Ovarian cancer

Orphan designation: Raludotatug deruxtecan Treatment of ovarian cancer, 19/02/2024 Positive

Retrieved on: 
Thursday, April 18, 2024
Ovarian cancer, 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 ovarian 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:

Orphan designation: Upifitamab rilsodotin Treatment of ovarian cancer, 09/12/2022 Positive

Retrieved on: 
Thursday, April 18, 2024
Community, Diagnosis, Civil service commission, Ovarian cancer, Cell death, Prevalence, Cell division, Disease, Clinical, Patient, Committee, EMA, IRIS, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of ovarian cancer in the European Union on 9 December 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • Upifitamab rilsodotin is composed of an antibody that binds NaPi2b and a drug called AF-HPA which prevents cell division, resulting in cell death.
  • 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:

Cardiff Oncology Presents Novel Preclinical Data at AACR Annual Meeting 2024 that Supports Ongoing First-line RAS-mutated mCRC Clinical Study

Retrieved on: 
Monday, April 8, 2024
Ovarian cancer, Cetuximab, CRDF, RAS, Patient, Bev, PLK1, Abstract, AACR, Bevacizumab, Cancer, Phase, Data, SCLC, Pharmaceutical industry

In combination, the abstracts underscore the significant potential of the company’s lead molecule onvansertib in metastatic colorectal cancer (mCRC) and other cancers.

Key Points: 
  • In combination, the abstracts underscore the significant potential of the company’s lead molecule onvansertib in metastatic colorectal cancer (mCRC) and other cancers.
  • In addition, we are particularly encouraged by our RAS-mutated mCRC preclinical data highlighting onvansertib’s ability to inhibit activation of the hypoxia pathway via the regulation of HIF1α.
  • All the abstracts are available on the AACR Online Program and will be published in the online Proceedings of the AACR.
  • Following the presentation, the posters will be posted to the “ Scientific Presentations ” section of the Cardiff Oncology website.

Medigene Presents Favorable Safety Profile of TCR-T Cells with Costimulatory Switch Protein at AACR Annual Meeting 2024

Retrieved on: 
Monday, April 8, 2024
TME, Toxicity, Ovarian cancer, Sarcoma, Tissue, Synovial sarcoma, IND, AACR, Safety, Immune system, Melanoma, TCR, Poster, CSP, Stomach, PD-L1, Vaccine

Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).

Key Points: 
  • Impaired T cell functionality and T cell exhaustion are driven by several factors within the hostile solid tumor microenvironment (TME).
  • This is one major factor that allows cancer cells to proliferate and metastasize without being recognized by the host immune system.
  • Enhanced, gated T cell functionality of CSP-armored rTCR-T cells increased secretion of interferon-γ (IFNγ) only when tumor cells simultaneously expressed the pHLA target antigen and PD-L1.
  • Rapid and sustained killing of 3D tumor cell-derived spheroids only occurred when PD-L1-positive tumor cells simultaneously expressed the specific pHLA target antigen.

Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

Retrieved on: 
Wednesday, April 3, 2024
Ovarian cancer, BofA Securities, PIN, U.S. FDA, Shearman, Webcast, Patient, Fast Track, Goldman Sachs, Morgan Stanley, LLP, Acquisition, Cancer, Spacecraft, Cooley LLP, DKK, Shearman & Sterling, ADC, USD, Law, Food, Pharmaceutical industry

Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

Key Points: 
  • Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).
  • The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms.
  • The addition of Rina-S to Genmab’s portfolio will enable Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors.
  • Based on the data from the ongoing Phase 1/2 clinical trial Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors.

Phio Pharmaceuticals Reports 2023 Year End Financial Results and Provides Business Update

Retrieved on: 
Tuesday, April 2, 2024
Skin care, Research, Lung cancer, Ovarian cancer, DP, Head, Conference, Face, Cell, Skin cancer, Immunotherapy, TIL, Clinical, Cancer, Cervical cancer, HNSCC, George Washington University, Patient, Gene, American Academy, D&O, IND, Centricity, AACR, Glioblastoma, Skin, Breast cancer, Scalp, Melanoma, Patent, SITC, Private law, FDA, BRD4, Food, Pharmaceutical industry

MARLBOROUGH, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ RNAi platform technology is designed to make immune cells more effective in killing tumor cells, today reported its financial results for the year ended December 31, 2023 and provided a business update.

Key Points: 
  • The latter clearance was significant since there are no drugs specifically approved to treat early stages I and II of cSCC.
  • As of February, the first two patients in our first cohort have completed treatment with PH-762 with no reported adverse events.
  • In 2023 we implemented a cost rationalization program driven by our transition from discovery research to product development.
  • At December 31, 2023 we had cash of $8.5 million as compared with $11.8 million at December 31, 2022.

HCW Biologics Reports Fourth Quarter 2023 and Fiscal Year End Financial Results And Business Highlights

Retrieved on: 
Monday, April 1, 2024
Research, Court of Chancery, Notifiable disease, Ovarian cancer, JAMS, Prejudice, District court, Inflammation, Patient, Sale, News, G&A, University, Cancer, Trial of the century, Bank statement, Loss, Complaint, Pancreatic cancer, Patent, Probability, Court, Pharmaceutical industry

MIRAMAR, Fla., April 01, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2023.

Key Points: 
  • MIRAMAR, Fla., April 01, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its fourth quarter and fiscal year ended December 31, 2023.
  • Dr. Hing C. Wong, Founder and CEO of HCW Biologics, stated, “These are exciting times at HCW Biologics.
  • Revenues: Revenues for the fourth quarters ended December 31, 2022 and 2023 were $1.3 million and $1.3 million, respectively.
  • Net loss: Net loss for the fourth quarters ended December 31, 2022 and 2023 were $5.4 million and $10.7 million, respectively.

Predictive Oncology Reports Year End 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
Consultant, CRH, Ovarian cancer, Conference call, Conference, Survival, Science, Intelligence, Drug discovery, Webcast, BIO, Research, Holocene, UPMC, KOL, G&A, Call, GMP, UPMC Magee-Womens Hospital, Cloud computing, CLIA, Drug development, Machine learning, Marketing, Artificial intelligence, Cryptocurrency

The company reported a net loss of approximately $14 million on total revenue of approximately $1.8 million for the year ended December 31, 2023.

Key Points: 
  • The company reported a net loss of approximately $14 million on total revenue of approximately $1.8 million for the year ended December 31, 2023.
  • “Perhaps most notably, we announced last quarter that we successfully delivered the results of our first campaign with Cancer Research Horizons.
  • Revenues for the years ended December 31, 2023, and December 31, 2022, were primarily derived from its Eagan operating segment.
  • Conference call and webcast details:
    Predictive Oncology management will host an investor conference call and webcast on Monday, April 1st, at 8:30am EDT.

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.

Aspira Women’s Health Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
Research, Ovarian cancer, California Department, Conference call, Conference, Development, MicroRNA, Artificiality, Patient, Travel, Cancer, Information technology, AUP, Society, Gynaecology, AACR, Poster, Medicare, Marketing, CMS, Human resources, Federal, Medi-Cal, Cryptocurrency

AUSTIN, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today reported its financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Aspira will be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements.
  • Aspira will be reimbursed at a rate of $897 for all Ova1Plus tests processed for Medi-Cal patients meeting applicable coverage requirements.
  • Gross profit margin was 57.5% for the year ended December 31, 2023, compared to 52.8% for the year ended December 31, 2022.
  • Subsequent to the end of the quarter, Aspira raised $5.5 million in gross proceeds in a registered direct offering and concurrent private placement.