OVM-200 Phase 1 clinical trial ( vaccine)

[Brysonal]

I thought I would start a new thread as the original was about the decision making but now I’m in it I realise a clean thread may help.

So today is day 15 of the trial and I am getting the second dose of the vaccine ( subject to clearing the screening this morning). I will then be observed for 4 hours before hopefully being let go home.

At day 8 I had a thorough check up and my bloods were improved so fingers crossed all is still good.

No side effects so far and I continue to work full time (have laptop with me today).

This trial allows me to stay on my hormone therapy so monthly Degarelix injection and daily Apalutamide continue. My PSA remained undetectable for the fifth month since my treatment package ended in June. Appreciate that can just be the doublet of hormones I am on and if so they will fail at some point.

Here is the trial details

clinicaltrials.gov/ct2/show...

Enjoy your day all!

[NickJoy]

Good luck today. Thank you for keeping us up to date. I sent the referral to them 2 weeks ago - have heard nothing back from them despite me sending a follow up email - hopefully some spaces will open up. Fingers and toes crossed for you.

[Brysonal in reply to NickJoy]

Hi Nicola

They are working in cohorts of three and prostate cancer went last and I’m number 12 so get may be going back to ovarian cancer for next three so you may have to wait till they are back to PCa.

My cohort will have had three doses before Christmas . My scan results came in today with ‘ evidence of scarring from radiotherapy but no evidence of tumours. docrates need well methinks!

[GreenStreet]

Thanks for the update. I hope all goes well today 👍

[Brysonal in reply to GreenStreet]

Thank you. Just a long day- brought my own food this time! I feel v lucky to be so well given last Novembers ‘mets everywhere’ news. Some on this clinical trial Ward getting three different types of chemo in one day today- not fun!

[Scout4answers]

interesting

This could be a game changer

[Brysonal]

I am aware PCa has proved ‘cold’ to immune therapy so far but this is a different angle and worked on mice! I know things work on mice and not humans though but gotta progress the science so fingers crossed.

[KocoPr]

This technology is fascinating and so hopeful for the future of beating not just cancer but other devastating diseases

nature.com/articles/d43747-...

[KocoPr]

Question? Do they take your blood sample once to produce the vaccine for all your injections or every time? From what I was reading it only take 3 days to make the vaccine from your immune system. I’m wondering since the immune system and the cancer are dynamic and the cancer may try to find a way to survive.

[Brysonal in reply to KocoPr]

The vaccine is made to order from the local McMillan vaccine centre but it’s not made from blood as far as I am aware but a way of splitting proteins and targeting survivin has been shown to trigger an immune response in mice

[KocoPr]

ok, i see. Thank you for clarifying that. Im still trying to understand it, but I think I’ll pass on deep dive to focus on my own castrate sensitive PC.

All of these new emerging technologies are just so fascinating that we seem to be getting closer to a cure.

[NPfisherman in reply to KocoPr]

KocoPr,

I like the way you think !!!

It's why I think we may see a chronic disease state in 5 years... There are bromodomain inhibitors coming to add on to SOC (a new class of drugs not targeted at AR -phase 2), and Osteodex for bony metastasis (ready for Phase 3), ARV-110--an AR Degrader--next generation AR drug (interim Phase 2 data out and looking for a move to Phase3), and VERU-111 (Phase 3 already started).

I see a 3 drug cocktail like HIV patients get that will provide disease control. Call me a visionary or call me a fool, but if the cure comes.... please.... Call me !!!

Fish

[Nusch in reply to NPfisherman]

Not only calling - let’s organize a party, if this materializes.

[NPfisherman in reply to Nusch]

Oh yeah... one in every country... it will be like making a pub crawl except internationally.. could last a year...

[Brysonal in reply to NPfisherman]

I note a nearly 90% reduction in cervical cancer has been seen since the HPV vaccine was released! Keep the faith!

[NPfisherman in reply to Brysonal]

It is why I watch vaccine and immunotherapy trials so closely...it will be a big part of the answer I believe...as various treatments and meds evolve, the potential for chronic disease state improves dramatically. We need Big Pharma to move the drugs at the phase 3 level ahead...too many drugs waiting for a Big Pharma partner... their game of squeezing small biotech companies while people die is unacceptable.

Fish 🐠

[Brysonal]

I am castrate sensitive too. It’s something to do with antigens and split proteins!

Any way both my MOs thought there was virtually no risk it would make my cancer worse or more difficult to treat and both supported me doing it.

I’m currently NED with undetectable PSA for 5 months and scan results today showing scarring from radiotherapy but no tumours identifiable from scans which feels good to hear after 7 months of aggressive treatment so to me it made sense to give it a go and it OVM-200 can trigger my immune system to join in the game before I go hormone resistant!

[Brysonal]

All done re injection 2 obs and ecg passed so nearly home. Long day though! Back next Thursday for full range of tests again!

[NPfisherman in reply to Brysonal]

Brysonal,

Great news.... Thanks for keeping us posted, Yes, you are generating some replies and interest. I haven't heard from the trial yet... Like you, it made sense to me to be able to continue my meds, and get an immune boost good against PCa, but other cancers as well.

Thanks again for participating.

Take care... sleep warrior...

Fish

[Soumen79]

Hi Brysonal,

Just so curious, you are saying blood numbers improved, these are the blood parameters related to immune response improvement?

You are spreading a wave of hope, I pray everything goes sturdy.

With regards

Soumen Chandra

[Brysonal in reply to Soumen79]

I haven’t had the immune response tests outlined in the trial yet as I haven’t completed the three doses yet ( 2/3 done)

I was referring to my bloods generally as my white and red blood counts have been down since I completed my treatment but am told that’s normal whilst on hormone therapy however my white blood count has jumped into the norms ( red blood count continues low but I had a heck of a list of treatment between Dec 21 and June 22 but am on a hormone therapy doublet still.

Hope that clarifys. I’ll keep updating as the trial progresses.

[Soumen79 in reply to Brysonal]

Of course it clarifies, thanks for all these. We are only grateful. Thank you sir!

[nobaday]

so 3 Lu177 reduced or eradicated the skeletal Mets and reduced size and uptake in prostate.

Then you added 3 x chemo… to zap non PSMA avid prostate cancer cells. And now on Apalutamide (instead and preferred to Abiraterone) and PSA now undetectable. Then you saw u could do the OVM-200 vaccine trial so why not do this as well.

So looks like Lu177, chemo, Apalutamide all very effective for you and you will stay with Apalutamide and degarelix hopefully for the long term with hope that PSA will remain undetectable. Is this about right for where you are now? You did not do further Lu177 or chemo sessions as the 3 of each brought the Mets and PSA right down?

[Brysonal]

Thanks correct but missing the radiotherapy. In order:

SBRT to two bone mets ( oglio at the time) but when failed:

Degarelix injection

Lu -177 x 3 ( PSMA positive cells)

Docetaxel x 3 ( PSMA negative cells)

20x VMAT radiation to prostate/ pelvis

2x Brachtherapy to prostate

Apalutamide

OVM-200 vaccine

No further Lu-177 or Chemo just the 3+3

Now on Degarelix and Apalutamide with clean scans and undetectable PSA.

As I’m stable I qualified for OVM-200 trial and on advise of MOs and much thought I decided to do it and have had 2/3 injections.

[nobaday]

For the OVM-200 effectiveness you no longer have Mets that can be monitored / measured by CT scans so there is no good way of seeing if OVM-200 is effective or if u have continued no Mets/ undetectable PSA , whether it is OVM-200 or Apalutamide or a combo or previous Lu177/ chemo holding the prostate cancer in check? As long as you stay ‘NED’ does it matter? But also could it mean that your goal would be to come off the meds and stay NED with the chance to live again at normal testosterone levels!!

In my situation I am chemo naive and have had 2xLu177 so far with 4 more Lu177 planned. My PSA is always low despite tumour growth at C3 and T8 to T12. PSA had climbed up to 0.16 over the summer from <0.008 . My last 2 readings after Lu177 have been 0.02. This seems good and I could claim reduction in PSA of around 90% !! But at these low PSA’s I’m just happy it’s headed back to nearly undetectable..

[Brysonal in reply to nobaday]

Immune response to OVM 200 as measured by ELISpot for T cell responses and ELISA for antibody responses. [ Time Frame: 24 Weeks ]

Per the trial secondaries