HPK1

Nimbus Therapeutics Presents New Positive Monotherapy Phase 1/2 Clinical Data of HPK1 Inhibitor in Treatment of Advanced Solid Tumors at 2024 ASCO Annual Meeting

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torsdag, maj 23, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Patient, Renal cell carcinoma, Nimbus, Therapy, Update, Syngenic, Endometrial cancer, Safety, Pancreatic cancer, ASCO, HPK1, B cell, Society, Combination therapy, Annual general meeting, RCC, Pharmaceutical industry

Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.

Key Points: 
  • Results are being highlighted in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL.
  • The Phase 1/2 multicenter, open-label trial is designed to assess NDI-101150 as a monotherapy (50-200 mg dose) and in combination with 200 mg pembrolizumab in the treatment of adults with advanced solid tumors.
  • The results being presented at the ASCO Annual Meeting include updated data from 44 patients in the dose escalation cohorts (n=38 on monotherapy, n=6 on combination therapy) and additional data from 15 patients in the dose expansion cohorts.
  • Results, as of March 18, 2024, showed:
    Treatment with NDI-101150 monotherapy was associated with clinical benefit in five out of 30 (16.7%) response-evaluable patients.

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

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onsdag, maj 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Nimbus Therapeutics Appoints Anita Scheuber, M.D., Ph.D., as Senior Vice President, Therapeutic Area Head, Oncology

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tisdag, maj 7, 2024
Biometrics, Health, Pharmaceutical, Clinical Trials, Oncology, University, Trillium, Nimbus, Drug, Trial of the century, Growth, WRN, Pfizer, GSK, Patient, University Hospital of Zürich, Harvard Medical School, Teaching hospital, HPK1, Therapy, Werner syndrome helicase, Biotechnology, Pharmaceutical industry

Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the appointment of Anita Scheuber, M.D., Ph.D., as Senior Vice President, Therapeutic Area Head, Oncology.

Key Points: 
  • Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the appointment of Anita Scheuber, M.D., Ph.D., as Senior Vice President, Therapeutic Area Head, Oncology.
  • “We are delighted to welcome Anita to the executive team as we enter a new stage of growth at Nimbus with plans to further expand our focus in oncology,” said Nathalie Franchimont, M.D., Ph.D, Chief Medical Officer at Nimbus.
  • Most recently, she provided strategic consulting to biotechnology companies, developing clinical development strategies for multiple early-stage oncology assets.
  • Previously, she served as Vice President and Head of Clinical Development, Oncology at Trillium Therapeutics (acquired by Pfizer in 2021).

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

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onsdag, april 24, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Information, Acalabrutinib, Colorectal cancer, BCL2, Follicular lymphoma, Patient, Comparison, TIS, HPK1, Tislelizumab, Lymphoid leukemia, Pharmaceutical industry

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

Key Points: 
  • Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis
    Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)
    BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia
    Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
    Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study
    Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305
    A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors
    Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

Nimbus Therapeutics Announces Expansion of Its Immunology Drug Discovery Pipeline

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fredag, januari 5, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Biology, Conference, Family, Partnership, Drug discovery, Metabolism, WRN, IND, Drug design, Werner syndrome helicase, Pain scale, MBA, Therapy, Eli Lilly and Company, HPK1, DSM-IV codes, AMPK, Investment, Patient, TYK2, Pharmaceutical industry

Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, announced the advancement and expansion of its pipeline with the addition of discovery programs targeting innate immunity pathways.

Key Points: 
  • Nimbus Therapeutics , LLC (“Nimbus Therapeutics” or “Nimbus”), a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, announced the advancement and expansion of its pipeline with the addition of discovery programs targeting innate immunity pathways.
  • "Building on the success of our TYK2 program, we are broadening our drug discovery engine to unlock new difficult-to-drug targets with compelling biology,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus.
  • “SIK and cGAS are critical targets in highly prevalent diseases that are well suited to Nimbus’ structure-based drug design approach.
  • Nimbus continues to expand its platform capabilities with ongoing investments in cutting-edge technology for drug discovery.

Treadwell Announces Strategic Pipeline Prioritization and Leadership Transitions

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onsdag, december 6, 2023
Workforce, Gene editing, TTK, Amgen, Breast cancer, Royal college, TCR, FDA, Acquisition, Cell, Research, Internal medicine, Drug, Physician, SAN, Panitumumab, Therapy, Oncology, Cancer, University, HPK1, Queen's University, Roivant Sciences, Patient, Surgeon, AML, PLK4, Pharmaceutical industry

TORONTO and SAN FRANCISCO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Treadwell Therapeutics, a clinical-stage biotechnology company developing novel first-in-class medicines for unmet needs in cancer, today announced that it is realigning its pipeline, workforce and management structure to support its highest value program and extend its cash runway to prioritize the execution of key near term value drivers and clinical milestones.

Key Points: 
  • Dr. Sidhu brings to Treadwell an extensive track record of success over the last nearly 20 years in hematologic and solid tumor oncology research and development.
  • “Roger brings a unique and broad set of skills and strategic thinking to Treadwell over a long and successful career.
  • We are confident that under his leadership, Treadwell will aggressively advance into an exciting new chapter in our mission to address unmet needs in difficult to treat cancers with first-in-class medicines,” said Shane Burgess, Executive Chair of Treadwell Therapeutics.
  • We would like to extend our deep gratitude to the Treadwell team, investigators and patients involved in our clinical programs.

Nimbus Therapeutics Presents Positive Preliminary Data from Clinical Trial of HPK1 Inhibitor in Solid Tumors at SITC Annual Meeting

Retrieved on: 
tisdag, oktober 31, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, CR, Renal cell carcinoma, Nivolumab, Society for Immunotherapy of Cancer, HPK1, MBA, Protein, Poster, Pharmacokinetics, SITC, Immunotherapy, B cell, Clinical trial, Annual general meeting, Pancreatic cancer, MAP4K, Safety, Society, Cancer, Therapy, Patient, Combination therapy, Pharmaceutical industry, Nimbus

The data presented at SITC include initial safety and efficacy results from single agent therapy (n=13) in the dose escalation portion of the trial.

Key Points: 
  • The data presented at SITC include initial safety and efficacy results from single agent therapy (n=13) in the dose escalation portion of the trial.
  • “We’re pleased to share these first clinical data from our clinical trial of NDI-101150.
  • In a second poster at SITC, Nimbus is presenting new preclinical data which support the potential for both broad immunotherapeutic potential and best-in-class selectivity of NDI-101150 among publicly disclosed HPK1 inhibitor programs to date.
  • “The data presented at SITC reinforce the potential first-in-class and best-in-class profile of our HPK1 inhibitor, and we will continue to work to realize its possible benefits to patients with cancer.”

Florida Cancer Specialists & Research Institute Physicians Contribute to Immunotherapy Treatment Advances at Global Meeting

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fredag, november 3, 2023
Drug development, Science, Patient, Trial of the century, Education, PD, Nivolumab, Hope, Pembrolizumab, Physician, CD22, MD, HPK1, Research, INT, Immunotherapy, ADC, FIH, Disease, Immune system, Safety, Society, Cancer, FCS, T cell, Vaccine, Pharmaceutical industry, Pharmacokinetics

FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.

Key Points: 
  • FORT MYERS, Fla., Nov. 3, 2023 /PRNewswire/ -- Florida Cancer Specialists & Research Institute (FCS) physicians will present at the Society for Immunotherapy of Cancer Annual Meeting this week in San Diego.
  • They will join stakeholders across the immune-oncology field worldwide to advance the science, discover breakthroughs and enhance education on cancer immunotherapy, which uses the body's own immune system to find, target and fight many forms of the disease.
  • "Immunotherapy is one of the most promising and successful treatment areas for cancer, even at the most advanced stages, said Lucio N. Gordan, MD , FCS President & Managing Physician.
  • "Through our robust and far-reaching clinical trials research program, FCS continues to contribute to cutting-edge research that is providing hope and improving outcomes for cancer patients worldwide."

BeiGene Strengthens Global Portfolio and Regains Full Rights from Novartis for Anti-PD-1 Antibody TEVIMBRA® (tislelizumab)

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tisdag, september 19, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Monoclonal antibody, BGNE, Cancer, Quality of life, SSE, OX40, LAG3, Patient, Medicine, European, Entrepreneurship, PD-L1, Safety, Tislelizumab, Pharmaceutical industry, BeiGene, HPK1, Novartis

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab).

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that it has entered into an agreement with Novartis to regain worldwide rights to develop, manufacture, and commercialize TEVIMBRA (tislelizumab).
  • “BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities.
  • BeiGene has agreed to provide Novartis with ongoing clinical supply of TEVIMBRA to support its clinical trials.
  • Under the agreement, Novartis was responsible for regulatory submissions and had the right to commercialize in these licensed countries following regulatory approval.

Nimbus Therapeutics Secures $210M Private Financing to Advance Next Wave of Tech-Enabled Small Molecule Medicines

Retrieved on: 
onsdag, september 6, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SR, Atlas Venture, Werner syndrome helicase, GV, AMPK, Atlas, General partnership, HPK1, WRN, MBA, GV (company), History, DSM-IV codes, Patient, Autoimmune disease, Eli Lilly and Company, Therapy, Pharmaceutical industry, Fine chemical, Nimbus

Nimbus Therapeutics , LLC ("Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of a $210 million private financing to advance its next wave of tech-enabled small molecule medicines.

Key Points: 
  • Nimbus Therapeutics , LLC ("Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of a $210 million private financing to advance its next wave of tech-enabled small molecule medicines.
  • “We’re proud to have built an R&D organization that is a paradigm of excellence in small molecule drug discovery and development.
  • Nimbus will continue the ongoing clinical development of NDI-101150, a hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with solid tumors.
  • “Nimbus has demonstrated its ability to advance early science through to successful product development multiple times.