![]() ![]() There was no evidence of cytokine release syndrome based on minimal participant symptoms and responses observed with other cytokines.Ĭonclusion: SON-1010, a novel presentation for rIL-12, was safe and well-tolerated in healthy volunteers up to 300 ng/kg. PK analysis showed two-compartment elimination in SB102 with mean T ½ of 104 h, compared with one-compartment elimination in SB101, which correlated with prolonged but controlled and dose-related increases in interferon-gamma (IFNγ). As expected with rIL-12, initial decreases in neutrophils and lymphocytes returned to baseline by days 9-11. All TEAEs were transient and no other dose relationship was noted. Results: Participants receiving SON-1010 at 100 ng/kg or higher tolerated the injection but generally experienced more treatment-emergent adverse effects (TEAEs) than those receiving the lowest dose. A non-compartmental analysis of PK was performed and correlations with the PD results were explored, along with a comparison of the SON-1010 PK profile in SB101. Safety was reviewed after day 22, before enrolling the next cohort. SON-1010 at 50-300 ng/kg or placebo administered subcutaneously on day 1 was studied at a ratio of 6:2, starting with two sentinels participants were followed through day 29. Methods: SB102 (NCT05408572) focused on safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) endpoints. After initiating a dose-escalation trial in patients with cancer (SB101), a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) phase 1 trial in healthy volunteers (SB102) was conducted. We developed a strategy to extend the rIL-12 T ½ that depends on binding albumin in vivo to target tumor tissue, using single-chain rIL-12 linked to a fully human albumin binding (F HAB) domain (SON-1010). Despite some signs of efficacy since then, most rIL-12 clinical trials have encountered hurdles such as short terminal elimination half-life (T ½), limited tumor microenvironment targeting, and substantial systemic toxicity. Unexpected toxicity in the first phase 2 study required careful attention to revised dosing strategies. 6Nucleus Network Pty Ltd, Melbourne, VIC, Australiaīackground: The benefits of recombinant interleukin-12 (rIL-12) as a multifunctional cytokine and potential immunotherapy for cancer have been sought for decades based on its efficacy in multiple mouse models.5InClin, Inc, San Mateo, CA, United States.4Centre for Medicine Use and Safety, Monash University, Melbourne, VIC, Australia.3Sarcoma Oncology Center, Santa Monica, CA, United States.2Momentum Metrix, LLC, Dublin, CA, United States.1Sonnet BioTherapeutics, Inc, Princeton, NJ, United States.Cini 1 Susan Dexter 1 Manuel DaFonseca 1 Justus Bingham 2 Isabelle Kuan 2 Sant P. Get ready for tacos and ceviche with small batch tequila and mezcal pairings. The menu, distinct from Border Grill’s Mexican fare, will be inspired by the chefs’ recent travels to Tijuana. Socalo will be open seven days a week with plans to serve breakfast, lunch, dinner, and happy hour. The restaurant’s name is a nod to both “SoCal” and zócalo, the Spanish word meaning town square, as Socalo has ambitions of being a central gathering place for the neighborhood. Socalo, which will be located inside the Gateway Hotel on the corner of Santa Monica Boulevard and 20th Street, is anticipated to open in the spring of 2019. The two chefs closed their 4th Street Santa Monica location of Border Grill in 2016. ![]() Now additional details are emerging about the restaurant’s name and projected opening date from the Santa Monica Daily Press. Eater previously reported that Susan Feniger and Mary Sue Milliken will be opening a new restaurant in Santa Monica. ![]()
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