Pancreatic Cancer - Competitive landscape, 2023

This “Pancreatic Cancer- Competitive landscape, 2023” report provides comprehensive insights about 250+ companies and 300+ drugs in Pancreatic Cancer 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

Pancreatic Cancer: Understanding

Pancreatic Cancer: Overview

Pancreatic cancer is a disease in which malignant or cancer cells form in the tissues of the pancreas. Pancreatic cancer begins in the tissues of the pancreas - an organ in the abdomen that lies behind the lower part of the stomach. Pancreatic cancer most frequently arises from pancreatic intraepithelial neoplasia (PanIN), the classic pre-neoplastic lesions, but can also arise from larger precursor lesions, namely, intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic neoplasms. It exhibits aberrant autocrine and paracrine signalling cascades that promote pancreatic cancer cell proliferation, migration, invasion, and metastasis. Pancreatic cancer also exhibits metabolic abnormalities and insensitivity to growth-inhibitory pathways. Loss of negative growth constraints is best exemplified by aberrant TGFβ signalling, which occurs due to increased expression of TGFβ isoforms. Although TGFβ is a physiological tumor suppressor, it promotes tumor progression in pancreatic cancer and many other solid tumors by exerting paracrine effects within the tumor microenvironment that lead to enhanced growth and metastasis. TGFβ can also directly induce pancreatic cancer cell proliferation by activating non-canonical signalling through mitogen-activated protein kinase (MAPK) phosphorylation, proto-oncogene tyrosine-protein kinase Src (SRC), and AKT phosphorylation, and by upregulating WNT7B expression through canonical SMAD4-dependent mechanisms. Pancreatic cancer may not cause early signs or symptoms. Signs and symptoms may be caused by pancreatic cancer or by other conditions. Pancreatic cancer is difficult to detect and diagnose as there are not any noticeable signs or symptoms in the early stages of pancreatic cancer. Also, the signs and symptoms of pancreatic cancer, when present, are like the signs and symptoms of many other illnesses. Pancreatic cancer is difficult to diagnose because the symptoms of pancreatic cancer are often mistaken for those of other illnesses, such as irritable bowel syndrome. It may go undetected until it's advanced. By the time symptoms occur, diagnosing pancreatic cancer is usually relatively straightforward; unfortunately, a cure is rarely possible. Patients with pancreatic cancer can choose from a variety of treatments. Clinical trials are being conducted to test various treatments, some of which are standard (currently used treatments). A new treatment might replace the standard one if clinical trials reveal that it is superior to the current one.

Report Highlights

• In March 2023, Adaptimmune Therapeutics plc. and TCR² Therapeutics Inc. (NASDAQ: TCRR), announced entry into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction to create a preeminent cell therapy company focused on treating solid tumors. The combination provides extensive benefits for clinical development and product delivery supported by complementary technology platforms. As a result, and following the closing of the transaction, it is anticipated that the combined company's cash runway will extend into 2026.
• In February 2023, Akamis Bio, announced an expansion of its ongoing partnership with the Parker Institute for Cancer Immunotherapy (PICI) to include a clinical collaboration with the Cancer Research Institute (CRI) that will focus on advancing novel treatments for pancreatic cancer. As part of the Akamis Bio, PICI, and CRI partnership, NG-350A, an immuno-stimulatory tumor gene therapy driving intratumoral expression of a CD40 agonist monoclonal antibody, will be evaluated in combination with standard-of-care chemotherapy and the CTLA-4 inhibitor ipilimumab (YERVOY®).
• In February 2023, Gritstone bio, Inc. announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the National Institutes of Health, to evaluate an autologous T cell therapy expressing a T cell receptor targeting mutated KRAS in combination with Gritstone's KRAS-directed vaccine candidate, SLATE-KRAS, in a Phase 1 study. Under the terms of the agreement, NCI will identify patients with metastatic cancer that are eligible for adoptive cell transfer based on the presence of a G12V or G12D KRAS mutation (KRASmut).
• In February 2023, Keymed Biosciences Inc., jointly announced a global exclusive license agreement with AstraZeneca for CMG901, a potential first-in-class Claudin 18.2 antibody drug conjugate (ADC). Under the license agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialization of CMG901 globally. CMG901 is currently in a Phase I clinical trial for the treatment of Claudin 18.2-positive solid tumors.
• In January 2023, AIM ImmunoTech Inc. announced it has entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca. Under the agreement, Erasmus MC is planning to perform an investigator-initiated clinical study, entitled “Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect. DURIPANC Study,” in which it will use both Study Drugs provided by AstraZeneca and AIM ImmunoTech.

Pancreatic Cancer: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Taiho Pharmaceutical

Taiho Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company, and a subsidiary of Otsuka Holdings, which focuses on developing cancer treatments. Taiho, headquartered in Tokyo, Japan, is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Being Japan's second-largest pharmaceutical company by prescription oral oncology sales, Taiho covers oncology related therapeutic areas including stomach cancer, colorectal cancer, pancreatic cancer, and breast cancer. Taiho also engages in research and development, manufacturing, and the marketing of pharmaceutical products. The company is principally active in the prescription market, but also develops over-the-counter medication, and is a full member of the Japan Pharmaceutical Manufacturers Association (JPMA).

Product Description: Abraxane

Abraxane, which is albumin-bound nanoparticles of paclitaxel that can be reconstituted with saline solution, has confirmed its safety and efficacy. It was developed by Abraxis BioScience, Inc. and is marketed worldwide by Celgene Corporation, the parent company of Abraxis BioScience. Taiho Pharmaceutical has development and marketing rights in Japan. Abraxane was approved in January 2005 by the U.S. FDA for treatment of breast cancer, and as of December 2014, it has been approved in 51 countries worldwide including the U.S. and European countries. In December 2014, Taiho Pharmaceutical Co., Ltd. announced that an antitumor agent "Abraxane I.V. Infusion 100 mg" received approval for the additional indication of unresectable pancreatic cancer by Japan's Ministry of Health, Labour and Welfare. The new indication was based on the results of Phase I/II clinical study in unresectable, advanced or recurrent pancreatic cancer patients conducted in Japan and an international Phase III study (MPACT) conducted by Celgene Corporation, Taiho Pharmaceutical's business partner. In September 2013, Abraxane was approved in the US as a first-line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

2. Company Overview: Ipsen Pharmaceutical

Ipsen Pharmaceutical a global biopharmaceutical company with a focus on innovation and specialty care, having the ambition to build a robust, valuable, and sustainable portfolio of medicines to meet patients and their healthcare teams' needs. Ipsen Pharmaceutical R&D strategy reinforces focus on in three main areas: oncology, rare disease and neuroscience. Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs. The Group has about 5,700 employees worldwide. Ipsen is listed in Paris and in the United States through a Sponsored Level I American Depositary Receipt program.

Product Description: ONIVYDE

Onivyde is a long-circulating, liposomal topoisomerase inhibitor designed to interrupt DNA replication in cancer cells. Onivyde enters cancer cells using a naturally occurring process (enhanced permeability and retention or EPR effect) and as macrophages unpack the liposomes, Onivyde is activated facilitating the release of the cytotoxic payload into the tumor, including irinotecan and its conversion into SN-38, its active metabolite. Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with a strong international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. Pharma Engine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan. Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.

3. Company Overview: Merck Sharp & Dohme LLC

Merck Sharp & Dohme LLC, known as MSD outside of the United States and Canada, are unified around purpose: Company use 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 Sharp & Dohme LLC are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. The company foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

Product Description: Keytruda (pembrolizumab)

KEYTRUDA (pembrolizumab) is an anti-programmed death receptor-1 (PD-1) therapy that works upon increasing the ability of the body's immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1, and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. It is used to treat adult pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. In May 2017, Merck announced that the US FDA had approved Keytruda (pembrolizumab) to treat adult and pediatric patients with unrespectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. In April 2022, the European Commission approved Keytruda (pembrolizumab) to treat the patients with select MSI-H or deficient mismatch repair (dMMR) solid tumors. In December 2018, pembrolizumab got approval in Japan for the treatment of advanced or recurrent MSI-High solid tumors that have progressed after cancer chemotherapy (for use only if refractory or intolerant to standard therapies).

Pancreatic Cancer: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Novartis AG

Novartis AG purpose is to reimagine medicine to improve and extend people's lives. The Company use innovative science and technology to address some of society's most challenging healthcare issues. Novartis AG discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Novartis has one of the industry's most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

Product Description: NIS793

NIS793 is a fully human anti-TGF-β IgG2 monoclonal antibody designed to inhibit the TGF-β pathway in tumor cells and to modulate the tumor microenvironment. In preclinical models, inhibiting TGFβ can reduce fibrosis characteristic of pancreatic and other solid tumor types, as well as enhance the response to chemotherapy and immunotherapy.NIS793 has shown proof of mechanism and acceptable safety profile in a first in-human trial in patients with advanced solid tumors and is in development for pancreatic cancer and other solid tumor types. A Phase II study is ongoing, and a Phase III trial in 1L mPDAC is planned to start enrolling patients later this year.

2. Company Overview: AB Science

Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. AB Science programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment. AB Science has developed a proprietary portfolio of molecules and the Company's lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris.

Product Description: Masitinib

Masitinib is a highly selective inhibitor of mast cell which gives therapeutic benefit by impacting on mast cell related remodeling of the tumor microenvironment. Masitinib is being developed in combination with chemotherapies for treatment of malignancies through its immunotherapeutic properties. The increased mast cell activity within the tumor microenvironment can promote disease progression through release of numerous pro-tumoral mediators, down-regulate the immune response to tumors, and modulation of macrophages towards a pro-tumoral state. The inhibition of the mast cell activity results in anti-tumor effect. Currently, the drug is in Phase III stage of Clinical trial evaluation for the treatment of Pancreatic Cancer.

3. Company Overview: Panbela Therapeutics

Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela's lead assets are Ivospemin (SBP-101) and Flynpovi. Panbela's pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies. The objective of Panbela's pipeline is the utilization of pharmacotherapies to reduce/normalize increased disease-associated polyamines using complementary pharmacotherapies.

Product Description: SBP-101

Ivospemin (SBP-101) is a proprietary polyamine analogue that, due to its unique chemical structure. It inhibits both S-adenosylmethionine decarboxylase 1 (AMD1) and ornithine decarboxylase 1 (ODC1), two key enzymes in polyamine biosynthesis, lowering intracellular polyamine concentrations and slowing or preventing targeted cell growth and division. Ivospemin provide a multi-targeted approach to reset dysregulated biology present in many types of diseases such as cancer and autoimmunity. The polyamine pathway at complementary junctions alter the disease. In particular, the drug have the potential to suppress and prevent tumor growth, enhance anti-tumor activity of other anti-cancer agents, and modulate the immune system. Currently, the drug is in Phase II/III stage of Clinical trial evaluation for the treatment of Pancreatic Cancer.

4. Company Overview: Intensity Therapeutics

Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRx℠ technology platform to create new, proprietary drug formulations that, following direct injection, rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity's product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors. In addition to partnerships with Merck and Bristol-Myers Squibb, the Company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) Vaccine Branch in 2014.

Product Description: INT230-6

INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient's malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.

5. Company Overview: TME Pharma AG

TME Pharma is a clinical-stage company focusing on developing novel therapies for treatment of the most aggressive cancers. The Company specialize in approaches targeting the tumor microenvironment (TME) in which cancer cells exist. The unique technology breaks tumor protection barriers against the immune system and blocks tumor repair by neutralizing chemokines in the TME. TME Pharma's approach works in combination with other forms of treatment to weaken tumor defenses and enable greater therapeutic impact. The clinical programs in glioblastoma and pancreatic cancer have delivered very promising results and further development is planned.

Product Description: Olaptesed pegol

NOX-A12 (olaptesed pegol) is an intravenously administered, PEGylated L-stereoisomer RNA aptamer that targets CXCL12 (C-X-C Chemokine Ligand 12), a key chemokine (signaling) protein. In cancer, CXCL12 acts as a communication bridge between tumor cells and their environment, promoting tumor proliferation, new blood vessel formation and metastasis and reduces tumor apoptosis (cell death). NOX-A12 binds to the CXCL12 “road sign”, neutralizing both the ability to anchor and the ability to interact with receptors on passing cells. This destroys the location information by de-anchoring the chemokine as well as preventing signaling via CXCL12's two receptors CXCR4 and CXCR7 present on various cell types in and around the tumor tissue.

Pancreatic Cancer Analytical Perspective

In-depth Commercial Assessment: Pancreatic Cancer 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.

• Pancreatic Cancer Competitive Landscape

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

Pancreatic Cancer Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

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

Key Players

• Panbela Therapeutics
• ERYtech Pharma
• Jiangsu HengRui Medicine Co., Ltd.
• FibroGen
• Novartis AG
• AB Science
• TME Pharma AG
• Intensity Therapeutics
• Silenseed LTD
• SynerGene Therapeutics
• Elevation oncology
• Salspera LLC
• Redx Pharma Plc
• AIM ImmunoTech Inc.
• Rain Oncology
• Jazz Pharmaceuticals
• Invyte Corporation
• Immodulon Therapeutics Ltd
• GSK plc
• Merck Sharp & Dohme LLC
• Roche
• Helsinn Healthcare SA
• Argenus Inc.
• Actuate Therapeutics
• OSE Immunotherapeutics
• Incyte Corporation
• Galera Therapeutics
• CSPC ZhongQi Pharmaceutical Technology
• Astellas Pharma Global Development, Inc.
• NanOlogy
• Theriva Biologics
• AstraZeneca
• Berg, LLC
• Agenus
• ABVC BioPharma, Inc.
• Boehringer Ingelheim
• Alligator Bioscience
• CARsgenTherapeutics Co.,Ltd
• Purple Biotech Ltd.
• Lisata Therapeutics
• Chongqing Precision Biotech Co., Ltd
• Cybrexa Therapeutics
• Bold Therapeutics
• BioNTech SE
• Bristol-Myers Squibb
• DEKA Biosciences
• Senhwa Biosciences
• Cue Biopharma
• Carisma Therapeutics Inc

Key Products

• Olaptesed pegol
• INT230-6
• SBP-101
• Masitinib
• NIS793
• siG12D LODER
• SGT-53
• Seribantumab
• Salmonella-IL2
• RXC004
• Rintatolimod
• RAIN-32
• Lurbinectedin
• Retifanlimab
• IMM-101
• GSK2256098
• Belzutifan
• Atezolizumab
• Anamorelin
• AGEN1423
• Elraglusib
• OSE2101
• Epacadostat
• GC4711
• Docetaxel
• Zolbetuximab
• NanoPac
• VCN-01
• Danvatirsen
• BPM31510
• Botensilimab
• ABV-1703
• BI 907828
• Mitazalimab
• CT041
• CM24
• CEND-1
• CEA-targeted CAR-T cells
• CBX-12
• BOLD-100
• BNT141
• BMS-813160
• DK210
• CX-5461
• CUE-102
• CT-0508

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