Genocea – Could this be the new treatment for herpes?

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herpes simplex 2, genocea, gen-003
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Genocea (NYSE: GNCA) is a biopharmaceutical company that is currently working on immunotherapy vaccines.


Genocea Pipeline

The major drug in their pipeline is called GEN-003, a vaccine for herpes simplex virus type 2 (HSV-2). While it’s not a vaccine in the traditional sense – getting inoculated will not make you immune to HSV-2 – it will reduce the viral load and the shedding for those who already have HSV-2.

The other drugs in their pipeline include immunotherapies for pneumococcus, chlamydia, epstein-barr virus, and personalized cancer therapies.

Understanding Herpes Simplex Virus Type 2 (HSV-2)

Herpes Simplex Virus Type 2, colloquially known as genital herpes, is quite ubiquitous in our society; roughly 1 in 5 people have it. It’s a lifelong virus that has no known cures at the moment. To make things worse, HSV-2 brings a level of negative social stigmata as well. That causes victims to feel ever more societal pressures which may cause distress.

Current common treatments include acyclovir and valacyclovir but they are not perfect. There can still be outbreaks here and there and that can disrupt a patient’s lifestyle for a few days.

Enter GEN-003

During the phase 2 trials for GEN-003, patients were given three injections over 21-day intervals and different end points were measured.

  • number of days with lesions within a year
  • number of recurrences within a year
  • duration of recurrences
  • viral shedding rate
The following table shows the data:
Endpoint 60/50
(n=43)
60/75
(n=44)
Placebo
(n=44)
Number of subjects contributing clinical data 43 44 44
Median genital lesion rate (percent of days with lesions over 12 months) 2.3 % 2.8 % 4.5 %
  Percent reduction versus placebo -49 % -37 % NA
  p-value versus placebo(1) 0.01 NS NA
Median number of recurrences over 12 months 1.5 2.0 4.0
  Percent reduction versus placebo -63 % -50 % NA
  p-value versus placebo(1) 0.01 NS NA
Median duration of recurrences (days) 2.7 4.0 3.6
  Percent reduction versus placebo -25 % 11 % NA
  p-value versus placebo(1) 0.02 NS NA
Kaplan-Meier estimate of percent recurrence free after first dose 20 % 16 % 7 %
  p-value versus placebo(2) 0.04 NS NA
Kaplan-Meier estimate of percent recurrence free after last dose 20 % 17 % 8 %
  p-value versus placebo(2) NS 0.05 NA
Number of subjects contributing shedding data 30 32 31
Viral shedding rate reduction from baseline -42 % -39 % -52 %
  p-value versus baseline(3) 0.02 NS 0.03
  p-value versus placebo (3) NS NS NA

 

In this 131-subject clinical trial, it was found that GEN-003 reduced the median genital lesion rate (or percent of days with genital lesions) by 49% (p=0.01) over the 12 months of post dosing at 60µg/50 µg.

The key thing of this study is that the study mirrored the dosage and the endpoint of phase 3’s study design.

The safety profile hasn’t changed since phase 1.

More posters can be viewed here and here.


Genocea Finances

As of 2Q earnings, the company has $35m in cash with a $15m burn rate.  The company will probably require funding soon.


Overall

I see promise in this vaccine, some may find a few injections more convenient than daily pills.  I am, however, cautious about the requirement of funding soon.

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Disclosure:  I have a long position in this company.

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