The Antibody Society published a report at the end of November 2019, which considered drug advances in the field of antibodies. According to the report, by 2020, 12 antibodies will be approved for regulation in the US or EU. However, the two drugs in this report, enfortumab vedotin and trastuzumab deruxtecan, have already been approved by the US FDA before mid-to-late December 2019. Both drugs are ADC.
The following is a brief introduction to the remaining five antiretroviral drugs in this report. Among them, the first 5 with non-cancer indicators and the last three with cancer indications.
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Eptinezuma
Eptinezumab is an anti-IgG1 monoclonal antibody targeting the calcitonin-related peptide (CGRP) and was developed to prevent migraines. Migraine is a common chronic neurological disorder characterized by frequent headaches. CGRP is a neuropeptide that is released during a migraine attack, plays an important role in migraine pathophysiology, and is a popular target for migraine drug development.
To date, there have been 3 monoclonal antibody migraine therapies targeting CGRP and its receptors: Amgen and Novartis Aimovig (targeting CGRP receptors) and Teva Ajovy (targeting CGRP) at Lilly Emgality (targeting -CGRP). Eptinezumab, developed by Alder BioPharmaceuticals, is administered intravenously once a month. It has fast and complete bioavailability, has high specificity and a strong commitment to CGRP adherence, and has shown clinical differentiation in clinical trials. In some patients, it showed a 100% response rate. Currently, the drug is being reviewed by the US FDA. If approved, tanezumab will be the first anti-migraine drug to be injected into the bloodstream quarterly.
2. Teprotumuma
The drug is a human anti-IgG1 monoclonal antibody entirely targeted to growth-like insulin factor-1 receptor (IGF-1R) and was developed to treat moderate to severe thyroid disease (TED). TED is a progressive, autoimmune disease caused by autoantigens that activate the signaling properties of IGF-1R cells in orbit, leading to a series of side effects, causing long-term, irreversible damage, including exophthalmos, strabismus, diplopia, and even blindness.
Horizon Pharma developed the drug. The results of a phase III confirmation study of OPTIC published in March 2019 showed that compared with the placebo group, patients with the teprotumumab treatment group had significantly improved eyeballs (especially the last point, p <0.001). Data from a phase II study showed that treatment with teprotumumab led to a significant clinical decrease in exophthalmos and active TED symptoms (pain, inflammation, redness, inflammation).
Currently, the drug is being first reviewed by the US FDA, and the target date for PDUFA is March 8, 2020. Earlier, the FDA awarded the drug teprotumumab drug, orphan drug certification, and accelerated TED certification. Last month, the FDA's Dermatology and Ophthalmology Advisory Committee (DODAC) unanimously agreed on the potential benefits of teprotumumab for effective TED over-the-counter risks. If approved by the FDA, the drug will be the first to treat an effective TED.
3. Inebilizuma
Inebilizumab is an artificial anti-monoclonal antibody targeting CD19 and developed for optic neuromyelitis spectrum disorder (NMOSD), a rare, debilitating, social autoimmune disease, most common in women. The disease manifests itself repeatedly, and each relapse leads to a continuous accumulation of disability, including blindness and paralysis, and sometimes even premature death. About 80% of NMOSD patients have aquaporin-4 autoantibodies (AQP4). These autoantibodies are thought to be produced by plasmablasts and plasma cells, which bind primarily to CNS astrocytes, which begin to attack, damaging the optic nerve, spinal cord, and brain.
Developed by Viela Bio, the drug has a high affinity for CD19, a highly expressed protein in B cells, including plasmablasts and other plasma cells that release antibodies. Inebilizumab is currently under review by the US FDA. In the United States and the European Union, the drug has been granted the NMOSD orphan drug status and has been granted the NMOSD drug status in the United States.
4. Satralizuma
Natalizumab is an anti-interleukin 6 receptor (IL-6R) humanized monoclonal antibody designed for the treatment of NMOSD. NMOSD patients experience a strong, unexpected relapse that directly leads to accumulated nerve damage. The drug may target IL-6R to inhibit the IL-6 signature. IL-6 is a cytokine and is believed to play a key role in NMOSD activation, which causes inflammatory inflammation, causing injury and paralysis.
Developed by Roche, Satralizumab is currently under review by the US FDA and accelerated testing by the European Union EMA. In the United States and the EU, the drug has been given the NMOSD orphan drug status. Data from two international phases III clinical studies (SakuraStar, SAkuraSky) confirm the effectiveness and safety of natalizumab as monotherapy and combined with baseline immunosuppressant: monotherapy significantly reduced the risk of recurrence by 55% and reduced the risk of recurrence by 74% in patients with AQP4-IgG4 serology. (2) The SAkuraSky study showed that of the total population studied and compared with placebo + baseline immunosuppressive agents, treatment with natalizumab + immunosuppressive reduced the risk of recurrence by 62% and reduced the risk of recurrence by 79% in four patients. AQP4-IgG4 serology.
In the United States and the European Union, Soliris is the only drug approved by NMOSD. It is given intravenously and is given every two weeks during storage. Natalizumab is administered by subcutaneous injection once every four weeks, and if approved, will be the most comprehensive treatment option for patients and caregivers.
5. leronlimab (PRO140
Leronlimab is an anti-IgG4 monoclonal antibody that aims to block chemokine receptor 5 (CCR5), a cellular receptor that plays a key role in HIV infection, tumor metastasis, and other autoimmune diseases, including NASH. In the treatment of HIV infection, the drug belongs to a new class of drugs called viral entry inhibitors that can hide CCR5 and protect these cells from infection by blocking the entry of large HIV (R5) subtypes of healthy T cells. At the same time, leronlimab does not appear to interfere with the normal function of CCR5 in mediating immune response.
Data from nine completed clinical studies have shown that leronlimab can significantly reduce or control the viral load of HIV in patients in each study. Phase IIb studies have shown that treatment with a single drug agent can prevent HIV transmission. Developed by CytoDyn, the drug has been successfully combined with standard antiretroviral drugs for critical phase III studies in HIV-positive patients and is in the process of advancing the United States FDA with an integrated biomedical (BLA) program. In addition to the HIVFree Web content, leronlimab is also designed for various cancers (including metastatic and non-metastatic breast cancer.
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