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Gilead Sciences to Release Third Quarter 2022 Financial Results on Thursday, October 27, 2022

On October 13, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its third quarter 2022 financial results will be released on Thursday, October 27 after the market closes (Press release, Gilead Sciences, OCT 13, 2022, View Source [SID1234622005]). At 4:30 p.m. Eastern Time that day, Gilead’s management will host a webcast to discuss the company’s third quarter 2022 financial results and will provide a business update.

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A live webcast will be available on the Investor Relations section of www.gilead.com and will be archived there for one year.

Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar

On October 13, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue) (Press release, Prestige BioPharma, OCT 13, 2022, View Source [SID1234622004]).

The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues. The meeting is expected to take place around November, and the BLA submission by the end of the year.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.

Lisa Park, CEO of Prestige Biopharma, commented: "This Type 4 Meeting will be the final gate of BLA submission for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA’s approval."

Results from a Randomized Controlled Trial Show That TissueCypher® Barrett’s Esophagus Test Results Can Significantly Improve the Accuracy of Risk Assessments and Adherence to Guideline-Recommended Patient Management

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]).

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.

Cleveland Diagnostics Announces Favorable Medicare Local Coverage Determination and Assignment of a CPT-PLA Code for IsoPSA®

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]).

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%.

Obatala Sciences Closes $3 Million Series A Funding Round Co-led by être Venture Capital and Ochsner Health

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]).

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.