Metastatic Colorectal cancer - Pipeline Insight, 2022

DelveInsight’s, “Metastatic Colorectal cancer - Pipeline Insight, 2022,” report provides comprehensive insights about 140+ companies and 140+ 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 that spreads, or metastasizes, to the lungs, liver or any other organ is called metastatic colorectal cancer (mCRC). The most common site of metastases for colon or rectal cancer is the liver. CRC cells may also spread to the lungs, bones, brain, or spinal cord. Approximately one-fifth of CRC cases are metastatic at the time of diagnosis. If a person has been treated for CRC and cancer cells have been found in these areas, it may be a sign that the original CRC has spread. mCRC is different from recurrent CRC. Most CRCs start as a growth on the inner lining of the colon or rectum. These growths are called polyps. Some types of polyps can change into cancer over time (usually many years), but not all polyps become cancer. The chance of a polyp turning into cancer depends on the type of polyp it is. There are different types of polyps.

""Metastatic Colorectal cancer - Pipeline Insight, 2022"" report by DelveInsight 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.
• On November 18, 2021 Gilead Sciences announced that it had exercised its options to three of Arcus Biosciences’ programs. Two are anti-TIGIT molecules, domvanalimab and AB308, and the other is etrumadenant and quemliclustat. The two companies have also added a research collaboration deal. Arcus shares popped 15% at the news.
• In September 2021, Erasca, announced a clinical trial collaboration and supply agreement with Pfizer Inc. for the BRAF inhibitor encorafenib (BRAFTOVI®). This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with encorafenib and the EGFR inhibitor cetuximab for the treatment of patients with BRAF V600E-mutant mCRC.
• In December 2021, Rottapharm Biotech announced a clinical collaboration with Agenus’ balstilimab (anti-PD-1) in collaboration with its lead candidate CR6086 in advanced colorectal cancer at the National Cancer Institute. Rottapharm Biotech’s clinical collaboration with Agenus offers a promising new combination therapy for patients with advanced pMMR/MSS mCRC where there is a high unmet need, and for a further range of potential applications in other immunotherapy-resistant tumors.
• On 11 May 2021, Shanghai Henlius Biotech and NeuPharma entered into a drug technology license agreement. NeuPharma will grant the Company a sublicensable exclusive license for related licensed patents and licensed know-how necessary or reasonably useful for the Company to research, develop, produce and commercialize the Licensed Product within the Licensed Territory (China).
• In November 2021, The US FDA granted a fast track designation to arfolitixorin as a potential therapeutic option for patients with metastatic colorectal cancer (mCRC). This serves as a strong external validation of arfolitixorin’s potential to benefit patients with this devastating disease.
• In January 2022, Gritstone bio, Inc. announced that the first patient was enrolled for inclusion in the Phase 2/3 GRANITE-CRC-1L trial. The trial evaluates the individualized neoantigen vaccine GRANITE in combination with immune checkpoint blockade for the first line (1L) maintenance treatment of newly diagnosed patients with metastatic, microsatellite-stable colorectal cancer (MSS-CRC). This trial has registrational intent and has been discussed previously with the FDA.

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 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
• Trilaciclib: G1 Therapeutics

Corsela (Trilaciclib) is a small-molecule, short-acting, inhibitor of cyclin-dependent kinases (CDK) 4 and 6 developed by G1 Therapeutics for its myeloprotection and potential antitumor efficacy and safety benefits in combination with cancer chemotherapy. CDKs govern cell cycle progression, and trilaciclib induces a transient, reversible G1 cell cycle arrest of proliferating hematopoietic stem and progenitor cells in bone marrow, thus protecting them from damage during chemotherapy.

It is a novel therapeutic approach, which is given before chemotherapy that temporarily blocks progression through the cell cycle. This provides two benefits. First, it proactively helps protect HSPCs in bone marrow leading to preservation of neutrophils, erythrocytes, and platelets (called myeloprotection) which reduces the occurrences and severity of neutropenia and other myelosuppressive consequences of chemotherapy.
• Famitinib: Jiangsu Hengrui Medicine

Famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Famitinib binds to and inhibits several RTKs, dysregulated in a variety of tumors, including stem cell factor receptor (c-Kit; SCFR), vascular endothelial growth factor receptor (VEGFR) 2 and 3, platelet-derived growth factor receptor (PDGFR) and FMS-like tyrosine kinases Flt1 and Flt3. Inhibition of these RTKs may result in an inhibition of tumor growth and angiogenesis, and eventually tumor regression in tumor cells overexpressing these RTKs. Famitinib is being evaluated in Phase III clinical trial to treat metastatic colorectal cancer.
• CMAB009: Mabpharm Limitied

CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Cetuximab is a recombinant chimeric human/mouse IgG1 monoclonal antibody that competitively binds to epidermal growth factor receptor (EGFR) and competitively inhibits the binding of epidermal growth factor (EGF). CMAB009, a recombinant anti-EGFR monoclonal antibody with the same amino acid sequence as cetuximab is being evaluated in a Phase III study to treat metastatic colorectal cancer.
• Trastuzumab Deruxtecan: Daiichi Sankyo

Trastuzumab deruxtecan is a HER2 directed antibody drug conjugate (ADC). Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.
• SCO-101: Scandion Oncology

Scandion Oncology’s leading product – SCO101 – is ingested as a capsule and has in preclinical studies shown to significantly improve the effect of standard cancer treatment when given in combination with the cancer drug. Moreover, SCO-101 inhibits key resistance mechanisms that allow the standardized cancer treatment to be effective again in patients with drug resistant disease. Therefore, SCO-101 has the potential to make the chemotherapy much more effective without increasing side effects for patients. The target indications are metastatic colorectal cancer and inoperable or metastatic pancreatic cancer, with more indications likely to follow. Currently it is being evaluated in Phase II stage of development to treat patients with metastatic colorectal cancer.
• BEY 1107: BeyondBio

Avotaciclib (formerly BEY 1107) is a CDK1 inhibitor being developed by BeyondBio for the treatment of pancreatic cancer and glioblastoma. The drug induces apoptosis through cell suicide mechanism by synchronizing the G2/M cell cycle phases of the glioblastoma and pancreatic cancer cells. Currently it is being evaluated in Phase I/II stage of development to treat metastatic colorectal cancer.
• Etrumadenant: Arcus Biosciences

Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist in the clinic, is designed to maximally inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by A2aR and A2bR, respectively. A2bR is also upregulated by certain cancer cells, such as in prostate cancer and KRAS- mutated cancers. As a result, Etrumadenant may uniquely block adenosine’s immunosuppressive and cancer cell-intrinsic effects. Developed specifically for the oncology setting, Etrumadenant achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. Etrumadenant has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily dosing. AB928 is currently being evaluated in several Phase I/II studies across multiple indications including metastatic colorectal cancer.

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

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. 140+ 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, G1 Therapeutics.
• Phases

DelveInsight’s report covers around 140+ 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
• Intradermal
• Intradermal/Intratumoral/Intravenous
• Intrahepatic arterial (IHA)
• Intralesional
• Intramuscular
• Intratumoural
• Intravenous
• Oral
• Oral/Intravenous
• Parenteral
• Subcutaneous
• Molecule Type

Products have been categorized under various Molecule types such as
• Gene therapies
• Immunotherapies
• Monoclonal antibodies
• Recombinant Fusion Proteins
• Small molecule
• Vaccine
• 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
• G1 Therapeutics
• Amgen
• Qilu Pharmaceutical
• Eisai Co Ltd
• Merck Sharp & Dohme
• Mirati Therapeutics
• Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
• Shanghai Henlius Biotech
• Amarin Corporation
• Mologen
• Sumitomo Dainippon Pharma Oncology
• Celltrion
• Merck Sharp & Dohme
• Jiangsu Hengrui Medicine
• Suzhou Zelgen Biopharmaceuticals
• Mabpharm Limitied
• Boehringer Ingelheim
• Chia Tai Tianqing Pharmaceutical
• Isofol Medical
• Suzhou Suncadia Biopharmaceuticals Ltd/ Jiangsu Hengrui Medicine
• AB Science
• Gritstone Bio, Inc
• Daiichi Sankyo
• Novartis
• Merck Sharp & Dohme
• Sunshine Guojian Pharmaceutical
• Pfizer
• Merck KGaA
• Jiangsu HengRui Medicine Co., Ltd.
• ALX Oncology
• Immunovative Therapies
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Precision Biologics
• Sanofi
• GC Pharma
• VAXIMM
• AstraZeneca
• AstraZeneca
• Yooyoung Pharmaceutical
• Med Pacto Inc.
• Exelixis
• GlaxoSmithKline
• Bristol Myers Squibb
• Merck Sharp & Dohme
• Bavarian Nordic
• Maxinovel Pharmaceuticals
• Shanghai Henlius Biotech
• Novartis
• Zucero Therapeutics
• Innovent Biologics
• Scandion Oncology
• Merck Sharp & Dohme Corp.
• AbbVie
• Beijing Biostar Technologies
• Seagen Inc
• Merck KGaA
• Teclison Ltd
• Symphogen A/S
• Sichuan Baili Pharmaceutical; SystImmune
• Karyopharm Therapeutics

Key Products
• Trilaciclib
• Sotorasib
• QL 1203
• Lenvatinib
• Olaparib
• MRTX 849
• KL 140
• HLX10 (Serplulimab) + HLX04
• Icosapent Ethyl
• MGN-1703
• Napabucasin
• CT-P16
• MK-4280A
• Famitinib
• Donafenib
• CMAB009
• BI 695502
• Anlotinib hydrochloride
• Arfolitixorin
• SHR 1701
• Masitinib
• GRT C901/GRT R902
• Trastuzumab deruxtecan
• Dabrafenib+ Trametinib
• GVAX Colon Vaccine
• CPGJ 602
• Axitinib
• Avelumab
• Apatinib
• ALX-148
• AlloStim
• AK 105
• NEO-102
• Isatuximab
• GC 1118
• ""VXM 01
• Durvalumab
• Tremelimumab
• YYB101
• Vactosertib
• Cabozantinib
• Niraparib
• Neoantigen Dendritic Cell Vaccine
• Navarixin
• CV301
• MAX-40279-01
• HLX208
• NIS793
• Pixatimod
• IBI310
• SCO-101
• Vicriviroc
• Veliparib
• Utidelone
• Tucatinib
• Tepotinib
• TATE
• Sym004
• SI-B001
• Selinexor