New immunotherapy agents in the oncology pipeline aim to predict the most important tumour antigens and formulate a personalised vaccine against them. With multiple catalysts coming up in Q4 2021, data from a number of early-stage biotech companies will have a profound impact on the industry’s sentiment regarding personalised neoantigen therapeutics, according to GlobalData.

Sakis Paliouras, Senior Oncology Analyst at GlobalData, comments, “While the field of personalised neoantigen therapeutics is booming and has received tremendous industrial investment, it remains unproven in the clinic. Thus, a definite positive signal in a sufficiently high number of patients will promote investor confidence and allow more molecules to reach late-stage clinical trials, allowing next-generation approaches to emerge.”

A number of catalysts are expected in Q4 2021. Specifically, Gritstone Bio/Merck & Co’s DNA vaccine GRANITE-001 is expected to provide a Phase I/II readout from patients with various solid tumours by September 2021. By December 2021, the field’s most promising approaches will be a lot clearer, with Roche/BioNTech’s mRNA vaccine autogene cevumeran, Geneos Therapeutics’ DNA vaccine GNOSPV-02 and BioNTech’s peptide vaccine NEOPV-01, all expected to release preliminary efficacy and safety data. So far there are reports of stable disease or even partial response signals, but where these agents can really offer something new is an expected favourable safety profile that allows combinations with other treatment modalities.

Paliouras continues, “Even earlier stage is the approach of targeting clonal neoantigens. Clonal neoantigens are believed to be present in all tumour cells and can be targeted with selected tumour-infiltrating cells that are afterward cultured and enriched. The leading company in this space is Achilles Therapeutics (Achilles) with its ATL001 program.”

The four molecules expected to launch first, autogene cevumeran, GRANITE-001, ATL001, and Genocea Biosciences’ GEN-009 have combined peak forecast sales of over $1 billion by 2027, according to GlobalData’s estimates. However, the field is in its infancy, and clinical validation of any of the approaches will greatly expand the total market value.

Paliouras adds, “A potential positive efficacy signal for Achilles upon the first clinical trial readout could be enough to kick-start the creation of a whole new class of clonal neoantigen therapeutics and lead to the formation of many startup companies with innovative approaches.”