Clovis Oncology, Inc. ( CLVS Quick Quote CLVS - Free Report) announced submission of two investigational new drug (“IND”) applications to the FDA for initiating clinical study on its lead compound in its peptide-targeted radionuclide therapy (PTRT) development program, FAP-2286. The company is developing the novel candidate as PTRT — lutetium-177 labeled FAP-2286 — and imaging agent — gallium-68 labeled FAP-2286 — targeting fibroblast activation protein.
The company plans to initiate a phase I/II study to evaluate FAP-2286 therapeutic agent in the first half of 2021, following a potential FDA clearance to the IND application. The phase I portion of the study will determine the dose and tolerability of the candidate. The phase II portion will consist of expansion cohorts planned in multiple tumor types.
The company will develop the FAP-2286 imaging agent as a diagnostic to identify patients with FAP-positive tumors appropriate for treatment with the FAP-2286 therapeutic agent.
Clovis stated that FAP-2286 is the first peptide-targeted radionuclide therapy targeting FAP to enter clinical development. It has been observed that FAP is highly expressed in more than 90% of breast, lung, colorectal and pancreatic carcinomas. Targeted radionuclide therapy is an emerging field in the treatment of cancer and successful development of FAP-2286 will likely be beneficial for the company as it will create a new avenue apart from its existing PARP inhibitor portfolio, which is highly competitive.
Shares of Clovis have declined 57.2% so far this year against the
industry’s increase of 7.5%.
The company is entirely dependent on the performance of its PARP inhibitor drug, Rubraca, for its revenues. The drug generated $121.2 million in sales in the first nine months of 2020, representing growth of 16.9% year over year. The company expects Rubraca sales in the fourth quarter 2020 to be $38-$40 million. The drug is approved for treating prostate cancer and as maintenance treatment for ovarian cancer.
Although sales of the drug grew year over year, it faces competition from other PARP inhibitors —
AstraZeneca’s ( AZN Quick Quote AZN - Free Report) Lynparza and Glaxo’s ( GSK Quick Quote GSK - Free Report) Zejula, approved for similar inidications. Pfizer’s ( PFE Quick Quote PFE - Free Report) Talzenna is another FDA-approved PARP inhibitor, which is approved for breast cancer.
Meanwhile, the company is evaluating Rubraca monotherapy as well as a combination regimen of Rubraca and Bristol Myers’ Opdivo in the phase III ATHENA study. The study is evaluating the regimens as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer.
Top-line data from the monotherapy cohort is expected in the second half of 2021. Data from this cohort will support a supplemental new drug application filing seeking label expansion of Rubraca as first-line maintenance treatment for ovarian cancer.
Top-line data from the combination cohort is expected in 2022 or later.
The company is also developing the drug as monotherapy or in combination with other therapies for lung, bladder, breast, pancreatic, gastric cancer and recurrent solid tumors with deleterious homologous recombination repair gene mutations.
Clovis currently carries a Zacks Rank #3 (Hold). You can see
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