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 Tempus, a leader in artificial intelligence and precision medicine, reported the expansion of its multi-year agreement with Janssen Research & Development, LLC (Janssen) (Press release, Tempus, DEC 1, 2021, View Source [SID1234596357]). The expanded scope is anchored in new AI-based work, in which Tempus will collaborate with a multidisciplinary team of data scientists at Janssen to enhance the discovery and development of therapies for oncology indications using AI/ML and real-world evidence (RWE). This agreement leverages Tempus’ platform, including its multimodal data library, genomic sequencing offerings, and TIME Trial Network of clinical sites to advance the recruitment of patients.

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Tempus’ platform is well positioned to solve many of the challenges clinical trial sponsors face, especially finding rare biomarker-driven patient populations. This work leverages Tempus’ AI capabilities to jointly create algorithms intended to further patient pre-screening efforts for specific cancer indications, including biomarker-selected cohorts. Tempus’ multidisciplinary team’s expertise spans clinical RWE, computational biology, software engineering, machine learning, and trial matching program management, and is a key factor in successfully leveraging an AI-enabled approach to trial recruitment.

"We’re excited to expand our collaboration to apply the Tempus AI platform," said Ryan Fukushima, Chief Operating Officer of Tempus. "We will explore leveraging our data to develop and co-develop novel AI applications to identify the best treatment options for patients in need, and ultimately accelerate the drug development process, bringing novel medicines to patients in a fraction of the time."

On December 1, 2021 Curie Therapeutics Inc. ("Curie"), a biotechnology company incubated by Atlas Ventures, Access Biotechnology and RA Capital Management, reported a Series A investment of $75 million by its founding syndicate to continue the development of its multimodal pipeline of precision radiopharmaceuticals to a broad range of high unmet need solid tumors (Press release, Curie Therapeutics, DEC 1, 2021, View Source [SID1234596380]).

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Commenting on the emergence of Curie from stealth, Dr. Simon Read, Curie Founder and Chief Executive Officer, said, "We envision a world where cancer care is transformed by precision radiopharmaceuticals and a future in which these drugs are increasingly integrated into mainstream treatment."

He added, "We founded Curie to maximize the potential of targeted radiopharmaceuticals for frank tumor ablation, as well as to harness the growing understanding of how radiobiology of targeted therapies can favorably modulate the tumor microenvironment as part of a rational sequence of care. Our team is unique. We have bought together seasoned leaders from pharmaceutical biotech R&D with radiobiology and radiochemistry experts drawn from both industry and academia. Backed by a syndicate of three of the foremost incubating venture firms, we have a pipeline underway and key radionuclide supply agreements for both alpha and beta radionuclide strategies to support our vision."

Dr. Dan Becker, Partner at Access Biotechnology and a member of Curie’s Board of Directors (BoD), said "Radiopharmaceuticals are emerging as potent, safe, and commercially viable options for cancer patients. While late-stage therapeutic radiopharmaceutical pipelines are predominantly focused on metastatic castration resistant prostate cancer and neuroendocrine tumors, we see a much broader opportunity to drug a broad spectrum of targets with our high therapeutic index, precision radiopharmaceuticals."

Dr. Kevin Bitterman, Partner at Atlas Ventures and a member of Curie’s BoD said, "All three syndicate members showed an early interest in the radiopharmaceutical space. We have been incubating Curie for 18 months with a focus on building a fully integrated company in which both peptidic and non-peptidic ligand R&D, radiochemistry, CMC and clinical translation can occur under one roof."

Dr. Josh Resnick, Managing Director of RA Capital Management and a member of Curie’s BoD, added, "This founding team has the ligand discovery breadth, company formation experience, and radiobiology and CMC experience required to build the leading precision radiopharmaceutical company. We are delighted to co-lead the series A round with Access Biotechnology and Atlas Venture."

Curie Management and Board of Directors

Curie’s management includes biotech leaders with broad experience across peptide discovery and development, radiochemistry, and in building top tier clinical stage peptide, radiopharmaceutical, and platform companies, including founder Simon Read, Ph.D. as CEO (former CSO of Ra Pharma, former Entrepreneur in Residence at Atlas Venture), Alonso Ricardo, Ph.D. as CSO (former Chief Technology Officer of Ra Pharma, former Entrepreneur in Residence at RA Capital Management), and Sandy Mong, M.D. as SVP of Business Development and Operations (former VP of Business Development and Operations of BridgeBio Pharma, former Entrepreneur in Residence at Atlas Venture). The broader team includes ligand discovery, radiopharmacology, radiochemistry talent from public and private peptide companies, radiopharmaceutical companies, as well as academia.

Curie’s BoD consists of Kevin Bitterman, Ph.D. (Partner, Atlas Venture), Dan Becker, M.D., Ph.D. (Partner, Access Biotechnology), Josh Resnick, M.D. (Managing Director, RA Capital Management), and Simon Read, Ph.D. (CEO, Curie Therapeutics).

On December 1, 2021 Imago BioSciences, Inc. ("Imago" or the "Company") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported that a virtual investor event will be hosted by the company’s management team following the company’s presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition (Press release, Imago BioSciences, DEC 1, 2021, View Source [SID1234596321]).

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Individuals interested in listening to the event at 11:00 a.m. ET on Sunday, December 12 may do so by dialing (844) 348-6880 for domestic callers, or (914) 800-3944 for international callers and reference conference ID: 4488627; or from the webcast link in the investor relations section of the company’s website at: www.imagobio.com. The webcast will be available in the investor relations section on the company’s website for 90 days following the completion of the call.

Imago will participate in two oral presentations on during the ASH (Free ASH Whitepaper) exposition and the abstracts are available on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org and can also be accessed through "Events and Presentations" on Imago’s investor relations website.

The titles of the oral presentations are:

Oral Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Advanced Myelofibrosis"
Presentation Date/Time: December 11, 2021, at 12:00 PM ET
Oral Presentation Title: "A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)"
Presentation Date/Time: Sunday, December 12, 2021, at 9:45 AM ET