RG6512 News - LARVOL Sigma

|||||||||| RG6512 / Roche
Preclinical Evaluation of NXT007 Using in Vitro and In Vivo Models of Hemostasis and Thrombosis (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_4093;
Further, there was no evidence of hypercoagulability or prothrombotic effects at anticipated therapeutic or supratherapeutic concentrations. Overall, our preclinical data support the ongoing clinical evaluation of NXT007 and suggest that it has the potential to bring even greater benefit to PwHA.

|||||||||| NXT007 / Roche
Journal: NXT007 does not interfere with the anticoagulant effects on tissue factor pathway inhibitor. (Pubmed Central) - Oct 6, 2024
Overall, our preclinical data support the ongoing clinical evaluation of NXT007 and suggest that it has the potential to bring even greater benefit to PwHA. No abstract available

|||||||||| NXT007 / Roche
NXT007, a novel bispecific antibody, in FVIII chromogenic substrate assays (Exhibition Hall) - May 17, 2024 - Abstract #ISTH2024ISTH_929;
NXT007 was engineered and optimized based on emicizumab, which shows FVIII-like activity in CSAs containing human, but not bovine coagulation factors. NXT007 concentration dependent increase in FVIII-like activity was seen in CSA with human reagents and using the human-bovine Technoclone kit, which gave the highest FVIII-like activities (137 IU/dL at 30

||||||||||  NXT007 / Roche
Enrollment closed:  A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants (clinicaltrials.gov) -  Apr 30, 2024
P1, N=48, Active, not recruiting,  Sponsor: Hoffmann-La Roche
NXT007 concentration dependent increase in FVIII-like activity was seen in CSA with human reagents and using the human-bovine Technoclone kit, which gave the highest FVIII-like activities (137 IU/dL at 30 Recruiting --> Active, not recruiting

|||||||||| NXT007 / Roche
Directed Assembly of Bispecific Antibodies by Electrostatic Steering () - Apr 19, 2024 - Abstract #IOSUMMITEUROPE2024IO_SUMMIT_EUROPE_117;
Using NXT007 as an example, I will discuss critical factors like pairing potency, titre, physicochemical properties, and purification when applying FAST-Ig to clinical candidate antibodies. Additionally, I will introduce a next-generation T cell engager targeting CLDN6 that also utilises FAST-Ig.

||||||||||  NXT007 / Roche
Enrollment open:  A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants (clinicaltrials.gov) -  Jan 18, 2024
P1, N=48, Recruiting,  Sponsor: Hoffmann-La Roche
Additionally, I will introduce a next-generation T cell engager targeting CLDN6 that also utilises FAST-Ig. Not yet recruiting --> Recruiting

||||||||||  NXT007 / Roche
New P1 trial:  A Study to Evaluate Single Subcutaneous Doses of NXT007 Among Injection Sites Abdomen, Upper Arm, and Thigh in Healthy Male Participants (clinicaltrials.gov) -  Jan 2, 2024
P1, N=48, Not yet recruiting,  Sponsor: Hoffmann-La Roche

|||||||||| NXT007 / Roche
Journal: NXT007-mediated hemostatic potential is suppressed by activated protein C-catalyzed inactivation of activated factor V. (Pubmed Central) - Dec 20, 2023
The NXT007-driven thrombin generation in FVIII-depleted FV plasma was suppressed by APC, similar to the reaction in native FV plasma. NXT007 did not impair APC-mediated downregulation of FVa in FVIIIdef-plasmas, regardless of the presence of FV mutation with APC resistance.

||||||||||  RG6512 / Roche
Enrollment open:  A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A (clinicaltrials.gov) -  Sep 8, 2023
P1/2, N=40, Recruiting,  Sponsor: Hoffmann-La Roche
NXT007 did not impair APC-mediated downregulation of FVa in FVIIIdef-plasmas, regardless of the presence of FV mutation with APC resistance. Not yet recruiting --> Recruiting

|||||||||| NXT007 / Roche
Journal: Efficient production of bispecific antibody by FAST-Ig and its application to NXT007 for the treatment of hemophilia A. (Pubmed Central) - Jun 24, 2023
FAST-Ig was also applicable to stable CHO cell lines for industrial production and demonstrated robust chain pairing with different subclasses of parent BsAbs. Thus, it can be applied to a wide variety of BsAbs both preclinically and clinically.

|||||||||| Hemlibra (emicizumab-kxwh) / Roche, NXT007 / Roche
Safety, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in Healthy Volunteers (NXTAGE Study) (Room:517) - May 18, 2023 - Abstract #ISTH2023ISTH_2281;
Thus, it can be applied to a wide variety of BsAbs both preclinically and clinically. Learning Objectives: Evaluate the data of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in healthy volunteer.Recognize the characteristics of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in healthy volunteer.Discuss the potential of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, as a future therapeutic option.

|||||||||| Hemlibra (emicizumab-kxwh) / Roche, NXT007 / Roche
Quantitative Estimation of the In Vivo Equivalent Factor VIII Activity of NXT007, an Emicizumab-Based, Next-Generation, Activated Factor VIII-Mimetic Bispecific Antibody, from Nonclinical Data () - Nov 29, 2022 - Abstract #ASH2022ASH_7015;
Model-based approaches supported application of the ternary complex approach for predicting the in vivo equivalent FVIII activity of NXT007. Findings from this research provided a basis for designing a phase I/II clinical study of NXT007 that is currently ongoing (NXTAGE; JapicCTI-194919).

|||||||||| NXT007 / Roche
Activated Protein C-Catalyzed Inactivation Pathway Down-Regulates NXT007-Mediated Hemostatic Function (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3873;
While, the %inhibition of PeakTh by APC (16 nM) in FV-L plasma with FVIIIAb and NXT007 was similar to FV-L plasma alone (~20%), indicating that APC could regulate NXT007-catalyzed hemostatic reaction by inactivation of FV(a) under the FV-L condition. We conclude that APC-catalyzed inactivation mechanisms could play a significant role on the down-regulation of coagulation in NXT007-mediated hemostasis.



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