Nanoform and Takeda to Collaborate on Plasma-Derived Therapy Formulation

Nanoform, based in Helsinki, Finland, announced in a press release on Aug. 15, 2024 that it would be partnering with Tokyo-based Takeda Pharmaceuticals on the development of what the two companies said would be innovative formulations of plasma-derived therapies, intended to treat patients with rare conditions (1).

Describing itself as a medicine performance-enhancing company, Nanoform said the pre-clinical development agreement is being made specifically with the plasma-derived therapies business unit of Takeda. Both companies said it is their combined goal to develop medicine candidates to clinic, then take them to market as finished products.

Under the partnership, after in-vitro proof-of-concept studies of a novel PDT formulation are completed, Nanoform will provide non-good manufacturing practice (GMP) nanomaterial to Takeda for the purpose of in-vivo studies. The results of the first of these studies are expected by early 2025. The value of the non-GMP, or pre-clinical, project aligns with Nanoform’s guided business model of €0.05 million to €0.5 million (approximately $55,000 to $550,000 US dollars) per non-GMP project (1).

Although the press release did not elaborate on the exact rare conditions Nanoform and Takeda would be developing treatments for, it said that plasma-derived therapies (PDTs) are built on 100 years of using plasma to form the basis of lifesaving options for people with rare or complex, chronic conditions—which are sometimes, for these patients, lifelong issues with no alternative treatment options (1).

“Global demand for [PDTs] has greatly increased over the past 20 years and is continuing to grow due to more rare diseases being diagnosed, more patients being identified, higher standards of care, and broader access to treatment,” the press release stated.

Nanoform said in the press release that the nanoforming technology handled by its biologics unit has the ability to yield drug molecules of large and tuneable size as well as morphology, all while retaining biological activity (1). The technology, according to the company, can impact novel routes of delivery, enhance drug loading and tailor release profiles, and ultimately lead to the engineering of new drug combinations.

“Direct nanoforming of biologics is a promising new approach to allow more life-changing large-molecule medicines to reach the market,” Edward Haeggström, PhD, CEO of Nanoform, said in the press release. “We look forward to entering in-vivo studies together with Takeda and expanding our already very positive relationship.”

Earlier in 2024, Nanoform announced the completion of the First Subject First Visit in a trial evaluating the relative bioavailability of its nanotechnology-enhanced enzalutamide (2). And Takeda received FDA approval for HYQVIA (immune globulin infusion 10% [Human] with recombinant human hyaluronidase), a subcutaneous immunoglobulin for treating chronic inflammatory demyelineating polyneuropathy, a rare neuromuscular disorder (3).

References

1. Nanoform Finland Oyj. Nanoform Collaborates with Takeda on Their Plasma-Derived Therapy Development. Press Release. Aug. 15, 2024.
2. Thomas, F. Relative Bioavailability Trial of Nanotechnology-Enhanced Enzalutamide is Underway. PharmTech.com, Jan. 10, 2024.
3. Mirasol, F. Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder. PharmTech.com, Jan. 24, 2024.