DLBCL

Prelude Highlights Continued Strength of Discovery Engine at 2024 AACR Annual Meeting

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화요일, 4월 9, 2024
Breast cancer, SMARCA4, MCL, Generation, Prelude, CDK2, CLL, NSCLC, Patient, SMARCA2, Selective estrogen receptor degrader, BCL2, Cancer, AACR, CRC, BTK, CDK9, DLBCL, Pharmaceutical industry

WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.

Key Points: 
  • Highly selective oral SMARCA2 degrader, PRT7732, shows robust anti-tumor activity in vivo as monotherapy and in combination with chemotherapy, at well-tolerated doses
    Next Generation CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of breast cancer, CRC and NSCLC
    WILMINGTON, Del., April 09, 2024 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting for its highly selective oral SMARCA2 degrader, its potentially best-in-class CDK9 inhibitor and its next-generation oral CDK4/6 inhibitor.
  • “These presentations demonstrate our core competencies in medicinal chemistry and cancer biology to optimize and deliver compounds to the clinic with the potential to succeed as differentiated first- and/or best-in-class new therapies,” said Andrew Combs, Ph.D., Chief Chemistry Officer at Prelude Therapeutics.
  • Peggy Scherle, Ph.D., Chief Scientific Officer at Prelude, stated, “Advancement of our second highly selective SMARCA2 degrader strengthens Prelude’s leadership position in the emerging use of SMARCA2 protein degradation as a potential treatment option for underserved patients with cancer.
  • With both a first-in-class IV SMARCA2 degrader, PRT3789, in Phase 1 clinical development and now our oral SMARCA2 degrader, PRT7732, expected to enter the clinic later this year, we believe these distinct modalities may offer new therapies for patients with SMARCA4 mutations.”
    Details on the poster presentations are as follows:
    Identified potent, selective, well-tolerated and orally bioavailable SMARCA2 degrader, PRT7732
    PRT7732 exhibits >3000-fold selectivity for SMARCA2 over SMARCA4, with low nanomolar potency in cell based assays
    Title: PRT2527, a Novel Highly Selective Cyclin-Dependent Kinase 9 (CDK9) Inhibitor, Has Potent Antitumor Activity in Combination with BTK and BCL2 Inhibition in Various Lymphoid Malignancies
    PRT2527 is efficacious as monotherapy in preclinical models of DLBCL, CLL and MCL, and combines with both BTK and BCL2 inhibition to improve depth and duration of responses
    Title: The Brain Penetrant CDK4/6 Inhibitor, PRT3645, is Highly Effective in Combination with Other Targeted Therapies in Preclinical Models of Breast Cancer, CRC and NSCLC
    Next generation CDK4/6 inhibitor, PRT3645, demonstrates preclinical synergy with SERDs, as well as MEK1/2 and CDK2 inhibition

Principal Investigator from City of Hope National Medical Center Invited to Present Clinical Data from Marker Therapeutics APOLLO Study at 11th Global Summit on Hematologic Malignancies 

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월요일, 4월 8, 2024
Principal, Malignancy, Risk, Patient, Food and Drug Administration, City, CRS, NHL, Mutagenesis, Therapy, Hematology, Bone marrow, B-cell lymphoma, APOLLO, Neurotoxicity, DLBCL, Cytokine release syndrome, Lymphoma, Press release

HOUSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported that Geoffrey Shouse, D.O., Ph.D., the Principal Investigator at City of Hope National Medical Center in Duarte, CA, was invited to present his clinical experience from the APOLLO study at the 11th Global Summit on Hematologic Malignancies in Whistler, BC, Canada (April 2-7, 2024). Dr. Shouse provided an overview on the clinical observations obtained at City of Hope on Saturday, April 6, 2024.

Key Points: 
  • Dr. Shouse provided an overview on the clinical observations obtained at City of Hope on Saturday, April 6, 2024.
  • During the presentation, Dr. Shouse showed that this study participant remains in CR nine months following initial treatment with MT-601.
  • This APOLLO participant had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.
  • Dr. Shouse’s presentation included data from two additional study participants that have been treated at City of Hope.

Biomea Fusion Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights

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월요일, 4월 1, 2024
Diagnosis, Research, Week, CD135, Administration, FMS, Growth, Menin, CLL, NSCLC, C-peptide, AML, BID, Diabetes, Insulin, Patient, Hypoglycemia, FLT3, G&A, Acute myeloid leukemia, Food, PDAC, Health Canada, Trial of the century, IND, Cancer, CRC, Safety, Research and development, Investment, FDA, DLBCL, DSM-IV codes, Pharmaceutical industry

In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.

Key Points: 
  • In 2023, initiated a Phase 2 study of BMF-219 in type 1 diabetes patients (COVALENT-112); initial readout anticipated in 2024.
  • Cash position of $177.2 million at the end of the fourth quarter of 2023.
  • REDWOOD CITY, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to treat and improve the lives of patients with metabolic diseases and genetically defined cancers, reported fourth quarter and full year 2023 financial results and corporate highlights.
  • “2023 was a pivotal year for Biomea as we reported first positive data in type 2 diabetes and initiated our first clinical study in type 1 diabetes.

Vincerx Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Update

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금요일, 3월 29, 2024
Patient, PTCL, G&A, IND, Prednisone, Neoplasm, Therapy, SMDC, Medicinal chemistry, Lymphoma, Research, Frontiers Media, RNA polymerase II, Body modification, Primate, RNA, NIH, CPT, Potential, Safety, CDK9, ADC, MCL1, Solubility, Oncogene, RNA polymerase, Venetoclax, Journal, Manuscript, Cancer, Peripheral T-cell lymphoma, AACR, Antibody, MYC, Downregulation and upregulation, DLBCL, Annual general meeting, HER2, European Hematology Association, EHA, Spacecraft, PDX, Bangladesh Technical Education Board, Journal of Medicinal Chemistry, Blood, Pharmaceutical industry

PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) --  Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models.
  • Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs.
  • For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively.
  • For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

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목요일, 3월 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

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월요일, 3월 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

Regeneron Provides Update on Biologics License Application for Odronextamab

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월요일, 3월 25, 2024
Regeneron Pharmaceuticals, Biologics license application, Patient, Orphan, EMA, European Medicines Agency, European, Safety, FDA, BLA, DLBCL, Lymphoma, Food, Pharmaceutical industry

Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma.

Key Points: 
  • Regeneron has been actively enrolling patients in multiple Phase 3 trials for odronextamab as part of the OLYMPIA program – one of the largest clinical programs in lymphoma.
  • Regeneron is committed to working closely with the FDA and investigators to bring odronextamab to patients with R/R FL and R/R DLBCL as quickly as possible.
  • Regulatory review of odronextamab remains ongoing by the European Medicines Agency (EMA) for the treatment of R/R DLBCL and R/R FL.
  • The potential use of odronextamab in R/R DLBCL and R/R FL is currently under clinical development and has not been approved by any regulatory authority.

BrightSpring Health Services’ Specialty Pharmacy Onco360® Celebrates Excellent Patient Care and Preferred Pharmacy Status

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목요일, 3월 14, 2024
Diagnosis, Health care, Disease, Selinexor, Partnership, Patient, Pharmacy, Multiple myeloma, Pharmacist, Cancer, B cell, NPS, Insurance, Patient satisfaction, DLBCL, Health, Hospital

“At BrightSpring Health Services, we are proud of our leading service lines like Onco360® as we continue to innovate in the health care industry and provide patients with life-improving and life-sustaining treatments,” said BrightSpring President and CEO Jon Rousseau.

Key Points: 
  • “At BrightSpring Health Services, we are proud of our leading service lines like Onco360® as we continue to innovate in the health care industry and provide patients with life-improving and life-sustaining treatments,” said BrightSpring President and CEO Jon Rousseau.
  • “It is an honor for Onco360® to be selected as the preferred pharmacy for XPOVIO® (selinexor) and shows the Company’s dedication to innovation, quality patient care and improving health outcomes.
  • Onco360® and its dedicated employees do a fantastic job of keeping BrightSpring’s important mission at the core of everything they do.”
    As another demonstration of BrightSpring and Onco360®’s commitment to patient care, this year, Onco360® celebrates excellent service and care that resulted in unmatched patient satisfaction scores.
  • “It’s incredibly important to us to provide patient care that prioritizes expertise, reliability, consistency, and overall satisfaction,” said Benito Fernandez, Chief Commercial Officer at Onco360®.

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

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수요일, 3월 13, 2024
AXL, PIN, Neutropenia, Growth, Rituximab, Sarcoma, ALT, NSCLC, ASH, FY, Progression-free survival, Skin infection, Patient, Follicular lymphoma, S&M, Research, EDT, Aes, Periodic breathing, G&A, University, Lung cancer, Insurance, AACR, DLT, Pancreatic cancer, Hyperglycemia, Society, Therapy, Clinical trial, Diffuse large B-cell lymphoma, PFS, CD22, ADC, Data, Fatigue, MD Anderson Cancer Center, FDA, DLBCL, Marketing, PSMA, IDMC, Pharmaceutical industry

LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.

Key Points: 
  • “In the fourth quarter we saw results of our strategy in action across a number of key areas.
  • A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings.
  • R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

BostonGene Announces Acceptance of Eight Abstracts to be Presented at the American Association for Cancer Research Annual Meeting 2024

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화요일, 4월 2, 2024
Biotechnology, Technology, AIDS, Health, General Health, Oncology, Health Technology, Medical Devices, Artificial Intelligence, Genetics, Clinical Trials, B-cell lymphoma, TLS, HIV, Patient, Lung, RNA, Abstract, AACR, Blood, San Diego Convention Center, DLBCL, Kidney cancer

BostonGene , a leading provider of AI-driven molecular and immune profiling solutions, today announced that eight abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024, which will be held from April 5 - 10, at the San Diego Convention Center in San Diego, CA.

Key Points: 
  • BostonGene , a leading provider of AI-driven molecular and immune profiling solutions, today announced that eight abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) Annual Meeting 2024, which will be held from April 5 - 10, at the San Diego Convention Center in San Diego, CA.
  • BostonGene will exhibit at booth #847.
  • BostonGene, together with its collaborators, will deliver presentations on various topics, including the feasibility and utility of using comprehensive genomic and transcriptomic analysis for patients with blood and solid cancers, RNA-based models for TLS prediction in both lung and pancreatic cancers, a transcriptomic-based model to distinguish sarcomatoid features in kidney cancer and the use of comprehensive molecular profiling to evaluate the impact of race and HIV status on the genetic landscape of patients with diffuse large B-cell lymphoma (DLBCL) in southern Africa.
  • Details of BostonGene’s poster presentations at the AACR Annual Meeting are below: