On September 10, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported the presentation of a significant study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain, from September 13-17 (Press release, Lunit, SEP 10, 2024, View Source [SID1234646486]).

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While Nivolumab plus chemotherapy has recently been approved as a standard first-line treatment for advanced gastric cancer (AGC), its efficacy varies among patients. This variability underscores the critical need for reliable biomarkers to predict treatment response. Lunit’s study addresses this pressing need, potentially offering a new tool to optimize patient care and treatment decisions.

Conducted in collaboration with leading Korean medical institutions, the research showcases the potential of Lunit’s AI-powered histopathology analyzer, Lunit SCOPE IO, in predicting treatment response and guiding treatment decisions for AGC via assessment of immune phenotype.

The study analyzed H&E images from 585 AGC patients, with Lunit SCOPE IO classifying tumors into two immune phenotypes—inflamed (IIP) and non-inflamed—based on the presence and distribution of tumor-infiltrating lymphocytes (TILs) from hematoxylin and eosin (H&E) slides that are readily available from a standard clinical workup. This classification provided valuable insights into the tumor microenvironment and helped predict treatment response, particularly in cases where traditional biomarkers like PD-L1 may not provide a complete picture.

Key findings include:

1. Patients treated with Nivolumab+Chemotherapy showed significantly longer median progression-free survival (mPFS) compared to Chemotherapy alone (8.2 vs. 5.9 months).
2. The inflamed immune phenotype group, classified by Lunit SCOPE IO, was associated with more pronounced PFS benefits from Nivolumab+Chemotherapy:

IIP: 5.2 months longer PFS for Niv+Chemo (mPFS of 11.0 vs 5.8 months)
Non-IIP: only 1.4 months longer PFS for Niv+Chemo (mPFS of 7.3 vs 5.9 months)
3. The predictive value of IIP was consistent across different PD-L1 expression levels.
4. Multivariate analysis confirmed IIP as an independent factor for PFS in patients treated with Nivolumab+Chemotherapy.

"By demonstrating that our AI-powered immune phenotype analysis can predict treatment response independently of PD-L1 status, we’re opening new possibilities for tailoring treatments in AGC," said Brandon Suh, CEO of Lunit. "This is particularly significant because gastric cancer continues to be a leading cause of cancer-related deaths globally, representing 7.7% of all cancer cases. Our AI technology has the potential to enhance the precision of treatment decisions, potentially leading to more effective therapies and better quality of life for patients with AGC."

Please visit Lunit’s poster session at 1411P to discover more about our findings and the innovative capabilities of Lunit SCOPE IO.

Poster presentation featuring Lunit SCOPE IO at ESMO (Free ESMO Whitepaper) Congress 2024:

"AI-powered immune phenotype predicts favorable outcomes of nivolumab (niv) plus chemotherapy (chemo) in advanced gastric cancer (AGC): A multi-center real-world data analysis" (1411P, September 16, 12:00~13:00 PM)

On September 10, 2024 Pillar Biosciences, Inc. reported that it has entered into a strategic partnership with AstraZeneca to expand laboratory access to molecular testing, using rapid, Next Generation Sequencing (NGS)-based liquid biopsy tumor profiling panels for detection of genetic cancer variants, with an initial focus on European markets and the UK (Press release, Pillar Biosciences, SEP 10, 2024, View Source [SID1234646485]).

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The partnership aims to rapidly identify tumors with clinically actionable genomic alterations via liquid biopsy profiling and intends to support faster diagnostic testing by increasing the local availability of plasma-based tumor profiling at leading clinical laboratories.

The work will initially leverage Pillar Biosciences oncoRevealTM Core LBx, Essential LBx, and Fusion LBx research-use-only (RUO) liquid biopsy kitted NGS panels. Pillar’s oncoRevealTM Core LBx panel, which interrogates 104 genes in circulating cell-free tumor DNA (cfDNA), oncoRevealTM Essential LBx panel, which interrogates 34 genes in cfDNA,and oncoRevealTM Fusion LBx, which interrogates various fusion forms from 18 driver genes via circulating cell-free tumor RNA (cfRNA), can be performed by any laboratory, with a sample-to-report time in less than three days. Laboratories will be able to batch test both cfDNA and cfRNA samples from >22 patients on a single Illumina NextSeq run, enabling economic value and scale of sequencing needed to properly profile at extremely high levels of sensitivity and specificity.

"Access to cost effective, easy to use, distributed NGS kits for liquid biopsy testing are critical to support local laboratories in providing clinically actionable results to oncologists and supporting critical treatment decisions for cancer patients globally," said Dan Harma, Chief Commercial Officer, Pillar Biosciences. "Pillar Biosciences LBx panels, including oncoRevealTM Core LBx, oncoReveal EssentialTM LBx and oncoRevealTM Fusion LBx will help provide in-house results locally within a few days vs. several weeks to receive results from sending out their patient samples for most clinical laboratories."

"We are committed to expanding global patient access to biomarker testing, and decentralized NGS solutions are key to this strategy," said John Longshore, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca. "These kit-based methods allow a broad range of laboratories to perform high-quality NGS testing, which improves patient access to targeted therapies. Pillar Biosciences sequencing panels provide rapid, simplified NGS workflows and bioinformatics, which are ideal to supporting our global efforts."

On September 10, 2024 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, reported a new milestone in the global introduction of the liquid biopsy test MSK-ACCESS powered with SOPHiA DDM, first announced in October 2023 (Press release, AstraZeneca, SEP 10, 2024, View Source [SID1234646484]). Under a definitive partnership agreement with AstraZeneca (LSE/STO/Nasdaq: AZN), SOPHiA GENETICS will accelerate the deployment of MSK-ACCESS powered with SOPHiA DDM to 20 locations worldwide over the next 12 months.

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Liquid biopsy testing offers a complementary alternative to solid tumor testing, which is not always feasible due to insufficient tissue, low quality tissue, or the invasiveness of the procedure. The testing works by isolating cell-free DNA (cfDNA) from blood plasma to uncover circulating tumor DNA (ctDNA). Isolating these DNA samples from a simple blood draw is less invasive than a traditional biopsy, helping to simplify patient monitoring and more quickly guide clinical decision-making.

MSK-ACCESS powered with SOPHiA DDM is a decentralized version of the highly validated liquid biopsy test developed by Memorial Sloan Kettering Cancer Center (MSK), a top cancer treatment and research institution. The solution combines the sophisticated analytics, state-of-the-art algorithms, and decentralized, cloud-based offerings of the SOPHiA DDM Platform, with the scientific and clinical expertise of MSK in cancer genomics to provide a best-in-class liquid biopsy solution.

By increasing availability of MSK-ACCESS powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand how liquid biopsy testing can complement solid tissue testing, and in some cases, provide greater benefit for labs and patients. This understanding will help support the case for broad global implementation. Additionally, through a dedicated real-world evidence study, researchers will be able to evaluate the operational benefits of liquid biopsy testing, including the speed of results and the ability of users to consistently achieve high-quality data in a variety of laboratory settings.

"Our collaboration with AstraZeneca has the potential to dramatically accelerate global access to liquid biopsy testing, especially in underserved populations, which in turn could contribute to reshaping diagnostics, treatment, and monitoring of cancer cases throughout the world. Their support is instrumental to making this improved access a reality," said Philippe Menu, M.D., Ph.D, Chief Medical and Chief Product Officer, SOPHiA GENETICS. "Additionally, the breadth and depth of real-world data that we will generate through the implementation of this decentralized liquid biopsy testing platform on a global scale will be unprecedented, providing novel avenues to accelerating cancer research."

Since launching MSK-ACCESS powered with SOPHiA DDM in April 2024, a first wave of 14 leading healthcare institutions worldwide have signed on to piloting and adopting the application. These institutions include renowned cancer centers and reference laboratories such as:

BioReference and Tennessee Oncology in the U.S.; Oncohelix in Canada; Dasa in Brazil; Universitätsklinikum Heidelberg in Germany; Stavanger University Hospital in Norway; IUCT Oncopole in France; Synnovis and South West Genomic Laboratory Hub, operating out of North Bristol NHS Trust in the U.K.; Sofiva Genomics in Taiwan; Syndicate Bio in Nigeria; A.O.U. Senese in Italy; and Karkinos Healthcare and Strand Life Sciences in India.

The partnership with AstraZeneca will further catalyze the adoption of MSK-ACCESS powered with SOPHiA DDM.

As more hospitals and labs go into routine, SOPHiA GENETICS and AstraZeneca, in collaboration with leading cancer institutes within the SOPHiA GENETICS community, will generate a vast set of real-world data from patients around the world with a variety of cancers. This data set has the potential to generate unique insights towards advancing cancer research and drug development.

"We are deeply committed to bringing liquid biopsy expertise to labs and institutions throughout the globe at an expedited pace, and are confident this rollout will further support access to testing and aid in providing data-driven treatment options to patients around the world," said Kristina Rodnikova, Head of Global Oncology Diagnostics, AstraZeneca.

The deployment of MSK-ACCESS powered with SOPHiA DDM was announced in October 2023 as part of a collaboration between SOPHiA GENETICS, AstraZeneca and MSK. Together, the three companies are working to combat global health inequities and advance cancer research.

On September 10, 2024 Qilu Pharmaceutical reported that during the World Conference on Lung Cancer (WCLC) held from September 7-10, 2024, in San Diego, California, updated findings from the Phase II clinical trial (INTELLECT study) were presented (Press release, Qilu Pharmaceutical, SEP 10, 2024, View Source [SID1234646483]). The study assessed the efficacy and safety of Qilu Pharmaceutical’s iruplinalkib tablets (Qixinke) in treating patients with anaplastic lymphoma kinase (ALK)-positive crizotinib-resistant non-small-cell lung cancer (NSCLC). The highlights were showcased in a poster presentation.

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Iruplinalkib, a next-generation ALK/ROS1 kinase inhibitor formulated by Qilu Pharmaceutical, was approved by NMPA in June 2023 for the treatment of patients with ALK-positive locally advanced or metastatic NSCLC who had disease progression after treatment with crizotinib or who were intolerable to crizotinib. In January of this year, iruplinalkib was approved for the first-line treatment of patients with ALK-positive NSCLC.

The trial is led by principal investigator, Prof. Yuankai Shi from the Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College. The results of the study were published in BMC Medicine in 2023. Updated data with an extended two-year follow-up were presented during the WCLC.

A total of 146 subjects were enrolled in this study. As of December 29, 2023, the median follow-up time was 42.41 months, revealing a median overall survival (OS) of 41.79 months. The investigator-evaluated objective response rate (ORR) was 63.7%, while the disease control rate (DCR) reached 94.5%. Additionally, the median duration of response (DoR) and median progression-free survival (PFS) were reported to be 14.06 months and 14.55 months, respectively.

According to the RECIST v1.1 evaluation criteria, the ORR and DCR in the subgroup with CNS metastasis at baseline (90 patients) were 55.6% and 93.3%, respectively. Both the median DoR and median PFS were 17.25 months, while the median OS stood at 43.01 months.

Based on RANO-BM criteria, intracranial complete response (CR) was achieved in 17 (18.9%) of the 90 patients with CNS metastasis at baseline. Among the 42 subjects with measurable intracranial lesions at baseline, the intracranial objective response rate (iORR) was 64.3% while the intracranial disease control rate (iDCR) reached 95.2%.

The safety profile was characterized by a 93.8% (137 cases) incidence of treatment-related adverse events (TRAEs), with 30.8% (45 cases) being grade 3 or 4. The most common TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and increased alanine aminotransferase (37.0%). No new safety signals were identified.

Long-term follow-up results from the INTELLECT study demonstrated that iruplinalkib provided an OS benefit with no new safety signal in patients with ALK-positive crizotinib-resistant advanced NSCLC.

On September 10, 2024 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, reported a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)’s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA (Press release, I-Mab Biopharma, SEP 10, 2024, View Source [SID1234646482]).

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Uliledlimab (TJ004309) is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Blocking CD73 allows anti-tumor immunity to proceed without the presence of an adenosine-induced "immunological fog". The WCLC 2024 presentation includes data from uliledlimab PK/PD analyses from three Phase 1 studies including patients with treatment naïve metastatic non-small cell lung cancer (mNSCLC).

"The PK/PD analysis presented at WCLC underscores our view that uliledlimab has the potential to be a differentiated, best-in-class, CD73 inhibitor. The data support our dose selection work and upcoming combination studies, with a study of uliledlimab plus pembrolizumab plus chemotherapy expected to begin in the first half of 2025," said Phillip Dennis, MD, PhD, Chief Medical Officer of I-Mab. "We are particularly encouraged by the E-R analysis, which showed a positive relationship between uliledlimab exposure and the probability of an overall response in patients with NSCLC, as well as positive target engagement data and dose proportional PK results. These data, plus a previously presented favorable safety profile and clinical efficacy, fortify our view that uliledlimab has the potential to meaningfully improve the care of patients with mNSCLC."

Poster Title: Integrated PK/PD Modeling for Uliledlimab, an Anti-CD73 Monoclonal
Antibody, in Non-Small Cell Lung Cancer Patients (Poster #2979)

Data are based on analysis of three Phase 1 studies conducted in China evaluating uliledlimab, as a monotherapy and in combination studies with the checkpoint inhibitors, toripalimab or atezolizumab, in patients with advanced cancers, including mNSCLC.

Key Findings Include:

Most of the simulated population (95%) could achieve the target threshold with 30 mg/kg of uliledlimab
Integrated PK/PD modeling and pharmacometrics analyses indicate there is a positive relationship between the probability of overall response and uliledlimab trough concentration in NSCLC patients
CD73 receptor occupancy (RO) in peripheral B cells achieved 90% or above and maintained at high levels until the end of treatment
The 30 mg/kg dose with a single boost dose on C1D8 provided uliledlimab concentrations that achieved the target concentration of 80 μg/mL immediately after the first dose and maintained this threshold afterward
A Ctrough target threshold of 80 μg/mL may be clinically meaningful, associated with PFS benefit and is achievable by a 30 mg/kg initial dose followed by a booster dose on Cycle 1, Day 8 (C1D8)
A full copy of the poster is available on the I-Mab website, on the "Innovation, Publications & Presentations" tab.