SON-1210 / Sonnet BioTherap - LARVOL DELTA

Sonnet BioTherapeutics Reports Fiscal Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "SON-1210 Upcoming Milestones...Q1 calendar year 2025: IND Submission; H1 calendar year 2025: 1st Patient Dosed in Investigator-Initiated Phase 1/2a Study."

IND • New P1/2 trial • Pancreatic Cancer • Solid Tumor

Sonnet BioTherapeutics Enters into Clinical Collaboration Agreement to Commence Investigator-Initiated and Funded Phase 1/2a Study of SON-1210 in Combination with Chemotherapy for the Treatment of Pancreatic Cancer (GlobeNewswire) - "Sonnet BioTherapeutics Holdings, Inc...announced it has entered into a Master Clinical Collaboration Agreement (the 'Agreement') with the Sarcoma Oncology Center, to advance the development of SON-1210, the Company’s proprietary, bifunctional version of human Interleukins 12 (IL-12) and 15 (IL-15), configured using Sonnet's Fully Human Albumin Binding (FHAB) platform, in combination with chemotherapy for the treatment of metastatic pancreatic cancer....Under the terms of the Agreement, the IIOC, led by Dr. Sant Chawla, Director of the Sarcoma Oncology Center, in collaboration with Sonnet, will prepare a protocol and conduct an investigator-initiated Phase 1/2a clinical study to evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin (“NALIRIFOX”) for the specific treatment of metastatic pancreatic cancer."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

SON-1210 - a novel bifunctional IL-12 / IL-15 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy. (PubMed, Front Immunol) - "Collectively, these findings support the suitability of SON-1210 for patient trials in terms of activity, efficacy, and safety, offering a promising opportunity for solid tumor immunotherapy. Linking cytokine payloads to a fully human albumin binding domain provides an indirect opportunity to target the TME using potent cytokines in cis that can redirect the immune response and control tumor growth."

Journal • Immunology • Melanoma • Oncology • Solid Tumor • IFNG • IL12A • IL15

Sonnet BioTherapeutics Announces Publication Demonstrating Suitability of SON-1210, the First Albumin-binding Bifunctional IL-12/IL-15 Fusion Protein, for Solid Tumor Immunotherapy (Issuer Direct) - "Sonnet BioTherapeutics Holdings...announced today the publication of extensive preclinical data on SON-1210 in Frontiers in Immunology....The paper...demonstrated the robust binding affinity of SON-1210 to albumin and the anticipated in vitro activity and tumor model efficacy that might be expected from the body of research on native IL-12 and IL-15. In the B16F10 melanoma model, a single dose resulted in a marked reduction of tumor growth that was concomitant with increased IFNg and augmented immune cell numbers and activity in the tumor microenvironment. Repeat doses in non-human primates displayed excellent safety and tolerability and were similarly accompanied by increased IFNγ levels."

Preclinical • Melanoma

Sonnet BioTherapeutics Announces Successful Completion of Two IND-Enabling Toxicology Studies with SON-1210 in Non-Human Primates (Issuer Direct) - "Sonnet BioTherapeutics Holdings...announced today that two IND-enabling toxicology studies have been completed in non-human primates (NHPs) using its lead bifunctional therapeutic candidate.....SON-1210 elicited no serious adverse events in repeat, subcutaneous dosing in a GLP toxicology study. SON-1210 was well-tolerated using dosing levels at least 50x higher than the highest anticipated human clinical dose level. Data show controlled induction of IFNg with no signs of cytokine release syndrome or off-target toxicity....Data analysis and reporting for both of these studies will enable the preparation of regulatory filings to begin during the first half of 2023 for first-in-human trials of SON-1210."

New trial • Preclinical • Oncology

Sonnet BioTherapeutics Announces an Agreement with Janssen for the Evaluation of Three Sonnet Product Candidates (Issuer Direct) - "Sonnet BioTherapeutics Holdings...announced today a collaboration agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, where in vitro and in vivo efficacy of SON-1010 (IL12-FHAB), SON-1210 (IL12-FHAB-IL15) and SON-1410 (IL18-FHAB-IL12) will be evaluated in combination with certain Janssen proprietary cell therapy assets. The agreement was facilitated by Johnson & Johnson Innovation. Sonnet shall supply the three referenced compounds for use in head-to-head studies. If successful and subject to provisions of the agreement, Sonnet could seek an expanded collaboration."

Licensing / partnership • Oncology

Sonnet BioTherapeutics Announces Preclinical Data Supporting Its Bispecific Interleukin Candidates at the American Association for Cancer Research (AACR) 2022 Annual Meeting (Yahoo Finance) - "Sonnet BioTherapeutics Holdings...announced today that data from preclinical studies of the company's proprietary Fully-Human Albumin Binding candidates, SON-1010, SON-1210, and SON-1410, will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2022....Sonnet's bispecific drug candidates are constructed with IL-12 on the FHAB platform (SON-1010) and include IL12-FHAB-IL15 (SON-1210) and IL18- FHAB-IL12 (SON-1410)....These studies demonstrate that beyond the powerful anti-tumor effects of IL-12 evident in the monospecific IL12-FHAB, in the bispecific format, IL-12 can synergize with other cytokines to produce superior anti-tumor activity."

Preclinical • Oncology

Sonnet BioTherapeutics Provides Fiscal Year 2022 First Quarter Business and Earnings Update (BioSpace) - "Sonnet provided the following corporate updates for the 2022 calendar year: Generating additional clinical product stability data for SON-1010 for the FDA in 1Q22; SON-1010 is on track for clinical study initiation in 2Q22...Completed R&D manufacturing for SON-1210 with initiation of a non-GLP pre-clinical toxicity study in non-human primateson track for 1H22. Completed sequence confirmation for SON-3015 and preparing for initial in vivo mice studies in 2H22. Lead optimization is underway to initiate CMC with cell line development for SON-1410 in 2Q22."

New molecule • New trial • Preclinical • Oncology

Sonnet BioTherapeutics Announces Abstract Accepted for Presentation in a Poster Session at the AACR 2022 Annual Meeting (Yahoo Finance) - "Sonnet BioTherapeutics Holdings...announced today that data from preclinical studies of the company's proprietary Fully Human Albumin Binding candidates, SON-1010, SON-1210, and SON-1410, will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2022, to be held April 8-13, in New Orleans, Louisiana."

Preclinical • Oncology

Sonnet BioTherapeutics Provides Fiscal Year 2021 Second Quarter Business and Earnings Update (Yahoo Finance) - "The Company successfully completed multiple NHP GLP toxicology studies with SON-1010 (FHAB-IL12) and is generating data to prepare an IND submission to initiate clinical studies in the second half of 2021...Sonnet expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022."

IND • Preclinical • Oncology

Sonnet BioTherapeutics Provides 2021 Business Update (BioSpace) - “SON-1210 (IL12-FHAB-IL15)…expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022; SON-3015 (Anti-IL6-FHAB-Anti-TGFβ): Sonnet is in the discovery phase of SON-3015 development and is currently panning the candidate for binding and stability, after which the preclinical bispecific product will be evaluated in a mice model, expected during the second half of 2021. Sonnet is planning to initiate commercial cell line development in the first quarter of 2022.”

IND • Preclinical • Oncology

Sonnet BioTherapeutics Provides Fiscal Year 2021 First Quarter Business and Earnings Update (Yahoo Finance) - "In SON-080 (low-dose recombinant fully human Interleukin 6, or IL-6), the Company is planning to file an IND and initiate Phase 1b/2a pilot efficacy clinical trials during the second half of 2021 for Chemotherapy Induced Peripheral Neuropathy (CIPN), followed by a Phase 1b/2a pilot efficacy trial for Diabetic Peripheral Neuropathy (SON-081) in 2022."

IND • New P1/2 trial • CNS Disorders • Colorectal Cancer • Diabetic Neuropathy • Gastrointestinal Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor