On September 28, 2020 HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL) (Press release, HUYA Bioscience, SEP 28, 2020, View Source [SID1234567701]). HBI-8000 already has ODD in Japan for peripheral T-cell lymphoma (PTCL).

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ATL is caused by latent infection of the human t-cell leukemia virus type 1 or HTLV-1 and is endemic in Japan with up to one million carriers and a disease incidence estimated at 0.05-0.10%. There are approximately 2,000 patients and as many as 700 – 1,000 deaths reported each year. It is primarily a disease of the elderly with poor prognosis, three-year survival rate in aggressive ATL after chemotherapy is 25% and few effective treatment options other than allogenic bone marrow transplantation and high dose chemotherapy in a subset of eligible patients.

"Effective treatment options for relapsed or refractory (R/R) aggressive ATL are very limited and the designation of ODD status recognizes the need for new treatment for this difficult-to-manage disease, I hope that development of HBI-8000 could be accelerated with the ODD," said Dr. Kunihiro Tsukasaki, MD PhD, Principal Investigator of HBI-8000 clinical study & Professor, Department of Hematopoietic Tumor, Saitama Medical University, International Medical Center.

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting viral antigens. This is a novel mechanism of action and does not overlap with currently available drugs. Recent clinical studies conducted by HUYABIO in Japan suggest clinical efficacy of HBI-8000 in this rare disease setting of R/R aggressive ATL.

"The orphan drug designation of HBI-8000 recognizes the potential of this agent to meet an important unmet medical need and ATL is a critical public health issue in Japan," said Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO. "The designation is appropriate for this rare malignancy, which afflicts an elderly population with such devastating effects. We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL."

On September 28, 2020 The National Comprehensive Cancer Network (NCCN) reported the publication of new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pediatric Hodgkin Lymphoma (Press release, NCCN, SEP 28, 2020, View Source [SID1234567698]). Hodgkin lymphoma is one of the most curable forms of pediatric cancer, with long-term survival rates of 90% or higher1. However, treatment can result in potentially life-threatening or -altering long-term side effects. These new recommendations from NCCN synthesize the latest evidence and expert-consensus to make sure every child receives appropriate, but not excessive, treatment.

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"There has never been a more important time for these NCCN Guidelines than during this pandemic, when many patients need to be treated at their local institutions—even when a trial is available—due to travel and caregiver limitations," said Jamie Flerlage, MD, MS, St. Jude Children’s Research Hospital, Chair, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "There are many treatment options to choose from for pediatric Hodgkin lymphoma; some are better than others depending on the patient’s stage and risk group. These guidelines have information to help providers weigh the benefits and potential setbacks of various options for treating each individual. We’ll continue to update these guidelines regularly and incorporate any important new data from ongoing clinical trials."

"With so many treatment options available, it’s crucial to present all the evidence that can guide providers to the best choices for their patients," said Susan Hiniker, MD, Assistant Professor, Radiation Oncology, Stanford Cancer Institute, Vice-Chair, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "It can be a challenge for individual practitioners to follow and interpret all the clinical trial data. The NCCN multidisciplinary panel of experts deliberated and debated carefully to be sure we’re sharing optimal approaches that are firmly rooted in evidence."

Hodgkin lymphoma accounts for approximately 6% of all childhood cancer diagnoses in the United States, with just over 1,000 people diagnosed under the age of 20 every year.2 Nearly half of all people diagnosed with Hodgkin lymphoma in the U.S. are 35 or younger.3

"The treatment approaches for children with Hodgkin lymphoma are very different than for adults, so we really needed a separate set of guidelines for this population," said Kara Kelly, MD, Division Chief, Pediatric Hematology/Oncology, Chair of Pediatrics at Roswell Park Comprehensive Cancer Center, Chief of the Roswell Park Oishei Children’s Cancer and Blood Disorders Program, and Member, NCCN Guidelines Panel for Pediatric Hodgkin Lymphoma. "Pediatric patients have fewer competing health concerns and may tolerate higher doses, which lowers their risk of relapse. These guidelines really focus on how to strike the right balance for disease control while reducing long-term effects from the treatment."

NCCN has been providing gold standard recommendations for clinical direction and policy in cancer management for 25 years with a proven track record for improving outcomes while reducing costs. NCCN Guidelines are available free-of-charge for non-commercial use at NCCN.org or via the Virtual Library of NCCN Guidelines App.

The organization began providing recommendations for managing childhood cancers with the NCCN Guidelines for Pediatric Acute Lymphoblastic Leukemia (ALL), which launched in May 2019. Since then, those guidelines have been translated into multiple languages, and harmonized for lower-resource settings in sub-Saharan Africa—as part of the group Allied Against Cancer working in collaboration with the African Cancer Coalition (ACC), American Cancer Society (ACS), the Clinton Health Access Initiative (CHAI), and IBM. They have also been re-written in non-medical terms as NCCN Guidelines for Patients: Pediatric ALL in order to empower parents and guardians as well as patients.

NCCN has subsequently published NCCN Guidelines for Pediatric Aggressive Mature B-Cell Lymphomas. Additional new guidelines for children with Wilms tumors and central nervous system cancers are coming soon.

"Our mission to improve and facilitate quality, effective, efficient, and accessible cancer care so patients can live better lives is never more pressing than it is with young people who have many years ahead of them," said Robert W. Carlson, MD, Chief Executive Officer, NCCN.

On September 28, 2020 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company pioneering a new class of oligonucleotide-based therapies called Antibody Oligonucleotide Conjugates (AOCs), reported that Sarah Boyce, President and Chief Executive Officer, Arthur Levin, Ph.D., Chief Scientific Officer, and Mike MacLean, Chief Financial Officer, will participate in a fireside chat at the Chardan 4th Annual Genetic Medicines Conference 2020 on Monday, October 5th, 2020 at 12:45 pm PDT (Press release, Avidity Biosciences, SEP 28, 2020, View Source [SID1234567696]). In addition, Dr. Levin will participate in a featured panel entitled "Small RNA Therapies: Upcoming Advancements in Delivery and Stabilization Chemistries" on Tuesday, October 6th, 2020 at 12:00 pm PDT. The conference is being held in a virtual format.

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A live webcast of the virtual fireside chat will be available on the Company’s website at www.aviditybiosciences.com in the Investor Resources section. A replay of the fireside chat will be archived on the site for 90 days.

On September 28, 2020 -Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will participate in the Jefferies Virtual Cell Therapy Summit on Tuesday, October 6th (Press release, Legend Biotech, SEP 28, 2020, View Source [SID1234567695]). Ying Huang, interim-Chief Executive Officer and Chief Financial Officer, will represent the Company in a session scheduled at 11:20 a.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Legend Biotech website at View Source

On September 28, 2020 Physicians’ Education Resource LLC (PER), a leading resource for continuing medical education, proudly reported it will present the International Society of Gastrointestinal Oncology (ISGIO) 17th Annual 2020 Gastrointestinal Oncology Conference, as a two-day continuing medical education (CME)-certified virtual, interactive meeting Oct. 2-3 (Press release, Physicians’ Education Resource, SEP 28, 2020, View Source [SID1234567694]).

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This year’s conference will be chaired by renowned expert Tanios S. Bekaii-Saab, M.D., professor, Mayo Clinic College of Medicine and Science, program leader, gastrointestinal cancer, Mayo Clinic Cancer Center and medical director, cancer clinical research office, Mayo Clinic.

"The ISGIO meeting has a long, rich history of providing quality CME-certified gastrointestinal (GI) cancer education to clinicians featuring some of the best minds in the field," said Phil Talamo, president of PER. "We look forward to utilizing our virtual interactive platforms, as well as expert speakers and resources, to deliver a highly engaging state-of-the-art two-day conference covering the hottest topics in GI cancer for 2020."

The 2020 Gastrointestinal Oncology Conference will provide the latest advances in the broad field of GI cancer research, as well as critical issues relevant to the care of persons with GI cancer. World-renowned thought leaders from different disciplines will educate clinicians using a combination of case-based learning, debates, panel discussions and didactic segments. Throughout the sessions, attendees will have the opportunity to interact with the faculty and ask questions via PER’s custom interactive platform.

Accredited by the Accreditation Council for Continuing Medical Education, this live activity will provide participants with the opportunity to earn 12.0AMA PRA Category 1 Credits.