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."

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 9, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share new data for TEVIMBRA (tislelizumab) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress (ESMO 2024) in Barcelona, Spain, September 13-17, 2024 (Press release, BeiGene, SEP 9, 2024, View Source [SID1234646423]). BeiGene has seven abstracts accepted at ESMO (Free ESMO Whitepaper) 2024, with one selected for the special session revisiting the ESMO (Free ESMO Whitepaper) Virtual Plenary held in February 2024.

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New Data Add to Evidence for TEVIMBRA Across Multiple Disease States

As an encore to the ESMO (Free ESMO Whitepaper) plenary, interim results from the RATIONALE-315 study show the statistically significant event-free survival (EFS) and trend for overall survival (OS) benefit favoring neoadjuvant tislelizumab plus chemotherapy with adjuvant tislelizumab vs. placebo plus chemotherapy with adjuvant placebo for patients with resectable non-small cell lung cancer (NSCLC) (session #VP1-2024, Sept. 13 from 4:17-4:29 p.m. CEST). These results further reinforce the data presented at ESMO (Free ESMO Whitepaper) 2023 showing major pathologic response (MPR) and pathologic complete response (pCR) rate were significantly improved: 56.2% vs 15.0% (P<.0001) and 40.7% vs 5.7% (P<.0001), respectively. The safety profile of the tislelizumab arm was consistent with that of individual therapies, with 72.1% (vs. 66.4% in the placebo arm) of patients in the tislelizumab arm experiencing grade ≥3 treatment-related adverse events (TRAEs) and 15.5% (vs. 8.0% in the placebo arm) experiencing serious TRAEs. The most common TRAEs were decreased neutrophil count, decreased white blood cell count and alopecia. Improvement in symptomology from RATIONALE-315 will also be shown as patient-reported outcomes (poster #1213P, Sept. 14).
Three-year overall survival data from RATIONALE-305 continue to demonstrate the long-term efficacy and safety of tislelizumab plus chemotherapy in patients with first-line advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) (poster #1437P, Sept. 16), as well as improvements in patient-reported outcomes (poster #1449P, Sept. 16).
Long-term outcomes in the ITT population as well as those receiving long-term exposure to tislelizumab plus chemotherapy as treatment for first line squamous NSCLC in RATIONALE-307 show a continued OS benefit with clinically promising four-year OS rates (poster #1323P, Sept. 14).
Relative effectiveness of tislelizumab vs. other anti-PD-1 treatments approved in the European Union and UK for second-line esophageal squamous cell carcinoma (ESCC) using anchored simulated treatment comparison of data from RATIONALE-302 and comparator clinical studies (poster #1417P, Sept. 16).
"TEVIMBRA has shown potential across multiple disease states, and the data at ESMO (Free ESMO Whitepaper) 2024 further supports its position as the foundational asset of our solid tumor portfolio," said Dr. med. Jan-Henrik Terwey, Vice President, Medical Affairs Europe at BeiGene. "As part of our commitment to bring innovative cancer medicines to more patients, we recently launched TEVIMBRA in EMA-approved indications in Germany, Austria and Norway, and we are working to make TEVIMBRA available across Europe."

TEVIMBRA in Europe

BeiGene recently launched TEVIMBRA in the first European countries following EU marketing authorizations for the treatment of eligible patients with ESCC and NSCLC. TEVIMBRA is also approved in the UK and Switzerland for eligible patients with advanced or metastatic ESCC.

"Advanced or metastatic ESCC and NSCLC are aggressive cancers with limited treatment options," said Markus Moehler, M.D., Ph.D., of the Johannes Gutenberg University Medical Center Mainz in Germany. "The availability of tislelizumab for these patients represents an important next step to advance the treatment landscape."

The European Commission approvals were based on the results from four randomized Phase 3 studies in the RATIONALE program: RATIONALE-302 (NCT03430843) for ESCC and RATIONALE-307 (NCT03594747), RATIONALE-304 (NCT03663205) and RATIONALE-303 (NCT03358875) for NSCLC. The approved indications for TEVIMBRA in the EU are:

In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC.
As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
As monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.
About TEVIMBRA (tislelizumab)

Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.