Proprietary Technology Research Articles

Predicting the sample size of randomized controlled trials using natural language processing.

Extracting the sample size from randomized controlled trials (RCTs) remains a challenge to developing better search functionalities or automating systematic reviews. Most current approaches rely on the sample size being explicitly mentioned in the abstract. The objective of this study was, therefore, to develop and validate additional approaches. 847 RCTs from high-impact medical journals were tagged with 6 different entities that could indicate the sample size. A named entity recognition (NER) model was trained to extract the entities and then deployed on a test set of 150 RCTs. The entities' performance in predicting the actual number of trial participants who were randomized was assessed and possible combinations of the entities were evaluated to create predictive models. The test set was also used to evaluate the performance of GPT-4o on the same task. The most accurate model could make predictions for 64.7% of trials in the test set, and the resulting predictions were equal to the ground truth in 93.8%. GPT-4o was able to make a prediction on 94.7% of trials and the resulting predictions were equal to the ground truth in 90.8%. This study presents an NER model that can extract different entities that can be used to predict the sample size from the abstract of an RCT. The entities can be combined in different ways to obtain models with different characteristics. Training an NER model to predict the sample size from RCTs is feasible. Large language models can deliver similar performance without the need for prior training on the task although at a higher cost due to proprietary technology and/or required computational power.

IMPACT-NSCLC: Innovative machine-learning protocols for accurate clinical biomarker testing in non-small cell lung cancer (NSCLC).

84 Background: Lung cancer is often detected in advanced stages and can benefit from biomarker testing to identify targeted therapeutics. The IMPACT-NSCLC study was designed to identify barriers to equitable biomarker testing for lung cancer patients and develop targeted interventions to help improve biomarker testing rates using a digital personal health record and AI-enabled analysis. Methods: IMPACT-NSCLC unites the O'Neal Comprehensive Cancer Center (UAB) and Novellia, a leading personal health record tool, in a two-part single-institution study of adult NSCLC patients. Novellia uses proprietary technology and AI-enabled services to help patients digitally collect retrospective health records from providers and track health records prospectively, offering researchers a novel method of collecting and evaluating longitudinal health data. Part 1 of the study involves a retrospective study of patients with advanced NSCLC, with advanced data modeling to identify barriers and predictive factors in biomarker testing. Part 2 focuses on developing, implementing, and evaluating targeted interventions based on Part 1’s findings with the goal of improving biomarker testing rates in both academic and community settings. Results: In Part 1, data were collected from 35 patients diagnosed with NSCLC from 2020-2024. Most were white (80.77%) and male (53.84%). Median age was 65 (range 51-79). Most received care at an academic (NCI-designated) cancer center (74.28%). Most were not on commercial insurance plans (85.71%), with the most common form being BCBS/Medicare B and Viva Medicare. Most patients had Stage IV NSCLC (82.85%). More patients received liquid NGS testing at diagnosis (91.42%) than tissue NGS testing at diagnosis (68.57%). Nearly all patients (82.85%) received combination therapy, such as pemetrexed, and pembrolizumab, following biomarker testing. Oncologists initiated treatment while biomarker testing results were pending or incomplete more often in non-academic settings (55.55% of cases) vs. academic settings (26.92%). Conclusions: The pilot analysis found that patients with NSCLC typically received biomarker testing at diagnosis, more often with liquid biopsy. However, oncologists, especially in non-academic settings, often started treatment before full biomarker testing was completed. Comprehensive biomarker testing was frequently not done at progression. Further analysis leveraging machine learning and advanced modeling of Part 1 data may reveal more predictive factors for these variations, guiding interventions in Part 2. Developing a scalable best-practice guide for comprehensive biomarker testing could improve health system efficiencies and outcomes for patients with NSCLC.

SAIL66, a next generation CLDN6-targeting T-cell engager, demonstrates potent antitumor efficacy through dual binding to CD3/CD137

BackgroundOvarian cancer remains a formidable challenge in oncology, necessitating innovative therapeutic approaches. Claudin-6 (CLDN6), a member of the tight junction molecule CLDN family, exhibits negligible expression in healthy tissues but...

Goodwill: concept, features and accounting treatment

The value of a company’s name, brand reputation, loyal customer base, solid customer service, good employee relations, and proprietary technology represent aspects of goodwill. Goodwill arises when businesses are acquired or merged. There are competing approaches among accountants to calculating goodwill. One reason for this is that goodwill involves factoring in estimates of future cash flows and other considerations that are not known at the time of the acquisition. In addition, the question arises: Should goodwill be recognized if the net assets of the acquired entity are negative when the entity is acquired?

Preclinical Evaluation of STI-8811, a Novel Antibody-Drug Conjugate Targeting BCMA for the Treatment of Multiple Myeloma.

Treatment for patients with multiple myeloma has experienced rapid development and improvement in recent years; however, patients continue to experience relapse, and multiple myeloma remains largely incurable. B-cell maturation antigen (BCMA) has been widely recognized as a promising target for treatment of multiple myeloma due to its exclusive expression in B-cell linage cells and its critical role in the growth and survival of malignant plasma cells. Here, we introduce STI-8811, a BCMA-targeting antibody-drug conjugate (ADC) linked to an auristatin-derived duostatin payload via an enzymatically cleavable peptide linker, using our proprietary C-lock technology. STI-8811 exhibits target-specific binding activity and rapid internalization, leading to G2/M cell-cycle arrest, caspase 3/7 activation, and apoptosis in BCMA-expressing tumor cells in vitro. Soluble BCMA (sBCMA) is shed by multiple myeloma cells into the blood and increases with disease progression, competing for ADC binding and reducing its efficacy. We report enhanced cytotoxic activity in the presence of high levels of sBCMA compared with a belantamab mafodotin biosimilar (J6M0-mcMMAF). STI-8811 demonstrated greater in vivo activity than J6M0-mcMMAF in solid and disseminated multiple myeloma models, including tumor models with low BCMA expression and/or in large solid tumors representing soft-tissue plasmacytomas. In cynomolgus monkeys, STI-8811 was well tolerated, with toxicities consistent with other BCMA-targeting ADCs with auristatin payloads in clinical studies. STI-8811 has the potential to outperform current clinical candidates with lower toxicity and higher activity under conditions found in patients with advanced disease. Significance: STI-8811 is a BCMA-targeting ADC carrying a potent auristatin derivative. We report unique binding properties which maintain potent cytotoxic activity under sBCMA-high conditions that hinder the clinical efficacy of current BCMA-targeting ADC candidates. Beyond disseminated models of multiple myeloma, we observed efficacy in solid tumor models of plasmacytomas with low and heterogenous BCMA expressions at a magnitude and duration of response exceeding that of clinical comparators.

Preclinical Characterization of ARX517, a Site-specific Stable PSMA-Targeted Antibody Drug Conjugate for Treatment of Metastatic Castration-Resistant Prostate Cancer.

Metastatic castration-resistant prostate cancer (mCRPC) is an advanced disease in which patients ultimately fail standard of care androgen-deprivation therapies and exhibit poor survival rates. The prostate-specific membrane antigen (PSMA) has been validated as a mCRPC tumor antigen with over-expression in tumors and low expression in healthy tissues. Using our proprietary technology for incorporating synthetic amino acids (SAAs) into proteins at selected sites, we have developed ARX517, an antibody drug conjugate (ADC) which is composed of a humanized anti-PSMA antibody site-specifically conjugated to a tubulin inhibitor at a drug-to-antibody ratio of 2. After binding PSMA, ARX517 is internalized and catabolized, leading to cytotoxic payload delivery and apoptosis. To minimize premature payload release and maximize delivery to tumor cells, ARX517 employs a non-cleavable PEG linker and stable oxime conjugation enabled via SAA protein incorporation to ensure its overall stability. In vitro studies demonstrate that ARX517 selectively induces cytotoxicity of PSMA-expressing tumor cell lines. ARX517 exhibited a long terminal half-life and high serum exposure in mice, and dose-dependent anti-tumor activity in both enzalutamide-sensitive and -resistant CDX and PDX prostate cancer models. Repeat dose toxicokinetic studies in non-human primates demonstrated ARX517 was tolerated at exposures well above therapeutic exposures in mouse pharmacology studies, indicating a wide therapeutic index. In summary, ARX517 inhibited tumor growth in diverse mCRPC models, demonstrated a tolerable safety profile in monkeys, and had a wide therapeutic index based on preclinical exposure data. Based on the encouraging preclinical data, ARX517 is currently being evaluated in a Phase 1 clinical trial ([NCT04662580]).

EHerbarium: A Global Platform for Exploring and Sharing Herbarium and Live Plant Images to Enhance Biodiversity Preservation

Historically, herbaria have been instrumental in preserving and studying plant biodiversity. The widespread use of smartphones has led to a surge in the digital documentation of plants. Over the last decade, herbarium digitizing projects are also underway. Many of the digitized herbarium images are available online through different portals. The examples of these portals include Kew Gardens and New York Botanic Garden Herbarium. Combining the latest mobile, cloud and AI technologies as well as plant taxonomy and herbarium artifacts, the mission of eHerbarium*1 is to provide an accessible digital platform for plant enthusiasts, including botanists, researchers, students, as well as the general public around the world, to collect, identify and share live plant and herbarium images. It promotes data collection and data sharing around the globe for biodiversity preservation. It further provides educational benefits about plants and the plant biodiversity around us and the world. eHerbarium offers access to an extensive collection of herbarium images from Kew’s Herbarium at the Royal Botanic Gardens, Kew. The platform is also extensible, allowing it to host images from other herbaria. In addition, this platform provides high-quality botanical visuals, enabling users to capture and share live plant photos or herbarium images, or upload from existing collections. Customizable licensing options facilitate community use and enhance collaborative botanical research. The platform’s AI-powered tools streamline plant identification, offering autocomplete suggestions for taxonomy details such as scientific name, family name or common names. Our proprietary technology ensures seamless and accurate botanical data entry by automatically retrieving corresponding scientific or common names. Additionally, eHerbarium enriches botanical records by automatically associating image locations with Biodiversity Information Standards (TDWG) Level 2 regions. TDWG Level 2 regions are specific geographical areas defined by TDWG to standardize the recording and reporting of biodiversity data. These regions, which typically correspond to large countries or significant subnational areas, help ensure consistent and accurate geographical referencing in botanical studies and herbarium records, while also respecting image owners' location privacy. eHerbarium has more than 40,000 worldwide downloads since its debut less than six months ago on March 18, 2024. We encourage further collaborations to expand our repositories for herbarium and live plant images. We also welcome partnerships to tailor the application to specific needs for natural history and biodiversity data collection.

OS Therapies to Develop ‘Tunable’ ADCs

OS Therapies is advancing a next-generation antibody-drug conjugate (ADC) technology platform, known as tunable ADCs (tADCs), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the company’s proprietary silicone linker technology, enabling the delivery of multiple payloads per linker.

Enhanced Immune Responses in Mice by Combining the Mpox Virus B6R-Protein and Aluminum Hydroxide-CpG Vaccine Adjuvants.

Novel adjuvants and innovative combinations of adjuvants (Adjuvant Systems) have facilitated the development of enhanced and new vaccines against re-emerging and challenging pathogenic microorganisms. Nonetheless, the efficacy of adjuvants is influenced by various factors, and the same adjuvant may generate entirely different immune responses when paired with different antigens. Herein, we combined the MPXV-B6R antigen with BC02, a novel adjuvant with proprietary technology, to assess its capability to induce both cellular and humoral immunity in mouse models. Mice received two intramuscular injections of B6R-BC02, which resulted in the production of MPXV-specific IgG, IgG1, and IgG2a antibodies. Additionally, it elicited strong MPXV-specific Th1-oriented cellular immunity and persistent effector memory B-cell responses. The advantages of BC02 were further validated, including rapid initiation of the immune response, robust recall memory, and sustained immune response induction. Although the potential of immunized mice to produce serum-neutralizing antibodies against the vaccinia virus requires further improvement, the exceptional performance of BC02 as an adjuvant for the MPXV-B6R antigen has been consistently demonstrated.

A Transformative Technology Linking Patient’s mRNA Expression Profile to Anticancer Drug Efficacy

As precision medicine such as targeted therapy and immunotherapy often have limited accessibility, low response rate, and evolved resistance, it is urgent to develop simple, low-cost, and quick-turnaround personalized diagnostic technologies for drug response prediction with high sensitivity, speed, and accuracy. The major challenges of drug response prediction strategies employing digital database modeling are the scarcity of labeled clinical data, applicability only to a few classes of drugs, and losing the resolution at the individual patient level. Although these challenges have been partially addressed by large-scale cancer cell line datasets and more patient-relevant cell-based systems, the integration of different data types and data translation from pre-clinical to clinical utilities are still far-fetched. To overcome the current limitations of precision medicine with a clinically proven drug response prediction assay, we have developed an innovative and proprietary technology based on in vitro patient testing and in silico data analytics. First, a patient-derived gene expression signature was established via the transcriptomic profiling of cell-free mRNA (cfmRNA) from the patient’s blood. Second, a gene-to-drug data fusion and overlaying mechanism to transfer data were performed. Finally, a semi-supervised method was used for the database searching, matching, annotation, and ranking of drug efficacies from a pool of ~700 approved, investigational, or clinical trial drug candidates. A personalized drug response report can be delivered to inform clinical decisions within a week. The PGA (patient-derived gene expression-informed anticancer drug efficacy) test has significantly improved patient outcomes when compared to the treatment plans without PGA support. The implementation of PGA, which combines patient-unique cfmRNA fingerprints with drug mapping power, has the potential to identify treatment options when patients are no longer responding to therapy and when standard-of-care is exhausted.

Safety evaluation of LIMAN technology based curcumin formulation through single dose and repeated dose administration in rodents and rabbits

Curcumin is well known for its diverse health benefits based on the traditional and current scientific evidence. The aim of the present study was to evaluate the safety of Maxicuma® made by using proprietary LIMAN technology that involves encapsulation of 40% curcuminoids with lipid matrix. The safety profile was studied with single dose and repeated dose oral administration of Maxicuma® in both rodents and non-rodents. The toxicity study was conducted at a range of 0.5 to 10 gm curcumin equivalent to human dose per day. None of the tested doses in any of the species produced treatment related clinical signs of toxicity with respect to haematology and blood chemistry parameters and mortality. Moreover gross and histopathological findings did not show any remarkable and treatment related changes. The treated animals exhibited normal weight gain and comparable feed intake. Based on the obtained results Maxicuma® up to 220 mg/kg oral dose could be considered as safe, tolerated and no observed adverse effect level (NOAEL) dose in rabbits.

End-to-End No-wait Scheduling for Time-Triggered Streams in Mixed Wired-Wireless Networks

Proprietary communication technologies for time-critical communication in industrial environments are being gradually replaced by Time-sensitive Networking (TSN)-enabled Ethernet. Furthermore, attempts have been made to bring TSN features into wireless networks so that the flexibility of wireless networks can be utilized, and the end-to-end timings for Time-Triggered (TT) streams can be guaranteed. Given a mixed wired-wireless network, the scheduling problem should be solved for a set of TT stream requests. In this paper, we formulate the no-wait scheduling problem for mixed wired-wireless networks as a Mixed Integer Linear Programming (MILP) model with the objective of minimizing the flowspan. We also propose a relaxation of the original MILP in the form of a 2-stage MILP formulation. Next, a scalable approach based on the greedy heuristic is proposed to solve the problem for realistic-size networks. Evaluation results show that the greedy heuristic is suitable for realistic problem sizes where the MILP-based approach is found to be practically infeasible. Furthermore, the impact of wireless requests on the performance of the greedy heuristic is reported.

Authorized Redundant Check Support in a Hybrid Cloud Environment

A hybrid cloud is made up of public and private clouds connected by standardized or proprietary technologies to provide data and application mobility. The deduplication with uneven privileges issue in cloud computing is addressed efficiently. an architecture for a hybrid cloud that employs both public and private clouds, with the data owners only using the public cloud for storage and the private cloud for data administration. To make data management in cloud computing scalable, duplication has lately become a commonly employed method. Deduplication reduces the amount of bandwidth you need, speeds up data transfers, and keeps your need for cloud storage to a minimum. To enable authorized duplicate checks in hybrid cloud architecture, the proposed system comprises a variety of new deduplication structures. Data confidentiality was protected before outsourcing by employing the convergent encryption method. A system authorized to use deduplication supports differential authorization duplicate checks. In the authorized duplication check approach, testbed tests are carried out using a prototype as proof of concept.

A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial

BackgroundSirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising. ObjectivesThe authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population. MethodsThis multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data. ResultsThe mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13). ConclusionsThe SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.

Clinical validation of Northstar Select, a novel liquid biopsy assay for comprehensive genomic profiling of solid tumors.

3072 Background: Comprehensive Genomic Profiling (CGP) liquid biopsy tests are vital tools for oncologists that enable the non-invasive detection of diverse somatic mutations, many of which correspond to targeted therapies, in circulating tumor DNA (ctDNA). However, these tests have less utility when ctDNA signal is low, which is common even in late-stage cancer patients. BillionToOne’s Northstar (NS) Select assay is a novel CGP test that seeks to leverage proprietary technology and novel calling algorithms to address this limitation by achieving higher sensitivity. Methods: Clinical samples for 182 unique patients with stage III or IV solid tumors were obtained via a prospective validation study assessing head-to-head concordance with widely adopted, commercially available ‘comparator’ liquid biopsy CGP assays. The study cohort was recruited from 1 large hospital center and 6 community clinics across the US and was diverse in patient demographics and clinical presentations. Over 15 different cancer types were represented in the cohort, with the majority of patients having either Lung, Breast, Colorectal, or Prostate cancer, all of which are commonly tested using liquid biopsies in the US. Pathogenic (including likely pathogenic) variants called by NS Select and/or the comparator assay were analyzed for concordance. For a subset of samples (N=28), white blood cell-derived genomic DNA was also processed to identify which variants were detected due to clonal hematopoiesis of indeterminate potential (CHIP). Results: In the head-to-head comparison, a large number of variants (N=380) were concordant between the two assays. In addition, NS Select detected 43% (N=147) more pathogenic variants than comparators when controlling for matched coverage regions. The majority of these variants were detected below the reported limit of detection of the comparator assays, but above the limit of detection of NS Select. The rate of CHIP mutations was not significantly different in the variants detected by NS Select (19.0% ± 7.6%) vs. comparators (17.2% ± 9.2%). Finally, the proportion of patients with no pathogenic variants detected was shown to be lower by 45% when using NS Select vs. the comparator assays (20/182 vs. 36/182). Conclusions: NS Select reported clinically useful information about the tumor for most patients. For patients in which ctDNA signal was high, NS Select had very high concordance with comparator tests. Furthermore, additional low-VAF pathogenic mutations identified by NS Select translated to a higher diagnostic yield compared to other CGP assays, and CHIP was ruled out as an explanation for these additional detections. This suggests that some patients with low levels of ctDNA would derive clinical benefit from testing with NS Select due to its high sensitivity.

An Extensive Review on Gas Hydrates: Recent Patents, Properties, Formation, Detection, Production, Importance, and Challenges

Introduction:: Gas Hydrates, or Clathrate Hydrates, have been the subject of increasing scientific and industrial attention due to their potential as an alternative energy source, their role in climate change, and their association with geohazards. The growth of new indigenous gas supply sources could impart a significant positive ripple effect on a country's economy, ecological balance, and energy landscape. This burgeoning interest has led to a surge in research and development, resulting in numerous patents related to the extraction, processing, and utilization of gas Hydrates. Objectives:: This review paper aims to provide an up-to-date, comprehensive overview of the properties, formation, detection, production, importance, challenges, and patent landscape of Gas hydrates. The integration of patented technologies into the field underscores the importance of intellectual property in shaping the future of energy, environment, and economic development. Methods:: Patented technologies in this field are contributing to making this resource more accessible and commercially viable. Moreover, the development of gas hydrates as an energy source could act as a safeguard for manufacturing jobs that are sensitive to gas prices, with proprietary technologies enhancing the efficiency and sustainability of the production process. Results:: On the environmental front, an uptick in the consumption of natural gas, known for its cleaner combustion, could herald positive change. Patented innovations in clean and efficient extraction and utilization methods for Gas Hydrates are instrumental in reducing the environmental impact. From the standpoint of energy security, a larger domestic slice of the energy pie, complemented by an extensive array of gas supply alternatives, could equip the nation to better navigate the unpredictable terrain of future energy scenarios. Conclusion:: The strategic patenting of key technologies in the exploration, production, and application of Gas Hydrates ensures competitive advantage and fosters innovation, driving forward the energy industry's evolution.

The Right Formula for Acne: Importance of Vehicle Formulation in Tazarotene 0.045% Lotion Design, Application, Tolerability, and Efficacy

The vehicles used for topical dermatological treatments can significantly contribute to treatment effects while also delivering ingredients to maintain skin barrier function and reduce irritation. Tazarotene 0.045% lotion was developed using proprietary polymeric emulsion technology to provide uniform and efficient delivery of the active ingredient as well as improved safety and tolerability compared to higher-dose tazarotene formulations. The lotion vehicle additionally provides rapid and sustained improvements in moisturization and skin barrier function with patient-friendly application and cosmetic properties. Compared with trifarotene 0.005% cream, tazarotene 0.045% lotion demonstrated ∼30% greater spreadability and a lower potential for irritation. In clinical trials and investigator-initiated studies, tazarotene 0.045% lotion demonstrated efficacy in the treatment of facial and truncal acne and improved skin oiliness. Facial acne improvements were similar among study participants grouped by sex, race, ethnicity, or age. In a head-to-head study, efficacy was comparable to tazarotene 0.1% cream with approximately half the rate of treatment-emergent adverse events. Tazarotene 0.045% lotion is a beneficial acne treatment option for patients of varying ages, races, ethnicities, and skin types, delivered in a formulation that can be easily used on the face, back, and chest.

Abstract PO1-05-08: Enhanced ER+ tumor growth inhibition of fulvestrant from effective oral delivery yielding elevated plasma concentrations

Abstract Fulvestrant has been a backbone of endocrine therapy (ET) for ER+/HER2- metastatic breast cancer (mBC) for over 20 years due to its nanomolar potency, purely antagonistic behavior, and well-tolerated adverse event (AE) profile. It remains the only selective estrogen receptor degrader (SERD) approved in ER+/HER2- mBC regardless of ESR1 mutation status. While ESR1 mutations reduce fulvestrant binding affinity, they do not implicitly lead to acquired resistance as with aromatase inhibitors (AIs) and can be overcome by increasing exposure.1 Further, preclinical evidence suggests that higher exposure to fulvestrant correlates with higher efficacy in rodents.2 Unfortunately, fulvestrant is currently delivered at its maximum feasible dose due to its poor solubility and a lack of effective drug delivery technologies. In response, several novel oral SERDs have been brought into clinical development to improve upon the efficacy of fulvestrant. However, multiple have failed to prove superior to fulvestrant in its intramuscular (IM) injection formulation and improvements from elacestrant (EMERALD) and camizestrant (SERENA-2) are largely attributed to patients with ESR1 mutations after prior ETs. Therefore, enabling higher exposure of fulvestrant could prolong progression-free survival and improve quality of life for ET-naïve mBC patients and those that have progressed on ETs. VeraMorph has leveraged a proprietary oral drug delivery technology to overcome the limitations of fulvestrant’s poor solubility and potentially help mitigate acquired resistance by improving exposure via daily oral dosing. The oral dosages, which consist of a novel polymer-based soft gummy, stabilize fulvestrant in simulated intestinal media up to 5 mg/mL without influencing fulvestrant permeability or causing cytotoxic effects. Pharmacokinetic (PK) studies of oral fulvestrant in rodents have demonstrated maximum plasma concentrations up to 450 ng/mL, a level roughly 20 times that of the average exposure from the monthly IM formulation in clinical settings. PK studies also demonstrated that oral exposure increased with a roughly dose-proportional relationship, with a reduction in AUC from day 1 to day 8 upon repeat dosing. In a cell-derived xenograft (CDX) study utilizing ER+ MCF-7 tumors implanted in athymic nude mice, once daily dosing via oral gavage of oral fulvestrant at 125 mg/kg was able to achieve a statistically significant 55% reduction in tumor growth by day 42 relative to a 50 mg/kg dose of the IM formulation delivered subcutaneously once per week, which was determined to create an equivalent exposure to the monthly IM human dose in separate studies. Oral fulvestrant yielded no observed adverse effects up to 125 mg/kg in both the 42-day CDX study in mice or an 8-day safety study in rats. Further, onset of action and acquired resistance are being tested by monitoring cell viability (via the MTT assay) with MCF-7 cells exposed to time profiles of fulvestrant exposure resembling oral and monthly intramuscular delivery. The study demonstrated that oral dosing reaches minimal cell viability 1-2 weeks faster than IM dosing. Also, preliminary data suggests that the onset of acquired resistance (as demonstrated by a resumption of cell growth) may occur faster from the steady exposure of IM dosing relative to the modulation of daily oral dosing. These results suggest that oral fulvestrant has the potential to finally realize the full potential of fulvestrant as an effective ET for metastatic breast cancer with a well-tolerated AE profile, enhanced efficacy, and reduced susceptibility to acquired resistance with applicability across all mBC patients. 1 Brett JO, Spring LM, Bardia A, Wander SA (2021) Breast Cancer Research, 23(1):1–15. 2 Wardell SE, et. al. (2020) Breast Cancer Research and Treatment, 179(1):67–77. Citation Format: Doug Godfrin, Matthew Butchbach. Enhanced ER+ tumor growth inhibition of fulvestrant from effective oral delivery yielding elevated plasma concentrations [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-05-08.

Drone-Assisted Particulate Matter Measurement in Air Monitoring: A Patent Review

Air pollution is caused by the presence of polluting elements. Ozone (O3), carbon monoxide (CO), carbon dioxide (CO2), nitrogen dioxide (NO2), sulfur dioxide (SO2), and particulate matter (PM) are the most controlled gasses because they can be released into the atmosphere naturally or as a result of human activity, which affects air quality and causes disease and premature death in exposed people. Depending on the substance being measured, ambient air monitors have different types of air quality sensors. In recent years, there has been a growing interest in designing drones as mobile sensors for monitoring air pollution. Therefore, the objective of this paper is to provide a comprehensive patent review to gain insight into the proprietary technologies currently used in drones used to monitor outdoor air pollution. Patent searches were conducted using three different patent search engines: Google Patents, WIPO’s Patentscope, and the United States Patent and Trademark Office (USPTO). The analysis of each patent consists of extracting data that supply information regarding the type of drone, sensor, or equipment for measuring PM, the lack or presence of a cyclone separator, and the ability to process the turbulence generated by the drone’s propellers. A total of 1473 patent documents were retrieved using the search engine. However, only 13 met the inclusion criteria, including patent documents reporting drone designs for outdoor air pollution monitoring. Therefore, was found that most patents fall under class G01N (measurement; testing) according to the International Patents Classification, where the most common sensors and devices are infrared or visible light cameras, cleaning devices, and GPS tracking devices. The most common tasks performed by drones are air pollution monitoring, assessment, and control. These categories cover different aspects of the air pollution management cycle and are essential to effectively address this environmental problem.

Assessment of Yield and Quality of Eggplant (Solanum melongena L.) Fruits Improved by Biodegradable Mulching Film in Two Different Regions of Southern Italy

Low-density polyethylene (LDPE) mulching films have an important function in crop cultivation; at the end of their life, however, their removal and disposal become both an economic and environmental problem. One possible alternative to low-density polyethylene (LDPE) mulch is provided by certified soil-biodegradable mulch films, such as those produced by Novamont and commercially available under the trade name MaterBi®. MaterBi is a biodegradable thermoplastic material made with starch and a biodegradable copolyester based on proprietary technology. In this study, we compared two biodegradable MaterBi®-based films (commercial and experimental films) with bare soil and a low-density polyethylene to evaluate their effect on yield and on a number of qualitative characteristics (organoleptic and nutraceutical composition) of eggplant fruits (cv Mirabelle F1) grown in two different regions in Southern Italy (Sicily and Campania). In our study, the use of biodegradable MaterBi® films improved not only yield and production parameters, such as the number and average weight of fruits, but also lipophilic and hydrophilic antioxidant activity and phenolic and ascorbic acid content. For many parameters, responses differed according to the cultivation environment and, in particular, the site’s pedoclimatic conditions. Our results suggest that biodegradable MaterBi®-based mulching films are a potentially valid alternative to traditional LDPEs, providing the production and quality benefits reported above and promoting environmental sustainability, thanks to their positive biodegradable properties.