MSI-H

Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer After Surgery With Curative Intent

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星期四, 五月 9, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, B21, Radiation, DFS, Paclitaxel, Food, Merck & Co., Immunotherapy, Eisai, Data monitoring committee, Rated R, PDUFA, ADC, Patient, Endometrial cancer, Cancer, MSI-H, Carboplatin, MRK, Pharmaceutical industry

The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.

Key Points: 
  • The study’s other primary endpoint of overall survival (OS) was not formally tested since superiority was not reached for DFS.
  • The safety profile of KEYTRUDA was consistent with that observed in previously reported studies; no new safety signals were identified.
  • Merck will work with investigators to share the results with the scientific community.
  • “We would like to thank all the patients, the investigators and our study collaborators for their participation in this trial.”
    In the U.S., KEYTRUDA has two approved indications in endometrial cancer.

Ligand and Agenus Enter Into $100 Million Royalty Financing Agreement

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星期二, 五月 7, 2024
Biotechnology, Pharmaceutical, Health, Oncology, FDA, Patient, Gilead Sciences, MSS, Lung cancer, Food, Pancreatic cancer, CRC, RAS, Partnership, Melanoma, MSI-H, Bristol Myers Squibb, Merck, Cancer, Anti-VEGF, Pharmaceutical industry

Under the terms of the agreement, Ligand will pay $75 million to Agenus at closing.

Key Points: 
  • Under the terms of the agreement, Ligand will pay $75 million to Agenus at closing.
  • In addition, Ligand has the option to invest an additional $25 million on the same terms on a pro rata basis.
  • Ligand’s portion of the milestones related to these six programs has the potential to exceed $400 million, with royalties in the low single digits.
  • In addition, Ligand will also receive a 2.625% royalty on future global net sales generated by BOT/BAL.

Agenus Reports First Quarter 2024 Results

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星期二, 五月 7, 2024
Biotechnology, Pharmaceutical, Health, FDA, CMO, MSS, Lung cancer, Ligand Pharmaceuticals, IST, Pancreatic cancer, Colorectal cancer, RECIST, Colitis, CRC, BOT, Biologics license application, Liver disease, Therapy, Index, Data, Patient, Sarcoma, BLA, Melanoma, Inc., BAL, MSI-H, Cancer

Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced results for the first quarter 2024.

Key Points: 
  • Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced results for the first quarter 2024.
  • In a concurrent press release accompanying Agenus’ earnings announcement, a $100M royalty financing agreement between Ligand and Agenus was reported.
  • First Quarter 2024 Financial Overview:
    We ended our first quarter 2024 with a cash and cash equivalent balance of $52.9 million, compared to $76.1 million on December 31, 2023.
  • Our cash used in operations for this first quarter was $38.2 million, compared to $40.6 million during the fourth quarter ended December 31, 2023.

European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite...

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星期一, 五月 6, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Type 2, PFS, Cancer, BMY, Nivolumab, MSI-H, Ipilimumab, Progression-free survival, Immunotherapy, ASCO, Checkmate, Patient, Society, EMA, Bristol Myers Squibb, European Medicines Agency, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II variation application for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).
  • The EMA’s validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
  • The study is ongoing to assess the other dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints.
  • Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial.

Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)

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星期三, 四月 10, 2024
Hypertelorism, DLT, Safety, Radiation, Pancreatic cancer, TSX, PR, Cancer, LFT, Regulatory T cell, Patient, MDNA, RDE, Duodenal cancer, Toxicity, Melanoma, BCC, MCC, AACR, VLS, MSI-H, PD, NK, Combination therapy, Pharmaceutical industry

March 22, 2024) include:

Key Points: 
  • March 22, 2024) include:
    Acceptable safety profile: No dose limiting toxicity (DLT) reported and no evidence of vascular leak syndrome (VLS).
  • A new lymph node lesion developed during a 8-week MDNA11 treatment break (vacation) was treated with a single course of radiotherapy prior to resumption of MDNA11.
  • A new lymph node lesion developed at week 16 while baseline target and non-target lesions remained stable or decreased.
  • Monotherapy expansion is continuing to enroll patients with metastatic melanoma, non-melanoma skin cancers (cSCC, MCC, and BCC) and MSI-H/dMMR tumors.

Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)

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星期二, 四月 9, 2024
Toxicity, PR, Combination therapy, VLS, MSI-H, PD, LFT, RDE, Duodenal cancer, Patient, Hypertelorism, Radiation, MCC, MDNA, AACR, TSX, DLT, Pancreatic cancer, Safety, Regulatory T cell, Melanoma, Cancer, BCC, NK, Pharmaceutical industry

March 22, 2024) include:

Key Points: 
  • March 22, 2024) include:
    Acceptable safety profile: No dose limiting toxicity (DLT) reported and no evidence of vascular leak syndrome (VLS).
  • A new lymph node lesion developed during a 8-week MDNA11 treatment break (vacation) was treated with a single course of radiotherapy prior to resumption of MDNA11.
  • A new lymph node lesion developed at week 16 while baseline target and non-target lesions remained stable or decreased.
  • Monotherapy expansion is continuing to enroll patients with metastatic melanoma, non-melanoma skin cancers (cSCC, MCC, and BCC) and MSI-H/dMMR tumors.

AACR 2024: Brenus Pharma Unveils Promising and Robust Pre-clinical Efficacy Extrapolating Human Conditions with STC-1010

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星期二, 四月 9, 2024
Research, Clinical Trials, Biometrics, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Cancer, Doctor, MSI-H, Metastasis, Communication, Immunotherapy, Colorectal cancer, Patient, MSI, STC, Team, Doctor of Philosophy, Master of Science, MSS, Neoplasm, Vaccine

This communication confirms the ability of Brenus’ next gen immunotherapy, STC-1010, to fight against resistant colorectal tumors with excellent tolerability.

Key Points: 
  • This communication confirms the ability of Brenus’ next gen immunotherapy, STC-1010, to fight against resistant colorectal tumors with excellent tolerability.
  • Additionally, multi-omics analysis of STC-1010 batches confirmed consistent quality and batch-to-batch reproducibility, through standardized and scalable production.
  • STC-1010 was tested in several models extrapolating human conditions (ex-vivo; in-ovo,) using PBMCs from different donors.
  • Results showed a significant immune response activation coupled with a massive and robust tumor killing that has been consistent with our 3 latest STC1010 batches manufactured.

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

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星期日, 三月 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

Ryvu Therapeutics to Present Preclinical Data on RVU120 and Synthetic Lethality Programs at the 2024 AACR Annual Meeting

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星期三, 三月 6, 2024
WBC, WRN, Lung cancer, RNA, Malignancy, Microsatellite instability, Proteome, Intellectual property, MMR, MPN, Glioblastoma, Neoplasm, Splenomegaly, DMPK, Phosphorylation, HDAC, STAT5, RNA-Seq, WES, Standard of care, Therapy, RecQ helicase, Phenotype, Ruxolitinib, DNA, DNA repair, Pancreatic serous cystadenoma, CDKN2A, Cancer, CRC, PIM, Arginine, MTA, Abstract, PDC, MTAP, Colorectal cancer, CRISPR, PV, MF, MSI-H, Cell, JAK, DNA mismatch repair, Medicine, Patient, Gene, PRMT5, Haematopoiesis, Mesothelioma, Pharmaceutical industry

Ryvu's partner Menarini to present data on MEN1703 (SEL24), demonstrating promising anti-tumor activity in preclinical models of myelofibrosis both as a single agent and combined with ruxolitinib.

Key Points: 
  • Ryvu's partner Menarini to present data on MEN1703 (SEL24), demonstrating promising anti-tumor activity in preclinical models of myelofibrosis both as a single agent and combined with ruxolitinib.
  • "We are excited to present our latest preclinical data at the AACR Annual Meeting, showcasing our significant progress in advancing novel small molecule therapies for oncology.
  • This year, we will present data from our most advanced preclinical project on MTA-cooperative PRMT5 inhibitors, the lead program within Ryvu's synthetic lethality pipeline.
  • Ryvu has developed potentially best-in-class MTA-cooperative PRMT5 inhibitors showing favorable drug-like properties and effective PRMT5 inhibition dependent on MTA binding.

Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population

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星期一, 一月 22, 2024
Oncology, Health, Infectious Diseases, Research, Science, Biotechnology, Patient, Neoplasm, Microsatellite, MSS, MSI-H, IST, DFS, BAL, Delays, Pathologic, Observational study, Rated R, Colorectal cancer, CRC, Diagnosis, BOT, Inc., Medical imaging

Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.

Key Points: 
  • Dr. Pashtoon Kasi, M.D., Director of Colon Cancer Research at Weill-Cornell Medicine, presented these findings at the ASCO-GI conference.
  • "BOT/BAL's potential impact on colorectal cancer is groundbreaking.
  • BOT/BAL Eliminates Circulating Tumor DNA (ctDNA): patients in the NICHE-1 study were tested for ctDNA, a biomarker closely associated with long-term Disease-Free Survival (DFS).
  • Neoadjuvant BOT/BAL in both MSS and MSI-H CRC resulted in marked tumor regression and robust immune cell infiltration in a very short interval.