1stOncology™: Cancer Intelligence Service – Page 9767 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Genetron Health Releases New Data Results of HCCscreen™ for Liver Cancer Early Screening in China

On March 24, 2021 Genetron Holdings Limited ("Genetron Health" or the "Company", NASDAQ:GTH), a leading precision oncology platform company in China that specializes in molecular profiling tests, early cancer screening products and companion diagnostics development, reported new data and results for HCCscreenTM, a blood-based early screening test for hepatocellular carcinoma ("HCC") (Press release, Genetron Health Technologies, MAR 24, 2021, View Source [SID1234577099]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

This multi-center prospective study, named the "HCCscreenTM Investigational Study" (HIT), is a collaboration between Genetron Health and the National Cancer Center China that started in 2019. Among a total of 1,615 HBsAg+ individuals that completed the follow-up phase by February 2021, the primary outcome showed that HCCscreenTM achieved 88% sensitivity and 93% specificity, compared with 71% sensitivity and 95% specificity, respectively, by ultrasound plus alpha-fetoprotein (AFP) combined. HCCscreenTM also achieved 40.9% positive predictive value (PPV) and 99.3% negative predictive value (NPV). The study results are summarized in the following tables:

Furthermore, stratified by tumor size, 49% (28/57) of the cases identified by HCCscreenTM were in early stage, i.e. <3cm. These patients are expected to have much better prognosis than advanced stage ones. Additionally, HCCscreenTM achieved sensitivities of 85% for tumor sizes of <3cm, 96% for 3-5cm, and 88% for >5cm. The results are summarized in the following table:

Previously, Genetron Health reported preliminary analysis results from the first 297 patients enrolled in the study. Compared with the preliminary results, the confidence interval of sensitivity had improved from 62%-100% to 80%-94%, and the confidence interval of specificity had improved from 89%-96% to 91%-94%. The preliminary study results are summarized in the following table:

"We are very pleased with the new HCCscreenTM data from this large, prospective cohort study, which showed overall better sensitivity data, and comparable specificity data versus the standard of care. These additional validation updates gave us more confidence about our assay’s performance, and we will move forward to initiate an NMPA registrational study in the second quarter of this year," said Mr. Sizhen Wang, co-founder and CEO of Genetron Health. "Overall, HCCscreenTM continues to be a leading liquid-biopsy early detection assay in hepatocellular carcinoma. We are delighted with our clinical and commercial progress to bring this product to more patients, and address an unmet, significant medical need in China."

About HCCscreenTM and Liver Cancer

In September 2020, Genetron Health received the U.S. Food and Drug Administration ("FDA")’s Breakthrough Device designation for HCCscreenTM, and the product has been commercialized recently as a lab developed test ("LDT") in China.

Globally, liver cancer is the fourth most common cause of cancer-related death and the sixth in terms of incidence1. China represents the largest market, accounting for almost half of the global incidences. New incidence in China was estimated to be around 393,000 per year, with 369,000 deaths2. Market data by Frost and Sullivan estimated that as of 2019, among the 120 million high risk liver cancer population in China, around 74 million were HBV carriers.

HCCscreenTM is powered by Genetron Health’s innovative and proprietary Mutation CapsuleTM technology, which enables detection of multiple methylation alterations in parallel with mutations in cell-free DNA from peripheral blood specimens.

References:

Villanueva, A. Hepatocellular Carcinoma. N. Engl. J. Med. 2019, 380, 1450–1462.
Globocan 2018. View Source Information on this website is not incorporated into this update and should not be considered part of this update. We have included any website as an inactive textual reference only.

Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results

On March 24, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and full year for the period ended December 31, 2020 (Press release, Lucence, MAR 24, 2021, View Source [SID1234577098]).

"We are very excited about the progress we have made, completing all the patients in the Phase 2B NAV3-31 trial and submitting our briefing book to the FDA were milestone accomplishments this past year," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We are looking forward to hearing back from the FDA and continuing our due diligence discussions with Jubilant over the near term."

Fourth Quarter 2020 Highlights and Subsequent Events

Announced positive results from continued analysis of subjects who have completed Arm 3 of the Company’s NAV3-31 Phase 2B study. These data further corroborated Navidea’s hypotheses that Tc99m tilmanocept imaging can provide robust, quantitative imaging in patients with active rheumatoid arthritis ("RA") and that this imaging can provide an early indicator of treatment efficacy.
Submitted a formal Type B Meeting Request to the U.S. Food and Drug Administration ("FDA"). The FDA granted the Type B meeting and the Company has submitted the Briefing Book. The FDA is currently reviewing these formal briefing documents containing results from the NAV3-31 Phase 2B study and the proposed Phase 3 design and protocol.
Achieved last patient, last visit in the Company’s NAV3-31 Phase 2B study. Study closeout and data analysis are ongoing.
Opened the first US site, Northwestern University, for enrollment in the Company’s NAV3-32 Phase 2B trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA.
Continued enrollment in the Investigator Initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals.
Received notice of patent grant from the USPTO for US 10,806,803: "Compositions for targeting macrophages and other CD206 high expressing cells and methods of treating and diagnosis."
Received a notice of allowance from the USPTO for the patent application: "Compounds and methods for diagnosis and treatment of viral infections" (US Patent Application 15/729,635).
Performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state and a synergistic effect on tumor growth reduction using the Company’s doxorubicin-containing construct with an approved checkpoint inhibitor therapy.
Appointed Malcolm G. Witter to the Company’s Board of Directors. Mr. Witter brings decades of financial and corporate governance experience to the board.
Entered into a Stock Purchase Agreement and Letter of Investment Intent with an existing investor, pursuant to which the Company issued to the investor 50,000 shares of newly-designated Series E Redeemable Convertible Preferred Stock (the "Series E Preferred Stock") for an aggregate purchase price of $5.0 million. The Series E Preferred Stock is convertible into a maximum of 2,173,913 shares of Common Stock.
Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team is working diligently to advance the technology in key disease areas, with an emphasis on our RA program. We have completed all patients and all visits in our NAV3-31 Phase 2B trial and we are eagerly anticipating feedback from the FDA on our briefing package and design of the Phase 3 trial. We continue to prepare for initiation of this trial and have also opened up enrollment for the NAV3-32 Phase 2B trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients. Concurrent with all of this, we have made exciting progress in our therapeutics pipeline and will continue to advance these towards the clinic."

Financial Results

Total net revenues for the fourth quarter 2020 were $219,000, compared to $119,000 for the same period in 2019. Total net revenues for the full year of 2020 were $914,000, compared to $651,000 for 2019. The increases were primarily due to increased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development coupled with increased license revenue from net transitional sales in Europe.
Research and development ("R&D") expenses for the fourth quarter of 2020 were $1.3 million, compared to $1.7 million in the same period in 2019. R&D expenses for the full year of 2020 were $4.9 million, compared to $5.3 million in the same period in 2019. The decreases were primarily due to net decreases in drug project expenses, including decreased Manocept therapeutic development costs, decreased Manocept diagnostic development costs, and decreased Tc99m development costs, offset by increased NAV4694 development costs. The net decreases also included decreased regulatory consulting and travel expenses offset by increased employee compensation.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2020 were $1.7 million, compared to $1.2 million in the same period in 2019. SG&A expenses for the full year of 2020 were $6.7 million, compared to $6.3 million in 2019. The net increases were primarily due to increased legal and professional services, employee compensation, European Medicines Agency annual fees for Lymphoseek, and franchise taxes, offset by decreased travel, depreciation and amortization, losses on disposal of assets, insurance, and investor relations services.
Navidea’s net loss attributable to common stockholders for the fourth quarter of 2020 was $3.0 million, or $0.11 per share, compared to $2.8 million, or $0.15 per share, for the same period in 2019. Navidea’s net loss attributable to common stockholders for the full year of 2020 was $11.4 million, or $0.48 per share, compared to $10.9 million, or $0.76 per share, for 2019.
Navidea ended the fourth quarter of 2020 with $2.7 million in cash and cash equivalents. Since December 31, 2020, the Company has received $7.9 million of cash related to the Series D and Series E Preferred Stock funding transactions. To date, the Company has received over $14 million of proceeds from the issuance of Series C, Series D and Series E Preferred stock.
Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Participants who would like to ask questions during the question and answer session will be prompted by the moderator, who will provide instructions.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Guardant Health Joins Forces With Patient Advocacy Groups to Raise Awareness of Importance of Complete Biomarker Testing for Patients With Advanced Colorectal Cance

On March 24, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company,reported with leading patient advocacy groups to expand the Clear Your View initiative to raise awareness of the important role complete biomarker testing plays in guiding initial treatment decisions for newly diagnosed advanced colorectal cancer (CRC) patients (Press release, Guardant Health, MAR 24, 2021, View Source [SID1234577097]). Current medical guidelines call for testing all six biomarkers in advanced CRC before starting treatment,2 yet more than 60 percent of patients are not receiving complete testing which puts them at risk for inappropriate therapy.1

Now in its second year, the Clear Your View campaign encourages oncologists to "stop, test, and wait" for complete biomarker testing results before starting first-line treatment. Last year, the campaign focused on improving biomarker testing rates in advanced non-small cell lung cancer (NSCLC), which remains suboptimal at 20 percent,3 and garnered support from patient advocacy groups GO2 Foundation for Lung Cancer, LUNGevity Foundation, ALK Positive, and Lung Cancer Action Network. Now the campaign expands its focus to colorectal cancer, the second leading cause of cancer death and third most commonly diagnosed cancer in the US,4 and garners support from Colorectal Cancer Alliance, Fight CRC, Global Colon Cancer Association, KRAS Kickers, and PALTOWN.

Targeted therapy matched to a patient’s genomic profile has been shown to significantly extend median overall survival rate for advanced CRC patients5 as well as NSCLC patients.7-13 Testing for all recommended biomarkers can help predict which patients are most likely to respond to a certain treatment and which will not respond, and is one of the best ways to ensure that the patient receives the best treatment from the start. For example, while over 60 percent of metastatic CRC patients have a biomarker that may predict poor response to anti-EGFR monoclonal antibody therapy, 72 percent of patients who received anti-EGFR therapy did not first complete guideline-aligned RAS and BRAF biomarker testing to determine eligibility – resulting in patients potentially receiving less efficacious, costly treatment.1 The growing number of targetable CRC biomarkers makes it imperative that all patients receive complete biomarker testing before starting first-line treatment.5

"For patients with advanced colorectal cancer, time is of the essence and receiving the best treatment from the start is critical in extending progression-free survival," said Andrew Spiegel, co-founder and executive director of the Global Colon Cancer Association. "We are proud to support the Clear Your View campaign and stand committed alongside Guardant Health, Colorectal Cancer Alliance, Fight CRC, KRAS Kickers, and PALTOWN to raising awareness and urgency around the importance of complete biomarker testing to improve survival for patients."

"Incredible progress has been made in personalized treatments for advanced colorectal cancer, including not only medicines in clinical trials, but available FDA-approved medicines, yet too many patients are missing out on these potentially life-changing treatments due to suboptimal biomarker testing rates," said Helmy Eltoukhy, Guardant Health CEO. "Additionally, many patients are being treated with potentially less efficacious treatments. Through the expansion of the Clear Your View initiative, we join the colorectal cancer community in urging wider adoption of complete biomarker testing to help ensure the best treatments for all patients suffering from advanced cancer."

Bruker Light-Sheet Microscopes at Major Comprehensive Cancer Center

On March 24, 2021 Bruker Corporation (Nasdaq: BRKR), a leading supplier of single-plane illumination microscopy (SPIM) technology for research on live cells and cleared biological samples, reported that two Luxendo MuVi and LCS SPIM light-sheet microscopes have been installed by Memorial Sloan Kettering Cancer Center (MSK) (Press release, Bruker, MAR 24, 2021, View Source [SID1234577096]). The funding for the two light-sheet fluorescence microscopes was supported by Cycle for Survival (View Source). The new SPIM microscopes will help researchers visualize the cellular and tissue hallmarks of cancer and translate those findings into better cancer treatment methods.

"By understanding how cells mobilize to build organs, researchers can glean insights into why some cells become cancerous and lead to organ destruction," said Dr. Anna-Katerina Hadjantonakis, MSK Chair of the Developmental Biology Program. "Instruments such as these are useful for imaging across differing length scales — from subcellular to single cells to tissue-level processes — allowing researchers to study cellular dynamics and cellular motion, processes that enable cells to metastasize."

"Light-sheet fluorescence microscopy has emerged as a uniquely powerful method for high-resolution, cleared-sample and dynamic biological imaging," added Dr. Lars Hufnagel, Vice President and General Manager of Bruker’s Luxendo light-sheet microscopy business. "We couldn’t be more pleased that our technology will be assisting the great MSK researchers and programs in such important work."

About the MuVi and LCS SPIM Systems
Bruker’s SPIM systems avoid sample phototoxicity by sequentially illuminating a stack of small slices of the organism, allowing scientists to observe living organisms for extended periods of time without photodamage. In particular, MuVi SPIM allows fast 3D imaging of live cells and living objects, such as spheroids and whole specimens, without the need of sample rotation. Despite the fact that sample rotation is not necessarily needed for a non-isotropic acquisition, the MuVi SPIM system provides this degree of freedom such that isotropic resolution can be achieved.

The modular LCS SPIM for large, cleared samples has been designed to be compatible with a broad variety of clearing solutions and sample sizes. Its new sample mounting approach and innovative optical design enables unprecedented acquisition times and minimizes sample distortions while seamlessly integrating into existing clearing and sample preparation pipelines. To handle the vast amount of data produced by the light-sheet technique, Lux DATA comprehensive data processing and storage provides fast transfer and large-capacity storage and leverages multi-core- and multi-GPU-based processing.

BiomX to Report Fourth Quarter and Full Year 2020 Financial Results on March 31, 2021

On March 24, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and live audio webcast on Wednesday, March 31, 2021, at 8:00 a.m. EDT, to report fourth quarter and full year 2020 financial results (Press release, BiomX, MAR 24, 2021, View Source [SID1234577095]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.