BCMA

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3

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Martedì, Dicembre 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Multiple myeloma, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Research, Food, Bone marrow, European Medicines Agency, Progression-free survival, ASH, CRS, Cohort, Risk, Disease, Cytopenia, Patient, PFS, BMY, Doctor of Philosophy, Division, FDA, Cell therapy, ORR, ASCT, Death, Survival, Grade, Neurotoxicity, Society, BCMA, HIV disease progression rates, Cytokine release syndrome, Boxed warning, Pharmaceutical industry, Hematology, Swissmedic, Idecabtagene vicleucel, OS

With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.

Key Points: 
  • With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.
  • Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.
  • Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months.
  • Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma are also under review with the European Medicines Agency and Swissmedic.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

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Venerdì, Dicembre 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Multiple myeloma, Lymphocytopenia, Fever, Bispecific monoclonal antibody, NYSE, Cytokine release syndrome, PFE, European Medicines Agency, Rash, European Commission, Pneumonia, Upper respiratory tract infection, CRS, Risk, Febrile neutropenia, Fatigue, EMA, Civil service commission, Patient, Sepsis, Thrombocytopenia, Probability, Periodic breathing, Appetite, CHMP, B-cell maturation antigen, Injection site reaction, Committee, Neutropenia, Diarrhea, Nausea, Arthralgia, RRMM, Anemia, BCMA, Immunotherapy, Hypokalemia, Urinary tract infection, Inc., HIV disease progression rates, Vaccine, Pharmaceutical industry, Pfizer, Nature Medicine

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.

Kite and Arcellx Announce Expansion in Strategic Partnership

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Mercoledì, Novembre 15, 2023
Research, Hospitals, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Multiple myeloma, Economics, Sparx, ASH, Patient, EPS, IPR, Cancer, Partnership, Lymphoma, BCMA, Hart–Scott–Rodino Antitrust Improvements Act, Pharmaceutical industry, Kite

“Given this, we are deepening our relationship with Arcellx to further support advancement of CART-ddBCMA, bolster our pipeline in multiple myeloma, as well as access opportunities in lymphoma.

Key Points: 
  • “Given this, we are deepening our relationship with Arcellx to further support advancement of CART-ddBCMA, bolster our pipeline in multiple myeloma, as well as access opportunities in lymphoma.
  • In expanding our strategic partnership with Arcellx, we are building upon the established synergy between Arcellx’s platform technologies and Kite’s industry-leading position in CAR T manufacturing and commercialization."
  • “Since entering into this strategic collaboration with Kite almost one year ago, we are thrilled with how the partnership is rapidly progressing and the alignment across our teams,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer.
  • Importantly, these efficiencies embody the trust developed with our Kite partners and do not alter the original agreement in principle or economics.

Alpine Immune Sciences Presents New Translational Data on Povetacicept in Systemic Lupus Erythematosus at American College of Rheumatology Convergence 2023

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Mercoledì, Novembre 15, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, APRIL, Rheumatology, WT, Patient, TACI, Inflammation, Lupus, American College, Glomerulonephritis, BAFF, SLE, ALPN, Immunoglobulin A, Trial of the century, BCMA, Autoimmunity, IgA nephropathy, Pharmaceutical industry, Vaccine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for povetacicept (ALPN-303) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced today that the Company presented new translational data for povetacicept (ALPN-303) in systemic lupus erythematosus (SLE) at the American College of Rheumatology Convergence 2023, November 10-15, 2023.
  • In SLE patients, BAFF- and APRIL-related genes (i.e., BAFF, APRIL, TACI, and BCMA) are increased in myeloid lineage cells and B cells compared to healthy adults.
  • Povetacicept, as compared to single BAFF or APRIL pathway inhibitors, more potently downregulates genes associated with activation in B cells.
  • Povetacicept significantly reduces multiple disease parameters in a mouse model of lupus, more effectively than WT TACI-Fc or conventional B cell depletion.

Alpine Immune Sciences Reports Third Quarter 2023 Financial Results

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Martedì, Novembre 14, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Immunoglobulin G, ASN, PMN, UPCR, Investment, Clinical trial, American Society of Nephrology, APRIL, Glomerular filtration rate, Administration, Patient, TACI, Inflammation, Immunoglobulin A, Neonatal Fc receptor, Lupus, Infection, Research program, BAFF, SLE, ALPN, Immunoglobulin M, MD, Development, EGFR, BCMA, Society, NIH Intramural Research Program, Autoimmunity, Proteinuria, AANEM, Pharmaceutical industry, Sewage treatment, Vaccine, Paint, IgA nephropathy, AbbVie, Alpine

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the third quarter ended September 30, 2023.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today reported financial results and company highlights for the third quarter ended September 30, 2023.
  • “Following our data presentation, we executed a follow-on equity offering of $150 million to bolster our balance sheet.
  • Cash Position and Runway: As of September 30, 2023, Alpine’s cash and investments totaled $227.2 million compared to $273.4 million as of December 31, 2022.
  • The respective increases of $0.8 million and $2.3 million were primarily attributable to increases in personnel and legal costs.

IASO Bio and Innovent Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023

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Lunedì, Dicembre 11, 2023
Huachung University, Multiple myeloma, Triple, Ophthalmology, HKEX, Safety, SAN, Hope, Treatment, Progression-free survival, ASH, Risk, Tongji Hospital station, Tongji Medical College, Patient, PFS, MRD, Marketing, Trial of the century, Medicine, VCN, Prognosis, Peking Union Medical College, ORR, Cancer, Survival, RRMM, BCMA, Quality of life, Society, Autoimmunity, Pharmaceutical industry, Medical device, Vaccine, Hematology

The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment.

Key Points: 
  • The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment.
  • As of December 31, 2022, with a median follow-up of 18.07 months, deep and sustained responses were observed in 103 evaluable patients.
  • Among these patients, the overall response rate (ORR) was 96.1%, and the stringent complete response/complete response (sCR/CR) rate was 77.7%.
  • Minimal residual disease (MRD) negativity rate is 94.2% in the total evaluable patients, and all patients who achieved CR or above were MRD negative.

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

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Domenica, Dicembre 10, 2023
Webcast, Multiple myeloma, Associate, Immunomodulatory imide drug, Safety, SAN, DNA, TSCM, Prodrug, Therapy, Gene, International, CRS, Tissue, Artificial intelligence, SCR, Cytogenetics, Patient, Conference call, Blood, Haemophilia, Conference, Graft-versus-host disease, ORR, TCE, Cancer, Transposase, Partnership, Roche, Malignancy, Antibody, Neurotoxicity, Kinetics, Haemophilia A, RRMM, Cyclophosphamide, BCMA, Physician, Investigator's brochure, Bone marrow, ITT, Vanderbilt-Ingram Cancer Center, Cytokine release syndrome, Vaccine, Pharmaceutical industry, Broadcasting, Hematology

The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).

Key Points: 
  • The Company is investigating P-BCMA-ALLO1 in partnership with Roche for the treatment of relapsed/refractory multiple myeloma (RRMM).
  • We are excited to have taken this first step with our early P-BCMA-ALLO1 clinical results.
  • They inspire us to further develop P-BCMA-ALLO1 in partnership with Roche, and to continue advancing our entire allogeneic TSCM cell-based CAR-T portfolio."
  • Title: Early Safety Results of P-BCMA-ALLO1, a Fully Allogeneic Chimeric Antigen Receptor T-Cell (CAR-T), in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
    Session Title: 704.

ORIEN to Present Abstracts at 65th Annual ASH Meeting Utilizing Aster Insights' Avatar Platform

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Venerdì, Dicembre 8, 2023
Multiple myeloma, Clinical, Research, Annual general meeting, Longitudinal, American Society of Hematology, ASH, EMMA, Data, Expression, FDA, Master of Science, FRCPC, MRCP, Hematology, Abstract, Drug discovery, Gene, Doctor of Philosophy, BCMA, Society, Health, Pharmaceutical industry, Vaccine, MD, Patient

 TAMPA, Fla., Dec. 8, 2023 /PRNewswire/ -- Aster Insights, the leading provider of scientific and clinical intelligence for oncology discovery, today announced upcoming research presentations at the American Society of Hematology's (ASH) 65th Annual Meeting, December 9-12 in San Diego, CA.

Key Points: 
  • TAMPA, Fla., Dec. 8, 2023 /PRNewswire/ -- Aster Insights , the leading provider of scientific and clinical intelligence for oncology discovery, today announced upcoming research presentations at the American Society of Hematology's (ASH) 65th Annual Meeting , December 9-12 in San Diego, CA.
  • Three abstracts will be shared at this year's ASH meeting by Moffitt Cancer Center, which co-founded the Oncology Research Information Exchange Network® (ORIEN) in 2006.
  • The investigations all utilize patient data from Aster Avatar, the best-in-class, deepest multimodal dataset for discovery research in oncology.
  • "ASH is a unique opportunity to demonstrate the impactful discoveries resulting from ORIEN and Aster Insights' discovery solutions," said Anand Shah, MD, Aster Insights CEO.

ISMP Announces 26th Annual Cheers Award Recipients

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Lunedì, Novembre 20, 2023
Western Kentucky University, Safety, Research, Organization, Life, RaDonda Vaught homicide case, Trauma, Sibling, FAAN, ADC, Hospital, Patient safety organization, MUHC, Patient, RN, Sinclair School of Nursing, Agency, House, BSN, Joint Commission, Vaccine, PPID, Boston Medical Center, American Hospital Association, University, Infection, Software, Information technology, BCMA, Approximation error, CPPS, Pharmaceutical industry, Nursing

PLYMOUTH MEETING, Pa., Nov. 20, 2023 /PRNewswire/ -- The Institute for Safe Medication Practices (ISMP) is proud to announce the 26th Annual Cheers Awards winners, who have shown outstanding dedication to reducing adverse events and infection exposure, and a Lifetime Award Winner who has focused her career on helping support practitioners involved in accidental errors that harm patients. This year's speaker will be RaDonda Vaught, a former nurse prosecuted for her role in a fatal medication error in one of the highest profile healthcare-related criminal cases in recent years.

Key Points: 
  • ISMP Cheers Awards winners are leaders in safety technology implementation and support for second victims of errors.
  • The ISMP Cheers Awards honor individuals, organizations, and companies that have set a standard of excellence in medication safety; for more information, visit: https://www.ismp.org/cheers-awards .
  • The winners of this year's ISMP Cheers Awards are:
    Boston Medical Center's Medication Safety and Quality Committee is receiving a Cheers Award for its implementation of barcode medication administration (BCMA) and positive patient identification (PPID) in ambulatory care settings.
  • One of the 2023-2024 ISMP Targeted Medication Safety Best Practices for Hospitals calls for expanding BCMA beyond inpatient areas.

Jiahui Health develops international CAR-T treatment platform in China

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Giovedì, Novembre 16, 2023
MGH, China International Import Expo, Patient, Biotechnology, Multiple myeloma, National Exhibition Centre, Convention center, Software, Diagnosis, Massachusetts General Hospital, Oncology, Parintintín, BCMA, JICC, Lymphoma, Pharmaceutical industry, Medical imaging, Expo

Jiahui Health and IASO Biotechnology announced a deepening of their strategic collaboration to jointly build a BCMA-targeted CAR-T Equecabtagene Autoleucel Injection treatment center and further promote the long-term sustainable development of the CAR-T international treatment platform.

Key Points: 
  • Jiahui Health and IASO Biotechnology announced a deepening of their strategic collaboration to jointly build a BCMA-targeted CAR-T Equecabtagene Autoleucel Injection treatment center and further promote the long-term sustainable development of the CAR-T international treatment platform.
  • Jiahui International Cancer Center has established an international CAR-T treatment team and has successfully carried out treatments in collaboration with various companies, including IASO Biotechnology and Fosun Kite.
  • Jiahui's CAR-T multidisciplinary treatment team, led by Dr. Vicky LEE, Director of the Jiahui International Cancer Center and Chief of Medical Oncology at Jiahui International Cancer Center, has conducted a series of studies in the clinical practice of novel technologies and has successfully developed various international treatments.
  • Jiahui International Cancer Center (JICC), affiliated with Shanghai Jiahui International Hospital in Shanghai, China, has a close strategic collaboration with Massachusetts General Hospital (MGH) and its cancer center.