Small Cell Carcinoma

BASKING RIDGE, N.J. & RAHWAY, N.J.--( BUSINESS WIRE )--Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, have expanded their existing global co-development and co-commercialization agreement for three investigational DXd antibody drug conjugates to include Merck’s MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager. The companies will jointly develop and commercialize MK-6070 worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. MK-6070 is a T-cell engager targeting DLL3, an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors, currently being evaluated in a phase 1/2 clinical trial . The companies are planning to evaluate MK-6070 in combination with ifinatamab deruxtecan (I-DXd) in certain patients with SCLC, as well as other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics. “ Expanding our oncology pipeline with a DLL3 T-cell engager further supports Daiichi Sankyo’s strategy to create new standards of care for patients with cancer worldwide,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “ We look forward to continuing our relationship with Merck with the addition of MK-6070 as it provides potential synergies with our established antibody drug conjugate collaboration, particularly ifinatamab deruxtecan, and demonstrates our shared commitment to advancing new medicines for patients.” “ Small cell lung cancer is an aggressive, fast-growing form of lung cancer and new treatment approaches are urgently needed,” said Dean Y. Li, MD, PhD, President, Merck Research Laboratories. “ We are pleased to build upon our collaboration with Daiichi Sankyo and look forward to evaluating the combination of MK-6070 and ifinatamab deruxtecan as a novel two-pronged approach targeting the underlying biology of small cell lung cancer along with other forms of cancer.” Financial Highlights Under the terms of the agreement, Merck will receive an upfront cash payment of $170 million and has also satisfied a contingent quid obligation from the original collaboration agreement. The companies will share R&D and commercialization expenses as well as profits worldwide, except for Japan where Merck retains exclusive rights and Daiichi Sankyo receives a royalty based on sales. R&D expenses related to MK-6070 in combination with ifinatamab deruxtecan will be shared in a manner consistent with the original agreement for ifinatamab deruxtecan. Merck will generally record sales for MK-6070 worldwide. About DLL3 Delta-like ligand 3 (DLL3), a Notch inhibitory ligand, is highly expressed on SCLC and other neuroendocrine tumors such as melanoma, small cell bladder cancer and metastatic castration resistant prostate cancer and is minimally expressed in normal tissues. 1 DLL3 is a promising therapeutic target where multiple treatment approaches are being explored. 1, 2 About MK-6070 MK-6070 is an investigational DLL3 directed tri-specific T-cell engager currently being evaluated in a phase 1/2 clinical trial as a monotherapy in certain patients with advanced cancers associated with expression of DLL3 and in combination with atezolizumab in certain patients with SCLC. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC in March 2022. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo is solely responsible for manufacturing and supply. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com . Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). References: 1 Owen D, et al. Journal of Hematology & Oncology . 2019; 12,61 2 Rudin C, et al. Journal of Hematology & Oncology . 2023; 16,66

Its prioritized programs demonstrate the greatest overall potential and near-term milestones, Carisma CEO Steven Kelly said. Carisma Therapeutics plans to let go of 37% of staffers and drop one of two clinical assets in an effort to fuel the immunotherapy-focused biotech into the third quarter of 2025. The update, shared this morning, sent the company’s stock down 9%, slipping from $2.27 per share at market open to $2.08 as of 12:30 p.m. ET today.    Since increasing its head count via a reverse merger with Sesen Bio in March 2023, Carisma's personnel costs have climbed. Now, the biotech is trimming the team and implementing a revised operating plan designed to cut general and administrative expenses, according to the April 1 release. Part of the restructure includes stopping development of CT-0508, a chimeric antigen receptor macrophage (CAR-macrophage) being studied among patients with HER2 overexpressing solid tumors in an open-label phase 1 trial. Last fall, the biotech shared early data from 14 patients that found the investigational treatment was well tolerated, remodeled the tumor microenvironment and induced anti-tumor T-cell immunity in certain patients. Despite this, Carisma sees more promise in its chimeric antigen receptor-monocyte (CAR-monocyte) approach and plans to stop recruiting new patients for the CT-0508 trial. The biotech is also ending a sub-study that evaluated CT-0508 in combination with Keytruda. Carisma will instead focus on CT-0525, an ex vivo gene-modified autologous CAR-monocyte cell therapy designed to treat solid tumors that overexpress HER2. An open-label phase 1 clinical trial assessing the candidate launched at the beginning of this year, according to ClinicalTrials.gov. The company expects to dose the first patient in the CT-0525 study in the second quarter and plans to report initial data by the end of 2024. The early-stage study has an estimated enrollment of six patients and a primary completion date set for March 2025. Carisma believes CT-0525 will build on the clinical anti-tumor activity observed with CT-0508 while allowing for significant dose escalation, improved tumor infiltration, increased persistence and reduced manufacturing time compared to CT-0508. Other prioritized pipeline programs include an in vivo CAR-M pact with Moderna. In 2022, the Big Biotech paid out $45 million in cash to work with Carisma on redirecting endogenous myeloid cells against tumor-associated antigens using mRNA/LNP. The prioritized programs demonstrate the greatest overall potential and near-term milestones, Carisma CEO Steven Kelly said in the April 1 release. The Philadelphia-based biotech is also pausing development of CT-1119, a preclinical anti-mesothelin CAR-monocyte, pending additional financing, according to the release. As of Dec. 31, 2023, Carisma had $77.6 million on hand, cash that is expected to fund the biotech after restructuring efforts take effect into the third quarter of 2025.

DUBLIN--( BUSINESS WIRE )--The "Prevention and Treatment of Prostate Cancer: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. The global market for prostate cancer care reached $35.3 billion in 2022. This market is expected to reach $56.4 billion by the end of 2028, growing at a CAGR of 8.3% from 2023 through 2028. As the second most diagnosed male cancer in the world, prostate cancer affects roughly 1.4 million people and kills more than 370,000 men each year, which represents about 4% of all cancer deaths worldwide. This cancer ranges from being a non-aggressive, slow-growing type that can do without treatment to an aggressive, fast-growing disease that needs intervention and timely treatment. Hence, early detection/screening, diagnosis and staging of prostate cancer are critical. The global market for prostate cancer screening and detection is projected to grow at a CAGR of 5.8% to reach $19.8 billion by the end of 2028. It is estimated that over 60% of age-eligible men remain unscreened for prostate cancer. A large, underserved population of unscreened and inadequately screened patients represents a significant opportunity for non-invasive biomarker tests in the prostate cancer screening market. The global market for prostate cancer pharmaceuticals was valued at $16.0 billion in 2022 and is expected to reach $29.6 billion by the end of 2028, at a CAGR of 11.0% during the forecast period. Continued incidence of prostate cancer, the world's growing elderly population, and increasing therapeutic innovations are key driving factors in the market for prostate cancer drugs. The direct cost for radical prostatectomy was estimated at $3.6 billion in 2022. This cost is expected to rise to $4.8 billion by the end of 2028. The growing popularity of robot-assisted laparoscopic prostatectomy (RALP) is expected to impact the overall radical prostatectomy market. Improved screening programs will result in an increase in radical prostatectomies, as this procedure is preferred in early detection stages. The radiotherapy device market is expected to grow as the incidence of prostate cancer worldwide continues to increase and better and more accurate imaging technologies combined with precise treatment strategies are developed. This market is expected to reach $2.2 billion by the end of 2028. This research study analyzes the state of prostate cancer care, including screening, detection and treatment, offers revenue forecasts, assesses future trends, and provides recommendations for the success of market participants. The scope of the study is global. This report estimates market data for 2022 (the base year) and provides forecasts for 2023 through 2028. Figures for 2023 are estimated, except where actual results have been reported. This report includes forecasts by product type and region from 2023 through 2028. Genetic testing for inherited prostate cancer risk assessment is beyond the scope of the report. The Report Includes 31 data tables and 63 additional tables An overview of the global market for the technologies for prevention and treatment of prostate cancer Analysis of global market trends, featuring historical revenue data for 2020-2022, estimated figures for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028 Evaluation of the current market size and revenue growth prospects specific to prevention and treatment of prostate cancer, accompanied by a market share analysis by test type, treatment type, drug type and geographic region Description of several types of prostate cancer, namely acinar adenocarcinoma, ductal adenocarcinoma, transitional cell (or urothelial) cancer, small cell prostate cancer and carcinoid and sarcomas Description of biomarker tests such as the prostate-specific antigen (PSA) test, digital rectal exam (DRE) and prostate biopsy, and a discussion on their advantages and limitations Information on poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, their limitations and approvals related to their use as targeted therapy for prostate cancer Coverage of approvals for metastatic castration resistant prostate cancer (mCRPC), and collaborations and licensing agreements for the treatment of prostate cancer Evaluation of the current and future market potential and an analysis of the regulatory framework and reimbursement scenarios Review of patents, product pipelines, ESG trends and emerging technologies related to prevention and treatment of prostate cancer Market share analysis of the key companies in the industry and coverage of mergers & acquisitions, joint ventures, collaborations, partnerships and other market strategies Profiles of leading market participants Key Attributes: Report Attribute Details No. of Pages 157 Forecast Period 2023 - 2028 Estimated Market Value (USD) in 2023 $37.9 Billion Forecasted Market Value (USD) by 2028 $56.4 Billion Compound Annual Growth Rate 8.3% Regions Covered Global Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview Prostate Cancer Biology of Prostate Cancer Symptoms Screening Diagnosis Localized Prostate Cancer Metastatic Prostate Cancer Watchful Waiting or Active Surveillance Treatment Chapter 4 Market Dynamics Market Drivers Increasing Prevalence of Prostate Cancer Active Surveillance and Screening Personalized Care Approvals for Metastatic Castration-Resistant Prostate Cancer Collaborations and Licensing Agreements Market Challenges Loss of Exclusivity and Genericization Shortage of Care Providers and Other Resources Market Opportunities Chapter 5 Screening and Diagnosis Market by Test Type Biomarker Tests PSA Tests Limitations of PSA Tests Biomarker Tests for Early Prostate Cancer Detection in Elevated PSA Settings Digital Rectal Exam Limitations of DREs Prostate Biopsy Grade (Gleason Score) of Prostate Cancer Prostatic Intraepithelial Neoplasia Atypical Small Acinar Proliferation Proliferative Inflammatory Atrophy Intraductal Carcinoma of the Prostate Limitations of Prostate Biopsies Imaging Technologies for Prostate Cancer Market for Prostate Cancer Screening/Diagnosis, by Test Type Biomarker Tests DREs Prostate Biopsies Chapter 6 Pharmaceuticals Market by Drug Type Hormone Therapy Androgen Deprivation Therapy Antiandrogen Therapies Hormone Therapy Uses in Prostate Cancer Treatment Targeted Therapy PARP Inhibitors Radioligand Therapies Small Molecule Targeted Agents Monoclonal Antibodies Chemotherapy Immunotherapy Market Revenue, by Drug Type Hormone Therapy Targeted Therapy Immunotherapy Chemotherapy Chapter 7 Market for Surgery and Radiation Therapy by Treatment Type Active Surveillance Radical Prostatectomy Robotic Prostatectomy Open Radical Prostatectomy Laparoscopic Prostatectomy Radical Prostatectomy Market Revenue Radiation Therapy External Beam Radiation Therapy Brachytherapy Combined Radiation Therapy Radiation Therapy Device Market Revenue Chapter 8 Market Breakdown by Region Chapter 9 Emerging Technologies and Developments Liquid Biopsy Multiparametric MRI Homologous Recombination Repair Gene Mutation Advanced Radiotherapy Techniques AI and Machine Learning Chapter 10 Pipeline Analysis Chapter 11 Competitive Intelligence Screening and Diagnosis Market Market for Radiation Therapy Devices Pharmaceuticals Market Chapter 12 Company Profiles Abbott Accuray Astellas Pharma Astrazeneca Bayer Danaher Corp. Dendreon Pharmaceuticals Elekta F. Hoffmann-La Roche Johnson & Johnson Services Pfizer Sanofi Siemens Healthineers For more information about this report visit https://www.researchandmarkets.com/r/wra8q3 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.