WILEX AG - Pipeline

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RENCAREX®*
CA9−SCAN
uPA Program
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Clinical Program

RENCAREX®* (WX-G250)

Compound Class	Chimeric monoclonal antibody
Indication	Renal cell cancer (RCC) and other solid tumours
Target	MN/CA IX antigen (also called: G250 antigen) The MN/CAIX antigen is expressed on over 90% of clear cell RCCs, but not on healthy kidney tissue. It is also present in a variety of other solid tumours including bladder, cervical, colon, breast, and non-small cell lung cancer.
Mode of Action	ADCC**
Development Status	Non-metastatic RCC, adjuvant therapy A pivotal Phase III trial with RENCAREX®* as adjuvant therapy of patients with non-metastatic RCC at high risk of relapse after surgery is currently recruiting. Metastatic RCC, combination therapy with cytokines RENCAREX®* has completed clinical Phase II trials in combination therapy with cytokines (IL-2 and IFN) in patients with metastatic RCC.
Orphan Drug Status	Orphan Drug Status for the U.S. and the EU in the indication RCC.
Partner	WILEX has granted Esteve S.A. the commercialization rights on RENCAREX®* in certain countries of South Europe including Spain, Italy, Portugal, Andorra and Greece.
Development Rationale	Standard therapy for non-metastatic RCC is resection of the affected kidney and any associated tumour mass followed by observation. There is no adjuvant treatment approved for patients after surgery, although there is a high relapse rate among patients after surgery. RENCAREX®* has proven to be safe and well-tolerated and is therefore ideally suited for this area of high medical need.
Background information	Please click here for further information on the RENCAREX®* program.

* temporary name while under development

* Antibody-dependent cellular cytotoxicity ("ADCC") is the mechanism by which antibodies induce natural killer ("NK") cells or other effector cells of the patient’s immune system to destroy tumour cells.

CA9-SCAN

Compound Class	radioactively labelled antibody for PET/CT
Indication	renal mass
Target	The monoclonal G250 antibody binds specific to a molecule on the cell area of the malignant tumour cells. This molecule, called Carbonic anhydrase IX (also CA-IX, MN and G250 antigene) is located on over 90 % of clear cell renal cell carcinoma, but not on normal renal tissue.
Mode of Action	The diagnosis of malignant kidney tumours by means of PET/CT
Development Status	Phase III registration trial approved
Development Rationale	CA9-SCAN may be used to detect clear cell renal cancer in patients with renal masses before surgery. Up to now only histopathology results after surgery can determine whether the tumour is benign or malignant. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.
Background information	Please click here for further information on the CA9-SCAN program. The labelled antibody CA9-SCAN targets clear cell renal cell carcinoma and accumulates in the tumour tissue. This accumulation can be visualised by means of Positron Emission Tomography (PET). The Company´s cooperation partner, the Ludwig Institute for Cancer Research, New York carried out a proof-of-concept trial in cooperation with the Memorial Sloane-Kettering Cancer Center, New York. This feasibility study found that a positive result with CA9-SCAN was confirmed as clear cell renal cell carcinoma in 100% of cases (positive predictive value).

WX-UK1

Compound Class	Small molecule serine protease inhibitor
Indication	Solid cancers (e.g. Breast-, Pancreas-, Ovarian- and Coloncancer)
Target	Urokinase Plasminogen Activator (uPA) system WX-UK1 targets uPA and other serine proteases, which play a key role in tumour metastasis and primary tumour growth.
Mode of Action	Anti-metastatic, non-cytotoxic agent
Development Status	In preclinical studies, WX-UK1 effectively blocks metastasis formation and primary tumour growth. In a clinical Phase Ia study with healthy volunteers, WX-UK1 was safe and well-tolerated at all doses tested. WX-UK1 as a single agent in cancer patients Two Phase Ib trials completed: WX-UK1 Ib trials in patients with solid tumours and patients with head & neck cancers have been successfully completed. WX-UK1 in combination with capecitabine in breast cancer and other solid tumours Phase I trial ongoing: A U.S. Phase I study with WX-UK1 in combination with the chemotherapeutic agent capecitabine in patients with breast cancer and other solid tumours is currently ongoing. The study is supported with a USD 5.0 million grant from the U.S. Department of Defense Breast Cancer Research Program.
Development Rationale	Preclinical studies have shown positive effects of WX-UK1 in combination with certain cytotoxic drugs in reducing tumour growth and metastases formation. WX-UK1 is currently in clinical development both as a single agent and in combination with chemotherapeutics for the treatment of patients with aggressive metastasizing solid tumours.
Background Information	Please click here for further information on the uPA program.

WX-671

Compound Class	Oral small molecule serine protease inhibitor, orally available pro-drug of WX-UK1
Indication	Solid cancers
Target	Urokinase Plasminogen Activator (uPA) system uPA and other serine proteases, which play a key role in tumour metastasis, are targeted.
Mode of Action	Anti-metastatic, non-cytotoxic agent
Development Status	In preclinical studies, WX-671 has shown to effectively block metastasis formation and to reduce primary tumour growth. Two Phase I studies with WX-671 in healthy volunteers (one single-dose study, one multi-dose study), which investigated pharmacokinetics, safety and oral bio-availability of the compound, have been successfully completed. Subsequently, WX-671 was moved into clinical development in cancer patients. WX-671 as single agent in cancer patients Phase Ib study ongoing: WX-671 is currently being studied in a Phase Ib trial with patients with head & neck cancer.
Development Rationale	Oral WX-671 is being developed for the chronic treatment of patients with aggressive metastasizing solid tumours.
Background Information	Please click here for further information on the uPA program.