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Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) is a clinical-stage biotechnology company based in Cranbury, New Jersey. The firm is pioneering the development of targeted immunotherapeutic drugs primarily aimed at treating cancers. Sonnet employs its proprietary FHAB (Fully Human Albumin Binding) technology, which utilizes a single-chain antibody fragment that binds to human serum albumin for targeted delivery to tumor and lymphatic tissues. This innovative platform enhances drug efficacy and safety by extending the half-life of therapeutic agents and concentrating them in the tumor microenvironment (TME).
Sonnet’s mission focuses on generating immuno-oncology candidates and advancing them to Phase II clinical assets. The company's current pipeline includes several promising products:
- SON-080 - A low-dose IL-6 aimed at treating chemotherapy-induced peripheral neuropathy (CIPN).
- SON-1210 - Combines IL-12 and IL-15 with Sonnet's FHAB for robust immune response targeting tumors.
- SON-1010 - Consists of a single-chain IL-12 linked with the albumin-binding domain for enhanced targeting and efficacy in cancer treatment.
Recent achievements include the publication of preclinical data demonstrating the efficacy of SON-1210 in reducing tumor growth in melanoma models. Additionally, the company reported positive safety and tolerability results from Phase 1 studies of SON-1010 in healthy volunteers and cancer patients.
Sonnet's collaboration with Genentech for the combination study of SON-1010 and atezolizumab (Tecentriq) in platinum-resistant ovarian cancer is a significant milestone. Financially, the company has successfully leveraged tax credits and managed its cash runway effectively, projecting operations funding into the latter part of 2024.
The company is also actively exploring strategic alternatives to maximize stockholder value, having engaged Chardan Capital Markets to assist in evaluating potential business development, partnerships, acquisitions, or mergers.
Sonnet BioTherapeutics (NASDAQ:SONN) announced dosing of 24 healthy volunteers in a Phase 1 clinical trial for SON-1010, aimed at assessing safety and pharmacokinetics (PK). SON-1010 shows a remarkable half-life of approximately 112 hours, significantly longer than the 12 hours of rhIL-12. Early results indicate successful induction of interferon gamma (IFNg) with minimal adverse events, allowing for potential dose escalation. The findings support the effectiveness of the FHAB platform in enhancing drug delivery to tumors, suggesting promising implications for future cancer therapies and potential market opportunities.
Sonnet BioTherapeutics (NASDAQ: SONN) announced a clinical collaboration with Roche to evaluate its lead product, SON-1010, alongside atezolizumab in a study targeting platinum-resistant ovarian cancer. Scheduled to begin in Q2 2023, the Phase 1b/2a trial (SB221) will assess safety and efficacy. SON-1010 is designed to enhance immune response in the tumor microenvironment, potentially improving treatment options for patients with limited alternatives. This marks Sonnet's first combination study, highlighting its importance for the company's growth strategy.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) reported its fiscal year 2022 results, highlighting significant development milestones. The company initiated two Phase 1 trials for SON-1010, showing promising safety data, and commenced a Phase 1b/2a trial for SON-080, with results anticipated in H1 2023. Sonnet plans a 30% operational expense reduction starting Q2 2023, focusing on enhancing pipeline efficiency and leveraging cost-effective R&D locations. After raising $6.5 million in common stock sales, Sonnet's cash on hand was $3.1 million as of September 30, 2022. Research and development expenses rose to $21.4 million, mainly due to advancing clinical trials.
Sonnet BioTherapeutics announced encouraging interim results from Phase 1 trials of SON-1010, a novel immunotherapeutic targeting advanced solid tumors. A total of 36 subjects have been dosed, with an ongoing dose escalation approved by safety review committees. Key findings include controlled induction of IFNγ and no instances of cytokine release syndrome. Notably, all but one patient remain in the study, and one has displayed tumor improvement after 6 months. The safety profile is favorable, with mild to moderate adverse events, suggesting SON-1010's potential in enhancing immunotherapy.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) announced a webcast on November 2, 2022, at 8:30 am ET to share initial clinical data from two studies involving SON-1010. The SB101 trial assesses the safety of SON-1010 in cancer patients, focusing on establishing the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Concurrently, the SB102 trial evaluates SON-1010 doses in healthy volunteers. Both studies aim to understand safety, pharmacokinetics, and immunogenicity, setting the stage for future immunotherapy combinations.
Sonnet BioTherapeutics (NASDAQ:SONN) announced a collaboration with Janssen Biotech to evaluate its products SON-1010, SON-1210, and SON-1410. The evaluation will focus on in vitro and in vivo efficacy in preclinical models, leveraging Janssen's proprietary cell therapy assets. If successful, Sonnet may pursue an expanded collaboration. This represents Sonnet's first head-to-head evaluation, which could inform oncology indications and potentially lead to a license agreement, as stated by CEO Pankaj Mohan.
Sonnet BioTherapeutics Holdings announced it has regained compliance with Nasdaq's minimum bid price requirement, meeting the $1.00 bid price for 10 consecutive trading days by September 30, 2022. However, the company is still not compliant with the stockholders' equity requirement of $2.5 million, having received a notice from Nasdaq on August 22, 2022. Sonnet has until October 6, 2022, to submit a plan to regain compliance, which, if accepted, could grant an extension of up to 180 days.
Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) has appointed Lori McNeill to its Board of Directors, also making her the Chairperson of the newly established Business Advisory Committee (BAC). With over 20 years in healthcare and a background at Pfizer, McNeill is expected to enhance Sonnet's strategic collaborations and communication efforts, particularly regarding government initiatives like the Cancer Moonshot. The BAC will guide the company on external partnerships and elevate its profile in immune oncology, coinciding with upcoming clinical trial data releases.
On September 21, 2022, Sonnet BioTherapeutics Holdings announced progress in their Phase 1 clinical trials for SON-1010 (IL-12-FHAB), having dosed 19 subjects so far. The initial safety review has cleared the way for continued dose escalation. SB101 focuses on advanced solid tumors, while SB102 involves healthy volunteers. No dose-limiting toxicities have been reported. Upcoming data on safety and cytokine-specific responses is expected in Q4 2022. This development marks a significant milestone in immunotherapy, with SON-1010 aiming to enhance safety and efficacy in cancer treatment.
Sonnet BioTherapeutics Holdings (NASDAQ:SONN) announced a 1-for-14 reverse stock split effective September 19, 2022. The split aims to elevate the share price above the $1.00 minimum for continued Nasdaq listing. Post-split, shares will decrease from approximately 69.6 million to 5.0 million. The initiative was approved by stockholders on September 15, 2022, and will also impact outstanding warrants and options. No fractional shares will be issued; cash payments will be provided instead for fractional interests. The par value remains at $0.0001 per share.
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