BioXcel Therapeutics. has filed a patent for a method of diagnosing, prognosing, and treating prostate cancer patients. The patent claims a method of selecting patients with castration resistant prostate cancer (CrPC) for combination therapy using a selective dipeptidyl peptidase inhibitor and a PD-1 axis antagonist. The patent also includes a method of treating CrPC patients with this combination therapy. GlobalData’s report on BioXcel Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on BioXcel Therapeutics, Cancer treatment biomarkers was a key innovation area identified from patents. BioXcel Therapeutics's grant share as of September 2023 was 15%. Grant share is based on the ratio of number of grants to total number of patents.

Method for treating castration resistant prostate cancer with combination therapy

Source: United States Patent and Trademark Office (USPTO). Credit: BioXcel Therapeutics Inc

A recently filed patent (Publication Number: US20230227918A1) describes a method for treating castration-resistant prostate adenocarcinoma cancer or castration-resistant neuroendocrine prostate cancer. The method involves administering two specific drugs to the subject: talabostat or a pharmaceutically acceptable salt thereof, and a PD-1 axis antagonist.

The patent claims that prior to treatment, a biological sample from the subject is analyzed to determine the amplification and/or expression level of certain genes. These genes include DPP-8, DPP-9, FAP, and programmed death ligand-1 (PDL-1) or CD274. If the amplification and/or expression level of these genes exceeds a predetermined threshold level, the treatment method described in the patent can be used.

The amplification and/or expression level of the genes can be determined using various methods such as amplification assays, hybridization assays, immunoassays, immunohistochemistry, western blot, northern blot, probe-based quantitative amplification assays, whole genomic sequencing, whole proteomic sequencing, RNA sequencing, polymerase chain reaction (PCR), or quantitative real-time polymerase chain reaction (qRT-PCR).

The biological sample used for analysis can include tumor cells, tumor-associated stromal cells, tumor-associated fibroblasts, tumor-associated macrophages, other immune-related cells like CD8+ T cells, MDSCs, and Tregs, NK cells, circulating tumor DNA (ctDNA), circulating tumor cells, or a combination of these.

The treatment method described in the patent is applicable to human subjects. The PD-1 axis antagonist used in the treatment can be a PD-1 antagonist, PDL-1 antagonist, or PDL-2 antagonist. Examples of PD-1 antagonists include ANA011, AUNP-12, BGB-A317, KD033, pembrolizumab, MCLA-134, mDX400, MEDI0680, muDX400, nivolumab, PDR001, PF-06801591, REGN-2810, SHR-1210, STI-Al 110, TSR-042, and XCE853, either alone or in combination.

Similarly, PDL-1 antagonists can include avelumab, BMS-936559, CA-170, durvalumab, MCLA-145, SP142, STI-A1011, STI-A1012, STI-AIOIO, STI-A1014, atezolizumab, or combinations thereof. PDL-2 antagonists can include AMP-224 and rHIgM12B7, either alone or in combination.

The PD-1 axis antagonist is administered at a dose ranging from about 0.01 to 30 mg/kg, while the total daily amount of talabostat administered to the subject is from about 100 micrograms to 2.0 milligrams.

In summary, the patent describes a method for treating castration-resistant prostate adenocarcinoma cancer or castration-resistant neuroendocrine prostate cancer by administering talabostat and a PD-1 axis antagonist to the subject. The treatment is determined based on the amplification and/or expression level of specific genes in a biological sample from the subject. The patent provides a range of PD-1 axis antagonists and dosage ranges for their administration.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies