PD-1 and PD-L1 Inhibitors - Competitive landscape, 2024

PD-1 and PD-L1 Inhibitors - Competitive landscape, 2024

DelveInsight’s, “PD-1 and PD-L1 Inhibitors - Competitive landscape, 2024,” 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 and PD-L1 inhibitors are classes of immunotherapy drugs designed to enhance the immune system's ability to fight cancer. The PD-1 receptor, found on the surface of T cells, and its ligand, PD-L1, present on tumor cells and some normal cells, play a crucial role in downregulating immune responses and promoting self-tolerance by suppressing T cell inflammatory activity. Cancer cells often exploit this pathway to evade immune detection. PD-1 inhibitors block the PD-1 receptor, while PD-L1 inhibitors block the PD-L1 ligand, both effectively preventing the interaction that leads to immune suppression. This blockade allows T cells to recognize and destroy cancer cells more effectively, leading to improved outcomes in several types of cancer, including melanoma, non-small cell lung cancer, and renal cell carcinoma

The mechanism of action of PD-1 and PD-L1 inhibitors revolves around blocking the inhibitory pathway that tumors use to evade the immune system. PD-1, a receptor on T cells, interacts with PD-L1, a ligand on tumor cells and other cells in the tumor microenvironment, to downregulate immune responses and promote immune tolerance. Over the past several years, studies have demonstrated improved outcomes with checkpoint inhibitors compared to conventional chemotherapy in advanced NSCLC. The expression of PD-(L)1 on tumor cell membranes via immunohistochemistry (IHC) has been most widely studied for use with anti-PD-(L)1 therapy in this setting.

PD-1 inhibitors, such as nivolumab and pembrolizumab, bind to the PD-1 receptor on T cells, while PD-L1 inhibitors, like atezolizumab and durvalumab, bind to the PD-L1 ligand on tumor cells. By blocking this interaction, these inhibitors prevent the ""off"" signal from being sent to T cells, thus enhancing T cell activation and proliferation. This reactivation of T cells enables them to recognize and destroy cancer cells more effectively, leading to improved anti-tumor immune responses. This blockade effectively disrupts the tumor's ability to hide from the immune system, restoring the immune system's capability to target and kill cancer cells. As a result, PD-1 and PD-L1 inhibitors have become critical components in the treatment of various cancers, demonstrating significant clinical benefits and improved patient outcomes.

The structure of PD-1 and PD-L1 inhibitors typically involves monoclonal antibodies designed to bind specifically to their targets. PD-1 inhibitors, such as nivolumab and pembrolizumab, are antibodies that bind to the PD-1 receptor on T cells, preventing its interaction with PD-L1. Similarly, PD-L1 inhibitors like atezolizumab and durvalumab are antibodies that bind to the PD-L1 ligand on tumor cells. These antibodies are large, Y-shaped proteins composed of two heavy chains and two light chains, featuring variable regions that recognize and attach to specific epitopes on PD-1 or PD-L1. This precise binding blocks the inhibitory signaling pathway, thereby reactivating T cell activity against cancer cells.

Similar to other inhibitory co-receptors, PD-1 is expressed on activated T cells, B cells, monocytes, dendritic cells (DCs), regulatory T cells (Tregs), and natural killer T cells (NKT). PD-1 expression is defined as a hallmark of T cell exhaustion, which is well-defined in chronic virus infection and cancer. In many types of cancers, PD-1 is expressed on a large proportion of tumor infiltrating lymphocytes (TILs). Among CD4 TILs, enhanced PD-1 expression is always observed on Treg cells, which may reflect their activation status, whereby the presence of active Treg cells indicates that the tumor microenvironment (TME) is in an immunosuppressive state.

Report Highlights.

In September 2024, The US Food and Drug Administration (FDA) has granted fast track designation to Innovent Biologics‘IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein to treat advanced unresectable locally advanced or metastatic melanoma.

In August 2024, China’s National Medical Products Administration (NMPA) Center for Drug Evaluation has granted breakthrough therapy designation to the novel Nectin-4–directed antibody-drug conjugate (ADC) 9MW2821 for the treatment of patients with locally advanced or metastatic urothelial carcinoma that has failed prior platinum-based chemotherapy and PD-1/PD-L1 inhibition.

In August 2024, Genprex, Inc. a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes announced that the Singapore Patent Office has granted a patent to Genprex that covers the use of the Company's lead drug candidate, Reqorsa® Gene Therapy, in combination with anti-PD-1 antibodies through 2037.

In July 2024, Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors (ICI).

In May 2024, Oncolytics Biotech® Inc. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq®) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer. Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel.

In January 2024, Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase I, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an IL-12 cytokine for an extended period of time, directly into the tumor microenvironment.

PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

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. For more than 130 years, Merck have brought hope to humanity through the development of important medicines and vaccines. Merck aspire to be the premier research-intensive biopharmaceutical company in the world – and today, Merck are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of Astellas’ and Seagen’s Padcev (enfortumab vedotin-ejfv) and Merck’s KEYTRUDA® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer. 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.

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 US 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: Roche

Roche is a leading global pharmaceutical and diagnostics company known for its focus on advancing science to improve people’s lives. Established in 1896, Roche operates across two primary divisions: Pharmaceuticals, where it develops innovative medicines, particularly in oncology, immunology, and neurology, and Diagnostics, where it leads in laboratory testing and personalized healthcare. Roche has pioneered treatments in cancer, HIV/AIDS, and influenza, and remains a strong player in biotech through personalized healthcare initiatives and collaborations with numerous medical institutions and research entities. With a commitment to sustainability and scientific excellence, Roche continues to make substantial investments in research and development, emphasizing precision medicine to offer targeted treatments.

Product Description: TECENTRIQ

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC), as well as certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: AstraZeneca

AstraZeneca is an Anglo-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford–AstraZeneca COVID-19 vaccine.

The company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group (itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993). Since the merger it has been among the world's largest pharmaceutical companies and has made numerous corporate acquisitions, including Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014). It has its research and development concentrated in three strategic centres: Cambridge, England; Gothenburg, Sweden and Gaithersburg in Maryland, US.

Product Description: Rilvegostomig

Rilvegostomig (AZD-2936) is a bi-specific antibody acts by targeting T cell immunoreceptor with Ig and ITIM domains (TIGIT) and programmed cell death protein 1 (PD1). It is derived from COM902 (anti-TIGIT antibody). It is administered through Intravenous route. Currently, the drug is in the Phase III stage of its development for the treatment of biliary cancer. The drug is also under development for the treatment of solid tumors, advanced or metastatic squamous or non-squamous non-small cell lung carcinoma, squamous or non-squamous non-small cell lung cancer and locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, cholangiocarcinoma and gallbladder cancer. The drug is in Phase III stage of development.

2. Company Overview: Incyte

Incyte is a biopharmaceutical company based in Wilmington, Delaware, focused on discovering, developing, and commercializing innovative medicines to address serious unmet medical needs, particularly in oncology and hematology. Founded in 1991, Incyte has gained recognition for its pioneering work in small molecule drug discovery, with Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor for myelofibrosis and polycythemia vera, being one of its flagship products. The company’s robust pipeline includes a range of targeted therapies and immunotherapies aimed at treating cancers, autoimmune disorders, and other challenging conditions. Incyte also collaborates with numerous pharmaceutical companies to expand its reach and impact, with a strong emphasis on advancing precision medicine and patient-centered care.

Product Description: INCB99280

INCB99280 is an investigational product from Incyte, designed as a potent and selective inhibitor targeting hematologic malignancies and solid tumors. It is a small molecule under clinical development, focusing on addressing cancers with high unmet medical needs, particularly those with specific genetic markers or mutations that drive cancer growth. While still in the experimental stages, INCB99280 is part of Incyte's broader pipeline strategy to develop next-generation oncology therapies, often aiming to enhance patient outcomes through targeted inhibition of cancer cell growth and survival pathways. The drug has recently completed Phase II clinical trial.

3. Company Overview: Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA.

Product Description: Balstilimab

Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. The drug is currently in Phase II stage of development.

4. Company Overview: Novartis

Novartis, headquartered in Basel, Switzerland, is one of the world’s largest pharmaceutical companies, focusing on innovative medicines to address a range of healthcare needs. Established in 1996 from the merger of Ciba-Geigy and Sandoz, Novartis operates through two main divisions: Innovative Medicines, which develops prescription drugs across areas like oncology, cardiology, immunology, and neuroscience, and Sandoz, its generics and biosimilars division. Known for pioneering work in cell and gene therapy as well as targeted cancer therapies, Novartis is committed to research and development, investing heavily in advanced therapeutics to tackle complex diseases. The company also emphasizes sustainability and global access to healthcare, with initiatives to improve affordability and delivery of essential medicines worldwide.

Product Description: FAZ053

FAZ053 (anti-PD-L1) is an investigational immuno-oncology treatment being developed by Novartis for patients with advanced cancers. It is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 (PD-L1). FAZ053 functions by binding to PD-L1 on tumor cells, preventing it from binding to the PD-1 receptor on T-cells. As such, it functions as an immune checkpoint inhibitor. By inhibiting this interaction, FAZ053 enhances the activation of T-cell-mediated anti-tumor response and renders cancer cells less able to evade that response. This is expected to result in a reduction in tumor growth and size. The drug is currently in Phase I stage of development.

5. Company Overview: Abbisko Therapeutics

Abbisko Therapeutics is a biopharmaceutical company. It discovers and develops of novel medicines to the treatment of cancers and other diseases. ABSK011 developed for the treatment of advanced HCC with hyperactivation of FGF19/FGFR4 signaling. ABSK021 is for the treatment of adult patients with TGCT, pancreatic cancer, colorectal cancer, cGvHD and ALS. It offers services such as drug discovery development and clinical trials. It owns an integrated research and development center in Shanghai Zhangjiang Hi-Tech Park to conduct immune-oncology drug development activities. Abbisko is headquartered in Shanghai, China.

Product Description: ABSK-043

ABSK-043 is under development for the treatment of advanced solid tumors and melanoma, breast cancer and endometrial cancer. The drug candidate acts by targeting Programmed Cell Death 1 Ligand 1. It is administered through oral route.

Further product details are provided in the report……..

PD-1 and PD-L1 Inhibitors Analytical Perspective by DelveInsight

In-depth Commercial Assessment: PD-1 and PD-L1 Inhibitors Collaboration Analysis by Companies

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 Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

PD-1 and PD-L1 Inhibitors Report Assessment

Company Analysis

Therapeutic Assessment

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

Astrazeneca

EQRx/CStone Pharmaceuticals

Pfizer

Incyte Corporation

Agenus

Novartis

BioNTech/Genmab

Merck KGaA

Jiangsu Hengrui Medicine

Abbisko Therapeutics

Genentech

Biotheus

Sichuan Baili Pharmaceutical/SystImmune

Key Products

Rilvegostomig

Sugemalimab

Sasanlimab

INCB 099280

Balstilimab

FAZ053

Acasunlimab

Avelumab

Retlirafusp alfa

ABSK 043

Atezolizumab

PM 8002

Emfizatamab


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