2023-08-02 15:58:47 ET
Summary
- Interim results from the phase 2 study, using EVX-01 for the treatment of patients with metastatic melanoma, is expected in Q4 of 2023.
- Positive preliminary results have already been established in using EVX-01 for metastatic melanoma patients and EVX-02 for adjuvant melanoma patients in phase 1/2a studies.
- Initiation of a phase 1 study using cancer vaccine EVX-03 for the treatment of patients with lung cancer and solid tumors is expected in Q4 of 2023.
- It is said that the melanoma market is expected to grow to $13.11 billion by 2029.
Evaxion Biotech A/S ( EVAX ) has made significant progress thus far in advancing a few candidates in its pipeline. That's because it is currently testing the use of EVX-01 in an ongoing phase 2 study for the treatment of patients with unresectable or metastatic melanoma. What I believe that investors might be able to capitalize on might be data to be released from this study which is rapidly approaching. It is said that results from this mid-stage study, using EVX-01 for the treatment of patients with metastatic melanoma, will be released in Q4 of 2023. Prior data, from a phase 1/2a study using EVX-01 for the treatment of this patient population, was quite promising.
Not only is there this catalyst to look forward to, but the company is now well capitalized going forward. The reason why is because of it being able to obtain financing commitments totaling up to $20 million with Negma Group. With this latest financing, it believes it will be able to fund operations into Q4 2024. This estimate of funding its operations is based on its ability to fully utilize the convertible note program. Lastly, it intends to use the cash to advance another candidate in the pipeline known as EVX-03, which is being developed to treat patients with lung cancer and solid tumors. If all goes well, then it intends to initiate enrollment of a phase 1 study using EVX-03 for these patient populations in Q4 of 2023.
EVX-01 For The Treatment Of Patients With Metastatic Melanoma Is On Track
The main clinical program in the pipeline for Evaxion Biotech deals with the use of EVX-01 for the treatment of patients with metastatic melanoma. Melanoma is the most serious type of skin cancer, which develops in the cells [melanocytes] that produce melanin. Melanin is the pigment that gives your skin its color. It is not entirely clear what causes melanoma, but it is believed that heavy exposure to ultra violet [UV] radiation might be one cause of it. Metastatic melanoma occurs as a result of cancerous cells from the original tumor spread to other parts of the body through the lymph or blood circulation, where then another tumor forms. This type of melanoma is typically not seen until stage 3 or stage 4 of disease. Common sites for metastases might be as follows:
- Liver
- Lungs
- Lymph nodes
- Brain
- Bones
The melanoma market opportunity is quite substantial and thus this is a good target option for this biotech. It is said that the melanoma market is expected to grow to $13.11 billion by 2029 . However, a good thing about this biotech is that it is also exploring the use of another drug EVX-02 for the adjuvant melanoma treatment setting as well. It has been able to achieve good data in targeting this adjuvant patient population as well. It reported positive data from a phase 1/2a study to look at the combination of EVX-02 plus nivolumab [OPDIVO] in patients who had undergone complete surgical resection of late-stage melanoma and were at high risk for recurrence. It was noted that all 10 patients who received the full dosing schedule of about eight immunizations with EVX-02 were relapse free at their last assessment . Of these 10 patients, nine complete the entire study and were relapse free at the 12-month end of study visit. However, it was noted that one patient was prematurely terminated, but it was not due to treatment with EVX-02. Regardless, this one patient was relapse-free at the last visit at nine months.
As I noted above, there is a major catalyst opportunity for investors to look forward to, which is the release of interim results from an ongoing phase 2 study. This mid-stage study is exploring the use of EVX-01 for the treatment of patients with metastatic melanoma and such results are expected in Q4 of 2023. It remains to be seen if this data will turn out to be positive, but one thing to look to would be prior data released from a phase 1/2a study in June of 2023 at ASCO. At this medical conference it was noted that about eight out of 12 patients [67%] had an objective response [OR] to EVX-01. This broke down into the following:
- Two patients with a complete response
- Six patients with a partial response
Not only was a good response rate achieved, but it was noted that treatment with this cancer vaccine was well tolerated. There were only mild grade 1 to 2 adverse events [AEs] that were noted with this treatment.
Financials
According to the 6-K SEC Filing , Evaxion Biotech had cash and cash equivalents of $10.2 million as of March 2023. It believed that this cash on hand would be enough to fund its operations until at least early December 2023. Of course, that is not a sufficient cash runway to fund itself, thus it had to raise additional cash by other means. That's why on Aug. 1 it entered into a binding agreement for financing of up to $20 million USD with Negma Group Investment Ltd. It is expected that this financing will be done over multiple tranches over a three-year period. The important things that this funding brought are a cash runway extension and the ability to advance its other personalized neoantigen cancer vaccine EVX-03. With the latest funding developed with Negma Group Investment Ltd., Evaxion has sufficient cash into Q4 of 2024. In terms of advancing EVX-03, it will be able to initiate a phase 1 study treating patients with lung cancer and solid tumors. This early-stage study is expected to start in Q4 of 2024.
Risks To Business
There are several risks that investors should be aware of before investing in Evaxion Biotech. The first risk to consider would be with respect to the release of interim results, which are expected from the phase 2 study using EVX-01 for the treatment of patients with metastatic melanoma. Even though prior results released at ASCO 2023 from the phase 1/2a study were positive, there is no guarantee that the interim analysis will produce similar or superior data. A second risk to consider would be with the advancement of EVX-02 plus Opdivo, which targeting adjuvant melanoma patients. Even though data released in April of 2023 was positive, this was a small number of patients. It remains to be seen if a larger study using this EVX-02 combination in this adjuvant melanoma patient population lives up to expectations.
A third risk would be with respect to the advancement of EVX-03, which is being developed for the treatment of patients with lung cancer and solid tumors. A Phase 1 study using EVX-03 for the treatment of these patient populations is expected to be initiated in Q4 of 2023. Even though Evaxion's cancer vaccines have done well in patients with metastatic melanoma, there is no assurance that a positive outcome will be achieved in patients with lung cancer/solid tumors. A fourth risk to consider would be the financial position that this biotech is in. While it does have enough cash for now with its recent $20 million funding from Negma Group Investment Ltd., it only has enough cash to fund its operations into Q4 of 2024. Thus, I believe starting by around mid-2024, it may have to start looking to raise cash again with another financial instrument.
Conclusion
Evaxion Biotech has done well to advance a few of its cancer vaccines in the pipeline. It is in good shape, because it has already reported positive preliminary data from two phase 1/2a studies, using EVX-01 and EVX-02 for the treatment of patients with metastatic melanoma. This was evidenced from the data released I noted above. That is one set of data from the melanoma adjuvant treatment setting at AACR in April of 2023 and then the other set of data from the other metastatic melanoma patient population at ASCO in June of 2023. The most important near-term catalyst would be the release of interim results from the phase 2 study, which is using EVX-01 for the treatment of patients with metastatic melanoma.
Interim results from this mid-stage study are expected in Q4 of 2023 and I believe that if positive, it could significantly boost shareholder value. Another smaller catalyst, which is also expected during this same time period, would be the initiation of a phase 1 study. This early-stage study is using EVX-03 for the treatment of patients with lung cancer and solid tumors. With the advancement of both EVX-01 and EVX-02 for the treatment of patients with melanoma [metastatic melanoma and adjuvant melanoma respectively], plus the ability to advance a third personalized neoantigen vaccine into phase 1 testing, I believe that investors might be able to capitalize on any potential gains made here.
For further details see:
Evaxion Biotech: Personalized Cancer Vaccine Biotech With Q4 2023 Catalyst