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CoImmune Announces Publication of Preclinical Results with SEAKER Cells in Solid Tumor Melanomas

On July 26, 2023 CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, reported the publication of preclinical results with Synthetic Enzyme-Armed Killer (SEAKER) cells in solid tumor melanomas in the peer-reviewed journal Cancer Immunology Research (Press release, CoImmune, JUL 26, 2023, View Source [SID1234633440]).

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The recently published paper titled, "Host Interactions with Engineered T cell Micropharmacies," describes seminal work by researchers at Memorial Sloan Kettering Cancer Center (MSK) including David A. Scheinberg, M.D., Ph.D., Chairman of the Center for Experimental Therapeutics and Deputy Director, Therapeutic Discovery, Sloan Kettering Institute (SKI), and Derek S. Tan, Ph.D., Chairman of the Chemical Biology Program, SKI. The work evaluates SEAKER cells designed to target solid-tumor melanomas in syngeneic mouse models using specific targeting with T cell receptor (TCR) engineered T cells. Results demonstrate that SEAKER cells localize specifically to tumors and activate bioactive prodrugs, providing efficacy against melanoma tumors in immunocompetent hosts.

"As we continue to advance a development program based on our proprietary chimeric antigen receptor (CAR) modified cytokine induced killer (CIK) cell platform, we are investigating technologies that could help deliver additional agents locally to tumor sites to mitigate tumor escape by loss of targeted antigens and tumor induced immunosuppression," said Charles Nicolette, Ph.D., Chief Executive Officer of CoImmune. "Our goal is to overcome the barriers to the treatment of solid tumors, and this new publication evaluating SEAKER cells in solid tumor melanoma models is another encouraging step in that direction."

CoImmune has acquired the rights to several technologies developed at MSK including SEAKER cells that combine the target-seeking power of immune cells with the ability to locally generate a potent anticancer drug at the tumor site without systemic toxicity, also referred to as a "micropharmacy."

"Genetically engineered, cytotoxic, adoptive T cells localize to antigen positive cancer cells inside patients, but tumor heterogeneity and multiple immune escape mechanisms have prevented the eradication of most solid tumors," said Dr. Scheinberg. "SEAKER cells can be designed to express a prodrug converting enzyme to achieve high active anti-tumor drug levels at tumor sites. This preclinical work demonstrates that the SEAKER platform is applicable to many adoptive cell therapies."

GC Genome enables the prognosis prediction and targeted treatment in breast cancer patients

On July 26, 2023 GC Genome Corporation, a leading genomic diagnostics company, reported the publication of a new study in Journal of the National Cancer Institute (JNCI), shedding light on the remarkable potential of utilizing circulating tumor DNA (ctDNA) copy number aberration (CNA) for prognosis prediction and molecular profiling in cancer patients in collaboration with the team of Dr. Joohyuk Sohn, MD, professor at Severance Hospital (Press release, GC Genome, JUL 26, 2023, View Source [SID1234633439]).

”We can gain vital insights into patient prognosis and make informed decisions regarding the most effective treatment strategies through ctDNA CNA analysis for breast cancer patients, ultimately improving patients’ outcomes," said Dr. Chang-Seok Ki, MD, CEO at GC Genome.

The study includes Low-pass whole-genome sequencing (LP-WGS)-based ctDNA data from 207 metastatic breast cancer (MBC) patients to investigate the prognostic value of ctDNA CNA burden, which was subsequently validated in 465 stage II-III triple-negative breast cancer (TNBC) patients who received neoadjuvant chemotherapy in phase III trial (NCT02441933).

High baseline ctDNA CNA burden was correlated with poor overall survival (OS) and progression-free survival (PFS) of MBC patients and poor disease-free survival was also observed independently of pathologic complete response (pCR), thereby emphasizing the robust prognostic significance of ctDNA CNA burden. PFS and OS are critical indicators of therapeutic efficacy in cancer patients.

”These results will indeed set a solid foundation in paving the way for the integrating of ctDNA CNA analysis into routine clinical practice, offering personalized and targeted treatment options,” said Dr. Eun-Hae Cho, MD, Chief Technical Officer at GC Genome. "Our dedication to further research aims to ensure that our technology can make valuable contributions to more individuals who are battling against cancer over the world.

Thermo Fisher Scientific Reports Second Quarter 2023 Results

On July 26, 2023 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended July 1, 2023 (Press release, Thermo Fisher Scientific, JUL 26, 2023, View Source [SID1234633436]).

Second Quarter 2023 Highlights

•Second quarter revenue was $10.69 billion, 3% lower versus the same quarter last year. Core organic revenue growth was 2%.
•Second quarter GAAP diluted earnings per share (EPS) was $3.51.
•Second quarter adjusted EPS was $5.15.

•The macroeconomic environment was more challenging in the second quarter and our PPI Business System helped the company to effectively navigate the environment.

•Strong execution of our proven growth strategy, launching a range of high-impact, innovative new products, including the groundbreaking Thermo Scientific Orbitrap Astral mass spectrometer, a significant advancement in mass spectrometry offering high resolution and speed to enable the discovery of new proteins and advance precision medicine; the Thermo Scientific Metrios 6, a fully automated scanning transmission electron microscope incorporating advanced machine learning to accelerate semiconductor development; the Gibco OncoPro Tumoroid Culture Medium Kit, to accelerate development of novel cancer therapies; and the first FDA-cleared assays for risk assessment and clinical management of preeclampsia, a serious pregnancy complication.

•Further strengthened our industry-leading commercial engine and trusted partner status with the opening of a state-of-the-art customer center of excellence in Milan, allowing us to consolidate capabilities from across the company to better serve our customers and enhance productivity.

•Shortly after the quarter ended, announced a definitive agreement to acquire CorEvitas for approximately $0.9 billion. Highly complementary to our leading clinical research business, CorEvitas provides regulatory-grade, real-world evidence solutions to pharmaceutical and biotechnology companies with objective data and clinical insights to improve patient care and clinical outcomes.

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•Building on our environmental, social and governance priorities, we published our 2022 Corporate Social Responsibility Report, highlighting our actions in these areas and reflecting our commitment to society and our stakeholders.

"The macroeconomic environment became more challenging in the second quarter. Economic activity in China slowed, and across the economy more broadly, businesses became more cautious in their spend," said Marc Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "The team is leveraging our PPI Business System to effectively manage through this dynamic environment."

Casper added, "Our experienced management team has a long track record of successfully navigating and capitalizing on dynamic macro environments. We are incredibly well positioned to create value for all of our stakeholders and ensure a bright future for our company."

Second Quarter 2023

Revenue for the quarter declined 3% to $10.69 billion in 2023, versus $10.97 billion in 2022. Organic revenue was 3% lower, Core organic revenue growth was 2%, and COVID-19 testing revenue was $0.08 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2023 was $3.51, versus $4.22 in the same quarter last year. GAAP operating income for the second quarter of 2023 was $1.58 billion, compared with $2.00 billion in the year-ago quarter. GAAP operating margin was 14.8%, compared with 18.2% in the second quarter of 2022.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2023 was $5.15, versus $5.51 in the second quarter of 2022. Adjusted operating income for the second quarter of 2023 was $2.37 billion, compared with $2.61 billion in the year-ago quarter. Adjusted operating margin was 22.2%, compared with 23.7% in the second quarter of 2022.

Annual Guidance for 2023

Given the macroeconomic environment, Thermo Fisher is revising revenue and adjusted EPS guidance for the full year. The company now expects 2023 revenue to be a range of $43.4 to $44.0 billion, with Core organic revenue growth of 2 to 4%, and adjusted EPS of $22.28 to $22.72.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Bio-Rad and QIAGEN announce patent settlement and cross-licensing agreement

On July 26, 2023 Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that the companies have agreed to settle their patent dispute pending in the U.S. District Court of Delaware pursuant to a global settlement and patent cross-licensing agreement relating to digital PCR technology (Press release, Qiagen, JUL 26, 2023, View Source [SID1234633435]).

The settlement provides for a cross-licensing agreement between Bio-Rad and QIAGEN granting each company mutual rights to their respective digital PCR technologies.

Prestige Biopharma completed the patient recruitment of 650 participants for the global Phase 3 clinical trial of Avastin biosimilar, HD204

On July 26, 2023 Prestige BioPharma (CEO Lisa Soyeon Park) reported that the company has completed the global Phase 3 clinical trial patient recruitment for the Avastin biosimilar (Bevacizumab biosimilar), HD204 (Press release, Prestige BioPharma, JUL 26, 2023, View Source [SID1234633433]).

According to the company, the clinical trial for HD204 with 650 enrolled patients is progressing smoothly, and they plan to apply for product approval as soon as valid data is secured by the end of this year. Additionally, Prestige BioPharma aims to expedite the commercialization process by rapidly completing the Phase 3 clinical trial for HD204, along with HD201 (Herceptin biosimilar), for which the European Medicines Agency (EMA) approval application is imminent.

The global Phase 3 clinical trial for HD204, conducted by Prestige BioPharma, spans multinational clinical trial sites and it involves a total of 650 patients as a large-scale project. Despite some delays in patient recruitment in certain countries due to the COVID-19 pandemic situation over the past two years, the company announced that they have recently completed recruitment up to the 650th patient and are progressing with drug administration swiftly. Especially for a large-scale Phase 3 trial, it is expected that this completion of patient recruitment will accelerate the overall pace of the clinical trial.

Furthermore, with the completion of patient recruitment for the global Phase 3 trial, Prestige BioPharma plans to pursue an aggressive product approval strategy to expedite the commercialization process. For the approval and sales of HD204 in Europe and the United States, the company has partnered with Intas Pharmaceuticals, which achieved 2 trillion won in sales last year and has a global sales network covering 85 countries, along with their subsidiary, Accord Healthcare, in the UK. Accord Healthcare is a global emerging player that has submitted more than 50 drug approval applications to the EMA since 2011 and is committed to immediately entering the fast-track commercialization process as soon as valid data for HD204 is secured.

Prestige BioPharma’s CEO, Lisa Soyeon Park, stated, "HD204 has already entered into licensing agreements for commercialization with Accord Healthcare and Pharmapark, and active discussions on sales-related partnerships with other global pharmaceutical companies are also underway." She further emphasized that as an antibody bio-pharmaceutical company with diverse pipelines of biosimilars and novel antibody drugs, they will accelerate commercialization through cooperative competition (co-opetition) with global pharmaceutical companies, focusing on advancing clinical progress and securing sales.