On September 10, 2024 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that it has initiated a registrational Phase 3 clinical trial of soquelitinib for patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) (Press release, Corvus Pharmaceuticals, SEP 10, 2024, View Source [SID1234646469]). The clinical trial is a randomized, controlled study that will evaluate the efficacy and safety of soquelitinib compared to standard of care chemotherapy.

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"The initiation of the soquelitinib Phase 3 trial for relapsed PTCL is an important milestone for Corvus and for patients suffering with this disease," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Soquelitinib has a unique mechanism of action based on selective ITK inhibition, which we believe has potential for the treatment of T cell lymphomas, as well as for solid tumors and a broad range of immune diseases."

The clinical trial (NCT06561048) is designed to enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. Patients will be randomized in a 1:1 ratio to receive either 200mg dose of soquelitinib two-times a day or standard of care chemotherapy with either belinostat or pralatrexate. The primary endpoint of the clinical trial is progression-free survival and secondary endpoints include overall survival, objective response rate, and duration of response. The trial is expected to enroll patients at approximately 40 sites in the United States, Canada, Australia and South Korea.

"We are excited to participate in this Phase 3 trial evaluating a new therapy for patients with relapsed/refractory PTCL," said Swaminathan P. Iyer, M.D., principal investigator of the study and Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center. "In earlier stage trials, soquelitinib has been well-tolerated and has demonstrated durable anti-tumor activity in patients with very advanced disease. Soquelitinib’s novel mechanism of action results in enhancement of the host anti-tumor response. In general, chemotherapy drugs have not produced lasting remissions and are sometimes associated with significant toxicity. There has been a scarcity of new ideas for the treatment of PTCL and we are eager to see if soquelitinib can offer these patients a more effective and safer treatment."

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 ICE Bioscience and NanoTemper Technologies reported an exciting new partnership to establish a Biophysical Joint Innovation Platform (Press release, ICE Bioscience, SEP 10, 2024, View Source;catname=icenews [SID1234647432]). The signing and unveiling ceremony took place at ICE Bioscience’s headquarters in Beijing, with senior leadership from both companies in attendance, including Dr. TJ Bing, Senior Vice President of ICE Bioscience, Dr. Qiang Xia, Vice President of ICE Bioscience, and Barrett Lee, NanoTemper’s Head of APAC Commercial.

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Dr. Bing and Mr. Lee officially signed the cooperation agreement and jointly unveiled the new platform, marking the beginning of an innovative collaboration aimed at advancing biophysics research and applications in drug discovery.

During the event, Dr. Bing welcomed the NanoTemper team and emphasized ICE Bioscience’s commitment to innovation and technology in drug discovery. He highlighted the company’s significant investment in R&D and the strategic alignment of NanoTemper’s Spectral Shift technology with ICE’s goals of exploring new targets, new technologies, and new assays.

Barrett Lee expressed NanoTemper’s appreciation for ICE Bioscience’s trust and enthusiasm for bringing cutting-edge technologies to global researchers. He shared his confidence that this partnership would support ICE Bioscience in becoming a leader in binding affinities and protein stability services, providing essential tools for high-throughput screening.

Following the unveiling, ICE Vice President Xia Qiang led the NanoTemper representatives on a tour of the newly established innovation platform, showcasing the company’s advancements in biophysical assays and outlining future objectives for the platform.

On September 10, 2024 Curium, a world leader in nuclear medicine, reported that in Spain, PYLCLARI is now available for patients with prostate cancer (Press release, Curium Pharma, SEP 10, 2024, View Source [SID1234646470]). PYLCLARI (INN: Piflufolastat (18F) also known as (18F)-DCFPyL) is indicated for the detection of prostate-specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in patients with prostate cancer in the following clinical settings:

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Primary staging of patients with high-risk prostate cancer prior to initial curative therapy
To localize recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum prostate-specific antigen (PSA) levels after primary treatment with curative intent
Benoit Woessmer, PET Europe CEO at Curium commented, "The availability of PYLCLARI in Spain is an important milestone for patients with prostate cancer and underscores our dedication to improving the choice of diagnostic PET radiopharmaceuticals. As we continue to redefine the experience of cancer through our trusted legacy in nuclear medicine, we are proud that the availability of PYLCLARI continues to grow and now covers seven countries including Austria, France, Germany, Greece, Italy, the Netherlands, and Spain."

In Spain, prostate cancer is one of the most common cancers among men with around 30,000 new cases diagnosed nationwide every year. PYLCLARI is being produced by Curium at two sites in Madrid and one site in Sevilla, ensuring timely and efficient distribution across the country.

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)