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▎Editor of WuXi AppTec's content team On September 29, 2021, AstraZeneca announced that its subsidiary Alexion has acquired Caelum Biosciences and obtained the treatment CAEL-101, which is in phase 3 clinical development
.
CAEL-101 is a potential "first-in-class" fiber-reactive monoclonal antibody for the treatment of light chain (AL) amyloidosis
.
Light chain amyloidosis is a rare systemic disease
.
Misfolded immunoglobulin light chains aggregate to form fibers, which accumulate in and around organs (including heart and kidney) throughout the body, causing extensive and increasing organ damage
.
The median survival time of confirmed patients is less than 18 months, and the most common cause of death is heart failure
.
CAEL-101 can be combined with misfolded different light chain protein subtypes and amyloid to reduce or eliminate amyloid deposits, thereby improving the patient's organ function
.
CAEL-101 has obtained orphan drug designation granted by the US FDA and European Commission as a potential therapy for patients with immunoglobulin light chain amyloidosis
.
In addition, the FDA granted CAEL-101 fast track qualification for the treatment of the disease in June 2021
.
Image source: 123RF In 2019, Caelum and Alexion reached a cooperation for the first time to promote the development of CAEL-101
.
It is expected that after the completion of the acquisition on October 5, 2021, Alexion will pay Caelum approximately US$150 million and may pay up to US$350 million in regulatory and commercial milestone payments
.
CAEL-101 is being evaluated in two phase 3 clinical trials to test the efficacy and safety of CAEL-101 in combination with current standard therapies (SoC) in the first-line treatment of patients with immunoglobulin light chain amyloidosis
.
The primary endpoint of the two clinical trials is the overall survival (OS) of patients, and enrollment of patients is ongoing
.
Mr.
Marc Dunoyer, Chief Executive Officer of Alexion, said: “The median survival time of patients with this disease after diagnosis is less than 18 months, so new treatment options are urgently needed
.
CAEL-101 may become the first targeted removal of starch in organs and tissues.
Such deposits, therapies that improve organ function, and ultimately prolong the lives of these patients
.
"Reference: [1] AstraZeneca to fully acquire Caelum Biosciences.
Retrieved September 29, 2021, from https:// /astraz/media-centre/press-releases/2021/astrazeneca-to-fully-acquire-caelum-biosciences.
htmlDisclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
CAEL-101 is a potential "first-in-class" fiber-reactive monoclonal antibody for the treatment of light chain (AL) amyloidosis
.
Light chain amyloidosis is a rare systemic disease
.
Misfolded immunoglobulin light chains aggregate to form fibers, which accumulate in and around organs (including heart and kidney) throughout the body, causing extensive and increasing organ damage
.
The median survival time of confirmed patients is less than 18 months, and the most common cause of death is heart failure
.
CAEL-101 can be combined with misfolded different light chain protein subtypes and amyloid to reduce or eliminate amyloid deposits, thereby improving the patient's organ function
.
CAEL-101 has obtained orphan drug designation granted by the US FDA and European Commission as a potential therapy for patients with immunoglobulin light chain amyloidosis
.
In addition, the FDA granted CAEL-101 fast track qualification for the treatment of the disease in June 2021
.
Image source: 123RF In 2019, Caelum and Alexion reached a cooperation for the first time to promote the development of CAEL-101
.
It is expected that after the completion of the acquisition on October 5, 2021, Alexion will pay Caelum approximately US$150 million and may pay up to US$350 million in regulatory and commercial milestone payments
.
CAEL-101 is being evaluated in two phase 3 clinical trials to test the efficacy and safety of CAEL-101 in combination with current standard therapies (SoC) in the first-line treatment of patients with immunoglobulin light chain amyloidosis
.
The primary endpoint of the two clinical trials is the overall survival (OS) of patients, and enrollment of patients is ongoing
.
Mr.
Marc Dunoyer, Chief Executive Officer of Alexion, said: “The median survival time of patients with this disease after diagnosis is less than 18 months, so new treatment options are urgently needed
.
CAEL-101 may become the first targeted removal of starch in organs and tissues.
Such deposits, therapies that improve organ function, and ultimately prolong the lives of these patients
.
"Reference: [1] AstraZeneca to fully acquire Caelum Biosciences.
Retrieved September 29, 2021, from https:// /astraz/media-centre/press-releases/2021/astrazeneca-to-fully-acquire-caelum-biosciences.
htmlDisclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
