Science

Overview

Catalyst’s scientists focus on creating improved, next-generation, pro-coagulant proteases and novel proteases that cleave targets in the complement cascade

We have a versatile protease engineering platform that feeds our research and development pipeline. One of our key competitive advantages is that our systemically dosed product candidates, due to the improvements we have made using our protease engineering platform, can be delivered subcutaneously which is less invasive, more convenient and more efficacious than intravenous IV drugs currently on the market. Our SQ product candidates demonstrate prolonged duration of activity enabling them to provide continuous therapeutic levels.

Publications

Click or tap the “Expand” buttons below to see a full list of our scientific publications, presentations and posters.

Publications

Phase 1, single-dose escalating study of marzeptacog alfa (activated), a recombinant factor VIIa variant, in patients with severe hemophilia   Gruppo RA, Malan D, Kapocsi J, Nemes L, Hay CRM, Boggio L, Chowdary P, Tagariello G, von Drygalski A, Hua F, Scaramozza M, for the Marzeptacog alfa (activated) Study Group Investigators. J Thromb Haemost 2018; 16: 1984–93.

Posters

Dose Selection For Subcutaneous Marzeptacog Alfa (Activated) In Subjects With Factor VII Deficiency Using Population Pharmacometric Clinical Trial Simulations   Catalyst Biosciences at the International Society for Thrombosis and Haemostasis (ISTH) Congress 2021 – July 19, 2021

Subcutaneous Marzeptacog Alfa (Activated) Effectively Treats Bleeding in FVII Deficient Rats Both When Administered Prior To or After Bleeding Has Started   Catalyst Biosciences at the International Society for Thrombosis and Haemostasis (ISTH) Congress 2021 – July 19, 2021

Dose Selection Of Marzeptacog Alfa (Activated) In Children With Hemophilia: A Population Pharmacokinetic Exposure Matching Strategy   Catalyst Biosciences at the International Society for Thrombosis and Haemostasis (ISTH) Congress 2021 – July 19, 2021

Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of ascending doses of subcutaneous marzeptacog alfa (activated) in adult subjects with hemophilia   International Society for Thrombosis and Haemostasis (ISTH) Virtual Congress 2020 – July 13, 2020

Marzeptacog alfa (activated) population pharmacokinetics (PK): Simulations for dose selection in Phase 3 trials   Catalyst Biosciences at the International Society for Thrombosis and Haemostasis (ISTH) Virtual Congress 2020 – July 13, 2020

Fast Onset of Action of Subcutaneously Administered Marzeptacog Alfa (Activated) Supports On-Demand Treatment in Hemophilia A Mice   Catalyst Biosciences at the EAHAD 2020 meeting – February 5, 2020

Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and safety of ascending doses of subcutaneous marzeptacog alfa (activated) in adult subjects with hemophilia   Catalyst Biosciences at the EAHAD 2020 meeting – February 5, 2020

The Combination of Marzeptacog Alfa (Activated) or Eptacog Alfa (Activated) with Emicizumab Appears Comparable in the Thrombin Generation Test in Hemophilia A   Catalyst Biosciences at the ASH 2019 meeting – Dec 8, 2019

ISTH 2019 – Quality of Life of Hemophilia Patients with Inhibitors – Opportunities for Improvement   Catalyst Biosciences at the ISTH 2019 meeting – July 6-10, 2019

Phase 2/3 Trial of Subcutaneously Administered Marzeptacog Alfa (Activated) An Engineered FVIIa In Hemophilia With Inhibitors -Pharmacokinetics, Pharmacodynamics, Safety and Efficacy   Catalyst Biosciences at the 60th American Society of Hematology Annual Meeting & Exposition, San Diego Convention Center, San Diego, CA – December 01, 2018

Pharmacokinetics and Pharmacodynamics of daily Subcutaneously Administered Marzeptacog Alfa (Activated) in Hemophilia dogs   CBIO EAHAD2017 FVIIa SC PK/PD Dogs – February 01, 2017

Presentations

Subcutaneous Marzeptacog Alfa (Activated) is Effective for On-Demand Treatment of Spontaneous Bleeding in Hemophilia A Rats   Catalyst Biosciences at the EAHAD 2021 meeting – February 3, 2021

Subcutaneous Marzeptacog Alfa (Activated) is Effective for On-Demand Treatment in Dogs with Hemophilia A   Catalyst Biosciences at the EAHAD 2021 meeting – February 3, 2021

Crimson 1 Study: Phase 3 study to evaluate the efficacy and safety of subcutaneous marzeptacog alfa (activated) for on-demand treatment and control of bleeding episodes in subjects with hemophilia A or hemophilia B, with inhibitors   Catalyst Biosciences at the ASH congress 2020 – December 7, 2020

ISTH 2019 – Phase 2/3 Trial of Subcutaneous Engineered FVIIa Marzeptacog Alfa (Activated) in Hemophilia A or B with Inhibitors: Efficacy, Safety and Pharmacokinetics   Catalyst Biosciences at the ISTH 2019 meeting – July 6-10, 2019

Publications

Safety, pharmacokinetics, and pharmacodynamics of a next-generation subcutaneously administered coagulation factor IX variant, dalcinonacog alfa, in previously treated hemophilia B patients   Chur Woo You, Seung-Beom Hong, Suyeong Kim, Ho-Jin Shin, Jin Seok Kim, Jung Woo Han, Soo-Jeong Kim, Do Young Kim, Martin Lee, Howard Levy. J Thromb Haemost. 2021;00:1–9.

Preclinical evaluation of a next-generation, subcutaneously administered, coagulation factor IX variant, dalcinonacog alfa   Timothy C. Nichols, Howard Levy*, Elizabeth P. Merricks, Robin A. Raymer, Martin L. Lee. PLOS ONE | October 28, 2020

Activity measurements of dalcinonacog alfa   Williams SC & Gray EM. Haemophilia. 2020; 26: 346-353.

Posters

Mitigation of Injection Site Reactions after Subcutaneous Administration of Dalcinonacog Alfa (DalcA) in Hemophilia B Using Preclinical Models   Catalyst Biosciences at the International Society for Thrombosis and Haemostasis (ISTH) Congress 2021 – July 19, 2021

Phase 2B Trial to Evaluate the Safety and Factor IX Levels of a Daily Subcutaneous Prophylaxis Treatment Regimen of Dalcinonacog alfa in Hemophilia B   Catalyst Biosciences at the WFH 2020 Virtual Meeting – June 15, 2020

ISTH 2019 – A Comprehensive In Silico And In Vitro Immunogenicity Risk Assessment of Dalcinonacog Alfa Shows No Increased Risk Compared With Wild-type FIX   Catalyst Biosciences at the ISTH 2019 meeting – July 6-10, 2019

Phase 1/2 Trial of Single and Multiple Dose Subcutaneously Administered Factor IX Variant Cb2679d/ISU304: Pharmacokinetics and Safety   Catalyst Biosciences at the 64th Annual Scientific and Standardization Committee Meeting of the International Society on Thrombosis and Haemostasis – July 18, 2018

Pharmacokinetics and Pharmacodynamics of daily Subcutaneously Administered CB2679D/ISU304 in Hemophilia B Dogs   CBIO EAHAD2017 FIX SC PK/PD Dogs – February 01, 2017

Pharmacokinetics of Subcutaneously Administered CB 2679D/ISU304 in minipig compared with BeneFIX   CBIO EAHAD2017 FIX SC PK/PD Minipigs – February 01, 2017

Pharmacokinetics of Subcutaneously Administered CB2679D/ISU304 in wild-type and Hemophilia B mice   Catalyst Biosciences, Inc.: Coagulation Factor IX at ASH Annual Meeting – December 03, 2016

Presentations

Phase 2b Trial to Evaluate the Safety & Factor IX Levels Resulting from a Daily Subcutaneous Prophylaxis Treatment Regimen of Dalcinonacog Alfa in Haemophilia B   Catalyst Biosciences at the EAHAD 2020 meeting – February 7, 2020

A Comprehensive In Silico and In Vitro Immunogenicity Risk Assessment of Dalcinonacog Alfa Shows No Increased Risk Compared with Wild-Type FIX   Catalyst Biosciences at the HDD 2019 meeting – August 21, 2019

Posters

CB 2782-PEG: a Complement Factor C3-Inactivating Protease and Potential Long-Acting Treatment for Dry AMD   Catalyst Biosciences at the 2019 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) – April 28, 2019

Discovery and Planned Optimization of a Complement Factor C3-Inactivating Alterase, CB-2782   Catalyst Biosciences, Inc. at 2018 Association for Research in Vision and Ophthalmology Annual Meeting – April 29, 2018

Presentations

Complement system in Acute Respiratory Distress Syndrome (ARDS)   ARDS summit – July 13, 2021

CB 2782-PEG: a Complement Factor C3-Inactivating Protease and Potential Long-Acting Treatment for Dry AMD   Catalyst Biosciences at the CBDD 2019 meeting – November 15, 2019

Molecular Evolution and Design of Pegylated CB 2782 as a Complement Factor C3-Inactivating Protease for Dry AMD   Catalyst Biosciences at the ASBMB Conference – September 15, 2019

Anti-Complement (C3) for Dry AMD   OIS Summit – August 08, 2016

Posters

CB 2679d-GT – A Novel Human Factor IX Variant Shows Enhanced Activity After Delivery Into Hemophilic Mice Using an AAV Capsid With High Liver Transduction   American Society of Gene & Cell Therapy meeting – May 12, 2020

AAV Based Hemophilia B Gene Therapy in Mice Using FIX-CB2679d-GT   Catalyst Biosciences at the 12th Annual Congress of the European Association for Haemophilia and Allied Disorders – February 6-8, 2019

Presentations

Combination of a Novel Chimeric AAV Capsid and Potency Enhanced FIX Variant for Hemophilia B Gene Therapy   Catalyst Biosciences at the World Federation of Hemophilia Virtual Summit 2020 – June 19, 2020

Hemophila B Gene Therapy in Mice using a Novel Chimeric AAV Capsid Combined with a Potency Enhanced FIX Variant   Catalyst Biosciences at the Gene Therapy for Blood Disorders meeting – March 4, 2020

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