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Last Post: 5/25/2022 11:56:31 AM - Followers: 30 - Board type: Free - Posts Today: 1

CATALYST BIOSCIENCES





Hemostasis

Stopping bleeding is good – preventing bleeding is better

 

All currently approved medicines for hemophilia are injected into a patient’s veins – at Catalyst, we believe that a clotting factor that could instead be injected just under the skin would enhance the treatment, and lives, of patients with hemophilia.

Catalyst is focused on the prevention of spontaneous bleeding in hemophilia, even during surgery, using our potent, coagulation factors to promote blood clotting. We plan to initiate two clinical trials in 2017, one in patients with Hemophilia B using our next-generation Factor IX, CB 2679d, and the other in hemophilia inhibitor patients using our next-generation Factor VIIa, marzeptacog alfa (activated) (formerly known as CB 813d).

Hemophilia is a rare but serious bleeding disorder

Hemophilia patients suffer from spontaneous bleeding episodes and substantially prolonged bleeding times that can become limb- or life-threatening following injury or trauma. In cases of severe hemophilia, spontaneous bleeding into muscles or joints is frequent and often results in permanent, disabling joint damage. Hemophilia results from a genetic or acquired deficiency of a protein required for normal blood coagulation.

Hemophilia patients are currently treated with replacement therapy of key coagulation proteins, Factor VIII for Hemophilia A or Factor IX for Hemophilia B.  A complication for hemophilia patients receiving factor replacement therapy is the production of antibodies against the replacement factor, also called inhibitors. The overall prevalence of inhibitor formation is up to 30% in patients with hemophilia A and up to 5% in patients with hemophilia B.

Inhibitor patients are treated with what are known as “bypass” agents that initiate coagulation by a pathway that is independent of Factor VIII or Factor IX.  There are currently two approved “bypass agents”, Factor VIIa (for example NovoSeven™) and FEIBA™.  However, current hemophilia drugs for patients with inhibitors have significant limitations regarding potency, duration of action and often require frequent dosing – and they are all injected intravenously which is not ideal for patients who predominantly take these medicines at home.

We believe that the shortcomings of currently approved therapies are barriers to prophylactic treatment strategies that, if surmounted, could provide meaningfully improved long-term clinical outcomes for patients. Catalyst's engineered proteases in the fields of hemostasis are designed to overcome the significant limitations of current treatment options, facilitate preventative treatment, and ultimately deliver substantially better outcomes for patients.

Factor IX

Catalyst created a portfolio of improved Factor IX proteases, including the clinical development candidate CB 2679d for treatment of hemophilia B, a life-long disease caused by a genetic deficiency in coagulation Factor IX.

The leading recombinant human Factor IX on the market for treating acute bleeding episodes in hemophilia B patients has a short half-life and is therefore not ideal for prophylactic treatment.

CB 2679d has shown significantly higher potency in pre-clinical studies versus other FIX products on the market and in development. Based on data from well-validated animal models of hemophilia, CB 2679d may provide hemophilia B patients with a viable subcutaneous prophylactic therapy.

Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d through Phase 1/2 proof-of-concept study in hemophilia B patients. After Phase 1, ISU Abxis retains exclusive commercial rights in Korea while Catalyst retains full development and commercial rights for CB 2679d outside of Korea.

Factor VIIa

Marzeptacog alfa (activated) (formerly known as CB 813d) is a next-generation Factor VIIa that was designed to allow for the effective, long-term, prophylaxis in hemophilia patients with inhibitors. Catalyst has successfully completed an intravenous Phase 1 clinical trial in patients with severe hemophilia A and B with and without inhibitors.

Catalyst designed marzeptacog alfa  (activated) (formerly known as CB 813d) to combine higher clot-generating activity at the site of bleeding and improved efficacy. Catalyst anticipates that this product candidate could be used for subcutaneous prophylactic treatment.

Positive results from an open label, multicenter Phase 1 intravenous dosing clinical trial of marzeptacog alfa (activated) (formerly known as CB 813d) were reported in June 2015. Marzeptacog alfa  (activated) (formerly known as CB 813d) was given intravenously to 25 non-bleeding hemophilia patients in single ascending dose cohorts who were then observed for up to 60 days post treatment. Results showed that single doses of marzeptacog alfa (activated) (formerly known as CB 813d) were well tolerated when administered to hemophilia A and B patients, and there were no instances of antibody response or thrombosis. Marzeptacog alfa (activated) (formerly known as CB 813d) demonstrated pharmacological efficacy as measured by significant shortening of aPTT (activated partial thromboplastin time) and PT (prothrombin time) for up to 48 hours post dosing. The results were presented in a poster session at the International Society on Thrombosis and Haemostasis (ISTH) Meeting in June 2015.

Factor Xa

Catalyst has identified Factor Xa variants that have enhanced potency, improved safety, and superior duration of action in preclinical models of bleeding compared with a competing Factor Xa in clinical development. Catalyst believes that a safe and effective Factor Xa product has the potential to be used both to treat hemophilia patients and to reduce blood loss in trauma and surgery in patients with normal coagulation systems and clotting activity or those who are taking anti-platelet agents or anticoagulants.

Catalyst’s FXa program has reached the lead candidate stage of research and is available for partnering.

 

Anti-Complement

Catalyst has developed and optimized a propriety method to create novel proteases that include anti-C3 protease assets such as CB 2782 for ischemia-reperfusion injury such as delayed graft function (DGF) after kidney transplantation and the preclinical leads in the dry age-related macular degeneration (AMD) program. In 2016, Catalyst reduced resources deployed towards its anti-complement research programs and all related research activities were discontinued. These assets are available for partnering.

The complement cascade is a series of molecular processes that plays a central role in the body’s inflammatory and immune responses and helps to localize specific immune system cells at the site of infection or inflammation. Drugs that target the complement cascade could potentially be used in a number of indications, including prevention of transplant rejection, age-related macular degeneration, cardiovascular disease, pulmonary diseases, and autoimmune disease.

CB 2782 is a novel protease derived from human membrane type serine protease 1 (MTSP-1) that cleaves complement factor 3 (C3) and may be developed to prevent delayed graft function (DGF) following kidney transplant as a result of ischemia-reperfusion injury. Other opportunities might include coronary artery bypass graft (CABG), acute myocardial infarction (AMI), and stroke. Catalyst also has earlier stage, distinct anti-complement lead molecules for dry age-related macular degeneration (dry AMD) and other chronic, and selected orphan, diseases.
 

Science

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

Improving Protease Drugs

Catalyst created improved protease variants using a rational design strategy. In this process, a small number of amino acids in a given protease are substituted in an iterative fashion with different amino acids to improve a molecule’s biological properties. This approach led to product candidates that have the potential to be improved versions of Factor VIIa, Factor IX, and Factor Xa that may have many important and differentiated advantages including higher activity, longer duration of action, and improved safety.

Creation of Novel Protease Drugs

Catalyst has developed and optimized a propriety method to create novel proteases that currently make up part of our partnering portfolio, including our anti-C3 proteases including CB 2782 for delayed graft function (DGF) and the leads in our dry age-related macular degeneration (AMD) program. In September 2016, Catalyst reduced resources deployed towards its anti-complement research programs and all related research activities were discontinued. Catalyst intends to explore licensing opportunities for its anti-complement programs in DGF and Dry AMD.


 

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CBIO News: Amended Current Report Filing (8-k/a) 05/24/2022 02:09:42 AM
CBIO News: Current Report Filing (8-k) 05/23/2022 04:38:21 AM
CBIO News: Catalyst Biosciences Sells Complement Portfolio for $60 Million 05/23/2022 04:30:00 AM
CBIO News: Additional Proxy Soliciting Materials - Non-management (definitive) (dfan14a) 05/10/2022 01:04:16 PM
CBIO News: Amended Statement of Beneficial Ownership (sc 13d/a) 05/10/2022 01:01:51 PM
PostSubject
#504   rock moment Frankestin 05/25/22 11:56:31 AM
#503   Let’s gooooo$$$$ INFINITI 05/24/22 03:40:37 PM
#502   Good consolidation day after this we blow past INFINITI 05/24/22 12:42:04 PM
#501   Twinkle Twinkle Little Star Frankestin 05/24/22 12:01:04 PM
#500   likewise! BEIJING BILL 05/24/22 11:46:21 AM
#499   Same$$$$GL INFINITI 05/24/22 11:45:44 AM
#498   Buying more in here chee chee cheee BEIJING BILL 05/24/22 11:45:18 AM
#497   Weeee INFINITI 05/24/22 11:16:30 AM
#496   Load up $$$$ INFINITI 05/24/22 09:49:15 AM
#495   Amended Current Report Filing (8-k/a) Source: Edgar (US Regulatory) INFINITI 05/24/22 09:17:41 AM
#494   Buhahahahahahah they haven't slept! Frankestin 05/24/22 04:20:12 AM
#493   Oh ok sounds good INFINITI 05/23/22 07:30:40 PM
#492   10k filed with the SEC. Mr B 05/23/22 07:30:18 PM
#491   Wont be surprised if this opens above $2 tomorrow INFINITI 05/23/22 06:18:21 PM
#490   Where you get that # from INFINITI 05/23/22 06:15:38 PM
#489   So not thinking $60 will even be the Mr B 05/23/22 06:05:54 PM
#488   it would be curious if tomorrow they launch Frankestin 05/23/22 05:53:42 PM
#487   Actual value per share is $1.93 is that accurate? Mr B 05/23/22 05:32:09 PM
#486   Let’s gooooo$$$ INFINITI 05/23/22 03:01:11 PM
#485   Weeeeeeeeeeeee Felesha 05/23/22 01:34:36 PM
#484   Load up wants to run again INFINITI 05/23/22 01:05:46 PM
#483   This sale is part of the ongoing strategic Frankestin 05/23/22 12:40:43 PM
#482   Let’s break $2 INFINITI 05/23/22 11:37:03 AM
#481   Me as well. Next leg up forming. GL bandit007 05/23/22 11:34:55 AM
#480   Got in looks mighty good here $$$ INFINITI 05/23/22 10:37:23 AM
#479   I have the feeling that everyone who sells Frankestin 05/23/22 10:14:11 AM
#478   1.09 +186% awesome day here. powerbattles 05/23/22 09:44:52 AM
#477   Quick 50% don’t blink Awl416 05/23/22 08:46:26 AM
#476   News Awl416 05/23/22 08:31:47 AM
#475   Catalyst Biosciences (CBIO, $0.58) RSI Indicator left the glens0 04/24/22 04:08:00 AM
#474   Catalyst Biosciences Reports Fourth Quarter and Year-end 2021 Operating glens0 04/22/22 02:59:38 PM
#473   Weekly pincher chart looking real close to breaking out. interloper 02/16/22 08:11:45 PM
#472   CBIO Huge volume spike on news. interloper 12/17/21 01:12:28 PM
#471   Restructuring and layoffs. willlbone 11/12/21 10:32:12 AM
#470   Adding Pennybuster 02/18/21 09:13:30 PM
#469   I wonder how the public offering at 5.75 A_Trader 02/12/21 07:28:38 AM
#468   RJ has them with a $20.00 target!!! now invest 12/30/20 10:17:16 AM
#467   JUST IN: $CBIO Catalyst Biosciences Receives US Patent whytestocks 10/14/20 04:00:24 PM
#466   Catalyst Biosciences, Inc. Is Maintained at Outperform by stockguard 09/05/20 12:41:39 PM
#465   Forwarded this tin the SEC to see if cfoofme 03/09/20 10:54:53 AM
#464   CBIO 7.41 - enters an agreement with Biogen RNsidersbuying 12/23/19 09:15:21 AM
#463   * * $CBIO Video Chart 12-19-2019 * * ClayTrader 12/19/19 05:12:12 PM
#462   News: $CBIO Catalyst Biosciences Announces Global License and whytestocks 12/19/19 10:45:22 AM
#461   Carl Icahn took stake today Biggeoff 12/19/19 08:40:34 AM
#460   News Awl416 12/19/19 08:16:04 AM
#459   * * $CBIO Video Chart 10-03-2019 * * ClayTrader 10/03/19 05:54:47 PM
#458   News: $CBIO Catalyst Biosciences Provides DalcA Phase 2b whytestocks 10/03/19 12:00:21 PM
#457   News: $CBIO 22NW: Catalyst Biosciences Needs Change Now whytestocks 10/02/19 12:54:32 PM
#456   VOLUME HAS SPIKED IN ANTICIPATION OF POSITIVE CLINICAL DATA TFMG 07/09/19 03:00:43 PM
#455   * * $CBIO Video Chart 07-08-2019 * * ClayTrader 07/08/19 03:56:36 PM
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