DL2

Galapagos announces full year 2023 results and outlook for 2024

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Thursday, February 22, 2024
Technology transfer, CD19, Filgotinib, Lupus, Multiple myeloma, DL2, Dermatomyositis, Acceleration, Baltic, BCMA, Mantle cell lymphoma, European Commission, Indolent lymphoma, JAK1, Safety, EBMT, RT, TYK2, CFO, PRAC, MAA, Richter's transformation, Euronext, Executive Committee, JAK, UC, Patient, SLE, Pharmaceutical industry

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

Galapagos presents at EBMT-EHA annual meeting 2024

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Thursday, February 15, 2024
Blood, Galapagos NV, European, Safety, Richter's transformation, CD19, Euronext, Multiple myeloma, EHA, DL2, EBMT, RT, Patient, Efficacy

Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.

Key Points: 
  • Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.
  • Further, previously disclosed safety, efficacy and feasibility data from EUPLAGIA-1 and ATALANTA-1 support the potential of Galapagos’ innovative approach to CAR-T manufacturing and of the transformational impact on patients with severe hematologic cancers.
  • “At Galapagos, we are committed to accelerating transformative innovation to address the unmet needs of patients with advanced cancers, and the data we are presenting today demonstrates our positive momentum toward this goal,” said Dr Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.
  • Moreover, the abundance of both CD4+ and CD8+ TN/SCM CAR-T cells in the final product correlated with CAR-T-cell exposure in patients.

Galapagos presents new encouraging data at ASH 2023 from ongoing CD19 CAR-T studies with GLPG5201 and GLPG5101

Retrieved on: 
Saturday, December 9, 2023
Cytokine release syndrome, DL2, Symantec Endpoint Protection, CRR, Mantle cell lymphoma, Doctor of Philosophy, University of Barcelona, Society, Galapagos NV, Euronext, Cancer, ASH, University, Non-Hodgkin lymphoma, Indolent lymphoma, RT, Richter's transformation, Poster, Congress, CRS, Patient, CD19, Safety, KOL, Pharmaceutical industry

The data suggest that Galapagos’ CAR-T point-of-care manufacturing platform can deliver fresh product in a median vein-to-vein time of seven days.

Key Points: 
  • The data suggest that Galapagos’ CAR-T point-of-care manufacturing platform can deliver fresh product in a median vein-to-vein time of seven days.
  • To further build a robust data package, patient recruitment of the Phase 1 dose-finding part of ATALANTA-1 is ongoing.
  • The data suggest that Galapagos’ point-of-care platform can deliver fresh product in a median vein-to-vein time of seven days.
  • Seven-day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5201) in Relapsed/Refractory CLL/SLL including Richter’s Transformation: Results from the Phase 1 Euplagia-1 Trial

HCW Biologics Reports Third Quarter 2023 Financial Results And Recent Business Highlights

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Tuesday, November 14, 2023
Letter of recommendation, Principal, Sale, Prejudice, Gynecologic Oncology (journal), University, IND, Bank statement, Gynaecology, JAMS, Loan agreement, Clinical trial, Patient, Insurance, Research, Division, Immunotherapy, G&A, TGF, District court, Ovarian cancer, Human, SITC, R, Loss, Court, Society, Professor, Notifiable disease, Inflammation, DL2, Pharmaceutical industry, Medical imaging, Vaccine, Cryptocurrency, Cancer, Liver, Obstetrics

MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.

Key Points: 
  • MIRAMAR, Fla., Nov. 14, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2023.
  • We are pleased to see the consistency of results in humans with those that we saw in our preclinical animal studies.
  • Third Quarter 2023 Financial Results:
    Revenues: Revenues for the quarter ended September 30, 2022 and 2023 were $1.8 million and $853,102, respectively.
  • Revenues for the nine months ended September 30, 2022 and 2023 were $5.4 million and $1.5 million, respectively.

Investigator Sponsor of HCW Biologics’ Phase 1 Clinical Trial Presented Human Data Readout and Anti-Cancer Mechanism of Action of HCW9218 at 38th SITC Annual Meeting

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Wednesday, November 8, 2023
Patient, Principal, Gynaecology, Masonic Cancer Center, Notifiable disease, Department of Obstetrics and Gynecology (Massachusetts General Hospital), Ovarian cancer, Human, TGF, University, Professor, Inflammation, Gynecologic Oncology (journal), SITC, Immunotherapy, DL2, Disease, Division, NK, Cytokine release syndrome, DRS, Tumor microenvironment, Safety, Society, Recommended maximum intake of alcoholic beverages, Pharmaceutical industry, Medical imaging, Vaccine, Liver, Obstetrics, Cancer

MIRAMAR, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, announced results from a preliminary human data readout from an ongoing Phase 1 clinical trial sponsored by the University of Minnesota to evaluate HCW9218, the lead drug candidate of HCW Biologics, in patients with solid tumors who failed at least two prior lines of therapy. Data from this study was presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”) by Melissa A. Geller, M.D., M.S., Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota who serves as a Principal Investigator of this trial.

Key Points: 
  • The trial is now in its final expanded dose level, and the Company expects it to be completed in the fourth quarter of 2023.
  • There has been one dose-limiting toxicity experience in this study, but it did not trigger stopping rules.
  • In addition, we believe, perhaps even more importantly, their extensive correlative studies provide valuable evidence that will inform our Phase 2 clinical studies in cancer indications.
  • With these strong results as a foundation, we believe we will be in a position to pivot to initiate our first Phase 2 clinical trial this year.”

Kymera Therapeutics Announces Third Quarter 2023 Financial Results and Provides a Business Update

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Thursday, November 2, 2023
First grade, Research, HS, AD, PD, Food, Safety, Dana–Farber Cancer Institute, Disease, Abstract, Immunology, Cutaneous T-cell lymphoma, Uveal melanoma, STAT3, International, Physician, GDF15, Webcast, Atopic dermatitis, Therapy, Investment, CTCL, Patient, Administration, Cash, Plasma, Lymphoma, Conference, IRAK4, Development, TPD, ASH, Growth, DL2, Hypotension, DL, Solar cycle 4, Arm, AACR, Thrombocytopenia, Fast Track, PTCL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Society, SD, Hidradenitis suppurativa, MDM2, Recurrence, Blood, Peripheral T-cell lymphoma, Neutropenia, AML, Merkel-cell carcinoma, Pharmaceutical industry, Vaccine, Fine chemical, Medical device, Angela Merkel, Sanofi, Black Majesty

ET

Key Points: 
  • ET
    WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2023, and provided business updates on its pipeline of protein degraders.
  • Collaboration Revenues: Collaboration revenues were $4.7 million for the third quarter of 2023 compared to $9.6 million for the third quarter of 2022.
  • Net Loss: Net loss was $52.9 million for the third quarter of 2023 compared to a net loss of $43.0 million for the third quarter of 2022.
  • Cash and Cash Equivalents: As of September 30, 2023, Kymera had $435 million in cash, cash equivalents, and investments.

Kymera Therapeutics to Present New Clinical Data from the Phase 1 Trial of STAT3 Degrader KT-333 at the ASH Annual Meeting

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Thursday, November 2, 2023
Cutaneous T-cell lymphoma, Patient, STAT3, PD, Fatigue, Human, PTCL, Factorization of polynomials, Nausea, Society, ASH, DL2, Relapse, Blood, Anemia, Peripheral T-cell lymphoma, Exposition, DL, Safety, Therapy, CTCL, Toxicity, Pharmaceutical industry, Vaccine, Pharmacokinetics

WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation, today announced that new KT-333 Phase 1 data highlighting safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical responses will be presented at the ASH 65th Annual Meeting and Exposition, taking place from December 9-12, 2023, in San Diego, California. Results released in an ASH abstract today include data as of a July 10, 2023 cut-off. The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date. In addition, preclinical data will be presented supporting the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia.

Key Points: 
  • Results released in an ASH abstract today include data as of a July 10, 2023 cut-off.
  • The poster presentation is expected to include additional data, including PK/PD, safety and results of disease response assessments from additional patients subsequent to the abstract cut-off date.
  • In addition, preclinical data will be presented supporting the potential of STAT3 protein degraders as a therapeutic approach in venetoclax-resistant Acute Myeloid Leukemia.
  • Title: Preliminary Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors

Adicet Bio Reports Positive Data from Ongoing ADI-001 Phase 1 Trial in Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL)

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Monday, June 26, 2023
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“Autologous CD19 CAR T therapies were studied on CAR T naïve patients with a median of 3 prior lines of therapy.

Key Points: 
  • “Autologous CD19 CAR T therapies were studied on CAR T naïve patients with a median of 3 prior lines of therapy.
  • In contrast, the ADI-001 Phase 1 trial enrolled patients with a median of 4 lines of prior therapy and, importantly, 50% had previously progressed on autologous CAR T therapy.
  • Unfortunately, approximately 60-70% of these patients progress, which represents a significant unmet medical need,” said Chen Schor, President and Chief Executive Officer of Adicet Bio.
  • Table 1 – Summary of Phase 1 ADI-001 Preliminary Efficacy Data as of the May 4, 2023 data-cut date:

Kymera Therapeutics Announces Updated Clinical Data from the Phase 1 Trials of STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413

Retrieved on: 
Friday, June 9, 2023
STAT3, Peripheral T-cell lymphoma, PD, Cutaneous T-cell lymphoma, Follicular lymphoma, DLBCL, Relapse, ICML, Immunomodulatory imide drug, Lymphoma, Pharmacokinetics, Constipation, TPD, DL2, Abdominal pain, B-cell lymphoma, PBMC, Leukemia, Dizziness, Patient, International Conference on Machine Learning, Plasma, MYD88, Cancer, ABC, Nausea, Toxicity, Infrared spectroscopy correlation table, Therapy, Conference, Safety, Fatigue, Bone marrow, Vaccine, Pharmaceutical industry, Television, Risk management, Medical imaging, IRAK4, Black Majesty, Fever

WATERTOWN, Mass., June 09, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate substantial target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed. The data were shared in the online abstract book of the International Conference on Malignant Lymphoma (ICML), taking place from June 13-17, 2023, in Lugano, Switzerland, and reflect a data cut-off date of February 3, 2023. On June 14, a KT-333 poster will be released at ICML and presented on June 16. Kymera will share updated results from both programs in conjunction with the poster release on June 14.

Key Points: 
  • Kymera will share updated results from both programs in conjunction with the poster release on June 14.
  • KT-333 is designed as a potent degrader of STAT3, a transcriptional regulator that has been linked to numerous cancers as well as to inflammatory and autoimmune diseases.
  • As previously announced, Kymera intends to present data evaluating anti-tumor activity in the target patient population later this year.
  • As previously announced, Kymera intends to present data evaluating anti-tumor activity in the target patient population later this year.

Galapagos to showcase CAR-T point-of-care manufacturing and initial Phase 1/2 CLL data with CD19 CAR-T candidate, GLPG5201, at the EHA 2023 congress

Retrieved on: 
Monday, June 5, 2023
CR, ORR, Toxic leukoencephalopathy, Infrared spectroscopy correlation table, RT, PD, CD19, Patient, DL2, CRS, Safety, Pharmaceutical industry

All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days.

Key Points: 
  • All patients received GLPG5201 as a fresh infusion with a median vein-to-vein time of 7 days.
  • The dose levels that are evaluated in the Phase 1 part of the study are 35x106 (DL1), 100x106 (DL2) and 300x106 (dose level 3 (DL3)) CAR+ viable T cells.
  • In the safety analysis of these 7 patients, adverse events were consistent with the known toxicities of CD19 CAR-T treatment.
  • None of the patients experienced a CRS higher than grade 2 at both dose levels and no ICANS was reported.