Remarkable and Inspiring Breakthrough Variant Activin Receptor Therapy

Introduction

This variant activin receptor therapy technology provides an innovative approach to promote tissue repair, regulate cellular growth, and modulate immune responses, positioning it as a breakthrough in regenerative and therapeutic medicine. By leveraging specially modified activin receptor polypeptides, this therapy opens doors for targeted treatments in conditions requiring tissue regeneration, immune system balance, and improved cellular function. For pharmaceutical and biotech companies focused on cutting-edge therapies, this technology is a valuable asset that supports the next generation of healthcare solutions, particularly in regenerative and chronic care sectors.

The Challenge: Enhancing Regenerative Processes

In regenerative medicine and immunotherapy, effective solutions often face significant challenges in balancing tissue growth and immune modulation. Conventional therapies may lack specificity, risking unwanted side effects or insufficient efficacy in targeting complex cellular pathways. Patients with chronic injuries, degenerative diseases, or immune dysregulation require advanced therapies that address the underlying cellular mechanisms responsible for growth and repair. A targeted, variant activin receptor approach presents a powerful answer to these challenges, enabling treatments that support both cellular health and recovery.

Targeted Therapy for Tissue Repair and Immune Balance

This therapy, built on a foundation of engineered activin receptor polypeptides, targets precise cellular pathways to promote tissue regeneration while maintaining immune stability. It works by modulating specific activin receptor variants, which play critical roles in cellular development and tissue health. As a result, patients treated with this therapy experience enhanced healing, reduced inflammation, and optimal cellular growth, making it especially effective for those recovering from injury, managing autoimmune conditions, or seeking advanced regenerative therapies. This unique approach supports long-term recovery and resilience, setting it apart from traditional regenerative solutions.

Key Benefits for Pharmaceuticals and Healthcare Innovators

For pharmaceutical companies, this variant activin receptor therapy technology offers a path to develop a suite of innovative therapies that cater to both tissue regeneration and immune modulation needs. Regenerative medicine practitioners gain a new tool to assist patients with chronic conditions or recovery requirements, offering a balanced, effective approach to healing. The therapy’s specificity and effectiveness make it valuable for a range of applications, from enhancing recovery outcomes to providing safe, targeted care for immune-compromised patients. This technology aligns with current trends in precision medicine, enabling personalized patient care.

Invest in Transformative Healing Solutions

Licensing this variant activin receptor therapy positions your company as a pioneer in regenerative and immune-modulating therapies. By offering an innovative, targeted solution for tissue repair and immune regulation, your business can lead the way in delivering transformative healthcare solutions. This technology is a strategic investment for companies dedicated to advancing patient outcomes, supporting long-term health, and expanding possibilities in regenerative medicine and chronic care.

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Abstract
Claims

The present invention provides variant activin IIB soluble receptor polypeptides and proteins capable of binding and inhibiting the activities of activin A, myostatin, or GDF-11. The present invention also provides polynucleotides, vectors and host cells capable of producing the variant polypeptides and proteins. Compositions and methods for treating muscle-wasting and other diseases and disorders are also provided.

What is claimed:

1. A pharmaceutical composition comprising i) an isolated protein comprising a variant activin IIB receptor polypeptide (vActRIIB) wherein vActRIIB comprises a polypeptide sequence having at least 95% identity to the amino acid sequence set forth at amino acids 25 through 134 of SEQ ID NO: 18, wherein the polypeptide comprises an amino acid substitution at position 28, and wherein the polypeptide is capable of binding myostatin, activin A, or GDF-11, and ii) a chemotherapeutic agent.

2. The pharmaceutical composition of claim 1, wherein the substitution at position 28 of the vActRIIB polypeptide is selected from the group consisting of A, F, Q, V, I, L, M, K, H, W and Y for E.

3. The pharmaceutical composition of claim 1, wherein the substitution at position 28 of the vActRIIB polypeptide is selected from the group of amino acids consisting of A, W and Y for E.

4. The pharmaceutical composition of claim 1, wherein the substitution at position 28 of the vActRIIB polypeptide is W.

5. The pharmaceutical composition of claim 1, wherein the isolated protein further comprises SEQ ID NO:79.

6. The pharmaceutical composition of claim 1, wherein the chemotherapeutic agent is a nucleoside analogue.

7. The pharmaceutical composition of claim 1, wherein the chemotherapeutic agent is 5-fluorouracil.

8. The pharmaceutical composition of claim 1, wherein the chemotherapeutic agent is dacarbazine.

9. A method of treating a gonadal cancer in a subject in need of such treatment comprising administering a therapeutically effective amount of the composition of claim 1 to the subject, wherein the substitution at position 28 is selected from the group of amino acids consisting of A, W, and Y for E.

10. The method of claim 9, wherein the cancer is ovarian cancer.

11. The method of claim 9, wherein the cancer is testicular cancer.

12. A method of reducing the size of a gonadal tumor mass in a subject in need of such treatment comprising administering an effective amount of the composition of claim 1 to the subject, wherein the substitution at position 28 is selected from the group of amino acids consisting of A, W, and Y for E.

13. The method of claim 12, wherein the tumor mass is resulting from testicular or ovarian cancer.

14. The pharmaceutical composition of claim 1, wherein the isolated protein further comprises SEQ ID NO:80.

15. The pharmaceutical composition of claim 1, wherein the polypeptide sequence has at least 99% identity to the amino acid sequence set forth at amino acids 25 through 134 of SEQ ID NO: 18, and wherein the polypeptide comprises an amino acid substitution at position 28.

16. The pharmaceutical composition of claim 15, wherein the substitution at position 28 of the vActRIIB polypeptide is W for E, and wherein the isolated protein further comprises an Fc domain linked to vActRIIB via a linker.

17. A method of reducing the size of a gonadal tumor mass in a subject in need of such treatment comprising administering to the subject: an effective amount of an isolated protein comprising a variant activin IIB receptor polypeptide (vActRIIB) wherein vActRIIB comprises a polypeptide sequence having at least 95% identity to the amino acid sequence set forth at amino acids 25 through 134 of SEQ ID NO: 18, wherein the polypeptide comprises an amino acid substitution at position 28, wherein the substitution at position 28 is selected from the group of amino acids consisting of A, W, and Y for E, and wherein the polypeptide is capable of binding myostatin, activin A, or GDF-11; and a chemotherapeutic agent.

18. The method of claim 17, wherein the tumor mass is an ovarian tumor mass.

19. A method of treating a gonadal cancer in a subject in need of such treatment comprising administering to the subject: an effective amount of an isolated protein comprising a variant activin IIB receptor polypeptide (vActRIIB) wherein vActRIIB comprises a polypeptide sequence having at least 95% identity to the amino acid sequence set forth at amino acids 25 through 134 of SEQ ID NO: 18, wherein the polypeptide comprises an amino acid substitution at position 28, wherein the substitution at position 28 is selected from the group of amino acids consisting of A, W, and Y for E, and wherein the polypeptide is capable of binding myostatin, activin A, or GDF-11; and a chemotherapeutic agent.

20. The method of claim 19, wherein the gonadal cancer is ovarian cancer.

Title

Variant activin receptor polypeptides and uses thereof

Inventor(s)

Jeonghoon Sun, Lei-Ting Tony Tam, Hui-Quan Han, Keith Soo-Nyung Kwak, Xiaolan Zhou, John Lu

Assignee(s)

Amgen Inc, Atara Biotherapeutics Inc

Patent #

8501678

Patent Date

August 6, 2013