On November 19, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported that it will release TruSight Oncology 500 v2 (TSO 500 v2), a new version of its flagship cancer research assay to enable comprehensive genomic profiling (CGP) (Press release, Illumina, NOV 19, 2024, View Source [SID1234648507]). The assay is currently under development, with global release planned for mid-2025. Detailed plans for the product will be shared November 21 in a spotlight presentation at the annual meeting of the Association of Molecular Pathology (AMP) in Vancouver, British Columbia.

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TSO 500 v2 assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample, to facilitate therapy selection research.

Key features of TSO 500 v2 include:

Faster turnaround time and reduced hands-on time
Sensitive variant calling and improved coverage of difficult genomic regions
Gold-standard Myriad Genomic Instability Score (GIS) to determine homologous recombination deficiency (HRD) status, included for all samples
New kit configurations with 50% less packaging, 70% fewer tubes, and improved usability
Automation methods available with flexible batch sizes
Integrated and automated data analysis, from sequencer to insights supported with DRAGEN secondary analysis and Illumina Connected Insights, or Velsera’s Clinical Genomics Workspace (CGW)
Broad platform compatibility
At AMP, several abstracts accepted for poster presentations will demonstrate preliminary analytical performance data and automation compatibility of TSO 500 v2. The studies support the assay’s applications for clinical research in identifying rare genetic biomarkers and fusion biomarkers.

TSO 500 v2 early access customer response

Wei Song, MD, PhD, director of Clinical Genomics and Molecular Pathology at the University of California, San Diego, is an early access customer testing TSO 500 v2.

"We are excited to assess the new features of the TruSight Oncology 500 v2 tissue assay, such as the faster workflow, improved coverage, and lower DNA/RNA input levels," he said. "Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples."

TruSight Oncology portfolio enables clinical research and in-vitro diagnostic CGP solutions

Illumina’s oncology portfolio has evolved over time to fit customers’ diverse needs for versatility and scalability. The TSO portfolio encompasses research-use-only (TSO 500 products) and in-vitro diagnostic (TSO Comprehensive) solutions across a range of low-, mid-, and high-throughput instrumentation. Illumina also announced today that TSO Comprehensive kits are now available to ship. In August, the company announced FDA approval of its TSO Comprehensive test and its first two companion diagnostic indications.

"In listening to our broad range of customers, we understand there are different needs for biomarker profiling, and Illumina has successfully introduced a continuum of solutions to address varying levels of need," said Traci Pawlowski, vice president of Clinical Solutions at Illumina.

CGP is a critical tool for identifying actionable alterations, including rare mutations, which enables precision medicine in accordance with professional guidelines. At AMP, several customer-led poster presentations will provide further evidence for the clinical utility of CGP and demonstrate its versatility in hospital and community oncology care settings.

Illumina will cohost a workshop with Bayer, featuring a panel discussion of key opinion leaders on the challenges and practice gaps in precision medicine implementation, and the coordination of a multidisciplinary team to ensure optimal biomarker detection and targeted therapy utilization

On November 19, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs) (Press release, Lantern Pharma, NOV 19, 2024, View Source [SID1234648508]).

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The dosing of the first patient in Japan marks a significant expansion of the HARMONIC trial into Asia, where there is a notably higher prevalence of never-smoker NSCLC patients compared to Western populations. The trial is being conducted at five sites across Japan, including the National Cancer Center Japan under the leadership of Dr. Yasushi Goto, a renowned physician-researcher focused on lung cancer.

"The initiation of patient dosing in Japan is a significant milestone for the HARMONIC trial and our mission to develop LP-300 as a potential new treatment option for never-smoker NSCLC patients," said Panna Sharma, President and CEO of Lantern Pharma. "Japan and other Asian countries have a significantly higher proportion of never-smokers among NSCLC patients, with estimates suggesting that 33-40% of new lung cancer cases in Japan occur in never-smokers. This expansion allows us to accelerate enrollment while addressing a critical unmet need in a region where this disease has a particularly high impact."

Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern Pharma commented, "This marks the achievement of a significant milestone for the Harmonic Trial. It is the beginning of an anticipated acceleration in enrollment following activation of sites in Japan as well as active screening of patients across sites in Taiwan. We are encouraged by the high level of interest from our clinical partners in Asia in this unique trial aimed at improving survival among never-smokers with lung cancer after relapsing from tyrosine kinase inhibitor-based treatment regimens."

The expansion into Japan and Taiwan follows encouraging preliminary results from the U.S. trial’s initial safety lead-in cohort, which demonstrated an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker NSCLC patients who have recurrent NSCLC and have stopped responding to tyrosine kinase inhibitor (TKI) based therapies.

ABOUT THE HARMONIC TRIAL

The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone. The trial is expected to enroll approximately 90 patients across sites in the United States and Asia. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

On November 19, 2024 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported that data were published on Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating AIM ImmunoTech’s drug Ampligen (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC) (Press release, AIM ImmunoTech, NOV 19, 2024, View Source [SID1234648494]). Results of the study were reported in The Journal for ImmunoTherapy of Cancer.

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"We are very excited with these promising results from our study of a new treatment combination for patients with this most highly aggressive form of breast cancer, triple-negative breast cancer," said study principal investigator Shipra Gandhi, MD, Associate Professor of Oncology and staff physician in the Department of Medicine at Roswell Comprehensive Cancer Center. "Because this initial study was in a small number of patients, it will be important to validate these findings in a larger study."

For more information on the data reported, please visit Roswell Park’s website to read its press release titled, "Roswell Park Clinical Trial Points Toward Promising New Therapy for Most Aggressive Type of Breast Cancer."

AIM CEO Thomas K. Equels stated: "The results of this pilot study suggest that the Ampligen-containing chemokine modulation regimen is capable of modifying the tumor microenvironment and releasing cytokines that attract killer T-cells into the early-stage triple-negative breast cancer tumor. These data are similar to those we have seen with Ampligen previously in late-stage TNBC, advanced recurrent ovarian cancer and pancreatic cancer. We look forward to collaborating with Roswell Park as this study advances to Phase 2. We believe in the power of Ampligen to work in conjunction with a variety of chemotherapy regimens and/or immune checkpoint inhibitors."

For more information about the study, please visit ClinicalTrials.com: NCT04081389.

About Roswell Park Comprehensive Cancer Center

From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email [email protected].

On November 19, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the Company has entered into an agreement under which Orion Corporation has settled all future contractual milestones, royalty and any other commitments towards Alligator in relation to two preclinical bispecific antibodies resulting from the discovery collaboration between the companies (Press release, Alligator Bioscience, NOV 19, 2024, View Source [SID1234648495]). No further development activities will be conducted under the collaboration agreement.

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"I am pleased that our successful collaboration has grown to this logical outcome. This divestiture sharpens our focus on our lead candidate mitazalimab, and this non-dilutive income constitutes an important element in advancing mitazalimab towards Phase 3" says Søren Bregenholt, CEO of Alligator Bioscience. "Following the unprecedented 18-month survival data announced earlier this year we expect several value inflection points on mitazalimab in the coming months. Notably among them, 24-months follow-up, as well as key progress in Phase 3 preparations in pancreatic cancer, which we are expected to further facilitate partnership discussions."

Van Lanschot Kempen acted as financial adviser to Alligator on the transaction.

On November 18, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin (Press release, Alentis Therapeutics, NOV 18, 2024, View Source [SID1234648462]). ALE.P02 is an investigational antibody-drug conjugate (ADC) targeting CLDN1, developed for CLDN1+ squamous cancers including but not limited to lung, head and neck, cervical and esophageal cancers.

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"We are encouraged by the FDA’s recognition of ALE.P02’s potential as a treatment for CLDN1+ squamous cancers," said Roberto Iacone, Chief Executive Officer of Alentis Therapeutics. "It reflects the importance of advancing ALE.P02 through clinical development, and it brings us one step closer to providing a new treatment option for patients."

Fast Track designation is designed to expedite the development and review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

"We have set out to develop ALE.P02 in the most rational way, following CLDN1 science and the clinical understanding of squamous cancers. The FDA’s support in this endeavor is certainly motivating," added Luigi Manenti, Chief Medical Officer of Alentis. "We are optimistic about the potential of ALE.P02 and look forward to the start of our first-in-human clinical trial in Q1 2025."

"Squamous cancers of various origin have been shown to overexpress CLDN1, making ALE.P02 a promising ADC to address the unmet medical needs of these patients," said Tony Mok Professor of Clinical Oncology at the Chinese University of Hong Kong. "CLDN1 is an exciting new target for ADCs and Alentis has been the frontrunner in developing anti-CLDN1 therapeutics."

About ALE.P02
ALE.P02 is a first-in-class ADC designed by linking a tubulin inhibitor, a potent cancer drug, to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination could be a powerful new tool to fight the many squamous cancers that overexpress CLDN1 with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA.