Novel injectable depot platform to control the spatial temporal exposure of therapeutics

Appel Sauce Studios, LLC is developing a breakthrough patented “therapeutic delivery hydrogel platform”. This novel Polymeric-NanoParticle hydrogel (PNP hydrogel) was invented by Dr. Eric Appel (Stanford) and Dr. Bob Langer (MIT). Appel Sauce Studios has exclusively licensed the PNP intellectual property portfolio from Stanford and MIT for use in all medical applications.

The PNP hydrogel is composed of hydrophobically-modified cellulose polymers and self-assembled core-shell nanoparticles comprising PEG-PLA. Unlike traditional covalently crosslinked hydrogels, PNP hydrogels are formed through strong yet dynamic physical interactions. This approach contrasts with prior hydrogels which have relied on irreversible covalent crosslinking chemistries. As a result, PNP hydrogels overcome the key limitations of prior hydrogel technologies, namely by superior: (i) product formulation without any cargo modifications reducing development and regulatory risks, (ii) shear-thinning to enable injection through high-gauge needles at forces relevant for standard autoinjectors, (iii) rapid self-healing and depot formation after injection, thereby mitigating burst release of the potent cargo and significantly reducing safety issues, and (iv) robust depot formation after injection due to their high yield stress.

Dr. Appel has published in-vitro and in-vivo studies demonstrating that PNP hydrogel can improve outcomes by controlling delivery of a wide range of cargoes including peptides, antibodies, vaccines, mRNA LNPs and CAR-T cells with cytokines.

Appel Sauce Studios’ is currently incubating the following ventures based on the novel PNP hydrogel platform. The first venture is expected to initiate First-in-Human clinical trials in H1 2028. • GelAuto: Monthly subcutaneous injection of PNP hydrogel loaded with rhIL-2 for prolonged systemic exposure to low dose IL-2 as a therapy for autoimmune diseases and neuroinflammatory diseases (e.g. ALS, Lupus, SLE). • GelCART: Co-delivery of CAR-T cells and immunomodulatory cytokines (e.g.; IL-2. IL-15) in PNP hydrogels for treatment of solid tumors. • GelOnc: Intra/peritumoral or intraperitoneal injection of PNP hydrogel loaded with cytokines or mAbs for prolonged local exposure. The initial focus is on delivery of rhIL-2 for prolonged local exposure of high dose IL-2 for treatment of solid tumors (e.g.; ovarian cancer, mesothelioma, H&N cancer, melanoma). • GelGLP: Monthly subcutaneous injection of PNP hydrogel loaded with GLP-1 peptide for improved blood glucose and weight management (e.g.; semaglutide). • GelVax: Co-delivery of vaccine antigens & adjuvants in PNP hydrogel to increase the potency, duration and breadth of vaccines (e.g.; improve flu vaccines response rates or compress regimen with single dose herpes zoster vaccine).

Appel Sauce Studios’ is continuing to explore other licensing or co-development opportunities with corporate partners to enable improved delivery of their therapeutic cargo in the PNP hydrogel.