2020 – Page 194 – 1stOncology™: Cancer Intelligence Service

IsoPlexis to Present at Evercore ISI’s 3rd Annual HealthCONx Conference on December 2, 2020

On November 25, 2020 IsoPlexis, the leader in single-cell functional proteomics, reported that Chief Executive Officer and Co-Founder, Sean Mackay, will present at Evercore ISI’s 3rd Annual HealthCONx Conference on Wednesday, December 2nd at 9:40 a.m. ET (Press release, IsoPlexis, NOV 25, 2020, https://www.prnewswire.com/news-releases/isoplexis-to-present-at-evercore-isis-3rd-annual-healthconx-conference-on-december-2-2020-301180662.html [SID1234571756]).

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A live webcast of the fireside chat will be made available on the company’s website at isoplexis.com.

Amgen To Present At The Evercore ISI Virtual HealthCONx Conference

On November 25, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the Evercore ISI Virtual HealthCONx Conference at 1:50 p.m. ET on Tuesday, Dec. 1, 2020. David M. Reese, M.D., executive vice president of Research and Development and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference (Press release, Amgen, NOV 25, 2020, https://www.prnewswire.com/news-releases/amgen-to-present-at-the-evercore-isi-virtual-healthconx-conference-301180785.html [SID1234571755]). Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome

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.

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

Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations

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]).

"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.

Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)

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.

"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.

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Year: 2020

IsoPlexis to Present at Evercore ISI’s 3rd Annual HealthCONx Conference on December 2, 2020

Amgen To Present At The Evercore ISI Virtual HealthCONx Conference

Approval of Phase I/II Clinical Trial of ATG-016 (Eltanexor), a Second Generation Selective Inhibitor of Nuclear Export (SINE), in Mainland China for the Treatment of Myelodysplastic Syndrome

Senhwa Announces Multiple IND Application Submissions to US FDA and Health Canada for the Treatment of Solid Tumors with BRCA2 or PALB2 Mutations

Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)