Sorrento Announces FDA Authorization to Proceed With Phase 2 Study of Abivertinib (Fujovee™) to Treat Metastatic Castrate Resistant Prostate Cancer (MAVERICK Trial)
- FDA granted IND clearance for Abivertinib (Fujovee™) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castrate resistant prostate cancer (mCRPC) at multiple centers in
the United States.
- Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) as well as Bruton's tyrosine kinase (BTK) and has been shown to inhibit extragonadal androgen production in preclinical models due to the interplay between BTK inhibition and 3βHSD.
- The study will enroll patients with progressive mCRPC harboring the adrenal-permissive HSD3β1(1245C) allele (germline heterozygous or homozygous) and will include two cohorts: abiraterone-naïve and abiraterone-progressing. Presence of the HSD3B1 allele is associated with earlier castration resistance and shorter overall survival.
- The global market for CRPC for 2021 was
$2.7 billion, with the U.S.accounting for 67% ( $1.83 billion), and a CAGR of 4.15%, projected to reach $4.56 billionwith the U.S.projected to account for 68% ( $3.08 billion) by 2031(1).
Extragonadal androgen production requires the activity of 3β-hydroxysteroid dehydrogenase isoenzyme-1 (3β-HSD1) encoded by the HSD3β1 allele and an identified single nucleotide polymorphism (SNP) can create an adrenal-permissive phenotype that allows for more rapid development of mCRPC resulting in earlier castration resistance and shortened overall survival. Increased BTK expression has been observed in various solid tumors, including prostate cancer, and it is believed that the interplay between BTK inhibition and 3βHSD is responsible. BTK inhibition has been shown to inhibit androgen production, particularly from extragonadal precursor steroids, in preclinical models. In addition to selectively targeting both mutant forms of EGFR (T790M and exon 19 and 21 mutations), Abivertinib irreversibly binds to the BTK receptor, preventing phosphorylation of the receptor. Abivertinib is an oral capsule taken twice daily and has been well tolerated across multiple cancer types in doses up to 300 mg twice daily.
The global market for CRPC for 2021 was
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic test solutions, including COVIMARK™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in
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(1) Datamonitor and Sorrento Internal Research.
Source: Sorrento Therapeutics, Inc.