| Molecule | Partner | Indication | China Ph3 / Pivotal | Clinical Status | |||
|---|---|---|---|---|---|---|---|
| Planning | Enrollment | Global | APAC | ||||
| Oncology | Sacituzumab govitecan (Trodelvy™) | mTNBC (2L) | BLA approved in US | NDA approved in Singapore; BLA accepted in China with priority review; NDA submitted in South Korea | |||
| HR+, HER2- (3L) | Phase 3 | ||||||
| mUC (2/3L) | BLA approved in US | Seek BLA approval based on US approval | |||||
| mTNBC (1L) | Phase 3 | ||||||
| NSCLC (1L） | Phase 3 | Join Gilead and Merck’s trial | |||||
| Asia basket trial | Phase 2 | - | |||||
| FGF401 | HCC | Phase 1/2 | |||||
| Immunology | Etrasimod | Ulcerative colitis | Phase 3 | South Korea and Taiwan included in multi-regional trial | |||
| Other autoimmune diseases (CD, AD) | Phase 2/3(1) | ||||||
| Cardio-Renal Disease | Nefecon | lgA nephropathy | NDA approved in US | NDA approved in US; Seek BLA approval based on US approval | |||
| Ralinepag | PAH | Phase 3 | |||||
| XNW1011 | Renal disease | Phase 2 | |||||
| Infectious Disease | PTX-COVID19-B and other COVID-19 Vaccines | COVID-19 | Phase 2/3 | ||||
| Eravacycline (Xerava™) | cIAI | NDA approved in US, EU, UK | NDA approved in Singapore; NDA filed in China and Hong Kong | ||||
| CABP | Phase 3 | - | |||||
| Taniborbactam (VNRX-5133) | cUTI | Phase 3 | |||||
| SPR206 | Gram negative infections | Phase 1 | |||||
| EDDC-2214 | COVID-19 oral antiviral treatments | Phase 1 | - | ||||
Sacituzumab govitecan is a first-in-class antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. Sacituzumab govitecan was granted accelerated approval by the U.S. FDA in April 2020 for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. In July 2020, our partner Immunomedics announced positive results from the randomized, confirmatory Phase 3 ASCENT Study, that showed that sacituzumab govitecan significantly improved progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) in this same patient population.
Greater China, South Korea, Mongolia, SE Asia
FGF401 is a potential first-in-class, ATP-competitive, reversible-covalent inhibitor of FGFR4 for which we obtained global commercial rights from Novartis. We are developing FGF401 for hepatocellular carcinoma (HCC), which represents 90% of all liver cancers and is highly prevalent in China, causing over 300,000 deaths per year. FGF401 has undergone a dose escalation study and a phase 1b study in cancer patients that demonstrated single agent responses in HCC patients.
Worldwide
Etrasimod is a potentially best-in-class next-generation, oral, highly selective modulator of the sphingosine-1-phosphate (S1P) receptor. Based on available data and its selectively engagement with S1P receptors 1, 4 and 5, we believe it may have an improved safety and efficacy profile compared to existing members of the class. Etrasimod met the predefined efficacy endpoints and was well tolerated in the randomized, double-blind Phase 2 OASIS study in moderately to severely active ulcerative colitis (UC), performed by our partner Arena Pharmaceuticals. Etrasimod may also have potential in additional autoimmune indications, including Crohn’s Disease and atopic dermatitis.
Greater China, South Korea
TARPEYO (budesonide developed under the project name NEFECON) is the first FDA-approved and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
TARPEYO (developed under the project name NEFECON) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy.
Greater China, Singapore, South Korea
Ralinepag is a next-generation, potent, selective oral IP prostacyclin receptor agonist being developed for the treatment of pulmonary arterial hypertension (PAH). This class of medicines has been shown to reduce mortality in PAH patients. In Phase 2 clinical trials, ralinepag demonstrated clinically meaningful and statistically significant efficacy in improving PAH patients’ clinical symptoms compared to placebo. An extended release formulation currently in global Phase 3 development, ralinepag XR, was designed to deliver intravenous prostacyclin-like potency and pharmacokinetics in an oral tablet.
Greater China, South Korea
XNW1011 is a next-generation covalent reversible BTK inhibitor that exhibits high selectivity, excellent pharmacokinetics property, robust target engagement and a safety profile that supports continued development based in part on results from a completed phase 1 study with healthy subjects conducted by SinoMab in China.
Global rights for renal disease
PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which is designed to encode the S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence’s Phase 1 study showed that PTX-COVID19-B demonstrated strong virus neutralization capability and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.
Greater China, Southeast Asia and Pakistan
Eravacycline is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as a first-line empiric monotherapy for the treatment of MDR infections, including MDR Gram-negative infections. It was approved in 2018 in the United States and the EU for the treatment of complicated intra-abdominal infections (cIAI) and is marketed by our partner Tetraphase Pharmaceuticals under the trade name Xerava. As a broad-spectrum antibiotic, eravacycline covers the majority of the key resistant pathogens in China. In vitro studies have demonstrated its potency in clinical isolates commonly found in China, not only in extended-spectrum beta-lactamase producing strains, or ESBLs, but also in clinically challenging pathogens such as carbapenem-resistant Enterobacteriaceae (CRE) and Carbapenem resistant Acinetobacter baumannii (CRAB).
Greater China, South Korea, SE Asia
Taniborbactam (formerly VNRX-5133) is a novel injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro and in vivo activity against both serine-beta-lactamases (SBLs) and metallo-beta-lactamases (MBLs). In a fixed dose combination with cefepime (a 4th generation cephalosporin), taniborbactam is expected to address unmet medical need for a safe and effective therapy for treatment of diseases due to MDR gram-negative bacteria, particularly extended spectrum beta-lactamase (ESBL) producing organisms, CRE and carbapenem resistant Pseudomonas aeruginosa.
Greater China, South Korea, SE Asia
SPR206 is a potentially best-in-class, novel polymyxin derivative that was designed to reduce the kidney toxicity that is seen clinically with polymyxin B and colistin. Polymyxins are antibiotics frequently used as a last resort for challenging MDR gram-negative infections, but they are associated with significant neurotoxicity and nephrotoxicity. In a double-blind, placebo-controlled Phase 1 clinical trial in healthy volunteers conducted by our partner Spero Therapeutics, SPR206 appeared well tolerated at doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections. Importantly, it also showed no evidence of nephrotoxicity at the doses tested.
Greater China, South Korea, SE Asia
EDDC-2214 is a novel and potent SARS-CoV-2 3CL protease inhibitor, which Everest will develop as an oral antiviral COVID-19 therapy. The main protease in SARS-CoV-2 is the 3CL protease. Compared to several other oral COVID-19 antivirals, EDDC-2214 exhibits better in-vitro potency and pre-clinical oral bioavailability. Clinical trials evaluating EDDC-2214 are expected to begin later this year.
Worldwide
