US-20260124219-A1 - CANNABINOID COMPOSITIONS AND METHODS OF USE THEREOF FOR IMMUNE MODULATION

Abstract

Compositions comprising one or more phytocannabinoids and methods of use thereof for treatment of cancer, immune modulation, and protecting the immune system are provided.

Inventors

• Akhil Alugupalli
• Kishore Alugupalli

Assignees

• SRIN THERAPEUTICS, INC.

Dates

Publication Date

20260507

Application Date

20250924

Claims (1)

1. 1 . A pharmaceutical composition comprising a nanoemulsion comprising one or more phytocannabinoid isolate(s) and at least four terpene isolates selected from limonene, myrcene, linalool, alpha-pinene, humulene, caryophyllene, β-caryophyllene, beta-pinene, α-phellandrene, Δ3-carene, α-terpinene, β-phellandrene, cis-ocimene, terpinolene, α-guaiene, δ-guaiene, elemene, guaiol, γ-eudesmol, β-eudesmol, agarospirol, bulnesol, and α-bisabolol.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is continuation of U.S. patent application Ser. No. 17/428,572, filed Aug. 4, 2021, which is a National Stage Entry under 35 U.S.C. 371 of International Patent Application No. PCT/US 2020/017311, filed Feb. 7, 2020, which claims priority to US Provisional Ser. No. 62/802,754 , filed Feb. 8, 2019, which is incorporated herein by reference. BACKGROUND OF THE INVENTION The human endocannabinoid system responds to endocannabinoids produced in the body as well as to phytocannabinoids, including cannabidiol [1]. CB1 and CB2 are the two major receptors for cannabinoids in both humans and mice [2-5]. Cannabidiol is a major non-psychoactive constituent of the cannabis plant. In June 2018, the FDA approved the first ever cannabis-derived medicine, Epidiolex, which contains cannabidiol as the active pharmaceutical ingredient (API), for treating childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome, which typically do not respond to anti-seizure medications [6]. Cannabidiol is proposed to treat a variety of other diseases including cancer [5, 7-11]. Cannabidiol possesses a number of anti-neoplastic properties, such as inhibiting cancer cell invasion and inducing apoptosis and autophagy of cancer cells [12-25]. Cannabidiol also improves the overall health of cancer patients and reduces the side effects of chemotherapy such as nausea, vomiting, and anorexia [26]. Furthermore, cannabidiol inhibits chemotherapy-induced neuropathic pain, through serotonin 1A receptors, without diminishing nervous system function or chemotherapy efficacy [27]. CB2 is also highly expressed on most cells of hematopoietic lineage including lymphocytes and macrophages and is required for efficient immune responses and maintaining immune homeostasis [22, 28-33]. Chemotherapy results in impairment of various arms of the immune system [34]. Chemotherapy can dampen pre-existing immune memory generated by prior vaccination and, as a result, patients receiving chemotherapy are more readily susceptible to a variety of infections than normal individuals. It is also known that the tumor microenvironment itself is a highly immunosuppressive environment. Therefore, such tissue environment hinders the anti-tumor activity of the immune system. Some immunotherapy drugs, which are referred to as immune checkpoint inhibitors, have the capacity to augment anti-tumor activity of the immune system. However, the very nature of chemotherapy (that is involved in the treatment of cancer patients), is that it adversely affects the immune system. Thus, there is presently a need for cannabinoid-based treatments for cancer and improving immune function in certain groups of individuals, such as chemotherapy patients. SUMMARY OF THE INVENTION The present disclosure relates to phytocannabinoid-containing compositions and methods of use thereof for improving aspects of the immune response. In one aspect, a nanoemulsion comprising one or more phytocannabinoid isolates and at least four terpene isolates is provided. In a further aspect, the composition includes olive oil, a surfactant, and sterile water. Phytocannabinoid isolates can be selected from cannabidiol, cannabidiphorol, tetrahydrocannabiphorol, cannabidiolic acid, tetrahydrocannabinol, tetrahydrocannabinolic acid, cannabigerol, cannabinol, cannabichromene, tetrahydrocannabivarin, and cannabidivarin, and, in certain embodiments, are found at a concentration in the range of 0.5 to 2000 mg/ml and have a purity equal to or greater than 90%. In certain embodiments, the phytocannabinoid isolate is cannabidiol, and the hydro-lipid excipient complex includes olive oil, polysorbate 80, water, limonene, linalool, myrcene, and alpha-pinene. In certain embodiments the nanoemulsion is characterized by a mean particle diameter size up to 900 nm. In certain embodiments, the compositions provided herein are suitable for or formulated for topical, oral, or sublingual administration in a solution, spray, drop, strip, cream, or capsule. In yet another embodiment, a method is provided for treating, inhibiting, and/or limiting the progression of a cancer in a subject that includes administering a nanoemulsion composition described herein. In certain embodiments, the subject has melanoma, lung cancer, or colorectal cancer. In certain embodiments, a nanoemulsion composition is administered in combination with another therapy, for example a chemotherapeutic agent, immunotherapy, or small molecule agent. In certain embodiments, a method is provided for treating, inhibiting, and/or limiting the progression inflammatory disease in a subject that includes administering a nanoemulsion composition described herein. In yet another embodiments, the method provided is intended to treat a subject that i) is being treated with chemotherapy or is recovering from chemotherapy; ii) received a bone marrow transplant or hematopoietic stem cell transplant; iii) received a bl