Who is NEOGAP?

A Swedish precision medicine ATMP

By Heather Main – ATMP Sweden Communicator

A couple of weeks ago I saw mention of NEOGAP in some meeting minutes. Ooh, I thought, a new Swedish ATMP company, how exciting! I immediately started drafting an email welcoming them to the Swedish ATMP space and notifying them of the Swedish ATMP initiatives that may be of interest to them. Of course, you should check their website before you press send….homepage – EpiTCer®, Andrea Salmén…some bells ringing here. The email quickly changed to ‘Are you a re-brand of TCER?’

The story was not as juicy as I had hoped, NEOGAP Therapeutics AB is the new name of TCER AB, the result of avoiding confusion with a German company that has a T cell product called TCER.

But, the story does not end there. Corona times mean most of us sit at home or in empty offices and suffer a significant decrease of ‘physical’ face to face interactions with our colleagues. This is the case for me. I see my ‘office mate’ Kristina Kannisto maybe once a month now and when I see her I can’t help but talk a mile a minute about anything I can imagine that I am pondering about the ATMP space. I mentioned to Kristina that I didn’t really understand what precision medicine really is and how it relates to ATMP. That I have been planning an article on it for a while but am still struggling to get a clear message myself. Kristina’s wisdom was, ‘NEOGAP is a fantastic example of a precision medicine’. That’s about as many words as she gets in once I start.

So I set up a meeting to chat with NEOGAP CEO Samuel Svensson to try to better understand an ATMP ‘precision medicine’.

What an amazing chat it was! Curing cancer without side effects? NEOGAP says ‘yes it can be done’. Technology based on patient cells, whole genome exome and RNA sequencing. This is really a ‘personalised’ medicine. Briefly, patient lymphnode derived T cells are exposed to recombinant neoantigens predicted from whole genome exome and RNA sequencing of patient tumour and somatic cells. The neoantigen activated T cells are expanded and delivered to ‘patients’…..as yet preclinical. The technology is based on two proprietary pillars;

• Software – which mutations are attractive targets? PIOR
• efficient neoantigen delivery EpiTCer – antigens on particles

Process overview

See the explanatory animation on NEOGAPs website.

Production of NEOGAPs pharmaceutical product, pTTL – Personalised Tumour Trained Lymphocytes will be performed at Vecura, Stockholm, Sweden. Clinical trials for this very exciting technology are expected to start already next year and will test the product concept on fatal solid tumours such as colorectal cancer.

The Whole Genome Exome Sequencing and RNA sequencing are critical diagnostic aspects that determine the product formulation, a crystal clear example of a precision medicine. This is far from an ‘off the shelf’ product and with that comes great opportunity but also great challenge, including the high costs associate in tailoring the product to a single patient. However, reimbursement planning may benefit from ever decreasing costs of sequencing methods and possible future allogeneic products may be possible for identified patient subgroups.

Another interesting aspect of this technology is the development of new and efficient software for interpreting sequencing data towards defining a product. This will be important to the development of many personalized ATMP products, where decisions in regard to the patient need to be done in a fashion that is standardized and does not vary depending on who is analyzing the data. Samuel Svensson from NEOGAP believes there is great potential to adapt their bioinformatic platform to other developers looking to personalize their product to a patient/disease.

How is NEOGAPs technology different to other well-known T cell technologies?

• TILs are patient tumour derived T cells that are non-selectively expanded using IL2, patients are preconditioned with lymphodepletion and often given systemic IL2. A relatively small proportion of tumour selective T cells are present in the final product. The TILs also have a relatively short survival compared to NEOGAP ‘central memory’ T cells.
• CAR T – current market approved selectively kill a cell type, tumour antigen independent eg. CD19 to kill all B cells, including the cancerous ones.
• TILs/DC ‘vaccination’ – this is quite similar to the NEOGAP technology with patient dendritic cells (DCs) being exposed to tumor lysate antigens but the tumour derived T cells are non-selectively expanded using IL2 rather than being activated by tumour antigen containing DCs.

When it comes to defining precision medicine as a field or a specific medicine as a ‘precision medicine’ it’s still a bit messy as there is no broadly accepted or adopted definition. In Sweden we should probably stick with that of the Swedish Governments Life Science strategy;

What is Precision Medicine?

Precision medicine refers to diagnostic methods and therapy for personalised investigation, prevention and treatment of disease, applied at the individual level or to parts of the population. The new opportunities precision medicine offers are based on progress in recent years in for example in molecular biosciences (omics technologies) and bioinformatics, as well as the advent of new high-resolution imaging techniques.