Syncromune Granted FDA Fast-Track Designation for SYNC-T SV-102 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

[God_Loves_Me]

FORT LAUDERDALE, Fla., July 01, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for solid tumor cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for SYNC-T SV-102 therapy, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC). SV-102 is part of Syncromune Inc.'s innovative SYNC-T platform, an in situ personalized therapy that uniquely employs a combination multi-target approach to cancer treatment, aiming to improve outcomes and quality of life for patients.

The Fast Track designation was granted based on the potential of SYNC-T SV-102 therapy to address the significant unmet need in treating patients with mCRPC. This advanced form of prostate cancer affects over 40,000 men in the U.S. alone and is associated with a very poor prognosis. The Fast Track process is designed to facilitate the development and expedite the review of therapies that treat serious conditions and fulfill an unmet medical need, with the goal of getting important new treatments to patients sooner. Fast Track designation provides Syncromune with several key benefits, including more frequent FDA interactions, eligibility for accelerated approval, and priority review.

source :streetinsider.com/Globe+New...

[KocoPr]

This AWESOME medicine/procedure for us warriors. I love this idea of attacking our cancer.

Here is some more info on its mechanism of action

aacr.org/about-the-aacr/new....

Link and colleagues developed a novel treatment approach to stimulate a systemic antitumor immune response for mCRPC. Their therapy, called SYNC-T, first uses a probe that is inserted directly into the primary or metastatic tumor to freeze a portion of the tumor, which causes the tumor cells to fracture (oncolysis) and release immune-stimulating neoantigens. In essence, this method generates a personalized in situ neoantigen cancer vaccine that serves to activate the immune system, Link explained.

Link added that the imaging and procedural techniques for inserting a probe into the prostate are similar to the methods routinely used by urologists to conduct prostate biopsies. Immediately following the oncolysis step, an investigational multitarget biologic drug called SV-102—which is a fixed-dose drug comprised of active pharmaceutical ingredients: an anti-PD-1 antibody, an anti-CTLA4 antibody, a CD40 agonist, and a TLR9 agonist—is infused into the area of lysis in the tumor.

“SV-102 simultaneously blocks two distinct mechanisms of immune suppression and activates two distinct mechanisms of immune enhancement, allowing the vaccine-induced T cells to activate and mount a systemic antitumor immune response,” said Link.

[Steel67]

I participated, in case anyone has a question pls DM me. I was one of the complete responders, through biopsy of the prostate…yet PSMA still shows persistent disease at 7 SIVmax

[Maxone73 in reply to Steel67]

Hi!

Side effects? Could you repeat the treatment or do they think it's useless?

[Steel67 in reply to Maxone73]

I went 3x- once per month Jan, Feb, March of this year. March prostate biopsy turned out negative- but PSMA last week shows the same, stable,residual disease. 7 SUV... I have two small bone Mets that improved very slightly 3 SUV, but I now have a small hilar node showing slight (3 SUV) avidity.

The monthly prostate MRIs required by the PI remain completely unchanged.

Downside, I’ve had diarrhea and slight joint pain since February…now doing an FMT

My PSA remained stable 0.08 through out and I’m on Daro monotherapy

So while they assessed me as a complete response, my take is inconclusive/too early to tell.

The Sponsor is Syncromune, the principal investigator is Williams Cancer Institute. The procedure is done in Mexico City.

I started down this track by meeting with Dr Onik. His procedure uses only one checkpoint inhibitor. $35K/per treatment- requiring multiple treatments. He estimated 40% of total, durable remission.

I then did some research and I found Williams doing an identical procedure using 4 immunotherapies at once. They were recruiting for a trial, I applied and was accepted.

At this point I would neither endorse nor dissuade anyone from investigating this route.

[Manilo in reply to Steel67]

I had 4 spine mets treated with SBRT and SuvMax went from 70 to 61 after 2 months. But PSA disappeared PSMA takes long time to vanish, it seems

[Nibiruian in reply to Manilo]

With SUVs that high, you'd be a great candidate for RLT. Ask your oncologist about Lu-177 and research Tb-161. Tb-161 in Australia is roughly $25k a treatment.

[God_Loves_Me in reply to Nibiruian]

can you share more details on TB-161 ? I mean clinic name and other contacts informations ?

[Nibiruian in reply to God_Loves_Me]

theranostics.ai/

They're doing Lu-177 in Germany and Tb-161 in Australia. Go with the Tb-161. 61 is a huge SUVmax number, either radiopharmaceutical should be highly effective. They use I&T both places.

[gsun in reply to Steel67]

Could you give us a report here on the process and your response?

[FRTHBST]

Wonder if this is related to Dr. Onik's procedure, though with the addition of novel drug combination. Sounds promising!

[Manilo in reply to FRTHBST]

Exactly I was thinking this is performed by Onik

[God_Loves_Me in reply to Manilo]

Its called "dendritic cells therapy"

[KocoPr in reply to Manilo]

I thought same thing

[Maxone73]

nice catch!

[traxcavator]

Now if we could get "them" to give up on the pretext that there is some difference between 'prostate cancer' and 'MCRPC', it might be possible to treat the PC before running us through the mill. Rather than shotgun biopsy followed by MRI guided biopsy then chemical castration we could do something like: PSA rises to some level. PSMA PET scan/MRI guided biopsy. Immediately attack the tumor with Syncromune. Why wait for it to progress to MCRPC?

I conjecture that the slow decline in PSA may be that the local treatment with Syncromune only attacks part of the index tumor. The destruction of the rest of the index tumor and any metastases depends on the immune system slowly attacking the remainder. Since the tumor environment is inhospitable to the immune system, it takes substantial time to infiltrate and destroy what's left.

This absolutely is Onik. It seems likely they already have some sort of statistics, since he's been doing this or some variations for years. I'd really like to know what their numbers may be.

John

[Maxone73 in reply to traxcavator]

I think they test on people who have less to lose and not much time (especially in phase 1) then they move up the ladder once they are done with phase 3, as they are trying to do with pluvicto. At least that’s what I have been seeing since I started checking trials. And yes, it is partially Onik work and I suspect he is also part of that company, I will check later.

[Maxone73 in reply to traxcavator]

garyonikmd.com/wp-content/u...

The fact that there is a dr Link in the authors list says a lot! Plus also Ft. Lauderdale rang a bell when I read the news 😛

[Manilo in reply to traxcavator]

Big pharmacy wants us to pay their venom

[traxcavator]

It seems likely they've treated numerous people over the four years since that was published. It would be useful to know whether the treatment has evolved since then. The article does say they treated both ADT naive and MCRPC patients with 55% response rates in the ADT naive patients, and 38% in the MCRPC patients.

Since they are ablating the tumor, one would expect a fairly rapid PSA drop proportionate to the percentage ablated. PSA decrease due to immune response would be slower, and more telling.

[KocoPr]

what the next step would be to biopsy the tumor before freezing and lysasing it and do genetic and proteomics to design the drug combinations that would be best suited to each individual’s cancer.

[MateoBeach]

Attended a presentation by Dr Gary Onik on the Cancer Lab forum. Very happy to see his method here being formally fast tracked as it is an amazing leap forward for treating many different metastatic cancers including mCRPC and mCSPC. The single session procedure is expensive (around $70,000 or more) has an overall complete response rate (complete clearing of all metastses on scans) of around 35-40% as I recall. Nothing else I know of comes close to that. Keeping it in my back pocket for future when applicable. MB

[God_Loves_Me in reply to MateoBeach]

Also think about , Turkey , Mexico and India. cos is less than 20k

[traxcavator in reply to MateoBeach]

Onik's 2020 paper that Maxone referenced says 38% response rate for MCRPC and 55% response rate for ADT naive PC. This may reflect that MCRPC patients may be less healthy. If they've been refining and trying other agents in combination, they may have different numbers by now.

It seems likely to me that the process can be repeated as long as they can find something on imaging they can hit with a syringe/probe. If there were a metastasis that was PSMA avid, it would be visible and could be hit. How effective it might be I can only speculate.

From my point of view, if one has elevated and rising PSA, there's no point in a biopsy. One might as well just do the treatment. If it works, there's not going to be any need for other drugs. (After my second biopsy, I said the next time someone sticks anything in there it's going to have to have some curative potential.)

John