Soft-tissue sarcoma

Telix 2023 Full Year Results: Inaugural Profit Achieved, Strong Revenue Growth Underpins Investment in Late-stage Pipeline

Retrieved on: 
Thursday, February 22, 2024
Marketing, Crown, Growth, U.S. FDA, BLA, Soft-tissue sarcoma, TLX, Ethics, ASX, Commercialization, Webcast, AEDT, Patient, Biologics license application, NDA, Research, Depreciation, Prostate cancer, Pharmaceutical industry

MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.

Key Points: 
  • MELBOURNE, Australia, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023.
  • Dr Christian Behrenbruch, Managing Director and Group CEO commented:
    “This is an excellent result which demonstrates the strength of the Telix business model.
  • Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.
  • Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.

Philogen provides update on pre-planned interim analysis of the Phase III FIBROSARC trial investigating Onfekafusp alfa (L19TNF) in patients with first-line advanced or metastatic Soft Tissue Sarcoma

Retrieved on: 
Tuesday, February 20, 2024
PFS, Soft-tissue sarcoma, MD, Doxorubicin, Progression-free survival, Risk, Science Translational Medicine, Safety, STS, Death, Patient, BIT, CSO, Phase, DSMB, Control arm, Pharmaceutical industry

SIENA, Italy, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that the Phase III FIBROSARC trial (NCT04650984) will continue as planned by the protocol. The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.

Key Points: 
  • The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis.
  • FIBROSARC is a Phase III 1:1 randomized trial (NCT04650984) which studies L19TNF in combination with doxorubicin (Experimental Arm) versus doxorubicin alone (Control Arm) in 118 patients as first-line therapy for advanced or metastatic Soft Tissue Sarcoma (STS).
  • The Phase III FIBROSARC trial was designed to demonstrate a significant clinical benefit of L19TNF plus doxorubicin compared to doxorubicin alone.
  • For more information about Onfekafusp alfa (also known as Fibromun), FIBROSARC Phase III study (NCT04650984), Soft Tissue Sarcoma, and Philogen, please visit https://www.philogen.com/investors/press-releases/ .

Orphan designation: (S)-N-(1-(3-Fluoro-2'-methoxy-[1,1'-biphenyl]-4-yl)-2-oxopiperidin-3-yl)-5-(pyridin-2-yl)thiophene-2-sulfonamide Treatment of soft-tissue sarcoma, 13/12/2023 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, IRIS, European Commission, Soft-tissue sarcoma, Committee, Patient, EMA, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - (S)-N-(1-(3-Fluoro-2'-methoxy-[1,1'-biphenyl]-4-yl)-2-oxopiperidin-3-yl)-5-(pyridin-2-yl)thiophene-2-sulfonamide
    - Intended use
    - Treatment of soft-tissue sarcoma
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2861
    - Date of designation
    - Sponsor
    Selabtec Sciences S.L.
  • Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • 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:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Intensity Therapeutics Reports Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 13, 2023
Cisplatin, Component, Food, Therapy, Toxicity, Treatment, Sarcoma, ODD, US Foods, IND, Exercise, Intensity, Administration, Soft-tissue sarcoma, Research, IPO, Plague, Cancer, Survival, R, Research and development, Security, Neoplasm, Metastasis, Pharmaceutical industry, Security (finance), Cryptocurrency, Patient

SHELTON, Conn., Nov. 13, 2023 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), a late-stage biotechnology company that applies novel engineered chemistry to discover and develop proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today reported financial results for the third quarter ended September 30, 2023, and provided a corporate update.

Key Points: 
  • "Metastatic soft tissue sarcoma continues to plague cancer patients who have poor survival outcomes and insufficient therapeutic options.
  • Presented Positive INT230-6 Data in Patients with Refractory Soft Tissue Sarcoma at the Connective Tissue Oncology Society (CTOS).
  • In November, the Company presented positive data from its ongoing Phase 1/2 clinical trial of INT230-6 at the CTOS annual meeting.
  • In July, Intensity announced that it had closed its IPO with the full exercise of its over-allotment option.

Adcendo ApS to Present Data on the Expression of the Novel ADC target uPARAP in Soft Tissue and Bone Sarcoma at the 2023 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Thursday, April 13, 2023
Abstract (summary), Molecular epidemiology, AACR, Drug development, Bone sarcoma, Catholic higher education, Faculty of Theology, Catholic University of Leuven, University Hospitals Cleveland Medical Center, KU, American Association for Cancer Research, Soft-tissue sarcoma, STS, Sarcoma, Cancer, UZ Leuven, ADC, Poster, Receptor (biochemistry), Spacecraft, Laboratory, Tumor microenvironment, Cooper University Hospital, Medical imaging, KU Leuven

Based on its differentiated expression profile, uPARAP is an attractive novel target for development of uPARAP-targeting ADCs in a broad range of sarcoma subtypes.

Key Points: 
  • Based on its differentiated expression profile, uPARAP is an attractive novel target for development of uPARAP-targeting ADCs in a broad range of sarcoma subtypes.
  • Additionally, uPARAP receptor levels may serve as a potential biomarker for patient enrichment in clinical studies of such uPARAP-targeting ADCs.
  • Dominik Mumberg, Chief Scientific Officer of Adcendo, said: "We are excited to share data on the expression of uPARAP in soft tissue and bone sarcoma.
  • In addition to its differentiated expression profile in multiple sarcoma subtypes uPARAP is a constitutively recycling endocytic receptor with unique internalization properties, making it a highly attractive ADC target."

Adcendo ApS to Present Data on the Expression of the Novel ADC target uPARAP in Soft Tissue and Bone Sarcoma at the 2023 American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Thursday, April 13, 2023
Abstract (summary), Molecular epidemiology, AACR, Drug development, Bone sarcoma, Catholic higher education, Faculty of Theology, Catholic University of Leuven, University Hospitals Cleveland Medical Center, KU, American Association for Cancer Research, Soft-tissue sarcoma, STS, Sarcoma, Cancer, UZ Leuven, ADC, Poster, Receptor (biochemistry), Spacecraft, Laboratory, Tumor microenvironment, Cooper University Hospital, Medical imaging, KU Leuven

Based on its differentiated expression profile, uPARAP is an attractive novel target for development of uPARAP-targeting ADCs in a broad range of sarcoma subtypes.

Key Points: 
  • Based on its differentiated expression profile, uPARAP is an attractive novel target for development of uPARAP-targeting ADCs in a broad range of sarcoma subtypes.
  • Additionally, uPARAP receptor levels may serve as a potential biomarker for patient enrichment in clinical studies of such uPARAP-targeting ADCs.
  • Dominik Mumberg, Chief Scientific Officer of Adcendo, said: "We are excited to share data on the expression of uPARAP in soft tissue and bone sarcoma.
  • In addition to its differentiated expression profile in multiple sarcoma subtypes uPARAP is a constitutively recycling endocytic receptor with unique internalization properties, making it a highly attractive ADC target."

2023 Kappa Delta Ann Doner Vaughn Award Presented to Michelle Ghert, MD, FRCSC, and the PARITY Investigators for First-Ever International Multi-Center Randomized Controlled Trial in Orthopaedic Oncology

Retrieved on: 
Friday, February 10, 2023
Cefuroxime, Clostridioides, Caregiver, Christianity in Singapore, McMaster University, Journal, Infection, Bone, Pelvic floor dysfunction, American Medical Association, Korea Disease Control and Prevention Agency, The Journal of Bone and Joint Surgery, Antibiotic prophylaxis, Antibiotic-associated diarrhea, Clostridioides difficile, Medicine, Patient, Cancer, Cefazolin, Megacolon, Staphylococcus, Oncology, Kappa Delta, Biostatistics, Incidence, Database, Bone sarcoma, Research, RCT, Soft-tissue sarcoma, Tibia, Mortality, Amputation, Risk, FRCSC, CDC, Optimism, Staphylococcus aureus, Immune system, Femur, Survival, MD, SSI, Quality of life, Surgeon, Bone disease, Doctor of Philosophy, JAMA Oncology, Dentistry, Pharmaceutical industry

Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating.

Key Points: 
  • Their work resulted in the first-ever international, multi-center randomized controlled trial (RCT) in orthopaedic oncology as well as the largest collaborative effort in orthopaedic surgery with regards to the number of countries collaborating.
  • "However, in orthopaedic oncology, where we treat rare diseases, it was a shift in our research paradigm.
  • I give a lot of credit to the first few clinical sites that joined the study as they took a leap of faith."
  • The PARITY investigators work resulted in 13 manuscripts published in peer-reviewed journals, including The Journal of the American Medical Association (Oncology).

Novel Antibody Therapies Market, 2035 - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 1, 2022
Health, Pharmaceutical, Growth, Lymphoma, Administration, Hairy cell leukemia, Antibody, Membrane protein, Combination therapy, Cell, Acute myeloid leukemia, Precursor cell, Partnership, Prostate, Graft-versus-host disease, Prostate cancer, Protein, T-cell lymphoma, Urinary bladder, Soft-tissue sarcoma, Bladder cancer, Research, Therapy, Immunotoxin, Mycosis fungoides, Publication, Type, B-cell lymphoma, Hodgkin lymphoma, Vaccine, Risk management, Pharmaceutical industry

The "Novel Antibody Therapies Market: Distribution by Type of Novel Antibody, Target Indication, Type of Therapy, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Novel Antibody Therapies Market: Distribution by Type of Novel Antibody, Target Indication, Type of Therapy, Route of Administration, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035" report has been added to ResearchAndMarkets.com's offering.
  • The 'Novel Antibody Therapies Market, 2022-2035' report features an extensive study on the current market landscape, offering an informed opinion on the likely evolution of the novel antibody therapies in the treatment of various diseases.
  • What are the different initiatives undertaken by big pharma players for the development of novel antibody therapies in the recent past?
  • How is the current and future market opportunity, related to novel antibody therapies likely to be distributed across key market segments?

United States Soft Tissue Sarcoma Pipeline Market Analysis and Competitive Landscape Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 2, 2022
Health, General Health, Competitive landscape, Research, Sarcoma, Epidemiology, Soft-tissue sarcoma, Medical imaging

The "US Soft Tissue Sarcoma Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US Soft Tissue Sarcoma Market and Competitive Landscape - 2022" report has been added to ResearchAndMarkets.com's offering.
  • The report provides comprehensive insights into Soft Tissue Sarcoma pipeline products, Soft Tissue Sarcoma epidemiology, Soft Tissue Sarcoma market valuations and forecast, Soft Tissue Sarcoma drugs sales and competitive landscape in the US.
  • Soft Tissue Sarcoma pipeline: Find out the products in clinical trials for the treatment of Soft Tissue Sarcoma by development phase 3, phase 2, and phase 1, by pharmacological class and companies developing the products
    Soft Tissue Sarcoma drugs: Identify key products marketed and prescribed for Soft Tissue Sarcoma in the US, including trade name, molecule name, and company
    Soft Tissue Sarcoma drugs sales: Find out the sales revenues of Soft Tissue Sarcoma drugs in the US
    Soft Tissue Sarcoma market valuations: Find out the market size for Soft Tissue Sarcoma drugs in 2021 in the US.
  • Find out how the market advanced from 2019 and forecast to 2027
    Soft Tissue Sarcoma drugs market share: Find out the market shares for key Soft Tissue Sarcoma drugs in the US
    Evaluate commercial market opportunity assessment, positioning, and segmentation for Soft Tissue Sarcoma products
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221102005552/en/

Avacta Announces AVA6000 Receives Orphan Drug Designation From the US Food and Drug Administration

Retrieved on: 
Monday, September 5, 2022
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Safety, Pharmacokinetics, Neoplasm, AIM, Degenerative disease, Sarcoma, Disease, US Foods, American Cancer Society, Food, ODD, Soft-tissue sarcoma, FDA, Radiation, Group, Orphan drug, Plasma protein binding, Adult, Doxorubicin, Review, Patient, Pharmaceutical industry, Medical imaging, Asota avacta

Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer and pre|CISION platforms, announces that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the companys lead pre|CISION drug candidate, AVA6000, for treatment of soft tissue sarcoma.

Key Points: 
  • Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer and pre|CISION platforms, announces that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the companys lead pre|CISION drug candidate, AVA6000, for treatment of soft tissue sarcoma.
  • This designation qualifies the developer of the drug for certain incentives, including, seven years of market exclusivity upon drug approval from the FDA.
  • This designation provides tax credits and other incentives for drug developers addressing rare diseases.
  • Most notably the Orphan Drug Designation will give Avacta, if AVA6000 is approved for treatment of soft tissue sarcoma, seven years of market exclusivity in the US, which is a significant commercial advantage.