Catalyst Biosciences Announces Oral and Poster Presentations at the International Conference on Complement Therapeutics
Catalyst Biosciences (NASDAQ: CBIO) recently presented at the International Conference on Complement Therapeutics (ICCT) from September 8-13, 2021. The focus was on the engineered Complement Factor I (CFI), particularly CB 4332, demonstrating improved pharmacokinetics and efficacy compared to plasma-derived CFI in preclinical models. This first-in-class product aims for weekly subcutaneous administration in patients with CFI deficiency. Catalyst has initiated the ConFIrm study to confirm CFI deficiencies, supporting future IND submissions and global clinical trials for CB 4332.
- Presentation of data at ICCT on the engineered CFI, CB 4332, indicating improved pharmacokinetics and efficacy.
- CB 4332 shows potential for effective replacement therapy in CFI deficiency, with first-in-human trials expected in 2022.
- Initiation of the ConFIrm study, measuring CFI levels in patients, paving the way for further studies.
- Potential delays in clinical trials due to COVID-19 and other factors.
- Dependence on the success of ConFIrm and ConFIdence trials to validate market potential for CB 4332.
- Risks associated with the need to raise additional capital and the possibility of project terminations.
SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today presented data at the International Conference on Complement Therapeutics (ICCT), being held September 8-13, 2021.
The oral presentation, “Complement Factor I (CFI) as a Protease Medicine: Engineered New Therapeutics for Complement-Mediated Disorders,” was presented by Natacha Le Moan, Ph.D., executive director, translational research, Catalyst Biosciences. This study described the use of Catalyst’s proprietary ProTUNETM platform to engineer a diverse library of enhanced CFI proteases that degrade C3b and/or C4b. Administration of the degraders resulted in improved cleavage of C4b and C3b as well as significant protection against an inflammatory cytokine response in a preclinical rodent model of sepsis.
The poster, “Enhanced Complement Factor I (CFI) properties of CB 4332 for replacement therapy in CFI deficiency,” by Eduard Gorina, M.D., vice president, clinical development, Catalyst Biosciences, demonstrated that CB 4332 showed improved pharmacokinetic properties in monkeys when compared with plasma-derived human CFI and comparable efficacy to plasma CFI. The data support a convenient weekly SQ dosing if confirmed in the first-in-human trials expected to commence enrollment in 2022. CB 4332 is Catalyst’s wholly owned, first-in-class, enhanced CFI, intended for prophylactic subcutaneous (SQ) administration in individuals with CFI deficiency.
"CFI deficiencies are genetic abnormalities that can increase susceptibility to infections caused by encapsulated bacteria or incidences of autoimmune and immune-complex diseases. The positive preclinical data presented at ICCT indicate that CB 4332 has the potential to be an effective replacement therapy in CFI-deficient patients by addressing the root cause of the deficiency,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst.
Dr. Usman continued, “Our complement portfolio, which we started building with CB 2782-PEG, a novel C3 degrader targeting dry AMD, now consists of two additional platforms - CFI-based proteins that can be used in a wide variety of complement diseases and immunomodulatory molecules, studying inflammation. We’re looking forward to providing additional updates from our complement programs.”
Catalyst recently launched the ConFIrm study with the screening of the first patient. The ConFIrm screening study will measure CFI levels and activity in patients who have diseases related to a CFI deficiency and who may potentially benefit from CB 4332 treatment. Those subjects with a confirmed CFI deficiency may subsequently enroll in the ConFIdence natural history study. Catalyst anticipates the submission of an Investigational New Drug (IND) application and initiation of a global clinical trial for CB 4332 in CFI deficiency in 2022.
A copy of the presentation materials can be accessed on the Scientific Publications section of the Catalyst website.
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and proteases from our ProTUNE™ C3b-C4b degrader and ImmunoTUNE™ C3a-C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways as well as other complement programs in development.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include, without limitation, statements about the product candidates of Catalyst Biosciences, Inc. (the “Company”) and the benefits of its protease engineering platform; plans to complete the ConFIrm and ConFIdence studies and the expectation that the studies will inform opportunities to develop CB 4332; plans to submit an IND; the potential markets for and advantages of the Company's complement product candidates, including CB 2782-PEG, CB 4332 and complement degraders; plans for the Company's collaboration with Biogen; and plans to start a global clinical trial of CB 4332 in 2022.
Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially, including, but not limited to, the risk that trials and studies may be delayed as a result of COVID-19, competitive products and other factors, that trials may not have satisfactory outcomes, the risk that the ConFIrm and ConFIdence trials will not validate the potential market for CB 4332; the risks that CB4332 and the Company’s complement degraders have not yet started human clinical trials, the risk Catalyst may elect to terminate or postpone ongoing development programs, including development of MarzAA or any of the Company’s complement assets; the risk that the Company will need to raise additional capital, which may not be available on favorable terms if at all; the risk that Biogen may terminate the Company's agreement, and other risks described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 4, 2021, the Quarterly Report on Form 10-Q filed with the SEC on August 5, 2021 and in other filings filed from time to time with the SEC. The Company does not assume any obligation to update any forward-looking statements, except as required by law.
Contact:
Ana Kapor
Catalyst Biosciences, Inc.
investors@catbio.com
FAQ
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