Catalyst Biosciences Receives US Patent for its Anti-Complement Factor 3 Portfolio of Engineered Proteases

Rhea-AI Summary

Catalyst Biosciences has secured an extension of patent protection for CB 2782-PEG until at least 2038, enhancing its market position. The patent covers engineered proteases that target complement factor 3 (C3), with therapeutic potential for conditions like dry age-related macular degeneration (AMD). Catalyst’s partnership with Biogen for CB 2782-PEG emphasizes its clinical significance. The announcement comes alongside an emphasis on expanding clinical candidates from their protease engineering platform, underscoring ongoing innovation within the company.

Positive

• Patent protection for CB 2782-PEG extended until at least 2038.
• Lead candidate CB 2782-PEG targets complement factor 3 for diseases like dry AMD.
• Collaboration with Biogen for CB 2782 enhances development opportunities.

Negative

• Forward-looking statements come with risks of delays and unsatisfactory trial outcomes.
• Potential adverse effects observed in trials, including generation of neutralizing antibodies.

CB 2782-PEG patent protection extended until at least 2038

SOUTH SAN FRANCISCO, Calif., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that the United States Patent and Trademark Office (USPTO) has issued US Patent Number 10,781,435 B2 entitled “Modified Membrane Type Serine Protease 1 (MTSP-1) Polypeptides and Methods of Use.” This patent covers Catalyst’s portfolio of engineered proteases that selectively cleave and degrade complement factor 3 (C3), including the lead candidate CB 2782-PEG, a potential best-in-class treatment for dry AMD currently partnered with Biogen. These modified proteases inhibit complement activation and have the potential to treat multiple diseases in which dysregulated complement activation plays a role. The newly issued patent provides protection until at least 2038.

“CB 2782 demonstrates the power of our protease engineering platform and focus on the complement cascade. We plan to leverage our platform to expand the number of candidates we move into clinical development over the coming years,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst Biosciences.

About Catalyst Biosciences
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet needs in rare hematologic and complement-mediated disorders. Our protease engineering platform includes two late-stage clinical programs in hemophilia; a research program on engineering of subcutaneous (SQ) complement inhibitors; and a partnered preclinical development program with Biogen for dry age-related macular degeneration (AMD). The product candidates generated by our protease engineering platform have improved functionality and potency that allow for: SQ administration of recombinant coagulation factors and complement inhibitors; low-dose, high activity gene therapy constructs; and less frequently dosed intravitreal therapeutics. Our most advanced product candidate is marzeptacog alfa (activated) (MarzAA), a next-generation SQ FVIIa entering a Phase 3 registration study in late 2020. Our next late-stage product candidate is dalcinonacog alfa (DalcA), a next-generation SQ FIX, which has demonstrated efficacy and safety in a Phase 2b clinical trial in individuals with Hemophilia B. We have a discovery stage Factor IX gene therapy construct - CB 2679d-GT - for Hemophilia B, that has demonstrated superiority compared with the Padua variant in preclinical models. Finally, we have a global license and collaboration agreement with Biogen for the development and commercialization of anti-complement Factor 3 (C3) pegylated CB 2782.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about Catalyst’s plans to move new product candidates into clinical development in the coming years, the potential benefits of products based on Catalyst’s engineered protease platform, plans to enroll the first patient into a Phase 3 registration study of MarzAA in late 2020, the potential for MarzAA and DalcA to effectively and therapeutically treat hemophilia subcutaneously, the superiority of CB 2679d-GT over other gene therapy candidates and the Company’s collaboration with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. 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 the COVID-19 virus and other factors, that trials may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of DalcA or MarzAA, including the generation of neutralizing antibodies, which has been observed in patients treated with DalcA, the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, including as a result of delays in development and manufacturing resulting from COVID-19 and other factors, the risk that Biogen will terminate Catalyst’s agreement, competition and other risks described in the “Risk Factors” section of the Company’s quarterly report filed with the Securities and Exchange Commission on August 6, 2020, and in other filings with the Securities and Exchange Commission. 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

What is the significance of the patent extension for CB 2782-PEG?

The patent extension until at least 2038 strengthens Catalyst's competitive advantage and protects its intellectual property related to the treatment for dry AMD.

How does the partnership with Biogen impact CBIO stock?

The collaboration with Biogen enhances the development and commercialization prospects for CB 2782-PEG, potentially positively influencing CBIO's stock performance.

What are the risks mentioned in Catalyst's press release regarding CB 2782-PEG?

Risks include possible trial delays, unsatisfactory outcomes, and adverse effects such as the generation of neutralizing antibodies in some patients.

What potential diseases could CB 2782-PEG treat?

CB 2782-PEG has potential applications in treating diseases associated with dysregulated complement activation, like dry age-related macular degeneration.

When is Catalyst expected to move into clinical development for new product candidates?

Catalyst plans to advance new product candidates into clinical development over the coming years, leveraging its protease engineering platform.