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DUBLIN--( BUSINESS WIRE )--The "Anti TIGIT Antibodies Clinical Trials & Market Opportunity Outlook 2028" report has been added to ResearchAndMarkets.com's offering. Anti TIGIT antibodies have emerged a promising approach in cancer immunotherapy, offering new hope for patients with various types of cancers, particularly solid cancers. TIGIT (T cell immunoreceptor with Ig and ITIM domains) is an inhibitory receptor expressed on T cells and natural killer (NK) cells, playing a crucial role in modulating immune responses. By targeting TIGIT, researchers aim to enhance the immune system's ability to recognize and eliminate cancer cells, potentially revolutionizing cancer treatment strategies. The therapeutic potential of TIGIT as a target for cancer immunotherapy lies in its function as an immune checkpoint molecule. When TIGIT interacts with its ligands, such as CD155 and CD112, it suppresses T cell sand NK cell activation, potentially allowing cancer cells to evade immune surveillance. By blocking this interaction with anti-TIGIT therapeutic approaches, researchers hope to reinvigorate the immune response against tumors, leading to improved clinical outcome for cancer patients. Among the various approaches for targeting TIGIT, monoclonal antibodies have emerged as the most widely used and promising agents. These antibodies are designed to specifically bind to TIGIT, preventing its interaction with its ligands and thus releasing the "breaks" on the immune system. Their high specificity and relatively low toxicity of antibodies make them attractive candidates for clinical development. The field of anti-TIGIT antibody development has seen rapid progress, with over 50 candidates currently in clinical development. This robust pipeline underscores the significant interest and potential of this approach in cancer treatment. Among these, more than five anti TIGIT antibodies have advanced to phase 3 clinical trials, representing the most advanced stage of clinical development before potential regulatory approval. These include Vibostolimab, Tiragolumab and Ociperlimab, developed by the pharmaceutical marker leaders, Merck Genentech and BeiGene, respectively. These phase 3 clinical trials are assessing the safety and efficacy of these anti-TIGIT antibodies in various cancer types, with a particular focus on non-small cell lung cancer (NSCLC). The emphasis on NSCLC is not surprising, given its high prevalence and the need for more effective treatment options. NSCLC represents a significant portion of lung cancer cases and has shown promising responses to immunotherapy approaches in the past. Several key factors are driving the market potential of anti-TIGIT antibodies. Firstly, there remains a substantial unmet medical need in cancer treatment, especially for patients who do not respond to or develop resistance to existing immunotherapies. Anti-TIGIT antibodies offer a novel mechanism of action that could address these challenges. Moreover, these antibodies show promising results in combination with established therapies like PD-1/L1 inhibitors, potentially expanding the market for both drug classes and improving treatment outcomes. This becomes visible in Merck's vision of developing a coformulation of its anti-TIGIT antibody Vibostolimab with its blockbuster anti-PD-1 antibody pembrolizumab for the treatment of various solid tumors. The broad applicability of anti-TIGIT antibodies across various cancer forms presents another significant market opportunity. While a majority of clinical trials currently focus on NSCLC, many other ongoing clinical trials are exploring their efficacy in other solid cancers tumors and hematological malignancies, which could lead to multiple approved indications, consequently increasing the anti-TIGIT antibody market size. As evident from the examples above, the competitive landscape for the anti-TIGIT antibody market is dynamic, with major pharmaceutical companies and biotechnology firms vying for market share. While Vibostolimab leverages the company's strong position in the immuno-oncology market, another, Domvanalimab, being developed by Gilead Sciences and Arcus Biosciences, benefits from a partnership between a major pharmaceutical company and a competent biopharmaceutical company. In conclusion, anti-TIGIT antibodies not only represent a significant advancement in cancer immunotherapy, but also present many opportunities for drug development and market expansion. With its potential to address unmet medical needs, broad applicability and alignment with personalized medicine, this emerging class of drugs is poised to capture a substantial portion of cancer immunotherapy market. Anti TIGIT Antibodies Clinical Trials & Market Opportunity Outlook 2028 Report Highlights: Anti TIGIT Antibodies in Clinical Trials: > 50 Antibodies First Anti TIGIT Antibody to Get Approval Within Next 5 Years Global Anti TIGIT Antibodies Clinical Pipeline Insight by Company, Indication and Phase Insight on More Than 50 Anti TIGIT Antibodies in Clinical Trials Anti TIGIT Antibodies Market Trends by Indication & Country Global Anti TIGIT Antibodies Market Dynamics Key Topics Covered: 1. Introduction to Anti TIGIT Antibody 1.1 Overview 1.2 Mechanism of Anti TIGIT Antibodies 1.3 Clinical Approaches to Target TIGIT 2. Global Anti TIGIT Antibodies Clinical Trials Overview 2.1 By Company 2.2 By Country 2.3 By Indication 2.4 By Patient Segment 2.5 By Phase 3. Global Anti TIGIT Antibodies Clinical Pipeline By Company, Indication and Phase 3.1 Research 3.2 Preclinical 3.3 Phase I 3.4 Phase I/II 3.5 Phase II 3.6 Phase III 4. Global Anti TIGIT Antibodies Market Outlook 4.1 Current Clinical & Market Trends 4.2 Future Market Outlook 5. Anti TIGIT Antibodies Market Trends by Indication 5.1 Cancer 5.2 Autoimmune & Inflammatory Disorders 5.3 Microbial Infections 6. Anti TIGIT Antibodies Market by Country 6.1 US 6.2 China 6.3 South Korea 6.4 Australia 6.5 UK 7. Combinations Approaches for TIGIT Therapy 8. TIGIT Co Inhibition with PD1 or PDL1 9. Global Anti TIGIT Antibodies Market Dynamics 9.1 Market Drivers 9.2 Commercialization Challenges 10. Competitive Landscape Akeso Biopharma BeiGene Bio-Thera Solutions Biotheus Compugen FutureGen Biopharmaceutical Merck Sharp & Dohme Nanjing Sanhome Pharmaceutical OriCell Therapeutics Phio Pharmaceuticals Roche Shanghai Henlius Biotech Shanghai Junshi Biosciences Simcere Pharmaceutical Group Tasrif Pharmaceutical For more information about this report visit https://www.researchandmarkets.com/r/sebifx 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.

RAHWAY, NJ, USA I August 08, 2024 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC). The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA ® ), Merck’s anti-PD-1 therapy, in combination with chemotherapy compared to atezolizumab in combination with chemotherapy, for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). At a pre-planned analysis, data showed that the primary endpoint of overall survival (OS) met the pre-specified futility criteria. Additionally, when compared to patients in the control arm, patients in the vibostolimab and pembrolizumab fixed-dose combination arm experienced a higher rate of adverse events (AEs) and immune-related AEs. A comprehensive analysis of this study is ongoing. Merck is notifying study investigators of the decision and that patients should stop ongoing treatment with the fixed-dose combination of vibostolimab and pembrolizumab and be offered the option to be treated with atezolizumab. Results will be shared with the scientific community. “Small cell lung cancer remains a difficult disease to treat, as evident by the seven percent five-year survival rate and limited advancements in treatment options,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “Innovative research plays a critical role in improving our understanding to help patients achieve better outcomes, and while we hoped the results would be different, we remain committed to investigating novel approaches to treat this debilitating disease. We are extremely grateful to all of the patients, caregivers and investigators for their participation in this study.” Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. In SCLC, Merck and Daiichi Sankyo recently announced that the first patient has been dosed in the IDeate-Lung02 Phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed SCLC versus treatment of physician’s choice of chemotherapy. Merck and Daiichi Sankyo also 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 that is currently being evaluated in a Phase 1/2 clinical trial (NCT04471727). The companies are planning to evaluate MK-6070 in combination with I-DXd in certain patients with SCLC, as well as other potential combinations. Merck obtained MK-6070 through its acquisition of Harpoon Therapeutics. Ongoing Phase 3 studies evaluating the vibostolimab and pembrolizumab fixed-dose combination in lung cancer, which are routinely monitored by external data monitoring committees, include KeyVibe-003 , KeyVibe-006 and KeyVibe-007 . Interim external data monitoring committee safety reviews have not resulted in any study modifications to date and the studies are undergoing ongoing comprehensive safety monitoring. About KeyVibe-008 KeyVibe-008 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05224141 ) evaluating a fixed-dose combination of vibostolimab and pembrolizumab (MK-7684A) in combination with etoposide and platinum chemotherapy followed by the vibostolimab and pembrolizumab fixed-dose combination versus atezolizumab in combination with etoposide and platinum chemotherapy followed by atezolizumab for the first-line treatment of patients with ES-SCLC. The primary endpoint is OS, and key secondary endpoints include progression-free survival, objective response rate, duration of response, all as assessed by blinded independent central review (BICR). The trial enrolled 460 patients who were randomized (1:1) to receive: About lung cancer Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. In 2024, the overall five-year survival rate for patients diagnosed with lung cancer is 25% in the United States. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. The two main types of lung cancer are non-small cell and small cell. Small cell lung cancer accounts for about 15% of all lung cancers. Patients with small cell lung cancer have a particularly poor prognosis, with an estimated five-year survival rate of 7% for patients in the United States with any stage of the disease. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. About Merck’s research in lung cancer Merck is advancing research aimed at transforming the way lung cancer is treated, with a goal of improving outcomes for patients affected by this deadly disease. Through nearly 200 clinical trials evaluating more than 36,000 patients around the world, Merck is at the forefront of lung cancer research. In non-small cell lung cancer, KEYTRUDA has six approved U.S. indications (see indications below) and is approved for advanced disease in more than 95 countries. Among Merck’s research efforts are trials focused on evaluating KEYTRUDA in earlier stages of lung cancer as well as identifying new combinations and fixed-dose combinations with KEYTRUDA. About vibostolimab Vibostolimab (MK-7684) is an investigational humanized anti-TIGIT antibody discovered and developed by Merck. Vibostolimab restores antitumor activity by blocking the TIGIT receptor from binding to its ligands (CD112 and CD155), thereby activating T lymphocytes that help destroy tumor cells. The fixed-dose combination of vibostolimab and pembrolizumab is being evaluated in a wide range of cancers, including lung, other solid tumors and blood cancers. About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. KEYTRUDA is not indicated for the treatment of patients with SCLC. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval of this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. 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.libproxy1.nus.edu.sg/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 . SOURCE: Merck

Immunotherapies and antibody-drug conjugates (ADCs) are all the rage, although many of the most successful cancer drugs of the last two decades pursue only a small set of proven targets.In a move that could expand this limited repertoire, Nectin Therapeutics said Thursday it has inked an agreement granting Immunome exclusive rights to a panel of antibodies directed against a "first-in-class" target – although what that target is exactly is being kept under wraps for now.Immunome is led by industry veteran Clay Siegall, who co-founded ADC pioneer Seagen (then known as Seattle Genetics) back in 1997. Seagen has since gone on to be acquired by Pfizer to the tune of $43 billion.Underexplored targets"The next generation of transformative antibody-drug conjugates will address novel targets by pairing high-quality antibodies with innovative linker-payload technology," Siegall said. "We appreciate the work Nectin has done on these antibodies and look forward to advancing them further."The collaboration aligns with Immunome's approach of pursuing underexplored targets, a strategy the company believes will drive the next wave of therapies in oncology. For more on the space, see – Vital Signs: Tracking the new converts to ADCs.Commenting on the alliance, Nectin CEO Fabian Tenenbaum told FirstWord that the target in question is a "specific antigen that is differentially expressed on a number of tumours that currently have significant unmet need, and [we] have seen really compelling evidence from our preclinical work in terms of both in vitro and in vivo efficacy, with a number of next-generation payload compounds."Tenenbaum also shed light on why Nectin chose to partner with Immunome, noting that Siegall "obviously has a tremendous track record in building Seagen," as do other senior team members at Immunome who have experience "developing and commercialising novel antibody-drug conjugates."While financial details of the agreement remain confidential, Nectin will receive an upfront payment and also be eligible for milestones and royalties. Meanwhile, Tenenbaum hinted at the potential timeline for development, saying "we do think that an IND (investigational new drug) filing and a Phase I can start within the next 24 months. That's a very reasonable timeline."The agreement doesn't include Nectin's internal pipeline candidates, but Tenenbaum indicated that the deal would bring capital to allow it to move some of its in-house assets forward.The company's most advanced project, NTX1088, is a monoclonal antibody directed against the PVR (CD155) immune checkpoint, and is currently in Phase I for solid tumours both as monotherapy and in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab). Nectin is also advancing NTX2R13, targeting CD112R (PVRIG), which is in the IND-enabling phase.It is working on a trio of ADCs as well: one targeting Nectin2 (NTX1107) for both solid and haematological cancers, another directed against Nectin4 (NTX1105) and a third against PVR (NTX8090), both for solid tumours.