Copanlisib

Bayer Provides Update on Aliqopa® (copanlisib)

Retrieved on: 
Monday, November 13, 2023
General Health, FDA, Health, Pharmaceutical, Oncology, Follicular lymphoma, Patient, Food, Pharmaceutical industry, Copanlisib, Bayer

Aliqopa® was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study.

Key Points: 
  • Aliqopa® was granted accelerated approval by the FDA in September 2017 based on CHRONOS-1, an open-label, single-arm Phase II study.
  • The FDA required clinical benefit to be confirmed through the CHRONOS-4 study.
  • Bayer intends to publish the results of CHRONOS-4 in a timely manner.
  • For questions related to ongoing access, please contact Bayer Medical Communications at 1-888-84-Bayer.

Bayer Presents New Data Across Oncology Portfolio at the 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Pharmaceutical, Health, Oncology, Docetaxel, Thyroid, Observational study, Mutation, ADT, Radium, Science, ASCO, DEAR, American Society of Clinical Oncology, Metastasis, Patient, NTRK, Annual general meeting, Disease, Copanlisib, RWE, Radium-223, FDA, Aryl hydrocarbon receptor, Safety, Society, ORR, TC, Enza, TRK, Medical imaging, Pharmaceutical industry, Daro District, Bayer

Bayer will highlight scientific research in oncology at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting , taking place from June 2-6, 2023.

Key Points: 
  • Bayer will highlight scientific research in oncology at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting , taking place from June 2-6, 2023.
  • These presentations continue to underscore the company’s commitment to drive treatment approaches through science and innovation in the oncology space.
  • Data featuring NUBEQA® (darolutamide) and Xofigo® (radium Ra 223 dichloride) will be showcased at ASCO.
  • NUBEQA data includes results from the DEAR trial, a retrospective, observational study evaluating real-world evidence (RWE) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

PROSTATE CANCER FOUNDATION-FUNDED RESEARCH IDENTIFIES PROMISING COMBINATION IMMUNOTHERAPY TREATMENT FOR ADVANCED PROSTATE CANCER

Retrieved on: 
Thursday, March 2, 2023
Immune system, Doctor of Philosophy, Safety, Death, Apoptosis, University, Prostate Cancer Foundation, MMSc, PD-1, Prostate cancer, Research, Cancer, TAM, PCF, Macrophage, Patient, PI3K, Tumor-associated macrophage, ADT, Mutation, Growth, Tumor microenvironment, Copanlisib, LOS, Clinical Cancer Research, PTEN, Dairy, Medical imaging, Pharmaceutical industry, MD

LOS ANGELES, March 2, 2023 /PRNewswire/ -- Immunotherapies have successfully treated many types of cancer with the exception of advanced prostate cancer that has become resistant to treatment, known as metastatic castration-resistant prostate cancer (mCRPC). New findings from a Prostate Cancer Foundation (PCF)-funded investigator reveal the mechanism by which prostate cancer cells reprogram the immune system to promote rather than suppress cancer, as well as a promising new combination therapy that could prevent them from developing this ability.

Key Points: 
  • LOS ANGELES, March 2, 2023 /PRNewswire/ -- Immunotherapies have successfully treated many types of cancer with the exception of advanced prostate cancer that has become resistant to treatment, known as metastatic castration-resistant prostate cancer (mCRPC).
  • New findings from a Prostate Cancer Foundation (PCF)-funded investigator reveal the mechanism by which prostate cancer cells reprogram the immune system to promote rather than suppress cancer, as well as a promising new combination therapy that could prevent them from developing this ability.
  • "These findings represent an exciting new opportunity to prevent prostate cancer cells from evading the immune system and a promising combination therapy for metastatic castration-resistant prostate cancer," said Howard R. Soule, PhD, Executive Vice President and Chief Science Officer of the Prostate Cancer Foundation.
  • These data suggest that the three-drug approach is needed to overcome treatment resistance in PTEN-mutated prostate cancer.

Spexis announces promising pre-clinical data with balixafortide in combination with various therapies on the market for treating B-cell lymphomas

Retrieved on: 
Sunday, December 18, 2022
Lymphatic system, Kidney, CXCR4, Clinical trial, Mantle cell lymphoma, Therapy, Lymphoma, BCR, Docetaxel, Copanlisib, PI3K, Università della Svizzera italiana, B-cell lymphoma, Rigidity, USI, MD, BTK, Fosun Pharma, Patient, Oncology, BLX, Research, Chronic lymphocytic leukemia, MTT, BCR-ABL, P13, Pharmaceutical industry, Fine chemical, Spexy Beast

The research was conducted under the leadership of Prof. Francesco Bertoni at the renowned Institute of Oncology Research in Bellinzona, Switzerland.

Key Points: 
  • The research was conducted under the leadership of Prof. Francesco Bertoni at the renowned Institute of Oncology Research in Bellinzona, Switzerland.
  • Juergen Froehlich, MD, Chief Medical Officer of Spexis, added: “These data support our ongoing evaluation to harness the clinical potential of balixafortide, building on existing clinical data and other research.
  • In addition, Spexis is analyzing existing BLX clinical and preclinical data to determine the appropriate development path forward, including potential new indications.
  • In line with this ongoing review, Spexis recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer.

Spexis announces promising pre-clinical data with balixafortide in combination with various therapies on the market for treating B-cell lymphomas

Retrieved on: 
Tuesday, December 13, 2022
Lymphatic system, Kidney, CXCR4, Clinical trial, Mantle cell lymphoma, Therapy, Lymphoma, BCR, Docetaxel, Copanlisib, PI3K, Università della Svizzera italiana, B-cell lymphoma, Rigidity, USI, MD, BTK, Fosun Pharma, Patient, Oncology, BLX, Research, Chronic lymphocytic leukemia, MTT, BCR-ABL, P13, Pharmaceutical industry, Fine chemical, Spexy Beast

Anti-proliferative activity was measured by the MTT assay in cell lines derived from mantle cell lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma.

Key Points: 
  • Anti-proliferative activity was measured by the MTT assay in cell lines derived from mantle cell lymphoma, chronic lymphocytic leukemia, and marginal zone lymphoma.
  • In addition, Spexis is analyzing existing BLX clinical and preclinical data to determine the appropriate development path forward, including potential new indications.
  • In line with this ongoing review, Spexis recently published data demonstrating synergistic efficacy in combination with docetaxel in metastatic prostate cancer.
  • Spexis is looking to partner either these pre-clinical leads or the entire platform itself, potentially in combination with complementary technologies.

Sermonix to Host Virtual Clinical Update on its ELAINE Phase 2 Clinical Programs

Retrieved on: 
Thursday, June 9, 2022
PTEN, Woman, Eli Lilly, MD Anderson Cancer Center, National Cancer Institute, EDT, Biology, Copanlisib, ER, Ligand Pharmaceuticals, ESR1, Lasofoxifene, Breast cancer, ASCO, Neoplasm, Duke University, PI, Therapy, Breast, MBC, Menopause, Center, HER2, GLOBE, Patient, Trastuzumab, FGFR, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Research, Fulvestrant, NASDAQ, Internet, PIK3CA, NCI, Duke Cancer Institute, CDK, Medicine, Drug development, Monroe Dunaway Anderson, Trial of the century, Genomics, CTEP, Lists of people executed in the United States, University, Duke, Mutation, Safety, Pharmaceutical industry, Medical imaging, SERM

Following Dr. Damodaran and Dr. Sammons presentations, the Sermonix leadership team will provide a company overview and update.

Key Points: 
  • Following Dr. Damodaran and Dr. Sammons presentations, the Sermonix leadership team will provide a company overview and update.
  • Her clinical focus is in breast medical oncology and she has expertise in treating patients with all subtypes of metastatic breast cancer.
  • She has designed and implemented several institutional, national and international clinical trials in advanced breast cancer.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

MEI Pharma and Kyowa Kirin Report New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2022

Retrieved on: 
Saturday, June 4, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Follicular lymphoma, Company, NHL, Copanlisib, Failure, Regulation, CRS, Neurology, Tumor lysis syndrome, COVID-19, Independent Review Committee, Engineering, Disclosure, Cancer, IRC, Pneumonia, COVID, Marketing, ORR, Food, B-cell lymphoma, Lymphoid leukemia, Industry, Diarrhea, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LPL, CR, Indolent lymphoma, MEI, ID, Intermittency, Kyowa Hakko Kirin, Infection, Stomatitis, SLL, Nephrology, Waldenström's macroglobulinemia, Private Securities Litigation Reform Act, ALT, Life, Adult, Research, Lymphocytosis, LinkedIn, Nature, Disease, DOR, FDA, Risk, Colitis, PEP, AST, PR, Twitter, Clinical trial, Rituximab, Lenalidomide, Orphan drug, Safety, Pharmaceutical industry, Fine chemical

As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR in the PEP.

Key Points: 
  • As of the data cutoff date, the data are not sufficiently mature to accurately estimate the final DOR in the PEP.
  • Zandelisib, a selective PI3K inhibitor, is an investigational cancer treatment being developed as an oral, once-daily, treatment for patients with B-cell malignancies.
  • In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib.
  • MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales.

MEI Pharma and Kyowa Kirin Provide Regulatory Update on Zandelisib Following Meeting with the FDA

Retrieved on: 
Thursday, March 24, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Private Securities Litigation Reform Act, Risk, MEI, Adult, Research, LPL, Lymphoid leukemia, IRC, Twitter, International, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Regulation, Disease, PI3K, Engineering, TSE, Nephrology, Marketing, Trial of the century, ORR, Follicular lymphoma, Industry, Kyowa Hakko Kirin, Copanlisib, Title 21 CFR Part 11, Life, NASDAQ, Investor, DOR, Neurology, Clinical trial, Mortality, Webcast, Failure, Lymphocytosis, Disclosure, ODAC, Independent Review Committee, CFR, FDA, Patient, Partnership, Company, LinkedIn, Organization, Intermittency, Rituximab, Waldenström's macroglobulinemia, IDT, Cancer, Food, Safety, Orphan drug, Lenalidomide, Doctor of Philosophy, COVID-19, Physician, Nature, SLL, Pharmaceutical industry, Fine chemical, 21 CFR PART 314.500, SUBPART H, ZANDELISIB, MEI PHARMA, KYOWA KIRIN

Our dialogue with the FDA has updated our understanding of the evolving regulatory view of the PI3K inhibitor drug class.

Key Points: 
  • Our dialogue with the FDA has updated our understanding of the evolving regulatory view of the PI3K inhibitor drug class.
  • Together with MEI Pharma, we will continue to work with the investigators, patients, and advocacy organizations to drive continued progress.
  • In April 2020, MEI and Kyowa Kirin entered a global license, development, and commercialization agreement to further develop and commercialize zandelisib.
  • MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S., with MEI booking all revenue from the U.S. sales.

Janux Therapeutics Appoints Byron Robinson, Ph.D., J.D., as Chief Strategy Officer

Retrieved on: 
Tuesday, March 1, 2022
Biotechnology, Medical Devices, Health, Pharmaceutical, Oncology, Risk, Cytokine release syndrome, Half-life, Therapy, Innovation, EGFR, Merck Group, TCE, Pharmacokinetics, University, PSMA, Security (finance), Immune system, Amgen, Toxicity, Trichloroethylene, Company, Safety, Limited partnership, U.S. Securities and Exchange Commission, Stern Global Programs, Senior, IND, News, Cancer, Nasdaq, Hematological Cancer Research Investment and Education Act, Trans Global Projects Group, Santa Barbara & Ventura Colleges of Law, Patient, Merck, CEO, Research, Copanlisib, Pharmaceutical industry, Bayer

Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Byron Robinson, Ph.D., J.D., as Chief Strategy Officer.

Key Points: 
  • Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the appointment of Byron Robinson, Ph.D., J.D., as Chief Strategy Officer.
  • Dr. Robinson brings 30 years of industry expertise and experience from key strategy roles at large pharma companies, including Merck KGaA, Bayer, and Amgen.
  • We are thrilled to welcome Byron to our executive leadership team, bringing his impressive track record of systematically evaluating market opportunities to drive successful clinical strategy, said David Campbell, Ph.D., President and CEO of Janux.
  • Prior to joining Janux, Dr. Robinson served as Senior Vice President of Clinical Development Strategy and Innovation at Merck KGaA.

CBMG Holdings' Novel CD19/CD20 Bi-specific CAR-T Cell Product Shows Early Promising Clinical Efficacy and Favorable Safety Profile in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Retrieved on: 
Thursday, June 10, 2021
Medical specialties, Anatomical pathology, Hematology, Lymphoma, Clinical medicine, Medicine, Orphan drugs, Antineoplastic drugs, Copanlisib

"C-CAR039 preliminary data has demonstrated an early favorable safety profile and encouraging efficacy in clinical trial in patients with r/r B-NHL," commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings.

Key Points: 
  • "C-CAR039 preliminary data has demonstrated an early favorable safety profile and encouraging efficacy in clinical trial in patients with r/r B-NHL," commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings.
  • We are also pleased that the FDA has recognized C-CAR039's potential as a treatment option for follicular lymphoma in granting it ODD.
  • This designation speaks to our therapy already showing promise in treating such serious illness and marks another significant regulatory milestone for our C-CAR039 product.
  • Dose escalation and expansion studies were conducted to evaluate the safety and efficacy of C-CAR039 in r/r B-NHL patients.