Adenocarcinoma of Lung

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

First human imaging data validate the potential of MT1-MMP as a novel target in the treatment of cancer and demonstrate positive properties of Bicycle Radionuclide Conjugates (BRC ® ) for radiopharmaceutical use Additional preclinical data demonstrate biodistribution of BRCs can be optimized to maintain high tumor uptake while significantly reducing kidney levels Company strategy focuses on pursuing novel targets using a range of isotopes to develop radiopharmaceuticals with first-in-class potential Bicycle Therapeutics to host conference call and webcast today at 8 a.m. ET CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ® ) technology, today announced the presentation of the first human imaging data validating the potential of MT1-MMP as a novel target in the treatment of cancer and demonstrating the positive properties of Bicycle Radionuclide Conjugates (BRC ® ) for radiopharmaceutical use, as well as preclinical data demonstrating optimized BRC radioisotope delivery at the European Association of Nuclear Medicine (EANM) 2024 Congress in Hamburg, Germany. “Since our founding, our goal at Bicycle Therapeutics has been to leverage the power of our platform in areas where we can have the most impact for patients. Over the years, we have built a robust pipeline of oncology therapies that includes targeted drug conjugates, immuno-oncology agents and now, radiopharmaceuticals,” said CEO Kevin Lee, Ph.D. “The exciting data presented at EANM underscore the potential of our Bicycle Radionuclide Conjugates to deliver a range of isotopes to novel cancer targets. Through our strategy of pursuing novel targets with first-in-class potential and selecting the isotope that best aligns with the target biology and indication, we have an opportunity to potentially broaden the use of radiopharmaceuticals to diagnose and treat cancer.” In line with Bicycle Therapeutics’ radiopharmaceuticals strategy, the company selected tumor antigen EphA2 as its second BRC target and signed a letter of intent with leading isotope technology company Eckert & Ziegler to put in place an agreement to supply a range of radioisotopes and develop and manufacture BRC molecules. Bicycle Therapeutics, through its internal pipeline of wholly owned molecules and strategic collaborations with industry and academic leaders in the field, aims to be at the forefront of the development of next-generation radiopharmaceutical therapies. Bicycle ® molecules have ideal properties for radioisotope delivery due to their low molecular weight, high selectivity and affinity for their intended target and rapid systemic clearance. “The data presented at EANM demonstrate how our Bicycle ® platform is a powerful tool for de novo identification of high-quality binders to important cancer targets. We believe the ability to optimize the biodistribution properties of our molecules, significantly reducing kidney retention while retaining rapid, selective uptake in tumors, position Bicycle Radionuclide Conjugates as a potentially best-in-class approach for targeted radionuclide therapy,” said Michael Skynner, Ph.D., chief technology officer of Bicycle Therapeutics. “MT1-MMP is the first target for radiopharmaceutical development that we are pursuing given its expression in many solid tumors such as non-small cell lung cancer, esophageal and triple negative breast cancer.” EANM 2024 Congress Data Highlights During an oral presentation, the German Cancer Consortium (DKTK) presented first human imaging data for a BRC targeting MT1-MMP. They focused on a case study in a 65-year-old male diagnosed with advanced pulmonary adenocarcinoma, the most common type of non-small cell lung cancer, in the lung and lymph nodes confirmed by endobronchial ultrasound (EBUS) biopsy. The patient received fluorine-18-labelled FDG-PET/CT imaging, and two weeks later received MT1-MMP PET/CT imaging up to one hour post injection of the gallium-68-labelled BRC tracer. Both scans revealed multiple lymph node metastases and bone metastases in the sternum. MT1-MMP imaging demonstrated tracer uptake in the primary tumor in the lung and lymph node and bone metastases, consistent with FDG imaging. Additionally, the MT1-MMP BRC tracer showed renal excretion, with all other organs showing only negligible tracer uptake. Clear imaging contrast was also observed at early time points. In an e-poster, Bicycle Therapeutics presented preclinical data demonstrating the suitability of Bicycle molecules to deliver indium to tumors in vivo due to their favorable properties, including specific tumor uptake, rapid tumor penetration and rapid renal elimination. Additionally, imaging showed how the biodistribution pro BRCs can be optimized to maintain high tumor uptake and retention while significantly reducing kidney uptake and retention. These data build on the body of preclinical data the company has published in this area demonstrating the use of Bicycle molecules to effectively deliver various radioisotopes, such as lutetium and lead, to tumors. Altogether, the data presented at EANM validate the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrate the translatability of BRC preclinical data and highlight the potential of Bicycle molecules for targeted radionuclide therapy. The e-poster, “Bicycle Radionuclide Conjugates for radioisotope delivery to solid tumors,” is available in the Publications section of the Bicycle Therapeutics website. Conference Call Details Bicycle Therapeutics will host a conference call and webcast today, Oct. 23, at 8 a.m. ET to review the first human imaging data and outline the company’s radiopharmaceuticals strategy. To access the call, please dial 833-816-1408 (U.S.) or +1-412-317-0501 (international) and ask to join the Bicycle Therapeutics call. A live webcast and replay of the conference call will be accessible in the Investor section of the Company’s website at . About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Toxin Conjugate (BTC ® ) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ® ) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle Radionuclide Conjugates (BRC ® ) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit . Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding validation of MT1-MMP as a target for the treatment of cancer, the suitability of BRCs for radiopharmaceutical use and the potential of this approach; Bicycle’s plans for an agreement with Eckert & Ziegler to develop, manufacture and supply a range of radioisotopes; Bicycle’s anticipated progress across its internal and partnered pipelines in radiopharmaceuticals, the translatability of Bicycle’s BRC preclinical data and the ability of the Bicycle platform to identify binders for cancer targets; Bicycle’s development across its R&D pipeline and the advancement of its product candidates, including zelenectide pevedotin, BT5528 and BT7480; and the therapeutic potential for Bicycles in oncology and other applications. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in research and development and in the initiation, progress and completion of preclinical studies and clinical trials and the identification and development of Bicycle’s potential and current product candidates; the risk that Bicycle may not realize the intended benefits of its platform, technology or partnerships; timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; the risk that preclinical studies and clinical trials may have unsatisfactory outcomes; potential adverse effects arising from the testing or use of Bicycle’s product candidates; the risk that Bicycle’s management have not focused the company’s activities on the clinical programs and research areas with the highest potential to maximize value creation; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 2, 2024, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts Investors: Stephanie Yao SVP, Investor Relations and Corporate Communications stephanie.yao@bicycletx.com 857-523-8544 Matthew DeYoung Argot Partners ir@bicycletx.com 212-600-1902 Media: Jim O’Connell Weber Shandwick media@bicycletx.com 312-988-2343

AstraZeneca's TKI Tagrisso generated sales of $5.8 billion last year but Johnson & Johnson's Rybrevant is poised to make its mark in the non-small cell lung cancer (NSCLC) market. The J&J med has picked up three FDA approvals in different NSCLC indications in the last seven months. Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC).Rybrevant has earned its third FDA nod in the last seven months, each covering a new indication. The U.S. regulator has signed off on Rybrevant plus standard-of-care chemotherapy (carboplatin and pemetrexed) to treat patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations who have had disease progression with an EGFR tyrosine kinase inhibitor (TKI).Rybrevant plus chemo is the first targeted regimen to cut the risk of disease progression by more than half in second-line EGFR-mutated advanced lung cancer, J&J said.The endorsement comes a month after J&J’s combo of Rybrevant and new, Yuhan-partnered TKI, Lazcluze, got a thumbs up for patients with newly diagnosed EGFR-mutated advanced NSCLC with one of the two common EGFR mutations at exon 19 or exon 21. That nod was backed by a phase 3 trial which showed that the combo reduced the risk of disease progression or death by 30% compared to Tagrisso as a first-line treatment.In March, the FDA blessed Rybrevant plus chemotherapy as a first-line treatment for NSCLC with EGFR exon 20 insertion mutations. That approval came after a study showed the combo cut the risk of progression or death by 60% over standard of care chemo.  The most recent FDA endorsement is based on results from the phase 3 MARIPOSA-2 study which showed that Rybrevant plus chemotherapy reduced the risk of disease progression or death by 52% over chemotherapy alone in patients who had shown disease progression on or after use of Tagrisso.Patients in the study survived without disease progression for a median duration of 6.3 months on the combo versus 4.2 months for chemo alone. Additionally, the overall response rate for those on the combo was 53% compared to 29% for the chemo group.“Rybrevant plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib (Tagrisso), in the first line,” Martin Dietrich, M.D., Ph.D., an oncologist at the Cancer Care Centers of Brevard, said in a release. The advancement of Rybrevant is positive news as the five-year survival rate is less than 20 percent for all people with advanced EGFR-mutated NSCLC. In the U.S. about 30,000 are diagnosed annually with EGFR-mutated NSCLC, J&J said.With the battery of approvals, Rybrevant is poised to begin to challenge Tagrisso, which generated sales of $5.8 billion in 2023.