Sorrento Announces FDA Clearance – GuruFocus.com
- The FDA has granted IND clearance for Abivertinib (Fujovee™) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castration-resistant prostate cancer (mCRPC) at multiple centers in United States.
- Abivertinib is a novel small molecule tyrosine kinase (TKI) inhibitor that selectively targets both mutant forms of epidermal growth factor receptor (EGFR) as well as Bruton’s tyrosine kinase (BTK) and has been shown to ‘it inhibits extragonadal androgen production in preclinical models due to the interaction between BTK inhibition and 3βHSD.
- The study will enroll patients with progressive mCRPC carrying the adrenal permissive HSD3β1 (1245C) allele (germinal heterozygote or homozygote) and will include two cohorts: abiraterone naïve and abiraterone progressing. The presence of the HSD3B1 allele is associated with earlier castration resistance and shorter overall survival.
- The global CRPC market for 2021 was $2.7 billion, with the United States accounting for 67% ($1.83 billion) and a CAGR of 4.15%, which is expected to reach $4.56 billion, US to account for 68% ($3.08 billion) by 2031(1).
SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (SRNE, “Sorrento”) today announced that it has received FDA clearance for its Investigational New Drug (IND) application for the abivertinib (Fujovee™) for the Phase 2 MAVERICK study to be conducted in participants with metastatic castration-resistant prostate cancer (mCRPC) at multiple centers in the United States. The MAVERICK study will be conducted in partnership with the Prostate Cancer Clinical Trials Consortium and will enroll participants with abiraterone-naïve and abiraterone-progressing mCRPC. The MAVERICK trial will be conducted as an open label study of abivertinib with abiraterone in up to 100 participants carrying the adrenal permissive HSD3β1 allele (heterozygous or homozygous). The primary objective of the study is to assess the efficacy of abivertinib with abiraterone via assessment of radiographic progression-free survival (rPFS) at 6 months and the primary endpoint is rPFS at 6 months. months defined as a percentage of subjects alive and progression-free per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for measurable disease and the Prostate Cancer Working Group 3 (PCWG3) criteria ) for bone metastases. Participants will remain on treatment until radiographic progression, unacceptable toxicity, intercurrent disease, or other reasons (such as subject withdrawal).
Production of extragonadal androgens requires activity of the 3β-hydroxysteroid dehydrogenase-1 (3β-HSD1) isoenzyme encoded by the HSD3β1 allele and an identified single nucleotide polymorphism (SNP) may create an adrenal permissive phenotype that allows development faster mCRPC resulting in earlier castration resistance and shortened overall survival. Increased expression of BTK has been observed in various solid tumors, including prostate cancer, and the interaction between BTK inhibition and 3βHSD is thought to be 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 by several types of cancer at doses up to 300 mg twice daily.
The global CRPC market for 2021 was $2.7 billion, with the United States accounting for 67% ($1.83 billion) and a CAGR of 4.15%, which is expected to reach $4.56 billion, US to account for 68% ($3.08 billion) by 2031(1).
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial-stage biopharmaceutical company developing novel therapies to treat cancer, pain (non-opioid treatments), autoimmune diseases and COVID-19. Sorrento’s multi-modal, multi-pronged approach to fighting cancer is enabled by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immunocellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”) and oncolytic viruses (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and coronavirus vaccines, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic testing solutions, including COVIMARK™.
Sorrento’s commitment to therapies that improve patients’ lives is also demonstrated by our efforts to advance a first-in-class, non-opioid pain management small molecule (TRPV1 agonist), resiniferatoxin (“RTX”) and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a new viscous gel formulation of a corticosteroid widely used for epidural injections to treat lumbosacral radicular pain, or sciatica, and to market ZTlido® (topical lidocaine system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a phase II trial in intractable pain associated with cancer and a phase II trial in patients with osteoarthritis. Positive final results from the CLEAR program of the pivotal Phase III trial for SEMDEXA™, its new non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.
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This press release and all statements made for and during any presentation or meeting contain forward-looking statements relating to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties. which could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Abivertinib (Fujovee™); the therapeutic and clinical potential of abivertinib; the potential safety and efficacy of abivertinib, including the potential efficacy of abivertinib against castration-resistant prostate cancer (CRPC); the global CRPC market in 2021 and the amount accounted for in the United States, the projected CAGR for the global CRPC market and the amount of the global CRPC market that the United States will represent by 2031; the expected number of participants in the Phase 2 MAVERICK study and the expected length of time trial participants will remain in the study. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements include, but are not limited to: risks relating to Sorrento’s technologies and prospects, including, but not to limit the risks related to the safety and efficacy of abivertinib; clinical development risks, including risks relating to the progress, timing, cost and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; the risks that the results of a clinical study may not meet any or all of the clinical study endpoints and that data generated from such studies may not support regulatory submission or approval; the risks that the results of prior tests, studies and trials will not be replicated in ongoing or future studies and trials; risks associated with the manufacture and supply of pharmaceutical products; the risks of using the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in executing its product candidate strategies; risks related to the global impact of COVID-19; and other risks described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and subsequent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and Exchange Commission, including the risk factors set forth in such documents. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statements in this press release unless the law requires it.
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Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are registered trademarks of Sorrento Therapeutics, Inc.
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(1) Datamonitor and Sorrento Internal research.