[Translation] Phase III clinical study comparing the efficacy and safety of A140 and Erbitux® combined with mFOLFOX6 regimen as first-line treatment for patients with RAS wild-type metastatic colorectal cancer

主要目的：比较A140和爱必妥®分别联合mFOLFOX6方案一线治疗RAS野生型转移性结直肠癌患者用药16周内的客观缓解率（ORR）。次要目的：1.评估RAS野生型转移性结直肠癌患者的无进展生存期（PFS）；2.评估RAS野生型转移性结直肠癌患者的总生存期（OS）；3.比较A140和爱必妥®分别联合mFOLFOX6方案一线治疗RAS野生型转移性结直肠癌患者的安全性和免疫原性（ADA），评估ADA与血药浓度的关系；4.评估RAS野生型转移性结直肠癌患者的疾病控制率（DCR）；5.评估RAS野生型转移性结直肠癌患者的缓解持续时间（DOR）。

[Translation]

Primary objective: To compare the objective response rate (ORR) within 16 weeks of A140 and Erbitux® combined with mFOLFOX6 regimen in the first-line treatment of patients with RAS wild-type metastatic colorectal cancer. Secondary objectives: 1. To evaluate the progression-free survival (PFS) of patients with RAS wild-type metastatic colorectal cancer; 2. To evaluate the overall survival (OS) of patients with RAS wild-type metastatic colorectal cancer; 3. To compare the safety and immunogenicity (ADA) of A140 and Erbitux® combined with mFOLFOX6 regimen in the first-line treatment of patients with RAS wild-type metastatic colorectal cancer, and to evaluate the relationship between ADA and blood drug concentration; 4. To evaluate the disease control rate (DCR) of patients with RAS wild-type metastatic colorectal cancer; 5. To evaluate the duration of response (DOR) of patients with RAS wild-type metastatic colorectal cancer.

Start Date31 Dec 2020

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

NCT04835142 / CompletedPhase 3

Phase III Clinical Study Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC

Compare the objective remission rate of A140 and Erbitux combined with mfolfox6 regimen in the first-line treatment of Ras wild-type metastatic colorectal cancer for 12 weeks

Start Date31 Dec 2020

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

CTR20171667 / TerminatedPhase 3

重组抗表皮生长因子受体（EGFR）人鼠嵌合单克隆抗体注射液（A140）联合mFOLFOX6方案一线治疗转移性结直肠癌患者的临床研究

[Translation] Clinical study of recombinant anti-epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody injection (A140) combined with mFOLFOX6 regimen as first-line treatment for patients with metastatic colorectal cancer

（1）评价抗EGFR单抗（A140）联合mFOLFOX6方案一线治疗RAS野生型的转移性左半结肠癌患者的有效性和安全性；（2）评价抗EGFR单抗（A140）联合mFOLFOX6方案一线治疗所有RAS野生型的转移性结直肠癌患者（包括左半结肠与右半结肠）的有效性和安全性。

[Translation]

(1) To evaluate the efficacy and safety of anti-EGFR monoclonal antibody (A140) combined with mFOLFOX6 regimen as first-line treatment for patients with RAS wild-type metastatic left-sided colon cancer; (2) To evaluate the efficacy and safety of anti-EGFR monoclonal antibody (A140) combined with mFOLFOX6 regimen as first-line treatment for all patients with RAS wild-type metastatic colorectal cancer (including left-sided and right-sided colon).

Start Date28 Feb 2018

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

100 Clinical Results associated with Cetuximab biosimilar (Sichuan Kelun)

100 Translational Medicine associated with Cetuximab biosimilar (Sichuan Kelun)

100 Patents (Medical) associated with Cetuximab biosimilar (Sichuan Kelun)

Literatures (Medical) associated with Cetuximab biosimilar (Sichuan Kelun)

01 May 2019·Veterinary anaesthesia and analgesiaQ2 · AGRICULTURAL & FORESTRY SCIENCE

Cardiovascular effects of two adenosine constant rate infusions in anaesthetized dogs

Q2 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Richter, Henning ; Joerger, Fabiola B ; Mosing, Martina ; Meira, Carolina ; Dennler, Mathias ; Ringer, Simone K

OBJECTIVE:

Adenosine induces vasodilatation. The aim of this study was to investigate cardiovascular effects of two adenosine constant rate infusion (CRI) doses in dogs.

STUDY DESIGN:

Experimental, longitudinal repeated measure design.

ANIMALS:

Ten healthy purpose-bred Beagle dogs.

METHODS:

Each dog was sedated with butorphanol. Anaesthesia was induced with propofol intravenously and maintained with sevoflurane (inspired oxygen fraction = 47-55%). Controlled mechanical ventilation was used to maintain normocapnia. Two doses of adenosine were administered as CRIs to each dog: 140 μg kg^-1 minute^-1 (A140) followed by 280 μg kg^-1 minute^-1 (A280). Pulse rate, invasive arterial pressure and stroke volume (by magnetic resonance phase contrast angiography) were measured at baseline, 3 minutes after starting adenosine and 3 and 10 minutes after discontinuing adenosine. Cardiac output, cardiac index and approximated systemic vascular resistances (approximate SVR) were calculated. Additionally, arterial blood gases, co-oximetry, electrolytes, glucose and lactate were measured and oxygen content and delivery calculated. One-way repeated measures analysis of variance (p < 0.05) was used for data analysis.

RESULTS:

A140 and A280 resulted in a significant decrease in arterial blood pressure [systolic (p = 0.008), mean (p = 0.003), and diastolic arterial pressure (p = 0.004)] and approximate SVR (p = 0.008) compared with baseline. No significant changes were detected for the other variables. All values returned to baseline within 3 minutes after adenosine discontinuation.

CONCLUSIONS AND CLINICAL RELEVANCE:

Adenosine CRI decreases arterial pressure by vasodilatation in healthy dogs. No additional effects were observed with the higher dose. The effects in compromised dogs remain to be investigated.

01 Dec 2016·Parasites & vectorsQ2 · MEDICINE

An antibody against an Anopheles albimanus midgut myosin reduces Plasmodium berghei oocyst development

Q2 · MEDICINE

ArticleOA

Author: Rodríguez, María C ; Tao, Dingyin ; Dinglasan, Rhoel R ; Lecona-Valera, Alba N ; Rodríguez, Mario H ; López, Tomás

BACKGROUND:

Malaria parasites are transmitted by Anopheles mosquitoes. Although several studies have identified mosquito midgut surface proteins that are putatively important for Plasmodium ookinete invasion, only a few have characterized these protein targets and demonstrated transmission-blocking activity. Molecular information about these proteins is essential for the development of transmission-blocking vaccines (TBV). The aim of the present study was to test three monoclonal antibodies (mAbs), A-140, A-78 and A-10, for their ability to recognize antigens and block oocyst infection of the midgut of Anopheles albimanus, a major malaria vector in Latin America.

METHOD:

Western-blot of mAbs on antigens from midgut brush border membrane vesicles was used to select antibodies. Three mAbs were tested by membrane feeding assays to evaluate their potential transmission-blocking activity against Plasmodium berghei. The cognate antigens recognized by mAbs with oocyst-reducing activity were determined by immunoprecipitation followed by liquid chromatography tandem mass spectrometry.

RESULTS:

Only one mAb, A-140, significantly reduced oocyst infection intensity. Hence, its probable protein target in the Anopheles albimanus midgut was identified and characterized. It recognized three high-molecular mass proteins from a midgut brush border microvilli vesicle preparation. Chemical deglycosylation assays confirmed the peptide nature of the epitope recognized by mAb A-140. Immunoprecipitation followed by proteomic identification with tandem mass spectrometry revealed five proteins, presumably extracted together as a complex. Of these, AALB007909 had the highest mascot score and corresponds to a protein with a myosin head motor domain, indicating that the target of mAb A-140 is probably myosin located on the microvilli of the mosquito midgut.

CONCLUSION:

These results provide support for the participation of myosin in mosquito midgut invasion by Plasmodium ookinetes. The potential inclusion of this protein in the design of new multivalent vaccine strategies for blocking Plasmodium transmission is discussed.

01 Nov 2009·Clinical research in cardiology : official journal of the German Cardiac SocietyQ2 · MEDICINE

Adenosine-induced maximal coronary hyperemia for myocardial fractional flow reserve measurements: comparison of administration by femoral venous versus antecubital venous access

Q2 · MEDICINE

Article

Author: Andreas Mügge ; Aydan Yazar ; Thomas Fadgyas ; Lucie Müller ; Alfried Germing ; Tim Holland-Letz ; Waldemar Bojara ; Michael Lindstaedt

BACKGROUND:

Maximal hyperemia is a critical prerequisite for correct fractional flow reserve (FFR) measurements. Continuous administration of adenosine by femoral venous access is considered the gold-standard. However, antecubital venous access is used as an alternative route of administration due to the increasing popularity of radial versus femoral access for coronary catheterization. Because of a potentially larger cross sectional venous area in the arm-theoretically associated with slower flow velocities-and the extremely short half-life of adenosine, there are concerns whether this route of administration is truly equivalent to the femoral route.

METHODS:

Fifty randomly selected patients with coronary artery disease were included. FFR was measured with a pressure monitoring wire and the recording was digitally stored. Hyperemia was successively induced by adenosine via the antecubital vein at a dose of 140 microg kg(-1) min(-1) (A140), via the antecubital vein at a dose of 170 microg kg(-1) min(-1) (A170), and via the femoral vein at a dose of 140 microg kg(-1) min(-1) (F140).

RESULTS:

Induction of hyperemia by A140 yielded significantly lower hyperemic responses than compared with A170 (P = 0.038) and F140 (P = 0.005). No significant difference was seen between adenosine administration by A170 versus F140. Hyperemic stimulation by A140 underestimated lesion severity near the ischemic threshold of FFR more frequently than the other modalities. There were no differences in side-effects between any of the dosages and routes of administration.

CONCLUSIONS:

The intravenous application of adenosine via antecubital venous access is feasible but slightly less effective than the femoral approach. In this setting, an antecubital dosage of 170 microg kg(-1) min(-1) is comparable to the standard dosage of 140 microg kg(-1) min(-1) in the femoral vein. In some patients, this regimen might prevent an underestimation of lesion severity.

100 Deals associated with Cetuximab biosimilar (Sichuan Kelun)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
RAS Wild Type Colorectal Cancer	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	09 Sep 2023
Squamous Cell Carcinoma of Head and Neck	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	09 Sep 2023
Metastatic Colorectal Carcinoma	Phase 3	CN	Sichuan Kelun Pharmacy Institute Co., Ltd.	28 Feb 2018

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