Cancer Vaccines - Competitive landscape, 2023

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

Cancer Vaccines: Understanding

Cancer Vaccines: Overview

The advent of cancer immunotherapy has revolutionized the field of cancer treatment and offers cancer patients new hope. Although this therapy has proved highly successful for some patients, its efficacy is not all encompassing and several cancer types do not respond. Cancer vaccines offer an alternate approach to promote anti-tumor immunity that differ in their mode of action from antibody-based therapies. Cancer vaccines serve to balance the equilibrium of the crosstalk between the tumor cells and the host immune system.

Preventive and Therapeutic Cancer Vaccines

Cancer vaccines can either be prophylactic (preventative) or therapeutic (curative). An exciting option for therapeutic vaccines is the emergence of personalized vaccines, which are tailor-made and specific for tumor type and individual patient. Prophylactic vaccines are designed to prevent a cancer from establishing itself and have proven to be successful in reducing the global burden associated with two cancer-causing viruses, Hepatitis B Virus (HBV) and Human Papilloma Virus (HPV). The US Food and Drug Administration (US FDA) has approved vaccines for cancer-associated with these viral infections. Therapeutic cancer vaccines have been tested in the clinic for several decades. Several different categories of therapeutic cancer vaccines are currently being evaluated. These include cellular (whole tumor/immune cells), viral vector, or molecular (peptide, TAA-encoding DNA, or RNA). The therapeutic efficacy of these agents has been improved by using the optimal formulation for vaccine delivery and by co-administration of immunological adjuvants, immune stimulatory cytokines and addition of costimulatory molecules.

Delivery Strategies

While a large number of strategies have been developed for the preparation and formulation of cancer vaccines (whole cell-, peptide- or nucleotide-based), it still remains challenging to develop an effective common delivery platform for these vaccines that would stimulate potent anti-tumor immune responses. To date, several vaccine delivery strategies have been developed that are currently in preclinical or clinical studies, including bacterial and viral vector-based strategies, DC-based delivery strategies and biomaterial-based delivery systems, each with their pros and cons.

Cancer vaccine therapy combined with other treatment modalities

Given the existence of such diverse vaccine platforms that potentially engage the innate and adaptive immune components, it is feasible and attractive to use combinatorial cancer vaccine therapy. In addition to cancer vaccines, a wide range of other promising immunotherapeutic modalities is being tested or approved for cancer treatment. These include adoptive cell transfer of ex vivo expanded tumor infiltrating lymphocytes, use of therapeutic antibodies (e.g., trastuzumab) for antagonizing oncogenic pathways and triggering antibody dependent cytotoxicity and phagocytosis, and administration of immune modulating antibodies targeting both co-inhibitory and co-stimulatory receptors on activated T cells or the corresponding ligands on APCs as well as tumor cells to enhance antitumor immune responses.

Report Highlights

• In February 2023, Personalis, Inc., a leader in advanced genomics for precision oncology, and Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced the companies have signed a new agreement to continue using the Personalis NeXT Platform® as part of upcoming clinical studies evaluating mRNA-4157/V940, an investigational personalized cancer vaccine, jointly developed by Moderna and Merck.
• In Januray 2023, GreenLight Biosciences, Inc., PBC
• and EpiVax Therapeutics Inc, signed an exclusive collaboration agreement to jointly develop and commercialize personalized mRNA-based vaccine candidates for cancers.
• In November 2022, IO Biotech entered into a fourth clinical trial collaboration and supply agreement with Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through a subsidiary. The purpose of the collaboration is to evaluate IO Biotech's lead candidate, IO102-IO103, in combination with KEYTRUDA® for patients with resectable tumors in at least two indications.
• In October 2022, Moderna, Inc. and Merck known as MSD outside of the United States and Canada, announced that Merck has exercised its option to jointly develop and commercialize personalized cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing Collaboration and License Agreement. mRNA-4157/V940 is currently being evaluated in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant treatment for patients with high-risk melanoma in a Phase II clinical trial being conducted by Moderna.
• In March 2022, NEC OncoImmunity , a subsidiary of NEC Corporation, and VAXIMM AG, a Swiss/German biotech company focused on developing an oral plug and play DNA vaccination technology to stimulate patients' cytotoxic T-cells targeting a wide range of cancer-related antigens, announced that the companies have signed an agreement under which NOI will acquire all of VAXIMM's neoantigen program assets. VAXIMM technology enables fast generation and delivery of personalized T-cell cancer vaccines and may overcome key issues faced by the neoantigen field.

Cancer Vaccines: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Dendreon Corporation

Dendreon is a biotechnology company. Its lead product, Provenge (known generically as sipuleucel-T), is an immunotherapy for prostate cancer. It consists of a mixture of the patient's own blood cells (autologous, with dendritic cells thought to be the most important) that have been incubated with the Dendreon PAP-GM-CSF fusion protein. Dendreon's name derives from the "Dendritic Cell" which forms a major component of the company's product candidates that use the "Dendreon Cassette Technology" to insert a disease-specific target protein into a general platform. Dendreon believes its process can be optimized and generalized to other diseases by exchanging the PAP component of Provenge with better targets specific to different diseased cells.

Product Description: Provenge

Sipuleucel-T is a personalized, autologous, cellular immunotherapy. Sipuleucel-T is a therapeutic cancer vaccine for prostate cancer. Sipuleucel-T selectively targets the prostate-specific antigen (PSA) known as prostatic acid phosphatase (PAP) that is expressed in around 95% of prostate cancers. It must be prepared specifically for each patient. In metastatic prostate cancer, it has extended survival by median 4.1 months (IMPACT Phase III trial data). Sipuleucel-T is marketed under the brand name Provenge by Dendreon Corporation. Sipuleucel-T was approved by the US Food and Drug Administration (FDA) on April 29, 2010, to treat asymptomatic or minimally symptomatic metastatic Hormone-Refractory Prostate Cancer (HRPC).

2. Company Overview: Merck & Co., Inc.

Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of its mission to save and improve lives. The company continues to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases - and aspires to be the premier research-intensive biopharmaceutical company in the world.

Product Description: H101

HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. While it is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

On 10 December, 2014 the USA Food and Drug Administration (FDA) approved Gardasil 9 (Human papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Moreover, in June 2020, it was approved for an expanded indication in the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.

Cancer Vaccines: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. The company's immunology research and development platform is focused on three areas: T-cell-based vaccination, Immuno-Oncology (focus on myeloid targets), Auto-immunity & Inflammation. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile. Tedopi (innovative combination of neoepitopes) is the the company's most advanced product.

Product Description: Tedopi

Tedopi (formerly known as OSE-2101), is a cancer vaccine being developed by OSE Immunotherapeutics for the treatment of certain types of lung cancer. It contains a combination of 10 optimized neo-epitopes, which are parts of proteins that structurally alter cancer cells and trigger strong immune responses against them. The epitopes present in Tedopi are optimized from five tumorous antigens. The epitopes express a minimum of one of the tumor antigens and generate a specific response from cytotoxic (aka killer) T-cells against cancer cells. Tedopi works by stimulating killer T-cells, enabling them to spot and eliminate cancerous cells, which is a key process in the treatment of disease. Tedopi has been granted orphan drug designation by the US Food and Drug Administration (FDA) and is recognized as a personalized medicine for the treatment of HLA-A2 positive NSCLC patients in Europe.

2. Company Overview: IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win® technology platform. The T-win® platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through clinical and preclinical development its other pipeline candidates. IO Biotech is headquartered in Copenhagen, Denmark.

Product Description: IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dehydrogenase (IDO) and PD-L1. The combination is currently investigated in Phase III trial for Melanoma and in Phase I/II for some other cancers.

IO102 and IO103 are IO Biotech's lead immuno-oncology candidates. Both compounds are based on IO Biotech's proprietary T-win® technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

3. Company Overview: PDS Biotech

PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company's proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them.

Product Description: PDS0101

PDS0101 is a novel investigational human papilloma virus (HPV)-targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. PDS0101 is given by a simple subcutaneous injection in combination with other immunotherapies and cancer treatments. Interim data suggests PDS0101 generates clinically effective immune responses, and the combination of PDS0101 with other treatments demonstrates significant disease control by shrinking tumors, delaying disease progression and/or prolonging survival. The combination of PDS0101 with other treatments does not appear to compound the toxicity of other agents. PDS0101 is currently being evaluated in four Phase 2 clinical trials for the treatment of various types of HPV-positive cancers.

Cancer Vaccines Analytical Perspective

In-depth Commercial Assessment: Cancer Vaccines 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.

Cancer Vaccines Competitive Landscape

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

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

Key Players

• Imvax
• Transgene
• BrightPath Biotherapeutics
• Vaccitech
• Amal Therapeutics
• Enterome
• Moderna, Inc.
• Ultimovacs ASA
• OSE Immunotherapeutic
• IO Biotech
• PDS Biotech
• LIKANGLIFE SCIENCES
• ISA Pharmaceuticals
• Voltron Therapeutics, Inc.
• RNAImmune

Key Products

• IGV 001
• TG4050
• BP1209
• VTP-1100
• ATP-128
• EO2401
• mRNA-4157
• UV1
• Tedopi
• IO102-IO103
• PDS0101
• LK101
• ISA101
• Research Programme (Cancer Vaccine)