squamous cell lung carcinoma

SARASOTA, Fla. and MIAMI, Oct. 24, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility, today announced an update regarding its clinic trial plans. The Company received regulatory approval from the Israeli Ministry of Health in July 2024 and subsequent institutional review board clearance to initiate patient enrollment in up to 7 academic centers for its clinical trial evaluating the safety and efficacy of NY-303, its GPC3-targeting NK Engager bispecific antibody, as a monotherapy for the treatment of hepatocellular carcinoma in patients not responding to first-line immunotherapy. “With the completion of the recent merger, we can now begin our focus on planning for the initiation of clinical trials with our lead GPC3-targeting NK engager bispecific antibody, which is a significant milestone for NAYA Biosciences,” commented NAYA Biosciences President and NAYA Therapeutics CEO Dr. Daniel Teper. “We are passionate about bringing new options to patients not responding to first line immunotherapy and expect that positive Phase I safety and preliminary efficacy data will support accelerated clinical development in HCC as well as exploration in additional solid and pediatric tumors.” The Phase 1 part of the trial will consist of a dose-escalation where patients responding to treatment will continue weekly administration as long as no disease progression is observed. Key endpoints include safety, pharmacokinetics, activity markers, preliminary clinical efficacy, and time-to-progression. NAYA is planning to start patient recruitment in early 2025 at leading medical centers in Israel including Hadassah Hospital, Sheba Medical Center, and Sourasky Medical Center. The Phase 2a part of the trial is anticipated to be expanded to the United States and Europe subject to additional regulatory approvals and will evaluate NY-303 at two dose levels selected in Phase I. Key efficacy endpoints will include objective response rate and progression-free survival. “Hepatocellular carcinoma is a leading cause of cancer death worldwide with a rapidly increasing global trend,” commented NAYA Therapeutics Chief Medical Officer Dan Chiche, MD. “Currently, less than 30% of patients treated with current standard of care respond to immunotherapy (confirmed objective response) and mean progression-free survival is less than 7 months. NY-303’s dual targeting of NK cells and GPC3 is a unique, novel mechanism of action supported by scientific data showing potential to unlock non-response to checkpoint inhibitors.” About HCC Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, often developing in individuals with chronic liver conditions like hepatitis B or C, cirrhosis, and Metabolic Dysfunction-Associated SteatoHepatitis (MASH). HCC is a global health challenge, with over 900,000 new cases annually, making it the sixth most common cancer worldwide. The incidence of HCC in the United States has been steadily rising. Survival rates for HCC are often low due to late detection. The five-year survival rate for liver cancer in the United States is around 20%, but this varies widely depending on the stage at diagnosis. For early-stage HCC, where surgical resection or liver transplantation is possible, survival rates can improve dramatically, while advanced stages have far poorer outcomes. Globally, survival rates are similarly low, with wide variation based on healthcare access and screening programs. Recent advances in immunotherapy such as immune checkpoint inhibitors are offering new hope for patients with advanced HCC but new treatment approaches are still critical for improving survival and quality of life for patients. About NY-303 NY-303 is a first-in-class therapeutic candidate that leverages the engagement and activation of natural killer (NK) cells using a bispecific antibody targeting both GPC3, an oncofetal protein uniquely expressed on liver cancer cells, and NKp46, a cell surface receptor on natural killer (NK) cells that plays a central role in NK cell activation and the elimination of target cells. The unique mechanism enables NY-303 to turn the tumor form a “cold” into a ‘hot’ stage making liver cancer cells susceptible against immunotherapy to target and destroy cancer cells. This innovative approach is especially promising for patients with liver cancer, such as hepatocellular carcinoma (HCC), who face limited treatment options and poor survival rates but also for other GPC3-expressing tumors like lung squamous cell carcinoma, ovarian cancer, and pediatric cancer. Currently, liver cancer therapies include surgery, liver transplantation, targeted drugs, and immunotherapies like checkpoint inhibitors, but the prognosis remains grim, especially for advanced-stage disease. With a global five-year survival rate of around 20%, and even lower in more advanced cases, there is a critical need for more effective therapies. NY-303 represents a new opportunity for liver cancer patients by harnessing the body’s immune system to specifically attack tumor cells and engage NK-cells. Unlike traditional treatments, this therapy is designed to offer potent anti-cancer effects with a potentially safer profile, reducing the side effects often associated with chemotherapy and other conventional treatments and overcoming non-responding tumors against immunotherapies. For patients with HCC, NY-303 could significantly improve outcomes by offering a more precise, targeted approach to eradicating cancer, which is critical given the high recurrence rates and challenges in treating advanced liver cancer. As part of the next generation of immunotherapies, NY-303 may redefine treatment possibilities and offer renewed hope to those facing this difficult diagnosis. About NAYA BiosciencesNAYA Biosciences (NASDAQ: NAYA) is a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility. Our hub & spoke model harnesses the shared resources of a parent company and agility of lean strategic franchises, enabling efficient acquisition, development, and partnering of assets and allowing for optimized return on investment by combining scalable, profitable commercial revenues with the upside of innovative clinical-stage therapeutics. NAYA’s expanding portfolio of assets currently includes NY-303, a GPC3 and NKp46 targeting bispecific antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in early 2025, NY-338, a CD38 and NKp46 targeting bispecific antibody for the treatment of multiple myeloma and autoimmune diseases with a differentiated safety and efficacy profile, and INVOcell®, an FDA-approved fertility device which has demonstrated comparable success rates to traditional In Vitro Fertilization (IVF). Safe Harbor StatementThis release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise. NAYA Investor & Media ContactAnna Baran-DjokovicSVP, Investor Relations+1-305-615-9162anna@nayabiosciences.com

SAN DIEGO, Oct. 24, 2024 /PRNewswire/ -- SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, announced today its innovative two-step multi-cancer screening strategy at the Early Detection of Cancer Conference in San Francisco. This approach is designed to significantly alleviate the financial burden of population-wide screening, offering more affordable Multi-Cancer Early Detection (MCED) tests. SeekIn also debuted the findings from its lung cancer early detection test study, marking a significant advancement in the field of cancer screening. SeekIn's two-step multi-cancer screening strategy SeekIn proposes a two-step MCED screening approach, beginning with cost-effective initial tests like OncoSeek®, followed by advanced secondary tests such as SeekInCare® for those who test positive. This two-step approach has the potential to significantly reduce the financial burden compared to using NGS-based MCED tests for population-level screening. In a study with 1,197 participants (617 with cancer and 580 without), the two-step MCED approach achieved a remarkable 12.9-fold reduction in the false positive rate, from 9.0% to 0.7%. When applied to a hypothetical screening of five million adults, the strategy reduced total cost by 6.6-fold ($713.6 million compared to $4,745 million) and cost per cancer patient identified by 5.2-fold ($33,534 compared to $172,828), offering significant savings over an NGS-based MCED test to screen five million adults. Lung cancer early detection with LungCanSeek® SeekIn also presented its LungCanSeek® test, a blood-based, non-invasive, and cost-effective solution for lung cancer early detection. In a study of 1,814 participants (1,095 with lung cancer and 719 without cancer) from three cohorts, LungCanSeek showed 83.5% sensitivity and 90.3% specificity by combining artificial intelligence (AI) algorithms with four protein tumor markers (PTMs). Moreover, LungCanSeek can also predict the possible histological subtypes. With a 77.4% subtype classification accuracy, it could offer valuable guidance for subsequent diagnosis and treatment. For lung cancer screening, SeekIn also recommends a two-step strategy: initial screening with LungCanSeek, followed by low-dose computed tomography (LDCT) imaging for positive cases. This integrated approach leverages the strengths of both tests, reducing false positives by over 10-fold and costs by 2.5-fold compared to sole LDCT screening in high-risk populations. About OncoSeek® OncoSeek® has been developed as a multi-cancer detection test that uses artificial intelligence to distinguish between cancer patients and non-cancer individuals by calculating the probability of cancer (POC) index based on the plasma levels of seven PTMs (i.e. AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1), gender and age of the subjects. OncoSeek® is a non-invasive, efficient, and cost-effective approach for multi-cancer early detection. OncoSeek® received CE-IVD Mark in September 2022. About SeekInCare® With the mission to detect cancer while it is still curable, SeekInCare® has been developed as a pan-cancer detection test that takes a panoramic view of blood cell-free cancer signatures and a multi-omics approach incorporating genomic and epigenetic alterations in conjunction with clinically validated protein biomarkers. Equipped with proprietary AI- and big data-driven CRS algorithm, SeekInCare exhibits superior effectiveness to detect dozens of cancer types at high specificity. SeekInCare is intended for use in individuals with elevated risks of cancer such as smoking, chronic hepatitis, aging, etc., in conjunction with the approved conventional single-cancer type screening tests. SeekInCare received CE-IVD Mark in November 2021. About LungCan Seek ® LungCanSeek® was developed to distinguish lung cancer patients from non-cancer individuals and predict potential histological subtypes, lung adenocarcinoma (LUAD), lung squamous cell carcinoma (LUSC), and small cell lung cancer (SCLC). The test employs AI algorithms based on four PTMs, along with the subject's gender and age. It represents a non-invasive, efficient, and cost-effective approach for the early detection of lung cancer. About SeekIn SeekIn Inc is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its creation, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn has also developed novel molecular tests for leukemia patients and its cancer early detection technology has also successfully been applied to canines. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcomes of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products, visit . SOURCE SeekIn Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

On August 29, 2023, Merck officially announced that in view of the unsatisfactory clinical trial data and the efficacy did not meet expectations, it decided to discontinue two phase 3 studies on the PD-1 inhibitor Keytruda (Palizumab) in the treatment of lung and skin cancer, namely KEYNOTE-867 and KEYNOTE-630 studies.   The interim analysis showed that the combination of Keytruda and stereotactic radiotherapy (SBRT) did not significantly improve event-free survival or overall survival in patients with stage I or II non-small cell lung cancer (NSCLC), so Merck decided to terminate the KEYMAT-867 study. The study was designed to evaluate the efficacy of Keytruda in the treatment of NSCLC.   In terms of safety assessment, the combination of Keytruda and SBRT was associated with a higher incidence of adverse events, including some resulting in death, than the combination of placebo and SBRT. Based on these findings, Merck determined that the risk to benefit ratio of Keytruda in this indication does not support continuation of the trial.   At the same time, Merck also terminated the KEYKEY-630 Phase 3 study, which was looking at Keytruda as an adjunct therapy for patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) undergoing surgery and radiation therapy, versus a placebo. During the pre-analysis period, Keytruda failed to achieve statistical significance on the primary endpoint (relapse-free survival), and the Independent Data Monitoring Committee recommended discontinuing the KEYNOTE-630 study on the basis that its effect was not significant.   Although the pre-analysis data was negative for Keytruda, Merck noted that overall survival has not been formally evaluated. The safety profile of Keytruda in the KEYNOTE-630 study was consistent with previous findings. The company has notified the researchers to stop the study and advised patients participating in the study to negotiate alternative treatment options with their healthcare providers. Merck will continue to analyze data from both trials and plans to share the findings with regulators and the scientific community.   Cancer treatment is an important strategic direction for Merck, and Keytruda has been successfully or approved for marketing in several cancer types, including lung, kidney, skin, breast, cervical, bladder and other cancers. Merck currently has more than 30 Phase 3 clinical studies in early stage cancer, covering 10 cancer species. The termination of the KEYNOTE-867 and KEYNOTE-630 studies are two of them. In August, Merck also had to terminate a Phase 3 study that was evaluating the efficacy of the PD-1 inhibitor Keytruda in combination with the anti-Tigit antibody vibostolimab and chemotherapy as a first-line treatment for extensive small-cell lung cancer. At the time, the Data Monitoring Board found that the overall survival data for Keytruda in this indication was invalid. At the same time, safety concerns also emerged, with patients receiving the combination regimen showing a higher incidence of toxicity, including some immune-related toxicities.   In May, Merck terminated another Phase 3 trial of a combination of Keytruda and vibostolimab in resected high-risk melanoma patients. That same month, Merck announced that Keytruda failed to meet expectations in a Phase 3 study of endometrial cancer. In patients with newly diagnosed high-risk endometrial cancer, PD-1 blockers did not significantly improve disease-free survival compared with placebo as chemotherapy adjunctive treatment, with or without radiotherapy.