Centessa Pharmaceuticals plc, a clinical-stage pharmaceutical company, discovers, develops, and delivers medicines that are transformational for patients.
The company's UK business is operated by Centessa Pharmaceuticals (UK) Limited, ('CPUK'), (formerly Centessa Limited) directly and, in respect of the SerpinPC program, through its wholly owned UK subsidiary, ApcinteX Limited. Its pipeline programs include:
Hemophilia Program
SerpinPC, the company’s most advanced product candidate, is an inv...
Centessa Pharmaceuticals plc, a clinical-stage pharmaceutical company, discovers, develops, and delivers medicines that are transformational for patients.
The company's UK business is operated by Centessa Pharmaceuticals (UK) Limited, ('CPUK'), (formerly Centessa Limited) directly and, in respect of the SerpinPC program, through its wholly owned UK subsidiary, ApcinteX Limited. Its pipeline programs include:
Hemophilia Program
SerpinPC, the company’s most advanced product candidate, is an investigational, subcutaneously administered novel inhibitor of activated protein C (‘APC’) for the treatment of hemophilia. The company is currently evaluating SerpinPC in registrational studies for hemophilia B (‘HB’) with and without inhibitors. The company dosed the first subject in the registrational PRESent-2 study of moderately severe to severe HB without inhibitors, and severe hemophilia A (‘HA’) with or without inhibitors in July 2023, and dosed the first subject in the registrational PRESent-3 study of HB with inhibitors in October 2023. In parallel, it continues to work with the U.S. Food and Drug Administration (‘FDA’) and a number of global regulators on its product process development and qualification activities. This streamlined, integrated development program is designed to support HB, with or without inhibitors, as the initial indication for SerpinPC. The FDA granted SerpinPC Orphan Drug Designation in September 2022, and Fast Track designation in May 2023, both for the treatment of HB. While the initial focus of its ongoing clinical development program is HB, with and without inhibitors, the company believe SerpinPC has the potential to treat all types of hemophilia regardless of severity or inhibitor status, and it may also prevent bleeding associated with other bleeding disorders.
Orexin Receptor 2 (OX2R) Agonist Program
ORX750 is an investigational, orally administered, selective OX2R agonist with a potential best-in-class profile for the treatment of narcolepsy and other sleep-wake disorders. In October 2023 at the World Sleep Congress, the company shared a set of preclinical data that showed ORX750 is a highly potent and selective orexin agonist that closely mimics the function of the endogenous peptide. The preclinical data also showed that ORX750 has the potential to address the underlying pathophysiology of orexin neuron loss in narcolepsy Type 1 (‘NT1’) and promote wakefulness during the day and suppress cataplexy, including at levels that correspond to very low predicted human doses. In addition, the data showed ORX750’s potential for expansion into broader sleep-wake disorders with normal orexin tone, including narcolepsy Type 2 (‘NT2’) and idiopathic hypersomnia (‘IH’).
LockBody Technology Platform
The company’s first LockBody candidate is LB101, a conditionally tetravalent PD-L1xCD47 bi-specific monoclonal antibody for solid tumors. It is currently evaluating LB101 in a Phase 1/2a first-in-human (‘FIH’), open-label, multicenter, dose escalation study with expansion cohorts to evaluate the safety, tolerability, and preliminary activity of LB101 in subjects with advanced solid tumors.
LB101 has two anti-CD-47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, in this case CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the proprietary human IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor. LB101 is in a Phase 1/2a FIH clinical trial for the treatment of solid tumors.
Strategy
The key elements of the company’s strategy are to evaluate opportunities to accelerate development timelines and enhance commercial potential of its programs in collaboration with third parties. The company owns full worldwide development and commercialization rights to each of its programs. It may selectively enter into collaborations where it believes that there is a strategic fit or benefit, or an opportunity to accelerate or expand the potential for the development and commercialization of its product candidates, or support life cycle management.
Regulations
The company is subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair the company’s ability to compete in domestic and international markets. It is also subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which it conduct activities.
Research and Development
Research and development expenses consist primarily of costs incurred in connection with the discovery and development of the company’s clinical and preclinical programs, net of reimbursements. Research and development expenses for the year ended December 31, 2023 were $124.4 million.
Intellectual Property
The company has entered into various license agreements to obtain the rights to use certain patents for the development and commercialization of its product candidates. As of December 31, 2023, following an internal reorganization, its subsidiary, Centessa Pharmaceuticals (UK) Limited owns one U.S. patent in connection with its LockBody technology platform; one issued U.S. patent and two granted non-U.S. patents in connection with its ZF874 program; and two issued U.S. patents and three issued non-U.S. patents, which include claims directed to compositions and methods of use of the lead anti-LIGHT antibody.
As of December 31, 2023, ApcinteX has a license to two issued U.S. patents, 50 issued foreign patents, including in France, Germany, UK, China, Japan, and Australia. ApcinteX’s licensed patent portfolio have claims directed to SerpinPC composition of matter, compositions of matter of other serpin variants, and method of use of SerpinPC. The issued patents expire in 2034.
Sales and Marketing
The company evaluates its commercialization strategy as it advances each product candidate through clinical development. In any core markets outside of the United States that it may identify, where appropriate, the company may utilize strategic partners, distributors, or contract sales forces to expand the commercial availability of its product candidates.
History
Centessa Pharmaceuticals plc was incorporated in 2020.