SBT-77-7101 / Sonoma Biotherapeutics - LARVOL DELTA

Sonoma Biotherapeutics Announces Upcoming Poster Presentation at the 10th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA) (Businesswire)

P1 data • Hidradenitis Suppurativa

“Phase 1b Study of SBT-77-7101, an Engineered CAR-T-Regulatory Cell Product, in Patients With Rheumatoid Arthritis: Interim Demographics and Safety” (Businesswire) - "In an interim demographics and safety review of Regulate-RA, participants with highly refractory RA demonstrated a favorable safety profile in the first two cohorts. SBT-77-7101 also shown favorable safety in the first cohort of Regulate-HS, a phase 1 study in hidradenitis suppurativa. Ongoing evaluation of safety, efficacy, PK, and PD will continue across escalating doses in Regulate-RA and Regulate-HS."

P1 data • Trial status • Hidradenitis Suppurativa • Rheumatoid Arthritis

Sonoma Biotherapeutics Announces Positive Interim Safety and Efficacy Data from Phase 1 REGULATE-RA Study of SBT-77-7101 in Refractory Rheumatoid Arthritis (Businesswire) - "By Week 4, across both dose levels, 4 out of 6 participants (67%) experienced ≥50% reduction in swollen and tender joint counts from baseline. Additionally, 5 out of 6 participants (83%) showed a reduction in both DAS28-CRP and CDAI, with 4 out of 6 participants (67%) achieving a reduction of DAS28-CRP score ≥2 and a reduction of CDAI ≥25.5; Participants in Cohort 2, who received a higher dose of SBT-77-7101, demonstrated deeper and more consistent reductions in joint counts compared to those in Cohort 1; Baseline disease activity was higher in Cohort 2, in which all participants showed clinically meaningful improvements in disease activity by Week 4, including 1 participant with a durable response through Week 24. Data for the remaining participants are still maturing, and follow-up is ongoing."

Late-breaking abstract • P1 data • Trial status • Rheumatoid Arthritis

A Phase 1 Study of Autologous CAR-Treg Cells in Refractory Rheumatoid Arthritis: Interim Report of Safety and Efficacy (ACR Convergence 2025) - "SBT777101 is an autologous Treg product transduced with a CAR specific for citrullinated proteins (CitP), which are present in the inflamed synovium of rheumatoid arthritis (RA) patients... In this ongoing phase 1 study, Cit-P–targeted CAR-Tregs demonstrate a favorable early safety profile, with preliminary clinical and mechanistic evidence of therapeutic activity in highly refractory RA participants. Table 1: Overview of (A) patient demographics and disease activity at screening for cohorts 1 and 2, and (B) safety events to date. AI or AN: American Indian or Alaska native; TEAE: Treatment-Emergent Adverse Event; MSK: Musculoskeletal; ICANS: Immune effector cell-associated neurotoxicity syndrome​; N: the number of subjects in the Safety Evaluable Set; n: the number of subjects in each category."

Clinical • IO biomarker • Late-breaking abstract • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Musculoskeletal Diseases • Rheumatoid Arthritis • Rheumatology • IL2

Phase 1b Study of SBT777101, an Engineered CAR-T-Regulatory Cell Product, in Patients With Rheumatoid Arthritis: Interim Demographics and Safety (ACR Convergence 2025) - "To date, CAR-Treg therapy targeting Cit-P demonstrates a favorable safety profile in this early phase study. Ongoing enrollment and follow-up will provide additional insights into characterization, pharmacodynamics and efficacy outcomes."

Clinical • IO biomarker • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL2

Sonoma Biotherapeutics Announces Upcoming Late-Breaking Oral and Poster Presentations at the 2025 American College of Rheumatology (ACR) Convergence (Businesswire) - "Late-breaking oral presentation of interim safety and efficacy data from the phase 1 study of SBT-77-7101, including a favorable early safety profile, with preliminary clinical and mechanistic evidence of therapeutic activity in refractory rheumatoid arthritis."

Clinical • Late-breaking abstract • P1 data • Rheumatoid Arthritis

REGULATE-RA: A Phase 1 Study of CAR-T Regulatory Cells Targeting Citrullinated Proteins in Refractory Rheumatoid Arthritis: Interim Safety and Tolerability (EULAR 2025) - "To date, CAR-Treg therapy targeting Cit-P demonstrates a favorable safety profile in this early phase study. Ongoing enrollment and follow-up will provide additional insights into efficacy and pharmacodynamic outcomes. SBT777101 targets citrullinated proteins."

Clinical • IO biomarker • P1 data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD4 • HLA-DRB1 • IL2

Sonoma Biotherapeutics Announces Poster Presentation at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress (Businesswire) - "Sonoma Biotherapeutics, Inc...will be sharing a poster presentation at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress, taking place in Barcelona on June 11-14, 2025."

P1 data • Rheumatoid Arthritis

Sonoma Biotherapeutics Receives $45 Million Milestone Payment from Regeneron under Ongoing Collaboration (Businesswire) - "Sonoma Biotherapeutics, Inc...announced today that it has received a $45 million milestone payment from Regeneron Pharmaceuticals, Inc., under the terms of its active collaboration to discover, develop and commercialize engineered Treg therapies for autoimmune diseases....Under the terms of the agreement, Sonoma Bio received $75 million in upfront payments, which included a $30 million equity investment in Sonoma Bio by Regeneron. Sonoma Bio was also eligible to receive an additional $45 million development milestone payment, which has now been achieved. Sonoma Bio continues to retain full ownership of its lead Treg cell therapy candidate, SBT-77-7101, and other programs in development."

Financing • Hidradenitis Suppurativa • Immunology • Rheumatoid Arthritis

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc. | Trial completion date: Jun 2026 ➔ Sep 2026 | Initiation date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Trial initiation date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc.

New P1 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Sonoma Biotherapeutics to Present Preclinical Data from Novel Treg Cell Therapy at Symposium on Hidradenitis Suppurativa Advances (Businesswire) - "Sonoma Biotherapeutics, Inc...will present preclinical data from its autologous chimeric antigen receptor (CAR) Treg product candidate for the treatment of hidradenitis suppurativa (HS) at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA). The meeting takes place October 13-15th in Phoenix, Arizona....'Our 7101 program targets citrullinated proteins, a hallmark of many autoimmune diseases, including rheumatoid arthritis and HS. Our results show that we can engineer CAR Tregs directly from HS patients’ cells that can target these proteins. This represents a novel therapeutic approach to restore the balance of the immune system to treat HS.'"

Preclinical • Hidradenitis Suppurativa • Immunology

Sonoma Biotherapeutics Raises $265 Million in an Oversubscribed Series B Financing to Translate the Promise of Cell Therapy into Curative Medicines for Autoimmune and Other Inflammatory Diseases (Businesswire) - “Sonoma Biotherapeutics…announced an oversubscribed $265 million Series B financing. Proceeds from the financing will be used to advance Sonoma Bio’s Treg cell therapy platform and a novel Teff conditioning biologic into the clinic to treat multiple, severe autoimmune and inflammatory diseases and to further invest in and scale up manufacturing operations in order to support supply for initial clinical studies…SBT-77-7101 CAR-Treg cells adapt the clinically proven paradigm of CAR-Teff cells in cancer…”

Financing • Oncology