Partial-response maximum-likelihood

Atara Biotherapeutics To Present Positive New Tab-cel® Clinical Data During Oral Session at ESMO Immuno-Oncology Annual Congress 2023

Retrieved on: 
Wednesday, November 29, 2023
Oncology, Health, Stem Cells, Clinical Trials, Research, Science, Biotechnology, CNS, ATRA, Epstein–Barr virus, Safety, Partial-response maximum-likelihood, PST, Disease, Northwest Biotherapeutics, ESMO, HCT, Patient, CET, ORR, SOT, Cancer, Symantec Endpoint Protection, PTLD, Neurotoxicity, Congress, Central nervous system, EBV, TTR, OS, PR, Vaccine, Pharmaceutical industry

These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.

Key Points: 
  • These results will be presented as an oral session at the European Society for Medical Oncology Immuno-Oncology (ESMO I‑O) Annual Congress taking place December 6-8, 2023, in Geneva, Switzerland.
  • “We’re pleased to share new multicenter data, including the first results from our ongoing multicohort EBVision trial and first clinical trial report of treatment with tab-cel in the first line setting.
  • The estimated one-year overall survival (OS) rate was 70.6% (95% CI: 43.0, 86.6) for all patients.
  • Date & Time: December 7, 2023, at 2:15 - 3:45 p.m. CET / 5:15 - 6:45 a.m. PST

Apollomics Announces Report of Activity of Vebreltinib in Glioblastoma Multiforme (GBM) with PTPRZ-MET Fusion

Retrieved on: 
Thursday, October 26, 2023
APLM, National Medical Products Administration, GBM, Temozolomide, NMPA, ESMO, SPARTA, Radiation, Cancer, Partial-response maximum-likelihood, New Drug Application, NDA, European Society for Medical Oncology, Patient, MET, Communication, Aviston, Illinois, Pharmaceutical industry

The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .

Key Points: 
  • The patient with GBM with PTPRZ-MET fusion who had previously received radiotherapy and temozolomide, was reported to have an impressive Partial Response (PR) after 8 weeks of treatment with vebreltinib monotherapy during participation in the SPARTA study ( NCT03175224 ) .
  • “PTPRZ-MET fusions are known to cause aggressive forms of GBM and are associated with poor prognosis.
  • We are pleased to achieve positive clinical results in patients with this deadly disease, further demonstrating the potential of vebreltinib as a new treatment for patients with cancers driven by MET alterations,” said Guo-Liang Yu, Ph.D., co-founder, Chairman and Chief Executive Officer of Apollomics.
  • GBM with MET fusion is an indication pursued by Apollomics and its China partner, Avistone Biotechnology.

BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)

Retrieved on: 
Thursday, September 28, 2023
Columbia University, PDAC, Pancreatic cancer, AACR, CXCR4, PRS, Hope, BioLineRx, Immunotherapy, Doctor of Philosophy, ASCO, TEL, MD, Patient, Pancreas, Columbia University Irving Medical Center, TASE, Cancer, Annual general meeting, American Society of Clinical Oncology, Liver, Rare, PD-1, American Association for Cancer Research, Gemcitabine, Partial-response maximum-likelihood, Society, Conference, Pharmaceutical industry

TEL AVIV, Israel, Sept. 28, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced encouraging data from the single-arm pilot phase of the investigator-initiated CheMo4METPANC Phase 2 combination clinical trial evaluating the company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

Key Points: 
  • The data were published in an online abstract as part of the American Association of Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts from September 27-30, 2023.
  • The pilot phase of the Phase 2 study enrolled 11 patients with metastatic pancreatic cancer.
  • A poster of the amended clinical trial design was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2-6 in Chicago, Illinois (see abstract ).
  • Most pancreatic cancer is incurable and unfortunately newer immunotherapy approaches, while beneficial against other solid tumor types, have had limited efficacy in pancreatic cancer due to immunosuppressive pathways.

Molecular Templates, Inc. Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Thursday, August 10, 2023
Intellectual property, PR, Therapy, PD, Symantec Endpoint Protection, Bank statement, Neoplasm, Immunomodulatory imide drug, Food, Aes, Food and Drug Administration, RECIST, MHC, Cancer, Bristol Myers Squibb, NSCLC, Immunoglobulin A, Bone disease, Sale, Monocyte, CD8, HIV disease progression rates, MDSC, PD-L1, Patient, CMV, TME, Biology, BMS, Private placement, FDA, ETB, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Partial-response maximum-likelihood, WalletHub, BCMA, Safety, Conference, Pharmaceutical industry, Nursing, Medical imaging, Security (finance), Vaccine, Medical device, Palladium

Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.

Key Points: 
  • Revenues for the second quarter of 2023 were $6.9 million, compared to $4.4 million for the same period in 2022.
  • Revenues for the second quarter of 2023 were comprised of revenues from collaborative research and development agreements with Bristol Myers Squibb and grant revenue from CPRIT.
  • Total research and development expenses for the second quarter of 2023 were $13.4 million, compared with $21.4 million for the same period in 2022.
  • Total general and administrative expenses for the second quarter of 2023 were $5.2 million, compared with $6.6 million for the same period in 2022.

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

Renaissance Pharma launches today and announces the in-licensing of Hu14.18K322A (Hu14.18) from St. Jude Children’s Research Hospital for the treatment of High-Risk Neuroblastoma

Retrieved on: 
Tuesday, August 1, 2023
Neuroblastoma, Maintenance, Pharma, Journal of Clinical Oncology, Survival, OS, Cancer, Record, Regulatory Agencies, Haematopoietic system, EMA, Senior, Radiation, Journal, Patient, GD2, Physician, Mab, European Journal of Oncology Nursing, EFS, Hospital, Phase, FDA, Partial-response maximum-likelihood, Pharmaceutical industry, Vaccine, Jude the Apostle, MD, Renaissance

Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.

Key Points: 
  • Jude”) for Hu14.18, a humanised antibody in development by St. Jude for the treatment of newly diagnosed high-risk neuroblastoma.
  • 50% of neuroblastoma patients have high-risk (HRNB) disease which has an overall survival of ~50% over 5 years3.
  • Lee Morley, Executive Chairman of Renaissance Pharma, said: “We couldn’t be more motivated by the prospect of bringing Hu14.18 to patients.
  • Renaissance Pharma now has its full attention on bringing this humanised antibody to market as expeditiously as possible.

MAIA Biotechnology Reports Updates on Disease Control Rates for THIO-101 Phase 2 Trial for Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, July 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Symantec Endpoint Protection, NYSE, RECIST, Neoplasm, Part, Partial-response maximum-likelihood, CPI, Patient, NSCLC, Safety, Pharmaceutical industry

MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced updates on disease control data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

Key Points: 
  • MAIA Biotechnology, Inc. (NYSE American: MAIA) today announced updates on disease control data in the Part A safety lead-in of its ongoing THIO-101 phase 2 trial, evaluating THIO in sequential combination with cemiplimab in patients with advanced Non-Small Cell Lung Cancer (NSCLC).
  • Of the first 11 patients enrolled in THIO-101 to complete at least 1 post baseline response assessment, 9 (82%) met the primary endpoint of disease control (defined as a Complete Response, Partial Response, or Stable Disease per RECIST 1.1).
  • All patients enrolled have previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC.
  • “The 82% disease control rate observed so far with this combination is highly encouraging, especially in the heavily pre-treated population with previous immune CPI resistance, where typically the Disease Control Rates are in the 25-35% range.

Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress

Retrieved on: 
Friday, June 9, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Pancytopenia, Complete Response Letter, Graft-versus-host disease, Intraparenchymal hemorrhage, European Hematology Association, CRS, Relapse, Encephalopathy, DLT, EMD, Rhizomucor, Dexamethasone, LBL, Congress, AML, Hematological Cancer Research Investment and Education Act, Cytokine release syndrome, EHA, Symantec Endpoint Protection, Mortality, Partial-response maximum-likelihood, Tumor microenvironment, Natural killer T cell, Acute myeloid leukemia, ORR, Safety, Disease, Pharmaceutical industry, Vaccine, Patient

“We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.

Key Points: 
  • “We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.
  • Many children and adults relapse after first line therapy and are left with very limited treatment options thereafter, often leading to high mortality.
  • Prior to enrollment, all patients had been heavily pretreated, with a median of 5 prior lines of therapy.
  • No cases of Graft versus Host Disease (GvHD), prolonged T-cell aplasia, or pancytopenia in the absence of disease were reported.

Atara Biotherapeutics Presents Updated Tab-cel® Clinical Effectiveness Data at ASCO 2023

Retrieved on: 
Monday, June 5, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Lymphoma, Northwest Biotherapeutics, EAP, Epstein–Barr virus, PRS, Symantec Endpoint Protection, EBV, PCNS, Cancer, HCT, SOT, ASCO, TTR, American Society of Clinical Oncology, MD, Patient, Microsoft Access, PTLD, Annual general meeting, ATRA, CR, Partial-response maximum-likelihood, Safety, Society, ORR, Disease, PR, Vaccine, Pharmaceutical industry

The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.

Key Points: 
  • The results will be featured in a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6 in Chicago.
  • Atara supported 27 EAP requests in Europe for patients with relapsed or refractory (r/r) Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) following solid organ transplant (SOT) or hematopoietic cell transplant (HCT).
  • “These data provide important insights on the effectiveness of EBVALLO™ in the real-world treatment setting,” said Dr. Sylvain Choquet, Head of the Clinical Hematology Department at Pitié-Salpêtrière, Paris, France.
  • Detailed results on baseline demographics and disease characteristics, and additional safety data including tab-cel exposure details, will be shared at the conference.

Artiva Biotherapeutics Presents Initial Data from First-in-Human Phase 1/2 Clinical Trial of AB-101 at the 2023 ASCO Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Complete Response Letter, Rituximab, Graft-versus-host disease, Northwest Biotherapeutics, Febrile neutropenia, CRS, Umbilical cord, Cyclophosphamide, NK, Toxicity, Șaeș, ASCO, Combination therapy, Bone marrow suppression, American Society of Clinical Oncology, Patient, Standard of care, Cytopenia, Annual general meeting, Steroid, Symantec Endpoint Protection, Partial-response maximum-likelihood, Society, Neurotoxicity, ORR, Safety, Vaccine, Pharmaceutical industry, Fever

Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.

Key Points: 
  • Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101.
  • The presentation will take place on Monday, June 5, during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
  • Myelosuppression, consistent with standard lymphodepletion regimens, was the most common Grade ≥ 3 toxicity, but was manageable with standard of care.
  • In the combination cohort, only one unrelated Grade 3 SAE of pyrexia was noted.​ There were no treatment-related AEs leading to discontinuation of AB-101.​