AVELOS THERAPEUTICS ANNOUNCES KRW 17 BILLION SERIES B FUNDING ROUND, SURPASSING KRW 30 BILLION TOTAL RAISED

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.

Foresight Diagnostics to Present New Data Showcasing Foresight CLARITY MRD Detection in Early-Stage Lung Cancer

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

Kinomica to Present Research Abstract on a Multi-drug Biomarker Signature to Predict Best First-line Treatments for Acute Myeloid Leukemia (AML) at the 2024 ASCO Annual Meeting

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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Illumina drives genomic testing as standard of care in oncology through collaborative research presented at ASCO

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."

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO® Annual Meeting

On May 29, 2024 Florida Cancer Specialists & Research Institute, LLC (FCS) physicians reported that it will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Florida Cancer Specialists & Research Institute, MAY 29, 2024, View Source;research-institute-share-cancer-care-discoveries-at-2024-asco-annual-meeting-302158316.html [SID1234643808]). Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals.

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Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO (Free ASCO Whitepaper).

"It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients."

Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale."

Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting:

Manish Patel, MD
Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer
Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors.
Dr. Patel is a co-author of eight additional presentations
Judy Wang, MD, FCS associate director of drug development
Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation.
She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author.
Dr. Wang is also a co-author of six additional presentations
Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3.
FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma."

The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored:

Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology.
Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors
Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO).
Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC)
Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer
FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD — H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC).
"We’re winning. We’re beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO (Free ASCO Whitepaper), including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer.

Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities:

Faithlore Gardner, MD
Todd Gersten, MD
Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring
Joel Grossman, MD
Elizabeth Guancial, MD
"Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide."

FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO (Free ASCO Whitepaper) 2024 Annual Meeting.

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO (Free ASCO Whitepaper) works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care.

View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf