For biologics that require precise dosing and consistent immunomodulatory effects, manufacturing challenges can emerge well before late-stage development.
Coya Raises $11.1 Million to Advance Immunomodulatory ALS Program
Key Takeaways
- Coya Therapeutics secured $11.1 million to advance manufacturing readiness for its lead biologic program, COYA 302, targeting neurodegenerative diseases.
- The financing reflects a trend of prioritizing manufacturing scale-up earlier in drug development to address challenges in biologics production.
Such targeted private investments underscore the growing importance of early manufacturing scale-up in de-risking immunomodulatory biologics for neurodegenerative diseases.
Coya Therapeutics (Coya), a US-based clinical-stage biotechnology company has secured $11.1 million in private
The financing includes a $10 million investment from Dr. Reddy’s Laboratories, a subsidiary of Coya’s existing strategic collaborator, and $1.1 million from Greenlight Capital, Coya’s largest institutional shareholder. The private placement involves the sale of approximately 2.5 million shares of Coya’s common stock. The transaction is expected to close around Jan. 30, 2026, subject to customary closing conditions (1).
Why are clinical-stage biotechs investing earlier in manufacturing scale-up?
Coya plans to use the net proceeds to accelerate
For biologics that require precise dosing and consistent immunomodulatory effects, manufacturing challenges can emerge well before late-stage development. Addressing process robustness, reproducibility, and supply-chain readiness earlier in development may reduce delays as programs advance toward pivotal trials or regulatory submission (3).
How does COYA 302 target immune dysfunction in neurodegenerative disease?
COYA 302 is designed to enhance the anti-inflammatory function of regulatory T cells while suppressing inflammatory activity driven by activated monocytes and macrophages. The investigational therapy combines LD IL-2 with cytotoxic T lymphocyte associated antigen-4 immunoglobulin and is intended for subcutaneous administration. By engaging complementary immunomodulatory mechanisms, the therapy aims to restore immune balance implicated in neurodegenerative disease progression.
COYA 302 is currently being evaluated in a Phase II randomized, multi-center, double-blind, placebo-controlled study (ALSTARS) to assess its safety and efficacy in patients with amyotrophic lateral sclerosis. The study reflects growing interest in regulatory T-cell-based approaches as potential disease-modifying strategies in neurodegenerative indications where inflammation is increasingly recognized as a contributing factor.
What does this financing signal about immunology investment priorities?
From an industry perspective, the financing underscores how manufacturing strategy is becoming central to clinical-stage value creation. Scaling production of biologics such as low-dose cytokines presents technical challenges related to consistency, dosing precision, and regulatory compliance. These issues can slow development timelines if addressed late (4).
Coya’s pipeline includes multiple modalities, including regulatory T-cell (Treg)-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapies. The company’s pipeline reflects a diversified approach to addressing systemic inflammation and neuroinflammation across neurodegenerative, metabolic, and autoimmune diseases (1).
As investor interest continues to converge on immune-modulating biologics with scalable manufacturing profiles, this latest financing illustrates how strategic capital deployment is shaping development pathways for next-generation neurodegenerative therapies.
References
- Coya Therapeutics . C
oya Therapeutics Announces $11.1 Million Private Placement . Press Release. Jan. 30, 2026 - Zurdo, J.; Arnell, A.; Obrezanova, O.; Early Implementation of QbD in Biopharmaceutical Development: A Practical Example. Biomed Res. Int. 2015, 2015, 605427. DOI:
10.1155/2015/605427 - Nash, A.; Aghlara-Fotovat, S.; Hernandez, A.; et al. Clinical Translation of Immunomodulatory Therapeutics. Adv. Drug Delivery Rev. 2021, 176, 113896. DOI:
10.1016/j.addr.2021.113896 - Walsh, G. Biopharmaceutical Benchmarks 2018. Nat. Biotechnol. 2018, 36, 1136–1145. DOI:
10.1038/nbt.4305
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