Leukemia (includes ALL, AML, APL, CLL, CML, MDS, Myeloproliferative Disorders, Myelofibrosis)

Vast Leukemia Dataset Could Help Researchers Match Therapies to Patients

(HHMI) Oct 17, 2018 - After years of work, researchers are releasing a massive dataset detailing the molecular makeup of tumor cells from more than 500 patients with an aggressive blood cancer called acute myeloid leukemia (AML). The dataset includes how hundreds of individual patients' cells responded to a broad panel of drugs in laboratory screens.

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AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

(AbbVie) Oct 17, 2018 - If granted, IMBRUVICA plus obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for first-line CLL treatment. The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer progression-free survival for IMBRUVICA plus obinutuzumab versus chlorambucil plus obinutuzumab in CLL/SLL.

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Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent Alvocidib in Phase 1b/2 Zella 102 Study in Patients with Myelodysplastic Syndromes (MDS)

(The Business Journals) Oct 16, 2018 - Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, today announced that the first patient has been enrolled in a Phase 1b/2 study, Zella 102, evaluating the investigational agent alvocidib, a cyclin-dependent kinase 9 (CDK9) inhibitor, plus decitabine in patients with myelodysplastic syndromes (MDS).

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Delving Where Few Others Have Gone, Leukemia Researchers Open New Path

(URMC) Oct 15, 2018 - A Wilmot Cancer Institute study uncovers how a single gene could be at fault in acute myeloid leukemia (AML), one of the deadliest cancers. The breakthrough gives researchers renewed hope that a gene-targeted therapy could improve AML survival rates, which have not budged in recent years.

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Constellation Pharmaceuticals Enhances and Expands Phase 2 MANIFEST Study of CPI-0610 in Myelofibrosis

(P&T Community) Oct 10, 2018 - Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, today announced several planned updates to the Phase 2 portion of its ongoing MANIFEST study, an open-label Phase 1/2 clinical trial of its BET inhibitor CPI-0610 in MF.

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Genetics Allows Personalized Disease Predictions For Chronic Blood Cancers

(Wellcome Sanger Institute [UK]) Oct 10, 2018 - The research also identified eight different genetic subgroups of myeloproliferative neoplasms that link with patterns of clinical disease and patient prognosis.

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Early Blood Cancer Trial Is Shuttered, Possibly Dimming Hopes For Promising Therapy

(STAT Plus) Oct 9, 2018 - A promising but controversial new approach to treating blood cancer could be in trouble in the earliest innings of human testing after Celgene pulled the plug on a trailblazing clinical trial. On Monday, Celgene terminated a Phase 1 study of CC-90002, which targets a protein that helps cancer cells stay out of the immune system’s crosshairs. In an update to ClinicalTrials.gov, Celgene said it canceled the CC-90002 study because early results “did not offer a sufficiently encouraging profile” to move forward.

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Affimed Puts On Hold Cancer Drug Trial After Patient Death

(Reuters) Oct 8, 2018 - Drug developer Affimed N.V. on Monday put on hold the testing of its experimental cancer drug following the death of a patient and two life-threatening events. The company’s shares slumped 25 percent to $3.82 in after-market trading. Affimed is testing the drug, AFM11, for treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma in two separate early-stage trials.

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Affimed Places AFM11 (CD19/CD3-Targeting T cell Engager) Phase 1 Program on Clinical Hold

(Affimed) Oct 8, 2018 - Affimed N.V., a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer mmunotherapies that harness the power of innate and adaptive immunity (NK and T cells), today announced that it has placed AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health authorities of its decision.

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bluebird bio Announces European Medicines Agency’s Acceptance of Marketing Authorization Application for LentiGlobin™ Gene Therapy for the Treatment of Transfusion-Dependent β-Thalassemia

(bluebird bio) Oct 5, 2018 - bluebird bio, Inc. announced today that the European Medicines Agency (EMA) accepted the company’s marketing authorization application (MAA) for its investigational LentiGlobin™ gene therapy for the treatment of adolescents and adults with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. LentiGlobin was previously granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA in July 2018, potentially reducing the EMA’s active review time of the MAA from 210 days to 150 days.

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NHS England Strikes Deal For Ground Breaking Cancer Treatment In A New European First

(NHS) Oct 5, 2018 - Adult cancer patients in England will receive a new game-changing therapy treatment under the first negotiated deal of its kind struck in Europe, NHS England chief executive Simon Stevens announced today. This is the first time adult NHS patients will have access to CAR-T, and follows a deal NHS England reached last month to make CAR-T available for children and young people with a rare form of leukaemia. The CAR-T therapy – Axicabtagene ciloleucel, also known as Yescarta – offers new hope for adult patients whose large cell lymphoma has returned or has stopped responding to previous treatment.

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MD Anderson and Cyclacel Pharmaceuticals Announce Strategic Alliance To Study Novel Cyclacel Medicines In Hematological Malignancies

(MD Anderson) Oct 4, 2018 - The University of Texas MD Anderson Cancer Center and Cyclacel Pharmaceuticals, Inc., today announced a three-year strategic alliance agreement that will enable clinical evaluation for safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and other advanced leukemias.

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Mayo Researchers Develop New Genetics-Based Prognostic Tool For Myelodysplastic Syndrome

(Mayo Clinic) Oct 1, 2018 - Researchers at Mayo Clinic have developed a new genetics-based prognostic tool for myelodysplastic syndrome. Their findings are published in the October print issue of Mayo Clinic Proceedings.

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Doctors Issue Caution over Missed Cancer Diagnoses Tied to Immune Disorder

(Cincinnati Children’s) Oct 1, 2018 - Physicians who specialize in a devastating and aggressive immune disorder called hemophagocytic lymphohistiocytosis (HLH) report in a new study that extra care should be taken to ensure an HLH diagnosis doesn’t obscure possible underlying cancers.

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FDA Grants De Novo Designation for Adaptive Biotechnologies’ clonoSEQ Assay to Detect and Monitor Minimal Residual Disease (MRD) in Patients with Multiple Myeloma and Acute Lymphoblastic Leukemia

(MarketWatch) Sept 28, 2018 - Adaptive Biotechnologies [®] announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo designation for the clonoSEQ [® ] Assay to detect and monitor minimal residual disease (MRD) in patients with multiple myeloma (MM) and B-cell acute lymphoblastic leukemia (ALL) using DNA from a patient’s bone marrow sample. The clearance of clonoSEQ marks several “firsts” for patients and for the FDA. The clonoSEQ Assay represents a first-in-class MRD assay that uses next-generation sequencing (NGS) technology to assess disease burden, representing an important additional use of NGS in cancer. clonoSEQ is the first and only assay to be cleared by the FDA for MRD assessment in any lymphoid cancer and the first FDA-cleared diagnostic assay powered by immunosequencing.

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FDA Authorizes First Next Generation Sequencing-Based Test To Detect Very Low Levels Of Remaining Cancer Cells In Patients With Acute Lymphoblastic Leukemia Or Multiple Myeloma

(FDA.gov) Sept 28, 2018 - Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow. “At the FDA, we’re continuing to maximize opportunities for innovation that can improve patient outcomes,” said FDA Commissioner Scott Gottlieb, M.D. “Today’s approval is an important step forward for patients suffering from ALL and multiple myeloma. Determining whether a patient has residual cancer cells remaining after treatment provides information on how well a patient has responded to therapy and how long remission may last.

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In Rare Case, Patient Developed Resistance To CAR-T After Cancer Cell Began Hiding In ‘Plain Sight’

(STAT/In The Lab) Oct 1, 2018 - To make CAR-T therapies, the pioneering cancer treatments, scientists introduce a gene into the body’s immune cells that turns them into cancer-homing attackers. But in one case described by scientists Monday, the gene was inadvertently delivered to a cancer cell instead, camouflaging it from the therapy and allowing the cancer to develop resistance to treatment.

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Ahead of Geron Blowup, Warning Signs Were Visible For Those Willing To See Them

(STAT) Sept 27, 2018 - It was right about Geron. Janssen, the pharma arm of Johnson & Johnson, decided to end a partnership with Geron to develop the blood disease drug imetelstat. And as you might expect, Janssen’s no-go decision caused Geron shares to plunge. The stock is down 62 percent to $2.39 in Thursday trading.

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Geron Announces Discontinuation of Imetelstat Collaboration by Janssen

(MarketWatch) Sept 27, 2018 - Geron Corporation today announced that Janssen Biotech, Inc. has terminated the 2014 Collaboration and License Agreement (CLA) with the Company. Janssen stated in their press release issued today that they made this decision as the result of a strategic portfolio evaluation and prioritization of assets within their portfolio. As such, Geron has regained the global rights to develop and commercialize imetelstat, a first-in-class telomerase inhibitor. "We are grateful for the collaboration with Janssen, who successfully managed two Phase 2 trials of imetelstat," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer.

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J&J Terminates Imetelstat Collaboration and Licensing Deal with Geron

(BioSpace) Sept 27, 2018 - Geron Corporation, located in Menlo Park, Calif., announced that Janssen Pharmaceutical Inc., a Johnson & Johnson company, has terminated their 2014 Collaboration and License Agreement. The two companies had teamed up to develop and commercialize imetelstat, a first-in-class telomerase inhibitor, for myelofibrosis and myelodysplastic syndromes. The effective date of termination, under the collaboration deal, is September 28, 2018. At that time, the rights licensed to the imetelstat program, which includes any intellectual property rights created via the collaboration, return to Geron. Janssen will have no further obligations to fund any of the ongoing clinical trials. The transition will take place over approximately 12 months with operational assistance from Janssen. Janssen will supply imetelstat to Geron for up to two years. Two clinical trials of imtelstat, IMbark for myelofibrosis and IMerge for myelodysplastic syndromes, will continue.

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