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    Home > Active Ingredient News > Antitumor Therapy > CD25 ADC shows positive treatment results in phase 1 clinical | Yimai Meng broke the news

    CD25 ADC shows positive treatment results in phase 1 clinical | Yimai Meng broke the news

    • Last Update: 2021-06-04
    • Source: Internet
    • Author: User
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    ★Pharmaceutical financingVenus Biosciences today completed hundreds of millions of RMB in Pre-A+ round of financing , CICC-Qide’s exclusive lead investment June 1, 2021/eMedClub News/--Recently, a commercial biotechnology company ADC Therapeutics announced its new anti-conjugate drug (ADC) camidanlumab targeting CD25 The results of the Phase 1 clinical trial of tesirine (Cami) were published on The Lancet Haematology, which is mainly used to treat relapsed/refractory Hodgkin and non-Hodgkin's lymphoma.

    The results of the trial showed that the overall response rate (ORR) for the treatment of Hodgkin’s lymphoma was 86% in the recommended starting dose of the Phase 2 Cami trial.

    Mehdi Hamadani, MD, professor of internal medicine in the Department of Hematology and Oncology at the Medical College of Wisconsin, said: “There is a huge unmet medical need for new therapies to improve the prognosis of patients with relapsed and refractory Hodgkin’s lymphoma.

    This patient population usually has Received a large number of pre-treatments.
    In this study, patients received a median of 5 systemic treatments.
    The
    phase 1 study showed that patients with relapsed or refractory Hodgkin’s lymphoma provide new treatment options.
    Encouraging potential.

    "Cami clinical trial results are positive ADC Therapeutics is a commercial-stage biotechnology company that improves the lives of cancer patients through its next-generation targeted antibody drug conjugates (ADC).

    The company is advancing its proprietary PBD-based ADC technology to change the treatment model for patients with hematological malignancies and solid tumors.

    ADC is a new type of drug consisting of a monoclonal antibody targeting a specific tumor-associated antigen and a payload coupled to the antibody, combining the targeted delivery of monoclonal antibodies with the tumor-killing potential of the payload.

    Cami is a product candidate for CD25-targeted ADCs.
    It is made up of CD25 monoclonal antibody HuMax-TAC ​​(licensed by Genmab) loaded with pyrrole benzodiazepine (PBD) dimer toxin warhead.

    Once Cami binds to target cells (can be CD25-expressing tumor cells or CD25-expressing Tregs), Cami will be internalized into the cell and the enzyme releases toxins to kill the target cell.

    Previously, the company's anti-conjugate drug (ADC) ZYNLONTA ™ (loncastuximab tesirine-lpyl) targeting CD19 has been approved by the FDA for the treatment of relapsed or refractory diffuse disease after two or more lines of systemic therapy B-cell lymphoma, which also uses the unique cytotoxin of PBD dimer.

    Recommended reading: FDA approved the first CD19-targeted ADC drug, and Linglu Pharmaceuticals owns Chinese rightsYimai Meng revealed that in the microenvironment of solid tumors, PBD dimer toxins released by combining with Tregs can also kill surrounding tumors At the same time, PBD dimer toxin has also been shown to induce immunogenic cell death.

    ▲ The pyrrole benzodiazepine (PBD) dimer cytotoxin has a unique mechanism of action (picture source: ADC Therapeutics official website) Cami's phase 1 trial is a multi-center, open-label, single-arm, dose-escalation and dose-extended Clinical trial, the trial recruited a total of 133 adult patients, of which 77 (58%) had classic Hodgkin’s lymphoma and 56 (42%) had non-Hodgkin’s lymphoma.

    The main results of the trial: the ORR of the total patient group was 58%, and 38 of 130 patients (29%) achieved complete remission.

    In a large number of pre-treated Hodgkin lymphoma patients, the ORR was 71%, and 32 of 77 patients (42%) achieved complete remission.

    In the pool of Hodgkin's lymphoma patients who received 45ug/kg (recommended starting dose for Phase 2), the ORR was 86%, and 18 of 37 patients (49%) achieved complete remission.

    In patients with Hodgkin’s lymphoma treated with 30ug/kg, the ORR was 55%, and it was reported that 7 of 20 patients (35%) achieved complete remission.

    Among patients with non-Hodgkin's lymphoma, the ORR was 38%, and 5 of 53 patients (9%) achieved complete remission.

    The overall median duration of remission for all patients with Hodgkin’s lymphoma was 6.
    6 months, and for patients with Hodgkin’s lymphoma treated at 45ug/kg it was 7.
    2 months.

    Cami showed acceptable safety.
    The most common adverse events included elevated liver enzymes (without liver synthesis dysfunction), rash, fatigue, edema or fluid accumulation, and nausea.

    Based on the results of the Phase 1 clinical trial, the Phase 2 trial is underway to further evaluate the safety and effectiveness of Cami in patients with relapsed or refractory Hodgkin’s lymphoma.

    In addition, the anti-tumor activity of Cami as a single agent showed positive results in the interim data of phase 2 clinical trials, with an ORR of 83%, a complete remission rate of 38%, and no new safety signals.

    These data highlight that Cami has great potential to meet the needs of receiving multiple treatments in the early stage.

    Summary Antibodies are popular drugs.
    At present, a large number of developers have poured in.
    Among them, ADC has a very promising development prospect and firmly attracts a large number of companies.

    Many leading companies have emerged in the foreign ADC field.
    Domestic competition has not yet heated up, and overall it is still in the blue ocean stage. Recommended reading: One wave is not flat, one wave rises again! Shijian Biologics Trop2 ADC application for clinical applicationYimai Meng broke the news that FDA approved the first CD19-targeted ADC drug, and Linglu Pharmaceutical has Chinese rights.
    Yimai Meng broke the news that it is actively deploying ADC! Qilu Pharma introduces MUC1 ADC drugYi Mai Meng broke the news reference materials: 1.
    https:// 2.
    WuXi AppTec "Express | Innovative ADC preliminary clinical trial results are positive, Hodge The total remission rate of patients with golden lymphoma can reach 86%.
    ” Yimike has always been committed to original news reports such as cutting-edge technologies, industry trends, and industry insights in bio-innovative drugs.
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