Grifols Teams Up with Startup, FcR Therapeutics, on Recombinant Therapies for Autoimmune Diseases

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Spain-based Grifols, a healthcare company and manufacturer of plasma-derived medicines, announced on Feb. 4, 2025 that it has formed a collaboration with the Netherlands-based FcR Therapeutics, a biotechnology startup, in which the companies will develop recombinant nanobodies to treat autoimmune diseases.

Under the agreement, Grifols will help seed FcR Therapeutics’ work and share its extensive knowledge on immunoglobulins, the human immune system, and recombinant proteins (1). The nanobodies, small highly specialized antibody fragments (2), would act to restrain or inhibit the activity of certain Fc receptors (FcRs), which are naturally occurring proteins on the surface of immune cells. FcRs play a crucial role in immune responses, such as driving inflammation or neutralizing pathogens (1,3).

“Grifols is excited to contribute its deepening knowledge of therapeutic antibody development, including recombinants, to FcR Therapeutics in its work to treat immune system disorders with unmet medical needs,” said Jörg Schüttrumpf, MD, Grifols’ chief scientific innovation officer, in a company press release (1). “We continue to enhance our internal innovation portfolio, covering late- and early stage projects across our core therapeutic areas, with complementary external capabilities to develop new treatments for patients.”

Autoimmune disorders are characterized by an overactive immune system in which certain FcRs facilitate attacks on the body’s own healthy tissue. By suppressing these FcRs’ action, one can regulate excessive immune activity. Therapy that includes immunoglobulins and their immunomodulatory effects normally aid in treating autoimmune diseases such as chronic inflammatory demyelinating polyradiculoneuropathy, immune thrombocytopenic purpura, and Guillain-Barré syndrome (1).

“We are thrilled to collaborate with Grifols, enabling us to develop key therapeutics for autoimmune patients around the world,” said Mark de Boer, CEO of FcR Therapeutics, in the press release. “We believe that targeting Fc receptors through our nanobody approach will truly change the course of autoimmune diseases and transform the lives of patients.”

Earlier in January 2025, Grifols submitted a biologics license application (BLA) to FDA for its new potential fibrinogen treatment (4). The company had announced Phase III clinical trial results in February 2024 that showed the fibrinogen therapy had achieved positive topline results. The therapy met the study’s primary endpoint of being as effective a treatment as the standard-of-care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency, while at the same time maintaining a good safety profile (5).

“A fibrinogen deficit impedes the body’s ability to arrest bleeding, which can lead to death in severe situations,” said Schüttrumpf in the company’s Jan. 9, 2025 press release announcing the BLA filing (4). “Grifols developed its new fibrinogen to be more convenient, faster to prepare and storable at room temperature, an advantage over alternatives such as cryoprecipitate or fresh frozen plasma when time is of the essence. We’re excited to get this innovative solution to patients.”

The company also submitted a marketing authorization application to regulatory agencies in several countries in October 2024 seeking approval of the fibrinogen therapy. The company expects to start treating patients in Europe with fibrinogen deficiency starting in the second half of 2025 and expects to roll out the treatment in the United States in the first half of 2026 (4).

References

1. Grifols. Grifols Collaborates with Startup FcR Therapeutics to Develop Recombinant Therapies for Autoimmune Diseases. Press Release. Feb. 4, 2025.
2. Ghaderi, H.; Alipour, A.; Holagh, A. M. Z.; et al. Recombinant Antibody Fragment Therapeutics: Current Status and Future Prospects of scFv, Nanobody, and Mimotopes. J. Drug Delivery Sci. Technol. 2023, 89, 105009. DOI: 10.1016/j.jddst.2023.105009
3. Nimmerjahn, F.; Ravetch, J. V. Fc‐Receptors as Regulators of Immunity. Adv. Immunol. 2007, 96, 179–204. DOI: 10.1016/S0065-2776(07)96005-8
4. Grifols. Grifols Submits Biologics License Application for Its New Fibrinogen Solution to US FDA. Press Release. Jan. 9, 2025.
5. Grifols. Grifols Announces Positive Topline Phase 3 Fibrinogen Clinical Trial Results. Press Release. Feb. 14, 2024.