Timeline

Vaccine Started

Dr. Saskia Biskup

Latest Updated on November 24th, 2021

 

First Trip (4 vaccination in one visit)

The Report

The below is the outcome that I have received after the first visit to doctor’s office (and Germany).
 
We have met four times to induce the immune response. As you know, the aim of the treatment with the personalized vaccine in Germany is to activate the patient’s own immune system to recognize and destroy tumor cells. The mechanism takes advantage of the fact that the tumor cells are distinct from normal cells and can be recognized by specialized immune cells if those are trained against the tumor cells. Tumor mutations are highly patient- and tumor-specific and some of those lead to production of novel protein sequences. The tumor cells present some of those mutation-derived novel protein sequences (neoantigens) on their surface. These neoantigens are different from those in normal cells and tumor-specific T cells can be able to recognize them.
 
To use this knowledge for vaccine development we first identified the tumor-specific mutations. To identify such mutations, we performed exome analyses of DNA from both tumors (malignant tissue) and from the blood (as normal control) using next-generation sequencing
 
The analyses included:
  • Whole-exome sequencing of tumor and normal tissue
  • Whole tumor transcriptome
  • Identification of tumor-specific nonsynonymous mutations (mutations that may lead to altered protein sequences)
  • Compilation of a clinical report including treatment recommendations
  • Genotyping of the patient’s HLA molecules
  • Prediction of which tumor-specific mutated peptides are most probably presented on the tumor cell surface by the patient-specific HLA types using novel computational methods
  • Database analysis to investigate the expression of the respective genes in this tumor type
  • Analysis of which peptides can be synthesized and dissolved in an injectable solution
  • Selection and recommendation of peptides which are predicted to elicit the most powerful immune response against the tumor: compilation of report.

Based on these analyses, to manufacture the personalized tumor neoantigen-specific peptide vaccine, the following steps have been performed:

  • Synthesis of the desired number of peptides
  • Preparation and quality control of the injectable multi-peptide vaccines (sufficient doses for one year)

 The personalized vaccine is applied along with an adjuvant (typically GM-CSF, Leukine® or Aldara®) to increase the stimulation of the immune system.

Repeated vaccinations are now being performed regularly according to a fixed treatment plan. The plan includes

  • A priming phase (4 vaccinations within 10 to 12 days) and
  • Subsequent monthly injections for about 10 months.
 
First vaccination: 23.08.2021

Application of the personalized vaccine together with Aldara® and Leukine® and blood draw for immune monitoring

Second vaccination: 24.08.2021

Application of the personalized vaccine together with Aldara® and Leukine® 

Third vaccination: 25.08.2021

Application of the personalized vaccine together with Aldara® and Leukine®

Fourth vaccination: 26.08.2021

Application of the personalized vaccine together with Aldara® and Leukine®

After these priming injections, we recommend administering boosting vaccinations every 4 to 6 weeks.  To the best of our knowledge and according to our experience, the treatment is in general well-tolerated.  We were happy to see that you tolerated the first four vaccinations very well.

Monitoring the immune response to the treatment is important for gauging its success and can help prevent potentially more severe side effects. As such immune monitoring is strongly recommended as an important
monitoring mechanism along with the vaccine treatment. We recommend doing the monitoring when Mohammed Banat will be here for the seventh vaccination.

For immune monitoring, blood is collected during the first injections and every 3 to 4 months thereafter. Immune cells (T cells and antigen presenting cells) are isolated and incubated with peptides of the vaccination cocktail. T cells specifically activated by a peptide will be identified by intracellular cytokine staining and FACS analysis. The patient receives a report highlighting the vaccine peptides that induced a significant immune (T cell) response. This information can in turn be used to control the immunogenicity of the vaccination regime and to further adjust the treatment plan.

From a clinical perspective immune monitoring is the only way to monitor the immune system. It is also the only way to quantitatively gauge the efficacy of the vaccine therapy. This information is also critical for effectively timing and spacing the vaccine injections for maximum impact.

My Experience

Yes, the vaccinee was painful.  That’s really how I felt!  
That doesn’t mean that it stopped me from going :)
I used to get pain in places more than others, so the doctor told me to pay attention to where were the least amount of pains are so we can schedule the next ones for (and I did follow that later, and that made a difference) 
 
The side effects beyond the pain were that I used to get some (acceptable) fatigue a couple times during the day of treatment.  I also had bloating that stayed around 10 days for no reason (it did the same in the second and third visits)
 

Second Trip (6th Vaccination)

Oct 4th, 2021

The vaccine itself was a little painful.   However, I have had difficulties afterwards as follows:

These were ones that I never had before (and never had afterwords in the following scheduled vacccines).

  • Around 1 PM:
    • So, during the first 30 min, I continued to have pain around the treatment
      location (7/10 of pain coming in and out).  
  • Around 1:30 PM
    • After that, it came down to 5/10 pain and stayed for an extra
      hour.   After that (and until now) I can’t feel any pain
  • Around 2PM:
    • feeling chills (no fever): my hands stay continuously chills and I’m
      so cold even if I am in a warm place.
  • Around 2:30:
    My whole body is in pain almost everywhere
    • lack back pain
    • back of chest pain
    • back of knee pain
    • back of neck pain
    • heel of foot pain
    • lost energy.
  • Around 3:00
    • Loss of energy (fatigue): It was difficult to stay standing (not
      enough power + feeling cold).  I had to sit to take
      rest.  
  • Around 3:30
    • I had to run to the hotel and take a hot shower (that calmed down the 
      “chill” feeling).  
    • I decided to continue to be in bed for now.  
    • The rest of the pain continues but is reduced.  The remaining
      pain is focusing on the lower back (the rest is easier).

There is a list of things that I did not have at any point in time:

  • Headaches
  • Losing further focus
  • Seizures or auras
  • Sore throats

 

Dr. Buskup’s Response

The doctor believed that this was most certainly caused by the Leukine and the symptoms were acceptable and will be getting better next time.
 

Third Trip (8th Vaccination)

Nov 12th, 2021

The vaccine was smooth, and I had no side effect of any sort (besides the annoying payment of the vaccine itself).   
 
She also decided to take the blood work that was scheduled in the following vaccinee a bit earlier to read what the progress looked like given the last side effects of last time.   I am expecting the outcome 4 weeks after this visit.    
 

Fourth Trip (9th Vaccination)

Dec 9th, 2021

That day went without symptoms following the vaccine.   The doctor also took another blood test that day.
 
On that visit, the doctor told me that most likely the initial readings are inspiring her that I won’t need to show every month, and that she will confirm the readings further in 10 days or so (which I am sharing below).
 

Dec 18th, 2021

Less than two weeks after the trip, the doctor told me the following: “I have fantastic news for you! We can indeed switch to vaccinations every two months”. 
 
She then shared with me the Immune Monitoring Report (5 pages, sample taken on Nov 9th, 2021).   It states: “These results indicate that the administration of the vaccine successfully induced or at least enhanced specific CD4+ and CD8+ T-cell responses towards at least eight of the 19 vaccinated mutation-spanning peptides, among them responses towards two driver mutation-spanning peptides.    
 

Jan 4th, 2021

Please note that a brain MRI (without contrast) was just done (pointing to 1 year passing after the last brain surgery).  
 
The outcome of the MRI Report said the following exact words “No significant changes could be seen to the previous study”
 

Jan 18th, 2021

I had Corona virus-positive (Omicron-BA.1).   I had a far better experience than the first time I had two years ago, and the most important symptom was a headache which lasted for two days.  

Fifth Trip (10th Vaccination)

Feb 16th, 2021

The vaccine went well, and I had no symptoms to complain about.   
 
The doctor shared with me the newer Immune Monitoring Report (5 pages, sample taken on Feb 16th, 2022).   The results were even better than the last one that was shared in December 2021.
 
 Yes, I had another immune monitoring blood sample taken too. 

Sixth Trip (11th Vaccination)

April 14th, 2021

 This is where next vaccine is scheduled and for me to see what the immune monitoring report looks like! 
 
 
Mohammad Banat

Mohammad Banat

I'm an entrepreneur who founded and runs an IT company in the Middle East. However, my life took an unexpected turn after I underwent brain surgery in 2009 to remove an Oligodendroglioma in my temporal lobe.

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