VectivBio Holding AG operates as a clinical stage biopharmaceutical company. The company focuses on the discovery, development and commercialization of life-transforming medicines for patients living with severe rare conditions for which there is a significant unmet medical need.
The company’s product pipeline focuses on rare gastrointestinal, or GI, metabolic disorders, and it intends to in-license or acquire additional transformational, differentiated rare disease assets. The company’s lead p...
VectivBio Holding AG operates as a clinical stage biopharmaceutical company. The company focuses on the discovery, development and commercialization of life-transforming medicines for patients living with severe rare conditions for which there is a significant unmet medical need.
The company’s product pipeline focuses on rare gastrointestinal, or GI, metabolic disorders, and it intends to in-license or acquire additional transformational, differentiated rare disease assets. The company’s lead product candidate, apraglutide, is a next generation, long-acting synthetic peptide analog of glucagon-like peptide-2, or GLP-2, which it is developing as a differentiated therapeutic for a wide range of rare diseases, with an initial focus on short bowel syndrome, or SBS.
Apraglutide is being evaluated in a global Phase 3 clinical trial called STARS for the treatment of patients with syndrome with intestinal failure (SBS-IF), and a global Phase 2 clinical trial called Stargaze for the treatment of patients with gastrointestinal acute graft versus host disease. The company also plans to evaluate apraglutide’s therapeutic potential in additional rare GI, liver, and other conditions that could benefit from GLP-2 activation. The company’s pipeline includes a platform of first-in-class preclinical small molecule assets known as Comet for the treatment of rare inherited metabolic diseases, or IMDs.
The company’s lead product candidate, apraglutide, is a next generation, long-acting, synthetic GLP-2 analog that is designed to increase nutrient absorption in the intestine and reduce the burden of PS, thereby improving patient quality of life. Apraglutide has been rationally designed to have unique properties to address the known issues with native GLP-2 and teduglutide.
As of December 31, 2021, the company had conducted three randomized, double-blind, placebo-controlled clinical trials and one non-controlled, open label clinical trial and in which it administered apraglutide to a total of 66 healthy volunteers and 16 patients with SBS.
The company initiated a Phase 3 clinical trial to assess the safety and efficacy of apraglutide for the treatment of SBS-IF in January 2021, expect to report topline results from the trial at the end of 2023. The company initiated a Phase 2 clinical trial to evaluate the safety, tolerability and absorption parameters of apraglutide in SBS-IF subjects with CIC (colon-in-continuity anatomy) in the second quarter of 2021 and expects to report first readout in the second half of 2023.
The company is evaluating the potential of apraglutide in each of these areas with a focus on rare diseases with no approved therapies or with significant unmet needs. The company expanded its pipeline to Inherited Metabolic Disorders (IMDs) with the acquisition of CoMET Therapeutics in September 2021.
Strategy
The company focuses on developing highly innovative therapies that target the physiological root causes of a disease to significantly improve the lives of patients. The key elements of the company’s strategy are to advance apraglutide through clinical development in patients with SBS-IF; maximize the potential of apraglutide in additional indications where GLP-2 is central to the disease pathophysiology; retain commercialization rights for its product candidates in the United States and Europe and opportunistically evaluate strategies to maximize the commercial potential of our product candidates outside these jurisdictions; combine its accomplished business development team with its experienced rare disease research and development capabilities to expand its product portfolio; continue to expand its strong collaborative relationships with key stakeholders to address the needs of patients in increasingly effective ways and shape the future standard-of-care for devastating rare diseases; and strengthen and expand its intellectual property to protect apraglutide.
Short Bowel Syndrome
SBS is a complex disease that is characterized by a patient’s inability to adequately absorb the fluids and nutrients that are necessary to survive. SBS occurs as a result of the physical loss or the loss of function of a significant portion of the small intestine or colon. In adults, SBS typically occurs as a result of surgeries that require removal of large portions of the small intestine or colon due to irreparable damage. For adult SBS patients, this irreparable damage is typically caused by physical trauma or conditions, such as Crohn’s disease, ulcerative colitis, ischemia or cancer. In infants and children, SBS is typically a consequence of congenital defects or decreases in intestinal absorptive capacity as a result of surgery.
SBS-intestinal failure, or SBS-IF, is defined as the reduction of gut function below the minimum function necessary for the absorption of macronutrients or water and electrolytes, such that intravenous supplementation is required to maintain health, growth and survival. As an organ failure condition, SBS-IF patients require parenteral support, or PS, which is the intravenous delivery of nutrition and fluids required for a patient’s survival through a central line catheter. When PS is administered at home, it can also be referred to as home parenteral nutrition, or HPN.
Apraglutide is a next-generation, long-acting synthetic GLP-2 analog that has been carefully engineered to improve the potency and selectivity, and provide a longer half-life and a more consistent on-target drug exposure than native GLP-2 and other GLP-2 analogs.
The company initiated a Phase 3 clinical trial (the STARS trial) to evaluate the safety and efficacy of once-weekly administration of 2.5 mg or 5 mg of apraglutide. In addition to the STARS trial, the company plans to conduct the following clinical trials to evaluate the efficacy of apraglutide in SBS-IF further and to support potential submissions of marketing applications for apraglutide in the United States, European Union, and Japan.
Intellectual Property
Apraglutide
As of February 14, 2022, the company exclusively licensed 25 issued patents and 5 pending patent applications worldwide, including one U.S. issued patent. The patents that the company exclusively licenses outside of the United States are issued in Algeria, Australia, Brazil, Canada, China, Europe, Hong Kong, India, Iran, Israel, Japan, Jordan, Korea, Macau, Mexico, New Zealand, Russia, Saudi Arabia, South Africa and Taiwan. The issued European patent is validated in 37 countries, including Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Macedonia, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The patent applications that the company exclusively licenses are pending in Argentina, Egypt, Kuwait and the United Arab Emirates. These patents and patent applications contain composition-of-matter claims to apraglutide and methods of treatment using apraglutide. Not accounting for any patent term adjustment, regulatory extension or terminal disclaimers, and assuming that all annuity and/or maintenance fees are paid timely, these patents, and if granted, these patent applications, will expire in 2030. In particular, U.S. Patent No. 8,580,918, European Patent No. 2490 709, Japan Patent No. 5755653 and China Patent No. CN102711802, which contain composition-of-matter claims to apraglutide and methods of treatment using apraglutide, expire in 2030, not accounting for any patent term adjustment, regulatory extension or terminal disclaimers, and assuming that all annuity and/or maintenance fees are paid timely.
The company also owns two pending U.S. non-provisional patent applications and one pending PCT application related to apraglutide. These pending patent applications contain composition-of-matter claims to ultrapure compositions of apraglutide, methods of manufacturing apraglutide, and methods of treatment using apraglutide. Not accounting for any patent term adjustment, regulatory extension or terminal disclaimers, and assuming that all annuity and/or maintenance fees are paid timely, the U.S. patent applications and patent applications claiming priority to this PCT application, if granted, will expire in 2041.
The company also owns one pending U.S. non-provisional patent application and one pending PCT application related to methods of treating GvHD (graft versus host disease) using apraglutide. Not accounting for any patent term adjustment, regulatory extension or terminal disclaimers, and assuming that all annuity and/or maintenance fees are paid timely, this U.S. patent application and patent applications claiming priority to this PCT application, if granted, will expire in 2042.
Pantetheine Derivatives
As of February 14, 2022, the company’s subsidiary Comet Therapeutics, Inc. owned six pending U.S. patent applications, 38 pending non-U.S. patent applications, and one pending PCT application related to novel pantetheine derivatives and related methods of treatment. Comet Therapeutics, Inc. also co-owns and exclusively licenses two granted U.S. Patents, one pending U.S. patent application, four granted non-U.S. patents (including one European patent which is validated in nine countries: Switzerland, Germany, Denmark, Spain, France, the United Kingdom, Ireland, Italy, and the Netherlands), and five pending non-U.S. patent applications related to novel pantetheine derivatives and related methods of treatment. Not accounting for any patent term adjustment, regulatory extension or terminal disclaimers, and assuming that all annuity and/or maintenance fees are paid timely, these patents, applications and patent applications claiming priority to the PCT application, if granted, will expire between 2034 and 2042.
The term of individual patents depends upon the legal term for patents in the countries in which they are obtained. In most countries in which the company has filed, including the U.S., the patent term is 20 years from the earliest filing date of a non-provisional patent application.
Research and Development Expenses
For the year ended December 31, 2021, the company’s research and development expenses included $50.2 million.
Government Regulation and Product Approval
The U.S. Food and Drug Administration (FDA) and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, marketing and promotion, distribution, post-approval monitoring and reporting, sampling, and import and export of drugs, such as those the company is developing.
History
VectivBio Holding AG was founded in 2019. The company was incorporated in 2019.
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