On March 24, 2021 Bioheng Biotech Co., Ltd, a clinical-stage biotechnology company dedicated on developing novel cellular immunotherapy for cancer, reported that it had secured $80 million in Series B Financing (Press release, Bioheng Biotech, MAR 24, 2021, View Source [SID1234577103]). The Series B was co-led by GL Ventures, the venture capital unit of Hillhouse Capital, Decheng Capital and Octagon Capital, with the participation of BlueRun Ventures China and Shenzhen Capital Group Company.

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Dr. Xiaohong He, Founder and Chief Executive Officer of Bioheng, stated, " We are thrilled to get recognition from such an excellent group of biotech investors and proud of the continued support from existing shareholders. Bioheng focuses on the development of allogeneic immuno-cell therapy. At present, we have made progress in several indications with promising clinical data. Proceeds from this financing will continue to be used to advance R&D capabilities, process development and clinical trials. We are looking forward to providing more affordable ‘off-the-shelf’ immuno- cell therapies to patients soon. "

"It is a great honor to continue supporting Bioheng in Series B financing. We have strong confidence in company’s technologies and management team," said Dr. Xiangmin Cui, Founder and Managing Director of Decheng Capital. "In the past two years, company has enriched the pipeline and made solid progress in multiple assets’ clinical development, demonstrating strong research and development capabilities."

Dr. Ting Jia, Founder and Chief Investment Officer of Octagon Capital, expressed, "Bioheng has a clear scientific vision, an outstanding teamwork spirit and unswerving sense of innovation. We are excited to have the opportunity to work with such an excellent team and will accompany them for a long journey."

On March 24, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company developing proprietary, intratumoral immunotherapy products to kill tumors and increase immune system recognition of cancers, reported that following receipt of the authorization from Health Canada, Intensity executed agreements with The Ottawa Hospital and The Ontario Institute for Cancer Research (OICR) to conduct a Phase II Randomized, Window of Opportunity (WOO) trial evaluating clinical and biological effects of intratumoral INT230-6 vs. no treatment in early stage breast cancer (Press release, Intensity Therapeutics, MAR 24, 2021, View Source [SID1234577102]).

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"There currently is no drug treatment available in the early presurgical setting with the ability to kill a tumor rapidly in the typical 4-week period from diagnosis to surgery," said Dr. Angel Arnaout, M.D., FRCSC, Professor of Surgery at University of Ottawa, Scientist at The Ottawa Hospital and Principal Investigator of the study. "Using INT230-6 to rapidly reduce a patient’s cancer cell burden and shut down proliferation in the timeframe from diagnosis to surgery is exciting and could offer increased clinical benefit. We are looking forward to initiating this study."

The trial is a Phase II, randomized, open label, multi-center study to enroll up to 60 patients with early-stage breast cancer. Patients, randomized 2:1 to treatment, will receive either three doses of INT230-6 on days 1, 8 and 15 post diagnosis or no treatment, the current standard of care (SOC) prior to resection. The study shall evaluate the change in pathological complete response compared to the standard of care. The primary endpoint is the proportion of patients who achieve a complete cell cycle arrest, defined as a reduction in the proportion of cells staining positive for Ki67, a widely used marker of cancer cell proliferation, as assessed by immunohistochemistry. The Ottawa Hospital will conduct subject enrollment and treatment and evaluate clinical responses, OICR will analyze subject immune responses and conduct biomarker analyses. Intensity will fund the trial and provide INT230-6 supply.

"Personalization is a major objective of modern medicine," said John Bartlett, Ph.D., Program Director, Diagnostic Development at OICR and Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto. "The ability to rapidly reduce a patient’s individual disease burden, diminish their cancer cells proliferation markers without causing systemic side effects and stimulate a patient-specific, anti-cancer T-cell response has the potential to create a new type of personalization for patients. We are eager to generate data that would help us understand INT230-6’s ability to train the immune system on a patient’s neoantigens prior to surgery without concurrent immune suppression."

"WOO trials form a key part of OICR’s new research strategy because they are essential in helping to identify new biomarkers and develop more precise diagnostics and treatments for patients," said Dr. Christine Williams, Ph.D., Deputy Director, OICR. "This trial is the first in our newly-launched Window of Opportunity Network, and it shows the promise and enthusiasm for WOO trials across the research community. We are proud to be working with proven clinical and industry partners like The Ottawa Hospital and Intensity Therapeutics to determine the effectiveness of INT230-6 in helping early-stage breast cancer patients."

"We are excited to collaborate with The Ottawa Hospital and OICR, two leaders in breast cancer research," said Ian B. Walters, MD, Chief Medical Officer at Intensity Therapeutics. "Killing cancer immediately after its diagnosis may give patients more peace of mind that all effort is being made to stop the cancer from growing or spreading prior to resection, as well as improve the cosmetic and functional outcome of the surgery. If this trial is successful, use of INT230-6 prior to surgery for breast cancer and other indications may be possible."

Lewis H. Bender, President and CEO of Intensity Therapeutics added, "According to our estimates, based on the American College of Surgeons database, there were approximately 60,000 early breast cancer patients in the U.S. in 2020 who did not receive any therapy prior to surgery. Killing tumors weeks in advance of resection may improve patient outcomes for long term benefit. We look forward to working with our colleagues at The Ottawa Hospital and OICR to determine the utility of INT230-6 in this early-stage patient population."

About Window of Opportunity (WOO) Studies

In WOO studies, patients receive a test agent(s) between their cancer diagnosis and standard treatment (usually surgery). The pre-operative setting, with treatment naive patients, enables an expedited analysis of therapeutic agents and focused biomarker research for better patient stratification. WOO studies are becoming a well-recognized development tool, particularly in breast cancer.

About the Intensity OICR OHRI Phase II WOO Study

Individuals interested in learning more about the study, or how to reach the study staff for participation, can visit www.clinicaltrials.gov and use the trial identifier NCT0478123. Participation in the trial will not interfere with or delay the date of surgery. The study is a Phase II Randomized Window of Opportunity Trial for Intratumoral INT230-6 (VINblastine CIsplatin) Evaluating Clinical and BioLogical Effects in early Stage Breast Cancer (the INVINCIBLE trial). Tumor tissue obtained at diagnosis and the time of the definitive surgical procedure will be analyzed for Ki67, a marker of complete cell cycle arrest (CCCA), cancer proliferation, immune biomarkers and pathological complete response (pCR), the absence of live cancer in the tumor and surrounding lymph nodes. There are a number of other objectives of the trial:

To assess the Residual Cancer Burden after treatment with INT230-6,
To characterize the overall safety of INT230-6 injected prior to surgery, and
To perform broad immune profiling of the blood in patients by assessing changes in CD4/CD8 T cells and identification of CD8 tetramers, and whether INT230-6 treatments results in an increase in infiltrating immune cells such as macrophages, NK, DC, CD4 T-cells, CD8 T-cells, regulatory T-cells.
About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, release of tumor antigens and recruitment of immune cells to the tumor. Results generated by both the Company and the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term protection from multiple re-challenges of the initial cancer and resistance to other cancers. The Company’s research published in the International Journal of Molecular Sciences in June 2020 and joint research with the NCI published in July 2019 in the Journal OncoImmunology as part of Intensity’s awarded CRADA , also showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. (Press release, Intensity Therapeutics, MAR 24, 2021, View Source [SID1234577102])

On March 24, 2021 Precision oncology company Lucence reported a partnership with Waseda University in Japan to develop a novel high-speed liquid biopsy laser-based imaging platform for early cancer detection (Press release, Lucence, MAR 24, 2021, View Source [SID1234577101]). The technology captures thousands of high-resolution individual images of circulating tumor cells and clusters from a blood sample with potential applications in early cancer detection and disease monitoring. Lucence plans to commercialize this liquid biopsy platform from their CLIA-licensed laboratory in Palo Alto.

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"More than 50% of cancer diagnoses happen in late stages of the disease, when treatment options are limited. Early cancer detection is critical to reducing mortality," says Dr. Tan Min-Han, Founding CEO and Medical Director at Lucence. "We are excited to combine our discovery of circulating tumor-vessel cell clusters in early cancers with Waseda University’s engineering expertise to build an early cancer detection technology platform."

"Identifying circulating tumor cells using conventional biomarkers often lead to false-negative results," says Professor Kenji Yasuda of Waseda University. "Together with Lucence, we visualize the end-product to be an easy-to-use diagnostic platform for rapid and automated detection of circulating tumor cells and cell clusters in liquid biopsies."

Dr Tan, a medical oncologist by background, led the landmark discovery of circulating tumor-vessel cell clusters1 in 2016 when he was at the Agency of Science, Technology and Research (A*STAR). These cell clusters are found in multiple tumor types, and can serve as an unique biomarker for early cancer detection. Through this partnership with Waseda University to develop a high-speed microfluidic imaging platform2, Lucence will build a circulating cell atlas, where circulating tumor cells and cell clusters can be analyzed with proprietary deep learning algorithms for further insights on cancer.

Lucence has secured exclusive technology licenses from Waseda University and A*STAR to support the development of this diagnostic platform for cancer screening and monitoring.

Lucence currently provides highly sensitive circulating tumor DNA liquid biopsy testing using LucenceAMPLIMARK, the company’s proprietary amplicon-based molecular watermarking sequencing approach, powered by an ever-improving library of deep learning algorithms. This collaboration enables the development of a new generation of ultrasensitive cancer screening tests profiling both circulating tumor DNA and cells, projected to be available in the United States in 2022.

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]).

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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.

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]).

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"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.