On November 25, 2020 Antengene Corporation Limited ("Antengene", HKSE stock code: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-inclass therapeutics in hematology and oncology, reported that the National Medical Products Administration (NMPA) has approved the clinical trial of ATG-016 (eltanexor) in patients with intermediate and higher risk myelodysplastic syndrome (MDS) according to the Revised International Prognostic Scoring System (IPSS-R) after the failure of hypomethylating agents (HMA) based therapy (Press release, Antengene, NOV 25, 2020, View Source [SID1234571754]). The trial is a Phase I/II, single-arm, open-label clinical study, aiming to evaluate the pharmacokinetics, safety and efficacy of ATG-016 (eltanexor) monotherapy.

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MDS is a heterogeneous group of clonal disorders of the bone marrow hematopoietic stem cells (HPSCs), characterized by ineffective hematopoiesis with peripheral blood cytopenia and a higher risk for developing acute myeloid leukemia (AML). Patients with high-risk MDS refractory to hypomethylating agents have a median overall survival (OS) of only 4 to 6 months with limited options for follow-up treatment. Pre-clinical studies have demonstrated that selective inhibitor of nuclear export (SINE) compounds are able to block the nuclear export of many tumor suppressor proteins (e.g. p53, IkB, p21) leading to their accumulation and activation in the nucleus thereby exerting anti-tumor effects. In addition, SINE compounds can also reduce the nuclear export and translation of many oncogenic mRNA (c-Myc, Bcl-2, Bcl-6, cyclin D) which are bound to elF4E and result in selective apoptosis of tumor cells. ATG-016 is a member of the latest-generation of SINE compounds. Compared to the first-generation nuclear export inhibitor, ATG-016 demonstrates minimal blood-brain barrier permeability and a broader therapeutic window. It has shown preliminary anti-cancer activity in high-risk MDS patients.

Dr. Jay Mei, the Founder, Chairman and CEO of Antengene expressed, "The approval of the ATG-016 clinical trial demonstrates the efficient execution of the Antengene R&D team and is also the first clinical trial approval obtained by Antengene in mainland China after its listing." He also mentioned, "Selinexor, the first-generation selective inhibitor of nuclear export, has shown extensive activity against hematological malignancies and solid tumors, and has been approved by the FDA for relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. As a second-generation orally available SINE compound, ATG-016 can reduce the blood-brain barrier penetration, thereby representing a broader therapeutic window with potentially less adverse events and better drug tolerability."

About ATG-016

ATG-016 (eltanexor) is a second-generation selective inhibitor of nuclear export compound. Compared to the

On November 25, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on next-generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that it has submitted multiple Investigational New Drug (IND) applications to the U.S. Food and Drug Administration (FDA) and Health Canada evaluating its investigational drug, CX-5461, for the treatment of patients with solid tumors with BRCA2 or PALB2 mutations (Press release, Senhwa Biosciences, NOV 25, 2020, View Source [SID1234571753]).

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"This IND submission is a key milestone in the clinical development of CX-5461. In a phase I study conducted by Senhwa’s clinical partner, Canadian Cancer Trial Group (CCTG), CX-5461 demonstrated clinically meaningful and lasting benefits in patients with specific tumor biomarkers that were resistant to platinum and other chemotherapeutics. The US and Canada clinical trials are being designed to further confirm the efficacy seen," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

CX-5461 was recently named as a PCF-Pfizer Global Challenge Award recipient. Specifically, it will be used in combination with Pfizer’s PARP inhibitor (PARPi), Talazoparib, to explore the therapeutic potential in prostate cancer, which is the second-leading cause of cancer death for men in the United States. In 2016, a recipient of the Stand Up to Cancer’s Dream Team Grant selected CX-5461 to study in their Phase I trial. This study’s clinical findings were featured in a spotlighted presentation at the 2019 annual San Antonio Breast Cancer Symposium (SABCS 2019). Due to the DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, PARPi resistance is ubiquitous in clinic. More than 40% of BRCA1/2-deficient patients fail to respond to PARPi.

"CX-5461 is a first-in-class G-quadruplex stabilizer within a novel class of therapy that accelerates dsDNA breaks and has proven human efficacy across certain tumor types. We believe CX-5461 has great potential as a therapeutic for patients who have developed resistance to PAPRi or other chemotherapies. This continues to be an unmet medical need in cancer treatment," said Dr. Tai-Sen Soong, CEO of Senhwa Biosciences.

About CX-5461

CX-5461 is designed to stabilize DNA G-quadruplexes of cancer cells and leads to disruption of the cell’s replication fork. While acting in concert with Homologous Recombination (HR) pathway deficiency, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, resulting in cancer cell death. CX-5461 in combination with Homologous Recombination Deficiency (HRD) tumors may be exploited through a synthetic lethality approach, targeting DNA repair defects in HRD tumors.

On November 25, 2020 Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, reported that it has submitted the MAA for BAT1706, a proposed biosimilar to Avastin (bevacizumab), to EMA (Press release, BioThera Solutions, NOV 25, 2020, View Source [SID1234571752]). Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein.

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"The submission of the MAA for BAT1706 marks a milestone for Bio-Thera as the first ex-China MAA or BLA submission," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706".

BAT1706 is a proposed bevacizumab biosimilar developed by the company. Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. Bevacizumab has been approved in Europe for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer.

A Biologics License Application seeking approval for BAT1706 for the treatment of metastatic carcinoma of the colon or rectum and non–small cell lung cancer is under review by the China National Medicinal Product Administration (NMPA). Bio-Thera intends to submit a BLA for BAT1706 to the U.S. Food and Drug Administration (FDA) before the end of 2020.

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar submitted for regulatory approval. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including golimumab, ustekinumab and secukinumab, and mepolizumab among others.

About BAT1706

BAT1706 is a monoclonal antibody that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the EU, Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. BAT1706 is an investigational compound and has not received regulatory approval in any country.

On November 25, 2020 Novocure (NASDAQ: NVCR) reported that Novocure’s Executive Chairman William Doyle and Chief Science Officer Dr. Uri Weinberg will participate in the 3rd Annual Evercore ISI 2020 Virtual HealthCONx Conference on December 1 through December 2, 2020 (Press release, NovoCure, NOV 25, 2020, View Source [SID1234571751]). Mr. Doyle and Dr. Weinberg will take part in a fireside chat at 11:20am EST on December 2, 2020 and will also participate in one-on-one meetings with investors throughout the event.

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A live audio webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations. Novocure has used, and intends to continue to use, its Investor Relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On November 25, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported that it experienced strong demand for its cancer screening tests and set a record in paid test volume in the third quarter (Press release, Anpac Bio, NOV 25, 2020, View Source [SID1234571750]). With a strong fourth quarter already underway, the Company forecasts a revenue growth of approximately 100% in 2020 over 2019, with a revenue range of US$3 million (~ RMB20 million) to US$3.3 million (~ RMB22 million). For 2019, the Company had a revenue of US$1.6 million (~ RMB10.9 million) (using a current US$ to RMB exchange ratio of ~ 6.6). We expect the strong momentum of YoY revenue growth due to market demand and customers accepting AnPac Bio’s novel cancer screening technology with multiple advantages (named cancer differentiation analysis (CDA) technology)) to continue into 2021. The Company plans to release its full year 2020 audited financial report in early March 2021.

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With COVID-19 mainly contained in China and most businesses returning to normal operations since May, the demand for the Company’s cancer screening tests has remained strong. Further, its average selling price (ASP) in 2020 is expected to increase compared to 2019, contributing to a higher revenue growth forecast. In 2020, the Company has launched a number of new products including an immunology test in China and the COVID-19 antibody test in the US.

Dr. Chris Yu commented, "Our strong paid test volume in the third quarter demonstrated our novel, biophysics based CDA technology and its advantages in cost effectiveness, the ability to detect early a wide range of cancer types (over 20 cancer types), and relatively high sensitivity and specificity are increasingly being accepted and recognized by the market and customers. With our successful IPO on the NASDAQ earlier this year, we are now focusing on three areas: new product development, product commercialization including in the US, and revenue growth through sales, with an emphasis on execution and speed. Having successfully executed our phase one goal to become a volume leader in cancer screening among new generation cancer screening technologies, we are now turning our attention to enhance our ASP and gross margin. We have recorded an increase in ASP and launched two new products, which paved the way for further business growth. We are optimistic about our Company including commercialization in the US and growth in 2021."