Key players in the neoantigen industry

As mentioned in previous chapters, two studies published in 2017 showed efficacy of neoantigen vaccines in humans. One of the studies was conducted by co-founders of Neon Therapeutics- Nir Hacohen and Catherine Wu. The other one was conducted by Ugur Sahin and colleagues from Biopharmaceutical New Technologies (BioNTech) Corporation and the Johannes Gutenberg University in Germany. Ugur Sahin is the founder & CEO of BioNTech. Neon Therapeutics and BioNTech are the leading players in the neoantigen vaccine industry. Besides them, Back Bay Life Science Advisors cataloged more than 30 companies who have laid claim to a neoantigen selection and/or priming method (see fig.9, [15]). These biopharmaceutical companies are building their own techniques and platforms to develop proprietary neoantigen vaccines and therapy methods. Below, we take a look at some of the key players in the industry. 

Fig. 9 Landscape of neoantigen companies. Source: Back Bay Life Science Advisors [15].

BioNTech

BioNTech was founded in Mainz, Germany in 2008. Now it has become a leading global biotechnology company for individualized cancer medicine. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range infectious diseases alongside its diverse oncology pipeline. 

BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Eli Lilly and Company, Genmab, Sanofi, Bayer Animal Health, Genentech, Genevant, Fosun, and Pfizer. Pfizer and BioNTech entered a collaboration in 2018 to develop mRNA-based vaccines for prevention of influenza. On March 17, 2020, Pfizer Inc. and BioNTech announced that the companies have agreed to a letter of intent regarding the co-development and distribution of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection. BioNTech’s COVID-19 mRNA vaccine program, BNT162, is expected to enter clinical testing by the end of April 2020. (Source: company website) 

BioNTech announced that it was acquiring Neon Therapeutics to bolster Immuno-Oncology Pipeline in January 2020. The deal has been approved by both companies’ boards of directors. It is expected to close in the second quarter of 2020.

Neon Therapeutics 

Neon Therapeutics is a leader in the field of neoantigen-targeted therapies, dedicated to transforming the treatment of cancer by directing the immune system towards neoantigens. Their proprietary neoantigen platforms including: 

RECON® Bioinformatics Engine, which can predict specific neoantigen peptides; Peptide chemistry and manufacturing capabilities;

NEON-STIMTM technology for inducing and monitoring T cell responses.  This proprietary method can stimulate T cells outside of the body (ex vivo), allows the company to test the immunogenicity of neoantigens, as well as to generate neoantigen-specific T cells and T Cell Receptors (TCRs) for use in our neoantigen-targeted therapies. This method also allows the company to extensively monitor the immune system and its corresponding effect on cancer, and therefore precisely define how products influence each patient’s immune system and how these immune changes put pressure on tumors. (Source: company website)

Fig. 10 Neon Therapeutics platform and scientific capabilities. Source: Company website.

Neon Therapeutics and Gritstone Oncology are two companies that both highlight their proprietary neoantigen discovery platforms. With faster computers, more economical sequencing methods, the companies can use big data and AI techniques to develop deep learning algorithms for neoantigen discovery.

Gritstone Oncology

Gritstone Oncology was founded in August 2015, headquartered in Emeryville, California, and listed on the Nasdaq Global Select Market under the ticker symbol GRTS from 2018. Its lead product, GRANITE, is a personalized neoantigen-based immunotherapy. The second product, SLATE, is based on shared neoantigen. The company has developed its product candidates using two key pillars. First one, proprietary machine learning-based platform, Gritstone EDGE™, which provides a powerful ability to predict from a routine tumor biopsy the tumor-specific neoantigens; and second, the ability to develop and manufacture potent immunotherapies. (Source: company website)

Genocea Biosciences

Genocea headquartered in Cambridge, Massachusetts, is a publicly traded company listed on NASDAQ under the ticker symbol GNCA. The company is working to create vaccines that stimulate the T cell arm of the immune system. Genocea designs vaccines using ATLAS, its revolutionary platform, to identify true T cell antigens. Their lead program, GEN-009, uses the ATLAS platform to optimize neoantigen selection for personalized cancer vaccines. GEN-009 is now in a Phase 1/2a clinical trial. (Source: company website)

Moderna

Moderna was founded in 2010 and headquartered in Cambridge, Massachusetts. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. The company’s pipeline includes development candidates for mRNA-based vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, and therapies spanning several therapeutic areas. Multiple clinical trials are underway.
Now Moderna has been a leading biotechnology company in the mRNA vaccine industry. In January 2020, Moderna announced development of a vaccine to inhibit COVID-19 coronavirus (SARS-CoV-2), in competition with other biotechnology companies, such as BioNTech, Gilead Sciences, Vaxart, Inovio Pharmaceuticals, and Novavax. The first clinical batch of the mRNA Vaccine (mRNA-1273) was shipped on February 24, 2020 from Moderna and delivered to NIH from the Company’s manufacturing facility in 42 days from sequence selection. In March 2020, the Phase I human study of the vaccine candidate began in partnership with the US National Institute of Allergy and Infectious Diseases. (Source: company website) 

Other Companies

Other biotech companies, such as Agenus, Immatics, Advaxis, Precision Biologics, Kite Pharma, also developed their own proprietary technologies and platforms to get a space in the neoantigen industry. CRO organizations offering gene sequencing service, bioinformatics service, peptide or RNA synthesis services are also involved in this industry chain. 

Outlook

Generally speaking, neoantigen vaccines and therapies are still new methods in cancer immunotherapy. Most of the clinical trials conducted and submitted are in phase 1 status, and pharmaceutical companies are attempting for more phase 2 trials. We are delighted to see more studies are covering a broader range of cancer types, even solid tumors. In particular, combination therapies using checkpoint inhibitors or chemotherapy could be more prevalent. As more scientific and clinical data reveals the efficacy of neoantigen-based vaccines and therapies in multiple cancer types, and a better understanding of biological properties of neoantigen, we have abundant reasons to believe that neoantigen-based therapies are promising area in cancer immunotherapies. 

Related articles

Chapter 1: What are neoantigens and how to identify them?

Chapter 2: Personalized neoantigen vaccines

Chapter 3: Neoantigen-based cancer immunotherapy

References

[15] BACK BAY LIFE SCIENCE ADVISORS, JUNE 1, 2018. “Neoantigen-based cancer immunotherapy: one step closer to the promise of personalized medicine.”