Alveolar soft part sarcoma

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

Retrieved on: 
Monday, November 13, 2023
CD38, Malignancy, PD-L1, Immunomodulatory imide drug, Neck, Bristol Myers Squibb, Research, Head, Alveolar soft part sarcoma, HIV disease progression rates, Patient, Part, ETB (company), TME, Therapy, Immunoglobulin A, Cancer, Symantec Endpoint Protection, BCMA, CMV, CPS, Biology, Pharmaceutical industry, Nursing, Vaccine, Medical imaging, Engineered wood

The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.

Key Points: 
  • The net loss attributable to common shareholders for the third quarter of 2023 was $4.2 million, or $0.82 per basic share and per diluted share.
  • Revenues for the third quarter of 2023 were $6.8 million, compared to $4.2 million for the same period in 2022.
  • Total research and development expenses for the third quarter of 2023 were $7.6 million, compared with $22.0 million for the same period in 2022.
  • Total general and administrative expenses for the third quarter of 2023 were $4.3 million, compared with $5.9 million for the same period in 2022.

Kineta Announces Positive KVA12123 Monotherapy Safety and Biomarker Data from its Ongoing Phase 1/2 VISTA-101 Clinical Trial

Retrieved on: 
Tuesday, October 3, 2023
Radiation, CRS, Clinical trial, DLT, Cancer, IL-6, Head, NSCLC, Immunotherapy, Neck, Alveolar soft part sarcoma, Non-small-cell lung cancer, RO, Cytokine release syndrome, Patient, VISTA, TME, Toxic leukoencephalopathy, Infrared spectroscopy correlation table, Ovarian cancer, Pembrolizumab, Safety, Pharmaceutical industry, Vaccine, Kineta, Part

“We are very pleased with the progress of our Phase 1/2 clinical trial, showing very compelling initial safety and pharmacokinetic data for KVA12123, which we believe significantly de-risks VISTA as a novel drug target,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta.

Key Points: 
  • “We are very pleased with the progress of our Phase 1/2 clinical trial, showing very compelling initial safety and pharmacokinetic data for KVA12123, which we believe significantly de-risks VISTA as a novel drug target,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta.
  • Primary objectives of the Phase 1/2 study are to evaluate the safety and tolerability of KVA12123 and to determine the recommended Phase 2 dose (RP2D).
  • The company will continue escalating monotherapy dose cohorts of KVA12123 in Part A and initiate Part B of the study to evaluate KVA12123 in combination with pembrolizumab.
  • Initial monotherapy efficacy data are anticipated in Q4 2023 and will be presented, along with safety data, at an upcoming medical conference.

Mineralys Therapeutics Announces Expansion of Planned Phase 2 Trial of Lorundrostat Alone and in Combination with SGLT2 Inhibitor to Treat Patients with Chronic Kidney Disease (CKD)

Retrieved on: 
Monday, July 17, 2023
Enzyme inhibitor, ARB, Optimism, Chronic kidney disease, Terminal, EGFR, Part, SGLT2, Alveolar soft part sarcoma, ASI, Hypertension, Proteinuria, Aldosterone, Patient, FAHA, Risk, ACE, Therapy, CKD, Safety, Pharmaceutical industry

RADNOR, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced details of an expanded two-part Phase 2 clinical trial for lorundrostat as a potential therapy to treat patients with Stage 2 to 4 chronic kidney disease (CKD), which is expected to start enrolling patients in the second half of 2023.

Key Points: 
  • “We are excited to move ahead with this trial to evaluate lorundrostat as a treatment for CKD.
  • This trial builds upon the amelioration of aldosterone-mediated uncontrolled hypertension we observed in our Target-HTN trial of lorundrostat.
  • “There is a growing consensus for the use of an SGLT2 inhibitor as a component of CKD treatment.
  • Subjects will receive either once daily combination treatment of lorundrostat 50 mg plus dapagliflozin 10 mg or placebo for 12 weeks.

EQS-News: CureVac Doses First Patient in Phase 1 Study of Cancer Vaccine Candidate for Surgically Resected Glioblastoma

Retrieved on: 
Tuesday, June 20, 2023
Vaccination, CureVac, Part, Messenger, Glioblastoma, Astrocytoma, Alveolar soft part sarcoma, HIV disease progression rates, Patient, Epitope, CVAC, Safety, Vaccine

CVGBM is based on CureVac’s proprietary second-generation mRNA backbone and features a single mRNA, encoding eight epitopes derived from known tumor-associated antigens with demon­strated relevance in glioblastoma.

Key Points: 
  • CVGBM is based on CureVac’s proprietary second-generation mRNA backbone and features a single mRNA, encoding eight epitopes derived from known tumor-associated antigens with demon­strated relevance in glioblastoma.
  • “We are excited to enter the execution phase of our cancer vaccine development strategy with a study that is designed to establish proof-of-principle for our advanced second-generation mRNA backbone in oncology,” said Dr. Myriam Mendila, Chief Development Officer of CureVac.
  • CVGBM is administered as a monotherapy after surgical resection and completion of radio­therapy with or without chemotherapy.
  • The study will consist of two parts, a dose-escalation part (Part A) and a dose-expansion part (Part B).

Y-mAbs Announces Presentation of GD2-SADA Study at ASCO

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Friday, May 26, 2023
Carcinoma, Radioimmunotherapy, Melanoma, Alveolar soft part sarcoma, Neoplasm, American Society of Clinical Oncology, Cancer, Research, Part, Sarcoma, Patient, Memorial Sloan Kettering Cancer Center, MSK, Liver, Poster, Massachusetts Institute of Technology, Therapy, Society, Safety, Pharmaceutical industry, Vaccine

Dose escalation is based two patients in cohort 1 and 2, followed by a classical 3+3 design.

Key Points: 
  • Dose escalation is based two patients in cohort 1 and 2, followed by a classical 3+3 design.
  • The study is actively enrolling, and the Company expects Parts A, B, and C will include 18, 12, and 32 patients, respectively, across 6-10 U.S. sites.
  • In a second infusion, a radioactive payload designed specifically to target the SADA molecules attached to the tumor target.
  • Researchers at MSK developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs.

Alnylam and Regeneron Report Positive Interim Phase 1 Clinical Data on ALN-APP, an Investigational RNAi Therapeutic for Alzheimer’s Disease and Cerebral Amyloid Angiopathy

Retrieved on: 
Wednesday, April 26, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, DSM-IV codes, ALN, Central nervous system, Cerebral amyloid angiopathy, CAA, Therapy, Bachelor of Medicine, Bachelor of Surgery, Eye, Clinical trial, Brain, Biomarker, Cerebrospinal fluid, CNS, Medication, Gene silencing, Spectrochimica Acta Part B, Patient, RNA interference, APP, Alveolar soft part sarcoma, FDA, Safety, Pharmaceutical industry, Medical device, Regeneron Pharmaceuticals, Part, Alnylam Pharmaceuticals

Twenty patients have been enrolled in three single-dose cohorts in Part A of the ongoing Phase 1 study in patients with early-onset Alzheimer’s disease.

Key Points: 
  • Twenty patients have been enrolled in three single-dose cohorts in Part A of the ongoing Phase 1 study in patients with early-onset Alzheimer’s disease.
  • All adverse events were mild or moderate in severity, with available cerebrospinal fluid data for white blood cells and protein appearing similar to placebo.
  • Early data for neurofilament light chain from a subset of cohorts (2 of 3 studied) looked comparable to placebo.
  • A live audio webcast of the call will be available on the Investors section of the Company’s website at www.alnylam.com/events .

Y-mAbs Announces First Patient Dosed in Phase 1 Clinical Trial of GD2-SADA

Retrieved on: 
Wednesday, April 5, 2023
PK, Disassembler, Carcinoma, Radioimmunotherapy, Interim, Melanoma, Therapy, Neoplasm, Cancer, Part, Alveolar soft part sarcoma, Sarcoma, Patient, Memorial Sloan Kettering Cancer Center, MSK, Liver, Massachusetts Institute of Technology, Safety, Vaccine

“We are excited to advance our SADA platform into the clinic for the first time with the initiation of patient dosing in this trial.

Key Points: 
  • “We are excited to advance our SADA platform into the clinic for the first time with the initiation of patient dosing in this trial.
  • This is a significant milestone for Y-mAbs in our efforts to potentially build a global franchise of radiotherapeutic assets,” said Thomas Gad, Founder, President, and Interim CEO.
  • “SADA can potentially generate the clinical data to further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses.
  • The Company expects a total of approximately 60 patients to be enrolled in the trial across 6-10 U.S. sites.

MAIA Biotechnology Reports Positive Topline Data from Part A Safety Lead-In of THIO-101 Phase 2 Trial for Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, April 11, 2023
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MAIA Biotechnology, Inc. (NYSE American: MAIA ) today announced positive topline data from the completed Part A safety lead-in of the Company’s THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and has commenced recruitment in Part B randomized efficacy/dose selection.

Key Points: 
  • MAIA Biotechnology, Inc. (NYSE American: MAIA ) today announced positive topline data from the completed Part A safety lead-in of the Company’s THIO-101 Phase 2 go-to-market trial in advanced Non-Small Cell Lung Cancer (NSCLC) and has commenced recruitment in Part B randomized efficacy/dose selection.
  • Topline data from Part A demonstrated that MAIA’s telomere-targeting agent, THIO, administered in sequential combination with Regeneron’s anti-PD-1 therapy, Libtayo® (cemiplimab), were generally well-tolerated.
  • Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients.
  • For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

Press Release:  Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis

Retrieved on: 
Monday, January 30, 2023
Inflammation, Bruise, Eosinophilic esophagitis, Safety, Conjunctivitis, European Commission, Eosinophilia, Ageing, EC, Esophagus, Alveolar soft part sarcoma, Patient, Union, Arthralgia, DSQ, Choking, Infection, Pain, Pharmaceutical industry, Medical imaging, EU, EOE, Dupilumab, Part

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.
  • The safety profile through 52 weeks was generally consistent with the safety profile observed at 24 weeks.

Caribou Biosciences Reports CB-010 ANTLER Phase 1 Trial Progress

Retrieved on: 
Monday, December 12, 2022
TRAC, RNA, Western literature, Rachel Haurwitz, Patient, Fast Track, Clinical trial, Annual report, Medicine, CST, CAR, Security (finance), FDA, University of California, Food, Safety, DNA, Phenotype, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Next, PD-1, Allotransplantation, ASH, Infrared spectroscopy correlation table, Spectrochimica Acta Part B, Risk, CR, Reindeer, Alveolar soft part sarcoma, Multicenter Automatic Defibrillator Implantation Trial, Orphan drug, CRISPR/Cpf1, Research, CRISPR, Genome, Lymphatic system, University, Vaccine, Pharmaceutical industry

BERKELEY, Calif., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported new 12-month clinical data from cohort 1 in the ongoing ANTLER Phase 1 trial, which show long-term durability following a single infusion of CB-010 at the initial dose level 1 (40x106 CAR-T cells). Cohort 1 results show:

Key Points: 
  • Today at the 64th Annual ASH meeting, a trial-in-progress poster is being presented to provide details of the design and objectives of the ANTLER Phase 1 trial for CB-010 in r/r B-NHL.
  • Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases.
  • “Caribou Biosciences” and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.
  • Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason.