Metastatic Colorectal Cancer - Pipeline Insight, 2025

The “Metastatic Colorectal Cancer - Pipeline Insight, 2025” report provides comprehensive insights about 150+ companies and 180+ pipeline drugs in Metastatic Colorectal Cancer 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

Metastatic Colorectal Cancer: Understanding

Metastatic Colorectal Cancer: Overview

Colorectal cancer (CRC) is the third most common, with metastasis being the major cause of death in the majority of patients. Common sites of distant metastasis are the liver and the peritoneum. CRC starts in the colon or the rectum. These cancers can also be called colon cancer or rectal cancer, depending on where they start. Colon cancer and rectal cancer are often grouped because they have many features in common. CRC may develop when polyps, mushroom-like growths inside the colon, grow and become cancerous or cells along the lining of the colon or rectum mutate and grow out of control, forming a tumor.

CRC usually begins as a polyp that develops in the inner lining of the rectum or colon and grows and converts slowly over several years. Once cancer develops, it can grow further into the wall of the colon or rectum and go on to invade blood or lymph vessels. Cancer cells can spread into nearby lymph nodes and also be carried in the blood vessels to other organs or tissues. The most common places for CRC to spread are the liver, lung, and peritoneum. But cancer can also spread to other parts of the body, such as the bones and brain.

After someone is diagnosed with CRC, staging is done to figure out if it has spread, and if so, how far. The stage of cancer describes how much cancer is in the body. It helps determine how serious the cancer is and how best to treat it. The earliest stage CRCs are called stage 0 (a very early cancer), and then range from stages I through IV. As a rule, the lower the number, the less cancer has spread. A higher number, such as stage IV, means cancer has spread more. And within a stage, an earlier letter means a lower stage. Although each person’s cancer experience is unique, cancers with similar stages tend to have a similar outlook and are often treated in much the same way.

Metastatic CRC is still an incurable disease for most of the patients, with most commonly liver, lung or lymph nodes and peritoneal metastases. In the past, 15 years ago, median overall survival (mOS) was approximately 12 months, and the 5-year survival rate was 13%. However, the survival rate of these patients has increased, mainly due to the combined treatment of metastases with surgery and systemic therapy. Long-term survival or even cure can be attained in 20-50% of the patients who undergo complete R0 resection of liver or lung metastases, and around 70% 5-year survival of these patients can be achieved.

However, in the field of systemic therapy, there has been significant progress with new drugs in recent years. There are more options of initial systemic chemotherapy, oxaliplatin, irinotecan, and fluoropyrimidines, in combination with targeted therapy with anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab, panitumumab) in case of KRAS wild type tumors or anti-vascular endothelial growth factor (VEGF) inhibitors (monoclonal antibodies bevacizumab, aflibercept, ramucirumab, regorafenib as per oral tyrosine kinase inhibitor). The combination of these novel chemotherapies and targeted therapy now extends the mOS up to 40 months.

"Metastatic Colorectal Cancer- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Metastatic Colorectal Cancer pipeline landscape is provided which includes the disease overview and Metastatic Colorectal Cancer treatment guidelines. The assessment part of the report embraces, in depth Metastatic Colorectal Cancer 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, Metastatic Colorectal Cancer 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 Metastatic Colorectal Cancer R&D. The therapies under development are focused on novel approaches to treat/improve Metastatic Colorectal Cancer.

Metastatic Colorectal Cancer Emerging Drugs Chapters

This segment of the Metastatic Colorectal Cancer 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.

Metastatic Colorectal Cancer Emerging Drugs

• HLX10 (Serplulimab) + HLX04: Shanghai Henlius Biotech

HLX10, a novel recombinant humanised anti-programmed cell death protein 1 (PD-1) mAb independently developed by Henlius, has the potential to treat a variety of solid tumours. HLX10 has exhibited better pharmacokinetics, pharmacodynamics properties, favourable safety, tolerability profile and anti-tumor activity in preclinical and early clinical research studies.

HLX04 is a bevacizumab biosimilar developed by Henlius independently in accordance with Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative), which can be used in the treatment of advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC). HLX04 can block the interaction between vascular endothelial growth factor (VEGF) and its receptors by binding with VEGF specifically, which then inhibits tumour angiogenesis and thus suppressing the growth and metastases of tumours.

Henlius has conducted multiple head-to-head comparisons between HLX04 and the reference bevacizumab including the analytical and preclinical study, phase 1 and phase 3 clinical studies. The results showed that HLX04 was highly similar to the reference bevacizumab in terms of quality, safety and efficacy. Currently the drug is in Phase III stage of its development for the treatment of metastatic colorectal cancer.

• Lenvatinib: Eisai Inc.

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below. Currently the drug is in Phase III stage of its development for the treatment of metastatic colorectal cancer.

• PEPI1018: Treos Bio

PolyPEPI-1018, Treos’ lead product candidate, is an off-the-shelf immunotherapy in clinical development for the treatment of metastatic colorectal cancer, co-developed with a candidate companion diagnostic. The therapy is in development as a first-line maintenance therapy and as a third-line treatment. The companion diagnostic uses Treos’ proprietary PASCal computational tool to identify Personal EPItopes (PEPIs) that are likely to induce antigen-specific T Cell responses in a patient. In silico trials predicted that these peptides induce exceptionally broad T cell responses against at least 3 tumor-specific antigens in high proportion of patients, without need of biopsy. PolyPEPI1018 was designed to induce polyvalent T cell responses in a large subpopulation of CRC patients using its PEPI TestTM platform which identifies Personal EPItopes (PEPIs) that are likely to induce antigen-specific T cell responses in a subject. Currently the drug is in Phase II stage of its development for the treatment of metastatic colorectal cancer.

• AUM-001: AUM Biosciences

AUM001 is a highly selective translation inhibitor. It selectively inhibits MNK 1/2 and thereby blocks phosphorylation of eIF4E. This, in turn, interferes with CAP mediated RNA translation, thereby impairing growth signals involved in cancer development, progression, and resistance to therapies. MNK is important in tumor microenvironment (TME) regulation, shifting the balance towards tumor inhibition. Moreover, inhibition of MNK kinases decreases the production of the pro-inflammatory cytokines like TNFα and IL-6, suggesting that MNK kinases and their substrates (eIF4E, hnRNP A1, Spry1/2) play a pivotal role in regulating the innate and adaptive immune compartment. This has the potential to turn “cold” tumors “hot”, increasing the proportion of tumors susceptible to immunotherapies. AUM001 demonstrated encouraging safety, tolerability and target engagement as a monotherapy in two Phase I clinical trials. The global Phase II trial is being conducted in collaboration with MSD, a tradename of Merck & Co., Inc., pursuant to a clinical trial collaboration and supply agreement for KEYTRUDA. Currently, the drug is in the Phase II stage of its development for the treatment of metastatic Colorectal Cancer.

• DKN-01: Leap Therapeutics, Inc.

Sirexatamab (DKN-01) is an investigational humanized IgG4-kappa monoclonal antibody that targets Dickkopf-related protein 1 (DKK1), a modulator of the Wnt signaling pathway. Overexpression of DKK1 has been associated with tumor progression and poor prognosis in various cancers, including colorectal cancer (CRC). In preclinical studies, DKK1 has been identified as a resistance mechanism to commonly used chemotherapy in colorectal cancer models. By binding to and neutralizing DKK1, sirexatamab aims to restore normal Wnt signaling, thereby inhibiting tumor growth and potentially enhancing the efficacy of other anticancer therapies. Currently the drug is in Phase II stage of its development for the treatment of Metastatic Colorectal cancer.

• RO7122290: Hoffmann-La Roche

RO7122290is a novel 4-1BB agonist that targets fibroblast activation protein-a (FAP), which is abundantly expressed by cancer-associated fibroblasts in many tumors. Simultaneous binding of FAP and 4-1BB results in clustering and activation of T- and natural killer cells at the tumor site and simultaneous antitumor activity, which has been demonstrated in preclinical models. Upon administration, the FAP/4-1BB-targeting fusion protein RO7122290 targets and binds to both FAP, localized on tumor stromal cells, and 4-1BB, expressed on a variety of leukocyte subsets including activated T-lymphocytes and natural killer (NK) cells. The simultaneous binding of FAP and 4-1BB results in local clustering of FAP-expressing tumor stromal cells and 4-1BB-expressing T-cells, and local immune cell activation through the promotion of T-cell activation, cytokine release and T-cell-mediated anti-tumor immune responses. 4-1BB, a surface glycoprotein of the tumor necrosis factor receptor superfamily, is an inducible costimulatory receptor that plays a key role in T-cell proliferation, survival and cytolytic activity. FAP is abundantly expressed by cancer-associated fibroblasts in the majority of solid tumors. The drug is currently in Phase I/II stage of its development for the treatment of metastatic colorectal cancer.

• E7386: Eisai

E7386 is a CBP / β-catenin inhibitor that inhibits protein-protein interactions between the transcription coactivator CBP and β-catenin, and regulates the Wnt signaling-dependent gene expression. Since E7386 acts on the CBP / β-catenin transcription complex located at the most downstream of the Wnt signaling, it is expected to inhibit not only ligand-dependent activation but also activation caused by gene mutations in Wnt signaling factors such as adenomatous polyposis coli (APC) and β-catenin. E7386 is an orally active selective inhibitor of the interaction between β-catenin and CREB binding protein, which is part of the Wnt/β-catenin signaling pathway, disrupts the Wnt/β-catenin signaling pathway in HEK293 and adenomatous polyposis coli (APC)-mutated human gastric cancer ECC10 cells. In preclinical models, E7386 has demonstrated antitumor activity against mouse mammary tumors developed in Mouse Mammary Tumor Virus (MMTV)-Wnt1 transgenic mice. Currently, the drug is in the Phase I/II stage of its development for the treatment of Metastatic Colorectal Cancer.

Metastatic Colorectal Cancer: Therapeutic Assessment

This segment of the report provides insights about the different Metastatic Colorectal Cancer drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Metastatic Colorectal Cancer

• There are approx. 150+ key companies which are developing the therapies for Metastatic Colorectal Cancer. The companies which have their Metastatic Colorectal Cancer drug candidates in the most advanced stage, i.e. Phase III include, Eisai Inc. and Shanghai Henlius Biotech.

Phases

The report covers around 180+ 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

Metastatic Colorectal 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

• 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.

Metastatic Colorectal Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Metastatic Colorectal Cancer 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 Metastatic Colorectal Cancer drugs.

Metastatic Colorectal Cancer Report Insights

• Metastatic Colorectal Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Shanghai Henlius Biotech
• Eisai Inc.
• Treos Bio
• AUM Biosciences
• Leap Therapeutics, Inc.
• Hoffmann-La Roche
• Replimune
• Qilu Pharmaceutical
• Lutris Pharma
• Ipsen
• Bold Therapeutics
• Pacylex Pharmaceuticals
• FivepHusion
• SystImmune
• Inspirna, Inc.
• Sapience Therapeutics
• Daiichi Sankyo
• Hutchmed
• Merus N.V.

Key Products

• HLX10 (Serplulimab) + HLX04
• Lenvatinib
• PEPI1018
• AUM-001
• DKN-01
• RO7122290
• E7386
• RP3
• QL 1706
• LUT014
• Liposomal irinotecan
• BOLD-100
• Zelenirstat
• Deflexifol
• SI-B003
• RGX202
• ST316
• Trastuzumab Deruxtecan
• Surufatinib
• Petosemtamab

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