SON-1010 / Sonnet BioTherap - LARVOL DELTA

EXPANSION OF A PHASE 1 STUDY OF SON-1010 (IL12-FHAB) ADDING TRABECTEDIN IN SOFT TISSUE SARCOMA: TRIAL IN PROGRESS (CTOS 2025) - P1 | "N/A"

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CD8 • IFNG • IL12A

Expansion of A Phase 1 Study of SON-1010 (IL12-FHAB) Adding Trabectedin in Soft Tissue Sarcoma: Trial in Progress (ESMO 2025) - P1 | "The combination of SON-1010 with trabectedin offers a unique opportunity to use this extended half-life version of IL-12 to augment the potential for tumor control in STS, which represents a significant unmet medical need. Clinical trial identification NCT05352750 Study Start 20Apr2022"

P1 data • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • CD8 • IFNG • IL12A

Evaluation of SON-1010 Using a Patient-Derived Tumoroid Platform to Support an Ongoing Phase 1 Study in Patients with Sarcoma (GlobeNewswire) - "This study utilizes Spanios’ advanced patient-derived tumoroid COMPASS platform, which is engineered to closely replicate the TME, along with physiological oxygenation that can influence cancer progression and treatment response. In contrast to conventional preclinical models—often based on animal testing and less representative of human biology—patient-derived tumoroids preserve the distinct genetic and environmental attributes of individual tumors. By replicating the different pH and oxygen concentrations ex-vivo, using our COMPASS platform with our NAM-based methodology, we seek to enhance the understanding of SON-1010’s efficacy against cancer cells. This approach is anticipated to yield more accurate and dependable predictions regarding the clinical performance of SON-1010 therapy."

Preclinical • Sarcoma • Soft Tissue Sarcoma

Sonnet BioTherapeutics Expands Clinical Evaluation of SON-1010 Dose Escalation with Atezolizumab in Ovarian Cancer (GlobeNewswire) - P1b/2a | N=165 | NCT05756907 | Sponsor: Sonnet BioTherapeutics | "Enrollment of the expansion group using the highest maintenance dose from the monotherapy study (the E6 dose of 1200 ng/kg) has been completed, providing an opportunity to study the safety of the combination in a larger population and get a preliminary efficacy readout later this year. A second partial response (PR) based on GCIG criteria was recently observed at the 2-month timepoint and confirmed by RECIST criteria 2 months later in a patient with PROC at that dose. Thus, 2 of the 3 patients (66%) at the E6 dose of SON-1010 had a significant tumor response. Given the strong safety profile at the top dose, the Safety Review Committee (SRC) recommended adding an E7 cohort using a maintenance dose of 1500 ng/kg to study its safety and effectiveness before proceeding to the randomized Phase 2a portion, which will evaluate patients with PROC at one of the two highest doses compared to the standard of care."

P1/2 data • Platinum resistant • Trial status • Ovarian Cancer

Sonnet Releases Virtual Investor "What This Means" Segment (Sonnet BioTherapeutics Press Release) - "As part of the segment, Raghu Rao, Interim Chief Executive Officer and Dr. Richard Kenney, Chief Medical Officer, discussed the recently announced positive safety results of SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab being evaluated in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the SB221 study)."

P1/2 data • Platinum resistant • Ovarian Cancer

Sonnet’s SON-1010 Demonstrates a Strong Safety Profile in Combination with Atezolizumab for Treatment of Platinum-Resistant Ovarian Cancer, Including a Partial Response at the Highest Dose (GlobeNewswire) - P1/2 | N=165 | NCT05756907 | Sponsor: Sonnet BioTherapeutics | "opline safety data in SB221 study suggest clinical benefit of SON-1010 in combination with atezolizumab (Tecentriq); The maximum tolerated dose (MTD) of SON-1010 was set at 1200 ng/kg in combination with atezolizumab in patients with platinum-resistant ovarian cancer (PROC), without dose-limiting toxicity or evidence of cytokine release syndrome at any dose level; Stable disease (SD) at four months post-initiation of dosing was seen in 5 of 15 evaluable patients (33%), with 4 continuing beyond 6 months; One patient with PROC who was dosed at the MTD had a partial response (PR) by RECIST criteria (44% decrease from baseline) and >2x decrease in the CA 125 biomarker."

P1/2 data • Platinum resistant • Ovarian Cancer

Sonnet BioTherapeutics Successfully Completes First Safety Review of SON-1010 in Combination with Trabectedin in Certain Sarcomas (GlobeNewswire) - P1 | N=36 | NCT05352750 | Sponsor: Sonnet BioTherapeutics | "The SB101 Safety Review Committee (SRC) met to evaluate the initial status of the patients in the expansion cohort, all of whom are receiving the SON-1010/trabectedin combination, as enrollment continues. After an average treatment of slightly over two months, one patient progressed and the other six are tolerating treatment....Meanwhile, five of the six patients in the SON-1010 high-dose monotherapy group (83%) showed stable disease at 4 months and four continue on trial at 6 months with no new safety concerns. The partial response (PR) in one of those patients persists, confirming the potential for benefit of SON-1010 monotherapy at the MTD in this small cohort. Overall, 13 of the 24 patients studied during SON-1010 dose escalation (54%) had evidence of monotherapy clinical benefit."

P1 data • Leiomyosarcoma • Liposarcoma

Sonnet BioTherapeutics Expands Phase 1 SB101 Trial to Evaluate Combination of SON-1010 with Trabectedin in Certain Sarcomas (GlobeNewswire) - "Sonnet...announced today an expansion of its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors to add a new cohort to evaluate the effect of SON-1010 in combination with trabectedin (Yondelis), following the successful completion of monotherapy dose escalation. This expansion will explore the immune-oncology impact of SON-1010 at the maximum tolerated (MTD) dose of 1200 ng/kg in combination with trabectedin...Enrollment in this cohort is underway and is expected to be completed in H1 calendar year 2025. Topline safety data of the combination with trabectedin is expected in H2 calendar year 2025; no new safety concerns have been reported to date. Additionally, the Company announced the release of a 'What This Means' segment to discuss the expansion of the Phase 1 clinical study which is now available....The Company expects to enroll up to 18 patients with unresectable, metastatic liposarcoma or leiomyosarcoma..."

P1 data • Trial status • Leiomyosarcoma • Liposarcoma • Soft Tissue Sarcoma

SON-1010: an albumin-binding IL-12 fusion protein that improves cytokine half-life, targets tumors, and enhances therapeutic efficacy. (PubMed, Front Immunol) - "We identified and developed a platform technology with prolonged half-life that can target IL-12 and other immune modulators to the TME. Safety and efficacy are being studied using SON-1010 as monotherapy and in combination with checkpoint blockade strategies."

IO biomarker • Journal • Immunology • Oncology • IFNG • IL12A

Sonnet BioTherapeutics Reports Fiscal Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Phase 1 Trial (SB101 Trial): Advanced Solid Tumors (Monotherapy)...The study has enrolled 24 subjects to date...SON-1010 Upcoming Milestones...Phase 1: Solid Tumors (Monotherapy)​: H1 calendar year 2025: Topline Efficacy Data​...Phase 1b/2a: PROC (Combo with Atezolizumab)​: Q1 calendar year 2025: Additional Safety Data​; H2 calendar year 2025: RP2D & Topline Efficacy Data."

Clinical data • Enrollment status • Ovarian Cancer • Solid Tumor

SON-1010 is also being evaluated in a Phase 1b/2a dose-escalation and proof-of-concept study (SB221) in combination with SON-1010 and atezolizumab... (GlobeNewswire) - "Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 2025."

Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Sonnet BioTherapeutics Announces Topline Safety Data Following Successful Completion of SON-1010 Monotherapy Dose Escalation in Phase 1 SB101 Trial (GlobeNewswire) - P1 | N=36 | NCT05352750 | Sponsor: Sonnet BioTherapeutics | "Sonnet BioTherapeutics...announced today that the results of SON-1010 at the highest dose have been formally evaluated by the Safety Review Committee in the Phase 1 SB101 clinical trial of SON-1010 (IL12-F_HAB) in adult patients with advanced solid tumors...'We have now successfully completed dose escalation in our first trial with SON-1010.'...The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to enhance the assessment of PK and PD at the MTD...No dose-limiting toxicities or related serious adverse events (SAE) have occurred...Of the 24 patients dosed to date, 17 (71%) had SD at the first follow-up CT, 12 of whom were progressing at study entry. 10 of the 21 evaluable patients (48%) remained stable at four months, suggesting SON-1010 clinical benefit, and one of those patients in the highest dose cohort, who has clear cell sarcoma, had a PR with a 45% reduction in tumor size..."

P1 data • Trial status • Oncology • Sarcoma • Solid Tumor

Sonnet BioTherapeutics Announces Publication Detailing the Discovery and Development of SON-1010, an Albumin-Binding IL-12 Fusion Protein, Demonstrating Its Mechanism of Action (GlobeNewswire) - "Sonnet BioTherapeutics Holdings, Inc...announced the publication of extensive discovery, development and preclinical data on SON-1010 demonstrating its mechanism of action in Frontiers in Immunology. SON-1010, Sonnet’s lead proprietary drug candidate, combines the Company’s fully human albumin-binding (FHAB) construct with a native single-chain IL-12 sequence to simplify delivery of the cytokine systemically....The Company is currently conducting a Phase 1 clinical trial of SON-1010 (IL12-FHAB) as a monotherapy in adult patients with advanced solid tumors (SB101; NCT05352750). The Company expects to report safety data from this study in Q4 2024. "

P1 data • Preclinical • Oncology • Solid Tumor

SB221: A PROOF-OF-CONCEPT STUDY TO ASSESS THE COMBINATION OF SON-1010 (IL12-FHAB) AND ATEZOLIZUMAB IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER (PROC): TRIAL IN PROGRESS (IGCS 2024) - P1/2 | "Once the likelihood of efficacy is shown with a Simon 2-stage design, Part 2 will then assess the potential for improved efficacy of the combination of SON-1010 with atezolizumab versus the standard of care (SOC) in PROC. Current Trial Status: The first dose-escalation cohorts have been enrolled and additional sites are being added to help with recruitment of patients with PROC."

Clinical • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • CD8 • IFNG • IL12A

Sonnet BioTherapeutics Completes Enrollment in Phase 1 Study of SON-1010 (IL12-FHAB) as a Monotherapy (SB101) for the Treatment of Solid Tumors (GlobeNewswire) - "Sonnet BioTherapeutics Holdings, Inc...today announced the completion of enrollment and initiation of dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. The Company expects to report topline data from this study in Q4 2024."

Enrollment closed • P1 data • Solid Tumor

Sonnet BioTherapeutics Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "SON-1010 Upcoming Milestones: Phase 1: Solid Tumors (Monotherapy)​: 2H 2024; Safety Data​; 1H 2025: Topline Efficacy Data​; Phase 1b/2a: PROC (Combo with Atezolizumab)​; Phase 1b/2a: PROC (Combo with Atezolizumab)​; 2H 2024: Additional Safety Data​; 2H 2025: RP2D & Topline Efficacy Data...Seeking partnership to support initiation of a Phase 2 clinical trial in DPN, a mechanistically synergistic and larger, high-value indication with unmet medical need."

P1 data • P1/2 data • Trial status • CNS Disorders • Gynecologic Cancers • Oncology • Ovarian Cancer • Pain • Solid Tumor

Sonnet BioTherapeutics to Present SB221 as a Trial in Progress at the ASCO 2024 Annual Meeting (GlobeNewswire) - "Sonnet BioTherapeutics Holdings...announced today that the SB221 study of SON-1010 (recombinant human Interleukin-12 linked to Sonnet’s fully-human albumin binding domain or IL12-FHAB) dosed in combination with atezolizumab (Tecentriq) will be presented as a ‘Trial in Progress’ poster at ASCO 2024....The work will be presented in a poster session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2024, to be held May 31 to June 4 in Chicago, Illinois."

Trial status • Gynecologic Cancers • Ovarian Cancer

SB221: A proof-of-concept study to assess the combination of SON-1010 (IL12-FHAB) and atezolizumab in patients with platinum-resistant ovarian cancer. (ASCO 2024) - P1/2 | "The first dose-escalation cohorts have been enrolled and additional sites are being added to help with recruitment of patients with PROC. Combination of SON-1010 with an ICI offers a unique opportunity to use this extended PK version of IL-12 to augment the potential for tumor control in PROC, which represents a significant unmet medical need."

Clinical • Melanoma • Oncology • Ovarian Cancer • Solid Tumor • CD8 • IFNG • IL12A

Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 as Monotherapy or Combined with an anti-PD-L1, along with an Increase in the Dose-Escalation Target (Sonnet BioTherapeutics Press Release) - P1/2 | N=165 | NCT05756907 | Sponsor: Sonnet BioTherapeutics | Sonnet BioTherapeutics Holdings, Inc...announced today that the safety of SON-1010 dosing has been formally reviewed in both of the current Phase 1 clinical trials and the Company is now increasing the target dose of SON-1010 during dose escalation....Safety in both of the active cancer trials has been reviewed by their respective Safety Review Committees at each step during dose escalation....One patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD) for almost 2 years before progressing - her ascites had resolved and tumors had shrunk at one point but she never reached a partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules."

P1/2 data • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Sonnet BioTherapeutics | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial primary completion date • Oncology • Solid Tumor

A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers. (PubMed, Front Immunol) - P1 | "Its extended half-life leads to a prolonged but controlled IFNγ response, which may be important for tumor control in patients. https://clinicaltrials.gov/study/NCT05408572, identifier NCT05408572."

Clinical • Journal • P1 data • PK/PD data • Oncology • Ovarian Cancer • Solid Tumor • IFNG • IL12A

Sonnet BioTherapeutics Announces a Publication Demonstrating Safety and Tolerability of SON-1010 in Healthy Volunteers (ACCESSWIRE) - P1 | N=32 | NCT05408572 | Sponsor: Sonnet BioTherapeutics | "Sonnet BioTherapeutics Holdings...announced today the publication of clinical data on SON-1010 in Frontiers in Immunology....The paper, entitled 'A phase I trial of SON-1010, a tumor-targeted, interleukin-12-linked, albumin-binding cytokine, shows favorable pharmacokinetics, pharmacodynamics, and safety in healthy volunteers', demonstrated safety and tolerability up to 300 ng/kg as a single ascending dose. In the B16F10 melanoma model....While doses above 100 ng/kg were tolerated, participants generally experienced more treatment-emergent adverse effects (TEAEs) than those receiving the lowest dose of 50 ng/kg. All TEAEs were transient and were consistent with published experience using recombinant IL‑12. More precise pharmacokinetic (PK) and pharmacodynamic (PD) data can be obtained using this non-genotoxic cancer therapy in healthy individuals, without a background of immunosuppression."

P1 data • PK/PD data • Oncology

Sonnet BioTherapeutics Provides Fiscal Year 2023 Business and Financial Update (Issuer Direct) - "Safety data from final dose escalation in the SB101 study are expected during the first half of 2024....Following FDA acceptance of the IND in August, Sonnet launched the SB221 study with several patients currently being dosed. This trial consists of a modified 3+3 dose-escalation design in Part 1 to establish the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab. Clinical benefit in PROC will be confirmed in an expansion group to establish the recommended Phase 2 dose. Part 2 of the study will then investigate SON-1010 monotherapy, its use in combination with atezolizumab, or the standard of care (SOC) for PROC in a randomized comparison to show proof-of-concept (POC). Initial safety data from Part 1 of the SB221 study are expected during the first half of 2024."

P1 data • Trial status • Ovarian Cancer

INTERIM ANALYSIS OF A PHASE 1 STUDY USING IL12-FHAB WITH OPTIMIZED PHARMACOKINETICS (CTOS 2023) - P1 | "SON-1010 has been tolerated well with a delayed PK profile and causes a controlled and prolonged elevation of IFN-γ. The PK comparison with dosing in healthy volunteers suggests that SON-1010 is being retained in tumor tissue, as the FHAB platform was designed to do. This monofunctional immunotherapeutic drug candidate may have a positive synergistic effect with an immune checkpoint inhibitor (ICI), particularly with 'cold' tumors that over-express SPARC like sarcoma and ovarian cancer."

P1 data • PK/PD data • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • CD8 • CXCL8 • IFNG • IL10 • IL12A • IL1B • IL6 • SPARC • TNFA

Sonnet BioTherapeutics Announces Abstract Accepted for Presentation by a Key Opinion Leader at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting (Issuer Direct) - "Sonnet BioTherapeutics Holdings...announced today that previously announced interim data from the SB101 clinical trial of the company's proprietary Fully Human AlbuminBinding (FHAB) candidate, SON-1010 (IL12- FHAB), will be presented by Dr. Sant Chawla, a key opinion leader in the field of sarcoma research, at the upcoming Connective Tissue Oncology Society Annual Meeting 2023, which will be held November 1‑4, in Dublin, Ireland."

P1 data • Solid Tumor