You may want to consider biotech speculative investment TCR2 Therapeutics (NASDAQ:TCRR) because its pipeline has been changed to focus on just a few key clinical products. Because the pipeline has shrunk, the company has cut its staff by 40% to save money. With this job loss, it now thinks it will have enough money to keep running until the start of 2025. The main medicine in the works is gavo-cel, which is being tested on women with ovarian cancer in a phase 2 trial. The company then focused on TC-510 and TC-520, which are next-generation clinical treatments for a number of types of tumors. While TC-520 goes after both solid tumors and blood cancers, TC-510 only goes after solid tumors. Even more, a reason to look into this biotech is that two catalysts are due to come out in the second half of 2023. One of these could be the release, in the second half of 2023, of data from the phase 2 clinical trial using gavo-cel on a group of people with ovarian cancer. The results of the phase 1 clinical trial using TC-510 to treat mesothelin tumors, which are also expected in the second half of 2023, would be a second thing that would speed things up. I think it’s a good biotech play to look into as a speculative investment because it has a refocused pipeline and could find something useful in the second half of 2023.
Gavo-Cel Therapy for Women with Ovarian Cancer
The most important clinical program that will be shown is the use of gavo-cel, which is being developed to treat solid tumors that are positive for mesothelin. TCR2 Therapeutics has already released positive results from phase 1 of the clinical study, which shows that this project is going well. This study included a total of 32 patients, who were split into four groups:
- Mesothelioma has been found in 23 people.
- There are 8 cases of ovarian cancer.
- One patient had cholangiocarcinoma.
28 of the 30 patients whose tumors could be measured shrank (93%) and those who got gavo-cel had a 77% disease control rate (DCR). Other endpoint indicators, like progression-free survival (PFS) and overall survival (OS), were also not too bad. This group of patients had a PFS of 5.6 months and an OS of 11.2 months, which shows that they were very durable. This set of clinical results isn’t bad, especially considering that TCR2 Therapeutics had to lower the dose after a few cohorts. What’s going on? Because dose levels 5 and 3.5 caused a lot of side effects, the standard recommended phase 2 dosage (RP2D) of DL3 (1×108 cells/m2 after lymphodepletion) was chosen. No new dose-limiting toxicities (DLTs) were seen as the dose was raised. When the data from the first part of the trial came out, these people were in pretty bad shape. Before getting gavo-cel, patients had averaged five other types of treatment.
Phase 2 of the trial went as planned, but the biotech company is making changes to see if they can extend or improve the clinical results. It is no longer trying to use gavo-cel to treat people with ovarian cancer. There are two main reasons why we are now paying more attention to people with ovarian cancer. The first reason is that some of these patients only partly responded at first. Another reason is that there is a much bigger market to look at. Reports say that by 2029, the global market for ovarian cancer could be worth $13.9 billion. Since more information about this group of ovarian cancer patients will be made public in the second half of 2023, the success of gavo-clinical cel will be looked at quickly.
As I said at the beginning of this article, TC-520 and TC-510, two more clinical drugs, are in the works. Still in the process of being called an “investigatory novel medication,” TC-520 (IND). This medicine goes after the CD70 protein, which lets scientists study its use in both solid tumors and blood cancers. TC-510 has moved forward and is now being tested on people with mesothelin tumors in phase 1 clinical trials. It is important to remember that this medicine is an improved version of gavo-cel that also co-expresses a PD-1:CD28 chimeric switch receptor. It is expected that this kind of addition will make the reactions stronger and last longer. In the second half of 2023, the results of the phase 1 trial will be made public. This will give investors another catalyst to look forward to. This is another attempt to find out if cancer treatments that target TCR2 mesothelin work.
According to its 10-Q SEC filing, as of December 31, 2022, TCR2 Therapeutics had $176 million in cash, cash equivalents, and investments. In the third quarter of 2022, cash on hand went up and reached $25.8 million. But I don’t think this will be the case in the future. It did this because it tried to change the way its pipeline worked so it could save money. Also, it has to make good use of its resources to create specific programs that it thinks will increase shareholder value. It cut its staff by 40% so that it could only focus on the few clinical goods listed above. Before this cut in staff, it thought that its cash reserves would be enough to keep it going until 2024. After letting people go, it now thinks it has enough money to keep going until the beginning of 2025.
Before putting money into TCR2 Therapeutics stock, traders and investors should be aware of a number of risks. The most dangerous part of the study’s ongoing program to treat people with ovarian cancer with gavo-cel would be Phase 2. Even though the biotech was able to get a few partial responses (PR) from these patients, it can’t be sure that it will be able to do so when more patients are added. Especially since more results from this study’s phase 2 will be released in the second half of 2023. The use of TC-510 in people with mesothelin tumors is another thing to think about. This is because the results of a phase 1 study using this drug to treat this group of people are expected in the second half of 2023. It is thought that TC-510, an improved version of gavo-cel that co-expresses a PD-1:CD28 chimeric switch receptor, may help these mesothelin-positive tumor patients live longer.
Based on what the study found, TCR2 Therapeutics stock is a great biotech speculation. The main reason for this is that gavo-cel has already shown that it can treat people with mesothelin tumors in a phase 1 part of a research study. Even more important, there are plans for two data readouts in the second half of 2023. During this time, the first piece of information would be how gavo-cel was used to treat people with ovarian cancer in phase 2 of the research. Even though gavo-cel has helped some people with ovarian cancer get a partial response, there is no guarantee that the same thing will happen when more study results come out in the second half of this year (PR). TC-510, which is an improved version of gavo-cel, would be the second catalyst. In the second half of 2023, the results of a phase 1 study using TC-510 to treat patients with mesothelin tumors are expected. I think gavo-cel is a good biotech play to consider as a speculative investment because it has shown that it can treat ovarian cancer patients, and a few milestones are expected in the second half of 2023.
Featured Image: Pexels @ Edward Jenner