EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) - Pipeline Insight, 2024

DelveInsight's, "EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) - Pipeline Insight, 2024" report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) pipeline landscape. It covers the 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.

Geography Covered:

• Global coverage

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Understanding

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Overview

Epidermal growth factor receptor (EGFR) mutations are the most common oncogenic drivers in non-small-cell lung cancer (NSCLC). Significant developments have taken place which highlight the differences in tumor biology that exist between the mutant and wild-type subtypes of NSCLC.

Epidermal growth factor receptor is a trans-membrane glycoprotein with an extracellular epidermal growth factor binding domain and an intracellular tyrosine kinase domain that regulates signaling pathways to control cellular proliferation. Epidermal growth factor receptor binding to its ligand results in autophosphorylation by intrinsic tyrosine/kinase activity, triggering several signal transduction cascades.

Constitutive or sustained activation of these sequences of downstream targets is thought to yield more aggressive tumor phenotypes. Mutations in epidermal growth factor receptor have been discovered in association with some lung cancers. Lung adenocarcinomas with mutated epidermal growth factor receptor have significant responses to tyrosine kinase inhibitors, although for unselected patients it does not appear to have a survival benefit. Both EGFR mutation and gene amplification status may be important in determining which tumors will respond to tyrosine kinase inhibitors.

Epidermal growth factor receptor (EGFR) is a transmembrane tyrosine kinase receptor that plays a central role in regulating cell division and death. It belongs to the HER family of receptors, which includes EGFR (HER1/ErbB1), ERBB2 (HER2/neu), ERBB3 (HER3), and ERBB4 (HER4). These receptors are characterized by an extracellular ligand-binding domain, a transmembrane domain, and a cytoplasmic domain containing the tyrosine kinase region followed by a carboxy-terminal tail with tyrosine autophosphorylation sites. Several growth factors, including EGF, transforming growth factor-a (TGF-a), amphiregulin (AR), epiregulin (EREG), heparin-binding EGF (HB-EGF), betacellulin (BTC), and epigen (EPG) bind to the ErbB receptors.

As the treatment of lung cancer has become progressively more biomarker-driven, and with the rapid emergence of effective matched targeted therapies, organizations have made attempts to define best practices for which tests are necessary and in what target population. This practice has its own set of challenges in keeping up with a rapidly changing field. Although sensitizing mutations in the EGFR gene were first described in 2004, followed by multiple trials showing that EGFR tyrosine kinase inhibitors (TKIs) were superior to chemotherapy in this subgroup of patients, it was not until 2011 that the first provisional recommendation was issued by ASCO endorsing routine testing of all patients with lung adenocarcinoma for EGFR mutations.5 In that same year, crizotinib was approved for treatment of anaplastic lymphoma kinase (ALK)-rearranged NSCLC, illustrating the rapid pace of adoption of targeted therapies and the challenges guidelines would have keeping pace.

"EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)- Pipeline Insight, 2024" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) pipeline landscape is provided which includes the disease overview and EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) treatment guidelines. The assessment part of the report embraces, in depth EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) R&D. The therapies under development are focused on novel approaches to treat/improve EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC).

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Emerging Drugs Chapters

This segment of the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Emerging Drugs

• BL B01D1: Sichuan Baili Pharmaceutical

BL-B01D1 is a potentially first-in-class bispecific ADC developed by SystImmune, targeting both EGFR and HER3, which are highly expressed in most epithelial tumors. BL-B01D1 is comprised of SystImmune's proprietary bispecific antibody and linker-payload which contains a stable, cleavable linker and a topoisomerase inhibitor. Currently, the drug is in the Phase III stage of its development for the treatment of NSCLC.

• PLB1004: Avistone Pharmaceuticals

PLB1004, a novel mono-anilino-pyrimidine small molecule inhibitor of EGFR, potently and irreversibly targets exon 20 insertion. The molecule also potently targets classical EGFR mutations ExDel19, L858R and T790M with a high degree of selectivity over wild-type EGFR. Currently, the drug is the Phase III stage of its development for the treatment of Non-small Cell Lung Cancer.

• TAK-186: Takeda

TAK-186 is an experimental EGFR-targeted bispecific antibody being developed by Takeda Pharmaceuticals for the treatment of non-small cell lung cancer (NSCLC). This bispecific T-cell engager (BiTE) is designed to bind both EGFR-expressing cancer cells and T-cells, facilitating immune-mediated destruction of tumor cells. TAK-186 offers a novel approach by leveraging the body's immune system to directly target EGFR-expressing tumors, including those resistant to traditional EGFR inhibitors. Currently in early-stage clinical trials, TAK-186 holds promise for enhancing the effectiveness of immunotherapy in NSCLC. Currently, the drug is in the Phase II stage of its development for the treatment of NSCLC.

• JMT101: Shanghai JMT-Bio Inc.

JMT101 is a monoclonal antibody drug developed by Shanghai Junshi Biosciences, targeting PD-1 (Programmed Death-1). It is designed to enhance the body's immune response against cancer cells by blocking the interaction between PD-1 and its ligands (PD-L1/PD-L2), thereby preventing immune suppression. In the context of non-small cell lung cancer (NSCLC), JMT101 has shown potential in improving anti-tumor activity when used alone or in combination with other treatments. By unleashing the immune system, it provides an immunotherapeutic option for patients, particularly those who may not respond well to traditional chemotherapy or targeted therapies. Currently, the drug is in the Phase II stage of its development for the treatment of NSCLC.

• DK210: DEKA Biosciences

DK210 (EGFR) is the first of several experimental therapeutics developed as part of Deka's platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10. While IL-2 is known to be toxic, when coupled with IL-10, toxicity is not only reduced but its potency is increased, thereby creating a more tolerable and effective treatment for patients. It is the first of several experimental therapeutics in Deka's platform of molecules which are being developed to treat both cancer and inflammatory diseases. These therapeutics, known as DiakinesTM, involve coupling two cytokines together onto a single chain variable fragment (scFv) targeting system to enhance their precision in targeting specific tissues. Currently, the drug is in the Phase I stage of its development for the treatment of NSCLC.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Therapeutic Assessment

This segment of the report provides insights about the different EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)
• There are approx. 40+ key companies which are developing the therapies for EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC). The companies which have their EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drug candidates in the most advanced stage, i.e. Phase III include, Sichuan Baili Pharmaceutical and Avistone Pharmaceuticals.
• Phases

DelveInsight's report covers around 50+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs.

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Report Insights

• EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs?
• How many EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) 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 EGFR Non-Small Cell Lung Cancer (EGFR + NSCLC) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Sichuan Baili Pharmaceutical
• Avistone Pharmaceuticals
• Takeda
• Shanghai JMT-Bio Inc.
• DEKA Biosciences
• ABVC BioPharma (Rgene Corporation)
• Wayshine Biopharma
• Taiho Oncology
• Bridge Biotherapeutics
• OBI Pharma

Key Products

• BL-B01D1
• PLB1004
• TAK-186
• JMT101
• DK210
• BLEX 404
• WSD0922-FU
• TAS3351
• BBT-207
• OBI-833