Sonnet BioTherapeutics Presents Compilation of Data Highlighting the Potential of SON-1010 as a Monotherapy or a Combination Therapy to Improve the Treatment of Solid Tumors
Sonnet BioTherapeutics (NASDAQ: SONN) presented data at the 2025 AACR:IO Conference showcasing their SON-1010 immunotherapy platform. The presentation highlighted their Fully Human Albumin Binding (FHAB®) technology, which enhances tumor targeting and extends the half-life of interleukin-12.
Key clinical findings revealed a 48% clinical benefit rate in advanced solid tumor patients, including a partial response at the highest dose in a clear cell sarcoma patient. The company is conducting multiple trials, including combinations with atezolizumab for platinum-resistant ovarian cancer and planned studies with NALIRIFOX for pancreatic cancer.
The FHAB platform addresses traditional cytokine therapy limitations by improving drug delivery to the tumor microenvironment (TME) and reducing toxicity risks. The technology demonstrates enhanced targeting through albumin binding to FcRn, GP60, and SPARC, resulting in increased activation of various immune cells and conversion of pro-tumor M2 MDSCs to inflammatory M1 APCs.
Sonnet BioTherapeutics (NASDAQ: SONN) ha presentato dati alla Conferenza AACR:IO 2025, mostrando la loro piattaforma di immunoterapia SON-1010. La presentazione ha messo in evidenza la loro tecnologia Fully Human Albumin Binding (FHAB®), che migliora il targeting dei tumori e prolunga la vita media dell'interleuchina-12.
I principali risultati clinici hanno rivelato un 48% di tasso di beneficio clinico nei pazienti con tumori solidi avanzati, inclusa una risposta parziale alla dose più alta in un paziente con sarcoma a cellule chiare. L'azienda sta conducendo diversi studi, incluse le combinazioni con atezolizumab per il cancro ovarico resistente al platino e studi pianificati con NALIRIFOX per il cancro pancreatico.
La piattaforma FHAB affronta le limitazioni della terapia tradizionale con citochine migliorando la somministrazione del farmaco all'ambiente microtumorale (TME) e riducendo i rischi di tossicità. La tecnologia dimostra un targeting migliorato attraverso il legame dell'albumina a FcRn, GP60 e SPARC, risultando in un'attivazione aumentata di varie cellule immunitarie e nella conversione delle MDSCs M2 pro-tumorali in APCs M1 infiammatorie.
Sonnet BioTherapeutics (NASDAQ: SONN) presentó datos en la Conferencia AACR:IO 2025, mostrando su plataforma de inmunoterapia SON-1010. La presentación destacó su tecnología Fully Human Albumin Binding (FHAB®), que mejora el direccionamiento del tumor y extiende la vida media de la interleucina-12.
Los hallazgos clínicos clave revelaron una tasa de beneficio clínico del 48% en pacientes con tumores sólidos avanzados, incluida una respuesta parcial en la dosis más alta en un paciente con sarcoma de células claras. La empresa está llevando a cabo múltiples ensayos, incluidas combinaciones con atezolizumab para el cáncer de ovario resistente al platino y estudios planeados con NALIRIFOX para el cáncer de páncreas.
La plataforma FHAB aborda las limitaciones de la terapia tradicional con citoquinas mejorando la entrega del fármaco al microambiente tumoral (TME) y reduciendo los riesgos de toxicidad. La tecnología demuestra un direccionamiento mejorado a través del enlace de la albúmina a FcRn, GP60 y SPARC, resultando en una activación aumentada de varias células inmunitarias y la conversión de MDSCs M2 pro-tumorales en APCs M1 inflamatorias.
Sonnet BioTherapeutics (NASDAQ: SONN)는 2025 AACR:IO 컨퍼런스에서 그들의 면역 요법 플랫폼 SON-1010에 대한 데이터를 발표했습니다. 발표에서는 종양 표적화와 인터루킨-12의 반감기를 연장하는 Fully Human Albumin Binding (FHAB®) 기술을 강조했습니다.
주요 임상 결과는 고급 고형 종양 환자에서 48%의 임상 혜택률을 나타냈으며, 특히 가장 높은 용량에서 명확한 세포 육종 환자에서 부분 반응이 있었습니다. 이 회사는 백금 내성 난소암을 위한 atezolizumab와의 조합을 포함하여 NALIRIFOX와의 계획된 연구를 포함한 여러 임상 시험을 진행하고 있습니다.
FHAB 플랫폼은 약물 전달을 종양 미세환경(TME)으로 개선하고 독성 위험을 줄임으로써 전통적인 사이토카인 치료의 한계를 해결합니다. 이 기술은 FcRn, GP60 및 SPARC에 대한 알부민 결합을 통해 향상된 표적화를 보여주며, 이는 다양한 면역 세포의 활성화를 증가시키고 종양 유발 M2 MDSCs를 염증성 M1 APCs로 전환하는 결과를 가져옵니다.
Sonnet BioTherapeutics (NASDAQ: SONN) a présenté des données lors de la conférence AACR:IO 2025, mettant en avant leur plateforme d'immunothérapie SON-1010. La présentation a souligné leur technologie de liaison à l'albumine entièrement humaine (FHAB®), qui améliore le ciblage des tumeurs et prolonge la demi-vie de l'interleukine-12.
Les résultats cliniques clés ont révélé un taux de bénéfice clinique de 48% chez les patients atteints de tumeurs solides avancées, y compris une réponse partielle à la dose la plus élevée chez un patient atteint de sarcome à cellules claires. L'entreprise mène plusieurs essais, y compris des combinaisons avec l'atezolizumab pour le cancer de l'ovaire résistant au platine et des études prévues avec NALIRIFOX pour le cancer du pancréas.
La plateforme FHAB traite les limitations de la thérapie traditionnelle par cytokines en améliorant la délivrance du médicament à l'environnement tumoral (TME) et en réduisant les risques de toxicité. La technologie démontre un ciblage amélioré grâce à la liaison de l'albumine à FcRn, GP60 et SPARC, entraînant une activation accrue de diverses cellules immunitaires et la conversion des MDSCs M2 pro-tumoraux en APCs M1 inflammatoires.
Sonnet BioTherapeutics (NASDAQ: SONN) präsentierte Daten auf der AACR:IO-Konferenz 2025, in denen ihre Immuntherapie-Plattform SON-1010 vorgestellt wurde. Die Präsentation hob ihre Fully Human Albumin Binding (FHAB®) Technologie hervor, die die Tumoransprache verbessert und die Halbwertszeit von Interleukin-12 verlängert.
Wichtige klinische Ergebnisse zeigten eine 48% klinische Nutzenrate bei Patienten mit fortgeschrittenen soliden Tumoren, einschließlich einer partiellen Reaktion bei der höchsten Dosis bei einem Patienten mit klarem Zell-Sarkom. Das Unternehmen führt mehrere Studien durch, einschließlich Kombinationen mit Atezolizumab für platinresistenten Eierstockkrebs und geplanter Studien mit NALIRIFOX für Bauchspeicheldrüsenkrebs.
Die FHAB-Plattform adressiert die Einschränkungen der traditionellen Zytokinterapie, indem sie die Medikamentenverabreichung an die Tumormikroumgebung (TME) verbessert und das Risiko von Toxizität verringert. Die Technologie zeigt eine verbesserte Zielgenauigkeit durch die Bindung von Albumin an FcRn, GP60 und SPARC, was zu einer erhöhten Aktivierung verschiedener Immunzellen und der Umwandlung von pro-tumoralen M2 MDSCs in entzündliche M1 APCs führt.
- 48% clinical benefit rate in advanced solid tumors
- Partial response achieved in clear cell sarcoma patient
- Multiple ongoing clinical trials with combination therapies
- Platform demonstrates improved drug delivery and reduced toxicity
- Most common adverse events reported at each dose level
- Clinical trials still in early phases
- Final efficacy data not yet available
Insights
Sonnet BioTherapeutics's AACR:IO Conference presentation showcases their innovative FHAB platform technology, which addresses fundamental limitations that have historically plagued cytokine-based cancer therapies. The platform ingeniously exploits albumin's natural properties - including its extended half-life, tumor accumulation via FcRn receptors, and binding to GP60 and SPARC proteins that are overexpressed in tumors - to create more targeted and durable immunotherapeutics.
Their lead candidate SON-1010 (IL-12-FHAB) has demonstrated preliminary efficacy with 48% clinical benefit in advanced solid tumor patients, including a notable partial response in clear cell sarcoma - a rare and typically treatment-resistant malignancy. This response rate merits attention as these are likely heavily pretreated patients with therapeutic options.
What distinguishes Sonnet's approach in the competitive IL-12 landscape is their multi-pronged strategy:
- Monotherapy for immunologically responsive tumors
- Combination with checkpoint inhibitors (atezolizumab) where SON-1010 may enhance T-cell infiltration and PD-L1 expression
- Alternating with immunoreactive chemotherapy (trabectedin) to exploit potential synergies
- Combination with aggressive chemotherapy (NALIRIFOX) in pancreatic cancer, where immunotherapy alone has historically underperformed
The bifunctional SON-1210 (IL12-FHAB-IL15) represents an even more sophisticated approach by combining two synergistic cytokines on a single molecule, potentially delivering complementary immune activation mechanisms to the tumor microenvironment.
For investors, key upcoming catalysts include the Q1 2025 safety update from the atezolizumab combination trial in platinum-resistant ovarian cancer and initiation of the SON-1210/NALIRIFOX pancreatic cancer trial. Given Sonnet's micro-cap status ($4.6M market cap), these clinical milestones are critical for demonstrating proof-of-concept for their platform technology and potentially attracting partnership interest from larger pharmaceutical companies seeking differentiated immuno-oncology assets.
Sonnet BioTherapeutics's FHAB platform represents a potentially elegant solution to the historical challenges that have cytokine therapies in oncology. The preliminary 48% clinical benefit rate in advanced solid tumors, while early-stage, compares favorably to historical response rates for single-agent immunotherapies in heavily pretreated populations.
From an investment perspective, Sonnet's approach to IL-12 delivery must be evaluated against competitors like Dragonfly Therapeutics, Cue Biopharma, and Werewolf Therapeutics, all pursuing enhanced IL-12 delivery strategies. Sonnet's albumin-binding approach offers theoretical advantages in extending half-life while potentially improving the therapeutic window through targeted tumor delivery.
The company's multi-pronged clinical strategy targets significant market opportunities:
- Platinum-resistant ovarian cancer (~15,000 patients annually in the US) with effective options beyond single-digit response rates to current therapies
- Pancreatic cancer (~60,000 new cases annually) where five-year survival remains below 10%
- Advanced solid tumors where novel combination approaches could address resistance to existing immunotherapies
However, investors should recognize significant risks. With a micro-cap valuation of $4.6M, Sonnet likely faces near-term financing challenges. The company's Q3 2024 financial report showed $7.1M in cash with a quarterly burn rate of approximately $3.2M, suggesting potential dilutive financing needs in coming months.
Key value inflection points include:
- Expanded efficacy data from the SON-1010 monotherapy trial
- Safety/preliminary efficacy from the atezolizumab combination study in Q1 2025
- Initiation of the SON-1210/NALIRIFOX pancreatic cancer trial
The most significant potential value driver remains validation of the FHAB platform technology, which if successful, could position Sonnet as an acquisition target for larger oncology players seeking differentiated cytokine delivery technologies. However, investors should view this as a high-risk, early-stage opportunity requiring substantial clinical validation before meaningful value realization.
Poster presented at the 2025 AACR:IO Conference
Company’s novel platform that delivers either mono- or bifunctional immunomodulators linked to a Fully-Human, Albumin Binding scFv domain (FHAB®) provides enhanced targeting to the tumor microenvironment (TME) and prolonged retention in the tumor
PRINCETON, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Sonnet BioTherapeutics Holdings, Inc. (the “Company” or “Sonnet”) (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, today announced the presentation of a compilation of data at the 2025 American Association for Cancer Research (AACR) IO Conference.
As part of the conference, Dr. Sant Chawla, Principal Investigator at the Sarcoma Oncology Center in Santa Monica, California, presented a poster entitled, “Combination immunotherapy with an albumin-binding interleukin-12 fusion protein that extends cytokine half-life, targets the tumor microenvironment, and enhances therapeutic efficacy.” This is the first time the overall strategy of Sonnet's Fully Human Albumin Binding (FHAB®) platform has been compiled with existing data and presented in a poster. The presented poster is now available on the Publications page of the Company’s website.
SON-1010 is the Company’s proprietary version of recombinant human interleukin-12 (rhIL-12), configured using genetic fusion to the FHAB platform, which extends the half-life and bioactivity of the IL-12 component due to binding native albumin in the serum. Albumin binding to FcRn, GP60, and SPARC results in an improved PK profile, decreased toxicity risk, and a broader therapeutic index preclinically, with significant targeting of the tumor microenvironment and increases in activated NK, NKT, Th1, and cytotoxic CD8 T cells, as well as marked repolarization of pro-tumor M2 MDSCs to inflammatory M1 APCs.
“Recombinant interleukins have generally had limited clinical success due to inefficient tumor targeting, short half-lives, and off-target toxicity. As previously disclosed, our novel FHAB platform has demonstrated the potential for us to design product candidates that safely extend the half-life of cytokines and deliver them to the tumor, where they can convert the immunological response from ‘cold’ to ‘hot’ and potentially realize the promise of immunotherapy. We are pleased to share the compilation of data in this poster presentation and look forward to announcing additional data from our ongoing studies evaluating our SON-1010 platform in 2025,” commented Pankaj Mohan, Ph.D., Founder and Chief Executive Officer of Sonnet.
Key Highlights:
- A platform strategy was developed that links cytokines to the FHAB as mono- or bifunctional fusions to bind native albumin at both physiologic and acidic pH, taking advantage of albumin’s long serum half-life and concentration in tumors, allowing delivery to and accumulation of the drug in the TME. IL-12 is a potent cytokine that stimulates the innate and adaptive immune responses, functioning in combination with other cytokines, like IL-15 and IL-18. Several approaches are currently being studied in humans, such as:
- SON-1010 monotherapy at the highest dose is continuing in patients with advanced solid tumors. In December 2024, the Company disclosed clinical benefit in
48% of patients, including a partial response at the highest dose in a patient with clear cell sarcoma. The poster reflects the current status of this trial. - Co-administration with a checkpoint inhibitor (atezolizumab) to activate local immune cells and upregulate PD-L1 in the TME. Safety has been monitored at each dose escalation step and the most common adverse events at each dose level have been updated for the results currently available.
- SON-1010 is being administered alternating with an immunoreactive chemotherapy drug (trabectedin) to enhance its ability to activate a pro-inflammatory phenotype in the TME.
- Alternating administration with a potent chemotherapeutic regimen (NALIRIFOX) will be done in front-line patients with pancreatic ductal adenocarcinoma (PDAC) to enhance their response.
- SON-1010 monotherapy at the highest dose is continuing in patients with advanced solid tumors. In December 2024, the Company disclosed clinical benefit in
- Each setting has the potential to augment the effects of the licensed therapy in populations that continue to have high unmet needs for an improved outcome. Immunotherapy allows greater flexibility in selecting potentially synergistic combinations for rational implementation.
- SON-1010 and SON-1210 address paramount safety and tolerability factors, which have traditionally hindered the use of therapeutic cytokines in the treatment of solid tumors, by extending the cytokine half-life and improving the therapeutic index that may result in better patient outcomes.
SON-1010 is being evaluated in a Phase 1b/2a dose-escalation and proof-of-concept study (SB221) in combination with SON-1010 and atezolizumab (Tecentriq®) (in collaboration with Genentech, a member of the Roche Group), which is focused on platinum-resistant ovarian cancer (PROC) (NCT05756907). The extended PK of SON-1010, along with its ability to induce IFNγ in the TME causing upregulation of PD-L1, creates an opportunity for synergistic activity. Enrollment remains ongoing and an update on safety at the MTD in that trial is expected in Q1 calendar year 2025. Another trial evaluating dose escalation of SON-1210 (IL12-FHAB-IL15), followed by its combination with NALIRIFOX in patients with metastatic pancreatic cancer, is expected to begin later this calendar year.
About SON-1010
SON-1010 is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. This single-chain antibody fragment was selected to bind albumin both at normal pH, as well as at the acidic pH typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be linked using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer, such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant to this approach. SON-1010 is designed to deliver IL-12 to local tumor tissue, turning ‘cold' tumors ‘hot' by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.
About Sonnet BioTherapeutics Holdings, Inc.
Sonnet is an oncology-focused biotechnology company with a proprietary platform for developing targeted biologic drugs with single or bifunctional action. Known as FHAB (Fully Human Albumin-Binding), the technology utilizes a fully human single chain antibody fragment (scFv) that binds to and "hitch-hikes" on human serum albumin (HSA) for transport to target tissues. Sonnet's FHAB was designed to specifically target tumor and lymphatic tissue, with an improved therapeutic window for optimizing the safety and efficacy of immune modulating biologic drugs. FHAB platform is the foundation of a modular, plug-and-play construct for potentiating a range of large molecule therapeutic classes, including cytokines, peptides, antibodies, and vaccines.
Sonnet’s lead program, SON-1010, or IL-12-FHAB, is in development for the treatment of advanced solid tumors, certain types of sarcoma, and platinum-resistant ovarian cancer (PROC). SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement with Roche in combination with atezolizumab (Tecentriq®) for the treatment of PROC. The Company is also evaluating its second product candidate, SON-1210, an IL12-FHAB-IL15 for solid tumors, in collaboration with the Innovative Immuno-Oncology Consortium (IIOC), and plans to commence an investigator-initiated and funded Phase 1/2a study for the treatment of locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC).
The Company’s SON-080 program is a low dose of rhIL-6 in development for Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Diabetic Peripheral Neuropathy (DPN). SON-080 demonstrated encouraging results in a Phase 1b/2a clinical trial, being well tolerated with no evidence of a pro-inflammatory cytokine response. In October 2024, Sonnet announced a license agreement with Alkem Laboratories, Inc. who will assume responsibility for advancing development of the SON-080 program into a Phase 2 study in DPN in India.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's cash runway, the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
JTC Team, LLC
Jenene Thomas
908-824-0775
SONN@jtcir.com
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