ASCT

Knight Therapeutics Reports First Quarter 2024 Results

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Giovedì, Maggio 9, 2024
Knight, DLBCL, News, ITP, Health maintenance organization, Hot, Vaginal discharge, Depreciation, Thrombocytopenia, Stomach, Inventory, Collection, Trial of the century, ASCT, Lymphoma, Patient, Acquisition, VVA, IAS, Menopause, Lenalidomide, Absorption, Blue balls, Bookkeeping

Inventories: As at March 31, 2024, inventories were at $95,400, an increase of $3,566 or 4%.

Key Points: 
  • Inventories: As at March 31, 2024, inventories were at $95,400, an increase of $3,566 or 4%.
  • Accounts payable and accrued liabilities: As at March 31, 2024, accounts payable and accrued liabilities were $94,711, an increase of $4,094 or 5%.
  • Cash, cash equivalents and marketable securities: As at March 31, 2024, Knight had $181,859 in cash, cash equivalents and marketable securities, an increase of $20,034 or 12% compared to December 31, 2023.
  • Knight will host a conference call and audio webcast to discuss its first quarter ended March 31, 2024, today at 8:30 am ET.

BioLineRx Announces Poster Presentation on Economic Model Data for APHEXDA® (motixafortide) as part of CD34+ Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma at ISPOR 2024

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Lunedì, Maggio 6, 2024
Cancer, International Society, Multiple myeloma, TEL, CD34, Value in Health, Filgrastim, Doctor of Philosophy, ASCT, BioLineRx, Patient, MPH, HSC, Pharmacoeconomics, Professional, G-CSF, Nursing

TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia.

Key Points: 
  • TEL AVIV, Israel, May 6, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new economic model data will be presented on APHEXDA® (motixafortide) for CD34+ hematopoietic stem cell (HSC) mobilization in patients with multiple myeloma at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – The Professional Society for Health Economics and Outcomes Research – 2024 conference, taking place May 5-8, 2024, in Atlanta, Georgia.
  • Autologous stem cell transplantation (ASCT) is part of the standard of care treatment paradigm for multiple myeloma and prolongs survival for patients with this cancer type.1 Historically, depending on induction regimens and mobilization strategies, approximately 50% to 75% of patients required more than one apheresis session to collect a target number of cells.2,3 Uncertainty in stem cell mobilization and the possible need for multiple apheresis sessions may result in psychological and logistical burden on patients, in addition to financial and operational inefficiencies for apheresis centers.
  • The data are expected to be published in Value in Health, Volume 27, Issue 6, S1 (June 2024.)
  • Presenter: Jeffrey R Skaar, PhD, Trinity Life Sciences, New York, NY and Jennifer L Lessor, MPH, BioLineRx USA, Inc., Waltham, MA
    The new economic model data to be presented at ISPOR 2024 builds on the evaluation of APHEXDA for CD34+ HSC mobilization in patients with multiple myeloma in apheresis center operations.

Caribou Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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Lunedì, Marzo 11, 2024
Fast Track, Regenerative Medicine Advanced Therapy, Cancer Immunology Research, Research, CRISPR, Rachel Haurwitz, Doctor of Philosophy, Orphan drug, AML, FDA, Food, Reindeer, AACR, Manuscript, Bone marrow, Amplification, Patent, Patient, ASCT, Asian literature, Acute myeloid leukemia, G&A, IND, Insurance, Pharmaceutical industry

BERKELEY, Calif., March 11, 2024 (GLOBE NEWSWIRE) --  Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the fourth quarter and full year 2023 and reviewed recent pipeline progress.

Key Points: 
  • “For our lead program, CB-010, we plan to present initial dose expansion data and the RP2D in the second quarter of 2024.
  • For our third program, CB-012, we are thrilled to have recently dosed the first patient in the AMpLify trial.
  • In December 2023, Caribou shared regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Type B clinical meeting.
  • CB-012: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances.

Knight Therapeutics Announces Launch of Minjuvi® in Brazil

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Giovedì, Febbraio 29, 2024
ANVISA, DCR, Knight Therapeutics, TSX, DLBCL, GUD, Therapy, Health, Non-Hodgkin lymphoma, Patient, ASCT, Lenalidomide, Knight, Resolution

MONTREAL, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Brazilian affiliate, United Medical Ltda.

Key Points: 
  • MONTREAL, Feb. 29, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Brazilian affiliate, United Medical Ltda.
  • Additionally, in October 2023, Knight received pricing approval for Minjuvi® from the Drugs Market Regulation Chamber (“CMED”).
  • “In line with Knight’s commitment to advancing healthcare in Latin America, we are excited to launch Minjuvi in Brazil, an innovative treatment option for addressing a current unmet medical need,” said Samira Sakhia, Knight Therapeutics President and CEO.
  • “Knight’s team in Brazil is thrilled to make Minjuvi® available to health care professionals and centers, improving DLBCL patient care in the country,” said Cristiane Coelho, Knight Therapeutics Brazil General Manager.

Summary of opinion: Keytruda, 22/02/2024 Positive

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Domenica, Marzo 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

InnoCare Announces First Prescription of Tafasitamab in Combination with Lenalidomide for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Under Greater Bay Area’s Early Access Program

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Lunedì, Gennaio 22, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, ASCT, Patient, Incidence, European Medicines Agency, Tafasitamab, HKEX, EMA, Immunotherapy, Food, DLBCL, FDA, Lenalidomide, BLA, Marketing, National Medical Products Administration, NHL, NMPA, Pharmaceutical industry

Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient.

Key Points: 
  • Through this program, the first prescription of tafasitamab in combination with lenalidomide was filled today at the Guangdong Clifford Hospital for an eligible DLBCL patient.
  • The early access program of the Greater Bay Area allows designated medical institutions in the area to access drugs and medical devices that have been approved by regulatory authorities for marketing in Hong Kong or Macao.
  • Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, “We are pleased to provide eligible patients access to tafasitamab in the Greater Bay Area.
  • DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globally.

Caribou Biosciences Appoints Tim Kelly as Chief Technology Officer and Highlights Multiple Clinical Catalysts Expected in 2024

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Domenica, Gennaio 7, 2024
Gene editing, FDA, Orphan drug, Troy University, Lymphoma, Multiple myeloma, Conference, Mechanics, Amplification, University, Rachel Haurwitz, Air force academy, ASCT, Regenerative Medicine Advanced Therapy, Food, CRISPR, UCB, AAV, Engineering, Patient, Medicine, Fast Track, Westmead Hospital, MD, Doctor of Philosophy, Reindeer, Infrared spectroscopy correlation table, United States Air Force, PST, Organization, AML, Pharmaceutical industry

-- Caribou to present at 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, at 11:15 am PST --

Key Points: 
  • In addition, Caribou highlighted successful execution across its allogeneic CAR-T cell therapy platform over the past year and provided an outlook on multiple clinical catalysts planned for 2024.
  • We are excited to kick off 2024 by welcoming Tim Kelly as Caribou’s chief technology officer,” said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer.
  • Appointed Tim Kelly as Caribou’s chief technology officer, leading the company’s process development and manufacturing organizations.
  • CB-012: Caribou plans to initiate patient enrollment in the AMpLify Phase 1 clinical trial in r/r AML in H1 2024.

Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024

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Martedì, Dicembre 12, 2023
ASCT, Regenerative Medicine Advanced Therapy, Food, FDA, CRISPR, Rachel Haurwitz, Reindeer, Doctor of Philosophy, Randomized controlled trial, Orphan drug, B-cell lymphoma, Patient, Fast Track, Pharmaceutical industry

BERKELEY, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today provided an update based on feedback from the U.S. Food and Drug Administration (FDA) following recent communications and a Type B clinical meeting regarding the CB-010 development program. The company has received the FDA’s feedback on a Phase 3 randomized controlled trial for CB-010, an allogeneic anti-CD19 CAR-T cell therapy in development for patients with second-line relapsed or refractory large B cell lymphoma (r/r LBCL). The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.

Key Points: 
  • The FDA stated that Caribou’s proposed comparator arm of platinum-based immunochemotherapy followed by high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) is acceptable.
  • “As our ongoing ANTLER trial progresses, we look forward to engaging again with the FDA ahead of initiating our planned Phase 3 pivotal trial.
  • In Q2 2024, the company plans to report initial dose expansion data from the ANTLER trial and share the recommended Phase 2 dose (RP2D) for CB-010.
  • Caribou plans to initiate a Phase 3 pivotal trial with this RP2D by year-end 2024.

Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone

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Lunedì, Dicembre 11, 2023
Isatuximab, ASCT, ITT, Associate, Bone marrow, EMN, MRD, Young, Multiple myeloma, Society, University of Turin, Lenalidomide, Odds ratio, ASH, University, Dexamethasone, NCAA University Division, AOU, Cell, Patient, Carfilzomib

The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).

Key Points: 
  • The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).
  • The respective rates of MRD negativity at sensitivity of 10-6 were 67% versus 48% (OR 1.93; p=0.006).
  • There was a statistically significant difference in MRD negativity rates after induction with Sarclisa in combination with KRd versus KRd (10-5: 45% versus 26%, p
  • Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes.

Adaptive Biotechnologies and Collaborators to Present More than 30 Abstracts Demonstrating the Actionability of clonoSEQ® MRD Testing in Blood Cancer Patient Care and Drug Development at the 65th ASH Annual Meeting

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Martedì, Dicembre 5, 2023
Sequence, ASCT, Skylark (rocket), NGS, MRD, Relapse, Durability, Haematopoietic system, Rituximab, Bortezomib, Minimal residual disease, CLL, ATLAS, Allotransplantation, B-ALL

Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Key Points: 
  • Updated Results of the Phase I BALLI-01 Trial of UCART22 Process 2 (P2), an Anti-CD22 Allogeneic CAR-T Cell Product Manufactured By Cellectis Biologics, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
    Undetectable MRD Status in Patients with R/R CLL/SLL with Stable Disease after Lisocabtagene Maraleucel Treatment: Exploratory Analysis of the TRANSCEND CLL 004 Study
    Fixed-Duration Pirtobrutinib Combined with Venetoclax ± Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia: Updated Results, Including MRD Data, from the BRUIN Phase 1b Study
    Impact of Sequence Uniqueness on MRD Monitoring in NGS Immunoglobulin Sequencing: An Analysis of Ig Loci Among >1200 Diffuse Large B-Cell Lymphoma Patients Tested By ClonoSEQ
    Epcoritamab SC Monotherapy Leads to Deep and Durable Responses in Patients with Relapsed or Refractory Follicular Lymphoma: First Data Disclosure from the Epcore NHL-1 Follicular Lymphoma Dose-Expansion Cohort
    Early Peripheral Blood Minimal Residual Disease Status By NGS in Patients with Newly Diagnosed Multiple Myeloma (MM) on a Phase 2 Trial Receiving Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd)
    Primary Endpoint Analysis from a Response Adaptive Phase II Clinical Trial of Carfilzomib, Lenalidomide, Dexamethasone Plus Daratumumab (KRd-Dara) in Patients with Newly Diagnosed Multiple Myeloma (NDMM)
    Sequential T-Cell Engagement for Myeloma (“STEM”) Trial: A Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy
    A Phase II Study of Isatuximab, Once Weekly Carfilzomib, Lenalidomide, Dexamethasone, in Newly Diagnosed, Transplant-Eligible Multiple Myeloma (The SKylaRk Trial)
    Longitudinal Assessment of Minimal Residual Disease (MRD) in the ATLAS Randomized Phase 3 Trial of Post-Transplant Treatment with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Versus Lenalidomide (R) Alone in Patients with Newly Diagnosed Multiple Myeloma (NDMM)
    Final Analysis of a Phase 2 Trial of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma (NDMM) without Autologous Stem Cell Transplantation (ASCT)
    Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
    Update for the "Watch" Registry, a Real-World Observational Study Using clonoSEQ® to Monitor MRD in Lymphoid Malignancies