On October 13, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data from a randomized controlled trial (RCT) showing that use of TissueCypher Barrett’s Esophagus Test results can significantly improve a physician’s accuracy in assessing the risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) in patients diagnosed with Barrett’s esophagus (BE), as well as adherence to guideline-recommended patient management strategies (Press release, Castle Biosciences, OCT 13, 2022, View Source [SID1234622003]).

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EAC is an aggressive form of esophageal cancer associated with poor outcomes, and the only known precursor condition to its development is BE. TissueCypher is Castle’s precision medicine test designed to predict progression to HGD and/or EAC within five years for patients diagnosed with BE.

"The study data showed that participants who ordered or received TissueCypher test results were up to 65.6% more likely to predict progression to HGD or EAC, (p<0.001), when compared to physicians who did not receive TissueCypher test results in our randomized trial," noted John W. Peabody, M.D., Ph.D., first study author and President of QURE Healthcare. "Importantly, subsequent to receiving test results and making their assessment, the intervention group was also more likely to adhere to guideline-recommended management strategies."

These and other results of the RCT were presented through a moderated poster presentation, titled "Results from a randomized controlled trial: introducing a precision medicine diagnostic tool increases adherence to guidelines in patients with Barrett’s esophagus," shared during the 30th United European Gastroenterology (UEG) Week. The poster may be viewed here.

In the RCT, 259 physicians were randomized to three groups and asked to evaluate clinical performance and value (CPV) vignettes with high- and low-risk patient scenarios based on clinical risk factors. A quality-of-care percentage (0-100%) score was generated from the CPVs based on the American College of Gastroenterology (ACG) and the American Society of Gastrointestinal Endoscopy (ASGE) guidelines. Quality-of-care scores improved significantly across all patient cases after physicians were given the TissueCypher test results.

"Barrett’s esophagus remains a persistent and real-world clinical challenge for endoscopists and patients. Individuals with non-dysplastic Barrett’s esophagus constitute the vast majority of cases, and for years, we have seen few updates in the management strategy of this patient population in particular," said Craig Munroe, M.D., gastroenterology medical director at Castle Biosciences. "We were very excited to present the results of the QURE study, which help further demonstrate TissueCypher’s potential to meaningfully advance the care of this important patient population. We believe the clinical utility and objective information provided by our test can equip physicians with the information they need to make more informed treatment plan decisions and move beyond the limitations in the current standard of care for risk stratification of patients with BE."

About TissueCypher Barrett’s Esophagus Test

The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for use in patients with endoscopic biopsy confirmed BE that is graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD); its clinical performance has been supported by nine peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test with its own unique CPT PLA code (0108U) and has been on the Medicare Clinical Laboratory Fee Schedule since January 2021. Additionally, the test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.

On October 13, 2022 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported two significant developments regarding the reimbursement of its novel non-invasive, blood-based prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, OCT 13, 2022, View Source [SID1234622002]).

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Medicare Administrative Contractor CGS Administrators, LLC (CGS) has issued a final Local Coverage Decision (LCD) providing favorable coverage for IsoPSA. IsoPSA will now be covered for the millions of men enrolled in Medicare nationwide and provide clearer information to patients and their doctors evaluating whether prostate biopsy is appropriate for them. Medicare covers 60 million men and women beneficiaries nationwide. The effective date for the LCD is November 20, 2022.

The AMA has awarded a Proprietary Laboratory Analysis code (CPT-PLA) for IsoPSA, thus providing the mechanism for payment required by payors to uniquely track and reimburse Cleveland Diagnostics for IsoPSA. This CPT-PLA code (0359U) will be effective January 1, 2023.

"We are very pleased to receive Medicare coverage and AMA coding for our IsoPSA test," said Arnon Chait, PhD, Chief Executive Officer of Cleveland Diagnostics. "These coverage and coding determinations are highly significant for physicians and patients, as they will expand access to IsoPSA, a test with multiple clinical indications related to prostate cancer, enabling better informed treatment decisions."

Up to 75% of the prostate biopsies performed in the US are negative for high-grade disease, placing undue burdens on patients, clinicians, and the healthcare system. Unlike the current standard of care in prostate cancer testing, prostate-specific antigen (PSA), which measures merely the concentration of PSA circulating in the blood, IsoPSA interrogates structural variants of PSA, providing clinicians and patients with greater clarity in identifying men who would benefit from prostate biopsy and who would not. In large, prospective multicenter studies of men scheduled for biopsy, IsoPSA demonstrated superior diagnostic accuracy compared to PSA in identifying patients with high-grade cancer. A large real-world clinical utility study has also shown that IsoPSA can reduce the number of unnecessary prostate biopsies by up to 55%.

On October 13, 2022 Obatala Sciences, a New Orleans biotechnology company recognized for speeding up therapies for obesity, diabetes, and cancer across diverse populations, reported the closing of a $3 million Series A finance round co-led by être Venture Capital and Ochsner Lafayette General Healthcare Innovation Fund II and joined by Benson Capital Partners, Elevate Capital Fund, and The Hackett-Robertson-Tobe Group (Press release, Obatala Sciences, OCT 13, 2022, View Source [SID1234622001]).

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The funding will be used to further the commercialization of its first-of-kind research-enabling products and platform for drug discovery and development. These solutions, provided to pharmaceutical companies, government labs, and researchers, are designed to accelerate the study and prevention of diseases in the fields of obesity, diabetes, cancer, and regenerative medicines.

"Recently the FDA has signaled the need to improve predictivity by reducing the use of animal-derived tissues, while the NIH has been calling for greater diversity in testing. Obatala Sciences’ diverse human-derived products are the exact solution designed for these market directions," said Jennifer Kuan, partner at être Venture Capital. "Obatala’s solutions enable their customers to significantly reduce failure rates, reduce the time to market, and thereby reduce costs. Combine that with Obatala’s extensive intellectual property portfolio, manufacturing strength, and rapidly growing customer base, and you can see why Obatala is positioned to be a leader in the 3D culture market."

"We are thrilled to have the support of our investment partners. Their belief in us, and their commitment to support minority-led companies and communities, like New Orleans, is changing the landscape for biotech companies like Obatala Sciences," said Obatala Sciences CEO Trivia Frazier, Ph.D., MBA. "This funding will accelerate the commercialization of our pipeline products as we work towards our milestones, which include the build-out of our lab at The Beach at UNO, a Research Park District located near the University of New Orleans campus, obtaining our ISO certifications, expanding our North American and international distribution network, and deepening our sales, marketing, and customer support teams to support our growing global customer base."

The Market Demand

Today, medical research and new drug development are hindered by the dependence on 2D cell culture and animal-derived data which yield high failure rates. In addition, current pre-clinical and clinical drug testing does not include representation across diverse patient populations. Responding to these short-comings, Obatala Sciences has developed a portfolio of patented and patent-pending solutions, including human-derived hydrogels for growing cells in 3D, adult human stem cells from a biobank of diverse populations, media for growing and differentiating cells, and complete tissue chip kits, such as fat-on-chip systems, which are currently available, and pancreas-on-a-chip, which is under development. These kits provide an essential platform for drug discovery and development, and when these tools are combined, they provide researchers with more accurate human-based data across diverse populations.

On October 13, 2022 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported that the U.S. Patent and Trademark Office has issued Patent No.11,459,398 titled, "Conjugates for Targeted Cell Surface Editing (Press release, Palleon Pharmaceuticals, OCT 13, 2022, View Source [SID1234622000])." The patent broadens Palleon’s intellectual property position and bolsters coverage for the company’s proprietary EAGLE platform, which is based on engineered human sialidase enzymes that restore antitumor immunity by degrading immunosuppressive sialoglycans on tumors and across immune cell types.

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The patented technology is part of an exclusive license Palleon has with Stanford University and originated in the laboratory of Carolyn Bertozzi, an inventor on the patent, and a scientific co-founder of Palleon Pharmaceuticals. Dr. Bertozzi was recently awarded the 2022 Nobel Prize for Chemistry for the invention of bioorthogonal chemistry, a technology which enabled the foundational science for Palleon’s platform.

"It is thrilling to see Palleon’s pioneering EAGLE platform reach this important milestone," said Dr. Bertozzi. "Therapeutic removal of sialic acid from cells in the tumor microenvironment, as this patent describes, has shown promising potential in generating an immune antitumor response in pre-clinical studies. This glyco-immunology approach could deliver meaningful benefits for patients who don’t respond to today’s immuno-oncology treatments."

The EAGLE platform enables the development of first-in-class therapies that strip sialic acids from both immune cells and cancer cells, restoring innate and adaptive antitumor immunity. This patent covers the use in cancer of tumor-targeted antibodies conjugated to sialidase, an enzyme that cleaves sialic acid.

"This patent provides important additional intellectual property coverage for an approach that, we believe, is key to expanding the promise of immunotherapy to millions of patients, especially to those patients with immune suppression who do not respond to currently approved immunotherapy agents," said Jim Broderick, M.D., Chief Executive Officer and founder of Palleon. "With this patent solidified, we are in a strong position to continue development of an entirely new class of investigational therapies within our rich, clinical-stage pipeline."

On October 13, 2022 Genuv Inc., a clinical-stage biotechnology company focused on innovative drug discovery for degenerative central nervous system diseases and advanced immuno-oncology therapeutics, reported a new drug candidate, GNUV205, a fusion of engineered IL2 and anti-PD-1 antibody that advances immuno-oncology science (Press release, Genuv, OCT 13, 2022, View Source [SID1234621999]). The drug candidate, for unspecified solid tumors, shows powerful anti-tumor activity without the toxicity typically associated with current IL-2 treatments.

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"We are excited by the promise shown by GNUV205," said Sungho Han, Ph.D., founder and CEO of Genuv. "Treatments targeting IL-2 are uniquely powerful, but have typically been plagued by systemic toxicity issues. Our strategy using a ‘no-alpha but attenuated beta gamma’ IL-2 variant fused with a unique anti-PD-1 via Genuv’s proprietary hetero Fc technology shows stronger binding affinity in the tumor microenvironment compared to marketed treatments Proleukine, Keytruda and Opdivo without Treg cell expansion."

Jenny Choih, Ph.D., K.M.D., Genuv’s director of clinical development and president of its U.S. subsidiary, said, "The preclinical results we will be sharing at the Immuno-Oncology Summit demonstrate conclusively how our drug candidate GNUV205 overcomes the limitations seen with many immune checkpoint inhibitors as well as IL-2 treatment. Many patients become refractory and need additional treatment options. In addition, for many patients, treatment can be limited by the severe systemic toxicities associated with traditional IL-2 treatments."

Genuv recently opened a U.S. subsidiary in Cambridge, MA to facilitate partnering activities and speed clinical development of GNUV205 and other immuno-oncology drug candidates.

Dr. Choih presented the poster with preclinical data on GNUV205. Details of the presentations are shown below.

Immuno-Oncology Summit: Oct. 12-14, Boston, MA

Poster number: P09
Title: GNUV205, a ‘No α and Attenuated IL-2’ Variant Fused with Novel Anti-PD-1, Potently Regresses Tumor Growth Without Toxicity via Selective Targeting to PD-1+ Teff Cell in Tumor Microenvironments
Presenter: Jenny Choih, Ph.D., K.M.D.