On December 1, 2021 McKesson Corporation (NYSE: MCK) reported that it will host an Investor Day on Wednesday, December 8, 2021 from 1:00 PM to 4:00 PM ET in New York City (Press release, McKesson, DEC 1, 2021, View Source [SID1234596355]). The meeting will feature presentations by McKesson’s leadership team and a live Q&A session with chief executive officer Brian Tyler and chief financial officer Britt Vitalone . Management will provide an overview of the company’s progress towards its goal of delivering sustainable growth and details around the company’s long-term financial outlook.

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Webcast and Presentations

The video webcast will be available live and archived on McKesson’s Investor Relations website, along with the company’s slide presentation, at investor.mckesson.com.

On December 1, 2021 Australian clinical-stage drug development company Noxopharm (ASX:NOX) reported that it has in-licensed novel RNA technology developed by Hudson Institute of Medical Research (Press release, Noxopharm, DEC 1, 2021, View Source [SID1234596378]). The exclusive global contract aims to maximize opportunities in RNA drug discovery and mRNA vaccine manufacture through Noxopharm’s wholly owned subsidiary, Pharmorage.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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According to Noxopharm CEO and Managing Director, Graham Kelly, "Pharmorage already had a strong business relationship with Hudson with a major initiative in anti-inflammatory drug development. The RNA technology and its anti-inflammatory functions is an obvious fit, and with mRNA vaccine technology looking increasingly likely to extend eventually to most if not all viral diseases, this is an extraordinarily timely development." Noxopharm has previous experience in developing anti-inflammatory therapeutics, which led to their current lead drug candidate, Veyonda.

As a first step, Pharmorage will develop Hudson’s mRNA vaccine enhancement opportunities, as the mRNA vaccine market is predicted to reach $23 billion USD by 2035. Though mRNA vaccine technology has had a strong debut, unwanted side effects remain common, including fatigue, severe headache, chills, and injection-site pain. These are directly related to the body recognizing mRNA therapeutics through the immune sensor Toll-like Receptor 7 (TLR7). However, according to Associate Professor Michael Gantier of Hudson, "We have discovered a new class of TLR7 inhibitors that can outcompete immune sensing of therapeutic RNAs, such as those used in mRNA vaccines; we propose that these inhibitors could be used in conjunction with therapeutic RNAs to limit their side effects in patients and maximize their therapeutic potential."

Pharmorage will also focus on advancing Hudson’s several lead RNA drugs through development as treatments for autoimmune and inflammatory diseases. These RNA drugs target the root of the inflammatory response — key immune sensors. Pharmorage has experience in this area, evidenced by their work on the development of a first-in-class tank-binding kinase 1 (TBK1) inhibitor, to be used in similar conditions.

On December 1, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the presentation of new investigational data in acute myeloid leukemia (AML) and sickle cell disease at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 11-14, in Atlanta, Ga. Astellas’ largest ASH (Free ASH Whitepaper) showing to date includes 11 AML abstracts, including four oral presentations (Press release, Astellas, DEC 1, 2021, View Source [SID1234596320]).

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"Research being presented at this year’s ASH (Free ASH Whitepaper) meeting investigates gilteritinib across the FLT3-mutation-positive AML disease continuum," said Ahsan Arozullah, M.D., M.P.H., Vice President, Medical Sciences-Oncology, Astellas. "Several presentations highlight data for gilteritinib in a wide range of patients – from newly diagnosed to relapsed or refractory patients, and in varying combination regimens."

Presentations will include results from two Phase 3 trials: three abstracts from LACEWING, a clinical trial which included patients with newly diagnosed FLT3 mutation-positive (FLT3mut+) AML who were ineligible for first-line intensive induction chemotherapy; and one from COMMODORE, a trial of gilteritinib versus salvage chemotherapy in patients with FLT3mut+ relapsed or refractory AML conducted in China, Malaysia, Thailand, Singapore, and Russia.

Astellas will also present research based on patients’ perspectives of AML symptoms, life impact and treatment. "A deeper understanding of patient experiences is vital as we seek better treatment approaches in all stages of AML," said Erhan Berrak, M.D., Vice President of Medical Affairs, Oncology, Astellas. "For example, one study to be presented at this year’s ASH (Free ASH Whitepaper) meeting investigated the patient experience after a stem-cell transplant, shedding light on both symptoms and emotional impact, which can inform efforts to better serve patients post-transplant."

In addition, Astellas plans to present new preclinical data on sickle cell disease (SCD) for ASP8731, a novel BACH1 inhibitor that potentially induces fetal hemoglobin (HbF). The data show potential to increase expression of antioxidant and HbF genes and reduce SCD-related pathophysiology. This may result in the reduction of hemolysis, inflammation, and vaso-occlusive pain crises in patients living with the condition.

"We are pleased to have the opportunity to present our preclinical data supporting further development of ASP8731, our BACH1 inhibitor," said Itsuro Nagase, Ph.D., D.V.M., Vice President and Primary Focus Lead, Mitochondrial Biology, Astellas. "These data further support our focus on mitochondrial disease research and the advances we are making across the Astellas research pipeline to develop novel therapies for patients with unmet medical needs."

Oral Presentations

Title: Symptoms and Impacts Reported by Patients with Acute Myeloid Leukemia (AML) in Remission Post-Stem Cell Transplant (Abstract 278).

Presenting author: Thomas Leblanc, M.D., M.A., Department of Medicine, Duke University School of Medicine, Durham, N.C., USA
Session Date/Time: Saturday, Dec. 11, 2:15 p.m. ET
Title: Phase 3, Open-Label, Randomized Study of Gilteritinib and Azacitidine vs Azacitidine for Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in Patients Ineligible for Intensive Induction Chemotherapy (LACEWING) (Abstract 700).

Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
Session Date/Time: Monday, Dec. 13, 3:30 p.m. ET
Title: Gilteritinib Versus Salvage Chemotherapy for Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia: A Phase 3, Randomized, Multicenter, Open-Label Trial in Asia (COMMODORE) (Abstract 695).

Presenting author: Jianxiang Wang, M.D., State Key Laboratory of Experimental Hematology, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China
Session Date/Time: Monday, Dec. 13, 3:45 p.m. ET
Title: Venetoclax in Combination with Gilteritinib Demonstrates Molecular Clearance of FLT3 Mutation in Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia (Supported by AbbVie, Astellas and Genentech) (Abstract 691).

Presenting author: Naval Daver, M.D., Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
Session Date/Time: Monday, Dec. 13, 2:45 p.m. ET
Title: ML-0207/ASP8731: A Novel BACH1 Inhibitor That Induces Fetal Hemoglobin in Treatment of Sickle Cell Disease (Abstract 854).

Presenting author: Greg Vercellotti, MD, Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minn., USA
Session Date/Time: Monday, Dec. 13, 6:30 p.m. ET
Poster Presentations

Title: A Phase 1, Dose-Escalation Study of Gilteritinib Combined with Chemotherapy in Patients Aged 6 Months to <21 Years with FLT3 Internal Tandem Duplication-Positive Relapsed or Refractory AML (Abstract 2315).

Presenting author: Philip Connor, M.B.B.S., Department of Pediatric Hematology/Oncology, Noah’s Ark Children’s Hospital for Wales, Cardiff, Wales, UK
Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET
Title: Impact of FLT3 Mutation Clearance After Front-Line Treatment with Gilteritinib Plus Azacitidine, or Gilteritinib or Azacitidine Alone in Patients with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy: Results from the Phase 3 LACEWING Trial (Abstract 3445).

Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
Session Date/Time: Monday, Dec. 13, 6-8 p.m. ET
Title: Patient Reported Outcomes in Patients with Newly Diagnosed FLT3mut+ Acute Myeloid Leukemia Ineligible for Intensive Induction Chemotherapy From LACEWING: A Randomized Phase 3 Trial of Gilteritinib and Azacitidine Versus Azacitidine Alone (Abstract 3058).

Presenting author: Eunice S. Wang, M.D., Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., USA
Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET
Title: First Salvage Therapy for Relapsed or Refractory Acute Myeloid Leukemia: Associated Health Care Resource Use and Costs (Abstract 1936).

Presenting author: Lori Muffly, M.D., M.S., Division of Blood and Marrow Transplantation, Stanford University, Stanford, Calif., USA
Session Date/Time: Saturday, Dec. 11, 5:30-7:30 p.m. ET
Title: Gilteritinib Can Be Safely Combined with Atezolizumab for The Treatment of Relapsed or Refractory FLT3-Mutated AML: Results of a Phase 1 Study (Abstract 2343).

Presenting author: Jessica K. Altman, M.D., Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Feinberg School of Medicine, Chicago, Ill., USA
Session Date/Time: Sunday, Dec. 12, 6-8 p.m. ET
Title: Patient and Physician Preferences for Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Patients Not Candidates for Intensive Chemotherapy (Abstract 4047).

Presenting author: Mo Zhou, Ph.D., Analysis Group, Boston, Mass., USA
Session Date/Time: Monday, Dec. 13, 6-8 p.m. ET
Online-Only Publication

Title: Real-World Use of FLT3 Tyrosine Kinase Inhibitors in Patients with Relapsed/Refractory FLT3 Mutation-Positive Acute Myeloid Leukemia in the United States (Abstract 5033).

About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia (AML) is an aggressive cancer that affects the bone marrow and blood, and its incidence increases with age.1,2 Of patients newly diagnosed with AML and tested for FLT3 mutations, approximately one-third have an alteration to the FLT3 gene. FLT3-ITD mutations have been associated with worsened disease-free survival and overall survival, and a higher risk of getting the disease more than once. FLT3 mutation status can change over the course of AML treatment, even after relapse.3-6

About Gilteritinib
Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor with demonstrated activity against FLT3-ITD, a common driver mutation that presents with a high disease burden and poor prognosis, and FLT3-TKD mutations.7 It was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global development, commercialization and manufacturing rights to gilteritinib.8

On December 1, 2021 GlaxoSmithKline (GSK) plc reported Target the Future, an international, multi-year initiative dedicated to advancing innovation and addressing key needs in the multiple myeloma community (Press release, GlaxoSmithKline, DEC 1, 2021, View Source [SID1234596337]). The programme will provide education on progress in the field of multiple myeloma, identify key challenges the community faces, and facilitate solutions to help create a better future for patients, their caregivers and loved ones.

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Target the Future was inspired by the recent advances in the field of multiple myeloma combined with the remaining challenges that patients face. Multiple myeloma is the third most common blood cancer worldwide[i] and second most common blood cancer in the US;[ii] it is generally considered treatable, but not curable.[iii] Despite recent treatment advances and the availability of newer and combination therapies, outcomes remain poor for patients with relapsed/refractory multiple myeloma.[iv]

"We’ve seen significant innovation in the development of new therapies for multiple myeloma during the past two decades, yet patients still face significant challenges, including access to care, emotional distress and disparities in outcomes among certain populations," said Tania Small, Vice President, Global Medical Oncology Franchise Head, GSK. "As part of our ongoing commitment to the myeloma community, we connected with patients and caregivers to identify some of the community’s key challenges, and now, we’re calling on innovative minds around the world to contribute potential solutions to help address these issues. Together, we can accelerate ideas that will make a positive and meaningful impact for patients with multiple myeloma."

Target the Future Think Tank Challenge

Target the Future aims to foster understanding of unmet needs in the multiple myeloma community and assist in developing solutions for these challenges. Beginning today, the programme’s Target the Future Think Tank Challenge will accept submissions of ideas to create a better future for the multiple myeloma community. A grant of £70,000 (equivalent to approximately $100,000) will be awarded to the strongest proposal that will bring the idea to life. Between now and 11 February 2022, patients, caregivers, healthcare professionals, researchers, data scientists, advocates or non-profit organisations can submit their proposals at www.targetthefuturemm.com. GSK will share the winning idea with the community and continue the programme in the years ahead to provide additional education and solutions for the myeloma community.

Persistent Challenges in the Multiple Myeloma Community

GSK consulted with patients and caregivers to identify key issues impacting the myeloma community that entrants could address with their proposals, including:

Understanding treatment options: While more treatments are available, understanding the appropriate options at each step of the journey can be difficult.
Getting the right care: Finding or traveling to the right healthcare provider can be hard for patients with limited transportation or location options.
Relieving the emotional burden: Managing stress associated with diagnosis, treatment, relapse, or the overall disruption to one’s life can be taxing for both patients and their caregivers.
Addressing disparities and inequities: New ideas can help ensure equal access to care and resources.
Entries for the Think Tank Challenge will be judged based on criteria such as potential to impact the issue(s), novelty of the idea, feasibility to execute and alignment with unmet needs. The submissions will be evaluated by a multidisciplinary advisory group comprised of people personally and professionally connected to the multiple myeloma community.

To learn more about Target the Future or apply to the Think Tank Challenge, please visit View Source

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, tumour cell targeting therapies and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

On December 1, 2021 RefleXion Medical, Inc., a therapeutic oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* (BgRT) for use in treating lung tumors (Press release, RefleXion Medical, DEC 1, 2021, View Source [SID1234596356]). The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. It is the first and only technology to use injected radiotracers to produce active signals, called emissions, from each tumor to guide treatment delivery.

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"Lung tumors are often fast moving, and a patient may have multiple tumors at the time of diagnosis, which limits the use of standard radiation techniques in the lungs," said Terence Williams, M.D., Ph.D., chair of radiation oncology at City of Hope Comprehensive Cancer Center. "The potential of biology-guided radiotherapy overcomes these limitations to offer us a promising, cost-efficient, comprehensive, and more targeted treatment for these common malignancies."

The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. Lung cancer is the most common cause of cancer- related death, accounting for 25% of all cancer deaths in the United States.1 The lungs are also among the most common location for metastatic tumors arising from cancers located in other parts of the body.

"The unmet need in lung cancer is staggering," said Todd Powell, president and CEO of RefleXion. "By harnessing the continuous biological interaction between the radiotracer and the cancer cells, BgRT has the potential to manage tumor motion with unprecedented precision. Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S."

The vision for BgRT is to expand treatment options for patients with all stages of cancer. Several recent lung cancer clinical trials combining radiotherapy with drug therapy demonstrate significant improvements in overall and progression-free survival, despite the inability of current technology to reach more than one to three tumors. BgRT aims to overcome this limitation and eventually deliver radiotherapy to more sites of disease in hopes of improving outcomes for more patients with advanced disease.