TrovaGene Inc (NASDAQ: TROV) has been a hot topic of discussion among the biotech investing community as of late. With consistent news releases coming out about the company’s lead drug candidate, Onvansertib, it’s hard to ignore the stock.
Now, there’s one big question. Is it time to jump in? While Onvansertib seems promising, there are always risks when investing, especially in the clinical-stage biotechnology space. So, is TROV worth the risk? Let’s dive in and find out!
What Is Onvansertib
TrovaGene’s claim to fame is its lead clinical candidate, known as Onvansertib. The drug is a once-daily, orally administered treatment for cancer. In scientific terms it is a PLK1 inhibitor. PLK1 is a master-regulator of cell proliferation and is commonly over-expressed among various cancer types.
By inhibiting PLK1, Onvansertib leads to mitotic arrest in prometaphase. In lamens terms, the drug causes the death of cancer cells in various leukemias, lymphomas and solid tumor types.
Important to the TROV story and the story of Onvansertib, the treatment has a relatively short half-life. In fact, the half-life of Onvansertibe is only 24 hours. This is important as the short half-life could lead to a reduction in toxicity and adverse events in patients receiving the treatment.
Recent Data Is Overwhelmingly Promising
Today, TROV is getting quite a bit of coverage after issuing a press release with the most up-to-date data from its Phase 1b/2 clinical trial of Onvansertib. In the trial, the company is assessing the treatment to find the maximum tolerated dose, tracking efficacy data in the process.
Through the trial, TrovaGene is providing Onvansertib in combination with either standard-of-care decitabine or low-dose cytarabine (LDAC). Data to date has proven to be positive. Here are the key points from the release:
- Onvansertib In Combination With Decitabine – In the Onvansertib in combination with standard-of-care decitabine arm of the trial, 6 patients are evaluable to date. So far, 3 of these patients, or 50% have achieved a complete response.
- Onvansertib In Combination With LDAC – The company also announced that in the Onvansertibe in combination with standard-of-care LDAC arm of the trial, the first complete response has been achieved.
- Clinical Benefit – Clinical benefit combines complete response data with partial response data and stable disease data. Overall, the clinical benefit achieved to date has been 90%.
- Dose-Limiting Toxicities – Finally, through the trial, the company has progressed to a 40mg/m2 dose level. So far, there have been no dose limiting toxicities observed. As a result, TROV is now enrolling for the 60mg/m2 dose of Onvansertib in combination with either LDAC or decitabine.
In a statement, Dr. Thomas Adams, CEO and Chairman at TROV, had the following to offer:
We are pleased with the response to treatment that we are seeing with onvansertib, as well as how safe and well tolerated it appears to be in this difficult-to-treat relapsed or refractory patient population.
As we continue advancing our AML trial to identify the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), we look forward to sharing additional readouts on the efficacy and safety of onvansertib and the potential opportunity to bring a much-needed new treatment option to relapsed or refractory AML patients.
Nonetheless, this hasn’t been the only data released as of late. In fact, on April 2, 2019, Trovagene issued another press release, announcing early data from a Phase 2 trial. In the Phase 2 clinical trial, Trovagene is assessing Onvansertib in combination with abiraterone (Zytiga) as a potential treatment for patients with metastatic Castration-Resistent Prostate Cancer (mCRPC). Here are the key points from that release:
- Early Response – So far, the company has seen an early PSA response when Onvansertib is added to Zytiga. This response has been observed in 2 of 6 patients to date. Also, one of the patients have already achieved the primary efficacy endpoint of disease control and a 30% reduction in tumor size by RECIST criteria.
- PSA Trajectory – In the patient that achieved the primary endpoint, PSA trajectory changed from 100% increase in 60 days prior to the study to an 8.4% increase during 84 days on the study. This indicates that Onvansertibe has altered the natural history of early abiraterone resistance.
- AR-V7 – Finally, both patients that showed an early response saw a decrease in PSA levels. Moreover, they both tested positive for AR-V7, a highly aggressive androgen receptor variant that is resistant to Zytiga because it no longer needs androgen for tumor growth.
- Safety & Tolerability – To date, TROV said that the combination treatment has proven to be safe and well tolerated. No unexpected, off-target toxicities have been reported in treated patients.
In a statement, Dr. Mark Erlander, CSO at TROV, had the following to offer:
We are encouraged by the signs of clinical activity observed to-date and intrigued by the potential to be able to effectively treat patients who are AR-V7 positive.
There are limited options, other than intensive chemotherapy which has a poor prognosis, in patients who are showing initial signs of resistance to treatment with Zytiga® and those that harbor the highly aggressive androgen receptor variant (AR-V7). We believe the combination regimen may provide a much-needed new therapeutic option for these patients.
The Market Potential Is Incredible
At the moment, TrovaGene is in clinical trials, using Onvansertib to tackle AML and mCRPC. At the moment, the AML market is expected to grow to be worth $1.5 billion per year by the year 2026 with a CAGR of around 14%.
The Prostate Cancer market offers up an even larger opportunity. In fact, it is estimated that the market in this indication will grow to be worth $12 billion by the year 2025.
Moreover, it’s worth mentioning that these are just two of a long list of potential cancer indications for Onvansertib. Should data continue in the positive direction, the drug could quickly become a highly valuable blockbuster treatment that taps into multiple billion+ dollar markets.
Catalysts On The Horizons
At the end of the day, TrovaGene likely has several catalysts coming. In the past, we have seen that the company doesn’t keep secrets when it comes to clinical progress. As a result, with two clinical studies ongoing, we can expect to see more interim data reports.
Moreover, the ends of these clinical studies will become catalysts as well. The final data readout in either the Phase 1b/2 AML trial or the Phase 2 mCRPC trial could lead to a strong run in value. All in all, this stock is likely to be pretty active ahead.
Consider The Risks
As mentioned at the beginning of this article, any time an investment is made in a clinical-stage biotechnology stock, there are risks that come with the move. In the case of TROV, the largest risks include:
- Potential Clinical Failure – Any time an investment is made in a clinical-stage biotech stock, there is always a chance that something could go wrong in clinical trials. While the data released by TrovaGene to date has been positive, we are still relatively early in the game and a clinical failure could prove to be painful.
- Dependence On The Investment Community – Because TROV is in clinical stages, the company is not yet generating revenue from product sales. As a result, the company is highly dependent on support from the investing community. The good news is that the company has had no problem getting its hands on the money it needs. In fact, in the past month, the company announced a $1.5 million investment at a premium to market value and the receipt of $3 million due to the exercise of warrants.
As a clinical-stage biotechnology company, TrovaGene comes with risks that are part of being at this stage in the game. However, the data surrounding the company’s Onvansertib candidate has been overwhelmingly promising to date. This combined with incredible support from the investing community and multiple catalysts on the horizons makes TROV a stock that’s hard to ignore.