Through its propriatary Neo-X-Prime platform, Alligator Bioscience has generated ATOR-4066 – a bispecific antibody aimed at boosting immune cells in cancer patients. Now, the company has been granted the first US patent protecting ATOR-4066. BioStock spoke with Alligator’s CEO Søren Bregenholt to better understand the importance of this patent.
When it comes to cancer therapy development, Alligator Bioscience is leveraging its expertise on the CD40 protein, which plays a major role in immune response regulation, through its two lead assets mitazalimab and ATOR-4066. The Swedish biotech is making headways with the clinical development of CD40 agonist mitazalimab.
Mitazalimab activates dendritic cells to enhance the immune system’s antigen presentation, and ability to selectively attacking cancer cells. According to the company, the candidate is a potential game changer in the treatment of solid tumours and has started delivering promising phase II data in metastatic pancreatic cancer with top-line phase II data expected in early Q1 2024. Read more here.
Neo-X-Prime platform to boost anti-tumour activity
Building on the experience with mitazalimab, Alligator has built antibody discovery platforms to develop next-generation cancer therapies. One of these is Neo-X-Prime, a novel class of bispecific conditional CD40 agonistic antibodies able to significantly and specifically boost anti-tumour immunity in the presence of an activating target. The molecules generated by this platform efficiently connect dendritic cells to tumour debris and are expected to be more precise, efficacious and safe than those from previous generations. Alligator believes that they will be able to provide benefits across a number of cancer indications.
ATOR-4066 as a next–generation cancer therapy
The first drug candidate based on Alligator’s Neo-X-Prime platform is ATOR-4066, a third generation CD40 agonist. It is designed to treat cancers expressing a specific molecule called CEACAM5. Two examples of such cancers are gastric and colorectal cancer.
According to Alligator’s CSO Peter Ellmark, who discussed the candidate’s potential in this interview with BioStock, targeting CD40 and CEACAM5 simultaneously makes ATOR-4066 more potent and specific with a very favourable safety profile. This makes ATOR-4066 well-placed to make a significant impact in the immuno-oncology space in the near future.
At Alligator’s Capital Markets Day held late last year, Ellmark mentioned how the preclinical data generated with ATOR-4066 thus far reflect its synergistic effect on T-cell activation when combined with a PD-1 checkpoint inhibitor. This is expected to not only boost the efficacy of PD-1 in tumours where these compounds are already approved, but also expand tumour types where PD-1 could be efficacious thanks to ATOR-4066 boosting the immune system. Read more.
US patent granted
This week, Alligator announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering ATOR-4066 in the treatment of cancer.
The patent, titled “Novel peptides,” provides ATOR-4066 with protection regarding methods of treating cancer and/or a tumour using a bispecific antibody comprising the complementarity-determining regions (CDRs) of the ATOR-4066 molecule.
This is the first patent of the ATOR-4066 intellectual property portfolio, which is expected to strengthen as more patents are filed and granted. Its accelerated application was part of the Cancer Immunotherapy Pilot programme, which provided a fast-track review for cancer immunotherapy-related patent applications in the US.
BioStock got in touch with Alligator’s CEO Søren Bregenholt to learn more about the significance of this milestone.
Søren, could you tell us more about ATOR-4066 and why it’s so promising?
– Tumours constantly try to evade the immune system by different mechanisms, e.g. by dampening the ongoing immune response and by inducing new mutations rendering the immune response obsolete. The data we have generated so far confirm that ATOR-4066 has a unique way of counteracting these mechanisms. Firstly, it activates dendritic cells and machrophages in a way that keeps the immune response going. Secondly, it allows the dendritic cells to direct the immune response towards the most recent tumour mutations. Thus, ATOR-4066 maintains a constant immune pressure on the tumour, limiting the tumour’s ability to escape and provide long lasting benefits for the patients.
Why is this patent important?
– Patents are important as they basically prevent your inventions from being copied for typically 20 years or more. This first ATOR-4066 patent is particularly important as it certifies that ATOR-4066 is novel and innovative when compared to existing bispecific CD40 antibodies. Together with our patents, applications and knowhow on the Neo-X-Prime platform and our proprietary RUBY antibody format, this patent is the foundation for building a strong patent portfolio protecting ATOR-4066.
Why did you register for a US patent?
– The US is the largest and most attractive pharmaceutical market in the world, and we clearly want to protect our inventions there. We apply for patents in a wide range of territories and expect to get broad global patent protection for ATOR-4066. The US patent was just the first one granted based on the fast-track review via the US Cancer Immunotherapy Pilot programme.
What is the market potential with ATOR-4066 in the US?
– As just discussed, ATOR-4066 is developed for treatment of CEACAM5 expressing tumours like colorectal cancer and gastric cancer, all cancers with high patient numbers and significant unmet medical need, even with the treatments available today. We believe that ATOR-4066 will provide new treatment options for these patients, either as a stand-alone or a combination treatment. I cannot provide a precise market potential, but clearly, if ATOR-4066 holds its promises, it will be significant and definitely worth the investment by becoming a blockbuster product.
What comes next for 4066?
– We are very encouraged by the preclinical data we have seen with ATOR-4066 as a front-runner for the Neo-X-Prime class of drugs and will continue to advance it towards clinical trials. We have just seen the first glimpse of early manufacturing data, and we are very encouraged.
Finally, is 4066 just the first of a potentially long list of cancer therapy candidates?
– Correct, we see a significant commercial potential in the Neo-X-Prime platform as it will allow us to develop a range of conditional CD40 agonist targeted towards different tumour antigens, meaning that we will be able to target defined and largely non-overlapping groups of cancers. We are working on a number of new discovery programmes to follow up on the success and promise of mitazalimab and ATOR-4066, but it is too early to reveal the specific targets.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.