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    Home > Medical News > Latest Medical News > Announcement of the clinical data of the new conjugation drug VDC!

    Announcement of the clinical data of the new conjugation drug VDC!

    • Last Update: 2021-12-07
    • Source: Internet
    • Author: User
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    Article source: Medical Rubik's Cube Pro

    Author: Haimer

    On November 15, American biopharmaceutical company Aura Biosciences announced its first virus-like drug conjugate (VDC) drug AU-011 in uncertain lesions (IL) and choroidal melanoma (choroidal melanoma, CM).
    Clinical data, including phase Ib/II safety and effectiveness data for intravitreal (IVT) injection, and phase II safety results for increased dose suprachoroidal (SC) administration


    Aura was founded in 2009 and is headquartered in Massachusetts, USA, dedicated to the development of targeted therapies for ophthalmic tumors and urinary system tumors
    In March of this year, Aura received US$80 million in financing led by Matrix Capital Management, and officially landed on Nasdaq on October 29, raising US$75.
    6 million, and its current market value is about US$590 million


    Aura's virus-like particle (VLP)-based technology platform enables the covalent binding of VLP to cytotoxic drugs to obtain VDC, which can selectively bind to heparan sulfate proteoglycan (HSPG) on the surface of solid tumors without binding to normal tissues.
    Thereby specifically killing tumor cells

    The development of this technology platform is based on the core discovery of the 2017 Lasker Prize winner Dr.
    John T.
    Schiller, who proved that VLP derived from human papillomavirus (HPV) can specifically bind to HSPG


    VLP is coupled with cytotoxic drugs to obtain VDC (Source: Aura official website)

    AU-011 is the fastest-growing VDC drug candidate in the Aura pipeline.
    It is used for the first-line treatment of CM and has been granted Fast Track and Orphan Drug Designation by the FDA

    AU-011 is unique in that it has a dual mechanism of action against tumors.
    First, its coupled powerful cytotoxic drug that can be activated by infrared light can produce high levels of singlet oxygen and specifically destroy the cell membrane of tumor cells.
    And organelles; secondly, after tumor cells rupture, neoantigens can be exposed and damage-related molecular patterns (DAMP) can be released, which further activates immune cells to produce an immune response and produce a killing effect on tumor cells

    This dual mechanism of action can be used for early treatment of primary lesions and can prevent distant metastasis of tumors


    AU-011's dual mechanism of killing tumors (Source: Aura official website)

    The Phase Ib/II clinical trial of AU-011 evaluated the safety and effectiveness of IVT administration in the treatment of IL and CM
    The trial included 56 patients, of which 14 patients with small but active tumors were treated with a two-cycle treatment plan, and the tumor growth rate, tumor control, and vision retention were evaluated as the efficacy endpoints

    After 12 months, the results showed that the tumor growth rate was significantly reduced, the tumor control rate was 64% (9/14), and the vision retention rate was 71%, which was significantly better than existing treatments


    The tumors of most patients are under control (Source: Aura official website)

    In terms of safety, AU-011 is generally safe and well tolerated.
    Adverse events such as intraocular inflammation and intraocular hypertension are all temporary, and the enrolled patients have no clinical sequelae

    A large number of patients (43/56) had tumors close to the fovea and optic disc of the retina.
    Only 2 patients with tumors located in the fovea experienced severe vision loss adverse events (SAE), and no other SAEs related to treatment were observed

    Affected by this good news, Aura shares rose 18.
    35% at the close of trading on November 15


    Aura stock price on November 15 (Source: Snowball)

    On the same day, Aura also announced the Phase II safety results of AU-011 SC administration
    In the preliminary safety data review of the initial dose escalation cohort (n=14), no treatment-related adverse events, meter-limiting toxicity, or grade 3/4 adverse events were reported

    Preliminary results show that AU-011 has positive safety and tolerability through SC administration


    Carol Shields, Director of Ophthalmology Oncology at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University, expressed his belief that AU-011 will provide patients with a safe and effective first-line treatment for early disease and protect their eyesight from damage.
    This is to ensure the quality of life of patients.
    The key part


    Note: The original text has been deleted

    Reference materials:

    [1] Aura Biosciences Presents Final Phase 1b/2 Data for its firstVirus-Like Drug Conjugate, AU-011, in Patients with Choroidal Melanoma at theAmerican Academy of Ophthalmology 2021 Annual Meeting (Source: Aura official website)

    [2] The new conjugate drug VDC is here! Aura completed a new round of financing of US$80 million, and its core products are moving towards phase III clinical trials (Source: Medical Rubik's Cube Pro)

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