On June 1, 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 results from twelve studies of selinexor, the world’s first approved oral selective inhibitor of nuclear export (SINE), were selected for the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, taking place in a virtual format on June 9 to 17 (Press release, Antengene, JUN 1, 2021, View Source [SID1234583350]).

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Selected Abstracts:

Phase 2 MARCH study of oral ATG-010 plus low dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma previously exposed to an immunomodulatory agent and a proteasome inhibitor.

Abstract #: PB1670

Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.

Abstract #: S188

Selinexor containing regimens in patients with multiple myeloma previously treated with anti-CD38 monoclonal antibodies.

Abstract #: EP1002

Oral selinexor, pomalidomide, and dexamethasone (XPd) at recommended phase 2 dose in relapsed/refractory multiple myeloma (MM).

Abstract #: EP1008

Ciltacabtagene Autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with ≥ 3 lines of prior therapy: A matching adjusted indirect comparison.

Abstract #: EP1049

Cost effectiveness comparison of belantamab mafodotin and selinexor in relapsed refractory multiple myeloma.

Abstract #: EP1173

Lymphocyte count effect on efficacy and safety of single agent oral selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL): A post-hoc analysis from phase 2B SADAL study.

Abstract #: EP530

Genomic correlates of respones to selinexor in multiple myeloma from the BOSTON study reveal a predictive signature.

Abstract #: EP936

Effects of selinexor on previously treated multiple myeloma (MM) with RAS-mutations.

Abstract #: EP966

Efficacy and safety of selinexor, bortezomib, and dexamethasone based on refractory status to lenalidomide in patients with previously treated multiple myeloma: A post-hoc analysis of the BOSTON study.

Abstract #: EP974

Survival among older patients with previously treated multiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.

Abstract #: EP976

Updated overall survival of eltanexor for the treatment of patients with hypomethylating agent refractory myelodysplastic syndrome.

Abstract #: EP924

On June 1, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) is "on site" for the ROLONTIS (eflapegrastim) manufacturing facility inspection (Press release, Spectrum Pharmaceuticals, JUN 1, 2021, View Source [SID1234583302]). Spectrum previously received notification from the agency that it would defer its decision on the BLA for ROLONTIS because an inspection of the Hanmi Bioplant in South Korea could not be conducted due to restrictions on travel related to the COVID-19 pandemic.

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"I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

On June 1, 2021 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference at 1:20 p.m. Eastern Time on Tuesday, June 8, 2021 (Press release, Neurocrine Biosciences, JUN 1, 2021, View Source [SID1234583319]). Kevin Gorman, Chief Executive Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On June 1, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that the Company will participate in the Goldman Sachs 42nd Annual Global Healthcare Conference (Press release, Silverback Therapeutics, JUN 1, 2021, View Source [SID1234583335]).

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Laura Shawver, Ph.D., Chief Executive Officer, and Valerie Odegard, Ph.D., President and Chief Scientific Officer, will represent Silverback at a fireside chat on Tuesday, June 8th, 2021 at 3:50 p.m. ET / 12:50 p.m. PT. The live webcast of the fireside chat will be available on Silverback’s investor relations website and a replay will be available for 30 days following the event. Members of the Silverback management team will also host investor meetings during the conference.

On June 1, 2021 Eucure Biopharma reported that it will present findings from two Phase I clinical trials at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from June 4th to 8th (Press release, Eucure, JUN 1, 2021, View Source [SID1234583351]).

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The first trial (poster #2580; NCT04481009) is designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of YH003 (an anti-CD40 monoclonal antibody (mAb)) combined with Toripalimab (Tuoyi; an anti-PD-1 mAb) in subjects with advanced solid tumors. As of December 31, 2020, there were no dose-limiting toxicity (DLT) events or severe adverse events (AE) observed in 9 subjects/3 dose levels (ranging from 0.03 to 0.3 mg/kg). Of the 5 subjects that completed at least one tumor assessment, one subject with ocular melanoma who failed prior Opdivo and Opdivo/Yervoy combination therapy achieved partial remission (PR), and two patients maintained stable disease (SD).

The second trial (poster #2577; NCT04357756) is a Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of an anti-CTLA-4 antibody, YH001, combined with Toripalimab in subjects with advanced solid tumors. As of December 31, 2020, no DLT or severe AE were observed at 4 dose levels (ranging from 0.05 to 1 mg/kg). Seven of 10 subjects completed at least one tumor assessment, of which 4 subjects maintained SD. As of March 1, 2021, one subject with GEJ cancer that maintained SD in the first tumor assessment achieved PR in the second assessment, with a 60.9% reduction in the target lesion compared to baseline.

About YH003
YH003 is a humanized IgG2 agonistic monoclonal antibody that targets CD40 signaling. Preclinical studies demonstrated that YH003 promotes antigen-presenting cell activation and infiltration of effector T cells into tumors. YH003 demonstrated potent anti-tumor effects in Biocytogen’s humanized CD40 mice, both alone and in combination with anti-PD-1 monoclonal antibodies. YH003 has been approved to enter Phase II trials in Australia for pancreatic cancer and PD1-resistant melanoma.

About YH001
YH001 is a humanized IgG1 monoclonal antibody that blocks the association of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) with CD80/CD86. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to enhance T-cell-mediated antitumor immune responses. Preclinical data indicates that YH001 outperforms Ipilimumab (a currently approved CTLA-4 drug) in CTLA-4 binding affinity and inducing ADCC activity.