Faron Pharmaceuticals - Innovative medical solutions (Part 2)

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Then, in addition to BONO:
Bexmarilimab solid tumor combination trial program expanding :rocket: :rocket:

Today we announced BEXAR — an investigator-initiated, randomized Phase I/II trial in first-line metastatic soft-tissue sarcoma evaluating bexmarilimab + standard-of-care chemotherapy doxorubicin, in collaboration with Vall d’Hebron Institute of Oncology (VHIO) (Barcelona) and sponsored by MEDSIR .

Anti-Clever-1 Ab treatment is known to improve chemotherapy response in preclinical models (Elorbany et al., Nature Communication 2024) and sarcomas show among the highest levels of Clever-1 expression — strong rationales for testing chemotherapy plus macrophage reprogramming with bexmarilimab to help overcome treatment resistance and improve treatment results. This is the second bex combination trial in solid tumors. This clinical study will be led by Dr. Cesar Serrano, a leading international sarcoma expert, ESMO sarcoma faculty member and sarcoma research group leader from the prestigious Vall d’Hebron Institute of Oncology (VHIO).

Proud to see our solid tumor program expanding!!

hashtag#Sarcoma hashtag#Oncology hashtag#Immunotherapy hashtag#ClinicalTrials hashtag#Bexmarilimab hashtag#Clever1 hashtag#Macrophages hashtag#Medsir

The best part is likely that Medsir is paying!!

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What is notable in this release is the randomized study. Apparently, some will receive doxorubicin alone and others Bex+doxo. Consequently, this is no longer just about PoC. PoC is “is the idea viable,” while a randomized I/II is “does it work safely and effectively in this setting” – the latter is a bigger step towards registration.

It’s great to see that things are gaining momentum now. Phase 1/2. In MATINS and BEXMAB, Bex has already been derisked, so an actual start with Phase 1 is not needed. The doxo-combo requires a formal safety assessment at the beginning, but from there it continues as Phase 2.

A Phase 1/2 has also been conducted with Pembro, with a patient count of 37. Without randomization ClinicalTrials.gov. In that study, “single agent Dox have a median progression-free survival (PFS) of 4.6 months (mo) and response rate (RR) of 14%”. If patients in BEXAR are just as difficult, the data readout should be quick. In such a difficult “high unmet need” disease, if Bex is helpful in a randomized setting, it could move directly to a registration study.

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Given this, we should probably bury any hopes of negotiating with Big Pharma regarding Phase 3 anytime soon


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It’s hard not to think that the business isn’t progressing with the current track record, and that they’ve now taken a step back to try and solidify the foundation. If this study succeeds, they will certainly be in a stronger position than before. Personally, I don’t see this as positive news based on the current information. One must be bold enough to consider this perspective as well. However, if there is some Big Pharma deal on the table, then it is certainly very good news that the research is being expanded.

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With the exception of Matins-02, solid tumor studies were always intended to be investigator-led. This means funding is primarily being sought for the completion of Bexmab Phase 2/3.

The sooner these investigator-led studies can be started, the better. Does anyone have any information on how long it takes from the current initiation announcement to the first patient’s first dose?

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If you think there is something exceptional here, then you should study this:

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In the short term, it’s obviously good that Medsir is paying, but they’re not doing it out of the goodness of their hearts:

kuva

Faron does get access to the study results, but the data and publication rights belong to Medsir.

https://www.medsir.org/innovative-oncology-clinical-trials

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MEDSIR is mentioned as a sponsor. It is interesting where it would get its money from in this case, if it were the funder. They have a network of top researchers. The EU has also been providing funding https://www.medsir.org/post/we-are-part-of-i3lung-a-project-funded-by-the-european-union.

The sponsor bears the responsibility for the operational implementation and the funder bears the financial responsibility.

Medsir’s task is to design and manage trials. Gilead has collaborated; they provided their drugs for one trial https://www.medsir.org/post/medsir-debiopharm-announce-the-first-patient-dosed-in-the-win-b-trial. Roche paid for the whole thing https://www.businesswire.com/news/home/20251212609556/en/Natera-and-MEDSIR-to-Collaborate-on-the-MiRaDoR-Trial-in-Breast-Cancer. It was funded by Roche and sponsored by MEDSIR.

In 2022, the Brazilian chain Oncoclinicas bought 49% of MEDSIR. https://www.fiercebiotech.com/cro/medsir-teams-goldman-sachs-backed-oncoclinicas-latin-american-market Goldman Sachs had ownership control of Oncoclinicas; now they are only the largest owner.

Is this also funded by Faron regarding MEDSIR, or is some other funding being sought? MEDSIR has raised 40 million with over 40 trials https://www.medsir.org/post/bring-your-clinical-idea-to-life-as-a-fully-funded-trial

Faron does not need a separate CRO, because MEDSIR.

Faron will likely provide bexmarilimab at its own expense.

Vall d’Hebron Hospital in Barcelona apparently provides the facilities, staff, and patient flow. Some of the trial costs (such as the cost of the standard of care, i.e., doxorubicin) might be covered by normal healthcare or the hospital’s own research grants.

Faron has free access to all research data. MEDSIR does not financially own the data; instead, IP rights are retained https://www.medsir.org/post/bring-your-clinical-idea-to-life-as-a-fully-funded-trial. MEDSIR/Vall d’Hebron researchers will likely be responsible for publications. The data they publish in articles and at scientific events may carry more weight than data from Faron’s own people, even though outside scientists have been involved as authors/presenters in BEXMAB-related studies as well.

Interesting and nice to get positive news from such networks.

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Confirmation for several views that have been written and shared on this forum. Attached is an excerpt from Redeye’s comments today regarding the MEDSIR and Vall d’Hebron trials, Google-translated. Redeye: “The involvement of MEDSIR and Vall d’Hebron University Hospital further strengthens the program’s credibility. Vall d’Hebron is one of Europe’s leading cancer centers with deep translational expertise in sarcoma, and MEDSIR has a strong track record of conducting high-quality, academically-driven oncology trials. This combination increases the likelihood that the study will yield robust translational and biomarker data, not just clinical response signals, which is particularly important for macrophage-targeting therapy, where mechanistic validation is key to long-term value creation.

Together, we argue that these initiatives illustrate Faron’s consistent and deliberate approach to selectively expanding bexmarilimab into a multi-purpose asset. Through investigator-led trials, the company increases bexmarilimab’s strategic optionality and long-term value in a resource-efficient manner. This expands commercial potential, diversifies the risk profile, and may strengthen potential partnership discussions.”

Full Redeye note: https://www.redeye.se/research/1146119/faron-pharmaceuticals-pipeline-expansion-through-investigator-led-trials?notificationId=6c1c6f29-0b51-490c-a9c2-b01170ef67bc

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Exactly. We also don’t know whether the study conducted by Medsir meets the regulator’s requirements. They won’t be proceeding directly to Phase III from this.

Of course, it’s good that information on whether the combo could work is obtained “for free.”

Bex+Doxo is therefore a completely new, previously unstudied combination. For this reason, it’s possible that the regulator will require dose-finding and optimization “again.” Doing so is unlikely to be in Medsir’s interest.

Only when Faron is granted an IND for this indication will we know more.

The MATINS IND concerned monotherapy and did not include sarcomas.

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I might be a slow learner, but I’m doing my homework.
BEXAR is being conducted in Europe, so the FDA and especially the IND do not apply.
European equivalence must be sought from the European regulator.
For MEDSIR & Vall d’Hebron, it should be easy because
Faron’s previous FDA/IND applications/statements support the application.

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As an investment case, access to the American market is essential.

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Things are not quiet at all regarding Faron. If only one had the time to look into it all


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https://www.tandfonline.com/doi/full/10.1080/1750743X.2026.2617035?__cf_chl_tk=M0rvP6RxZSot7SdlqxtXoNPeoTsEMHmJip17esxEXSM-1769523691-1.0.1.1-tYGrx5bk3oP6Wqp3X_IO4qKKOBuP1gOhxABgpk4r1dY#d1e638

The review contains a wealth of information about the effects of Bex, the rationale for combinations, etc. Let’s start, for example, with the solid tumor trial matter.

Why chemotherapy and Bex?

(Doxorubicin in BEXAR and paclitaxel in FINPROVE.)
Verified translation of an excerpt from the review:
“Several cytostatics, such as paclitaxel and doxorubicin, induce immunogenic cell death (ICD). It is a process that strengthens the anti-tumor immune response by bringing ‘danger signals,’ such as calreticulin, to the cell surface and by releasing ATP and HMGB1 protein from dying cancer cells.
These damage-associated molecular patterns (DAMP signals) recruit and activate antigen-presenting cells, expanding the range of tumor antigens available for the immune system to process. As a Clever-1 inhibitor, bexmarilimab enables macrophages to both phagocytose (ingest) this increased antigen load and adopt a pro-inflammatory, antigen-presenting phenotype.
This combination thus offers a synergistic strategy: chemotherapy increases the number of tumor antigens and their immunogenicity (the ability to elicit a response), while bexmarilimab enhances their presentation and promotes T-cell priming.”

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“Elevated sClever-1 has been linked to resistance to PD-1 blockade, while treatment with bexmarilimab reduces circulating levels, directly connecting target engagement with alleviation of systemic immune suppression. These findings position sClever-1 not only as an active mediator of immune evasion but also as a pharmacodynamic biomarker with potential utility for patient selection and therapy monitoring.”

It’s a pity that no source was provided for this in the text. By what mechanism does Bex reduce sClever-1? My understanding is that it relates to receptor internalization and thus a reduction in shedding. But that sentence would imply that Bex directly reduces sClever-1 levels, such as by binding to it directly. How does it work?

One thing that is really difficult, yet essential to understand, is the relative importance of different regulatory pathways. I’m personally under the impression that Clever-1 is not very significant. It is, after all, mainly just an LDL-scavenging receptor; the immunological effects only occur “far downstream.”

image

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Well, Clever-1 isn’t very significant in a healthy body, but blocking it is significant precisely because it releases macrophages and other myeloid cells into a more immunologically active state.

EDIT: or more accurately, the role of Clever-1 is likely significant in a healthy body as a limiter of the immune response. But in a cancer patient, its expression is harmful and blocking it is significant.

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I’m writing this from memory, so you should check the details separately, but I believe that in the sClever-1 paper from Maija’s lab, it was presented that soluble Clever-1 is secreted both as a cleaved version and as exosomes. If I recall correctly, Bex inhibits both the cleavage of Clever-1 and the secretion of Clever-1 exosomes. IGF2R was presented as a receptor for Clever-1 in that Maija paper, and HLA-E in this newer post. Both IGF2R and HLA-E are involved in the regulation of the immune response.

In addition to LDL, Clever-1 also recognizes lipopolysaccharides, which are molecules specific to bacterial cell walls. Thus, the biological function of Clever-1 likely also relates to the anti-bacterial vs. anti-viral response in macrophages, and soluble Clever-1 potentially plays a role in regulating this response. Against cancer, that response should be shifted to be more anti-viral-like, so that the immune system focuses more on killing its own cells. However, the immune system is a very complex system with many different components whose interactions can produce unexpected effects. Therefore, this case is by no means certain until the final trials have been completed.

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Here are Antti’s comments as Faron expands bexmarilimab’s clinical trial program into solid tumors. :slight_smile:

The company is supporting a new investigator-initiated Phase I/II BEXAR study, which investigates the tolerability, safety, and preliminary efficacy of the drug candidate in soft tissue sarcoma in combination with standard of care. The news represents Faron’s first concrete move in solid tumors since the MATINS study. The company shared its plans regarding BEXAR at its CMD in the fall of 2024, so the start of the study was expected.

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According to the 2024 prospectus (page 68), Karvonen is a board member of Pacta sunt servanda Oy, and according to Euroclear, Pacta sunt servanda Oy holds 104,000 Faron shares. Karvonen therefore still indirectly owns these shares.

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This has been cleared up, a rather trivial mistake on my part, I must admit. I’ll try to be more careful in the future.

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The company’s future financing is unclear and the investor calendar is empty. A good situation for current owners? Not a single negative-toned message has come out regarding Bex results or from any researcher regarding the science. Certainly, there are cautious and expectant comments, as Dr. Zeidan expressed in his first Faron webinar he participated in. I don’t remember what the topic was or if results have matured from it, I don’t know. Does anyone have memory/info on that?

The pipeline is progressing and news of the next financing must come to light soon. Faron is a phase 2 company and if that changes now, it’s a big game changer and at the same time, long-term plans have been redone. The Traumakine experience is there and the big money targets for the solid tumor side have been communicated. Hiring Bono, Ralph, and Jurriaan and paying the bank doesn’t look like a strategy change.

However, Money and those who have it talk and rule, no matter how much one is in the driver’s seat. It would be great to hear an interview with Juho to see if he still feels like he’s in the driver’s seat?

Bex is the Jalkanens’ life’s work from decades ago and they have surely timed the market entry for the best window, considering patents are expiring and no competitor is in sight. It’s also good to remember that hundreds of millions have flowed into the company to advance Bex from old and new parties. Nowadays, when information is more easily available about everything, I reckon that financiers get better data, and since money finds its way to money more and more often in today’s world, that’s likely the direction this is heading too.

Around Hikka’s anniversary, there could be positive news about blood cancers. Or could it be that the big picture strategy has been changed after all, so that e.g. the start of Phase 3 has been postponed and now they are first seeing what Finnprove, Bexar, Blaze, Matins -02 bring to the table. A good player and especially a businessman can change even a major strategy on the fly, for example, due to and above all as a result of partner discussions. Especially when we’re talking about hundreds of millions and even billions of euros, which were shown in those slides of Ralph’s former company.

Something big will likely happen before the Annual General Meeting at the end of March. Or otherwise, they might as well book the Gatorade [Center] for their meeting, when the “lottery folk” sign up for Turku on March 30, 2026.

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