VEGF

Adverum Biotechnologies Reports First Quarter 2024 Financial Results and Provides Pipeline Highlights

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четверг, мая 9, 2024

REDWOOD CITY, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the first quarter of 2024. The company also provided recent pipeline highlights.

Key Points: 
  • “Our presentation will feature a 26-week landmark interim analysis, which is expected to serve as the basis of our FDA end-of-Phase 2 meeting.
  • The award was granted under the Adverum Biotechnologies, Inc. 2017 Inducement Plan, as amended and restated, and will vest over four years, subject to continued service with Adverum.
  • Stock-based compensation expense included in research and development expenses was $1.1 million for the first quarter of 2024.
  • Stock-based compensation expense included in general and administrative expenses was $3.0 million for the first quarter of 2024.

Therini Bio Announces Positive Preclinical Data Supporting the Development of THN391 in Neurodegenerative Ocular Diseases

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среда, мая 8, 2024

SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases. The data was detailed in a poster presented by Aaron Kantor, Ph.D., Head of Translational Sciences at Therini Bio, at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle, WA, on May 7, 2024.

Key Points: 
  • SACRAMENTO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Therini Bio, Inc., a clinical-stage biotech company developing fibrin-targeting immunotherapies for neurodegenerative diseases driven by vascular dysfunction, today announced positive preclinical data supporting the development of its lead candidate, THN391, for the treatment of neurodegenerative ocular diseases.
  • Therini Bio has developed a potential first-in-class therapeutic monoclonal antibody, THN391, that is designed to selectively block fibrin-mediated neuroinflammation without interfering with fibrin’s coagulation properties.
  • In preclinical models of macular degeneration and diabetic retinopathy, THN391 and its analogs demonstrated effectiveness in protecting against vascular and neuronal degeneration.
  • “We are very encouraged by our data demonstrating the effectiveness of THN391 in rodent models of neurodegenerative ocular diseases,” said Joel Naor, M.D., Chief Medical Officer - Ophthalmology at Therini Bio.

XyloCor Therapeutics Positive EXACT Phase 2 Data for Lead Candidate XC001 Simultaneously Presented at Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions and Published in Circulation: Cardiovascular Interventions

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четверг, мая 2, 2024

XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented final results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions, May 2-4, 2024 in Long Beach, CA.

Key Points: 
  • XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented final results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions, May 2-4, 2024 in Long Beach, CA.
  • These encouraging results supporting XC001’s safety and efficacy potential are being simultaneously published in Circulation: Cardiovascular Interventions .
  • XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor (VEGF) isoforms.
  • In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through minimally-invasive transepicardial delivery (direct administration to the heart).

EQS-News: Formycon announces commercial launch of FYB201 (Ranibizumab) in Canada (RanoptoTM) and Switzerland (Ranivisio®)

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пятница, мая 3, 2024

Press release // April 11, 2024

Key Points: 
  • Press release // April 11, 2024
    Commercial launch opens up additional key markets in Europe and North America, making FYB201 available in a total of 17 countries worldwide
    Munich, Germany – Formycon AG (FSE: FYB) and Bioeq AG announce the commercial launch of FYB201, a biosimilar to Lucentis®1(Ranibizumab), in Canada and Switzerland.
  • The launch follows the marketing authorization granted by Health Canada under the trademark RanoptoTM2and Swissmedic under the trademark Ranivisio®3.
  • FYB201 was developed by Bioeq AG, a joint venture between Formycon AG and Polpharma Biologics Group BV.
  • In Canada and Switzerland, FYB201 has been approved for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious retinal diseases.

Panbela Announces Poster Presentation at American Association for Cancer Research:

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четверг, апреля 18, 2024

MINNEAPOLIS, April 18, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA)(“Panbela”), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024.

Key Points: 
  • MINNEAPOLIS, April 18, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA)(“Panbela”), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024.
  • Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines.
  • The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden.
  • Details of the presentation are as follows:
    Additional meeting information can be found on the AACR website: https://www.aacr.org/meeting/aacr-annual-meeting-2024/abstracts/

Isarna Therapeutics Announces Phase 2 Clinical Data Presentations at Upcoming Ophthalmology Conferences

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четверг, мая 2, 2024

Isarna Therapeutics today announced upcoming oral presentations at the OIS Retina Innovation Summit on May 4th and the Association for Research in Vision and Ophthalmology (ARVO) Meeting on May 7th, both in Seattle, WA.

Key Points: 
  • Isarna Therapeutics today announced upcoming oral presentations at the OIS Retina Innovation Summit on May 4th and the Association for Research in Vision and Ophthalmology (ARVO) Meeting on May 7th, both in Seattle, WA.
  • Isarna’s Chief Medical Officer, Prof. Marion R. Munk, will present updated clinical data from its Phase 2 BETTER study evaluating the company’s lead program, ISTH0036.
  • ISTH0036 is an RNA-based antisense molecule that blocks the production of transforming growth factor-beta (TGF-β), a leading driver of fibrosis in ophthalmic pathology.
  • Patients selected for the trials included both newly diagnosed patients and those who have already been treated with anti-VEGF therapeutics.

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2024

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среда, мая 1, 2024

Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2024.
  • In January 2024, followed by a presentation at ELCC 2024 in March 2024, Akeso announced updates from its Phase II AK112-201 trial data.
  • Also at ELCC 2024, Summit and Akeso highlighted promising ivonescimab Phase II data in NSCLC patients with brain metastases.
  • Operating cash outflow for the three months ended March 31, 2024 and 2023 was $30.1 million and $13.1 million, respectively.

Arsenal Biosciences Announces First Patient Dosed in Phase 1/2 Clinical Trial of AB-2100 in Development as a Treatment for Clear-cell Renal Cell Carcinoma

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вторник, апреля 30, 2024

Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, today announced that the first patient has been dosed with AB-2100 in a multi-center, open-label Phase 1/2 clinical trial for patients with clear-cell renal cell carcinoma (ccRCC).

Key Points: 
  • Arsenal Biosciences, Inc. (ArsenalBio), a clinical stage programmable cell therapy company focused on engineering advanced CAR T-cell therapies for solid tumors, today announced that the first patient has been dosed with AB-2100 in a multi-center, open-label Phase 1/2 clinical trial for patients with clear-cell renal cell carcinoma (ccRCC).
  • These engineering features will potentially enable the patient’s immune system to destroy ccRCC cells without harming normal tissues.
  • “Kidney cancer is an immunologically responsive malignancy with several FDA approved immunotherapies on the market.
  • A multi-center, open-label phase 1 dose escalation trial ( NCT05617755 ) of AB-1015, under investigation for the treatment of ovarian cancer, is currently enrolling.

Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

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пятница, апреля 26, 2024

The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland.

Key Points: 
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland.
  • If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2
    “People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes.
  • The trial investigated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC.
  • Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC.

MEI Pharma Board of Directors Aligns on Strategy to Advance Voruciclib and ME-344

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четверг, апреля 11, 2024

With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.

Key Points: 
  • With the MEI Board aligned around our strategy, we have a productive framework to advance both clinical programs in a manner intended to address significant medical needs while prioritizing a measured and objective-based allocation of our resources,” said David Urso, president and chief executive officer of MEI Pharma.
  • The plan builds on encouraging recently reported voruciclib clinical data and ME-344 data separately reported today.
  • Under the plan, the ongoing voruciclib development strategy will be guided by future clinical trial results and applicable regulatory authority advice.
  • The goal of the formulation effort is to increase biological activity, improve patient convenience of administration and increase commercial opportunity.