On June 24, 2021 Nucleai (www.nucleaimd.com), a precision medicine company using AI-powered image analysis technology to support novel pathology-based biomarker development, and Merck KGaA, Darmstadt, Germany, a leading science and technology company, reported that they have entered into a long-term collaboration to leverage Nucleai’s image analysis and biomarker discovery platform for several Merck KGaA, Darmstadt, Germany clinical stage oncology assets (Press release, Nucleai, JUN 24, 2021, View Source [SID1234584335]).

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As part of the collaboration, Merck KGaA, Darmstadt, Germany will leverage Nucleai’s platform for exploratory research, with the potential to further develop identified pathology-based biomarkers as companion diagnostics. The collaboration will further utilize Nucleai’s technology to expand onto Merck KGaA, Darmstadt, Germany’s analysis capabilities, enabling faster turnaround time and scale for future studies.

Nucleai’s platform analyzes tissue images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may help predict patient response. These biomarkers hold the potential to provide better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. To develop its platform, Nucleai leverages proprietary datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel.

"We are thrilled to announce another major collaboration with a leading pharmaceutical company like Merck KGaA, Darmstadt, Germany to identify and develop novel biomarkers for their oncology assets. By combining real world and clinical trial datasets, with an integrated and scalable technology platform, we are harnessing the power of AI and big data and setting the standard for future precision medicine collaborations, adds Avi Veidman, CEO and Co-Founder of Nucleai."

On June 24, 2021 Personal Genome Diagnostics Inc. (PGDx) reported a strategic collaboration with Massachusetts General Hospital (MGH) (Press release, Personal Genome Diagnostics, JUN 24, 2021, View Source [SID1234584334]). The two organizations will work closely on the development of innovative solutions aimed at enabling seamless introduction of next-generation sequencing and genomic-based tumor profiling capabilities across a diverse set of clinical operations and laboratory settings.

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"PGDx is thrilled to collaborate with MGH, one of the nation’s most highly regarded research hospitals and a leader in advancing the field of genomic testing into clinical cancer care for the benefit of patients," said Megan Bailey, Chief Executive Officer of PGDx. "Our elio tissue complete platform enables comprehensive tumor profiling and assessment of tumor mutation burden, which can be used to inform treatment strategies that employ targeted immunotherapies and other advanced precision medicines. This collaboration will aid in our goal of ensuring this powerful technology is broadly accessible to patients across all types of healthcare settings."

Cancer care in the 21st century requires comprehensive genetic information. The field of oncology has firmly embraced genetic tumor testing into patient care. One of the biggest challenges, however, is having access to all diagnostic information at the right time to make the best treatment decisions possible. The increased demand for testing has resulted in increased pressures on laboratories to implement high-throughput sequencing services.

"Despite dramatic advances in the number of targeted therapies and biomarkers identified in non-small cell lung cancer, several studies have shown that fewer than 50% of patients diagnosed with this disease receive comprehensive genomic profiling," said Lauren Ritterhouse, MD, PhD, Associate Director of MGH’s Center for Integrated Diagnostics. "Many of these instances are associated with a lack of access to multigene next-generation sequencing panels."

The collaboration between PGDx and the MGH recognizes the critical importance of empowering local laboratories. The groups will initially focus on a Precision Diagnostics solution that comes with a playbook and enables seamless introduction of next-generation sequencing testing across many laboratories. The groups are also committed to creating an on-site training program with a special emphasis on laboratory and clinical operations to accomplish broad-scale patient access.

"Next-generation sequencing is complex, and overcoming the various constraints puts many laboratories in a tough position," said Ritterhouse. "MGH is known for bringing discoveries to patients. And we believe it is important to focus our attention on facilitating a solution that will enable broader patient access to precision diagnostics."

On June 24, 2021 Gliknik Inc., an immunology company dedicated to patients with cancer and autoimmune disorders, reported that it has successfully completed an $11.5 million Series C Preferred Stock financing (Press release, Gliknik, JUN 24, 2021, View Source [SID1234584333]). First In Ventures (FIV) led the Series C with SAISO Partners and affiliates of RDA Ventures and Garden Street Holdings also participating. The proceeds are targeted to progress the growing pipeline of Gliknik product candidates. Gliknik has secured $81 million to date to advance its programs.

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"We believe that Gliknik has created several potential best-in-class mid-stage assets," said Scott Roth, managing partner of FIV. "This capital will help unlock the potential of these compounds and uniquely positions Gliknik to make a difference for patients with cancer or autoimmune disorders."

Funding will help advance Gliknik clinical and pre-clinical programs, including:

A randomized double-blind, placebo-controlled phase 2 study of Gliknik immuno-oncology compound biropepimut-S, which is nearing completion. Clinicians are assessing two-year endpoints in the prevention-of-recurrence of high-risk squamous cell oral cavity cancer.
Gliknik immune modulating compound GL-2045, a recombinant mimetic of pooled human IVIG, which is a potent clinical candidate under active development by Gliknik licensee Pfizer for autoimmune diseases. Gliknik believes that based on potency, purity and anticipated convenience, GL-2045 has the potential to be a disruptive advance for autoimmune diseases that could help address the current critical shortage of IVIG.
GL-0719 is a new type of complement modulator, which is designed to control diseases while leaving critical host defense systems intact. GL-0719 is poised to enter a phase 1 trial in 2021.
Other compounds in preclinical development
Kyle Rusconi, a founder of FIV, is joining the Gliknik Board. "During the last several years, Gliknik has created a significant pipeline of important compounds," said Mr. Rusconi. "This scientific development was done in a capital-efficient manner that preserved shareholder equity."

"We are humbled by the depth of support from our investor base and welcome the addition of discerning investors with a long-term view," said Gliknik CEO David Block.

On June 24, 2021 Foundation Medicine, Inc. and its collaborators reported results from a Dana-Farber Cancer Institute-led study that used genomic testing, including Foundation Medicine’s liquid-based comprehensive genomic profiling (CGP) test, FoundationOneLiquid CDx, among several assays, to investigate resistance mechanisms in 38 patients with cancer treated with a KRAS G12C inhibitor (Press release, Foundation Medicine, JUN 24, 2021, View Source [SID1234584332]). The study found a complex landscape of acquired resistance mechanisms, with putative resistance mechanisms identified in 45% of patients. These mechanisms were diverse, and some patients (18%) had multiple resistance alterations. Study findings support the need for development of additional KRAS inhibitors and combination treatment strategies and reinforce the utility of liquid biopsy assays in evaluating resistance. The study, "Acquired Resistance to KRAS G12C Inhibition in Cancer," was published yesterday in The New England Journal of Medicine.

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The KRAS oncogene encodes a protein frequently altered in cancer, and mutations typically occur at hotspots in the protein, increasing the activity of KRAS and driving pro-tumorigenic signaling. Although KRAS mutations are among the most common cancer drivers, only recently have investigational KRAS inhibitors entered clinical development, with the first KRAS inhibitor just approved for certain patients with lung cancer. In this study of patients receiving an investigational therapy, researchers identified multiple resistance pathways – in some cases even within a single sample – through the use of genomic testing from several labs. These findings help researchers better understand the landscape of acquired resistance to KRAS inhibitors to inform the development of additional therapeutics targeting KRAS alterations or combination therapies designed to block oncogenic signaling and result in clinical responses.

"Resistance mechanisms to cancer treatment are often complex, which is challenging for oncologists and researchers to describe and effectively counter. That’s why we were excited to help incorporate genomic testing though Foundation Medicine’s comprehensive liquid biopsy assay into this study – one of the first analyzing resistance mechanisms to KRAS inhibitors," said Alexa Schrock, Ph.D., Director, Clinical Development at Foundation Medicine. "Comprehensive liquid biopsy assays not only enable widespread access to genomic testing, which is particularly appealing to patients with treatment resistance, but they also provide insights to help drive the development of new therapeutic approaches for these patients."

The study included a total of 38 patients, 27 with non-small cell lung cancer (NSCLC), 10 with colorectal cancer and one with appendiceal cancer. Using multiple genomic tests, mechanisms of putative resistance to adagrasib monotherapy were detected in 17 patients (45% of the cohort), eight of whom had multiple resistance mechanisms. In one patient with NSCLC (tested with FoundationOne Liquid CDx), testing revealed acquired KRAS alterations including H95D, R68S​, G12W​ and G12V, as well as acquired RTK and MAPK pathway alterations.

This clinical analysis was aided by a deep mutational scanning screen of a library of KRAS G12C variants that systematically defined potential secondary alterations conferring resistance to KRAS G12C inhibition. The findings suggest a diverse landscape of KRAS G12C inhibitor resistance mechanisms, which can help inform novel therapeutic strategies to effectively overcome this drug resistance in patients with cancer.

About FoundationOneLiquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

On June 24, 2021 Mevion Medical Systems reported that the first proton center in the Mountain West, the Senator Orrin G. Hatch Center for Proton Therapy, has opened at Huntsman Cancer Institute (HCI) at the University of Utah (U of U) and began treating patients on May 11th with the MEVION S250i Proton Therapy System (Press release, Mevion Medical Systems, JUN 24, 2021, View Source [SID1234584331]). Despite the challenges of the COVID-19 pandemic, the Mevion team successfully installed the MEVION S250i in 7 months from the delivery of the accelerator.

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HCI is the only National Cancer Institute-designated Comprehensive Cancer Center in the Mountain West and serves a geographic region that includes all of Utah, Idaho, Montana, Nevada, and Wyoming.

"After more than a decade of monitoring and evaluating the evolution of proton therapy technology, along with the needs of our patients, we are excited to officially launch our proton center and to provide this extraordinary treatment option to our patients," said Bill Salter, Ph.D., Senior Director of Radiation Oncology at HCI and Professor and Chief of the Division of Medical Physics at the U of U. "Our initial experience of treating both adult and pediatric tumors has already made evident the unique clinical capabilities of proton technology."

The center features Mevion’s industry leading HYPERSCAN pencil beam scanning technology and Adaptive Aperture pMLC. The powerful duo provides faster and more precise dose delivery and minimizes damage to surrounding healthy tissue and sensitive organs at risk. HCI has also integrated a diagnostic CT on-rail system and a surface-guidance tracking system, enabling a state-of-art Image-Guided Proton Therapy (IGPT) configuration to align and treat patients with the upmost accuracy.

Thanks to the reduced size and complexity of the MEVION S250i, the HCI Center for Proton Therapy was placed in a small available space alongside HCI’s existing radiation therapy department. This significantly decreased the project construction and operation cost and allows the cancer center to share existing resources and give patients access to all of HCI’s cancer treatment and research offerings under one roof.

"It is to our greatest pleasure that the underserved patients in the Mountain West now have access to proton therapy," said Tina Yu, Ph.D., chief executive officer of Mevion Medical Systems. "We are honored to partner with HCI to make this happen and look forward to our many years of collaboration and research to further advance this superior treatment modality."

As the leading supplier of compact proton therapy systems in the United States, Mevion has been selected by more leading cancer centers, including NCI-Designated Cancer Centers, and has treated over 6,000 patients worldwide.