On August 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394 (Press release, Personalis, AUG 2, 2022, View Source [SID1234617306]). These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing.

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Personalis’ patent portfolio protects its pioneering work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with part-per-million sensitivity. Personalis is seeking both injunctive relief and monetary damages based upon Foresight’s infringement of these patents.

"Personalis has been active in whole human genome sequencing from very early on. By 2013, when we first began filing the applications that led to the patents we are asserting against Foresight, Personalis had already received customer orders to sequence and analyze over 1,000 human genomes and had realized the power of utilizing whole genome sequencing alongside our advanced targeted sequencing methods," said Personalis CEO, John West.

Personalis launched its ultra-sensitive MRD solution, NeXT Personal, in late 2021. NeXT Personal leverages many elements of the asserted patents, including the use of whole genome sequencing to identify up to 1,800 variants that are specific to a patient’s cancer, thereby achieving superior signal-to-noise in the detection of ctDNA in plasma samples. NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection.

"Personalis has invested hundreds of millions of dollars in research and development across a broad array of disciplines for over a decade, and we stand firm in our resolve to protect that investment and our leadership position in the field. NeXT Personal is our most recent product leveraging our pioneering work. We believe that it represents the most sensitive MRD approach for solid tumors and can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected," Mr. West added.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.

On August 2, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276) (Press release, BioThera Solutions, AUG 2, 2022, View Source [SID1234617305]). The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8009 and to determine the recommended phase 2 dose.

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B7-H3 is an immunomodulatory transmembrane N-linked glycoprotein that is overexpressed in a number of solid tumors including small cell lung cancer, non-small cell lung cancer, breast cancer, and others but has a limited distribution and a lower level of expression in normal human tissues. Differences in expression levels make B7-H3 an potential target for ADC drug development. BAT8009 was developed using Bio-Thera’s proprietary anti-B7-H3 antibody and ADC linker-payload that includes a cleavable and systemically stable linker and a small molecule topoisomerase I inhibitor. The small molecule topoisomerase I inhibitor payload carried by BAT8009 has a strong cell membrane penetration ability, so when the target cancer cells are killed, the payload can potentially be released and further kill nearby cancer cells, producing a bystander effect and overcoming the heterogeneity of the tumor. BAT8009 has demonstrated high anti-tumor activity and good stability and safety in both in vitro and in vivo pharmacological studies and is a potential "best-in-class" ADC that targets B7-H3. BAT8009 is the second ADC drug using Bio-Thera’s proprietary new ADC platform administered to patients, representing another important milestone in the company’s research and clinical development in the field of innovative oncology drugs.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT8009 is designed to assess the safety and tolerability of BAT8009. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate the pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Of note, Bio-Thera Solutions is developing several additional ADCs targeting Folate Receptor, HER2 and two other targets along with additional innovative oncology assets directed at important IO targets, including PD-1/CD47, OX40, CTLA-4, and TIGIT assets that are in early-stage clinical studies.

On August 2, 2022 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to THIO, a telomere-targeting agent currently in development to evaluate its activity in multiple cancer indications, for the treatment of small-cell lung cancer (SCLC) (Press release, MAIA Biotechnology, AUG 2, 2022, View Source [SID1234617304]). This is the second orphan drug designation granted to THIO, following receipt of orphan designation for hepatocellular carcinoma (HCC).

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"Receiving our second Orphan Drug Designation is an impressive regulatory milestone that highlights the FDA’s recognition of THIO’s potential to improve outcomes for patients with SCLC and HCC," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We believe there is a significant, multi-billion-dollar opportunity for THIO across many difficult-to-treat cancers and we look forward to advancing THIO towards the market and to patients in need for more effective therapies."

"Patients with SCLC have exceptionally poor prognosis, with only 6% of patients remaining alive five years after diagnosis," said Mihail Obrocea, MD, Chief Medical Officer of MAIA. "While clinical progress in SCLC treatment has been incredibly slow to evolve, an increased understanding of the disease biology has demonstrated that targeted therapies, like THIO, may offer a novel therapeutic option for SCLC."

Sergei Gryaznov, Ph.D., Chief Scientific Officer of MAIA, added, "There is significant room for improvement in the treatment landscape for SCLC, with the currently available standard-of-care therapies providing incremental benefit to patients. We are optimistic about our telomere-targeting approach to provide clinical benefit in patients with SCLC, CRC and HCC who have failed first-line therapies and we look forward to evaluating our approach in a future trial."

Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths. Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC. About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body. SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for its designated indication.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On August 2, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX), has conveyed coverage for the Guardant Reveal molecular residual disease (MRD) test (Press release, Guardant Health, AUG 2, 2022, View Source [SID1234617303]). Guardant Reveal is a blood test that detects circulating tumor DNA (ctDNA) in blood after surgery to help oncologists identify cancer patients with residual or recurring disease who may benefit most from adjuvant therapy. It is the first blood-only liquid biopsy test available for MRD testing in patients with colorectal cancer (CRC).

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The decision means Guardant Reveal is covered for fee-for-service Medicare patients in the United States with stage II or III CRC whose testing is initiated within three months following curative intent therapy. "We are pleased that Medicare has taken this important step to make MRD testing more widely available and help oncologists make more informed treatment decisions for their patients with colorectal cancer," said Helmy Eltoukhy, Guardant Health co-CEO.

Medicare’s policy decision adds to the coverage of Guardant Health tests for cancer patients. In December 2019, Palmetto GBA expanded local coverage determination (LCD) of the Guardant360 assay, making it the first liquid biopsy to be broadly covered for use across the vast majority of advanced solid tumors. In March 2022, Palmetto GBA also conveyed coverage for Guardant360 TissueNext, the company’s first tissue-based test to help oncologists identify patients with advanced cancer who may benefit from biomarker-informed treatment.

On August 2, 2022 Agilent Technologies Inc. (NYSE: A) reported that Professor Gerhardt Attard has been selected to receive a prestigious Agilent Thought Leader Award. Prof Attard is a John Black Charitable Foundation Endowed Chair in Urological Cancer Research at University College London (UCL) (Press release, Agilent, AUG 2, 2022, View Source [SID1234617302]). Professor Attard is prominent for his innovative research and clinical trials using cutting-edge liquid biopsy technologies to identify biomarkers to monitor drug response and cancer progression in patients with advanced prostate cancer. The technique is non-invasive and, therefore, ideal for tracking tumor response to therapy and the evolution of cancer mutation.

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Professor Attard is an influential oncology clinician-scientist whose work has enabled the application of modern genomics clinical solutions, such as liquid biopsy, to create the next generation of diagnostics and prognostic tools in the fight against cancer. Professor Attard’s research supported by this award will generate important data using relevant samples from clinical trials to identify and test changes in the circulating tumor DNA methylome that could be used as biomarkers for cancer progression and resistance to available therapies.

"The Agilent Thought Leader Award will support my group’s work interrogating tumor epigenetic information in plasma DNA. As translational researchers, one of our key remits is to transition new discoveries into clinically-implemented tests," said Professor Attard. "I am thrilled to receive this award. It is a great honor and important opportunity for my team and our collaborators to work with some of the industry leaders in the diagnostics field."

"My group primarily studies blood collected from men with advanced prostate cancer, but I expect our findings to have relevance to and support new tests for other cancer types," Professor Attard added. "I am confident that this partnership will accelerate our delivery of diagnostics that will provide cancer physicians more precise information to tailor treatment paradigms and improve patient outcomes."

"Agilent continues to invest in research on the important segment markets we serve," said Ronda Allen, head of R&D, Assays and Reagents, Diagnostics and Genomics Group at Agilent and executive sponsor of the award. "The important work conducted through this award will support scientific developments in the cancer genomics space and we believe Professor Attard will be a brilliant asset in that endeavor."

"Philanthropic gifts like the Agilent Thought Leader Award are crucial to enabling UCL’s world-leading scientists to make life-saving discoveries, that could alter the clinical landscape for advanced prostate cancer patients and those with other cancers," said Angharad Milenkovic, vice-president of Advancement at UCL. "We’re grateful to our philanthropic partners at Agilent, who share our vision for improving cancer diagnosis and treatment, and for their generous funding of Professor Attard’s research."

Professor Attard holds an advanced Cancer Research UK Clinician Scientist award and is Team Leader of the Treatment Resistance Group at the UCL Cancer Institute.

The Agilent Thought Leader Award program promotes fundamental scientific advances by contributing financial support, products, and expertise to the research of influential thought leaders in the life sciences, diagnostics, and chemical analysis space. To learn more, visit the Agilent Thought Leader Award website.