Taiwan biotech with break through potential - Ever Supreme Bio Technology (6712 TW)

I dare say this is a company NO people (at least 99.9%) has heard of. With some luck, it has the potential to achieve a break through in biotech/cell therapy. It is doing cutting edge research and maybe even world leading work.

MV is US$500M. It is a biotech in Taiwan. Stock has gone nowhere for 5 years.

Ever Supreme (ES) was spun off from the China Medical University Hospital (TaiChung) in 2016. Its goal is to harness and commercialize the know-how and IPs of CMUH.

An important point to make is ES is NOT your typical biotech. ES has two businesses: i) CDMO, and ii) drug development. For its CDMO (contract development and manufacturing organization) division, Taiwan has a system where ES can charge hospitals for cell preparation services for autologous cell therapy. Not a particularly big business US$30M in sales in 2024, growing and profitable (net margin of >25% in recent years).

Its CDMO business is a big deal because ES then leverages the cash flow to fund its drug development. Unlike the typical small biotech, if a drug fails, it is pretty much the end of the road. In the case of ES, it is underpinning by a solidly profitable and growing CDMO division. It can live to fight for another day.

The really interesting aspect of ES is its drug division. To me, it is right at the cutting edge in the world. Its key clinical candidate is an allogeneic cell therapy product targeting solid tumours (triple negative breast cancer, non small cell lung cancer, colorectal, and glioblastoma).

Allogeneic cell therapy is about taking blood/cells from healthy people. Edit the cells. These cells will then be injected into patients. These little cells act as "heat seeking missiles" seeking out cancer cells and kill them. It is a step up from autologous cell therapy where cells are taken from the patient and then re-injected back in the body after editing. Allogeneic cell therapy has many advantages over autologous cell therapy (cost, efficacy, no wait time).

Another exciting thing about cell therapy is technology advances is such that we are at this age of synthetic biology where we can edit the cells with multiple edits to empower these "cell warriors" with multiple features/weapons.

The backdrop is so far we have autologous cell therapies that work well for liquid/blood cancers. BUT no cell therapy has proven to be capable of attacking solid tumours.

In the case of ES, the alphabet "soup" goes something like this: "Dual ICP (HLA-G and PD-L1)-

targeting + Secreting Nb-based PD-L1/CD3-targeting BiTE". Translation = its cells look for HLA-G and PD-L1 on cancer cells. BITE = bispecific T cell engager (anti body that connects body other immune cells with cancer cells). Put simply, it will seek out cancer cells itself, plus directing other immune cells to attack these cancer cells.

It is still an early stage biotech. It has just wrapped up its phase 1 program. We only have data on 12 patients. It is about to start its phase 2 program.

What interests me about ES is this... It has so far release data on 12 patients (up to medium dose). So far, it has a PR on colorectal (2 low dose) and a CR (4 medium doses) on glioblastoma. CR means complete response i.e. all the cancer cells are gone after treatment. In my mind, it is a BIG deal because glioblastoma is very much a turn off the light on the way out once it advances kind of cancer. Almost a cure but let's see if it is durable.

What is interesting about the CR in glioblastoma is it was initially only a partial response.... BUT it has since converted to CR i.e. the injected cells kept on fighting for months and eventually finished off all the cancer cells.

An important point to make is (being allogeneic cell therapy) safety looks good so far. Only 4 cases of cytokine release syndrome (grade 1).

So now.... This is the key to watch..... Because it looks like its cell therapy can be persistent in the body (and safety is OK), it has dosed another 3 patients on high doses (but no data yet). Remember high dose means there are more allogeneic cells in the body hunting down cancer cells. Efficacy should improve. Let's see how these 3 patients fare.

Beyond the current clinical trial, ES is working on the next generation of cell therapy (in vivo) as well. Furthermore, it is working on clinical programs on neurogenerative/CNS indications.

The path forward ? It plans to start its Phase 2A clinical program. If all goes according to plan, the drug can be approved in Taiwan (for Taiwan only) in 2028. It is looking for a partner to fund the clinical program in USA/EU and take the drug global.

Two catalysts to look for: i) better efficacy for its high dose cohort (?), ii) can it secure a business partner to take the drug global ?

Note that it is very early days. In cell therapy, people look for efficacy (i.e. partial response/complete response) and durability (would the cancer cells come back). Phase 2 trial is about finding answers to the key questions of overall survival/progression free survival.

Clearly, there are risks with ES. But quite amazing how a little biotech in Taiwan can come up with such innovation. And potentially a break through in cell therapy.

The sky is the limit here if the drug works :)

PS... Interactive Brokers can buy Taiwan stocks these days.

Note: Do your own research. Not financial advice. I may own the stock.