Annexin Pharmaceuticals intends to change how the eye disease retinal vein occlusion, RVO, is treated. With the biological drug candidate ANXV The company wants to offer a more effective and patient-friendly treatment for the disease, which is one of the most common causes of vision loss and affects more than 16 million people globally.
Annexin is also developing the same candidate for cancer treatment, where the company has identified two areas where ANXV could have potential clinical benefit. One is immuno-oncology treatments, which still face the challenge of counteracting cancer's ability to inhibit the immune system. The other area is conjugation – or the transport of chemotherapy drugs, where such an ANXV conjugate could improve the effect of the drug and also reduce the often serious side effects for patients.
Top line data in RVO approaching
In RVO, which is Annexin's primary focus, current treatments often involve repeated injections of so-called anti-VEGF drugs directly into the eye, which only alleviate some of the consequences of RVO. The goal of ANXV is instead to attack the cause of the disease by reducing the tendency of red blood cells to stick together, and in the best case, dissolve or reduce the blood clot that causes vision loss. ANXV can also have anti-inflammatory and cell-repairing effects. The company is conducting a Proof-of-Concept Phase II study in the US, which includes patients with newly diagnosed and untreated RVO.
The study has been fully recruited with 15 patients since the end of April and ANXV has not caused any safety or tolerability problems to date. In addition, the majority of patients have shown stable or improved visual acuity and swelling in the eye. The treating physicians have also assessed that among the patients who have received ANXV and have been followed for at least three months, 8 out of 10 have not required any or only one anti-VEGF treatment. Typically, patients affected by RVO need about four such treatments in the first six months, which gives Annexin reason to believe that the candidate works in patients as hoped.
The company's intention is to enter into out-licensing and/or partnership agreements for ANXV and in the ongoing business development work, which Annexin has a strong focus on, there is significant interest - not least in new mechanisms for treating the disease. Top line data from the phase II study, and thus the company's largest trigger to date, is expected in the summer of 2024.
Two important tracks in cancer
In cancer treatment, both independent research and Annexin's own preclinical studies indicate that ANXV has the potential to reduce the uncontrolled growth of cancer cells. ANXV can achieve this in two ways. One way is by increasing the immune system's ability to attack cancer cells, which independent researchers at reputable institutes in the US have shown is possible. The second way that ANXV can work in cancer is by chemically binding the candidate to a cytotoxic agent, forming a so-called ANXV conjugate.
Results from Annexin's preclinical studies show that ANXV conjugates have been successful in killing cancer cells from a patient with the difficult-to-treat form of triple-negative breast cancer. The company believes this is because the chemotherapy is more specifically targeted and, thanks to ANXV, is taken up into the cancer cells, which can improve the effectiveness of chemotherapy while likely reducing its side effects. Just like within RVO, the company intends to pursue clinical development in cancer together with a partner.
Carry out rights issue of SEK 45,1 million
Annexin is now conducting a rights issue of approximately SEK 45,1 million in total. The issue is secured to approximately 90 percent by subscription commitments and issue guarantees from a number of the company's existing shareholders as well as the board and management. The capital contribution will primarily be used to complete the phase II study in RVO, but also preparatory studies in cancer, pharmaceutical product-related costs, business development and other costs related to R&D.
CEO tells more
BioStock spoke with the CEO Anders Haegerstrand about the upcoming issue, the company's projects and why, in his opinion, one should participate in the investment round.
ANXV is a so-called biological drug candidate, which statistically has a higher probability of reaching the market compared to other types of drug candidates. How do you view ANXV's chances of success?
– ANXV is very similar to the body's own protein Annexin A5 and this reduces the risk of unexpected side effects. With the data we have seen so far in the ongoing RVO study, the chances have of course increased. However, larger randomized studies must determine whether ANXV can become a future so-called First-In-Class and first-line choice for RVO, or whether ANXV might be best combined with one or a few anti-VEGF injections. We consider the value of stabilizing the disease, which otherwise often becomes chronic, and at the same time reducing the use of anti-VEGF drugs to be very great.
You are expecting top line data from the phase II study in RVO during the summer, which is arguably your biggest trigger so far. What do you hope the results will show?
– We are very pleased with the favorable safety and tolerability profile of ANXV reported so far. It is very promising that so many patients have shown improved or unchanged visual acuity, often in combination with reduced retinal swelling and with little or no need for standard anti-VEGF treatment. Our hope is that we will see continued promising results also for the patients treated with the highest dose of 6 mg and that after final reporting we can proceed with the next clinical study, hopefully together with a partner.
What kind of results would give you a solid negotiating position with potential licensing partners?
– We are looking for a long-term partner who wants to develop ANXV in RVO, but also in other eye diseases as ANXV has broad potential. For example, this could be vision problems caused by diabetes. Our goal is to find a global partner but are open to regional arrangements in certain smaller but commercially important territories. The timing of entering into an agreement is always difficult to predict and a good conclusion to our phase II study is important. It is very positive that we are increasingly being noticed and invited to congresses. Most recently, at the beginning of May, we held presentations in Seattle in connection with specialist meetings in eye diseases.
You have ongoing projects in two different cancer tracks. What is the status of these and what are the next steps in each project?
– The cancer initiative aims to be able to use ANXV partly as a so-called immuno-oncology drug that will help the body's immune system attack cancer cells, and partly in the form of a conjugate drug where ANXV acts as a transporter of the cytotoxic agent directly to the cancer tumor with the aim of killing the cancer cells. Within the first part, we have concrete plans for patient selection, but need to confirm that strategy and when that is done, we will have a good clinical study design for a first patient study. This is an important part of the business development work, because partnerships are also our main focus in cancer. Within the second part, the ANXV conjugate, we expect results from studies in animal models in Q3 and after that we believe that interest in our cancer initiative will increase.
Annexin has a strong ownership base, as demonstrated by the majority of the current largest shareholders participating in the offering. What benefits does this bring to you?
– In the current investment climate, it is a great advantage to have a strong and supportive owner base. Recently, our largest owner, Mikael Lönn, was also elected to the board. Mikael has extensive experience from the pharmaceutical industry as an investor and entrepreneur, which will be of great importance as we move towards partnership discussions and late-stage clinical development.
You are conducting a rights issue of approximately SEK 14 million at SEK 28 per share between May 45,1–0,25. How is it that, while many other research companies of similar size are forced to put a large discount on their issues, you do not have to do this?
– We have assessed that our clinical RVO project, with more promising data and a close in sight, makes a discount less important. We see the fact that the issue is approximately 90 percent guaranteed as confirmation of this and we hope that many shareholders will want to subscribe for shares in this exciting phase for the company. We now look forward to continued development with the summer's top-line data as the next important milestone.
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