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.

On August 2, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid", the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that its wholly-owned CLIA-certified and CAP-accredited laboratory, LucidDx Labs Inc. ("LucidDx Labs"), has entered into participating provider agreements with preferred provider organizations Prime Healthcare, Three Rivers Provider Network, and Galaxy Health Network (the "PPOs"), as well as Alivio Health, a specialized diagnostic laboratory network (Press release, Lucid Diagnostics, AUG 2, 2022, View Source [SID1234617301]).

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The PPOs and Alivio Health collectively provide access to millions of lives through the provider networks they have compiled for their clients, including third-party administrators, insurance companies, self-insured companies, corporations, and government entities, to access. Pursuant to the agreements, persons covered by clients of the PPOs and Alivio will have in-network access to Lucid’s EsoGuard DNA test, the first and only commercially available test capable of serving as a widespread tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk chronic heartburn patients. The agreement provides rates of reimbursement as a percent of charges for services rendered to such covered persons by LucidDx Labs, including performance of the EsoGuard test.

"We are excited to join these provider networks and continue to expand our reach, offering in-network access to EsoGuard esophageal cancer prevention testing to millions of persons covered by their clients and payers," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "Securing broad commercial reimbursement for EsoGuard testing remains one of our most important near-term strategic goals and key value drivers. Our talented and expanding market access team will continue to work tirelessly to secure many more such agreements covering millions more lives."

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element—the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. A recently updated American College of Gastroenterology clinical practice guideline endorses nonendoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.

On August 2, 2022 InterVenn Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, reported the start of enrollment in its prospective cohort study for early detection of colorectal cancer and adenomas (Press release, InterVenn Biosciences, AUG 2, 2022, View Source [SID1234617300]). This confirmatory Noninvasive Identification of Colorectal Cancer and Adenomas in Early Stages – better known as the NICE Study – is intended to validate InterVenn’s platform to detect early colorectal cancers and precancerous adenomas with a high degree of accuracy from a groundbreaking low volume of blood.

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"InterVenn Biosciences was established with the mission that no one should ever be blindsided by disease. Early detection is critical for fulfilling this promise to significantly improve patient outcome and survival," said Tillman Pearce, Chief Medical Officer of InterVenn Biosciences. "The initiation of recruitment in our prospective NICE Study is a significant step forward for InterVenn to demonstrate that our platform has clinical utility to enable and accelerate detection of CRC at earlier stages than conventionally possible today with other methods."

The NICE Study represents the next phase in InterVenn’s advancement toward improving cancer screening, building on the pilot data that the company presented at the ASCO (Free ASCO Whitepaper) healthcare conference in early June. The pilot data demonstrated positive results for the InterVenn perspectIV platform measuring glycosylation of circulating plasma proteins, detecting early CRC and precancerous advanced adenomas with high sensitivity from a low volume of peripheral blood (typically ~100uL).

The multicenter NICE observational study (NCT05445570) is enrolling participants prior to a colonoscopy across major gastroenterology centers, such as Borland Groover, Louisiana Research Center, Paragon Rx Clinical, East View Medical Research, and Blue Ridge Medical Research. This study will support current and future discovery as well as generate clinical evidence for InterVenn’s oncology portfolio developed on InterVenn’s perspectIV platform.

"As a premier G.I. practice, Borland Groover is deeply committed to fighting colon cancer with all available tools and is excited to be part of this trial," said Borland Groover Principal Investigator, Bharat Misra, MD. "While colonoscopy is the gold standard for Colorectal Cancer (CRC) screening, many patients are reluctant to have this procedure. A blood-based screening test is more appealing to our patients who are reluctant to getting screened via colonoscopy and is the future of colon cancer screening."

InterVenn’s oncology program includes a series of liquid biopsy-based assays that InterVenn develops to address a variety of cancers. InterVenn is building a robust pipeline of liquid biopsy tests to unlock the untapped, rich layer of biology called the glycoproteome, which is, in simple terms, the entire set of sugars on proteins. Because of the essential roles glycoproteins play in physiological functions, the glycoproteome has the potential to be highly significant for real-time clinical decision-making.

Validation from the NICE Study will bring InterVenn’s innovation to colorectal cancer screening, which can potentially help prevent and treat the disease in the future. With approximately 110MM people considered average risk for colorectal cancer in the United States, the US market size for colorectal cancer screening represents a potential $18 billion annual market opportunity.

For more information about the NICE Study for CRC, please contact [email protected]