Faron Pharmaceuticals - Innovative medical solutions (Part 2)

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This thread is a continuation of the comment: Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 1) - #10986 käyttäjältä Cujo_Jr .

Previous thread: Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 1)

Remember to focus on the quality of your posts – this is currently the Forum’s most popular thread, meaning that a crowd the size of a small ice arena is following it, so take the time and put thought into your messages. By sharing information and different perspectives in good spirit, things will turn out well. :slight_smile:

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Faron Pharmaceuticals - Innovatiivisia lääketieteen ratkaisuja (Osa 1)
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Will Faron get a partner before December?

  • Yes
  • No
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The ownership list had been updated. In my opinion, no particularly surprising changes, but it’s interesting that one person had bought over 90,000 shares, and based on Google, the person would be (at least someone with the same name) a cancer expert from Northern Finland. So, someone who understands these matters quite well has invested almost a quarter of a million of their own money.

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From the tax data, I saw that my friend earned 176,000 euros in earned income in 2023. So, he invested about a year’s worth of salary into Faron’s shares. My friend has strong faith.

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Heights Capital Management Inc. updated, however, only on 7.8.2025. This is the one whose sales are most interesting, because it may be selling those shares it received against the loan.

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If you mean Jussi Koivu (change 91,200, now owns 91,200), he appears to be an oncologist and professor in Oulu, and according to LinkedIn, he was Faron’s Medical Director of Oncology from Aug 2020 to Aug 2024. He certainly has a reasonably good understanding of what drug is in question. And he might still have acquaintances at Faron; I’m not saying he would use any insider information. But he surely knows where he invested when he bought 91,200 shares. In my opinion, a reasonably good sign.

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It has certainly shown good vision and is a very good sign.

Net, one has had to earn for several years, because one has to buy food and pay other expenses.

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This is what I got from Maija’s presentations at the IUIS Congress.

I cannot assess if there is anything new in the content provided on the IUIS website.

Feel free to delete if already old / or just title information.

IUIS 2025 Maija Hollmen presentations:

Oral:

Poster:

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Yes, they are very significant. But if one doesn’t immediately understand everything oneself and posts a well-reasoned explanation from an AI here, it’s immediately considered advertising. So maybe some layman could explain the meaning more confusedly and as their own opinion, which would then be acceptable on the forum.

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These have at least generally been discussed in the thread. Not that anyone would remember it :smiley:. You can search for it in thread part 1 among 10,000 messages.

Maija’s oral presentation:

Dual mechanism, i.e., Bex immunoactivates; enhances the presentation of macrophage antigens, i.e., cancer cell components, to immune cells, T-cell activation, and the number of NK (Natural Killer) cells. In addition, the energy supply of cancer cells is disrupted. The study’s dataset combines safety, efficacy, and mechanistic data. Detailed information on how bexmarilimab modifies the bone marrow microenvironment.

Poster or presentation poster:

Clever-1 is Bex’s target on cell surfaces. The presence of Clever is associated with immune suppression. This target protein, Clever-1, has also been observed circulating independently in “sacs” in the body, i.e., in a soluble form, which is called soluble-Clever-1 or sClever-1. Macrophages secrete it. Cancer patients have it in abundance. It suppresses cancer-destroying T-cells and weakens the efficacy of PD-1 drugs, meaning it is beneficial for cancer. Thus, Bex would have a use.

An important formal aspect, in addition to the aforementioned scientific observations, is that the results are accepted into a prestigious international immunology congress. This already validates the results, and the rest will be in publications.

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Thanks to Vino_Pino for the explanation :+1:

And why I think these are so significant in partner negotiation situations. As I understand it, for the first time, a larger set of clinical results are more broadly linked to a biological mechanism → dual mechanism

  • Biomarker data previously at a hypothesis level or with a small group, now validated in clinical patients + use in trial design → trial success probability increases and precision medicine can be designed.
  • NK cell activation → NK cells are crucial in AML and important in PD-1 combo when T-cells are exhausted, NK cells continue the fight.

So both significantly improve Faron’s negotiating position because Bex looks more like a “platform” for many treatments than just MDS.

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It seems that our science department is slowly starting to give a thumbs up to Bex. Now, it would be good for us to hold onto our hats, as the media, entertainment, and larger investor entities are starting to feed interesting and sometimes frightening views into the media stream. I manage myself towards moderation and the idea that in addition to media literacy, ‘stock market literacy’ is now needed. As the factual side strengthens, psychological influence simultaneously increases. The strength of views is tested day by day =) A big thumbs up to the forum experts and thank you for your valuable fact-based insights and now for strengthening my belief. Go Faron Go

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I can elaborate a bit on this point. Biologically, T cells and NK cells target different types of cells.

Normal cells express HLA-A/B/C antigens, which present the cell’s own proteins on the cell surface. The T-cell receptor on the surface of T cells recognizes the HLA-A/B/C receptor and the part of the target cell’s protein within it. T cells mature in the thymus to avoid recognizing proteins of normal cells. Thus, mature T cells practically only recognize foreign proteins, such as viral proteins or mutated proteins in cancer.

NK cells, on the other hand, recognize cells that lack HLA-A/B/C receptors, meaning NK cells recognize cells that are not targetable by T cells. If cancer treatment is performed with PD(L)-1 inhibitors (these target T-cell activation), ultimately, in recurrent cancer, there is a higher probability of a selected cancer cell population remaining that has lost the expression of HLA-A/B/C genes on its surface, and thus survived T-cell-mediated cell death.

In the first part of MATINS, disease control correlated, if I recall correctly, with the NK cell response as a biomarker for BEX treatment efficacy. This is likely because a large proportion of MATINS patients were melanoma patients who had received PD-(L)1 inhibitors as standard first-line treatment. In such cases, the remaining cancer cells have likely been selected to express less HLA-A/B/C receptors and are not targetable by T cells. Additionally, the immunosuppressive tumor microenvironment in these cases would inhibit NK cell activation. This is why the upcoming PD-(L)1 + BEX combination therapy is so interesting. It targets two parallel immunosuppression pathways simultaneously, which should make a response much more likely.

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Investors are now eagerly awaiting a partnership, but what else could be expected? Survival data should be coming any moment now, but what about the next responses? Results were obtained in early June and again in early August. Would the next readout then be in early October?

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According to the earnings release, no new survival data is coming anytime soon:

Outlook

Many BEXMAB patients in r/r MDS remain on drug and are doing well, so giving the final survival readout is delayed, which is a good thing. Same goes to frontline patients where many have moved on to transplant and if all go well for the patients, we will not be getting survival data for frontline HR MDS any time soon. Next, we’ll be reporting on the dynamic positive changes that happen in the body when treated with Bex and Aza together at the annual ESMO congress, and then further follow-up data at ASH towards the end of the year.

I think it would be quite reasonable to assume and expect that the active members of this thread would at least read the company’s releases before commenting?

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BioCity symposium 2025 has come and gone (28.8 - 29.8)

Starts on 3.9

The 13th annual meeting of the society of hematologic Oncology (Soho 2025)

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Well, shoot, it’s tournament fatigue, not everything interesting stays in my mind when I’m reading.

So, ESMO in about six weeks (Oct 17-21).

https://www.esmo.org/meeting-calendar/esmo-congress-2025

And now that I’m digging deeper into my memory, Bono said in the spring that new results will always be published in conjunction with major congresses going forward. The exception proves the rule, and August’s results certainly weren’t related to any congress, but the driving force seemed to be the mediocre results from June (which were collected in May).

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Participation in the ESMO congress was at least announced by Faron well in advance (300725)

SOHO is more mysterious.

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I asked questions in the webcast (part 1 in the thread), let’s see what was answered, the moderator shortened some questions.

Q. Is the FDA guidance now such that AA and final approval together (in the announcement “entire HR MDS”) cover r/r and first-line, which would mean that regarding the survival of non-randomized Phase 2 patients in the r/r setting, it is not relevant for r/r marketing authorizations this September? And not for responses?

A. The FDA does not need more information on r/r. Potential AA brings preliminary marketing authorization for first-line and r/r. Faron was previously under the impression that first-line responses could only lead to r/r approval. Hence Faron’s current satisfaction. (However, I recall that they would have mentioned trying for AA with Phase 2 results a long time ago, as some others had received approvals earlier.) And Faron started asking a year ago what kind of Phase 3 is needed for r/r marketing authorization, and now a significantly larger market is available. (Albeit with initial slowdowns)

Q. Run-in phase at the beginning of Phase 3. What is the more precise protocol for those patients who received the dose that is being discontinued? How many patients are needed, and is it mainly about adverse event analysis? What ultimately made the FDA require a mini-Phase 2 trial at the beginning? Project Optimus or a specific observation?

A. 40+40+40, so 80 will be in the final analysis. There were only a few patients at the 1 mg/kg dose and Project Optimus. Even the smallest dose showed efficacy and only minor side effects. (So the logic is; what if the efficacy is the same but the side effects are less. Faron is not entirely sure about this efficacy matter)

Q. How many study sites are targeted/in discussions for Phase 3? Is Asia included in any case?

A. 80-90 sites. Europe and USA. Japan from Asia at least. Multicontinental.

Q. What was discussed with the FDA about biomarkers (MDS)?

A. Practically all patients are Clever-1 positive. No difference in responses is observed based on Clever-1 concentration between patients. The FDA did not require a biomarker either. All MDS patients are included for approval purposes.

Q. Treatment of TP53 patients as a separate entity?

A. They respond to Bex+aza treatment with responses similar to non-TP53 mutation patients (WT). They are stratified so that the placebo and Bex groups have the same number of TP53 patients, so it does not affect the results between groups.

Q. Preclinical lymphoma study. The previous deadline was the end of June 25. When will it be announced whether development will continue or not? If it continues, will there likely be data for scientific meetings? Any other announcement? Would there be no need for patenting, as Faron was just granted a patent until 2040 for the treatment of Clever-1-positive cancers, which include these lymphomas?

A. It has certainly not been forgotten. Progress has been made. Patient samples have been studied, but we are not yet at the point where a go/no-go decision can be made on whether to proceed to clinical patient studies. More preclinical work will be done. This will be reported in future webcasts. Bono reiterates that we are talking about the most common lymphomas.

Q. Sarcoma trial Bexar in France, which cytostatic/medication is combined with Bex? Radiation therapy? What stage of disease are the patients in question? All soft tissue sarcomas including r/r GIST?

A. The cytostatic is doxorubicin, decades old, which is standard treatment worldwide. It is given with Bex as a first-line treatment for metastatic soft tissue sarcoma.

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Soft tissue sarcomas are quite rare. If bex + doxorubicin shows preliminary efficacy and safety, then orphan drug + fast track will likely come quickly.

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