Clinical trial met primary endpoint of safety and tolerability
IND submission planned in Q1 2023 to initiate U.S. multicenter study
ZURICH, Switzerland I January 24, 2023 IMemo Therapeutics AG (“MTx”), an innovator in the field of antibody discovery and development, announced today positive safety and tolerability data from a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (“BKV”) infection in renal transplant patients, meeting its primary endpoint.
In this phase I, single-blind, partially randomized, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV (ClinicalTrials.gov: NCT05358106). No relevant adverse events were seen up to the highest dose of 2000 mg and pharmacokinetics were found to be normal and linear. MTx plans to submit an Investigational New Drug Application (“IND”) during the first quarter 2023 to initiate a multicenter study in the U.S.
“This initial clinical data for AntiBKV is very encouraging. We believe that AntiBKV, with its 100x more potent neutralization capacity than benchmark antibodies, if confirmed in clinical studies, could present a game-changer for patients who are currently seriously underserved,” said Dr. Jürgen Beck, Chief Medical Officer of Memo Therapeutics AG.
“AntiBKV has the potential to be a best- and first-in-class antibody for the treatment of BKV infection in kidney transplant recipients. With 50,000 kidney transplant procedures carried out in the US and Europe alone, AntiBKV addresses a large and rapidly growing market, with an estimated size well beyond USD 1 billion,” said Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
BKV infection poses a significant threat in kidney transplantation, with serious adverse effects on graft function and ultimately patient survival. Due to the immunosuppressive drug regimen, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients. Up to 10% of these cases progress to BKV associated nephropathy, which poses a serious threat to the transplant. There is currently no disease modifying therapy available to treat BKV infection except for the lowering of immunosuppression. However, this significantly increases the risk of a graft rejection reaction, leading to impaired functionality and longevity, or graft failure.
MTx was supported by Vakzine Project Management GmbH (“VPM”) based in Hannover, Germany, responsible for translational project management and clinical trial oversight, and by Accelagen Pty Ltd (“Accelagen”) based in Melbourne, Australia, for clinical trial management.
About Memo Therapeutics AG
Memo Therapeutics AG (“MTX”) is a clinical-stage biopharma company developing best-in-class therapeutic antibodies to transform the lives of patients with virus infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients. This infection can lead to loss of kidney function, as well as organ failure and rejection. Memo’s pipeline consists of additional therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus (“CMV”), as well as undisclosed immuno-oncology targets.
The pipeline derives from MTx’s industry-leading throughput and functional screening capabilities, which can cover the entire antibody repertoire. Using its immortal cell libraries and unique nano droplet technology, MTx identifies and isolates the most potent antibodies based on functionality at an unprecedent rate, including discovering ultra-rare antibodies that competing technologies fail to identify. MTx is a private company located in Schlieren / Zurich, Switzerland.
SOURCE: Memo Therapeutics
Post Views: 254
Clinical trial met primary endpoint of safety and tolerability
IND submission planned in Q1 2023 to initiate U.S. multicenter study
ZURICH, Switzerland I January 24, 2023 IMemo Therapeutics AG (“MTx”), an innovator in the field of antibody discovery and development, announced today positive safety and tolerability data from a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (“BKV”) infection in renal transplant patients, meeting its primary endpoint.
In this phase I, single-blind, partially randomized, placebo-controlled clinical trial, 40 healthy adult volunteers were administered single and multiple ascending intravenous doses of AntiBKV (ClinicalTrials.gov: NCT05358106). No relevant adverse events were seen up to the highest dose of 2000 mg and pharmacokinetics were found to be normal and linear. MTx plans to submit an Investigational New Drug Application (“IND”) during the first quarter 2023 to initiate a multicenter study in the U.S.
“This initial clinical data for AntiBKV is very encouraging. We believe that AntiBKV, with its 100x more potent neutralization capacity than benchmark antibodies, if confirmed in clinical studies, could present a game-changer for patients who are currently seriously underserved,” said Dr. Jürgen Beck, Chief Medical Officer of Memo Therapeutics AG.
“AntiBKV has the potential to be a best- and first-in-class antibody for the treatment of BKV infection in kidney transplant recipients. With 50,000 kidney transplant procedures carried out in the US and Europe alone, AntiBKV addresses a large and rapidly growing market, with an estimated size well beyond USD 1 billion,” said Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
BKV infection poses a significant threat in kidney transplantation, with serious adverse effects on graft function and ultimately patient survival. Due to the immunosuppressive drug regimen, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients. Up to 10% of these cases progress to BKV associated nephropathy, which poses a serious threat to the transplant. There is currently no disease modifying therapy available to treat BKV infection except for the lowering of immunosuppression. However, this significantly increases the risk of a graft rejection reaction, leading to impaired functionality and longevity, or graft failure.
MTx was supported by Vakzine Project Management GmbH (“VPM”) based in Hannover, Germany, responsible for translational project management and clinical trial oversight, and by Accelagen Pty Ltd (“Accelagen”) based in Melbourne, Australia, for clinical trial management.
About Memo Therapeutics AG
Memo Therapeutics AG (“MTX”) is a clinical-stage biopharma company developing best-in-class therapeutic antibodies to transform the lives of patients with virus infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients. This infection can lead to loss of kidney function, as well as organ failure and rejection. Memo’s pipeline consists of additional therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus (“CMV”), as well as undisclosed immuno-oncology targets.
The pipeline derives from MTx’s industry-leading throughput and functional screening capabilities, which can cover the entire antibody repertoire. Using its immortal cell libraries and unique nano droplet technology, MTx identifies and isolates the most potent antibodies based on functionality at an unprecedent rate, including discovering ultra-rare antibodies that competing technologies fail to identify. MTx is a private company located in Schlieren / Zurich, Switzerland.
SOURCE: Memo Therapeutics
Post Views: 254
