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 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported it has successfully delivered a second development candidate to Biogen and earned an $8 million milestone payment (Press release, C4 Therapeutics, SEP 10, 2024, View Source [SID1234646468]). This marks the final development candidate under this strategic collaboration.

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"We are thrilled to deliver a highly catalytic, brain penetrant orally bioavailable BiDAC degrader development candidate to Biogen in their pursuit of discovering, developing and delivering innovative therapies that improve the lives of patients," said Andrew Hirsch, president and chief executive officer. "It is rare that discovery collaborations deliver one, much less two, development candidates to the partner. This result is a testament to the dedication of the Biogen and C4T teams and the productivity of our TORPEDO platform, which has demonstrated its potential to design innovative degraders against a broad range of target classes. Since our founding in 2015, we have discovered and advanced four development candidates for our clinical pipeline and delivered two development candidates to Biogen, an impressive feat for a company of our size. We are proud to continue advancing the exciting field of targeted protein degradation and bring new medicines to patients."

Under the terms of the strategic collaboration established in 2018, C4T provided expertise and research services in targeted protein degradation and Biogen provided scientific and drug development capabilities. Biogen is responsible for all future clinical development and commercialization for development candidates delivered under the collaboration. Previously, C4T earned an $8 million payment in April 2024 after Biogen accepted delivery of a first development candidate in an undisclosed indication as part of this collaboration.

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 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."