Genmab teamed up with Johnson & Johnson to develop the fast-acting antibody drug Darzalex
November 07, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];The drug has been on the market and has gained wide acclaim in the market. However, as technology advances, many competitors are eager to beat Darzalex. To further expand the market potential of Darzalex, the two companies plan to develop a series of clinical studies to develop the subcutaneous injection of Darzalex to replace the existing intravenous injection of Darzalex.
In fact, the company has recently published a number of prior data, suggesting that the subcutaneous injection of Darzalex can eliminate the inconvenience caused by the existing intravenous dosage form, and on the other hand, ensure the effectiveness and safety of the drug. In fact, Darzalex has published a series of excellent clinical data in the past two years, but this intravenous method allows patients to take longer, which has become one of the biggest defects of the current drug.
It takes 8 hours for the first intravenous injection of Darzalex in the clinic, and it takes 5-6 hours to re-inject the drug. Considering that the patient is treated, the patient needs to receive a weekly treatment during the first 8-week course of treatment. The Darzalex administration method can be said to be very lengthy. This is why MorphoSys is currently in the research stage of the anti-CD38 drug MOR202 is recognized as the biggest challenger of Darzalex. The theoretical delivery time of MOR202 is only 2 hours.
Therefore, if the Darzalex administration method is changed from intravenous injection to subcutaneous injection, it will undoubtedly greatly shorten the administration time. The researchers believe that the timing of subcutaneous administration of Darzalex will be only 20-30 minutes depending on the dose. In addition, the researchers plan to use Darzalex in combination with human hyaluronidase to ensure that the Darzalex effect into the abdominal cavity is comparable to intravenous injection.
The results of early research are also exciting. In a clinical phase I study involving 41 participants, only one patient with a subcutaneous administration of Darzalex had a first-degree asphyxia condition and one patient with a second-grade high fever. Although the side effects associated with injection are only 22%, most of the symptoms are mildly controllable or only occur during the first injection.
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