On September 4, 2022 Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, reported the launch and roll-out of Galen 3.0, a transformative solution offering new detection capabilities and a broad set of features to support pathologists in the diagnosis of multiple tissue types across various digital pathology workflows (Press release, Ibex Medical Analytics, SEP 4, 2022, View Source [SID1234618976]). Galen 3.0 is CE-Marked, approved in additional countries and now generally available to Ibex customers.

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Creating a new modality for cancer diagnosis, Galen is the first and most widely deployed AI technology in pathology and used in routine clinical practice at laboratories, hospitals, and health systems worldwide. Galen supports pathologists across numerous diagnostic tasks during the review of breast, prostate, and gastric biopsies and helps improve the quality of cancer diagnosis, reduce turnaround time, boost productivity and improve user experience for pathologists. Galen demonstrated outstanding outcomes across clinical studies performed in multiple pathology labs and diagnostic workflows1,2,3,4,5.

Galen 3.0 incorporates the very latest evolution of Ibex’s AI algorithms for detecting cancer and other clinically relevant features in prostate, breast, and gastric biopsies. To ensure very high accuracy and generalizability, Ibex trained the Deep Learning networks on huge, enriched data sets from laboratories worldwide that were digitized by multiple scanning systems, including rare prostatic malignancies such as intraductal carcinoma, neuroendocrine tumor, colorectal adenocarcinoma, lymphoma, and urothelial carcinoma. Galen also calculates a Gleason score, tumor size and percentage for each cancer slide, potentially enabling pathologists to save review time and reduce subjectivity.

"With an estimated 1.9 million new cancer cases diagnosed in the United States alone this year, we are excited to bring Galen 3.0 to pathology labs worldwide, providing clinically validated, automated decision-support tools that help pathologists diagnose cancer more rapidly and more accurately to support the high demand," said Issar Yazbin, Vice President of Product Management at Ibex. "Keeping our customers’ needs central to our research and development, we are proud to deploy Galen 3.0, bringing enhanced detection capabilities, improved user experience, increased interoperability tools and ease of implementation into existing clinical workflows."

Galen 3.0 features an open API (Application Programming Interface) accelerating interoperability and seamless integration with image management solutions, lab information systems and digital pathology workflow solutions. The Ibex API is already used in multiple collaborations between Ibex and leading digital pathology partners where Ibex’s AI findings are seamlessly integrated to the partners’ solutions. Version 3.0 also includes new customizable reporting modules, enabling every customer site to tailor the slide and case reports according to their own needs.

Ibex Medical Analytics presents at the European Congress of Pathology which takes place in Basel, Switzerland, between September 3-7 (booth no. 1).

On September 3, 2022 Yingli Pharma (the "Company" or "Yingli"), a clinical stage biotechnology company developing oral small molecule drugs for cancers with high unmet need, reported that the first patient has been dosed in a Phase 2 trial evaluating linperlisib, a potent inhibitor of the delta isoform of PI3 kinase (PI3Kδ) in patients with relapsed/refractory peripheral T/NK cell lymphoma (r/r PTCL) (Press release, Yingli Pharmaceutical, SEP 3, 2022, View Source [SID1234618977]).

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This single arm study will evaluate the safety, efficacy and pharmacokinetics of orally administered linperlisib under a strategic collaboration with The University of Texas MD Anderson Cancer Center. Additional trial sites will include medical centers in the United States and Italy.

"We are pleased to commence this study of linperlisib in the United States in patients suffering from advanced PTCL," said Michael Hui, MBA, chief executive officer of Yingli. "Linperlisib is a next generation inhibitor of PI3Kδ with enhanced selectivity and potency to offer strong anti-tumor effect while minimizing potential adverse reactions. We are encouraged by the safety and preliminary efficacy data obtained in Phase 1 dose-finding studies in China and look forward to further evaluating linperlisib’s potential in this Phase 2 study."

"Patients living with advanced PTCL, an aggressive type of lymphoma, face limited treatment options and most do not respond or stop responding to available therapies. Linperlisib may provide a solution for these patients who need an expanded treatment armamentarium, and we’re excited to continue studying the drug’s potential as we start the Phase 2 study."

Linperlisib, a convenient once daily oral drug, is a small molecule inhibitor of PI3Kδ, a validated target in lymphomas due to its critical role in cell proliferation and survival. This Phase 2 (NCT05274997), single arm, open-label trial will evaluate the safety, efficacy and pharmacokinetic properties of linperlisib monotherapy in adult patients with r/r PTCL who have failed at least one prior line of systemic therapy. Enrolled participants will receive linperlisib 80mg once daily orally in a 28-day cycle. The primary outcome is overall response rate to treatment. Secondary outcomes include duration of response, overall survival, progression-free survival, adverse effects and pharmacokinetics parameters. An estimated 97 patients will be enrolled in the study.

About Linperlisib

Linperlisib (YY-20394) is a highly selective and potent PI3Kδ inhibitor that has shown a favorable safety profile, encouraging anti-tumor activities and promising PK and pharmaceutical properties as an oral once-a-day agent in late-stage clinical development. A Phase 1 clinical trial was completed in 2020 demonstrating linperlisib to be a safe and tolerable agent, and a recommended Phase 2 dose of 80 mg QD was established. Linperlisib was awarded NMPA Breakthrough Therapy status in China, leading to a Phase 2 study in follicular lymphoma (FL) that was completed and submitted in 2021 to China marketing authority for approval. In addition, linperlisib received FDA Orphan Drug Designations for FL, CLL/SLL and T cell lymphoma. Multiple linperlisib clinical trials in FL, PTCL, other lymphomas, solid tumors, combination with gemcitabine/oxaliplatin in r/r DLBC and combination with therapeutic PD1 antibody are underway in China. Preliminary results of single agent linperlisib from a relapsed or recurrent PTCL Phase1b study were reported at ASCO (Free ASCO Whitepaper) 2021, indicating an overall response rate of 70% with 33% CRs for this difficult to treat and aggressive form of lymphoma.

On September 2, 2022 The National Institute of General Medical Sciences (NIGMS) reported that has awarded $1,729,532.72 to Collaborations Pharmaceuticals, Inc. (CPI) and the University of Arizona to generate in vitro data and develop MegaTransÒ machine learning software for drug discovery (Press release, Collaborations Pharmaceuticals, SEP 2, 2022, View Source [SID1234618941]).

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"The objective of MegaTrans is to develop a new computational system and tools for integrating human transporter data into drug discovery pipelines, as well as enabling its analysis and visualization. It will also assist with developing computational tools for quantitatively modeling drug-drug interactions of xenobiotics. We will generate data for transporters which currently have a paucity of data in the public domain, use validated machine learning algorithms, access the latest curated datasets and develop a user-intuitive interface and visualization system to enable predictions. MegaTrans will be developed as commercial quality software and then commercialized by licensing to companies, as well as used in fee-for-service consulting projects. In Phase I of this project, we have collaborated with Dr. Steven Wright and Dr. Nathan Cherrington at the University of Arizona to generate numerous models for important human drug transporters. CPI have also developed the prototype for MegaTransÒ, curating numerous transporter datasets then generating and tested the resulting models. This Phase II award will allow us to perform additional in vitro testing (at the University of Arizona) to expand our models and develop MegaTransÒ further as a commercial product available for licensing by pharmaceutical and other groups so they can benefit from our expertise." said Sean Ekins, CEO, CPI.

Drs. Stephen Wright and Nathan Cherrington of the University of Arizona are long-term collaborators with Collaborations Pharmaceuticals, Inc. This joint effort builds upon extensive experience and extends the mechanistic understanding of drug disposition to the whole patient by accurately predicting functional disposition. This collaboration is now poised at the forefront of understanding xenobiotic disposition and predicting the mechanistic features that determine human exposure and response to drugs.

We are not aware of any other company pursuing such an approach to both generate new high value datasets or models, performing testing of their own models and creating a wide array of transporter models. MegaTrans can be applied in these various companies or organizations to aid in decision making or in regulatory submissions.

On September 2, 2022 Artificial intelligence (AI) biotech company Owkin reported that two first-in-class rapid, affordable AI-based diagnostic solutions designed to improve outcomes for patients with breast cancer and colorectal cancer have been approved for use in Europe (Press release, Owkin, SEP 2, 2022, https://www.fiercebiotech.com/medtech/owkins-ai-identify-breast-colorectal-cancers-scores-eu-approval [SID1234619036]).

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Owkin Dx RlapsRisk BC and Owkin Dx MSIntuit CRC have received CE-IVD approval for diagnostic use in the European Union. By using AI to analyze digital pathology images, they are designed to help clinicians make precision medicine – diagnostic and treatment based on a patient’s individual characteristics – more accessible to more patients at an earlier stage of their disease.

RlapsRisk BC is the first CE-IVD approved digital pathology-based AI diagnostic that predicts the risk that early breast cancer patients will relapse. MSIntuit CRC is the first CE-IVD approved AI solution that enables the identification of microsatellite stable (MSS) patients from routine histology slides, enabling a significant reduction in time and the number of diagnostic tests for detecting MSI in clinical practice.

These are the first approved diagnostics products developed by Owkin, which aims to develop more biomarker pre-screening and outcome prediction diagnostics across a range of disease areas. Owkin’s mission is to join patient care with medical research to discover new mechanisms of diseases and derive better treatments for unmet medical needs.

Meriem Sefta, Chief Diagnostics Officer at Owkin, said:

Our mission is to use AI to find the right treatment for every patient. Novel drugs allow us to personalize treatments to patients’ individual disease characteristics, promising a new era of precision medicine. But one roadblock that doctors face is finding these patients rapidly, accurately and efficiently.

Our first approved diagnostic solutions could help millions of patients with breast or colorectal cancer to receive the therapies they need sooner. This is a crucial moment in Owkin’s mission to use AI to better understand diseases and develop more accurate diagnostics and treatments for patients.

Owkin Dx RlapsRisk BC

RlapsRisk BC is an AI prognostic solution that predicts whether a breast cancer patient (ER+/HER2-) will go on to relapse after treatment, informing oncologists which high-risk patients may benefit from targeted therapies and which low-risk patients could potentially avoid chemotherapy.

The solution aims to revolutionize breast cancer care management by using AI to assess the risk of relapse after treatment from digital images of tissue samples. Currently, breast cancer patients at risk of relapse are identified through expensive, time-consuming molecular or genetic testing. RlapsRisk BC offers doctors a way to identify patients at risk of relapsing by using AI on digital pathology data that will already be held on nearly all breast cancer patients in around 15 minutes.

Dr Magali Lacroix-Triki, MD, PhD, an expert breast pathologist at the Department of Medical Biology and Pathology, Institut Gustave Roussy, Paris, said:

Owkin’s RlapsRisk BC enables pathologists to provide oncologists and patients with insights on the risk of relapse, crucial information for the treatment decision-making to avoid unnecessary chemotherapy. Thanks to RlapsRisk, HER2-, ER+ patients will benefit from an automated and accurate prognosis test using just a simple, standard-stained tumor slide.

AI-based digital pathology diagnostics could help us to provide a comprehensive analysis of each tumor from just one representative standard-stained tumor slide, in a complementary process to the pathologist’ diagnosis. This would democratize access to precision medicine, unlocking a new era of treatment for patients across the world.

Caption: RlapsRisk BC provides an interpretability report to the pathologist with a risk score, derived from the most predictive regions of the histology slide. Image shown may represent the range of the product, or be for illustration purposes only and may not be an exact representation of the product.

It offers comparable performance to standard molecular testing, yet uses far more readily-accessible data, reducing turnaround time and democratizing access to precision medicine.

RlapsRisk BC was developed with Gustave Roussy after winning the 2019 "AI for Health” challenge grant from Region Île de France. Its corresponding research has been presented at ESMO (Free ESMO Whitepaper) 2021 and USCAP 2022.

Owkin Dx MSIntuit CRC

MSIntuit CRC is an AI digital pathology diagnostic solution that pre-screens for a biomarker in colorectal cancer tumors known as microsatellite instability (MSI) – a defect in a cell’s ability to correct mistakes that occur when DNA is copied. This diagnostic rules out microsatellite stable (MSS) phenotypes, allowing pathologists to concentrate their resources on confirming those patients who exhibit MSI.

By using an AI model to analyze digital images of tissue samples, doctors are able to more efficiently screen patients when compared to standard testing techniques, which include time and patient tissue sample-consuming polymerase chain reaction (PCR) testing or immunohistochemistry.

Professor Magali Svrcek, MD, PhD, Sorbonne Université, AP-HP, Saint-Antoine Hospital, Department of Pathology, Paris, said:

As colorectal cancer is the third most common cancer in the world, it is crucial that we are able to screen patients for biomarkers that make them eligible for potentially lifesaving treatments. dMMR/MSI screening should be performed on all colorectal cancer patients, but pathologists’ time and resources are often too stretched.

Owkin’s new AI diagnostic solution MSIntuit CRC will roughly half the number of cases requiring screening. It is designed to help more patients receive treatment sooner. AI-based digital pathology algorithms like these, developed in consultation with pathologists, will soon become an integral part of our daily practice. They will help patients to benefit from the best treatment for them sooner – a new era of personalized medicine.

Patients with MSI-high tumors are eligible for treatment with the novel immunotherapy drug pembrolizumab, which a 2020 clinical trial found led to significantly longer progression-free survival than standard treatment when received as first-line therapy for MSI-H–dMMR metastatic colorectal cancer.

MSIntuit CRC provides an interpretability report to the pathologist, in which the most predictive regions found by the model on the histology slide are outlined.

MSIntuit CRC will help clinicians to gain accurate insights into patients’ individual needs at an earlier stage, enabling a precision medicine approach to treatment. By ruling out those patients who would not benefit from immunotherapy, MSIntuit CRC introduces a pre-screening step which saves pathologists’ and oncologists’ time and resources. Such an optimization supports the scaling of MSI screening for more patient populations and further disease indications.

MSIntuit was created by using deep learning – a type of AI that replicates how the human brain gains knowledge – on hundreds of patient samples until it could accurately detect the presence of MSI on images of tumors. Its accuracy has been validated by a clinical blind validation study on hundreds more patient samples.

On September 2, 2022 Crinetics Pharmaceuticals reported that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, will be presenting data from a planned two-year interim analysis from the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM) being held in São Paulo, Brazil from September 3-7, 2022 (Press release, Crinetics Pharmaceuticals, SEP 2, 2022, View Source [SID1234618942]).

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DETAILS OF THE ORAL PRESENTATION IS AS FOLLOWS:
Congress: Brazilian Congress of Endocrinology and Metabolism (CBEM)
Title: Paltusotine shows long-term safety and IGF-1 maintenance in the ACROBAT Advance study
Date/Time: September 4, 2022 at 3:30 pm BST / 2:30 pm EDT
Enrollment in the Advance OLE study was offered to participants from the Phase 2 ACROBAT Evolve and Edge studies of acromegaly patients who were under a variety of degrees of baseline biochemical control as defined by insulin-like growth factor-1, or IGF-1, levels when treated with regimens that included an injected somatostatin receptor ligand (SRL).

ABOUT ACROMEGALY
Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism. Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

ABOUT PALTUSOTINE
Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily oral option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.