ESMO

Purple Biotech Presents Data of its Phase 1 Head & Neck Cancer of NT219 in combination with Cetuximab at ESMO TAT Congress 2024

Retrieved on: 
Tuesday, February 27, 2024
Head, Neoplasm, DCR, Cetuximab, ESMO, Aes, Drug resistance, Escape Room, Immunotherapy, SCCHN, University, Nausea, Squamous-cell carcinoma, Tumor microenvironment, Patient, Congress, HPV, Plasma, Colorectal cancer, Pharmaceutical industry

REHOVOT, Israel, Feb. 27, 2024 (GLOBE NEWSWIRE) --   Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced clinical results from its Phase 1/2 dose escalation study of NT219 in combination with cetuximab in the treatment of patients with recurrent/metastatic head and neck cancer (R/M SCCHN).

Key Points: 
  • The Phase 1/2 dose escalation study (NCT04474470) evaluated NT219 as a monotherapy in various indications and in combination with cetuximab in the treatment of R/M SCCHN and colorectal cancer.
  • As of cut-off date of January 25, 2024:
    Seventeen patients with R/M SCCHN were enrolled in the combination arm of NT219 + cetuximab.
  • The median number of prior lines of therapy was 2 and 94% of the patients received prior immunotherapy.
  • “We were encouraged to see anti-tumor activity in HPV negative patients,” said Dr. Michael Schickler, Purple Biotech’s Head of Clinical and Regulatory Affairs.

Arvinas Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 27, 2024
CDK4, ESPP, Research, BCL6, Sale, Exercise, LRRK2, ARVN, CDK7, ATM, HER2, Genentech, European Medicines Agency, Congress, Development, Breast cancer, Pfizer, CBR, ESMO, Everolimus, Greyhawk, ESR1, Oncology, Enrollment, Investment, Insurance, Prostate cancer, PFS, Food, Ribociclib, Bayer, Administration, Patient, Neutropenia, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Median PFS of 11.1 and 11.0 months in patients with ESR1 wild-type and ESR1 mutant tumors, respectively.
  • Announced the appointment of Randy Teel, Ph.D., Arvinas’ current senior vice president of corporate and business development, to the role of interim chief financial officer and treasurer.
  • The Arvinas Board of Directors has launched a formal search process to identify Mr. Cassidy’s permanent replacement.
  • Revenues: Revenue was $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023 as compared with $131.4 million and $38.0 million for the year and quarter ended December 31, 2022.

Lirum Therapeutics Presents Positive Data on LX-101, a Novel Clinical-Stage Targeted Therapy, at the 2024 ESMO Targeted Anticancer Therapies Congress; Highlighting LX-101’s Potential in IGF-1R Prominent Cancers

Retrieved on: 
Monday, February 26, 2024
Neoplasm, ESMO, Therapy, Patient, Poster, Oncology, Pharmaceutical industry

Lirum’s presentation “LX-101, a novel, clinical-stage, payload-bearing IGF-1R targeted therapy demonstrates activity in patients with high IGF-1R tumor expression” will be presented in the Hall Bordeaux at the Palais des Congrès.

Key Points: 
  • Lirum’s presentation “LX-101, a novel, clinical-stage, payload-bearing IGF-1R targeted therapy demonstrates activity in patients with high IGF-1R tumor expression” will be presented in the Hall Bordeaux at the Palais des Congrès.
  • The poster presentation covers patient outcomes in the previous Phase 1a studies with LX-101, with a focus on those patients that we determined to have high IGF-1R tumor expression.
  • The poster presentation is available on the Lirum website ( www.lirumtx.com ) under the Investors and Media tab.
  • Lirum is also developing LX-101 in certain autoimmune diseases, including thyroid dye disease, where IGF-1R has been clinically and commercially validated.

CEL-SCI Corporation Issues Letter to Shareholders

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Head, Neck, EMA, Health Canada, ESMO, Condition, Neoadjuvant therapy, Plasma protein binding, Neoplasm, Immunotherapy, Physician, Marketing, SCCHN, FDA, Food, BLA, Letter, Risk, European, Patent, COVID, Patient, Policy, MHRA, NOCC, United, Survival, Congress, NIHR, Diagnosis, Pembrolizumab, CGMP, PD-L1, Radiation, Pharmaceutical industry

CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
  • This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • These features make it easy to write a label for Multikine, which is essential for drug approval.

Oncolytics Biotech® Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Thursday, March 7, 2024
Neoplasm, Research, Toxicity, SCCA, FOLFIRINOX, Trifluridine/tipiracil, PR, Society, Breast, Health, Poster, Immunotherapy, Anal cancer, Pancreatic cancer, Fast Track, Anal, Progression-free survival, SITC, Pelareorep, Annual general meeting, Congress, Cancer, Gastrointestinal cancer, AB, International, Cohort, ESMO, Conference, Safety, TILS, Tumor microenvironment, Clinical trial, Survival, MOA, Oncology, Colorectal cancer, TIL, Blood, FDA, TSX, Thought, Pancreatic Cancer Action Network, Anal canal, PDAC, Patient, ONC, Pharmaceutical industry

ET

Key Points: 
  • ET
    SAN DIEGO and CALGARY, AB, March 7, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the fourth quarter and year ended December 31, 2023.
  • General and administrative expenses for the fourth quarter of 2023 were $4.2 million, compared to $3.7 million for the fourth quarter of 2022.
  • Research and development expenses for the fourth quarter of 2023 were $4.7 million, compared to $4.8 million for the fourth quarter of 2022.
  • The net loss for the fourth quarter of 2023 was $3.9 million, compared to a net loss of $8.6 million for the fourth quarter of 2022.

J INTS BIO, Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, accepted for presentation at the upcoming American Association for Cancer Research 2024 meeting in USA (AACR 2024)

Retrieved on: 
Monday, February 26, 2024
NSCLC, Traffic barrier, Severance Hospital, EGFR, ESMO, ASCO, Permeability, Catholic University of Korea, National Cancer Center, Hospital, Asan Medical Center, AACR, Society, University, Seoul National University Hospital, Patient, Clinical trial, Oncology, Mutation, Trial of the century, Cancer, Pharmaceutical industry

J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.

Key Points: 
  • J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.
  • The topic of the presentation is "Phase 1/2 clinical trial of JIN-A02, a 4th generation EGFR-TKI for 3rd generation EGFR-TKI resistant patients in EGFR mutated advanced/metastatic non-small cell lung cancer".
  • In August last year, J INTS BIO registered the first patient for the global Phase 1/2 clinical trial of 'JIN-A02' at Severance Hospital in Korea.
  • A J INTS BIO official said, "The global clinical trial for 'JIN-A02' is progressing well and is receiving interest in the global market."

J INTS BIO, Phase 1/2 study of 'JIN-A02', a Novel Oral 4th Generation EGFR TKI, accepted for presentation at the upcoming American Association for Cancer Research 2024 meeting in USA (AACR 2024)

Retrieved on: 
Monday, February 26, 2024
NSCLC, Traffic barrier, Severance Hospital, EGFR, ESMO, Multimedia, ASCO, Permeability, Catholic University of Korea, National Cancer Center, Hospital, Asan Medical Center, AACR, Society, University, Seoul National University Hospital, Patient, Clinical trial, Oncology, Mutation, Trial of the century, Cancer, Pharmaceutical industry

J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.

Key Points: 
  • J INTS BIO will present a poster during the "Phase I Clinical Trials in Progress" session, which will be held on April 8 from 1:30 to 5:00 p.m.
  • The topic of the presentation is "Phase 1/2 clinical trial of JIN-A02, a 4th generation EGFR-TKI for 3rd generation EGFR-TKI resistant patients in EGFR mutated advanced/metastatic non-small cell lung cancer".
  • In August last year, J INTS BIO registered the first patient for the global Phase 1/2 clinical trial of 'JIN-A02' at Severance Hospital in Korea.
  • A J INTS BIO official said, "The global clinical trial for 'JIN-A02' is progressing well and is receiving interest in the global market."

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

Retrieved on: 
Friday, February 23, 2024
IIT, ESMO, ASCO, FDA, GEJ, Acceptability, ODD, Stomach, GC, Society, GI, Bone marrow, Patient, Clinical trial, CDE, Oncology, IND, Chinese, Epithelial cell adhesion molecule, Pharmaceutical industry

SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ).

Key Points: 
  • EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low.
  • IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ".
  • She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China.
  • Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells.

CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

Retrieved on: 
Thursday, February 15, 2024
Oncology, Health, FDA, Manufacturing, Clinical Trials, Other Manufacturing, Pharmaceutical, Head, Neck, EMA, Health Canada, ESMO, Condition, Neoadjuvant therapy, Physician, Marketing, SCCHN, Food, BLA, Risk, European, Patient, Policy, United, NOCC, Congress, NIHR, Diagnosis, Corporation, Research, Plasma protein binding, Pharmaceutical industry

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter.
  • CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.

Medigene Announces Indication Selection for the Clinical Development of its Lead 3rd Generation TCR-T Therapy Program in Solid Tumors

Retrieved on: 
Monday, February 12, 2024
Incidence, Progression-free survival, Co-stimulation, ESMO, HLA, Quality of life, Cancer, Sarcoma, AACR, Stomach, Planegg, Ovarian cancer, Patient, Synovial sarcoma, PD-L1

MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by costimulatory switch protein PD1-41BB

Key Points: 
  • MDG1015 is a first-in-class, third generation TCR-T therapy targeting NY-ESO-1/ LAGE-1a, armored and enhanced by costimulatory switch protein PD1-41BB
    Planegg/Martinsried, February 12, 2024.
  • Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, today announced the selection of gastric cancer, ovarian cancer and two types of soft tissue sarcomas, myxoid/round cell liposarcoma and synovial sarcoma, as the initial clinical indications for its lead candidate MDG1015.
  • Preclinical data presented in 2023 at the AACR and ESMO conferences demonstrated the clear potential of MDG1015 to improve clinical outcomes in solid tumors.
  • “The selection of these cancers as targets for MDG1015 is an important step as we advance towards the first-in-human trial.