Proteasome inhibitor

European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma

Retrieved on: 
Thursday, August 18, 2022
Hematologic disease, Apoptosis, Antibody, Multiple myeloma, INN, EU27, HIV disease progression rates, Survival, Nasdaq Stockholm, Dexamethasone, RRMM, Death, Cancer, Toxicity, Aminopeptidase, Incidence, PDC, B cell, Corporate communication, European Economic Area, Research, Patient, Bone marrow, Company, Proteasome inhibitor, OCEAN, CET, CHMP, ECIS, Infection, Melphalan, Lymphatic system, News, Nasdaq, Capital, European Commission, Transplant, Adult, Disease, Pharmaceutical industry, EU, EEA

Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).

Key Points: 
  • Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).
  • "The approval of Pepaxti in Europe is foundational for Oncopeptides, and brings excellent news for patients and shareholders," says Jakob Lindberg, CEO Oncopeptides AB.
  • "Despite the introduction of novel therapies, patients with triple class refractory disease have a high unmet medical need, since their treatment options ultimately become exhausted."
  • This multi-center single arm study evaluated 157 patients with relapsed or refractory multiple myeloma, of whom 97 were triple-class refractory and had received at least four prior lines of treatment.

European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma

Retrieved on: 
Thursday, August 18, 2022
Hematologic disease, Apoptosis, Antibody, Multiple myeloma, INN, EU27, HIV disease progression rates, Survival, Nasdaq Stockholm, Dexamethasone, RRMM, Death, Cancer, Toxicity, Aminopeptidase, Incidence, PDC, B cell, Corporate communication, European Economic Area, Research, Patient, Bone marrow, Company, Proteasome inhibitor, OCEAN, CET, CHMP, ECIS, Infection, Melphalan, Lymphatic system, News, Nasdaq, Capital, European Commission, Transplant, Adult, Disease, Pharmaceutical industry, EU, EEA

Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).

Key Points: 
  • Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).
  • "The approval of Pepaxti in Europe is foundational for Oncopeptides, and brings excellent news for patients and shareholders," says Jakob Lindberg, CEO Oncopeptides AB.
  • "Despite the introduction of novel therapies, patients with triple class refractory disease have a high unmet medical need, since their treatment options ultimately become exhausted."
  • This multi-center single arm study evaluated 157 patients with relapsed or refractory multiple myeloma, of whom 97 were triple-class refractory and had received at least four prior lines of treatment.

DGAP-News: Heidelberg Pharma Announces First Patient Dosed with Antibody Targeted Amanitin Conjugate HDP-101 in Multiple Myeloma

Retrieved on: 
Tuesday, February 15, 2022
Index (publishing), Lymphatic system, Non-Hodgkin lymphoma, Patient, ADC, Quality of life, Cancer, Company, Investigator, HIV disease progression rates, HPHA, Winship Cancer Institute, ISIN, MD Anderson Cancer Center, Multiple myeloma, Proteasome inhibitor, Phase, Hope, BCMA, Frankfurt Stock Exchange, Safety, Hematology, Neoplasm, Oncology, PSMA, CD37, FSE, Amanitin, MTD, Diagnosis, Bone pain, Heidelberg University, Survival rate, MM, Pharmaceutical industry, Emory University, Multiple Myeloma, Heidelberg Pharma, MULTIPLE MYELOMA, HEIDELBERG PHARMA

Dr. Andrs Strassz, Chief Medical Officer of Heidelberg Pharma, commented: "It is an important step for Heidelberg Pharma to have the first patient dosed in our study.

Key Points: 
  • Dr. Andrs Strassz, Chief Medical Officer of Heidelberg Pharma, commented: "It is an important step for Heidelberg Pharma to have the first patient dosed in our study.
  • This Phase I/IIa study will test a new mode of action in oncology and is the first trial to evaluate an antibody drug conjugate carrying Amanitin as active component in patients.
  • For many patients with multiple myeloma, currently available therapies lead to relapses despite initial success, necessitating further treatment options.
  • Heidelberg Pharma AG is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0/ WKN A11QVV / Symbol HPHA.

U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by Innovent and IASO Bio

Retrieved on: 
Monday, February 14, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAN, Multiple myeloma, Integrity, Eli Lilly and Company, NMPA, Motherboard, BCR, Alkylation, Senior, Social conditions in Honduras, Fragment crystallizable region, CD3, Chemistry, CD8A, Company, Kidney failure, National Medical Products Administration, Proteasome inhibitor, MD Anderson Cancer Center, Frost & Sullivan, Anemia, Degenerative disease, Nature, Hope, Autoimmunity, Bevacizumab, LinkedIn, Stock exchange, Marketing, Breakthrough therapy, News, Orphan, Drug development, Patient, Cancer, Food, CMC, Bone, Control, BCMA, HKEX, Environment, CAR, FDA, ODD, Bone marrow, Metabolism, Trial of the century, Pharmaceutical industry, Healthcare, Fine chemical, Food and Drug Administration Safety and Innovation Act, Incyte

In February 2021, IBI326 was granted Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA) for the treatment of R/R MM.

Key Points: 
  • In February 2021, IBI326 was granted Breakthrough Therapy Designation by China's National Medical Products Administration (NMPA) for the treatment of R/R MM.
  • In February 2022, IBI326 was granted "Orphan Drug Designation" by the FDA for the treatment of relapsed/refractory multiple myeloma.
  • IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases.
  • It was also granted Orphan Drug Designation by the U.S. Food and Drug Administration in October 2021.

Avacta Selects Second pre|CISION™ Pro-drug Candidate for Development

Retrieved on: 
Tuesday, January 18, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, Proteasome inhibitor, Group, Multiple myeloma, Toxic leukoencephalopathy, Safety, IND, Cancer, Review, AIM, FAP, CTA, Investigational New Drug, Pharmaceutical industry

This enzyme is in high abundance in most solid tumours but, crucially, not in healthy tissues.

Key Points: 
  • This enzyme is in high abundance in most solid tumours but, crucially, not in healthy tissues.
  • The pre|CISION platform therefore offers a way to reduce systemic exposure to, and improve the safety of, these effective and affordable cancer drugs.
  • In this way the pre|CISION platform is intended to increase the tolerability of chemotherapies and achieve better clinical outcomes for patients.
  • Dr Alastair Smith, Chief Executive of Avacta Group, commented: We are excited by the early pre-clinical data for AVA3996, the second of Avactas pre|CISION pro-drugs following on from AVA6000.

US Oncology Research, The US Oncology Network and Ontada Announce Data Presentations Across Areas of Critical Need at 2021 American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Thursday, December 9, 2021
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Health, Technology, McKesson Corporation, Exposition, Rituximab, Safety, Polatuzumab vedotin, Network, Lenalidomide, FACOG, Physician, FACS, Umbralisib, Prednisone, Lymphoma, Research, CD79B, Multiple myeloma, Interview, Community, Observational study, B-cell lymphoma, Malignancy, Non-Hodgkin lymphoma, Bone marrow, Cancer, FDA, Society, ASH, Relapse, Proteasome inhibitor, The Network, Lymphatic system, ET, Science, Education, DLBCL, Hematology, Prognosis, MM, Medical imaging, Fine chemical, Pharmaceutical industry, Medicine, US Oncology Research, The US Oncology Network, Ontada, US ONCOLOGY RESEARCH, THE US ONCOLOGY NETWORK, ONTADA

The ASH Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will take place in Atlanta, Georgia and virtually from Dec. 11-14, 2021.

Key Points: 
  • The ASH Annual Meeting, a leading scientific event in malignant and non-malignant hematology, will take place in Atlanta, Georgia and virtually from Dec. 11-14, 2021.
  • However, there is still need for advances, said Robert L. Coleman, MD, FACOG, FACS, chief scientific officer, US Oncology Research.
  • Ontada is an oncology real-world data and evidence, clinical education and provider technology business dedicated to improving the lives of cancer patients.
  • US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials.

Active Biotech: Tasquinimod clinical  development in multiple myeloma advances into combination therapy following completion of the initial phase of the ongoing trial in the US

Retrieved on: 
Sunday, October 3, 2021
Biotechnology, IRD, Therapy, Dexamethasone, Partnership, USD, Sweden, Multiple myeloma, Laquinimod, Bone marrow, Infection, Platelet, University, NASDAQ, Perelman Center for Advanced Medicine, Patient, Population, Lymphatic system, Anemia, CEO, Proteasome inhibitor, Disease, B cell, ACTI, Drug resistance, EU, CFO, Survival, Safety, International Myeloma Foundation, Naptumomab estafenatox, Lenalidomide, CET, Pharmaceutical industry, Medical imaging

Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients.

Key Points: 
  • Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients.
  • Our preclinical laboratory models suggest that this combination strategy may be a particularly effective way to utilize tasquinimod in myeloma therapy."
  • Tasquinimod has demonstrated a clear therapeutic potentialin preclinical models of multiple myeloma, when used as a single agent and in combination with standard multiple myeloma therapy.
  • Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma.

BeiGene Announces the Approval in China of KYPROLIS® (Carfilzomib) for Injection for Adult Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Friday, July 9, 2021
Pharmaceutical, Health, Other Health, Drugs, Orphan drugs, Clinical medicine, Chemical compounds, Carfilzomib, Epoxides, Morpholines, Peptides, Multiple myeloma, Proteasome inhibitor, Breakthrough therapy, Daratumumab, Multiple Myeloma, KYPROLIS® (carfilzomib) for injection, BeiGene, MULTIPLE MYELOMA, KYPROLIS® (CARFILZOMIB) FOR INJECTION, BEIGENE

The approval of KYPROLIS provides us with an important opportunity to offer adult patients in China with relapsed or refractory multiple myeloma a proteasome inhibitor with high selectivity and irreversibility as a treatment option for their disease.

Key Points: 
  • The approval of KYPROLIS provides us with an important opportunity to offer adult patients in China with relapsed or refractory multiple myeloma a proteasome inhibitor with high selectivity and irreversibility as a treatment option for their disease.
  • KYPROLIS is approved in the U.S. for the following:
    as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
  • KYPROLIS is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
  • Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy.

Trillium Therapeutics Announces Dosing of First Patient in Phase 1b Study of TTI-622 in Combination With Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Wednesday, April 28, 2021
Clusters of differentiation, Orphan drugs, CD47, Cancer research, Medicine, Multiple myeloma, Health sciences, Proteasome inhibitor, Health care, CD38

CD47 binds to SIRP\xce\xb1 on macrophages and delivers a \xe2\x80\x9cdon\xe2\x80\x99t eat me\xe2\x80\x9d signal that inhibits the ability of macrophages to engulf and destroy cancer cells.

Key Points: 
  • CD47 binds to SIRP\xce\xb1 on macrophages and delivers a \xe2\x80\x9cdon\xe2\x80\x99t eat me\xe2\x80\x9d signal that inhibits the ability of macrophages to engulf and destroy cancer cells.
  • \xe2\x80\x9cThis is the first patient to receive TTI-622 in combination with another anti-cancer agent, and we are eager to build upon the monotherapy activity that we have observed in multiple hematologic cancers.
  • Approximately 30 relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of therapy which must include a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody will be enrolled.
  • \xe2\x80\x9cCD47 is overexpressed in multiple myeloma and the overexpression is further increased in relapsed multiple myeloma.

Oncopeptides initiates U.S. Expanded Access Program with melflufen in triple-class refractory multiple myeloma

Retrieved on: 
Thursday, October 1, 2020
Drugs, Orphan drugs, Health, RTT, Breakthrough therapy, Antineoplastic drugs, Multiple myeloma, Pyrazines, Proteasome inhibitor, Melflufen, Daratumumab, Selinexor

Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma.

Key Points: 
  • Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma.
  • The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).
  • The Expanded Access Program was initiated following the Company's June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration, FDA, for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma.
  • "Despite therapeutic advances, multiple myeloma remains incurable," said Paula O'Connor, U.S. Head of Medical Affairs at Oncopeptides.