On March 24, 2021 EirGenix, Inc. (6589.TT) reported that the Phase III clinical trial (Trial No.: EGC002, NCT03433313) of its breast cancer biosimilar, EG12014 (proposed trastuzumab biosimilar, also called EGI014), has met its primary endpoint (Press release, EirGenix, MAR 24, 2021, View Source [SID1234577104]). EG12014 has shown equivalent efficacy to Herceptin in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile. EirGenix will proceed with the preparations for submissions of Biologics License Application (BLA) to the U.S. FDA, Market Approval Application (MAA) to European Medicines Agency (EMA) and New Drug Application to TFDA, exact timings remain confidential.

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This phase III clinical trial is a multi-national, multi-center, randomized, double-blinded study involving female with early, HER2-positive breast cancer. The purpose of the trial was to demonstrate the therapeutic equivalence in terms of efficacy between EG12014 to Herceptin, and to compare the safety, immunogenicity and PK between the two trastuzumab products. A total of 807 enrolled patients were randomly assigned in a 1:1 ratio to one of the two parallel treatment groups and received anthracycline-based chemotherapy every 3 weeks for 12 weeks (cycle 1 to 4). After chemotherapy, patients received EG12014 or Herceptin in combination with paclitaxel, every 3 weeks for 12 weeks (cycle 5 to 8). All patients were scheduled for tumor removal surgery (breast and axillary lymph nodes) 3 to 6 weeks after completion of neoadjuvant therapy (pre-operative treatment). Two (2) to 6 weeks after surgery, eligible patients continued with trastuzumab therapy in the adjuvant study to complete 12 months of overall trastuzumab treatment (adjuvant cycle 1 to 13), followed by a 20-week long-term safety follow-up (after final dose of trastuzumab).

During tumor removal surgery, samples were collected for assessment of a pathologic complete response (pCR) by an independent central laboratory. The primary endpoint of pCR is defined as absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ (ypT0/is ypN0). Demonstration of therapeutic equivalence in regards to the pCR between the two treatment groups (EG12014 vs Herceptin) in the pre-operative treatment setting was based on the pre-specified risk ratio (0.741 – 1.349) and probability difference (-0.13 – 0.13). The topline results demonstrated that EG12014 met equivalence to Herceptin in terms of clinical response in both analysis populations (per-protocol and full-analysis sets). Additionally, the safety profiles of the two treatment arms were shown to be comparable in the pre-operative treatment setting.

According to Roche’s annual report, global sales of Herceptin totaled 3.73 billion CHF in 2020. The US and EU market are 1.36 billion CHF and 0.67 billion CHF respectively. Herceptin sales were 34% lower than in 2019, driven by biosimilar competition, which was introduced in the second half of 2019 in the US and mid-2018 in Japan and Europe. Upon approval Sandoz AG, a global leader in generics and biosimilars will sell EG12014 globally in all markets except for Taiwan and Mainland China, as per the licensing agreement signed with EirGenix in April 2019. The licensing agreement included a signing fee and milestone payments , and a profit sharing of product sales in the authorized markets after product launch. The revenue from the milestone payments will be recognized in stages in accordance to standard accounting procedures and will serve to benefit the company’s current operations and further development. In 2019, Taiwan’s National Health Insurance (NHI) paid approximately 1.657 billion New Taiwan Dollars (NTD) for Herceptin.

Current demand for complex biological drugs has increased and will continue to rise in the future. With the drug patents of major biological drugs set to expire in the near future, the development of biosimilars has been greatly encouraged within the industry. The demand has been driven by the need for more cost-effective drugs in countries with limited medical resources. EirGenix is currently the first and only biopharmaceutical company in Taiwan to have successfully signed a licensing agreement with a global pharmaceutical company for a biosimilar. EirGenix is also one of only a handful of Taiwanese biopharmaceutical companies to have independently developed a biosimilar product into Phase III clinical trials and successfully demonstrating its equivalent efficacy. With such developmental achievements, EirGenix is rightfully worthy of investors’ attention and expectations.

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.
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