This section highlights FDA-related milestones and regulatory updates for drugs developed by Sonnet BioTherapeutics (SONN).
Over the past two years, Sonnet BioTherapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SON-080, SON-1010, SON-1210, SON-1400, and SON-1411. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SON-080 - FDA Regulatory Timeline and Events
SON-080 is a drug developed by Sonnet BioTherapeutics for the following indication: In Chemotherapy-Induced Peripheral Neuropathy (CIPN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SON-080
- Announced Date:
- October 9, 2024
- Indication:
- In Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Announcement
Sonnet BioTherapeutics announced that it has entered into a licensing agreement (the "Licensing Agreement") with Alkem Laboratories Limited ("Alkem") for the research, development, manufacturing, marketing and commercialization of its molecule SON-080 for the treatment of diabetic peripheral neuropathy (DPN) in India and the manufacturing, marketing and commercialization of chemotherapy induced neuropathy (CIPN) and autonomic neuropathy in India.
AI Summary
Sonnet BioTherapeutics has entered into a licensing agreement with Alkem Laboratories Limited to advance its molecule SON-080 in India. The deal covers research, development, manufacturing, marketing, and commercialization for treating diabetic peripheral neuropathy (DPN), as well as the manufacturing, marketing, and commercialization of SON-080 for chemotherapy induced neuropathy (CIPN) and autonomic neuropathy in India. Under the terms of the agreement, Sonnet will receive an upfront payment of $1.0 million and may earn an additional $1.0 million in milestone payments, along with a royalty in the low double digits on net sales, after certain expenses. SON-080, a proprietary version of recombinant human Interleukin-6, utilizes the same mechanism of action for all three neuropathies. This partnership positions Alkem to fund the necessary clinical trials for DPN, potentially expanding SON-080’s market reach and addressing significant unmet medical needs in India.
Read Announcement- Drug:
- SON-080
- Announced Date:
- July 24, 2024
- Indication:
- In Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Announcement
Sonnet BioTherapeutics announced encouraging data from the Phase 1b portion of its Phase 1b/2a clinical trial evaluating SON-080 for the treatment of CIPN (the "SB211 study").
AI Summary
Sonnet BioTherapeutics announced encouraging results from the Phase 1b portion of its Phase 1b/2a clinical trial for SON-080 in treating chemotherapy-induced peripheral neuropathy (CIPN). The trial, conducted at two sites in Australia using a new version of recombinant human Interleukin-6, showed that SON-080 was well-tolerated at both tested doses (20 µg and 60 µg). Importantly, the treatment did not trigger a pro-inflammatory cytokine response, and the most common side effect was transient, mild injection site erythema.
Quality of life and pain surveys revealed a trend toward rapid improvement in neuropathy symptoms compared to placebo, with benefits lasting even after the 12-week treatment period ended. These promising findings support the potential of SON-080 for nerve repair and pain relief, paving the way for a Phase 2 trial in Diabetic Peripheral Neuropathy, for which Sonnet is seeking a partnership to advance the development program.
Read Announcement
SON-1010 - FDA Regulatory Timeline and Events
SON-1010 is a drug developed by Sonnet BioTherapeutics for the following indication: Advanced Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SON-1010
- Announced Date:
- April 4, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced positive safety results of SON-1010 (IL12-FHAB) at the highest dose combined with atezolizumab in the Phase 1b/2a clinical trial in adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC) (the SB221 study).
AI Summary
Sonnet BioTherapeutics announced positive safety results from the SB221 Phase 1b/2a study, where SON-1010 (IL12-FHAB) was used at its highest dose along with atezolizumab. The trial involved adult patients with advanced solid tumors or platinum-resistant ovarian cancer (PROC). In this study, the maximum tolerated dose was set at 1200 ng/kg without any dose-limiting toxicity or signs of cytokine release syndrome. Additionally, signs of clinical benefit were noted—five out of 15 evaluable patients had stable disease at four months, and one PROC patient at the highest dose showed a partial response, with a 44% tumor size reduction and a significant decrease in the CA 125 biomarker.
The positive safety profile supports moving forward to the expansion phase and further comparison in Phase 2a, aiming to improve treatment for patients with PROC and advanced tumors.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- March 26, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced positive findings from the first safety review of the expansion cohort in its Phase 1 SB101 clinical trial evaluating SON-1010, the Company's proprietary version of recombinant human interleukin-12 (rhIL-12) configured using genetic fusion to Sonnet's Fully Human Albumin Binding (FHAB®) platform, in combination with trabectedin (Yondelis®) in adult patients with advanced leiomyosarcoma (LMS) or liposarcoma (LPS).
AI Summary
Sonnet BioTherapeutics announced positive safety findings from the first review of its Phase 1 SB101 trial expansion cohort. In this study, SON-1010—an innovative recombinant human interleukin-12 (rhIL-12) engineered using the company’s Fully Human Albumin Binding (FHAB®) platform—is tested in combination with trabectedin (Yondelis®) in adult patients with advanced leiomyosarcoma or liposarcoma. The initial safety review, which included seven patients treated at the maximum tolerated dose (MTD) of 1200 ng/kg, found no unexpected toxicities. Adverse events observed were mostly mild or moderate, suggesting that SON-1010 and trabectedin do not negatively impact each other. These encouraging results allowed the study to move forward with plans to enroll up to 18 patients in this combination therapy cohort, setting the stage for further evaluation of potential clinical benefits in treating these challenging sarcoma cases.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- February 26, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced the presentation of a compilation of data at the 2025 American Association for Cancer Research (AACR) IO Conference.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- January 21, 2025
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced 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.
AI Summary
Sonnet BioTherapeutics is expanding its Phase 1 SB101 clinical study of SON-1010 (IL12-FHAB) for adult patients with advanced solid tumors. After successful monotherapy dose escalation, the study will now add a new cohort to evaluate SON-1010 in combination with trabectedin (Yondelis®), an approved treatment for certain soft-tissue sarcomas. The study will test the combination at the maximum tolerated dose of 1200 ng/kg, aiming to enhance trabectedin’s therapeutic window and stimulate a stronger local immune response in the tumor microenvironment.
Enrollment in this new cohort is underway and is expected to finish by the first half of 2025, with topline safety data anticipated in the latter half of the year. This study expansion could offer a promising new treatment option for patients with advanced soft-tissue sarcomas by combining two complementary mechanisms to potentially improve progression-free survival.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- December 9, 2024
- Indication:
- Advanced Solid Tumors
Announcement
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-FHAB) in adult patients with advanced solid tumors.
AI Summary
Sonnet BioTherapeutics today announced that the Safety Review Committee has formally evaluated the highest dose of SON-1010 in its Phase 1 SB101 clinical trial for adults with advanced solid tumors. In this study, the maximum tolerated dose was established at 1200 ng/kg, and importantly, no dose-limiting toxicities or cytokine release syndrome were observed at any dose level. Nearly half of the evaluable patients (48%) maintained stable disease at four months, and one patient in the highest dose cohort experienced a partial response with a 45% decrease in tumor size according to RECIST criteria. These results suggest that SON-1010’s design, which uses the FHAB technology to extend IL-12’s half-life and improve tumor targeting, may offer a promising combination potential with other therapies while maintaining a manageable safety profile.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- December 4, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced the publication of extensive discovery, development and preclinical data on SON-1010 demonstrating its mechanism of action in Frontiers in Immunology.
AI Summary
Sonnet BioTherapeutics has published extensive discovery, development, and preclinical data in Frontiers in Immunology detailing how its lead drug candidate, SON-1010, works. SON-1010 combines a fully human albumin-binding (FHAB®) construct with a single‐chain IL‑12 sequence to extend the cytokine’s half-life and target tumors more effectively. The study explains that single-chain variable fragments (scFv) were selected from a human phage display library for their strong binding properties under normal and acidic conditions. This unique approach improves stability and allows the immune system to convert “cold” tumors into “hot” ones, potentially enhancing the effects of immunotherapy.
CEO Pankaj Mohan emphasized that this publication displays the detailed research behind the FHAB platform, setting the stage for future therapies that overcome challenges like short cytokine half-life and inefficient tumor targeting. These findings help advance safer, more effective immunotherapeutic treatments for cancer.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- September 18, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics announced that Topline safety data of SB101 Phase 1 study expected by Q4 2024
AI Summary
Sonnet BioTherapeutics Holdings announced that their Phase 1 SB101 clinical trial for the targeted immunotherapy SON-1010 has completed enrollment and begun dosing in adult patients with advanced solid tumors. The study uses an adaptive design with dose escalation to assess safety, tolerability, and pharmacokinetics/pharmacodynamics. So far, the trial has not observed any dose-limiting toxicities, and most reported adverse events have been mild and transient.
The company expects to report topline safety data from the SB101 study in Q4 2024. This milestone is key in validating SON-1010, which is designed to turn “cold” tumors “hot” by stimulating the immune system, and could define the optimal dosing for further development in targeted cancer therapy.
Read Announcement- Drug:
- SON-1010
- Announced Date:
- September 18, 2024
- Indication:
- Advanced Solid Tumors
Announcement
Sonnet BioTherapeutics 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.
AI Summary
Sonnet BioTherapeutics has reached an important milestone by completing patient enrollment and beginning dosing in its Phase 1 SB101 clinical trial of SON-1010 (IL12-FHAB) in adult patients with advanced solid tumors. This trial, which enrolled 24 participants, is designed to evaluate the safety, tolerability, and appropriate dosage of SON-1010 as a monotherapy. SON-1010 is a targeted immunotherapy that uses a unique platform to extend IL-12’s half-life and focus its activity on the tumor microenvironment, aiming to turn “cold” tumors “hot.” Early safety data has been encouraging, with adverse events remaining mild and no severe toxicities observed. The company expects to release topline safety data in the fourth quarter of 2024, which will also include additional insights into the pharmacokinetics and tumor targeting abilities of this promising therapy.
Read Announcement
SON-1210 - FDA Regulatory Timeline and Events
SON-1210 is a drug developed by Sonnet BioTherapeutics for the following indication: For the Treatment of Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SON-1210
- Announced Date:
- August 19, 2024
- Indication:
- For the Treatment of Pancreatic Cancer
Announcement
Sonnet BioTherapeutics 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.
AI Summary
Sonnet BioTherapeutics announced a Master Clinical Collaboration Agreement with the Sarcoma Oncology Center to advance SON-1210, its proprietary bifunctional drug candidate. SON-1210 is designed as a version of human Interleukins 12 (IL-12) and 15 (IL-15) using Sonnet’s Fully Human Albumin Binding (FHAB®) platform. The collaboration will focus on a Phase 1/2a clinical study testing SON-1210 in combination with chemotherapy for the treatment of metastatic pancreatic cancer, a disease with a high unmet medical need. Experts from the Sarcoma Oncology Center and Sonnet will work together to create a study protocol that incorporates several chemotherapeutic agents, including NALIRIFOX, an FDA-approved chemotherapy for metastatic pancreatic cancer. The goal is to gather valuable clinical data that can potentially improve treatment outcomes and further validate the efficiency of Sonnet's innovative albumin-binding technology in targeting tumor cells.
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SON-1400 - FDA Regulatory Timeline and Events
SON-1400 is a drug developed by Sonnet BioTherapeutics for the following indication: for the treatment of cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SON-1400
- Announced Date:
- June 13, 2024
- Indication:
- for the treatment of cancers.
Announcement
Sonnet BioTherapeutics Holdings, Inc. announced the generation and in vitro characterization of two novel drug candidates SON-1400 (IL18BPR-FHAB), each containing a modified version of recombinant human interleukin-18 (IL-18BPR).
AI Summary
Sonnet BioTherapeutics Holdings, Inc. announced they have generated and characterized two new investigational drug candidates. One of these candidates, SON-1400 (IL18BPR-FHAB), is a monofunctional fusion protein that incorporates a modified version of recombinant human interleukin-18 (IL-18BPR). This modified IL-18 is designed to keep its normal binding to the IL-18 receptor while reducing or eliminating binding to the inhibitory IL-18 binding protein (IL-18BP), which often limits the effectiveness of IL-18 in cancer treatments. By linking IL-18BPR to their proprietary Fully Human Albumin Binding (FHAB) platform, Sonnet aims to extend the drug’s half-life and enhance its targeting of the tumor microenvironment. These promising in vitro results suggest that SON-1400 could help overcome current challenges in delivering IL-18 based therapies in oncology.
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SON-1411 - FDA Regulatory Timeline and Events
SON-1411 is a drug developed by Sonnet BioTherapeutics for the following indication: for the treatment of cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SON-1411
- Announced Date:
- June 13, 2024
- Indication:
- for the treatment of cancers.
Announcement
Sonnet BioTherapeutics Holdings, Inc announced the generation and in vitro characterization of two novel drug candidates, SON-1411 each containing a modified version of recombinant human interleukin-18 (IL-18BPR).
AI Summary
Sonnet BioTherapeutics Holdings, Inc. announced the generation and in vitro characterization of two new drug candidates, SON-1411 and SON-1400. Both candidates feature a modified version of recombinant human interleukin-18 (IL-18BPR), designed to bind the IL-18 receptor while avoiding binding to the natural inhibitor IL-18BP. SON-1411 is a bifunctional fusion protein that combines IL-18BPR with single-chain IL-12 using the company’s proprietary FHAB platform. This approach targets tumors by extending the half-life and enhancing the bioactivity of the drug, potentially turning “cold” tumors “hot” by stimulating the immune response. Meanwhile, SON-1400, a monofunctional fusion protein containing IL-18BPR, was produced in E. coli, while SON-1411 is manufactured in Chinese Hamster Ovary cells. These advancements could lead to improved cancer immunotherapy strategies, offering new hope for effective treatments.
Read Announcement
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