Cancer treatments

 FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer and Grants Priority Review

Retrieved on: 
Monday, January 13, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Clinical medicine, Drugs, Medicine, RTT, Cancer treatments, Genentech, Angiogenesis inhibitors, Bevacizumab, Ovarian cancer, PARP inhibitor, Olaparib, Anti–vascular endothelial growth factor therapy, PAOLA-1, Ovarian Cancer, LYNPARZA® (olaparib), the AstraZeneca and Merck Strategic Oncology Collaboration, Merck

Overall Grade 3 or above (AEs) were 57% for LYNPARZA added to bevacizumab and 51% for bevacizumab alone.

Key Points: 
  • Overall Grade 3 or above (AEs) were 57% for LYNPARZA added to bevacizumab and 51% for bevacizumab alone.
  • Discontinuation of treatment occurred in 20% of patients on LYNPARZA plus bevacizumab discontinued treatment vs. 6% on bevacizumab alone.
  • LYNPARZA is the only PARP inhibitor with two positive randomized Phase 3 trials in the 1st-line maintenance setting for advanced ovarian cancer.
  • If approved, this would be the fourth indication for ovarian cancer patients in the U.S. for LYNPARZA.

Allogene Therapeutics and SpringWorks Therapeutics Announce Clinical Collaboration to Evaluate ALLO-715 in Combination with Nirogacestat in Multiple Myeloma

Retrieved on: 
Monday, January 13, 2020
Chemistry, Multiple myeloma, RTT, B-cell maturation antigen, Potentiator, Natural sciences, Medicine, Monoclonal antibodies, Cancer treatments

This agreement will evaluate ALLO-715, Allogenes investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy in combination with SpringWorks investigational gamma secretase inhibitor (GSI), nirogacestat, in patients with relapsed or refractory multiple myeloma.

Key Points: 
  • This agreement will evaluate ALLO-715, Allogenes investigational anti-B-cell maturation antigen (BCMA) AlloCAR T therapy in combination with SpringWorks investigational gamma secretase inhibitor (GSI), nirogacestat, in patients with relapsed or refractory multiple myeloma.
  • The search to find long-lasting and potentially curative therapies for patients with multiple myeloma continues to evolve.
  • SpringWorks is currently enrolling patients in a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors.
  • SpringWorks is pursuing a combination therapy approach to evaluate nirogacestat as a BCMA potentiator across modalities by collaborating with industry leaders.

CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab for the Treatment of Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Monday, January 13, 2020
Drugs, Cancer treatments, Clinical medicine, Breast cancer, Triple-negative breast cancer, Orphan drugs, Management of HIV/AIDS, Antibody-drug conjugates, PRO 140, Sacituzumab govitecan

CytoDyn has been cleared by the FDA to proceed with its Phase 2 trials for both GvHD and NASH.

Key Points: 
  • CytoDyn has been cleared by the FDA to proceed with its Phase 2 trials for both GvHD and NASH.
  • We look forward to working with the FDA and continuing to provide additional data that further supports leronlimab as a potential treatment option for patients.
  • The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer (mTNBC).
  • CytoDyn is therefore conducting aPhase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

Adaptimmune Announces that SPEAR T-cell Platform Delivers Initial Responses in Four Solid Tumor Indications

Retrieved on: 
Monday, January 13, 2020
Medicine, Clinical medicine, Medical specialties, Cancer treatments, Virotherapy, Cancer immunotherapy, Immunotherapy, Immunology, Immune system, Adoptive cell transfer, Chimeric antigen receptor T cell

These data further confirm the potential of Adaptimmunes SPEAR T-cell platform for patients with multiple solid tumors.

Key Points: 
  • These data further confirm the potential of Adaptimmunes SPEAR T-cell platform for patients with multiple solid tumors.
  • These responses demonstrate that our proprietary SPEAR T-cell platform is clearly active and can overcome the challenges of treating a range of solid tumors with a T-cell therapy product, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer.
  • Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer.
  • The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) Tcell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Guardant Health and NRG Oncology Initiate Randomized Trial to Investigate Circulating Tumor DNA Guided Adjuvant Therapy in Stage II Colon Cancer

Retrieved on: 
Monday, January 13, 2020
Medicine, Clinical medicine, Cancer, Anatomical pathology, DNA, Cancer treatments, Infectious causes of cancer, RTT, Adjuvant therapy, Circulating tumor DNA, Colorectal cancer, Cancer staging

The NRG-GI005 COBRA study, or Circulating TumOr DNA (ctDNA) as a Predictive BiomarkeR in Adjuvant Chemotherapy in Stage II Colon Cancer, is a prospective multi-center randomized controlled trial that will enroll 1,408 patients with resected stage II colon cancer who meet their physicians criteria for active surveillance.

Key Points: 
  • The NRG-GI005 COBRA study, or Circulating TumOr DNA (ctDNA) as a Predictive BiomarkeR in Adjuvant Chemotherapy in Stage II Colon Cancer, is a prospective multi-center randomized controlled trial that will enroll 1,408 patients with resected stage II colon cancer who meet their physicians criteria for active surveillance.
  • Today we lack tools to predict which patients with stage II colon cancer have been successfully treated by surgery alone and which need further treatment.
  • We look forward to working with Guardant Health and using their LUNAR-1 assay for this study.
  • Because five-year survival rates for stage II colon cancer are relatively high, most of these patients are not offered adjuvant chemotherapy after surgery.

Iovance Biotherapeutics Obtains License to Develop and Commercialize a Novel IL-2 Analog

Retrieved on: 
Sunday, January 12, 2020
Cancer treatments, Virotherapy, Iovance Biotherapeutics, Immunotherapy, Health, Companies

This product further adds to our research efforts in making safe and more potent TIL products with the potential opportunity for chronic administration.

Key Points: 
  • This product further adds to our research efforts in making safe and more potent TIL products with the potential opportunity for chronic administration.
  • Iovance will focus on GMP manufacturing of IOV-3001 during 2020 and may initiate IND-enabling activities as early as 2021.
  • Iovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers.
  • Certain matters discussed in this press release are forward-looking statements of Iovance Biotherapeutics, Inc. (hereinafter referred to as the Company, we, us, or our).

Atara Biotherapeutics to Present 2020 Key Milestones and Progress in Bringing Off-The-Shelf, Allogeneic T-Cell Immunotherapies to Patients in Need at the 38th Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Sunday, January 12, 2020
Cancer treatments, Virotherapy, Immunology, Immunotherapy, Autoimmunity, Atara

An archived replay of the webcast will be available on the Company's website for 14 days following the live presentation.

Key Points: 
  • An archived replay of the webcast will be available on the Company's website for 14 days following the live presentation.
  • Atara Biotherapeutics ( @Atarabio ) is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases.
  • Ataras technology platform leverages research collaborations with leading academic institutions with the Companys scientific, clinical, regulatory and manufacturing expertise.
  • Our Southern California hub is anchored by the state-of-the-art Atara T-cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California.

Zymeworks Announces Agreement with Pfizer and Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (palbociclib)

Retrieved on: 
Sunday, January 12, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Clinical medicine, Cancer treatments, Medicine, Cancer, HER2/neu, Antineoplastic drugs, Genentech, Quinazolines, NeuVax, Breast Cancer, ZW25

Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study.

Key Points: 
  • Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced the initiation of a Phase 2 trial evaluating ZW25 combination therapy and an agreement with Pfizer which advances the study.
  • In an ongoing Phase 1 clinical trial, Zymeworks is evaluating ZW25 as a single agent and in combination with chemotherapy as potential treatments for patients with HER2-expressing cancers (clinicaltrials.gov: NCT02892123 ).
  • For patients with HER2-positive GEA, ZW25 is being studied in a Phase 2 trial as a first-line treatment in combination with standard of care chemotherapy (clinicaltrials.gov: NCT03929666 ).
  • Zymeworks plans to initiate a registration-enabling Phase 2 trial in previously-treated or recurrent HER2-positive biliary tract cancer in 2020.

Global Gene Therapy Market Outlook and Projections, 2019-2027, Featuring Profiles of the Top 5 Players: Novartis, Amgen, Orchard Therapeutics, Kite Pharma, and uniQure - ResearchAndMarkets.com

Retrieved on: 
Friday, January 10, 2020
Health, Genetics, Branches of biology, Biology, Life sciences, Cancer treatments, Emerging technologies, Biotechnology, Molecular biology, Gene therapy, Axicabtagene ciloleucel, Kite Pharma, Chimeric antigen receptor T cell

The "Global Gene Therapy Market Outlook and Projections, 2019-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Gene Therapy Market Outlook and Projections, 2019-2027" report has been added to ResearchAndMarkets.com's offering.
  • According to the World Bank, more than 2,300 clinical trials on gene therapy were carried out in 2017.
  • Besides, gene therapy is becoming a significant sector in bioscience industry research and can be produced on a commercial-scale, which is projected to further expand its application range.
  • Yescarta - axicabtagene ciloleucel are the most recently approved gene therapeutics available in the global market that treats large B-cell lymphoma.

Announcement of iPSC Derived Gene-modified NK Cell Development Targeting Solid Tumors

Retrieved on: 
Friday, January 10, 2020
Branches of biology, Medicine, Biology, Cancer treatments, Stem cells, Immune system, Virotherapy, Cancer immunotherapy, Induced pluripotent stem cell, Immunotherapy, Natural killer cell, Chimeric antigen receptor T cell

("Healios") has been moving forward with efforts to create next generation immunotherapies for solid tumors by combining its iPS cell and gene editing technology expertise.

Key Points: 
  • ("Healios") has been moving forward with efforts to create next generation immunotherapies for solid tumors by combining its iPS cell and gene editing technology expertise.
  • In this notice we are disclosing that we have decided to add the development of allogeneic, iPS cell derived gene-modified natural killer (NK) cells to our pipeline (development code: HLCN061).
  • We are moving forward with development of iPSC derived cells to provide new treatments for patients suffering from refractory cancers.
  • Under this policy, we have decided to begin promoting research and development for a next generation cancer immunotherapy using allogeneic, iPSC derived NK cells that have had specific functions reinforced using gene editing technology in order to target solid tumors.