MRD

Adaptive Biotechnologies Provides Strategic Review Update and Announces Preliminary First Quarter 2024 Revenue

Retrieved on: 
Tuesday, April 2, 2024
MRD, Adaptation, Interim, Genetics, Investment, ADPT, CFO, Management

Management will provide further details on the process and outcome of the strategic review during the conference call this afternoon.

Key Points: 
  • Management will provide further details on the process and outcome of the strategic review during the conference call this afternoon.
  • Total revenue of approximately $41 to $43 million for the first quarter of 2024, an increase of approximately 12% compared to the first quarter of 2023.
  • MRD revenue of approximately $31 to $32 million for the first quarter of 2024, an increase of approximately 47% compared to the first quarter of 2023.
  • Adaptive Biotechnologies announced that Tycho Peterson, chief financial officer (CFO), will be departing the company to pursue another opportunity.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

IMUNON Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
Transfer, Ovarian cancer, Immunotherapy, Patient, Lung, Vaccine, Good manufacturing practice, Sale, CMC, IND, Bangladesh Technical Education Board, IPR, Investment, Clinical trial, Neoplasm, Research, Primate, DNA, NOL, MD Anderson Cancer Center, Trial of the century, ITT, Safety, MRD, Interim, Silicon Valley Bank, Vaccination, Food, CMOS, Elsevier, CD8, Drug discovery, SVB, CRS, University, Death, SARS-CoV-2, Earnings call, Lassa mammarenavirus, PFS, Immunoglobulin G, FDA, OS, CD4, Temperature, Progression-free survival, COVID-19, Mouse, Messenger, Human, Wistar Institute, Hospital

LAWRENCEVILLE, N.J., March 28, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immuno-oncology therapies and next-generation vaccines, today reported financial results for the year ended December 31, 2023. The Company also provided an update on its clinical development programs with IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase 2 clinical development for the treatment of first-line, locally advanced-stage ovarian cancer, and on its PlaCCine modality, a proprietary mono- or multi-cistronic DNA plasmid and a synthetic DNA delivery technology for the expression of pathogen antigens in preclinical studies for the development of next-generation vaccines.

Key Points: 
  • “We remain on track to report topline results mid-year from the OVATION 2 Study with IMNN-001 in advanced ovarian cancer.
  • In September 2023, the Company announced interim PFS and OS data with IMNN-001 in its OVATION 2 Study.
  • The Company is hosting a conference call to provide a business update, discuss 2023 financial results and answer questions at 10:00 a.m. Eastern time today.
  • To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll) and ask for the IMUNON 2023 Earnings Call.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

Retrieved on: 
Monday, March 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

Exai Bio to Present New Breast Cancer Data at the American Association for Cancer Research (AACR) 2024 Annual Meeting

Retrieved on: 
Monday, April 8, 2024
Oncology, Medical Devices, Health, Genetics, Clinical Trials, Biotechnology, Survival, Patient, RNA, DNA, Cancer, University, Biology, Woman, AACR, Catalog, Breast cancer, MRD, DCIS, Blood, Medical imaging

Exai Bio today announced new breast cancer data at the American Association for Cancer Research (AACR) 2024 annual meeting.

Key Points: 
  • Exai Bio today announced new breast cancer data at the American Association for Cancer Research (AACR) 2024 annual meeting.
  • In addition, the study showed the platform’s unique capability to distinguish low grade, less aggressive DCIS from invasive breast cancer with 87% sensitivity, at 90% specificity using a standard blood sample.
  • These results suggest the potential for Exai's platform to aid in tailoring adjuvant treatment for individual triple negative breast cancer patients.
  • oncRNAs are actively secreted from living cancer cells and are stable and abundant in the blood of cancer patients.

Hartwig and Ultima Genomics Collaborate to Reduce Costs for Whole Genome Cancer Profiling, Minimal Residual Disease Testing and Generating Genetic Data at Scale

Retrieved on: 
Monday, April 8, 2024
Biotechnology, Medical Devices, Health, Genetics, Oncology, Database, Genetic testing, Disease, Patient, NGS, Research, Cancer, Ultima, Architecture, MRD, Medical foundation, Hartwig, Blood, SNV, Medical imaging

This collaboration aims to reduce test costs and make complete genome-based cancer diagnostics accessible for more patients to have better informed cancer treatment.

Key Points: 
  • This collaboration aims to reduce test costs and make complete genome-based cancer diagnostics accessible for more patients to have better informed cancer treatment.
  • In parallel, platform strengths will be explored for minimal residual disease detection in blood of cancer patients with a one-size-fits-all solution that builds on pre-existing complete tumor profile information.
  • “Collaborating with Hartwig to deploy our technology toward whole genome cancer profiling, MRD testing and generating genomic information at scale is an exciting milestone,” said Gilad Almogy, CEO of Ultima Genomics.
  • Furthermore, lower costs can enable Hartwig to affordably create genetic datasets at national population scale to improve cancer research and ultimately outcomes for future patients.

Labcorp Announces Expansion of Precision Oncology Portfolio to Support Pharmaceutical, Biopharma, and Clinical Research in Advancing Drug Development Programs

Retrieved on: 
Monday, April 8, 2024
ACT, Gene, Biotechnology, Acceleration, LOH, CDX, Risk, Patient, NGS, Biomarker, Research, MSI, DNA, Cancer, Spacecraft, AACR, MRD, Recurrence, FDA, Health, Plasma, Neoplasm, Medicine, Pharmaceutical industry

BURLINGTON, N.C., April 8, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the strategic expansion of its precision oncology portfolio, solidifying its commitment to advancing cancer research and patient care on a global scale. The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market.

Key Points: 
  • The announcement underscores Labcorp's dedication to investing in scientific, diagnostic and laboratory innovations to support its pharmaceutical, biotechnology and clinical research partners in bringing groundbreaking therapies to market.
  • "Our portfolio expansion enhances our integrated services to empower our partners with the solutions and support they need to advance their development programs and make a lasting difference in patients' lives."
  • Labcorp recently announced the commercial availability of Labcorp Plasma Detect, the first clinically validated, tumor-informed, whole-genome sequencing circulating tumor DNA (ctDNA) MRD solution for research and investigational use.
  • Labcorp's deep scientific expertise and comprehensive solutions include specialized pre-clinical discovery, biomarker and companion diagnostics (CDx) development and post-commercialization capabilities.

Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date

Retrieved on: 
Friday, March 22, 2024
MYGN, Diagnosis, Genetic testing, Patent, Combinatorics, Genetics, Patient, Neoplasm, Research, DNA, Myriad Genetics, Doctor of Philosophy, Oncology, Medicine, University, MD Anderson Cancer Center, MRD, Intellectual property, FDA, Estate (law), Pharmaceutical industry

U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers Myriad’s foundational and proprietary method of preparing cell free DNA.

Key Points: 
  • U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers Myriad’s foundational and proprietary method of preparing cell free DNA.
  • This method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing.
  • Specifically, the patented method relates to the manner in which a sample is sufficiently enriched with ctDNA that it can be detected, if present, with high sensitivity and specificity.
  • “The 2016 filing date of this patent—at the advent of MRD development—highlights Myriad’s foresight about the potential role of tumor-derived cell-free DNA in the expanding field of cancer diagnostics,” said Paul J. Diaz, President and CEO, Myriad Genetics.

Vor Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Wednesday, March 20, 2024
Toxicity, Administration, Gene, Editas Medicine, CD33, AML, Patient, IND, Food and Drug Administration, Research and development, HSC, Lymphocyte, Phenotype, Clinical trial, MRD, FDA, Antigen, Pharmaceutical industry

The first patient was dosed in January 2024, and multiple patients are expected to be dosed in the first half of 2024.

Key Points: 
  • The first patient was dosed in January 2024, and multiple patients are expected to be dosed in the first half of 2024.
  • The Company expects to report further engraftment and protection data from the VBP101 clinical trial in the second half of 2024.
  • The increase in G&A expenses was primarily attributable to an increase in personnel expenses, including an increase in share-based compensation expense.
  • Net Loss: Net loss for the fourth quarter of 2023 was $26.3 million, compared to $23.9 million for the fourth quarter of 2022, and for the year ended December 31, 2023, was $117.9 million, compared to $92.1 million for the year ended December 31, 2022.

Allogene Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Update

Retrieved on: 
Thursday, March 14, 2024
Research, Kite Pharma, PIN, CLL, Disease, AID, Patient, EFS, Observation, Pivotal, Cancer, Renal cell carcinoma, Bank statement, News, RCC, Therapy, CRISPR, Projection, MRD, GAAP, Autoimmune disease, Cyclophosphamide, CD19, Pharmaceutical industry

These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.

Key Points: 
  • These restated financial statements have no impact on the Company’s cash, cash equivalents and marketable investments, cash runway or business operations.
  • Research and development expenses were $54.7 million for the fourth quarter of 2023, which includes $7.0 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $17.2 million for the fourth quarter of 2023, which includes $8.2 million of non-cash stock-based compensation expense.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.