Claims for Patent: 10,143,723

Summary for Patent: 10,143,723

Title:	Methods of using OX40 ligand encoding polynucleotides
Abstract:	The disclosure relates to compositions and methods for the preparation, manufacture and therapeutic use of polynucleotide molecules comprising an mRNA encoding an OX40L polypeptide. Also provided is a method for activating T cells or increasing the number of NK cells in a subject in need thereof.
Inventor(s):	Frederick; Joshua P. (Boston, MA), Bai; Ailin (Newton, MA)
Assignee:	ModernaTX, Inc. (Cambridge, MA)
Application Number:	15/996,140
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,143,723
Patent Claims:	1. A method for treating cancer in a subject by inducing or enhancing an anti-tumor immune response, comprising administering to the subject a messenger RNA (mRNA) encoding an OX40L polypeptide, wherein the mRNA comprises a 3' untranslated region (UTR) comprising at least one microRNA-122 (miR-122) binding site, thereby treating cancer in the subject by inducing or enhancing an anti-tumor immune response. 2. The method of claim 1, wherein the miR-122 binding site is a miR-122-3p binding site. 3. The method of claim 1, wherein the miR-122 binding site is a miR-122-5p binding site. 4. The method of claim 3, wherein the miR-122-5p binding site comprises the nucleotide sequence as set forth in SEQ ID NO: 26. 5. The method of claim 1, wherein the OX40L polypeptide comprises the amino acid sequence as set forth in SEQ ID NO: 1. 6. The method of claim 1, wherein the mRNA comprises an open reading frame, and wherein the open reading frame comprises a nucleotide sequence as set forth in SEQ ID NO: 4 or a nucleotide sequence at least 90% identical to SEQ ID NO: 4. 7. The method of claim 1, wherein the mRNA comprises a nucleotide sequence as set forth in SEQ ID NO: 65 or a nucleotide sequence at least 90% identical to SEQ ID NO: 65. 8. The method of claim 1, wherein the mRNA is chemically modified. 9. The method of claim 8, wherein the mRNA is fully modified with chemically-modified uridines. 10. The method of claim 9, wherein the chemically-modified uridines are N1-methylpseudouridines (m1.psi.). 11. The method of claim 8, wherein the mRNA is fully modified with 5-methylcytosine or is fully modified with N1-methylpseudouridines (m1.psi.) and 5-methylcytosine. 12. The method of claim 1, wherein the mRNA is formulated in a lipid nanoparticle. 13. The method of claim 12, wherein the lipid nanoparticle is administered intratumorally. 14. The method of claim 1, comprising administering an effective amount of a PD-1 antagonist, a PD-L1 antagonist or a CTLA-4 antagonist. 15. The method of claim 14, wherein the PD-1 antagonist is an antibody or antigen binding portion thereof that specifically binds to PD-1, wherein the PD-L1 antagonist is an antibody or antigen binding portion thereof that specifically binds to PD-L1, and wherein the CTLA-4 antagonist is an antibody or antigen binding portion thereof that specifically binds to CTLA-4. 16. The method of claim 15, wherein the PD-1 antagonist is selected from the group consisting of nivolumab, pembrolizumab, and pidilizumab, wherein the PD-L1 antagonist is selected from the group consisting of durvalumab, avelumab, and atezolizumab, and wherein the CTLA-4 antagonist is selected from the group consisting of ipilimumab and tremelimumab. 17. The method of claim 1, wherein the anti-tumor immune response in the subject comprises T cell activation and wherein the T cell activation reduces or decreases the size of a tumor, or inhibits growth of a tumor, in the subject. 18. The method of claim 1, wherein the anti-tumor immune response in the subject comprises increasing the number of NK cells in the tumor microenvironment.

Details for Patent 10,143,723

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	03/25/2011		2035-12-23
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	For Injection	125514	09/04/2014		2035-12-23
Merck Sharp & Dohme Corp.	KEYTRUDA	pembrolizumab	Injection	125514	01/15/2015		2035-12-23