On November 30, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported the regulatory approval of HBI-8000, brand name Hiyasta, monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan (Press release, HUYA Bioscience, NOV 30, 2021, View Source [SID1234596262]).

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"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The application of the supplemental indication for R/R PTCL is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Hiyasta, in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Hiyasta that will benefit even more patients."

About Hiyasta

HBI-8000 is an epigenetic immunomodulator with several approved indications including monotherapy for two subtypes of Non-Hodgkin’s Lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor nivolumab.

On November 30, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that the VAL-083 treatment arm in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma multiforme (GBM) has been activated at its first Canadian site, Sunnybrook Health Sciences Centre in Toronto (Press release, Kintara Therapeutics, NOV 30, 2021, View Source [SID1234596281]).

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The Kintara treatment arm is also currently actively recruiting at 30 U.S. sites as of November 24, 2021.

The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a patient-centered, Phase 2/3 adaptive platform trial evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM. Since January 2021, GCAR has accelerated the pace of clinical site activation with increased awareness in the medical community of Kintara’s arm of the study. GCAR plans to enroll 150-200 patients in the Kintara arm of the study at over 40 sites in the U.S. and Canada with potential to increase this total to 65 clinical trial centers worldwide.

"The Kintara treatment arm joined the GBM AGILE study in January of this year, and is already active at 31 sites in the US and Canada," stated Timothy Cloughesy, M.D., Professor of the Neurology and Molecular and Medical Pharmacology program at the University of California, Los Angeles and Principal Investigator for the GBM AGILE study. "This international clinical site, which we expect to be the first of many international sites, demonstrates the ability of GCAR’s GBM AGILE platform trial to materially accelerate the clinical development timelines for the company."

"The entire Kintara team remains excited by the pace at which our treatment arm is being executed in the study," commented Robert E. Hoffman, Kintara’s Chief Executive Officer. "With 31 sites already active, including our first international site, we are delighted to witness GCAR’s exceptional clinical trial execution capabilities that drew us to participate in this exciting and highly efficient registrational study."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with GBM through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies, or combinations of therapies, from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE may be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

On November 30, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported that it will present data at two upcoming medical meetings for two of its cytokine immuno-oncology programs: IL-2 agonist, bempegaldesleukin (BEMPEG), and IL-15 agonist, NKTR-255 (Press release, Nektar Therapeutics, NOV 30, 2021, View Source [SID1234596299]). The company will be presenting clinical data for BEMPEG from the ongoing PROPEL study in patients with non-small cell lung cancer (NSCLC) at the 2021 European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress in Geneva, Switzerland from December 8 to December 11, 2021. In addition, two clinical data presentations for NKTR-255 in patients with relapsed/refractory hematologic malignancies will be presented during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia from December 11 to December 14, 2021.

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Presentation at 2021 ESMO (Free ESMO Whitepaper)-IO:

Abstract #140P: "Preliminary results from PROPEL: A phase 1/2 study of bempegaldesleukin (BEMPEG: NKTR-214) plus pembrolizumab (PEMBRO) with or without chemotherapy in patients with metastatic NSCLC," Felip, E., et al.

ePoster will be on display on the ESMO (Free ESMO Whitepaper)-IO 2021 virtual meeting platform on Monday, December 6, 2021, at 12:00 pm GMT (7:00 a.m. ET)
Presentations at ASH (Free ASH Whitepaper)

Abstract #3134: "Safety, Tolerability, PK/PD, and Preliminary Efficacy of NKTR-255, a Novel IL-15 Receptor Agonist, in Patients with Relapsed/Refractory Hematologic Malignancies," Shah, N., et al.

Presenter: Nina Shah, M.D.
Session 203: Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III
ePoster will be on display on the ASH (Free ASH Whitepaper) 2021 virtual meeting platform on Monday, December 13, 2021, at 6:00 a.m. ET
Abstract #2815: "Pharmacodynamic Analysis of CAR-T Cell Persistence in Patients with Hematologic Malignancies Treated with NKTR-255, an IL-15 Receptor Agonist That Enhances CD8+ T cells: Preliminary results from a Phase 1 Study," Turtle, C., et al.

Presenter: Alexandre Hirayama, M.D.
Session 704: Cellular Immunotherapies: Clinical: Poster II
ePoster will be on display on the ASH (Free ASH Whitepaper) 2021 virtual meeting platform on Sunday, December 12, 2021, at 6:00 a.m. ET
Company to Host Webcast Analyst and Investor Conference Call During ESMO (Free ESMO Whitepaper)-IO Congress 2021

The company will host a conference call and webcast for analysts and investors on Monday, December 6, 2021, at 1:00 p.m. GMT (8:00 a.m. ET) during the 2021 ESMO (Free ESMO Whitepaper)-IO Congress. The call will include Dr. Daniel Johnson, medical oncologist at the Gayle and Tom Benson Cancer Center and Deputy Director, Precision Cancer Therapies (Phase I) Research Program at Ochsner Medical Center, and Dr. Mehmet Altan, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center.

The event will follow the publication of the NKTR-214 (BEMPEG) PROPEL poster (Abstract #140P) on Monday, December 6, 2021.

Analyst Call:

Date and Time: Monday, December 6, 2021, at 1:00 p.m. GMT (8:00 a.m. ET)

Dial-in: 877-881-2183 (toll-free) or 970-315-0453 (enter access code 7797059)

Investors and analysts can also view slides and listen to the live audio webcast of the presentation at View Source The event will also be available for replay for two weeks on the company’s website, www.nektar.com.

Biography for Daniel Johnson, M.D.

Daniel Johnson, M.D. is a medical oncologist at Ochsner Medical Center who specializes in treating patients with melanoma, lung cancer, and head and neck cancer. His specific research interests include strategies to overcome immunotherapy resistance and prevent immunotherapy related toxicities. He has published multiple peer-reviewed articles and presentations at national meetings pertaining to the management and underlying mechanisms of immune toxicity. Dr. Johnson is also a clinical investigator focusing on designing and implementing clinical trials intended to optimize the safety and efficacy of immune checkpoint inhibitors. Dr. Johnson received his M.D. from Louisiana State University (LSU) School of Medicine. He completed his internship and residency at LSU Internal Medicine Residency Program and completed his fellowship in hematology and medical oncology at the University of Texas MD Anderson Cancer Center. Dr. Johnson is board-certified in medical oncology and hematology by American Board of Internal Medicine.

Biography for Mehmet Altan, M.D.

Mehmet Altan, M.D., is an Assistant Professor in the Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. His current research areas include identification of mechanisms for primary and secondary resistance to immunotherapies and predictive markers for immunotherapy toxicities. He also works on translational research projects for identification of spatiotemporal dynamics of the tumor microenvironment in response to immunotherapy to define potential therapeutic targets.

On November 30, 2021 Neuramedy reported that NM-101 (tomaralimab), a monoclonal antibody against TLR-2 Alpha-synucleinopathies are neurodegenerative diseases caused by the abnormal accumulation of misfolded alpha-synuclein in neurons and glial cells (Press release, Neuramedy, NOV 30, 2021, View Source [SID1234632172]). There are three major types of alpha-synucleinopathies: Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA).

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Misfolded alpha-synucleins can promote neuroinflammation and neuronal loss and also spread to the neighboring neurons, which are mediated by Toll-like Receptor-2 (TLR-2). Furthermore, TLR-2 is found to be up-regulated in alpha-synucleinopathies.

Therefore, the inhibition of TLR-2 would be one of the promising therapeutic strategies to slow down or halt the progression of alpha-synucleinopathies, along with the therapies targeting alpha-synuclein.

Neuramedy, headquartered in Seoul, is a biotech company focusing on novel therapeutic approaches to treat alpha-synucleinopathies, based on the findings above.

Neuramedy’s NM-101 (tomaralimab) is a first-in-class humanized IgG4 monoclonal antibody against TLR-2 which was originally developed and termed ‘OPN-305’ by Opsona Therapeutics (Dublin, Ireland) for the treatment of myelodysplastic syndrome in 2015. Neuramedy took over the patent and global rights for tomaralimab from Opsona in 2019 and is now applying it to PD.

The company is expanding the potential application of tomaralimab to the treatment of Alzheimer’s disease (AD) in conjunction with Amyloid Solution (Seongnam, South Korea) under the name of ‘AS-M801’, considering that TLR-2 is also up-regulated in beta-amyloidopathy like AD and activated by beta-amyloid as in PD and by alpha-synuclein.

Neuramedy is also developing its novel BBB-penetrating antibody (NM-301) for the treatment of neurodegenerative diseases, in collaboration with Aptamer Sciences, a front-runner in Aptamer Technology that will provide antibodies with a BBB shuttle.

In parallel with these, the company is additionally developing its innovative small molecules (NM-401, NM-402, and NM-403) that can inhibit the aggregation of alpha-synucleins for the treatment of various alpha-synucleinopathies (PD, MSA, and DLB), conjointly with Yungjin Pharm.

Neuramedy is planning to initiate its phase 1b/2a clinical trials of NM-101 for the treatment of AD in the U.S. next year.

On November 30, 2021 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy, reported the opening of a new clinical study in collaboration with Dr. Duane Mitchell at the University of Florida (Press release, Immunomic Therapeutics, NOV 30, 2021, View Source [SID1234596263]). RENEW (NCT04963413) is designed to evaluate the ability to generate pp65 Lysosomal Associated Mediated Protein (LAMP) RNA-pulsed dendritic cells in patients who have completed standard external beam radiation and concomitant temozolomide and who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

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This is an extension of the Phase 2 ATTAC-II study (NCT02465268) where eligibility is limited to those patients who have had surgery but have not yet received chemoradiation. The RENEW pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care surgery and chemoradiation and who are currently receiving adjuvant temozolomide chemotherapy.

"The RENEW pilot study’s expansion of the eligibility criteria allow a number of untreated patients with GBM to participate in a clinical study that includes our novel dendritic cell vaccine," said Dr. Bill Hearl, Chief Executive Officer at Immunomic Therapeutics, Inc. "We look forward to continued evaluation of ITI’s platform in both the ongoing ATTAC-II and the RENEW studies in an effort to address this clear and pressing unmet medical need."

ITI is developing several dendritic cell vaccines for the treatment of cancer, including ITI-1000 for glioblastoma multiforme (GBM), with key opinion leaders in cancer immunotherapy for brain tumors, John Sampson, M.D., Ph.D. from Duke University and Duane Mitchell, M.D., Ph.D. from the University of Florida. ITI’s dendritic cell vaccine is designed to target the pp65 viral antigen of Cytomegalovirus (CMV) that is expressed in GBM, but not in normal brain cells. In the ATTAC studies, the GBM patients’ white blood cells are removed, matured into dendritic cells (DCs), and modified to generate a vaccine to the pp65 viral protein when fused to the Lysosomal Associated Membrane Protein 1 (LAMP1) protein for antigen presentation. This dendritic cell vaccine is then returned to the patient. As observed in the ATTAC studies (ATTAC-GM: NCT00693639), ITI believes this approach may harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV in GBM and potentially other cancers.

About Glioblastoma (GBM)

According to the American Association of Neurological Surgeons, GBM is an aggressive brain cancer that often results in death within 15 months of diagnosis. GBM develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. GBM is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that GBM represents about 15% of all primary brain tumors and approximately 10,000 cases of GBM are diagnosed each year in the U.S.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase II clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at three clinical sites in the United States. For more information on the ATTAC-II study, please visit (NCT02465268).

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein 1 (LAMP1), an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach puts UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in a Phase II clinical trial as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.