PD-1 and PD-L1 Inhibitors- Competitive Landscape, 2022

PD-1 and PD-L1 Inhibitors- Competitive Landscape, 2022

DelveInsight’s, “PD-1 AND PD-L1 Inhibitors- Competitive landscape, 2022,” report provides comprehensive insights about 180+ companies and 200+ drugs in PD-1 and PD-L1 Inhibitors Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered • Global coverage PD-1 AND PD-L1 Inhibitors: Understanding PD-1 AND PD-L1 Inhibitors: Overview PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer. T cells constantly monitor our body for abnormal cells and eliminate them before they can turn into cancer. A key step in tumor development is finding ways to avoid or shut down the immune system. When a T cell becomes activated, it also needs a stop signal in order to make sure it does not get over-activated. This can be done through inhibitory receptors, such as PD-1. After activation, T cells increase the expression of PD-1 on their surface, allowing them to receive a shutdown signal. Tumor cells take advantage of this system by expressing binding partners of PD-1, prematurely shutting down the T cells. Programmed death 1 (PD-1) proteins bind with two ligands, namely Programmed death-ligand 1 (PD-L1) and Programmed death-ligand 2 (PD-L2). Programmed death-ligand 1 (PD-L1) in humans is encoded by the CD274 gene. PD-L1 is also known as cluster of differentiation 274 (CD274). It is a 40 kDa type 1 transmembrane protein that plays a major role in suppressing the immune system during particular events, such as pregnancy, tissue allograft, autoimmune disease, and other disease states such as hepatitis. Normally the immune system reacts to foreign antigens where there is some accumulation in the lymph nodes or spleen which triggers a proliferation of antigen-specific CD8+ T cell. PD-L1 binds to its receptor, PD-1, found on activated T cells, B cells, and myeloid cells to modulate activation or inhibition. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of “off switch” that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them hide from an immune attack. Monoclonal antibodies that target either PD-1 or PD-L1 can block this binding and boost the immune response against cancer cells. These drugs have shown a great deal of promise in treating certain cancers. PD-1 inhibitors: These drugs are given by IV (intravenously). Examples of drugs that target PD-1 include: Pembrolizumab (Keytruda), Nivolumab (Opdivo), Cemiplimab (Libtayo). These drugs have been shown to be helpful in treating several types of cancer, and new cancer types are being added as more studies show these drugs to be effective. Examples of drugs that target PD-L1 include: Atezolizumab (Tecentriq), Avelumab (Bavencio) and Durvalumab (Imfinzi). Report Highlights • In September 2022, Merck (NYSE: MRK), announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW): • KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer at high risk of recurrence, based on data from the KEYNOTE-522 trial; • KEYTRUDA as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on data from the KEYNOTE-564 trial • KEYTRUDA in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment, based on data from the KEYNOTE-826 trial • KEYTRUDA as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection, based on data from the KEYNOTE-716 trial • In July 2022, TRACON Pharmaceuticals, Inc. announced the enrollment of the 36^th patient in the ENVASARC pivotal trial at the 600 mg dose of envafolimab, which enables the initial independent data monitoring committee (IDMC) interim efficacy analysis to proceed. The interim analysis is expected to occur in the fourth quarter of this year. • In January 2022, Merck announced that the European Commission has approved KEYTRUDA as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Company Profiles & their Late-stage Drug Profiles 1. Company Overview: Merck Merck, known as MSD outside of the United States and Canada, are unified around the purpose: company uses the power of leading-edge science to save and improve lives around the world. Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. Merck also continue to strengthen the portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.   Product Description: Keytruda Pembrolizumab is the active ingredient of Keytruda, which is a humanized monoclonal antibody that binds to the programmed cell death – 1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. Pembrolizumab is an IgG4 kappa immunoglobulin and has an approximate 149 kDa molecular weight. Keytruda has received approval for advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, microsatellite-instability-high cancer, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Small Cell Lung Cancer (SCLC), Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma and advanced urothelial bladder cancer. In January 2020, Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy 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. 2. Company Overview: Laekna Therapeutics Laekna is a clinical-stage global biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide. Product Description: FAZ053 FAZ053 (anti-PD-L1) is an investigational immuno-oncology treatment being developed by Laekna Therapeutics for patients with advanced cancers. It is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 (PD-L1). Upon administration, anti-PD-L1 monoclonal antibody FAZ053 binds to PD-L1, blocking its binding to and activation of its receptor programmed death 1 (PD-1), which may enhance the T-cell-mediated anti-tumor immune response and reverse T-cell inactivation. Laekna plans to start trials on combination therapies as soon as possible in order to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China. 3. Company Overview: Genentech Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system. In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. Product Description: TECENTRIQ TECENTRIQ (atezolizumab), is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells. Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery. 4. Company Overview: Tracon Pharmaceuticals Inc. TRACON is a clinical-stage biopharmaceutical company utilizing a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. Product Description: Envafolimab Envafolimab is a novel, single-domain PD-L1 antibody that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently dosing in the ENVASARC pivotal Phase 2 trial in the US sponsored by TRACON and has been accepted for priority review by the Chinese National Medical Products Administration for the treatment of MSI-H cancer patients. Envafolimab is also being studied in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer. Further product details are provided in the report…….. Future of Competitive Landscape of PD-1 AND PD-L1 INHIBITORS is estimated to be very strong. Key emerging drugs include Envafolimab, TECENTRIQ and many other. PD-1 AND PD-L1 INHIBITORS Analytical Perspective by DelveInsight • In-depth PD-1 AND PD-L1 INHIBITORS analysis: Assessment of Products The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form. • PD-1 AND PD-L1 INHIBITORS clinical assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, and route of administration, molecule type. PD-1 AND PD-L1 INHIBITORS Report Assessment • Company Analysis • Therapeutic Assessment • Approved/Pipeline Assessment • Inactive drugs assessment • Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: • How many companies are developing PD-1 AND PD-L1 INHIBITORS drugs? • How many PD-1 AND PD-L1 INHIBITORS drugs are developed by each company? • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of PD-1 AND PD-L1 INHIBITORS ? • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the PD-1 AND PD-L1 INHIBITORS therapeutics? • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? • What are the clinical studies going on for PD-1 AND PD-L1 INHIBITORS and their status? • What are the key designations that have been granted to the emerging and approved drugs?   Key Players • Merck • Laekna Therapeutics • Genentech • Tracon Pharmaceuticals Inc. • Celgene • MedImmune • Hangzhou Sumgen Biotech • Lepu Biopharma • Harbour BioMed • Curis • BeiGene • Apollomics Key Products • Envafolimab • Keytruda • FAZ053 • TECENTRIQ • Durvalumab • SG 12473 • LP 002 • HBM 9027 • CA 170 • Tislelizumab • Geptanolimab

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