On May 29, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) (Press release, Jazz Pharmaceuticals, MAY 29, 2024, View Source [SID1234643813]). Under the Prescription Drug User Fee Act (PDUFA), FDA has set a target action date of November 29, 2024.

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"The priority review designation for zanidatamab underscores the critical need for new treatment options for patients with locally advanced or metastatic HER2-positive BTC, a devastating disease with a poor prognosis," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Upon approval, zanidatamab will be the first HER2-targeted treatment specifically indicated for these patients, and we look forward to the opportunity to deliver this new treatment option to the BTC community."

Jazz’s BLA submission is based on results from Cohort 1 of the Phase 2b HERIZON-BTC-01 clinical trial (NCT05152147) of zanidatamab in previously treated patients with unresectable, locally advanced, or metastatic HER2-positive BTC (defined as in situ hybridization [ISH] positive and immunohistochemistry [IHC] 2+ or 3+). The trial demonstrated a primary endpoint of 41.3% [95% confidence interval (CI): 30.4, 52.8] confirmed objective response rate (cORR) by independent central review (ICR) and results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023, published in The Lancet Oncology, and included in the 2023 Best of ASCO (Free ASCO Whitepaper) program. Overall survival, updated duration of response and additional long-term follow-up data from the Phase 2b HERIZON-BTC-01 trial will be presented at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting 2024.

Additionally, the global, open-label, randomized HERIZON-BTC-302 Phase 3 trial (NCT06282575) to evaluate the efficacy and safety of zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC is ongoing and is open for enrollment. HERIZON-BTC-302 is expected to serve as the confirmatory trial for zanidatamab in BTC.

About Zanidatamab
Zanidatamab is an investigational HER2-targeted bispecific antibody that can simultaneously bind two non-overlapping epitopes of the HER2 receptor, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China.

About Biliary Tract Cancer
BTC, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for <1% of all adult cancers globally and are often associated with a poor prognosis1,2. The human epidermal growth factor receptor 2 (HER2) is a well-validated target for antitumor therapy in other cancers. Across the U.S., Europe, and Japan, approximately 12,000 people are diagnosed with HER2+ BTC annually.

On May 29, 2024 Avelos Therapeutics, a leading innovator in the development of novel anti-cancer drugs, reported to have completed a successful Series B funding round totaling KRW 17 billion (approximately $12.3 million USD) on April 30 (Press release, Avelos Therapeutics, MAY 29, 2024, View Source [SID1234643812]). Leading this effort was Stassets Investment, alongside new investors LSK Investment, Medytox Venture Investment, Shinhan Capital and Heungkuk Securities. Avelos’ existing funders–SV Investment, Mirae Asset Venture Investment, Quad Investment Management and Timefolio Capital–also made financial contributions. This latest funding round brings Avelos’ total raised to KRW 30 billion (approximately $21.7 million USD) between seed (KRW 2 billion), Series A (KRW 10 billion), and Series B funding.

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Founded on Sept. 1, 2021 by new drug development experts CEO Young Whan Park, CTO Soongyu Choi and Head of Business Development Kangsik Yun, Avelos focuses on developing small molecule synthetic drugs targeting synthetic lethality, DNA damage response and cell cycle regulation. Currently, the company is developing four new anti-cancer drug pipelines.

At the forefront of Avelos’ world-class innovation is AD1208, a first-in-class MASTL kinase inhibitor, preclinical candidate of the AVS1001 project designed to affect mitosis in cell cycle process and DNA damage response. This drug offers an option for cancer patients who have been unresponsive to current drugs, and can treat colon cancer, stomach cancer, breast cancer, ovarian cancer and prostate cancer. An oral medication, AD1208 demonstrates excellent efficacy in selectively inhibiting cancer cells in both laboratory and animal testing. Clinical trials are scheduled to start in the second half of the year, following preclinical toxicity study, using funding from the Series B investment.

In April, Avelos disclosed preclinical research findings for AVS1001 project at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2024). The company now aims to begin full-scale development.

In addition to AVS1001, Avelos has three other projects in its pipeline, aimed at promising targets in the DNA damage response field. Among them, the AVS1002 project is planning to identify a development candidate by the end of this year, for treating patients with homologous recombination deficiency (HRD) in the DNA damage response. This is of significant interest to those in the field of synthetic lethality, as inhibiting this target raises expectations for effectively treating patients resistant to approved drugs in this field, especially PARP inhibitors, or those with HRD that current PARP inhibitors cannot cover. Avelos plans to select candidates later this year and conduct preclinical toxicity study in 2025. As with the development of AD1208, the Series B funding will support these advancements.

With these notable achievements in research and development, Avelos plans to identify collaborative Korean research partners and facilitate global technology transfer in 2025. The company also plans to list on the KOSDAQ stock market after securing two additional clinical-stage substances.

"The successful completion of the Series B investment, despite challenging conditions with decreased biotech sector investments, underscores the market’s high regard for our expertise, capabilities and growth potential," said Young Whan Park, CEO of Avelos. "The global competitiveness of all treatments in development and adherence to our challenging development timeline have been critical to our success. With this investment, we aim to cultivate globally competitive new anti-cancer drugs and evolve into a leading global biotech firm specializing in world-class synthetic lethality."

"Following a focus on securing our R&D pipeline, our next strategic move will include establishing a foundation for global expansion," said Soongyu Choi, Ph.D., who was promoted from CTO to co-CEO in January of this year. He also emphasizes that our scientists at Avelos design and strive for the best outcomes that increase the probability of success in novel drug development.

To learn more about Avelos Therapeutics, visit avelostx.com.

On May 29, 2024 Foresight Diagnostics, a leader in ultra-sensitive liquid biopsy-based minimal residual disease (MRD) detection, reported its upcoming poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Foresight Diagnostics, MAY 29, 2024, View Source [SID1234643811]). In partnership with Memorial Sloan Kettering Cancer Center and Stanford University, this study showcases the improved sensitivity and superior clinical performance of MRD detection by Foresight CLARITY in early-stage non-small cell lung cancer (NSCLC) within the post-operative adjuvant setting as compared to MRD detection by conventional liquid biopsy-based methods.

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Foresight CLARITY MRD detection platform is powered by PhasED-Seq, a technology that utilizes a patient’s unique set of phased variants to identify circulating tumor DNA (ctDNA) as a measure of residual disease. Research shows that over 50% of NSCLC patients harbor ctDNA levels below 1 part per ten thousand (1×10-4), which is the typical limit of detection of conventional MRD assays. By leveraging its proprietary phased variant technology, Foresight CLARITY delivers an analytical sensitivity of less than 1 part per million (<1×10-6).

One of the most challenging questions in oncology is determining which patients still have residual cancer in their bodies after their primary tumor has been removed and which are truly disease free. Using ctDNA MRD to identify patients who might benefit from further treatment after surgery (termed ‘adjuvant treatment’) is a promising but challenging approach due to the low levels of ctDNA MRD at this timepoint. In their poster presentation "Ultrasensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) detection in early-stage non-small cell lung cancer (NSCLC)," Foresight and its partners evaluated the ability of Foresight CLARITY to identify patients who are MRD positive post-surgery and predict survival benefit from adjuvant therapy.

Key findings include:

>2x improved detection: In pre-treatment samples, Foresight CLARITY accurately detected ctDNA MRD in 62% (13 of 21 cases) of early-stage (I and II) lung adenocarcinomas compared to a detection rate of only 29% (6 of 21 cases) by conventional SNV-based methods.
>2x improved clinical sensitivity: Foresight CLARITY detected MRD at the post-therapy landmark in 67% of patients (12 out of 18 cases) who relapsed compared to conventional SNV-based methods only detecting MRD in 28% (5 out of 18 cases).
Superior clinical performance in an adjuvant setting: Retrospective analysis of this cohort using Foresight CLARITY showed that post-operative ctDNA MRD positive patients that received adjuvant therapy demonstrated significantly improved outcomes and achieved MRD clearance compared to ctDNA MRD positive patients that did not receive therapy (see figures). Among post-operative ctDNA MRD negative patients, no significant difference in outcomes was observed between those who did and did not receive adjuvant therapy.
"Based on these results, we now have another new tool that can help clinicians determine the need for post-operative treatment," said Dr. James Isbell, thoracic surgeon at Memorial Sloan Kettering Cancer Center and lead poster author.

"We are optimistic that these results will encourage the utilization of ctDNA MRD detection in drug development and clinical trials for lung cancer, which to date has been hampered by the performance level of many existing assays," said Dr. David Kurtz, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We look forward to continuing and expanding our partnerships with academia and pharmaceutical companies to allow us to continue building evidence around ctDNA MRD utilization in both the adjuvant and neoadjuvant settings."

For more information, please attend our poster session (details below), visit booth IH#16, or request a meeting with our team.

Abstract #8078

Ultrasensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) detection in early-stage non-small cell lung cancer (NSCLC)

– Presenting Author: James Isbell, MD, MSCI
– Date: June 3, 2024
– Poster Session: 1:30pm-4:30pm CT

Citation

Isbell, et al. AACR (Free AACR Whitepaper) 2023

On May 29, 2024 Kinomica Ltd., a developer of KScan precision oncology diagnostics, reported that it will be presenting data on a multi-drug biomarker signature for accurately predicting best first-line treatments in newly-diagnosed acute myeloid leukemia patients at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which will be held May 31 – June 4, in Chicago, IL (Press release, Kinomica, MAY 29, 2024, View Source [SID1234643810]).

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"AML is a heterogeneous malignancy with poor prognosis. Several treatments are approved for AML, but clinical trials have shown that current stratification approaches to determine patients’ eligibility produce false positives and negatives," said Arran Dokal PhD, CTO of Kinomica. "Here, we used phosphoproteomics to build signatures that accurately predict which of the approved therapies venetoclax plus azacitidine, intensive chemotherapy (IC), or IC plus midostaurin may be more efficacious for a given patient."

Details of the poster presentation are as follow:

Poster Title: Multi-drug algorithm to accurately predict best first-line treatments in newly-diagnosed acute myeloid leukemia (AML)

Presenter: Pedro Rodriguez Cutillas at Barts Cancer Institute

Authors: Pedro Rodriguez Cutillas[1], Weronika E. Borek[5], Josie A. Christopher[5], Luis Veiga Nobre[5], Amy Campbell[5], Janet Kelsall[5], Federico Pedicona[5], Nazrath Nawaz[5] , David N. Perkins[5] , Pedro Moreno Cardoso[5] , Andrea Arruda[2], Alexander Joseph Ambinder[3], Sayantanee Dutta[4], Paolo Gallipoli[1], Heinz Sill[4], Gabriel Ghiaur[3], Mark D. Minden[2], Andrew Williamson[5], John G. Gribben[1], Arran David Dokal[5]

Organizations: [1] Barts Cancer Institute, [2] Princess Margaret Cancer Centre, [3] Johns Hopkins University, [4] Medical University of Graz, [5] Kinomica Ltd

Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Session Date and Time: Monday June 3, 2024, 9:00 AM – 12:00 PM CDT

Poster Board Number: 84

Abstract Presentation Number: 6525

The Abstract is available on the ASCO (Free ASCO Whitepaper) online itinerary planner here.

About Kinomica

Kinomica is a developer of precision oncology diagnostics. The company has developed KScan, a phosphoproteomic diagnostic platform to help clinicians better realize the full potential of precision medicine by predicting which of the drugs currently approved to treat a disease a particular patient will respond best to, thereby aiding clinical decision making. Learn more at www.kinomica.com and follow us on LinkedIn.

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On May 29, 2024 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported some of its latest research being presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, May 31–June 4 in Chicago (Press release, Illumina, MAY 29, 2024, View Source [SID1234643809]). Highlights include data from several studies in partnership with Labcorp, a global leader of innovative and comprehensive laboratory services; research with Sarah Cannon Research Institute (SCRI) demonstrating further evidence to support the use of comprehensive genomic profiling (CGP) over single-gene testing (SGT); and the latest data supporting the development of Illumina’s molecular residual disease (MRD) assay, which is currently underway in collaboration with major pharma companies. In total, Illumina had 14 abstracts accepted to the meeting.

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"Illumina is proud of our collaborations across all areas of the oncology, research, clinical, and payer communities to produce strong evidence to further enable genomic testing for patients with cancer," said Nicole Berry, head of the Americas region at Illumina. "Through this continued commitment, we can support our customers and partners to achieve their precision oncology goals for the benefit of patients everywhere."

Illumina and Labcorp: innovation-driven research

Illumina and Labcorp share five abstracts accepted at ASCO (Free ASCO Whitepaper). The organizations have a longstanding partnership working to build evidence of the clinical impact and value of comprehensive biomarker testing for patients across different cancer types, to ultimately increase community oncology physicians’ access to the latest genomic testing. Among the joint abstracts accepted is a poster presentation on the development and application of a machine learning algorithm trained on multiomics biomarkers for the detection of tumor microsatellite instability (MSI), which is common in certain cancers (Abstract 1554). The study analyzed samples from 1838 patients with colorectal cancer using comprehensive genomic and immune profiling (CGIP). The study findings indicate that the machine-learning-driven approach accurately assessed MSI status of colorectal cancer and endometrial adenocarcinomas using CGIP data.

"Through our partnership with Illumina, we are deploying innovative research opportunities that leverage the strengths of our respective teams," said Shakti Ramkissoon, MD, PhD, vice president, medical lead for oncology at Labcorp. "This algorithm is especially exciting as a potential tool to improve assessment of MSI status."

Greater evidence supporting CGP over SGT

Illumina continues to work with leading research institutions to validate the clinical utility and value of CGP testing. CGP is a single next-generation sequencing assay that assesses hundreds of genes, including relevant cancer biomarkers, for therapy guidance. This year, a real-world analysis done with SCRI will present data demonstrating the performance of CGP versus SGT in guideline-recommended biomarker selection in non-small-cell lung cancer (NSCLC) (Abstract 8640).

"The findings showed that patients with stage IV NSCLC who underwent SGT received results for all nine guideline-recommended biomarkers only 1.2% of the time, as compared to 71.7% of the time for patients tested with CGP testing," said Vivek Subbiah, MD, chief, Early-Phase Drug Development at SCRI. "Our findings clearly indicate that relying solely on single-gene testing or hot-spot testing leads to incomplete biomarker testing, which can compromise targeted therapy treatments for patients with NSCLC. To ensure optimal patient outcomes, it is imperative that we transition to comprehensive next-generation sequencing as the standard of care for NSCLC."

This work builds on evidence presented by Illumina and its collaborators at ASCO (Free ASCO Whitepaper) 2023, including a study with Labcorp that demonstrated that the initial use of SGT increases subsequent CGP test cancellations, and concluded that SGT practice in the community oncology setting does not meet practice guideline recommendations and negatively impacts the potential benefit of subsequent CGP for NSCLC patients (2023 Abstract 6506).

Data shows progress on MRD assay

At ASCO (Free ASCO Whitepaper) 2024, Illumina will present an analytical performance evaluation of its MRD assay, highlighting its fast turnaround time, low input requirements, and high sensitivity and specificity over existing market options (Abstract 3060). Earlier this year, Illumina announced collaborations with pharmaceutical companies to innovate on its MRD research assay, which is currently under development on a whole-genome backbone.

"We’re committed to delivering impactful research to help enable genomic testing in oncology care," said Pratheesh Sathyan, head of Oncology for the Americas region at Illumina. "The work being presented at ASCO (Free ASCO Whitepaper) this year, which includes research conducted with Eurofins, Labcorp, and SCRI, will help advance access to precision oncology solutions for patients."