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bioAffinity Technologies Announces Precision Pathology Services’ Validation of Novel Non-Invasive Early Lung Cancer Test

On September 14, 2021 bioAffinity Technologies, a privately held biotech company advancing innovative cancer diagnostics, reported that Precision Pathology Services, a CAP/CLIA-certified anatomic and clinical pathology laboratory, has fully validated the clinical performance of CyPath Lung, a non-invasive flow cytometric test for early-stage lung cancer (Press release, BioAffinity Technologies, SEP 14, 2021, View Source [SID1234587687]). Precision Pathology licensed bioAffinity’s intellectual property for development of CyPath Lung as a laboratory developed test (LDT).

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"Physician reports can be generated immediately after flow cytometry acquires sample data. Looking beyond lung cancer, we believe our automated platform can be successfully applied to cancer diagnostic tests for several other cancers, which will improve overall survival rates for patients through early diagnosis and treatment."

"We are confident that the validations we have completed and the systems we have implemented will enable high scalability of the CyPath Lung flow cytometry test," said Roby Joyce, MD, President of Precision Pathology. "We will be adding this test to our menu of services in the coming months. This is a very exciting time for us. Lung cancer is the leading cancer killer. Our test for early detection of this dreaded disease can help many people live longer and healthier lives."

Validation of CyPath Lung was conducted in accordance with College of American Pathologists (CAP) guidelines and Clinical Laboratory Improvement Amendments (CLIA) regulations. The CAP/CLIA validation establishes and validates the performance of CyPath Lung, including accuracy, precision, reproducibility and analytical specificity, that are necessary for commercialization. After Precision Pathology adds CyPath Lung to its menu of tests, physicians will be able to order the test for their patients at high risk for lung cancer who receive a positive screening result or are otherwise suspected of having the disease.

"Precision Pathology rightfully enjoys an excellent reputation for quick turnaround times while providing accurate pathology diagnoses. The company is known for its exceptionally responsive and helpful service to the physicians and patients it serves," bioAffinity President and CEO Maria Zannes said. "Dr. Joyce and his team will bring the same very high quality to the commercialization of CyPath Lung. CyPath Lung is in excellent hands."

CyPath Lung is a flow cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home, a particular benefit during the COVID-19 pandemic. The sample is shipped overnight to the laboratory for processing. Sample data is acquired by flow cytometry, a technique that can count, sort and profile individual cells with remarkable speed. Using an automated analysis with pre-set parameters, CyPath Lung profiles the lung environment, including the presence of cancer-associated cells. Data acquisition and physician reports can be generated in minutes.

bioAffinity Technologies recently completed a test validation trial of CyPath Lung evaluating sputum from people at high risk for lung cancer, including patients with the disease and others who were cancer-free. The trial resulted in 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 mm.

The U.S. Preventive Services Task Force recommends that smokers and former smokers at high risk for lung cancer undergo annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be more successfully treated. The National Lung Cancer Screening Trial (NLCST) of more than 53,000 participants resulted in a 20% decrease in lung cancer-specific mortality when LDCT screening was performed in high-risk patients. However, screening by LDCT had a low 3.8% positive predictive value (PPV) which raises the risk of unnecessary, invasive and costly procedures for those who test positive. In the NLCST, for every 100 people who received a positive LDCT, less than four of those individuals actually had lung cancer.

"CyPath Lung can assist physicians in determining next steps after a patient presents with a positive LDCT result, particularly in many cases where the lung nodule is considered indeterminate. In our test validation trial, bioAffinity successfully tested the automated analysis program used by CyPath Lung and found it to be fast and very robust in predicting who has cancer and who was at high risk but did not have lung cancer," Zannes said. "Physician reports can be generated immediately after flow cytometry acquires sample data. Looking beyond lung cancer, we believe our automated platform can be successfully applied to cancer diagnostic tests for several other cancers, which will improve overall survival rates for patients through early diagnosis and treatment."

TumorGen and PhenoVista Join Forces to Illuminate Metastasis

On September 14, 2021 TumorGen Inc., a biotechnology company, and PhenoVista Biosciences LLC, a specialized contract research organization, reported that they are partnering to characterize metastatic cancer cell clusters (MCCCs) (Press release, TumorGen, SEP 14, 2021, View Source [SID1234587686]). By revealing the traits that govern MCCCs, they hope to identify potential therapeutic targets and catalyze efforts to develop much-needed anti-metastatic drugs.

"The analytical imaging power PhenoVista can bring to our MCCC capture technology is essential," said TumorGen Founder, President and CEO, Jeffrey K. Allen, Ph.D. "Working directly with PhenoVista will help leverage our MCCC capture capabilities to identify unseen drug targets. With this data, TumorGen will be well-positioned to begin commercialization efforts and establish partnerships with biopharmaceutical companies focused on emerging anti-metastatic therapeutics."

TumorGen will use its microfluidic platform to capture MCCCs from patient blood. PhenoVista will apply its specialized cell analysis technologies to illuminate how these clusters hold together and avoid the body’s immune response. Revealing these inter-cellular signals will change how we understand metastasis, leading to new therapies.

"Characterizing MCCCs with our high-content imaging technology could reveal the critical inter-cellular communication within the cluster that makes it so deadly," said James Evans, Ph.D., PhenoVista Biosciences CEO. "Illuminating the complex interactions between cancer cells and immune cells, such as macrophages, and neutrophils, will reveal how MCCCs evade immune surveillance and form new tumors."

Metastasis (the spread of malignant cells throughout the body) causes over 90% of cancer deaths. Scientists have known MCCCs drive this spread but have lacked easy methods to investigate these critically important cell clusters. Also significant is that MCCCs contain both cancer and immune cells, thus providing the opportunity to develop cutting-edge therapies based on immuno-oncology which can inhibit metastasis.

"Understanding MCCC cell status, including whether immune cells are tumor suppressive or tumor supportive, is critically important," said Darren Finlay, Ph.D., Director of Tumor Analysis at Sanford Burnham Prebys Medical Discovery Institute, an NCI-Designated Cancer Center. Finlay is co-investigator on TumorGen’s recent SBIR grant from the National Cancer Institute. "These findings could provide huge insights to leverage the immune system to develop first-in-class, anti-metastatic drugs."

Cleveland Diagnostics Presents New Data Supporting the Clinical Validation and Clinical Utility of IsoPSA at the 2021 Annual Meeting of American Urological Association

On September 14, 2021 Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported that Eric Klein, MD, Chairman of the Glickman Urological & Kidney Institute at Cleveland Clinic, delivered two presentations at the annual meeting of the American Urological Association regarding the company’s prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, SEP 14, 2021, View Source [SID1234587685]).

In the first presentation, entitled "IsoPSA: Clinical Performance of a Single Parameter, Structure Based Test for High Grade Prostate Cancer in a Large, Multicenter, Prospective Validation Trial", Dr. Klein provided data used to validate the diagnostic accuracy of the novel, structure-based IsoPSA assay to improve early detection strategies for prostate cancer vs. standard of care PSA and % free PSA tests. In the prospective, multicenter study of 1,093 men IsoPSA showed an AUC of 0.790 for the detection of high grade cancer (Gleason grade group 2 or higher) (vs. 0.674 for PSA and 0.727 for % free PSA). IsoPSA had a sensitivity of 90% for high-grade prostate cancer, and specificity of 47% (compared to 21% for PSA and 14% for % free PSA). Data were consistent and reliable across patients who were biopsy naïve and who had a prior negative biopsy, and IsoPSA maintained its statistical accuracy across a wide range of elevated PSA values (from 4ng/mL to 100ng/mL).

In the second presentation, entitled "IsoPSA Reduces Provider Recommendations for Biopsy and MRI in Men with Total PSA ≥ 4ng/mL: A Real-World Observational Clinical Utility Study", Dr. Klein reported that 38 providers practicing in a variety of clinical settings evaluating 900 patients for prostate cancer substantially altered their behavior and patient management decisions following IsoPSA testing. Provider recommendations for biopsy and MRI were modified post-IsoPSA in 66% of cases in this prospective study, and concordance between IsoPSA results and biopsy recommendations was very high. Overall, IsoPSA test results reduced provider biopsy recommendations by 55% and MRI recommendations by 9%. In twenty cases, biopsies that were recommended after, but not before, IsoPSA testing, led to the detection of additional prostate cancers that would have been missed had it not been for IsoPSA testing.

"The data from these two studies demonstrate that IsoPSA is not only effective at detecting high-grade prostate cancer, but also holds promise to change the diagnostic paradigm, which could result in both improved patient outcomes and reduced costs to the healthcare system," said Eric Klein, MD.

"The real world implications of these findings are important and considerable," added Arnon Chait, PhD, CEO of Cleveland Diagnostics, Inc. "Using IsoPSA, we believe that providers save lives, and save the healthcare system considerable money while doing so. Reducing the number of unnecessary biopsies, increasing biopsy yield, and distinguishing high grade disease risk from low grade or benign disease with an effective blood test will be critical to savings lives, costs, and significantly improve overall patient care."

The 2021 American Urological Association annual meeting was held virtually this year from September 10-13, 2021. More information can be found at www.aua2021.org.

Andes Raises USD 15 Million in Series A Funding Co-Led by Leaps by Bayer and Cavallo Ventures

On September 14, 2021 Leaps by Bayer, the impact investment arm of Bayer AG, reported that it has co-led a USD 15 million Series A investment round in agriculture and biotechnology innovator, Andes, with Cavallo Ventures (Press release, Andes Biotechnologies, SEP 14, 2021, View Source [SID1234587684]). Other new investors Builders VC, Germin8, Accelr8 and Wilson Sonsini participated, alongside existing investors KdT Ventures and Endurance.

Through its novel seed treatment technology, called ‘Microprime’, Andes is reducing the need for synthetic fertilizers. The California-based company has developed a process for seamlessly integrating seeds with a unique library of microbes that colonize the seed’s root structure. This kick-starts a process known as biological nitrogen fixation, enabling the crop to draw down nitrogen from the air instead of relying on synthetic nitrogen fertilizers.

By developing self-sustaining Microprime seeds, Andes reduces the need for synthetic fertilizers, which require huge amounts of energy to produce and account for 3%, or 1.5 gigatons, of global greenhouse emissions. In enabling microbes to ride along with the seeds as they get planted, Andes’ Microprime technology provides a highly scalable solution that saves growers time and money.

The first generation of Microprime treated corn seeds will provide the equivalent of 30 to 50 lbs/acre of nitrogen through biological nitrogen fixation. The company is creating second generation microbes that target doubling the amount of nitrogen provided by the Microprime seeds.

Andes is also developing microbial strains for nature-based permanent carbon capture solutions to sequester and store CO2 from the atmosphere into the soil. This initially focuses on capturing carbon via microbial-powered corn crops. If deployed successfully at scale, it could capture gigaton-levels of carbon from corn and other crops. With the world’s total annual greenhouse gas emissions estimated to be 50 gigatons, nature-based carbon capture could make a sizeable contribution to global decarbonisation.

Agriculture currently consumes 50% of habitable land and 70% of the earth’s fresh water. Andes and Leaps by Bayer are committed to better using these resources through more efficient and sustainable agricultural practices.

Dr. Jürgen Eckhardt, Head of Leaps by Bayer said: "We invest in paradigm-shifting advances that can radically reduce the environmental impact of agriculture. Andes is an exceptional example of that: using novel seed technology to reduce the use of synthetic fertilizers and developing the next generation of agricultural carbon capture solutions. It’s exciting that our funding will help the Andes team scale its current offering and explore the possibilities of truly world-changing technologies like carbon capture."

"We are well past the need for sustainable products and practices. We can only avoid an irreparable climate disaster through solutions that are highly scalable and reliable," Gonzalo Fuenzalida, Andes CEO, explained. "At Andes we are seamlessly integrating the power of microbes within seeds to dramatically cut the need for synthetic fertilizers. This investment will allow us to expand on this success, as well as expand our technology to utilize the millions of acres of agricultural land to capture and store carbon emissions."

Andes will use part of the funds to scale its self-sustaining, nitrogen-fixing seeds across the U.S. market and expand into South America. The balance of funding will be invested to advance further research and development into Andes’ complementary nature-based permanent carbon capture technology.

KSQ Therapeutics Announces First Patient Dosed in Phase 1 Study of KSQ-4279, a First-in-Class USP1 Inhibitor, in Patients with Advanced Solid Tumors

On September 14, 2021 KSQ Therapeutics, a biotechnology company developing drugs to treat cancer and autoimmune diseases using its proprietary, integrated discovery platform to systematically screen the whole genome in cancer and immune cells, reported the initiation of dosing in a Phase 1 clinical study of KSQ-4279, a first-in-class USP1 inhibitor, in patients with advanced solid tumors (Press release, KSQ Therapeutics, SEP 14, 2021, View Source [SID1234587683]).

"This is an important milestone for KSQ as we initiate clinical development of KSQ-4279, a compound that offers great potential for robust and durable anti-tumor activity in a number of cancers," said Qasim Rizvi, Chief Executive Officer of KSQ. "This is also a strong proof point for both our team and our CRISPRomics platform, which quickly enabled us to identify and validate USP1 as a promising target that exploits synthetic lethality in cancers with specific DNA repair defects. This work was part of our broader efforts to run expansive genome-scale screens across both a diverse range of cancer cell lines and multiple immune cell types, including T cells, NK cells, and Tregs. We believe that the insights derived from our platform create tremendous opportunities to develop therapies with curative potential for a wide range of cancers, in particular solid tumors and autoimmune diseases."

"KSQ-4279 showed tumor growth inhibition as a single agent and led to deep and durable tumor regressions when administered in combination with a PARP inhibitor in multiple preclinical tumor models," said Frank Stegmeier, Ph.D., Chief Scientific Officer of KSQ. "Based on these data, we believe that KSQ-4279 has the potential to be an important treatment for many different tumor types. Additional preclinical data indicate combination opportunities beyond PARP inhibitors, which sets KSQ-4279 up as a potential pipeline of treatments within a single molecule."

KSQ-4279 preclinical data highlights:

KSQ-4279 is active as a monotherapy in ovarian PDX models, with tumor regressions observed at doses well below its maximum tolerated dose.
KSQ-4279 activity is seen in cancers that harbor specific defects in homologous recombination (HR), a genetic driver event that is prevalent in several solid tumor types.
The combination of KSQ-4279 with a PARP inhibitor led to more pronounced antitumor activity than either agent alone across multiple ovarian and TNBC PDX models, leading to durable tumor regressions in settings where PARP inhibitors only achieved partial tumor control.
Preclinical safety data indicate that KSQ-4279 is well-tolerated.
KSQ-4279 induces cell cycle arrest and DNA damage leading to apoptosis and cell death in BRCA1 mutant cells.
Functional genomic resistance screens indicate that the major genetic drivers of resistance to USP1 and PARP inhibitors are distinct, indicating that combination treatment may be able to delay or prevent the emergence of resistance.
KSQ utilized its proprietary CRISPRomics platform to identify the deubiquitinating enzyme USP1 as an attractive cancer target with established roles in DNA damage repair processes that are distinct from PARP inhibitors and other approaches currently being tested in the clinic. Potent and highly selective inhibitors of USP1 were developed, and profiling of the clinical development candidate KSQ-4279 across a large collection of tumor models confirmed an enriched response rate in cancers with genetic alterations in BRCA1/2 or other HRD lesions.

This Phase 1 clinical trial is being conducted at five centers in the United States and is expected to enroll approximately 140 patients with advanced solid tumors. It is a dose-escalation and expansion study of KSQ-4279 as a monotherapy and in combinations. The study’s primary endpoint is to assess the safety of KSQ-4279 both alone and in combination, determine the maximum tolerated dose, and establish a recommended Phase 2 dose level. Secondary endpoints include characterizing the pharmacokinetics of KSQ-4279 and evaluating its preliminary antitumor activity both alone and in combination. The trial will also explore potential predictive biomarkers and other genetic factors and their correlation with clinical outcomes.