Lymphoma

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

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Sunday, January 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.

Viracta Therapeutics Provides Clinical Update and Outlook for 2024

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Thursday, January 4, 2024
SDD, NPC, Food, Stage 2, Nasopharyngeal carcinoma, Lymphoma, DLBCL, FDA, PTLD, ODD, SAN, Therapy, Peripheral T-cell lymphoma, Patient, PTCL, Pharmaceutical industry

SAN DIEGO, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today provided a clinical update, including its roadmap for advancing Nana-val’s clinical development in 2024. Nana-val (nanatinostat in combination with valganciclovir), is the company’s all-oral investigational therapy targeting Epstein-Barr virus-associated cancers.

Key Points: 
  • Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma (PTCL) cohort of patients treated with Nana-val (n=11) in the first quarter of 2024.
  • Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024.
  • Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma (DLBCL) and R/R EBV+ post-transplant lymphoproliferative disorder (PTLD) by year-end 2024.
  • Best responses through the fifth dose cohort included two confirmed partial responses and five stable diseases out of 17 patients.

FDA Grants Breakthrough Device Designation for Geneseeq's Multi-cancer Early Detection Solution

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Wednesday, January 3, 2024
Food, Nucleic acid thermodynamics, Risk, Multimedia, FDA, Lung, Cancer, Ageing, Trial of the century, DNA, Prostate, Esophagus, WGS, SOC, Lymphoma

TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

Key Points: 
  • TORONTO, Jan. 3, 2024 /PRNewswire/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).
  • The test outperforms current standard of care (SOC) screening methods in common cancer types, such as prostate, lung and liver cancers.
  • It also detects cancer types currently without effective SOC screening methods, such as esophagus, endometrial, gastric, pancreatic cancers and lymphoma.
  • This FDA Breakthrough Device Designation follows the CanScan™ assay kit's CE approval in January 2023, marking another significant recognition from an internationally authoritative institution.

SELLAS Provides Corporate Updates and Highlights Key Upcoming Milestones

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Wednesday, January 3, 2024
Mesothelioma, Therapeutic index, Doctor of Science, Food, Survival, Lymphoma, Bone marrow, BLA, Ovarian cancer, GPS, MRD, FDA, Type, CMC, CR2, MD, Nivolumab, WT1, Clinical trial, SLS, Acute myeloid leukemia, Patient, Safety, PTCL, AML, Pembrolizumab, Pharmaceutical industry

NEW YORK, Jan. 03, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided a business update and will host a corporate webinar at 8:30 am ET.

Key Points: 
  • “2023 was a very productive year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • Dr. Stergiou continued: “We hope to build on this excellent progress and look forward to multiple clinical milestones that have the potential to create significant value for our shareholders.
  • Meaningful cell killing activity, defined as ≥50% reduction in blasts in the bone marrow, was observed at several dose levels.
  • This study is fully funded by the Company’s partner for SLS009, GenFleet Therapeutics (Shanghai), Inc. and is being conducted in China.

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

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Tuesday, January 2, 2024
Marketing, PV, INN, Risk, MPA, Shivering, CD20, PML, Pemphigus vulgaris, Inflammation, Infection, Anatomy, Lymphoma, IIA, Skin, Chills, Fever, ATC, Joint, Bone marrow, GPA, Disease, Nose, Allergy, Glucocorticoid, NHL, CLL, Safety, Rheumatoid arthritis, Patient, Medical Subject Headings, Cyclophosphamide, Immune system, Granuloma, Antibody, Vincristine, International, Arthritis, Language, Mouth, Follicular lymphoma, Microscopic polyangiitis, Select, B cell, Methotrexate, Prednisolone, TNF, CHOP, Blood, Vasculitis, European Medicines Agency, Doxorubicin, Chronic lymphocytic leukemia, DMARD, Medical device

Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ruxience, rituximab, Date of authorisation: 01/04/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

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Tuesday, January 2, 2024
Liver, Marketing, MP, Heart, MRI, INN, Risk, MTX, Pneumonia, Fungus, AZA, UC, Eating, Inflammation, Ankylosing spondylitis, Infection, Fungal infection, Diagnosis, Anatomy, Ulcer, Lymphoma, IIA, Skin, Vasculitis, Yeast, Psoriasis, ATC, Joint, Pain, Psoriatic arthritis, Syringe, Disease, Nose, Allergy, Lower respiratory tract infection, Nonsteroidal anti-inflammatory drug, Hepatitis B virus, Safety, Heart failure, CRP, Disorder, Rheumatoid arthritis, Sepsis, Magnetic resonance imaging, Leukemia, Patient, Medical Subject Headings, Walking, Immune system, Ulcerative colitis, International, Arthritis, Language, Blood, Hepatitis B, Medication package insert, Tuberculosis, Select, Medicine, Methotrexate, Azathioprine, TNF, X-ray, Mercaptopurine, European Medicines Agency, Spine, DMARD, Pharmaceutical industry

Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Simponi, golimumab, Date of authorisation: 01/10/2009, Revision: 49, Status: Authorised

Oncternal Therapeutics Updates the Status of its Phase 1/2 Study of ONCT-808, a ROR1-Targeting Autologous CAR T, in Patients with Relapsed or Refractory Aggressive B-cell Lymphoma

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Tuesday, December 26, 2023
Food, CMR, Pneumonia, FDA, Cytokine release syndrome, SAN, Therapy, FDG, CRS, Patient, CD19, Safety, Lymphoma, Communication, Pharmaceutical industry

No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report.

Key Points: 
  • No evidence of his lymphoma was found histologically, based on the patient’s initial autopsy report.
  • Salim Yazji M.D., Chief Medical Officer at Oncternal Therapeutics, commented, "The safety of every patient who participates in our studies is of the utmost priority for us.
  • We believe these early disease response data indicate that ONCT-808 is a particularly potent autologous CAR T product with the potential to address significant unmet needs for patients with aggressive B-cell malignancies.
  • With this clear path forward, we plan to implement the protocol amendment as rapidly as possible."

SELLAS Receives FDA Orphan Drug Designation for SLS009 for Treatment of Peripheral T-cell Lymphomas

Retrieved on: 
Thursday, December 21, 2023
Marketing, Doctor of Science, Food, FDA, CDK9, HDAC, ODD, MD, Therapy, SLS, Belinostat, Patient, Acute myeloid leukemia, Safety, Diagnosis, PTCL, Lymphoma, Bone marrow, Pharmaceutical industry

NEW YORK, Dec. 21, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for SLS009, the Company’s novel and highly selective CDK9 inhibitor, for the treatment of relapsed/refractory (r/r) Peripheral T-cell Lymphomas (PTCL).

Key Points: 
  • “We are delighted to announce the FDA’s granting of ODD for SLS009, marking another significant milestone following the recent Fast Track Designation by the FDA for PTCL,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
  • “In the recently completed dose-escalation portion of the Phase 1 trial in r/r hematological malignancies, SLS009 achieved clinical responses in PTCL including two patients reaching complete response.
  • The patients who achieved complete response in the SLS009 study were previously treated with regimens containing an HDAC inhibitor.
  • These benefits include assistance in the drug development process, tax credits for qualified clinical costs, exemptions from certain FDA fees and seven years of marketing exclusivity.

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

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Monday, December 18, 2023
Patient, Immunotherapy, NGS, Neoplasm, PR, CDKN2B, CDK2, Histology, Glioma, DLT, CYCC, Lung, CDK9, PLK1, Metformin, Half-life, Melanoma, Hyperglycemia, Blood, Cyclacel, Cancer, Endometrial cancer, T-cell lymphoma, Mesothelioma, Head, Laboratory, Pancreatic cancer, MTAP, Biomarker, Tablet, Lymphoma, NSCLC, Deletion, PRMT5, Neck

BERKELEY HEIGHTS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announced today interim results from its Phase 1, dose escalation 065-101 study of fadraciclib (“fadra”) in patients with advanced solid tumors and lymphoma.

Key Points: 
  • “The data suggest tumor sensitivity in patients with one or more of three abnormalities, CDKN2A, CDKN2B and/or MTAP deletion subject to confirmation in further studies.
  • The Phase 2 part of 065-101 is designed to evaluate fadra safety and efficacy in cohorts defined by histology and/or next generation sequencing (NGS).
  • “After retrospectively analyzing a subset of previously treated Phase 1 patients who experienced clinical benefit with fadra, we found four patients with CDKN2A, CDKN2B and/or MTAP deletions.
  • CDKN2B deletions occur in over 30% of several solid tumors, including bladder, glioma, pancreatic, esophageal, lung (incl.

Viracta Therapeutics Announces Orphan Drug Designation Granted by the U.S. FDA to Nana-val for the Treatment of Nasopharyngeal Carcinoma

Retrieved on: 
Tuesday, December 12, 2023
NPC, Food, Nasopharyngeal carcinoma, Post-transplant lymphoproliferative disorder, Drug development, FDA, Disease, Plasmablastic lymphoma, ODD, Therapy, T-cell lymphoma, B-cell lymphoma, EBV, Valganciclovir, Patient, Lymphoma, Pharmaceutical industry

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to Nana-val (nanatinostat in combination with valganciclovir), the company's all-oral investigational therapy targeting Epstein-Barr virus (EBV)-associated cancers, for the treatment of nasopharyngeal carcinoma (NPC). This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas. The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.

Key Points: 
  • This represents the first ODD granted for Nana-val in Epstein-Barr virus-positive (EBV+) solid tumors and outside of EBV-associated lymphomas.
  • The FDA previously granted Nana-val ODD for the treatment of T-cell lymphoma, post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and EBV+ diffuse large B-cell lymphoma, not otherwise specified.
  • "This orphan drug designation highlights the urgent need for new targeted treatment options for patients with rare diseases such as nasopharyngeal carcinoma, which is highly associated with EBV," said Mark Rothera, President and Chief Executive Officer of Viracta.
  • With sites open and enrolling the sixth dose cohort of the study, we are on track to expand into the Phase 2 portion in 2024.