Latest news with #EGFR
Business Wire
14 hours ago
- Business
- Business Wire
Vir Biotechnology Announces First Patient Dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN™ Dual-Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors
SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Company's Phase 1 clinical trial evaluating VIR-5525, an investigational dual-masked T-cell engager (TCE) targeting EGFR (epidermal growth factor receptor). VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC). The Phase 1 clinical trial (NCT06960395) is a first-in-human open-label, non-randomized study designed to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab. VIR-5525 is Vir Biotechnology's third dual-masked TCE in clinical trials. It incorporates the Company's clinically validated in-licensed PRO-XTEN™ masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity. EGFR is a clinically validated target known to play a key role in cancer. 1 Although EGFR-targeting therapies are available, they often face limitations due to the development of resistance mechanisms 2 and high toxicities associated with treatment. 3 'We are excited to bring our third PRO-XTEN™ dual-masked T-cell engager VIR-5525 to the clinic as we further our mission of transforming the lives of people living with hard-to-treat solid tumors,' said Marianne De Backer, Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. 'This achievement is a testament of Vir Biotechnology's commitment to advancing innovative therapies that address substantial unmet needs in oncology.' 'EGFR has been well characterized as a key oncogenic driver and a marker of poor prognosis in cancer. Traditional therapies have significant limitations, creating a substantial unmet need for highly efficacious and well-tolerated options,' said Mark Eisner, MD, MPH, Chief Medical Officer, Vir Biotechnology. 'VIR-5525 harnesses the anti-tumor power of T-cell engagers with a dual-masking approach designed to unlock an expanded therapeutic index. We look forward to evaluating the potential of this clinical candidate in our Phase 1 trial.' The first patient dosing of VIR-5525 triggers a $75 million milestone payment as part of the Company's 2024 exclusive worldwide license agreement with Sanofi for the PRO-XTEN™ platform and clinical-stage T-cell engagers. This anticipated milestone payment has been held as restricted cash since the transaction closing and was excluded from the Company's $1.02 billion in cash, cash equivalents and investments reported as of March 31, 2025. The payment will be recognized as a research and development expense in the third quarter of 2025. Dose escalation continues for Vir Biotechnology's dual-masked TCEs VIR-5818 (targeting a variety of HER2-expressing solid tumors) and VIR-5500 (targeting PSMA in metastatic castration-resistant prostate cancer). Initial Phase 1 data presented in January 2025 showed compelling early clinical response signals and promising safety profiles for both clinical candidates in heavily pretreated patients. The Company is advancing multiple preclinical dual-masked TCEs against clinically validated targets with potential applications across a variety of solid tumors with high unmet need. These undisclosed candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using Vir Biotechnology's antibody discovery platform and the Company's proprietary dAIsY™ (d ata AI s tructure and antibod y) artificial intelligence engine. About VIR-5525 T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5525 is an investigational dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT06960395) designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab. VIR-5525 combines a bispecific EGFR and CD3 binding TCE with the PRO-XTEN™ masking technology. The PRO-XTEN™ masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked TCEs and increase their efficacy and tolerability. Additionally, the mask is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing for less frequent dosing regimens. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. Vir Biotechnology has exclusive rights to the PRO-XTEN™ masking platform for oncology and infectious disease. PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. References: 1 Sigismund S, Avanzato D, Lanzetti L. Emerging functions of the EGFR in cancer. Mol Oncol. 2017 Nov 27;12(1):3–20. 2 Hrustanovic G, Lee BJ, Bivona TG. Mechanisms of resistance to EGFR targeted therapies. Cancer Biol Ther. 013 Jan 28;14(4):304–314. 3 Zhao Y, Cheng B, Chen Z, Li J, Liang H, Chen Y, Zhu F, Li C, Xu K, Xiong S, Lu W, Chen Z, Zhong R, Zhao S, Xie Z, Liu J, Liang W, He J. Toxicity profile of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung cancer: A systematic review and network meta-analysis. Crit Rev Oncol Hematol. 2021 Apr; 160:103305; Liu T, Jiang S, Teng X, Zhong L, Liu M, Jin Y, Dong M. A comparison of panitumumab and cetuximab in the treatment of KRAS wild-type metastatic colorectal cancer: a systematic review and meta-analysis. Immunopharmacol Immunotoxicol. 2023 Feb; 45(1):1-9. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'should,' 'could,' 'may,' 'might,' 'will,' 'plan,' 'potential,' 'aim,' 'expect,' 'anticipate,' 'promising' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of VIR-5525, both as a monotherapy and in combination with pembrolizumab, as a treatment for a variety of EGFR-expressing solid tumors in areas of high unmet need, and Vir Biotechnology's belief that VIR-5525 and the PRO-XTEN™ masking technology can circumvent the traditionally high toxicity associated with unmasked TCEs and unlock an expanded therapeutic index; Vir Biotechnology's preclinical and clinical development plans and expectations for its TCE assets, including protocols for and enrollment into ongoing and planned clinical studies, potential dosing regimens, target endpoints and data readouts; Vir Biotechnology's delivery and recognition of the $75 million milestone payment pursuant to the 2024 exclusive worldwide license agreement with Sanofi; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; Vir Biotechnology's use of artificial intelligence and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later-stage or larger-scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology's available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology's filings with the U.S. Securities and Exchange Commission, including the section titled 'Risk Factors' contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Time Business News
a day ago
- Health
- Time Business News
Cutting-Edge Technologies in Lung Cancer Testing
A lung cancer diagnostic test is a medical procedure that is used to detect the presence of cancer cells in the lungs. These tests include imaging techniques (such as X-ray and CT scan), tissue biopsy, spit cytology, and advanced methods such as liquid biopsy and molecular tests to identify the type and phase of cancer. The growth of lung cancer diagnostic test market is inspired by increasing demand for personalized treatment based on the government's initiative for cancer screening and genetic profiling. Key Growth Drivers and Opportunities Rising Demand for Personalized Treatment: Increasing demand for personal treatment is significantly increasing the development of lung cancer diagnostic test market, as it requires accurate and wide diagnostic equipment to identify specific genetic mutations, biomarkers and cancer sub-types. Personal remedies, such as targeted drugs and immunotherapy, have greatly rely on accurate clinical consequences for tailor treatment schemes for individual patients. This has increased adopting advanced clinical techniques such as liquid biopsy, next generation sequencing (NGS), and molecular testing. Since healthcare provider and patients want more effective, less aggressive and sewn treatment approaches, the demand for high-collective clinical trials continues to promote market expansion. Challenges Lung cancer diagnostic test market faces many borders that can obstruct its growth and access. High costs associated with advanced clinical technologies such as PET scans, liquid biopsy and next generation sequencing make them less cheap in countries with less and moderate income. Additionally, delayed diagnosis in delayed diagnosis due to limited infrastructure, lack of efficient health professionals, and lack of awareness in the reduction of available tests. In some clinical methods, false positive or negative can also cause incorrect diagnosis, affecting the consequences of treatment. Regulatory barriers and variability in testing accuracy further limited widely adopting innovative clinical equipment in clinical settings. Innovation and Expansion An Innovative Lung Cancer Screening Trial for High-Risk Individuals has been launched by the EQUAL Study In May 2025, Researchers at the Dana-Farber Cancer Institute have begun testing a new, in-house blood test in an effort to screen for lung cancer and identify those who are at a higher risk of developing the disease even if they have never used tobacco. As lung cancer is becoming more common in younger people and among Asian or Hispanic/Latinx people who have never used tobacco, the team, led by the principal investigator and thoracic oncologist, associate director of Dana-Farber's Cancer Care Equity Program, designed the study. Epidermal growth factor receptor (EGFR) gene mutations can be common in the Asian and Hispanic/Latinx populations, which is the subject of the EQUAL (EGFR ctDNA Quantitative Assessment for Lung Cancer screening in Asian and Latinx populations) study. Possessing this mutation increases the risk of lung cancer because EGFR type mutations are linked to the illness. Additionally, the number of cancer diagnoses among Asian or Hispanic/Latinx individuals is increasing at a faster rate. The LuNGS Alliance has launched a Free NGS Biomarker Screening Program for Lung Cancer In March 2025, For patients with lung cancer throughout India, the Cancer Research and Statistics Foundation (CRSF)-led LuNGS Alliance has announced free lung NGS biomarker testing. AstraZeneca, Pfizer, and Roche support this program, and 4baseCare is the official lab partner. The initiative's goal is to raise awareness of precision oncology as a crucial, easily accessible, and reasonably priced therapy option for lung cancer. 4baseCare's TARGT First Solid test provides a thorough examination of 72 frequently mutated genes, revealing actionable biomarkers that allow for individualized treatment regimens based on each patient's own genetic profile. The test finds mutations that match FDA and NCCN-approved medications, enabling oncologists to offer more individualized, potent treatments that can greatly enhance patient outcomes. Inventive Sparks, Expanding Markets The key players operating in the lung cancer diagnostic test market includes Abbott, Illumina, Inc., Thermo Fischer Scientific, QIAGEN, Quest Diagnostics Incorporated, NeoGenomics, NanoString, Myriad Genetics Inc., F. Hoffmann-La Roche Ltd, Danaher, Agilent Technologies, Inc., AstraZeneca, Sanofi, and Janssen Pharmaceuticals, Inc. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
New Indian Express
3 days ago
- Health
- New Indian Express
Triplet therapy offers a cure for cancers resistant to conventional treatments
When standard cancer treatments begin to fail, especially in aggressive or advanced stages, oncologists are increasingly turning to a newer strategy known as 'triplet therapy'. Far from being just a combination of three drugs, this approach is designed to hit cancer from multiple angles at once — disrupting its growth, cutting off its support systems, and awakening the body's own immune response. Triplet therapy, doctors say, is now emerging as a powerful option for cancers that were once considered extremely difficult to manage, such as metastatic prostate cancer and advanced head and neck cancers. Triplet therapy works on the principle that cancer is not a static disease. It evolves, adapts, and finds new ways to bypass single-line or even double-line treatments. By using three agents, often from different therapeutic classes like chemotherapy, targeted therapy, and immunotherapy — doctors can slow down or stall this progression. Each component is chosen not just for its individual effect, but for how well it complements the others. This approach is proving particularly useful in cancers that have grown resistant to conventional methods. Low-dose strategy One of the most promising applications of triplet therapy is in advanced or recurrent head and neck cancers. These cases are often difficult to treat, especially when the patient is not strong enough to undergo high-dose chemotherapy or radiation. In such scenarios, oncologists are using a low-intensity yet smartly engineered regimen. It includes oral metronomic chemotherapy — typically methotrexate and celecoxib — given continuously at low doses to minimise toxicity. Instead of the traditional 'shock and kill' method of chemotherapy, this low-dose strategy steadily weakens the tumour by cutting off its blood supply (a process called anti-angiogenesis) and reducing its ability to recover. Alongside this, a targeted therapy like erlotinib is added to inhibit the epidermal growth factor receptor (EGFR), a common driver of cell growth in head and neck tumours. By blocking EGFR, cancer cell division slows dramatically. Completing the trio is low-dose nivolumab, an immune checkpoint inhibitor that helps the body's own T-cells recognise and attack the tumour, even when the immune system has become exhausted or desensitised. According to Dr Sreenivas BJ, consultant medical oncologist at HCG Cancer Centre, this approach is not just about survival — it improves symptoms, preserves quality of life, and most importantly, is affordable and feasible even in low-resource settings. Patients who would have previously received only palliative care now have a shot at active disease control. Meanwhile, another form of triplet therapy is showing promise in metastatic prostate cancer, particularly in patients whose disease continues to spread despite being on hormone therapy. This stage — known as metastatic castration-resistant prostate cancer — is notoriously difficult to manage. Doctors are now using a strategy that combines androgen deprivation therapy (ADT), targeted drugs, and chemotherapy to push back the disease. ADT reduces levels of testosterone and other male hormones that prostate cancer cells rely on. However, many tumours eventually find ways to grow despite this hormonal suppression. This is where targeted therapy comes in. Depending on the genetic mutations present in the tumour, drugs such as PARP inhibitors (like olaparib) may be added to exploit the cancer cells' weakened DNA repair mechanisms. Chemotherapy, typically using docetaxel, then directly attacks fast-dividing cells and works synergistically with hormone therapy. Dr Sai Vivek V, consultant in medical and haemato-oncology at Aster Whitefield Hospital, notes that this combination is not only delaying disease progression but also improving overall survival. In several cases, patients on this triplet regimen have lived longer and with better quality of life than those on standard therapy alone. Risks and side effects However, doctors believe that combining three potent agents naturally brings added complexity. Side effects differ based on the drugs used and the patient's overall condition. In the head and neck cancer regimen, side effects tend to be milder like fatigue, mild nausea, or skin rash due to the use of low-dose medications. In prostate cancer, where drugs are stronger, the risks include reduced blood counts (raising infection risk), gastrointestinal issues, and fatigue. Targeted therapies, while precise, can also affect healthy cells with similar biological markers, sometimes leading to high blood pressure or changes in liver enzyme levels. Doctors manage these risks through careful monitoring and dose adjustments. Supportive care is essential, including medications to boost blood counts, control nausea, or manage blood pressure. The goal is always to maintain the effectiveness of the treatment while keeping patients as comfortable and functional as possible, doctors explain. Layered approach What sets triplet therapy apart is its proactive, layered approach. Rather than waiting for one treatment to fail before adding another, oncologists say they are now designing therapies that strike on multiple fronts from the outset. This is a shift away from the traditional stepwise escalation model and reflects a more modern understanding of how cancer behaves in the body. In India, where cost and access to care remain critical concerns, the head and neck cancer model using low-dose oral drugs offers an especially practical solution. At the same time, genetic testing is becoming more accessible, allowing oncologists to tailor prostate cancer treatments to the specific mutations in a patient's tumour. However, experts say that triplet therapies are not without challenges but they represent a major evolution in how we think about cancer treatment — less about 'more drugs', and more about smarter combinations.
Yahoo
3 days ago
- Business
- Yahoo
Taiho Oncology and Cullinan Therapeutics Announce Acceptance of Abstracts for Zipalertinib at the IASLC 2025 World Conference on Lung Cancer
Updated efficacy data will be presented from the REZILIENT1 trial of zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab Preliminary findings to be shared from the cohort of patients with uncommon non-ex20ins EGFR mutations enrolled in the REZILIENT2 trial of zipalertinib PRINCETON, N.J. and CAMBRIDGE, Mass., July 22, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., today announced the presentation of new data from zipalertinib REZILIENT1 and REZILIENT2 trials at the International Association of the Study of Lung Cancer's (IASLC) 2025 World Conference on Lung Cancer (WCLC), to be held September 6-9, 2025, in Barcelona, Spain. The abstracts accepted for mini oral presentations include updated efficacy and safety data from the Phase 2b REZILIENT1 trial, focusing on patients with EGFR ex20ins NSCLC previously treated with amivantamab, as well as the preliminary efficacy and safety results from the Phase 2 parallel cohort REZILIENT2 trial in patients with advanced or metastatic NSCLC harboring uncommon non-ex20ins EGFR mutations. "Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to sharing updated data from the REZILIENT1 and REZILIENT2 trials at the upcoming 2025 World Conference on Lung Cancer, suggesting the potential for zipalertinib to make a meaningful difference in the lives of patients with certain types of NSCLC." "Despite advances in the treatment landscape, there remains significant unmet need for NSCLC patients with EGFR exon 20 insertion mutations and for those with uncommon non-ex20ins EGFR mutations," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Taken together, the updated results from REZILIENT1 and new data from the REZILIENT2 study highlight the potential of zipalertinib to play an important role in the evolving treatment landscape for patients with NSCLC harboring less common EGFR mutations." Session titles and information for the two abstracts are listed below. Full abstract details will be available via the conference website at 1 p.m. EDT August 13, 2025. Title: Zipalertinib in NSCLC Patients (Pts) With EGFR Exon 20 Insertion (Ex20Ins) Mutations Who Received Prior Amivantamab Session Name: MA08 - Common and Uncommon EGFR Mutations, New Treatments in the HorizonSession Type: Mini Oral PresentationSession Date: Tuesday, September 9, 2025Session Time: 11:30 a.m. – 12:45 p.m. CESTPresenter: Zofia Piotrowska, MD Title: Phase 2 Interim Results of Zipalertinib in Patients With NSCLC Harboring Uncommon Non-Exon 20 Insertion EGFR MutationsSession Name: MA08 - Common and Uncommon EGFR Mutations, New Treatments in the Horizon Session Type: Mini Oral PresentationSession Date: Tuesday, September 9, 2025Session Time: 11:30 a.m. – 12:45 p.m. CESTPresenter: Hibiki Udagawa, MD, PhD About ZipalertinibZipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About Taiho Oncology, mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. About Cullinan TherapeuticsCullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at and follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, and other statements that are not historical facts. The words "believe," "continue," "could," "estimate," "expect," "intends," "may," "plan," "potential," "project," "pursue," "will," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption "Risk Factors" in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts Taiho OncologyLeigh Labrie+1 609.664.9878 LLabrie@ Cullinan TherapeuticsInvestorsNick Smith+1 401.241.3516nsmith@ Media Rose Weldon +1 215.801.7644 rweldon@ View original content to download multimedia: SOURCE Taiho Oncology Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
6 days ago
- Business
- Globe and Mail
EGFR + NSCLC Pipeline Appears Robust With 25+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, 'EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Pipeline Insight, 2025' report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) pipeline landscape. It covers the EGFR + NSCLC pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore our latest breakthroughs in EGFR + NSCLC research. Learn more about our innovative pipeline today! @ EGFR + NSCLC Pipeline Outlook Key Takeaways from the EGFR + NSCLC Pipeline Report In July 2025, ETOP IBCSG Partners Foundation announced a primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with the third-generation EGFR-TKI lazertinib, in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial. In June 2025, BlossomHill Therapeutics conducted a study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles. In June 2025, Merck Sharp & Dohme LLC organized a study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). DelveInsight's EGFR + NSCLC pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for EGFR + NSCLC treatment. The leading EGFR + NSCLC Companies such as Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics and others. Promising EGFR+NSCLC Pipeline Therapies such as IN10018, Furmonertinib, Oral S-1 + Oral Osimertinib, YH25448, JS111 capsules (AP-L1898), Osimertinib, Gefitinib, RC108, Sunvozertinib, and others. Stay informed about the cutting-edge advancements in EGFR + NSCLC treatments. Download for updates and be a part of the revolution in cancer care @ EGFR + NSCLC Clinical Trials Assessment EGFR + NSCLC Emerging Drugs Profile CLN-081 is a novel irreversible Epidermal Growth Factor Receptor (EFGR) inhibitor. It is administered through oral route, and is developed by Cullinan Oncology. The drug is being developed in association with Taiho Pharmaceuticals. The drug is currently being investigated in the Phase III stage of development for the treatment of EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC). BPI-361175: Betta Pharmaceuticals BPI-361175 is a novel, oral, highly potent and selective 4th generation EGFR inhibitor developed by Betta Pharmaceutical Co., Ltd. The new chemical entity targets EGFR C797S mutation and other EGFR related mutations that are resistant to 3rd generation EGFR TKI in non-small cell lung cancer (NSCLC) and other solid tumors. It shows excellent inhibitory effect and selectivity in vitro assay and exhibits significant anti-tumor activity in a variety of xenograft models harboring EGFR C797S or other related mutations. The IND application of BPI-361175 has been approved by NMPA. Currently, the drug is the Phase I/II stage of its development for the treatment of Non-small Cell Lung Cancer. G1T38: G1 Therapeutics G1T38 is an investigational, oral CDK4/6 inhibitor designed to be used along with other targeted therapies for various oncology indications. G1 Therapeutics has entered a clinical trial collaboration to assess its G1T38 in combination with AstraZeneca's Tagrisso (osimertinib) in a Phase Ib/II clinical trial to treat patients suffering from EGFR mutation-positive non-small cell lung cancer (NSCLC). Currently, the drug is being evaluated in the Phase I/II stage in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer. JANX008: Janux Therapeutics JANX008, is a TRACTr that targets Epidermal Growth Factor Receptor (EGFR), and is being developed by Janux Therapeutics for the treatment of various solid tumors including non-small cell lung cancer. According to preclinical studies, JANX008 showed potent cleavage dependent anti-tumor activity, with limited toxicities in healthy tissues or CRS. JANX008, is currently being evaluated in phase I clinical trial for the treatment of various solid tumors. The EGFR + NSCLC Pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of EGFR + NSCLC with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for EGFR + NSCLC Treatment. EGFR + NSCLC Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. EGFR + NSCLC Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the EGFR + NSCLC market. Learn more about EGFR + NSCLC Drugs opportunities in our groundbreaking EGFR + NSCLC research and development projects @ EGFR + NSCLC Unmet Needs EGFR + NSCLC Companies Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics and others. EGFR Non-Small Cell Lung Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Subcutaneous Oral Intramuscular EGFR + NSCLC Products have been categorized under various Molecule types such as Monoclonal antibody Small molecule Peptide Discover the latest advancements in EGFR + NSCLC treatment by visiting our website. Stay informed about how we're transforming the future of oncology @ EGFR + NSCLC Market Drivers and Barriers, and Future Perspectives Scope of the EGFR + NSCLC Pipeline Report Coverage- Global EGFR + NSCLC Companies- Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics and others. EGFR+NSCLC Pipeline Therapies- IN10018, Furmonertinib, Oral S-1 + Oral Osimertinib, YH25448, JS111 capsules (AP-L1898), Osimertinib, Gefitinib, RC108, Sunvozertinib, and others. EGFR + NSCLC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination EGFR + NSCLC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III For a detailed overview of our latest research findings and future plans, read the full details of EGFR + NSCLC Pipeline on our website @ EGFR + NSCLC Emerging Drugs and Companies Table of Contents Introduction Executive Summary EGFR Non-Small Cell Lung Cancer: Overview Pipeline Therapeutics Therapeutic Assessment EGFR Non-Small Cell Lung Cancer – DelveInsight's Analytical Perspective Late Stage Products (Phase III) CLN-081: Cullinan Oncology Drug profiles in the detailed report….. Mid Stage Products (Phase II) Drug Name: Company Name Drug profiles in the detailed report….. Early Stage Products (Phase I/II) BPI-361175: Betta Pharmaceuticals Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Key Companies EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Key Products EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Unmet Needs EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Market Drivers and Barriers EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Future Perspectives and Conclusion EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Analyst Views EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. 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