DelveInsight’s, “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 Metastatic Colorectal Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Metastatic Colorectal Cancer therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive Metastatic Colorectal Cancer pipeline products in this space.
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Key Takeaways from the Metastatic Colorectal Cancer Pipeline Report
- In May 2025, Mirror Biologics Inc. announced a study of CryoVax®. personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body.
- In May 2025, AstraZeneca conducted a study will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.
- In May 2025, Menarini Group conducted a Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.
- In May 2025, Amgen organized a Phase 3 study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301).
- In May 2025, Agenus Inc. announced a Phase 2 study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.
- In May 2025, Arcus Biosciences Inc. announced a Phase 1b/2 study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer.
- DelveInsight’s Metastatic Colorectal Cancer pipeline report depicts a robust space with 150+ active players working to develop 180+ pipeline therapies for Metastatic Colorectal Cancer treatment.
- The leading Metastatic Colorectal Cancer Companies such as 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. and others.
- Promising Metastatic Colorectal Cancer Therapies such as Regorafenib, Cyclophosphamide, Capecitabine, NV1020, MRTX849, Pembrolizumab, Cetuximab, erlotinib, FOLFOX, and others.
Discover how the Metastatic Colorectal Cancer treatment paradigm is evolving. Access DelveInsight’s in-depth Metastatic Colorectal Cancer Pipeline Analysis for a closer look at promising breakthroughs @ Metastatic Colorectal Cancer Clinical Trials and Studies
Metastatic Colorectal Cancer Emerging Drugs Profile
- 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.
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.
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.
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 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.
The Metastatic Colorectal Cancer pipeline report provides insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Metastatic Colorectal Cancer with aggregate therapies developed by each company for the same.
- It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Metastatic Colorectal Cancer Treatment.
- Metastatic Colorectal Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Metastatic Colorectal Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
- Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Metastatic Colorectal Cancer market.
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Metastatic Colorectal Cancer Companies
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. and others.
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
- Parenteral
- Intravenous
- Subcutaneous
- Topical
Metastatic Colorectal Cancer Products have been categorized under various Molecule types such as
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
Download DelveInsight’s latest report to gain strategic insights into upcoming Metastatic Colorectal Cancer Therapies and key Metastatic Colorectal Cancer Developments @ Metastatic Colorectal Cancer Market Drivers and Barriers, and Future Perspectives
Scope of the Metastatic Colorectal Cancer Pipeline Report
- Coverage- Global
- Metastatic Colorectal Cancer Companies-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. and others.
- Metastatic Colorectal Cancer Therapies- Regorafenib, Cyclophosphamide, Capecitabine, NV1020, MRTX849, Pembrolizumab, Cetuximab, erlotinib, FOLFOX, and others.
- Metastatic Colorectal Cancer Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Metastatic Colorectal Cancer Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Which companies are leading the race in Metastatic Colorectal Cancer drug development? Find out in DelveInsight’s exclusive Metastatic Colorectal Cancer Pipeline Report—access it now! @ Metastatic Colorectal Cancer Emerging Drugs and Major Companies
Table of Content
- Introduction
- Executive Summary
- Metastatic colorectal cancer: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Metastatic colorectal cancer – DelveInsight’s Analytical Perspective
- In-depth Commercial Assessment
- Metastatic colorectal cancer Collaboration Deals
- Late Stage Products (Phase III)
- Lumakras (sotorasib): Amgen
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Axitinib: Pfizer
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- NX 1607: Nurix Therapeutics Inc
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug Name: Company Name
- Drug profiles in the detailed report…..
- Inactive Products
- Metastatic colorectal cancer Key Companies
- Metastatic colorectal cancer Key Products
- Metastatic colorectal cancer- Unmet Needs
- Metastatic colorectal cancer- Market Drivers and Barriers
- Metastatic colorectal cancer- Future Perspectives and Conclusion
- Metastatic Colorectal Cancer Analyst Views
- Metastatic Colorectal Cancer Key Companies
- Appendix
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