On December 1, 2021 Physicians in the United States can now order the liquid biopsy-based Target Selector NGS Lung Panel test directly from Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services (Press release, Quest Diagnostics, DEC 1, 2021, View Source,-Expanding-its-Menu-of-Advanced-Cancer-Diagnostics [SID1234596323]). Developed by Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, the lab-developed liquid biopsy test aids genomic profiling in patients with advanced non-small cell lung cancer (NSCLC), helping physicians identify potential targeted therapies and monitor the effectiveness of treatment .

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With a physician’s order, individuals are now able to provide a blood specimen for testing at one of Quest’s 2,200 conveniently located patient service centers across the United States. Collected specimens will be forwarded to Biocept’s CLIA-certified, CAP-accredited laboratory in San Diego for testing.

The Target Selector NGS Lung Panel contributes to better patient outcomes by providing physicians with direction on therapeutic options for those battling NSCLC. Healthcare providers may perform genomic profiling of tissue to aid their selection and response monitoring of gene-targeted NSCLC therapies. However, patients are not always able to have a tissue biopsy, which can take weeks to produce a result and may be limited by the quality and quantity of tissue that can be collected. Liquid biopsies identify genetic material from tumor cells that are shed and circulate in the blood stream, complementing insights from tissue biopsies and reducing dependence on tissue.

The addition of this blood-based panel to Quest’s advanced diagnostic testing menu enables Quest to provide actionable insights in an easier and less invasive manner, supplementing its services in tissue biopsy.

"By providing Biocept’s Target Selector NGS Lung Panel test under our advanced diagnostics portfolio, Quest will enable more physicians and patients to receive insights necessary to provide the appropriate treatment for NSCLC," said Kristie Dolan, General Manager, Oncology Franchise, Quest Diagnostics. "Our relationship with Biocept is the latest example of how Quest’s scale and expertise helps innovators reach larger markets and serve patients most in need."

"Our collaboration with Quest Diagnostics reflects our shared commitment to excellence in oncology diagnostics and allows us to serve more patients nationwide and expand our customer base, with the goal of improving care for those with lung cancer," said Michael Nall, President and CEO, Biocept. "The Target Selector NGS Lung Panel provides critical information to aid in the creation of more personalized treatment plans for patients with NSCLC and help oncologists get the answers they need to provide the best care possible."

Biocept’s multi-gene, tumor-specific NGS Lung Panel allows physicians and researchers to use a simple blood sample to analyze actionable biomarkers associated with specific solid tumor types. It combines Biocept’s liquid biopsy biomarker testing expertise with next generation sequencing and decision support resources. The biomarkers included in the Target Selector NGS Lung Panel are those that physicians frequently rely upon when making treatment decisions for their patients diagnosed with NSCLC. The assay is targeted and actionable—the majority of the biomarkers investigated are based on National Comprehensive Cancer Network guidelines and/or FDA-approved therapies.

Quest Diagnostics is the world’s leading provider of cancer diagnostics, providing physicians and health systems a single source solution via the most comprehensive capabilities in anatomic pathology and molecular diagnostics. Quest’s innovative test menu includes various options for screening, diagnosis, treatment and monitoring recurrence. The company provides a range of pathology services through its AmeriPath and Dermpath specialty businesses.

On December 1, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that the US Food and Drug Administration (FDA) is allowing the Company’s Investigational New Drug (IND) application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM) to go forward (Press release, Moleculin, DEC 1, 2021, View Source [SID1234596322]). With this IND now cleared, Moleculin plans to initiate a Phase 1 open label, single arm, dose escalation study of the safety, pharmacokinetics and efficacy of oral WP1122 in adult patients with GBM.

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The Company believes WP1122 has significant potential as both an antiviral therapy and as a cancer therapy. Moleculin recently announced its plans to initiate a Phase 1a clinical trial of WP1122 in healthy volunteers in the United Kingdom to facilitate future testing in COVID-19 patients. This new US IND sets the stage for parallel development of WP1122 as a cancer therapy. Consistent with its strategy of leveraging external funding for many of its clinical trials, Moleculin intends to seek opportunities for an investigator-initiated clinical trial of WP1122 in cancer patients in 2022.

"This IND underscores our dual pronged approach to the development of WP1122 for the treatment of both certain types of cancers and viruses. In addition to the trial in the UK designed to position WP1122 as an antiviral therapy, we can now be advancing the cancer therapy path in parallel. Along with GBM, we believe WP1122 has the potential to be well suited as a treatment for other highly glycolytic cancers such as pancreatic cancer," commented Walter Klemp, Chairman and CEO of Moleculin.

GBM is the most aggressive malignant primary brain tumor and remains as an incurable tumor with a median survival of only 15 months1. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors,2 and despite advancements, survival rates for patients with GBM have shown no notable improvement in population statistics in the last three decades.3 The average annual age-adjusted incidence rate of GBM is 3.19 per 100,000 persons in the United States.4

1 Koshy M, Villano JL, Dolecek TA, Howard A, Mahmood U, Chmura SJ, et al. Improved survival time trends of glioblastoma using the SEER 17 population-based registries. J Neuro Oncol. 2012;107(1):207–12

2 Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, et al. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006–2010. Neuro Oncol. 2013;15 Suppl:2ii–56.

3 De Vleeschouwer S, editor. Brisbane (AU): Codon Publications; 2017 Sep 27.

4 Thakkar J, Dolecek TA, Horbinski C, Ostrom QT, Lightner DD, Barnholtz-Sloan JS, et al. Epidemiologic and molecular prognostic review of glioblastoma. Cancer Epidemiol. Biomarkers Rev. 2014;23(10):1985–96.

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

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 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN) (Press release, BeyondSpring Pharmaceuticals, DEC 1, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-receives-complete-response-letter-from-the-fda-for-plinabulin-new-drug-application-for-prevention-of-chemotherapy-induced-neutropenia-cin [SID1234596319]). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form.

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The FDA’s CRL indicated that the results of the single registrational trial (106 Phase 3) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

"BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy," said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. "The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally."

BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.

Plinabulin is the first drug candidate submitted for FDA approval that has the potential to work in the critical first week of chemotherapy treatment before G-CSF is effective, to prevent the onset and improve clinical outcomes of CIN.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA-stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation and priority review from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.