On March 21, 2021, Aeglea BioTherapeutics, Inc. (the "Company") reported that it entered into a license and supply agreement (the "License Agreement") with Immedica Pharma AB ("Immedica"), pursuant to which Immedica licensed the product rights for commercialization of pegzilarginase in the European Economic Area, United Kingdom, Switzerland, Andorra, Monaco, San Marino, Vatican City, Turkey, Saudi Arabia, United Arab Emirates, Qatar, Kuwait, Bahrain, and Oman. Upon signing, the Company is entitled to an upfront payment of $21.5 million from Immedica (Filing, 8-K, Aeglea BioTherapeutics, MAR 21, 2021, View Source [SID1234576942]). Under the terms of the License Agreement, the Company is eligible to receive aggregate regulatory and commercial milestone payments of up to approximately $130.0 million. Additionally, the Company is entitled to receive royalties in the mid-20 percent range on net sales of the product in certain countries that may result from the License Agreement. The Company will continue to be responsible for certain clinical development activities and the manufacturing of pegzilarginase and will retain commercialization rights in the U.S. and rest of the world.

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On March 21, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing, and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that it will present the preclinical data on the synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit diffuse large B-cell lymphoma (DLBCL) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held in a virtual format on April 10-15 and May 17-21, 2021 (Press release, Antengene, MAR 21, 2021, View Source [SID1234576930]).

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Title: Synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit DLBCL
Permanent Abstract Number: 1380
Abstract Link: View Source!/9325/presentation/2406

Covering the most cutting-edge advances and regarded globally as the very pinnacle of cancer research, the AACR (Free AACR Whitepaper) Annual Meeting is one of the largest and most anticipated scientific events in the cancer research field globally. The abstract entitled "Synergistic effect of the combination of XPO1 and mTORC1/2 inhibition for the treatment of triple-hit DLBCL" now available on the AACR (Free AACR Whitepaper)’s website, is the first publication from the preclinical study investigating ATG-010 (XPO1 inhibitor) and ATG-008 (mTORC1/2 inhibitor).

ATG-010, also known as selinexor, is the world’s first approved selective inhibitor of the nuclear export protein XPO1. ATG-010 induces the apoptosis of cancer cells in vitro and in vivo through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating proteins, and by down-regulating the intracytoplasmic levels of various oncogenic proteins without affecting normal cells.

ATG-008, also known as onatasertib, is a next-generation dual mTORC1/2 inhibitor. mTORC1 and mTORC2 are critical mediators of the PI3K-AKT pathway, which is commonly mutated in many cancers, thus leading to the hyperactivation of mTOR signaling. ATG-008 could reduce the proliferation and promote the apoptosis of tumor cells through the dual-inhibition of mTORC1 and mTORC2.

ATG-010 (selinexor) is approved in the U.S. and Israel for the treatment of multiple myeloma (MM) and DLBCL, and has been included in five treatment regimens by the National Comprehensive Cancer Network (NCCN) Guidelines. Multiple clinical studies have shown that the special mechanism of action (MoA) of ATG-010 allows the drug candidate the therapeutic utility in combination with a variety of antitumor drugs, such as anti-PD-L1 antibodies, for improved efficacy and reduction in treatment-related adverse events. Other studies carried out by Antengene also showed that the dual-inhibition of XPO1 and mTOR has the effect of bolstering antitumor activities.

At present, Antengene is conducting several trials of ATG-010 in China for the treatment of MM, DLBCL, non-small cell lung cancer (NSCLC), endometrial cancer, peripheral T-cell lymphoma and NK/T cells lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for ATG-010 in multiple APAC markets including China, Australia, Singapore and South Korea. Meanwhile, Antengene has also initiated several clinical trials of ATG-008 in China and other APAC markets for the treatment of advanced hepatocellular carcinoma (HCC), advanced NSCLC, advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations, and in combination with an anti-PD-1 antibody in advanced solid tumors including HCC.

On March 21, 2021 Harbour BioMed (HBM) (HKEX: 02142) reported the dosing of the first patient in its open Phase I clinical study of HBM4003 for Chinese patients suffering from advanced melanoma and other solid tumors (study No. 4003.2) (Press release, Harbor BioSciences, MAR 21, 2021, View Source [SID1234576929]). This study will evaluate the safety, tolerability, PK/PD, and anti-tumor activity of HBM4003 in combination with teriprizumab (PD-1 antibody) in the treatment of solid tumors. Prior to this, the China National Medical Products Administration (NMPA) has approved this combined study of HBM4003 and PD-1 antibody/chemotherapy for patients with NSCLC and other solid tumors.

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Professor Jun Guo, Deputy Dean of Beijing Cancer Hospital, Deputy Director of Beijing Institute for Cancer Research and Director of Melanoma Department, said: "Due to the special subtype of melanoma in China, treatment for this disease is especially challenging, resulting from poor prognosis, low survival rate, and the limited efficacy of current PD-1 monotherapy of around 16 percent. Innovative solutions that can improve the treatment efficacy and patients’ overall survival is urgently needed. As this study by Harbour BioMed unfolds, we look forward to providing more effective and safer treatment options to Chinese patients with melanoma and other solid tumors in a near future."

"HBM4003 is a new generation of anti-CTLA-4 antibody. Based on its unique mechanism, it has shown great safety and strong anti-tumor activity in pre-clinical studies." Dr. Wang Jingsong, Founder, Chairman and CEO of Harbour BioMed said. "Each year, there are about 4 million newly diagnosed cancer patients in China and there is an urgent need for innovative drugs and therapeutic solutions for cancer treatment. We will continue to accelerate the global development of HBM4003 for multiple cancers, so that we can help cancer patients around the world to live better and longer lives."

About HBM4003

HBM4003 is the fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. HBM4003 shows enhanced antibody-dependent cell cytotoxicity (ADCC) killing activity and is extremely specific to high CTLA-4 Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug.

On March 19, 2021 Optieum Biotechnologies reported that the company has entered into a research collaboration with Daiichi Sankyo Company (Press release, Optieum Biotechnologies, MAR 19, 2021, https://optieumbio.com/wp-content/uploads/2021/03/20210319_Announcement-of-Research-Collaboration-with-Daiichi-Sankyo.pdf [SID1234639139]). Optieum Biotechnologies intends to use its Eumbody System technology to identify a new functional single chain fragment variables (scFvs) that can be utilized for CAR-T cell against the target of interest selected by Daiichi Sankyo.

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Eumbody System is a single-chain antibody generation system yielding CAR-T cells with superior antitumor function developed by Dr. Toshiki Ochi, co-founder of Optieum Biotechnologies, which exclusive license is granted to Optieum Biotechnologies.

Under the terms of the agreement, Optieum Biotechnologies will receive an undisclosed upfront payment, and is eligible for payments associated with the achievement of certain development milestones.

On March 19, 2021 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, reported that it will be added to the Russell 2000 Index as part of the planned first quarter IPO additions scheduled to join the Russell US Indexes after US equity markets close on March 19, 2021 (Press release, Kinnate Biopharma, MAR 19, 2021, View Source [SID1234579512]).

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"Kinnate’s inclusion in the Russell 2000 Index marks an exciting milestone following our successful IPO in December 2020 and is a testament to the incredible progress we have made in building a pipeline of targeted therapy candidates for underserved cancer populations," said Nima Farzan, Chief Executive Officer of Kinnate Biopharma. "We are pleased to be part of the Russell Indexes and look forward to telling our story to a broader audience of investors and other key stakeholders."

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. The Russell 2000 Index measures the performance of the small-cap segment of the U.S. equity market. The index is a subset of the Russell 3000 Index and represents approximately 10 percent of the total market capitalization of that index. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a leading global index provider.