Carcinoma

Orphan designation: Tarlatamab Treatment of small cell lung cancer, 12/01/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Carcinoma, Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of small cell lung cancer on 12 January 2024.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • For information on ongoing clinical trials in the EU, see:
    Key facts
    - Active substance
    - Tarlatamab
    - Intended use
    - Treatment of small cell lung cancer
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2876
    - Date of designation
    - Sponsor
    Minervum 7061
    4817 ZK Breda
    The Netherlands
    Tel.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Treatment of small cell lung cancer, 19/02/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Carcinoma, Patient, Committee, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of small lung cell cancer on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

EQS-News: Abivax reports 2023 financial results and operational update

Retrieved on: 
Wednesday, April 10, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Auron Unveils Preclinical Data Supporting its Lead Program and Ability of its AURIGIN™ Platform to Generate Targeted Cancer Therapies at AACR Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
KAT2B, Gene, Algorithm, Growth, AML, Carcinoma, DRIVE, Biomarker, Acute myeloid leukemia, Cancer, AI, Developmental biology, NEPC, Senior, Translation, AACR, Doctor of Philosophy, Neoplasm, Therapy, Machine learning, Annual general meeting, Vaccine

NEWTON, Mass., April 09, 2024 (GLOBE NEWSWIRE) -- Auron Therapeutics, a biotechnology company focused on developing next-generation targeted therapies by identifying and inhibiting the oncogenic cell states of cancer, today announced two poster presentations at the American Association for Cancer Research (AACR) Annual Meeting. The Company highlighted the distinct ability of its AURIGIN™ platform to identify both cell state plasticity, the proliferative state in which cancer cells grow, and the causative gene targets. In a second poster, Auron shared preclinical data from its program targeting KAT2A/B, an AURIGIN-identified histone acetyltransferase driving small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and acute myeloid leukemia (AML). These data led to the nomination of AUTX-703, an orally available and selective KAT2A/B degrader development candidate, for which Auron expects to file an IND in 2024.

Key Points: 
  • The Company highlighted the distinct ability of its AURIGIN™ platform to identify both cell state plasticity, the proliferative state in which cancer cells grow, and the causative gene targets.
  • In a second poster, Auron shared preclinical data from its program targeting KAT2A/B, an AURIGIN-identified histone acetyltransferase driving small cell lung cancer (SCLC), neuroendocrine prostate cancer (NEPC), and acute myeloid leukemia (AML).
  • These data led to the nomination of AUTX-703, an orally available and selective KAT2A/B degrader development candidate, for which Auron expects to file an IND in 2024.
  • “The understanding that cellular plasticity contributes to aggressive and treatment-resistant tumor growth underscores the need for innovative, targeted approaches.

ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer

Retrieved on: 
Monday, April 8, 2024
JHU, NCI, Development, Carcinoma, CRADA, National Cancer Institute, MSKCC, IND, Investigational New Drug, Genomics, Immune system, Bangladesh Technical Education Board, FDA, SCLC, Food, Pharmaceutical industry

This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

Key Points: 
  • This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.
  • The trial ( NCT06287775 ) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”.
  • “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.
  • “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annual Meeting

Retrieved on: 
Sunday, April 7, 2024
Skin cancer, Immunotherapy, Risk, Patient, SAN, RP1, University, MD Anderson Cancer Center, Society, AACR, Carcinoma, CSCC, SITC, PD-L1, Skin, Pharmaceutical industry

The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).

Key Points: 
  • The results were initially presented late last year at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC).
  • In the evaluable patient population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC) and three had merkel cell carcinoma.
  • Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline.
  • RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers.

23andMe to Present Data on Two Clinical Stage Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting 2024

Retrieved on: 
Friday, April 5, 2024
23andMe, Prevalence, Plasma, Genetics, NKG2D, Patient, SAN, Neoplasm, Data, Endothelium, Immunodeficiency, Cancer, Adenocarcinoma, PBMC, Biology, CD200, AACR, Therapy, Immunohistochemistry, NK, Carcinoma, The Cancer Genome Atlas, PD-1, Vaccine

Data also show soluble ULBP6 is a dominant immunosuppressor compared to other soluble NKG2D ligands due to its highest binding affinity to NKG2D among all NKG2D ligands.

Key Points: 
  • Data also show soluble ULBP6 is a dominant immunosuppressor compared to other soluble NKG2D ligands due to its highest binding affinity to NKG2D among all NKG2D ligands.
  • ULBP6 is a stress-induced ligand that is upregulated on the surface of cancer cells and binds to the activating immunoreceptor NKG2D found on NK and T cells.
  • The presentations will be available on the 23andMe Investor Relations and Therapeutics websites on April 8, 2024.
  • Title: 23ME-01473, a novel anti-ULBP6/2/5 monoclonal antibody, reinvigorates anti-tumor NK cell function through NKG2D and FcγRIIIa activation

Abivax reports 2023 financial results and operational update

Retrieved on: 
Tuesday, April 2, 2024
Q&A, Nomination, New Drug Application, Patient, Shanda, MRO, G&A, IND, EQT, Marketing, Research, EST, McKinsey & Company, Carcinoma, Schering-Plough, Partnership, Webcast, SVP, IBD, Inflammatory Bowel Diseases, American College, Safety, Phase 10, Compensated emancipation, BB Biotech, URD, IPO, F2G, Sofinnova, FDA, AbbVie, EUR, Abstract, Takeda, Pharmaceutical industry

Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.

Key Points: 
  • Total number of employees at the end of December 2023 was 61 and significantly increased compared to 2022, due to the implementation of the U.S. and European operational infrastructure.
  • Cash position (including other financial assets of EUR 9.0M) at the end of 2023 was EUR 261.0M, compared to EUR 27.0M at the end of 2022.
  • A webcast will be organized on Monday, April 8, 2024, at 2:30 p.m. CEST (8:30 a.m. EST) following the announcement of the 2023 yearly results.
  • The Abivax management will give an overview of the Company’s 2023 highlights and projects going forward, followed by a live Q&A session.

Genelux Corporation Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 1, 2024
Research, Lung cancer, Medical school, Shanghai Jiao Tong University, Carcinoma, Fast track (FDA), Form, Patient, G&A, School, IPO, Hope, Security (finance), Guggenheim Partners, Investment, Platinum, Interim, Genelux Corporation, FDA, Pharmaceutical industry

WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.

Key Points: 
  • – $23.2 million in cash, cash equivalents and short-term investments –
    WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.
  • Currently, 21 sites have been activated to enroll patients with additional sites identified and in various stages of activation ( NCT05281471 ).
  • Genelux and our partner Newsoara co-sponsor the trial, which is being conducted by Newsoara in greater China.
  • Cash, cash equivalents and short-term investments were $23.2 million as of December 31, 2023 compared to $0.4 million on December 31, 2022.