On December 15, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported today its financial results for the fiscal year ended September 30th, 2022 and provided a business update (Press release, Sonnet BioTherapeutics, DEC 15, 2022, View Source [SID1234625324]).

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Pankaj Mohan, Ph.D., Founder and CEO commented, "This was a defining year for Sonnet, as we initiated two Phase 1 clinical trials with SON-1010 that yielded encouraging initial safety data and a Phase 1b/2a trial with SON-080 that is expected to yield data in the first half of 2023. Work is progressing as scheduled on our pipeline, and we are particularly pleased with the Janssen collaboration, which marked an important milestone for our business development activities. Partnering continues to be a focal point of our business strategy, with our R&D pipeline being prioritized based on external interest. Beginning in our second fiscal quarter of 2023, we are committing to generating significant operating expense reductions of approximately 30% in accordance with our prioritization goals. Further, we fully integrated Sonnet’s low-cost R&D engine with product development activities in cost advantaged locations, including India and Australia. On behalf of our team, we are looking forward to a very productive 2023."

Fiscal Year 2022 and Recent Corporate Updates

Sonnet’s Execution Platform: Sonnet has built a unique, highly capable low-cost execution platform for the development of our pipeline. The highly experienced small team of executives and senior managers has assembled a best-in-class global network of outsourced vendors for rapid execution. Most of the vendors are strategic collaborators, providing a preferential status with negotiated cost. Sonnet has chosen a strategic CMC collaborator in India and has negotiated the cost to be significantly less than the expense incurred from a similar US- or Europe-based vendor. Sonnet is conducting two of the company’s three ongoing clinical trials in Australia, which carries a substantial cost reduction relative to US trials via the Australian government’s R&D credit program. The major advantages of this approach include optimized direct investment into projects with expenses that can be rapidly scaled up or down depending on the number of projects.

Financings Completed: On August 15, Sonnet closed a private placement of preferred stock and warrants for net proceeds of $2.1 million. The preferred stock sold in the private placement converted into an aggregate of 552,283 shares of common stock on September 30, 2022, at a conversion price of $4.074 per share, and as of the date of this press release all of the warrants sold in the private placement are outstanding, entitling the holders thereof to purchase an aggregate of 276,140 shares of common stock at an exercise price of $4.074 per share between February 15, 2023 and the expiration date of August 15, 2027.

In addition, as of the market close on December 14, 2022, Sonnet has sold an aggregate of 3,056,526 shares of its common stock under the At-the-Market Sales Agreement with BTIG, LLC dated August 15, 2022, for total net proceeds of $6.5 million, including 2,391,989 shares sold for net proceeds of $4.6 million subsequent to September 30, 2022.

Announced Collaboration Agreement with Janssen Biotech: On October 31st, Sonnet announced a collaboration agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, where in vitro and in vivo efficacy of SON-1010 (IL12-FHAB), SON-1210 (IL12- FHAB-IL15) and SON-1410 (IL18- FHAB-IL12) will be evaluated in combination with certain Janssen proprietary cell therapy assets. The agreement was facilitated by Johnson & Johnson Innovation. Under the terms of the agreement, Sonnet shall supply the three referenced compounds for use in head-to-head in vitro and in vivo efficacy studies. If successful and subject to the provisions of the agreement, Janssen could exercise its option and Sonnet could then seek an expanded collaboration.

Intellectual Property in Process: Beyond various provisional patents that have been applied for globally, on November 24th, Sonnet received a Decision to Grant Patent No. 2019-566563 from the Japan patent office. Entitled, "Albumin Domain Fusion Proteins", the intellectual property covers Sonnet’s Fully Human Albumin Binding (FHAB) technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention that also provide extended pharmacokinetics (PK). Pending formal issuance upon receipt of a small registration payment, the patent would carry an estimated term effective until February 20, 2038.

Sonnet is pleased to provide the following updates on its pipeline assets:
SON-1010 (IL12-FHAB): On November 2nd, Sonnet announced interim data from the SB101 and SB102 dose-escalation studies of SON-1010. SB101 is a multiple-dose trial for adult patients with advanced solid tumors (NCT05352750) that commenced in April and has now started treating the fourth dose cohort. SB102 is a single-ascending dose trial in healthy volunteers (NCT05408572) that started in July and is dosing the third cohort. The Safety Review Committees found no safety concerns and approved advancing to the next higher dose levels for both studies. Data from the primary analyses of both trials are expected during the second calendar quarter of 2023.

The clinical dose-escalation strategy was developed based on the ability to use this non-cytotoxic drug in a single-ascending dose (SAD) study in healthy volunteers to rapidly provide clean PK/PD data without interpretation challenges from prior cancer treatment effects. The initial safety and PD data are being used to evaluate the immune response to SON-1010 and predict the effect of further dose escalation. IL-12 has been shown to stimulate the production of interferon-gamma (IFNγ), which is necessary for its antitumor effects. Sonnet is using the known protective effects of IL-12 dose timing to minimize toxicity and extend the maximum tolerated dose (MTD).

The adverse events observed to date have been generally mild/moderate, transient in nature, and have all been tolerable. In addition, they have been less numerous and less intense with subsequent doses. Acute inflammation in both studies was assessed with a Luminex bead assay for multiple cytokine analytes. IL-12p70 (used to measure SON-1010 concentration) was readily quantified and demonstrated extended pharmacokinetics. The resulting increase in IFNγ (showing an IL-12 effect and potential for tumor control) was dose-related, controlled, and prolonged. There was minimal/no signal for IL-1β, IL-6, IL-8, or TNFα and no indication of cytokine release syndrome (CRS). IL-10 was also induced at a low level, as expected. Even though these patients with advanced solid tumors have been heavily pretreated and many had actively progressive disease at study entry, all but one patient remain on study.

Of the 6 patients from the first two cohorts evaluable for follow-up at this latest cutoff, 5 of the 6 had stable disease at the first follow-up scan, with one patient progressing who is now off study. As of the most recent scan, 2 of the 5 stable disease patients remain stable, while the others had tumor growth that may represent either tumor inflammation or unconfirmed progression. One patient with endometrial stromal sarcoma who was progressing at study entry now has evidence of improvement after 6 months on SON-1010 with smaller tumors and complete resolution of her ascites.

SON-080 (low-dose IL-6): On June 22nd, Sonnet announced that a Phase 1b/2a clinical trial of SON-080 had been authorized to commence. This study (SB211) is being conducted at multiple sites in Australia in patients with persistent chemotherapy-induced peripheral neuropathy (CIPN) and is expected to yield initial top line clinical safety data during the first half of 2023. Pursuant to a license agreement the Company entered with New Life Therapeutics Pte., Ltd of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN with the objective of initiating an ex-US pilot efficacy study in the second half of 2023.

SON-1210 (IL12-FHAB-IL15): SON-1210, Sonnet’s first bispecific candidate, is undergoing a non-human primate (NHP) study with the in-life portion on track to be completed in the fourth calendar quarter of 2022. Manufacturing and drug supply are secured with a lyophilized drug product formulation being prepared during the first calendar quarter of 2023, which is expected to be suitable for first-in-human clinical trials. Initiation of the regulatory authorization process is scheduled to commence during the first half of 2023.

SON-1410 (IL18-FHAB-IL12): Regarding SON-1410, Sonnet’s second bispecific pipeline candidate, cell line development and process development is ongoing, with early experimental drug supply suitable for formulation and analytical method development activities, in addition to small quantities for use in early development proof-of-concept in vitro studies. Process development activities will continue through 2023, with the potential to generate drug suitable for initial in vivo mouse studies by the end of the 2023 calendar year.

SON-3015 (anti-IL6-FHAB-anti-TGFβ): Regarding SON-3015, early-stage bispecific drug has been generated and has been stored for future use in in vivo mouse studies. Sonnet has elected to place the SON-3015 development program on hold for expense reduction purposes.

Fiscal Year Ended September 30, 2022 Financial Results

Jay Cross, CFO, elaborated on Sonnet’s performance, saying, "2022 was an important year for Sonnet, during which we were able to effectively deploy our capital to make important pipeline progress. As we move into the 2023 calendar year, in addition to our continued focus on funding the company, we will look to establish cost savings by reducing expenditures on tertiary programs, such as SON-3015, which is being placed on a development hold. In the cases of SON-1210 and SON-1410, work continues and will pivot around potential partnership interest, as the compounds advance towards the clinic. With collaborations in place, we will be in a position to further evaluate our operating expense infrastructure."

● As of September 30, 2022, Sonnet had $3.1 million cash on hand and subsequently raised $4.6 million in net proceeds from the At-the-Market Sales Agreement with BTIG, LLC.
● The Company currently has outstanding 7,934,156 shares of common stock and warrants to purchase an aggregate of 3,972,323 shares of common stock, with a weighted average exercise price per share of $19.21.
● Research and development expenses were $21.4 million for the year ended September 30, 2022, compared to $16.6 million for the year ended September 30, 2021. The increase of $4.8 million was primarily due to increased expenditures for the development of the cell lines for IL12-FHAB, IL12-FHAB-IL15 and SON-080 in connection with the initiation of a Phase 1 clinical trial for SON-1010 and preparation for a Phase 1b/2a pilot-scale efficacy study with SON-080 in CIPN; acquired in-process research and development the milestone payment incurred in connection with various license and research and development agreements, including the XOMA Collaboration Agreement; and an increase in payroll expense as we continue to develop our product candidates.
● General and administrative expenses were $8.6 million for the year ended September 30, 2022, compared to $8.9 million for the year ended September 30, 2021. The decrease of $0.3 million was primarily due to a decrease in payroll and share-based compensation expense.

On December 15, 2022 TriSalus Life Sciences, Inc. ("TriSalus" or the "company"), an oncology company in the process of going public through a business combination transaction (the "Business Combination") with MedTech Acquisition Corporation (Nasdaq: MTAC) ("MedTech" or "MTAC"), reported that it has expanded the reach of its ongoing Pressure-Enabled Regional Immuno-Oncology ("PERIO-01" and "PERIO-02") clinical program (Press release, TriSalus Life Sciences, DEC 15, 2022, View Source [SID1234625325]).

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In recent months TriSalus has opened five new PERIO-01 (NCT04935229) clinical trial sites, at Stanford University Hospitals, University of California Los Angeles, University of Colorado’s Anschutz Medical Campus, University of Washington Medical Center and University of Miami’s Sylvester Comprehensive Cancer Center, in addition to five previously activated sites. The PERIO-01 trial is studying an investigational drug, SD-101, delivered intravascularly by the TriNav Infusion System ("TriNav") using the company’s proprietary Pressure-Enabled Drug Delivery ("PEDD") method of administration. The study is evaluating whether this platform approach with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with uveal melanoma with liver metastases. In addition to these U.S. sites, TriSalus anticipates opening future PERIOTM-01 clinical trial sites in the United Kingdom, Europe, and Canada.

In parallel, TriSalus opened PERIOTM-02 (NCT05220722) trial sites at Columbia University and University of Colorado Denver, along with Rhode Island Hospital – which was announced last month as part of an expanded research collaboration with Lifespan Health System. The PERIOTM-02 trial, expected to add additional sites in 2023, is evaluating whether this same platform approach with SD-101 and PEDD can improve the performance of systemic checkpoint inhibitors in treating patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma.

Both the PERIO-01 and PERIO-02 trials, which were initiated at The University of Texas MD Anderson Cancer Center as part of a multi-year strategic collaboration agreement, are studying the ability of SD-101 delivered by the PEDD method of administration to overcome two major challenges in treating patients with liver and pancreatic tumors: immunosuppression and high intratumoral pressure. These two barriers can limit the delivery and efficacy of therapeutics, such as immunotherapy drugs, from reaching their targets and result in poor outcomes.1-5

TriSalus recently shared initial findings from both clinical studies, which indicate the potential of the company’s therapeutic platform to improve immunotherapy outcomes for patients with liver and pancreatic tumors.

The company has also published promising pre-clinical data in Cancer Gene Therapy6 highlighting the potential of SD-101, a toll-like receptor 9 class C ("TLR9C") agonist, to deplete or favorably reprogram myeloid-derived suppressor cells ("MDSCs") that have been shown to contribute to the limited success of immunotherapy in the liver.7 The lead author was Chandra Gosh, PhD, a biomedical scientist and project leader for TriSalus. Pre-clinical data was also presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 37th Annual Meeting, which indicated that SD-101 has a distinct biologic profile relative to other TLR agonists. The pre-clinical findings align with recently released clinical data which supported the potential that SD-101 may reduce MDSCs in patient liver tumors.8-10

"The expansion of the PERIO-01 and PERIO-02 trials represents meaningful progress for our research program—extending trial access to patients across a broader geographic area and increasing the number of partnerships with leading cancer centers," said Steven C. Katz, MD, FACS, Chief Medical Officer at TriSalus. "Further, our pre-clinical work indicates a solid scientific foundation to inform our approach as we seek to advance immunotherapy treatment options for patients with liver and pancreatic tumors. We look forward to building on this momentum for the PERIO programs."

On December 15, 2022 Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that it submitted a new drug application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for HyBryte (synthetic hypericin) in the treatment of early stage cutaneous T-cell lymphoma (CTCL), a rare cancer and area of unmet medical need affecting over 25,000 patients in the U.S.(Press release, Soligenix, DEC 15, 2022, View Source [SID1234625322]). The Company estimates the potential worldwide market for HyBryte to be in excess of $250 million for the treatment of CTCL.

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"The submission of our NDA is a significant milestone for Soligenix, positioning us well to fulfill our promise to offer an innovative first-in-class therapy to the CTCL community of patients, families and healthcare professionals," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. The clinical results we’ve generated throughout the development program support the potential for HyBryte to serve as an important front-line treatment in the management of this chronic cancer. We look forward to working with the FDA through the review process. As the NDA has been granted both FDA orphan drug and fast track designations, we anticipate potential approval in the second half of 2023 as we continue advancing our preparations for U.S. launch, which is currently targeted for first quarter 2024."

About HyBryte
HyBryte (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The recently published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle, 116 patients received HyBryte treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte treatment in the first cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment groups also revealed a statistically significant improvement (p<0.0001) between the two groups, indicating that continued treatment results in better outcomes. HyBryte continued to be safe and well tolerated. Additional analyses also indicated that HyBryte is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte’s mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

The Phase 3 CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the U.S., with approximately 3,000 new cases seen annually.

On December 15, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it dosed the first patient in its Phase 1b study of R289, an IRAK1/4 dual inhibitor, in patients with lower-risk myelodysplastic syndromes (MDS) who are refractory or resistant to prior therapies (Press release, Rigel, DEC 15, 2022, View Source [SID1234625321]).

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"R289’s dual inhibition of IRAK1 and IRAK4 has the potential to provide a more robust suppression of the pro-inflammatory environment that causes lower-risk MDS by blocking inflammatory cytokine production," said Wolfgang Dummer, M.D., Ph.D., Rigel’s chief medical officer. "The initiation of our Phase 1b study demonstrates our continued ability and commitment to bringing innovative, investigational candidates for hematology-oncology indications into the clinic. We believe R289 may represent a promising new approach to treating patients with lower-risk MDS and look forward to investigating R289 further in this Phase 1b study."

Rigel’s open-label, Phase 1b study of R289 is expected to enroll approximately 22 patients with lower-risk MDS who are refractory or resistant to prior therapies (NCT05308264). The primary objective of the study is safety, with secondary and exploratory objectives to assess preliminary efficacy and characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of R289. The safety and efficacy data from this Phase 1b study, along with the safety and PK/PD data from the completed first-in-human (FIH) study in heathy volunteers, are intended to be used to determine the recommended Phase 2 dose for future clinical development of R289 targeting lower-risk MDS.

About R2891
R289 is a prodrug of R8351, an IRAK1/4 dual inhibitor, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients2.

On December 15, 2022 Philogen reported its attendance at JP Morgan 2023 (Press release, Philogen, DEC 15, 2022, View Source [SID1234625320]).

Prof. Dr. Dario Neri, CEO and CSO of Philogen, and Dr. Emanuele Puca, Investor Relations and Business Development, will be available for meeting to explore novel collaboration opportunities.

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