cancer and Blood Disorders for our RefleXion X1 platform," said Todd Powell, president and CEO at RefleXion. "This sale expands our commercial momentum into the southern United States, a large and growing market known for embracing new technologies that deliver cutting-edge patient care."

Installation of the RefleXion X1 machine, which will be located at the main campus in Fort Worth, is expected to begin in early 2022.

Medicare Issues Local Coverage Determination for Biocept’s Target Selector™ Breast Cancer Assay to Detect the HER2 Biomarker from Circulating Tumor Cells

On July 21, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that it has received a positive final Local Coverage Determination (LCD) that expands Medicare coverage for use of its Target Selector assay to identify the HER2 biomarker from circulating tumor cells (CTCs) (Press release, Biocept, JUL 21, 2021, View Source [SID1234585030]). This coverage determination from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDx) was effective July 4, 2021.

About 20% of breast cancers are HER2-positive, with metastatic cancers more likely to be HER2-positive and approximately 20% of HER2-positive patients experiencing recurrence each year. Given the efficacy of various anti-HER2 therapies, testing for HER2 is one of the most important sources of information used by oncologists in making treatment decisions for patients with breast cancer. As a result, guidelines for breast cancer recommend that all patients with new primary or newly metastatic breast cancer be tested for HER2. Traditionally, testing has been performed using tissue. However, adequate tissue from the original biopsy may not be available, and additional invasive biopsy procedures are often impractical and associated with complications.

"Target Selector is a highly sensitive assay for identifying HER2 status that is less invasive, more time-efficient and more cost-effective than tissue biopsy," said Michael Dugan, M.D., Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "Metastatic tumors often show genetic changes that are associated with disease progression and frequently have features of HER2 gene amplification that are not present in the primary tumor. Target Selector’s ability to both detect and characterize the tumor cells provides critical information to help identify patients who may benefit from advanced targeted therapies, with the potential to significantly improve patient outcomes."

The MolDx program was developed by CMS to identify and establish coverage and reimbursement for molecular diagnostic tests. To receive a favorable MolDx coverage determination, assays must demonstrate clinical utility, fulfill the CMS reasonable and necessary criteria, and meet analytical and clinical validity standards. The LCD, which includes other cancer biomarkers in addition to HER2, is posted on the CMS website and can be accessed here.

"This coverage determination for our Target Selector assay is important for physicians and patients, as it expands access to a test that can provide the opportunity to find answers that may otherwise not be available from traditional approaches," said Michael Nall, President and CEO of Biocept. "We are very pleased with this achievement and are excited to be making significant progress on a number of fronts that address critical needs in oncology and support public health efforts."

Biocept’s combined cell-based and cell-free liquid biopsy tests assess actionable cancer biomarkers from a patient’s blood and, uniquely, from cerebrospinal fluid (CSF) as well. Following the full commercial launch of its CSF assay, CNSide, Biocept submitted an initial application for Breakthrough Device Designation to the U.S. Food and Drug Administration (FDA). While the initial submission was recently denied, the company continues to pursue Breakthrough Device Designation for CNSide and is gathering data based on the feedback provided by the FDA to further support its submission. The test is currently marketed as a Lab Developed Test (LDT) in Biocept’s CLIA certified and CAP accredited lab. CNSide is designed to improve the clinical management of patients with suspected metastatic cancer involving the central nervous system.

The company also continues to provide COVID-19 testing services to help manage the impact of COVID-19 in long-term care facilities, schools and other public facilities it serves. Biocept has received more than 450,000 samples for SARS-CoV-2 testing since launching this service in June 2020. The samples are processed using Biocept’s RT-PCR-based technology at its CLIA-certified, CAP-accredited, high-complexity molecular laboratory in San Diego.