Cancer Vaccine Race Heats Up: Moderna, Merck, BioNTech, and Others Vie for Breakthroughs in 2024

The pursuit of effective cancer vaccines is intensifying, with several pharmaceutical giants making critically important strides in clinical trials. Unlike customary vaccines that prevent diseases, these therapeutic cancer vaccines are engineered to stimulate a patient’s immune system. The goal is to train T cells to specifically identify and eradicate cancer cells within the body. Moderna and merck are at the forefront with their melanoma vaccine, while BioNTech is concentrating on pancreatic cancer. Transgene, OSE Immunotherapeutics, and Nykode Therapeutics are also key players, each targeting diffrent cancers with their unique vaccine candidates. These advancements leverage personalized medicine, using a patient’s genome sequencing to pinpoint unique cancer characteristics, paving the way for more targeted and cost-effective vaccine growth.

Moderna and Merck’s Melanoma vaccine V940 (mRNA-4157)

Moderna and Merck are collaborating on V940 (mRNA-4157), a melanoma vaccine that signifies a significant leap in personalized cancer treatment. This vaccine is meticulously designed to target the unique genetic characteristics inherent in a patient’s specific cancer.

Vaccine Characteristics

V940 is composed of a single synthetic mRNA strand capable of encoding up to 34 neoantigens derived from a patient’s specific cancer genetic profile. When presented, these neoantigens trigger the activation and proliferation of T cells. These activated T cells then continuously monitor the body for cancer cells displaying the same neoantigens, enabling a highly targeted immune response.

Current Status

Phase IIb trial results, released in April 2023, revealed promising outcomes.Patients treated with a combination of V940 + Keytruda experienced a 44% reduction in the risk of cancer recurrence or death compared to those treated with Keytruda alone. This significant finding led the U.S. Food and Drug Management (FDA) to grant the vaccine breakthrough therapy designation. In July, Moderna and Merck announced the initiation of a phase III trial, aiming to recruit 1,089 participants, with an expected completion date in 2029.

BioNTech’s pancreatic Duct Adenocarcinoma (PDAC) Vaccine Autogene Cevumeran (BNT122)

BioNTech, in collaboration with Genentech, is developing autogene cevumeran (BNT122), a vaccine targeting pancreatic duct adenocarcinoma (PDAC), a especially aggressive and difficult-to-treat cancer.

Vaccine Characteristics

This vaccine comprises mRNAs derived from 20 patients’ personalized neoantigens. It is administered in conjunction with atezolizumab,an immune checkpoint inhibitor,to enhance the immune response.

Current Status

Previous Phase I trials have shown that the vaccine effectively induced a substantial number of T cells targeting neoantigens in PDAC patients. Notably, many of these patients experienced prolonged periods without cancer recurrence, a significant achievement given the high recurrence rates associated with PDAC. In October 2023, BioNTech announced the commencement of the Phase II trial, which will involve 206 patients divided into two groups: one receiving a combination of vaccine + atezolizumab + standard chemotherapy and the other receiving standard chemotherapy only. The trial is anticipated to conclude in 2029. Autogene cevumeran is also currently undergoing Phase II trials for colorectal cancer and melanoma.

Transgene’s Viral Vector Vaccine TG4050

Transgene is advancing its viral vector vaccine,TG4050,developed in collaboration with NEC,utilizing NEC’s artificial intelligence system to screen and identify personalized neoantigens.

Vaccine Characteristics

TG4050 is designed to elicit T cell activity even in patients with compromised immune systems, including those over 65 years of age or with low circulating lymphocytes.

Current Status

The vaccine is currently in Phase I trials for ovarian cancer and HPV-negative head and neck cancer. Early results have demonstrated a robust immune response in patients.As of June 2023,subjects receiving the vaccine have not experienced relapse,and both studies are projected to be completed in 2024.

Tedopi, an Advanced Non-small Cell lung Cancer (NSCLC) vaccine for OSE Immunotherapeutics

OSE Immunotherapeutics is focusing on Tedopi, a vaccine targeting advanced non-small cell lung cancer (NSCLC).

Vaccine Characteristics

Tedopi is an antigen peptide mixture designed to initiate antitumor T cells.The selected antigens are commonly expressed in NSCLC patients and in the HLA-A2 phenotype.

Current Status

In September 2023, OSE Immunotherapeutics announced positive results from Tedopi’s Phase III trial. The trial involved 219 NSCLC patients who had developed resistance to immune checkpoint inhibitors or had not responded to chemotherapy. patients treated with Tedopi showed substantially improved survival rates and quality of life compared to those receiving standard chemotherapy. Tedopi is also being evaluated in a Phase II trial for patients with PDAC and recurrent ovarian cancer.

Nykode Therapeutics’ cervical Cancer Candidate VB10.16

Nykode Therapeutics is developing VB10.16, a vaccine candidate targeting cervical cancer.

Vaccine Characteristics

VB10.16 is a DNA plastid-based vaccine that combines 20 neoantigens with a unit designed to attract antigen-presenting cells (APCs). depending on the type of APC attracted, the vaccine can initiate T cells (to kill neoantigen-carrying tumor cells) or B cells (to produce antibodies against neoantigen-carrying cells).

Current Status

Nykode Therapeutics announced encouraging results from the Phase IIa trial of VB10.16 in April. The vaccine was administered in combination with Roche’s atezolizumab to a total of 52 subjects. After a one-year follow-up, vaccinated patients showed a median overall survival of 16.9 months, with PD-L1-positive patients exhibiting survival rates exceeding 25 months. A larger Phase II trial of VB10.16 for the treatment of cervical cancer is scheduled to begin at the end of 2023.

Conclusion

The development of cancer vaccines is a rapidly evolving field, with several promising candidates showing

Cancer Vaccine Revolution: Are We on the Cusp of a Cure?

Is the current wave of cancer vaccine research truly revolutionary, or just another incremental step forward in the fight against cancer?

Senior Editor: Dr.Anya Sharma, welcome. your expertise in oncoimmunology is widely respected. The recent breakthroughs in cancer vaccines, particularly the work of Moderna, Merck, and BioNTech, have generated immense excitement.Can you provide an overview of this rapidly evolving field?

Dr.Sharma: Thank you for having me. The advancements in cancer vaccine technology are indeed groundbreaking. We’re moving beyond simply preventing disease; these are therapeutic vaccines, designed to harness the bodyS own immune system to actively target and destroy existing cancer cells. This represents a paradigm shift in cancer treatment, moving toward a more personalized and potentially curative approach. This wave of cancer vaccine development is not simply incremental,but marks a critically important leap. We are now entering an era where tailored therapies can be designed to match the unique genetic makeup of a patient’s tumor, targeting the specific neoantigens driving the cancer’s growth. This is far beyond anything previously possible.

Senior Editor: Let’s dive into the specifics. What makes these personalized cancer vaccines so different from traditional vaccines? What are some of the key mechanisms behind their effectiveness?

Dr.Sharma: Traditional vaccines prevent infection by preparing the immune system to encounter a known pathogen. They act prophylactically.Personalized cancer vaccines differ considerably. These vaccines are therapeutic, targeting the unique molecular fingerprints — the neoantigens — of a patient’s specific tumor. This personalized approach uses genomic sequencing to identify these unique neoantigens. The vaccine then presents these neoantigens to the immune system,essentially “training” T cells to recognize and eliminate cancer cells that display those same neoantigens. This is a targeted attack, unlike the broader approach of traditional chemotherapy or radiation. The effectiveness hinges on this precise targeting and the ability to generate a robust and long-lasting immune response capable of controlling or eliminating cancer cells.

Senior Editor: Moderna and Merck’s melanoma vaccine, V940 (mRNA-4157), has shown remarkable promise. Can you elaborate on its characteristics and potential impact?

Dr. Sharma: The V940 vaccine is a prime example of personalized immunotherapy.Its use of mRNA technology enables the encoding of numerous neoantigens from a patient’s tumor for a targeted attack. Phase IIb trial results demonstrated a significant reduction in cancer recurrence and mortality when used in conjunction with Keytruda and this, coupled with the FDA granting it breakthrough therapy status, underscores the potential of next-generation cancer vaccines for treating melanoma.

Senior Editor: BioNTech’s work on pancreatic duct adenocarcinoma is another exciting area. Pancreatic cancer is notoriously tough to treat. What advances are being made here?

Dr. Sharma: BioNTech’s autogene cevumeran (BNT122) represents a major step forward in tackling pancreatic adenocarcinoma which is a very aggressive cancer commonly presenting with poor prognosis.The vaccine works by identifying the unique cancer neoantigens expressed by a patient’s tumor and using these as the basis for producing a targeted vaccine. The use of personalized neoantigens together with an immune checkpoint inhibitors such as atezolizumab is a new approach that enables better detection and destruction of tumor cells. Early clinical trials showcase the potential to significantly improve outcomes for patients with this notoriously difficult-to-treat cancer. The hope is that this approach will substantially increase overall survival rates in patients.

Senior Editor: Beyond Moderna and BioNTech, other companies are developing innovative cancer vaccines. can you highlight some of their approaches and the different cancer types they are targeting?

Dr. Sharma: Absolutely. Transgene is leveraging AI to identify personalized neoantigens for its viral vector vaccine, TG4050. OSE Immunotherapeutics’ Tedopi shows promise against non-small cell lung cancer, while Nykode Therapeutics’ VB10.16 is demonstrating positive results in cervical cancer. Each company is employing unique technological approaches and targeting different types of cancer using different technological approaches. This illustrates the collaborative and diverse nature of this critical research. These diverse approaches highlight the potential of cancer vaccines to treat a wide array of cancers.

Senior Editor: What are some of the biggest challenges that remain in cancer vaccine development and how are researchers addressing them?

Dr. Sharma: Despite recent breakthroughs, challenges remain.ensuring a strong and sustained immune response across diverse patient populations is vital, and finding ways to enhance the immune system’s ability to “see” and eliminate cancer cells is key. Improving cost-effectiveness and accessibility is another crucial issue. Researchers are addressing these using advancements in mRNA technology, immunomodulatory agents, and improved vaccine formulations, the improved understanding of the interplay between tumor cells and the immune system.

senior Editor: What is your outlook for the future of cancer vaccines?

Dr. Sharma: The future is incredibly promising. We are witnessing a convergence of several key fields: genomics, immunology, and computational biology. This convergence is accelerating the pace of innovation and leading to more effective and personalized cancer therapies. The ongoing development and clinical trials point towards a future where cancer vaccines are a standard part of the treatment arsenal, considerably improving the quality of life and survival rates for cancer patients.

Senior Editor: Dr. Sharma,thank you for providing such insightful and valuable information. This interview sheds a much-needed light on this pivotal moment in the field of cancer treatment. Readers, please share your thoughts and insights in the comments below, and don’t hesitate to share this informative interview on social media. The race for a cancer cure is intensifying; we’ll keep you updated!