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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
Newsfilter· 2025-04-04 13:00
Core Insights - The SB221 study demonstrated positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC), allowing the study to advance to the expansion phase [1][5][6] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg, with no dose-limiting toxicity or cytokine release syndrome observed [1][2][3] - A partial response (PR) was noted in one patient, with a 44% decrease in tumor size and a significant reduction in the CA 125 biomarker [1][3][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 combined with atezolizumab, with a focus on establishing the MTD [2][8] - A total of 19 subjects were treated during the dose escalation phase, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with only one serious adverse event (Grade 2 pneumonitis) reported [3][5] Clinical Implications - The results indicate that SON-1010 may be particularly effective in treating immunologically 'cold' tumors, such as ovarian cancer, by enhancing the immune response [4][7] - The study's findings suggest a potential synergistic effect when SON-1010 is used in combination with immune checkpoint inhibitors [5][6] - The safety profile observed in this trial is promising, especially given the historical safety concerns associated with rhIL-12 therapies [5][6] Future Directions - The SB221 trial will proceed to a Phase 2a randomized comparison with standard care for PROC patients [1][8] - Sonnet BioTherapeutics is seeking partnership opportunities to support the later stages of SON-1010's development [6][11]
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· 2025-04-04 13:00
Core Insights - The SB221 study demonstrates positive safety results for SON-1010 in combination with atezolizumab for patients with platinum-resistant ovarian cancer (PROC) [1][5] - The maximum tolerated dose (MTD) of SON-1010 was established at 1200 ng/kg without dose-limiting toxicity or cytokine release syndrome [1][3] - The study showed a partial response (PR) in one patient and stable disease (SD) in 33% of evaluable patients at four months [1][5] Study Design and Results - The SB221 study aimed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SON-1010 with atezolizumab, focusing on establishing the MTD [2][8] - A total of 19 subjects were treated, with one patient achieving a PR at the highest dose [2] - Common adverse effects included fatigue, fevers, and gastrointestinal symptoms, with no significant toxicity observed [3][5] Clinical Implications - The results indicate that SON-1010 may enhance the efficacy of immune checkpoint inhibitors (ICIs) in treating 'cold' tumors like ovarian cancer [4][5] - The study's findings are encouraging given the historical safety concerns associated with rhIL-12, suggesting a potential for improved tumor control [5][6] - The ongoing trial will assess longer-term safety and tumor responses, with a focus on expanding the dataset for efficacy evaluation [6][8] Company Overview - Sonnet BioTherapeutics is focused on developing targeted biologic drugs using its Fully Human Albumin-Binding (FHAB) platform [10][11] - SON-1010 is designed to deliver IL-12 to tumor tissues, potentially improving the safety and efficacy profile of immunomodulators [7][10] - The company is also exploring partnerships to support the later stages of SON-1010's development [6][11]
Sonnet Announces Release of Corporate Update Video
Globenewswire· 2025-04-01 20:15
Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeted to the tumor microenvironment (TME) [1] - The company utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs, which enhances the safety and efficacy of immune-modulating biologic drugs [2] Lead Programs - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain types of sarcoma, and ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [2] - The second program, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors, with an upcoming investigator-initiated Phase 1/2a study for pancreatic cancer in collaboration with the Sarcoma Oncology Center [2]
Sonnet Announces the Passing of Founder and CEO Pankaj Mohan, Ph.D.
Newsfilter· 2025-04-01 11:30
Core Viewpoint - Sonnet BioTherapeutics Holdings, Inc. announced the passing of its founder and CEO, Pankaj Mohan, and appointed Raghu Rao as Interim CEO while promoting Stephen McAndrew to President and Chief Business Officer [1][2] Company Overview - Sonnet is a clinical-stage biotechnology company focused on developing immunotherapeutic drugs targeting the tumor microenvironment (TME) [1][3] - The company utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for creating targeted biologic drugs [3] Leadership Transition - The Board of Directors has unanimously approved the appointment of Raghu Rao as Interim CEO and Stephen McAndrew as President and Chief Business Officer [1][2] - The Board plans to initiate a search for a permanent CEO [1] Product Development - Sonnet's lead program, SON-1010 (IL-12-FHAB), is in development for treating solid tumors, certain sarcomas, and ovarian cancer [4] - SON-1010 is currently being evaluated in a Phase 1/2a study in collaboration with Roche for platinum-resistant ovarian cancer [4] - The company is also developing a second program, SON-1210 (IL12-FHAB-IL15), for pancreatic cancer in collaboration with the Sarcoma Oncology Center [4]
Sonnet BioTherapeutics Successfully Completes First Safety Review of SON-1010 in Combination with Trabectedin in Certain Sarcomas
Globenewswire· 2025-03-26 13:05
Core Insights - SON-1010 is being evaluated as a combination therapy with trabectedin (Yondelis) for advanced soft tissue sarcoma, showing potential for immune mechanism synergies and enhanced progression-free survival [1][2] - The initial safety review indicated no unexpected toxicities in early dosing, allowing for full enrollment of up to 18 patients [1][2] - SON-1010 monotherapy demonstrated clinical benefit in 83% of patients at the maximum tolerated dose, including a confirmed partial response in a patient with clear cell sarcoma [1][2] Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs [1][8] - The company utilizes the Fully Human Albumin Binding (FHAB) platform to enhance the safety and efficacy of its drug candidates, including SON-1010 [6][8] - SON-1010 is designed to deliver interleukin-12 to local tumor tissue, potentially converting 'cold' tumors to 'hot' tumors and stimulating immune responses [6][8] Clinical Trial Details - The Phase 1 SB101 trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010, with a maximum tolerated dose established at 1200 ng/kg [7] - The trial includes an expansion cohort for patients with unresectable, metastatic leiomyosarcoma or liposarcoma, with a goal to assess the combination therapy's effectiveness [3][5] - The study has treated 7 patients so far, with plans to enroll up to 18 patients in total [3][7] Market Opportunity - The global market opportunity for trabectedin is estimated at $2.1 billion, highlighting significant unmet medical needs in the treatment of sarcomas [1][5] - The combination of SON-1010 and trabectedin is positioned for potential advancement into larger Phase 2 studies, which could establish a new treatment paradigm for soft tissue sarcomas [5][9]
Sonnet BioTherapeutics Receives Notice of Allowance for U.S. Patent Covering Composition of Matter of Specific Amino Acid Substitutions of its IL-18 Binding Protein Resistant Variant Protein
Globenewswire· 2025-03-19 12:50
Core Insights - Sonnet BioTherapeutics Holdings, Inc. has received a Notice of Allowance from the USPTO for a second patent related to its modified version of Interleukin-18 (IL-18), which enhances its effectiveness by binding to the IL-18 receptor while avoiding the inhibitory IL-18 Binding Protein [1][2] - The allowed patent covers various amino acid substitutions in the IL-18 protein, potentially opening up licensing opportunities independent of Sonnet's FHAB platform [1][2] - The company is developing two novel drug candidates, SON-1411 and SON-1400, which utilize the FHAB platform to enhance the therapeutic efficacy of IL-18 and IL-12 in oncology [1][4] Company Overview - Sonnet is focused on developing targeted biologic drugs using its proprietary Fully Human Albumin Binding (FHAB) technology, which aims to improve the safety and efficacy of immune-modulating biologic drugs [4] - The lead program, SON-1010, is in clinical development for advanced solid tumors and is being evaluated in combination with Roche's atezolizumab [4] - The company is also advancing SON-080 for Chemotherapy-Induced Peripheral Neuropathy and has entered a licensing agreement with Alkem Laboratories for its development in India [5] Product Details - SON-1411 is a bifunctional fusion protein combining IL-18 and IL-12, designed to enhance immune responses against tumors by stimulating IFNγ production [3][4] - The FHAB technology allows for targeted delivery to tumor and lymphatic tissues, potentially improving the therapeutic window for various cancer treatments [4][5] - SON-1400 is a monofunctional fusion protein that also utilizes the FHAB platform to extend the half-life and biological activity of IL-18 [1][2]
Sonnet BioTherapeutics Holdings, Inc. Participates in the Virtual Investor “Top 5 for ‘25” On-Demand Conference
Globenewswire· 2025-03-11 12:45
Company Overview - Sonnet BioTherapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on developing targeted immunotherapeutic drugs, utilizing a proprietary platform known as FHAB (Fully Human Albumin-Binding) [4] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, enhancing the safety and efficacy of immune-modulating biologic drugs [4] Product Development - The lead program, SON-1010 (IL-12-FHAB), is in development for advanced solid tumors, certain sarcomas, and platinum-resistant ovarian cancer, currently undergoing a Phase 1/2a study in collaboration with Roche [5] - A second product candidate, SON-1210 (IL12-FHAB-IL15), is being evaluated for solid tumors in partnership with the Innovative Immuno-Oncology Consortium, with plans to initiate a Phase 1/2a study for pancreatic ductal adenocarcinoma [5] - The SON-080 program, a low dose of rhIL-6, is in development for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, showing promising results in a Phase 1b/2a trial and is advancing to a Phase 2 study in India under a license agreement with Alkem Laboratories [6] Recent Events - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where the CEO presented key reasons for investment interest in Sonnet for 2025 [2][3]
Sonnet BioTherapeutics Announces That Its Proprietary Antibody Drug Conjugate (ADC) Platform is Available for Drug Discovery Partnerships with Potential for Producing Multiple Pipeline Drug Candidates
Globenewswire· 2025-02-19 13:35
Core Insights - Sonnet BioTherapeutics is advancing its proprietary Antibody Drug Conjugate (ADC) platform designed to address technical challenges associated with ADCs, aiming to enhance value for cancer patients [2][3] - The initial proof-of-concept ADC construct, SON-5010, demonstrated similar efficacy to Kadcyla and trastuzumab-MMAE in preclinical studies, indicating its potential in cancer treatment [1][3] ADC Platform Development - The ADC platform utilizes a flexible payload capacity and controllable drug-antibody ratios (DAR), allowing for the creation of various ADC candidates [2][3] - The platform is differentiated by its stable structural integrity, extended conjugation site flexibility, and potential for enhanced tumor penetration [2][3] SON-5010 Details - SON-5010 is produced through a two-step process involving the expression and purification of targeting scaffold and payload domains, followed by chemical linkage [2][3] - In vivo comparisons showed that SON-5010 achieved similar tumor reduction activity to Kadcyla without detectable toxicity in a mouse model [3] Strategic Partnerships and Future Plans - The company is seeking value-driven discovery partnerships to further develop its ADC candidates [2][3] - Sonnet plans to continue global prosecution of its intellectual property related to the ADC platform while exploring collaboration opportunities [3] Company Overview - Sonnet BioTherapeutics focuses on oncology and has developed the FHAB (Fully Human Albumin-Binding) technology for targeted biologic drugs [5] - The lead program, SON-1010, is in development for advanced solid tumors and is being evaluated in a Phase 1/2a study in combination with Roche's atezolizumab [5]
Sonnet BioTherapeutics Selected for Poster Presentation at the 2025 AACR IO Conference
Globenewswire· 2025-02-18 14:15
Core Insights - Sonnet BioTherapeutics Holdings, Inc. announced that its abstract has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) IO Conference, highlighting its focus on targeted immunotherapeutic drugs [1] Company Overview - Sonnet is an oncology-focused biotechnology company that utilizes a proprietary platform known as FHAB (Fully Human Albumin-Binding) for developing targeted biologic drugs [2] - The FHAB technology employs a fully human single chain antibody fragment that binds to human serum albumin for targeted transport to tumor and lymphatic tissues, aiming to enhance the safety and efficacy of immune-modulating biologic drugs [2] - The lead program, SON-1010 (IL-12-FHAB), is in development for advanced solid tumors, certain sarcomas, and platinum-resistant ovarian cancer, currently evaluated in a Phase 1/2a study in collaboration with Roche [2] - The second product candidate, SON-1210 (IL12-FHAB-IL15), is being developed for solid tumors in partnership with the Innovative Immuno-Oncology Consortium, with plans for a Phase 1/2a study for pancreatic ductal adenocarcinoma [2] - The SON-080 program, focusing on low-dose rhIL-6 for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, has shown promising results in a Phase 1b/2a clinical trial and is advancing into a Phase 2 study in India under a license agreement with Alkem Laboratories [2]
Sonnet BioTherapuetics(SONN) - 2025 Q1 - Quarterly Report
2025-02-13 21:15
Financial Performance - Total assets increased to $7,182,027 as of December 31, 2024, compared to $2,771,030 as of September 30, 2024, representing a growth of 159%[12] - Collaboration revenue for the three months ended December 31, 2024, was $1,000,000, a significant increase from $18,626 in the same period of 2023[14] - Total operating expenses rose to $3,849,422 for the three months ended December 31, 2024, compared to $1,297,497 in the prior year, marking an increase of 196%[14] - Net loss for the three months ended December 31, 2024, was $3,160,706, compared to a net loss of $1,168,509 for the same period in 2023, reflecting a 170% increase in losses[14] - Cash at the end of the period increased to $4,861,503 from $149,456 at the beginning of the period, indicating a net increase of $4,712,047[18] - The company recorded total liabilities of $3,145,458 as of December 31, 2024, compared to $3,256,769 as of September 30, 2024, showing a decrease of approximately 3.4%[12] - For the three months ended December 31, 2024, the net loss was $3.16 million, compared to a net loss of $1.17 million for the same period in 2023, representing a 170% increase in losses[18] - Net cash used in operating activities was $2.91 million for Q4 2024, slightly improved from $3.09 million in Q4 2023[18] - The company raised $7.71 million from the issuance of common stock in Q4 2024, compared to $3.84 million in Q4 2023, indicating a 101% increase in financing activities[18] - Cash at the end of the period was $4.86 million, up from $3.02 million at the end of Q4 2023, reflecting a 61% increase in cash reserves[18] Shareholder Information - The company reported a weighted average of 2,022,818 shares outstanding for the three months ended December 31, 2024, compared to 474,699 shares in the same period of 2023[14] - The number of shares outstanding increased to 3,007,431 as of December 31, 2024, from 650,284 at the end of September 2024[12][16] - The weighted-average number of shares for diluted net loss per share remains the same as for basic net loss per share due to the anti-dilutive effect of dilutive securities[51] - The Company has a total of 5,161,565 potentially dilutive securities excluded from the computation of diluted shares as of December 31, 2024, compared to 805,931 in 2023[54] - As of December 31, 2024, the Company had a total of 5,789,600 outstanding warrants[91] Clinical Development - The company initiated a U.S. clinical trial (SB101) for its lead asset SON-1010 in oncology patients with solid tumors in Q2 2022[21] - Sonnet BioTherapeutics received FDA clearance for its Investigational New Drug (IND) application for SON-1010 in March 2022, allowing clinical development to proceed[21] - The company created a wholly-owned Australian subsidiary for conducting clinical trials, with an Australian study (SB102) of SON-1010 initiated in Q3 2022[21] - In January 2023, Sonnet announced a collaboration with Roche to evaluate SON-1010 with atezolizumab for platinum-resistant ovarian cancer, with the trial approved in June 2023[22] - Sonnet expanded its Phase 1 SB101 clinical study of SON-1010 in January 2025 to include a new cohort with trabectedin, which was approved as a second-line treatment in early 2024[23] - The Data Safety Monitoring Board cleared the Phase 1b/2a study of SON-080 in chemotherapy-induced peripheral neuropathy to proceed to Part 2 in early 2024[26] - Sonnet entered into a License Agreement with Alkem Laboratories in October 2024 to develop SON-080 for diabetic peripheral neuropathy in India[26] - SON-1210, a lead bifunctional construct, is being developed for solid tumors, with a Phase 1b/2a study in pancreatic cancer initiated by the Sarcoma Oncology Center[27] - SON-080 is advancing in clinical trials for Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy, with a Phase 1b/2a study approved in Q3 2022[26] Financing and Capital Structure - The Company has a committed equity facility allowing it to sell up to $25.0 million in common stock, with $24.9 million available as of December 31, 2024[84] - The Company closed a public offering on October 26, 2023, raising net proceeds of $3.9 million through the sale of 163,281 shares and warrants[81] - A subsequent public offering on November 7, 2024, generated net proceeds of $4.2 million from the sale of 155,000 shares and warrants[85] - The Company raised approximately $3.5 million from a registered direct and PIPE offering completed on December 10, 2024[90] - The Company recorded a contract asset of $0.5 million related to the Alkem Agreement, representing unbilled collaboration revenue[80] - The New Life Agreement generated $1.0 million in non-refundable upfront cash payments, fully recognized by December 31, 2023[72] - Under the Alkem Agreement, the Company will receive $1.0 million in upfront payments and up to an additional $1.0 million in milestone payments, along with low double-digit royalties on net sales in India[75] Expenses and Liabilities - Total accrued expenses and other current liabilities as of December 31, 2024, amounted to $1,394,520, an increase from $942,489 as of September 30, 2024, with research and development expenses rising to $969,684 from $617,545[59] - The company has contingent milestone payments totaling $3.8 million to XOMA upon achieving certain development milestones related to product commercialization[61] - The company incurred a $0.1 million technology access fee upon execution of the Navigo Agreement, with additional contingent milestone payments of up to $1.0 million based on evaluation and development milestones[70] - The company has a one-time fee obligation of $1.5 million or 5% of the first upfront payment received from a third-party partnership under the SOC Agreement for the development of SON-1210[67] - The Company incurred $12,000 in license fees under the Brink Agreement during the three months ended December 31, 2024 and 2023[65] Management and Governance - The company appointed Donald Griffith as Chief Financial Officer effective February 21, 2025, following the resignation of Jay Cross[100] - Stephen McAndrew was appointed as Chief Business Officer, with an annual base salary of $330,000 and eligibility for a performance-based cash bonus of up to 35%[101]