Rxi Pharmaceuticals (NASDAQ:RXII)
On Thursday March 31, 2016 Rxi Pharmaceuticals announced that it had received a patent from the United States Patent and Trademark Office — USPTO — for the company’s sd-rxRNA technology platform that covers CTGF — Connective Tissue Growth Factor. In essence the patent covers the company’s lead clinical product RXI-109, which is in phase 2 testing in patients with hypertrophic scars. This patent is not expected to expire until 2029, which means the company will be the only one utilizing RXI-109 for dermal scarring.
Why is this patent news an important step for Rxi? It is important because it protects the IP of RXI-109 which has already shown positive results against hypertrophic scars at 3 months. The investigators and blinded panels both concluded that RXI-109 performed better than control during that time period. Secondly, the proof that the company’s technology works in hypertrophic scars opens the door to partnership abilities. Both these points are mentioned by the CEO in this quote:
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“This issue notification from the USPTO further strengthens RXi’s Intellectual Property position in the area of dermal scarring,” said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, “From our ongoing Phase 2 clinical trial, we have already reported preliminary results indicating that the use of RXI-109 after scar revision surgery had a visible, beneficial effect on the suppression of hypertrophic scarring, at three months following revision surgery. This patent enhances our ability to broadly protect our proprietary technology, including our anti-fibrotic compounds for the treatment of dermal scarring, reinforcing the potential for future commercial and business development opportunities.”
Partnerships are a huge goal for Rxi in 2016. The CEO has made it clear that the company is interested in building shareholder value through a potential pharmaceutical partnership. How can one track the progress of the company’s partnership interactions? Of course it is against SEC regulations, and not good business practices to mention what possible pharmaceutical companies Rxi is in discussions with. But what the CEO could say was every encouraging:
In addition, business development contacts and interactions with other pharmaceutical and biotech companies have more than tripled in the past 6 months as compared to the previous 6-month period. As you can see from our progress in the last several months, our team continues to be very dedicated to continuing this momentum through 2016.”
As noted above the past 6 months saw a triple in the amount of interested parties to collaborate with Rxi. This makes sense, because the company has an array of products it can target using its sd-rxRNA technology platform. The CEO and company have noted many times in their presentations that once a particular gene target is chosen its takes 4 months to develop a target against it and file a patent on it. With the ability for Rxi to generate a target with such a low lead time, it should not be surprising that it has seen a surge in interested parties for collaborations.
All this is great but why should shareholders be interested in Rxi pharmaceuticals as an investment? It is because the company has plenty of catalysts in 2016 that should create shareholder value:
- RXI-109-1402 Phase 2 study in hypertrophic scars is expected to report early results in 2nd half of 2016 for both cohorts 3 and 4
- RXI-109-1501 study in retinal scarring of age-related macular degeneration is expected to report preliminary phase 1/2 data on safety, and efficacy 2nd half 2016
- Phase 2 study for Sampcyprone treating patients with Warts. The study is expected to enroll completely by the 2nd half of 2016, with preliminary results out by the end of 2016
- Human testing to begin for one of the two cosmetology targets the company is targeting. The company expects to start testing on humans by the end of 2016
- Potential pharmaceutical partnerships in 2016 as the implied goal of the company
Genocea Bisociences (NASDAQ:GNCA)
On March 31, 2016 shares of Genocea Biosciences finished the day up by 94% after the company announced that it had received positive phase 2 results in patients with genital herpes. The company used its vaccine, known as GEN-003, to treat these patients with genital herpes over a 12-month time frame. The trial was successful because the GEN-003 vaccine showed a statistically significant reduction of viral shredding compared to the baseline measurement.
The vaccine was even able to meet on all the secondary endpoints of the trial as well. It was also shown to be safe and tolerable in all patients which is a huge plus for a vaccine that treats genital herpes. There is high hopes that such a treatment from Genocea will actually reach the market. This is because standard of care treatment with antivirals require patients to take one pill everyday for 12 months. On the other hand, treatment with GEN-003 would only require one vaccine treatment that would last up to 12 months.
The only uphill battle now is for the vaccine to show statistically significant results in a phase 3 clinical trial along with FDA approval. Investors will have to await a phase 3 trial before there is the possibility that GEN-003 can eventually be approved, pending positive clinical results. Before then the company intends to release additional clinical data from another phase 2 trial targeting the same indication. This data is expected to be read out by the third quarter of 2016, and if positive could provide another catalyst for shareholders.
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Disclosure: Author is Long Rxi Pharmaceuticals (RXII)
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