Clovis (CLVS) requests authorization to conduct a clinical study on a new drug

Clovis Oncology, Inc. CLVS has announced the submission of two Investigational New Drug (“IND”) applications to the FDA to initiate a clinical study on its lead compound in its Peptide-Targeting Radionuclide Therapy (PTRT) development program, FAP- 2286. The company is developing the new candidate as PTRT – lutetium-177-labeled FAP-2286 – and imaging agent – gallium-68-labeled FAP-2286 – targeting the fibroblast activating protein.

The company plans to launch a Phase I / II study to evaluate the therapeutic agent FAP-2286 in the first half of 2021, following possible FDA clearance for the IND application. The phase I portion of the study will determine the candidate’s dose and tolerability. The phase II part will consist of expansion cohorts planned in several types of tumors.

The company will develop the FAP-2286 imaging agent as a diagnostic to identify patients with FAP-positive tumors suitable for treatment with the FAP-2286 therapeutic agent.

Clovis said FAP-2286 is the first radionuclide therapy targeting peptides targeting FAP to enter clinical development. It has been observed that FAP is strongly expressed in over 90% of breast, lung, colorectal and pancreatic carcinomas. Targeted radionuclide therapy is an emerging area in cancer treatment and the successful development of FAP-2286 will likely be of benefit to the company as it will create a new avenue outside of its existing portfolio of PARP inhibitors, which is very competitive. .

Clovis shares are down 57.2% so far this year against an industry increase of 7.5%.

The company is entirely dependent on the performance of its PARP inhibitor drug, Rubraca, for its revenue. The drug generated $ 121.2 million in sales in the first nine months of 2020, up 16.9% year-over-year. The company expects Rubraca’s fourth quarter 2020 sales to be $ 38 million to $ 40 million. The drug is approved for the treatment of prostate cancer and as a maintenance treatment for ovarian cancer.

Although sales of the drug have increased year on year, it faces competition from other PARP inhibitors – AstraZeneca‘s AZN Lynparza and Glaxo‘s GSK Zejula, approved for similar indications. PfizerAnother FDA-approved PARP inhibitor that’s approved for breast cancer is Talzenna’s PFE.

Meanwhile, the company is evaluating Rubraca monotherapy as well as a combination regimen of Rubraca and Opdivo from Bristol Myers in the phase III study ATHENA. The study evaluates treatment regimens as a first-line maintenance treatment for newly diagnosed advanced ovarian cancer.

The first data from the monotherapy cohort is expected in the second half of 2021. The data from this cohort will support an additional new drug application to expand the label of Rubraca as a first-line maintenance treatment for cancer. of the ovary.

The first data from the combined cohort is expected in 2022 or later.

The company is also developing the drug as monotherapy or in combination with other therapies for cancer of the lung, bladder, breast, pancreas, stomach and recurrent solid tumors with deleterious mutations in the repair gene. homologous recombination.

Clovis Oncology, Inc. Price

Clovis Oncology, Inc. Price

Clovis Oncology, Inc. Price

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Zack Rank

Clovis currently wears a Zacks Rank # 3 (Hold). You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.

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