Annexin Pharmaceuticals AB

STOCKHOLM, Oct. 25, 2023 /PRNewswire/ -- Annexin Pharmaceuticals announces that all patients in the first dose group with the lowest dose have now completed treatment in the company's clinical phase 2 study in patients with retinal vein occlusion (RVO) with the investigational drug candidate ANXV. No limiting treatment-related side effects have been reported and the company has received recommendation to proceed with treatment of patients in the next dose group. An expected accelerated recruitment rate means that last patient in is planned to the first quarter of 2024. "It is very gratifying that we see continued progress in this important study. Five out of seven dedicated eye clinics have now treated patients with good experiences, which bodes well for continued recruitment. With more patients treated, we now hope to be able to confirm the promising effect signals, and with an increased dose, hopefully also strengthened", says Anders Haegerstrand, CEO of Annexin Pharmaceuticals. All six planned patients have now completed treatment in the phase 2 study's first patient group (cohort) where the patients were treated at the lowest dose level, 2 mg/day, for five days. No limiting side effects have been observed in the first cohort and after the recommendation by an independent Safety Review Committee, which evaluates the study based on safety, among other things, the first patient has now been treated in the second cohort of the study, where up to ten patients are planned to be treated with the higher dose, 4 mg/day, for five days. After two patients have been treated with the higher dose, a safety evaluation will be performed before the remaining patients can be enrolled. The company intends to continuously update the market on any efficacy signals, or any treatment-related side effects, as clinical data and other patient information have been verified and assessed by experts. "During the autumn, we have visited several of our active eye clinics in the US and we are experiencing great enthusiasm after the promising signals of effect. We also see an increase in recruitment rates after we changed the study protocol and removed the placebo group. We remain committed to our plan to have all patients included in the study during the first quarter of next year and to be able to report 4-month follow-up data thereafter", says Dr. Anna Frostegård, Chief Scientific and Medical Officer at Annexin Pharmaceuticals. In August 2023, Annexin reported promising efficacy signals in two out of four patients treated with ANXV in the ongoing Phase 2 study. The positive findings warranted, among other things, extended patient follow-up and removal of the placebo group in the study as the ANXV treatment did not give rise to any serious treatment-related side effects. About the Phase 2 study Annexin's Phase 2 clinical trial includes patients who have recently received their RVO diagnosis, but who have not been treated with the standard anti-VEGF therapy. It is an open-label study in which patients receive ANXV followed by anti-VEGF (if needed) and followed for up to four months with examinations to evaluate safety, tolerability and any signals of efficacy related to ANXV. The company plans to include up to 16 patients, of which six patients have been treated at the lower dose level, 2 mg/day, and up to ten patients are intended to be treated at the higher dose level, 4 mg/day. About retinal vein occlusion (RVO) RVO is a vascular disease of the eye in which blood flow in the veins of the retina is blocked. The disease often leads to severe visual impairment or blindness and a need for long-term treatment. The treatments for RVO that are available today are injected directly into the eye, usually monthly, and have no effect on the blockage of blood vessels that causes RVO. According to a 2021 report by Transparency Market Research, the value of the RVO market is estimated to reach approximately USD 20 billion by 2025, and it is expected to grow by approximately 7 percent annually over the next 10 years. For further information, please contact: Anders Haegerstrand, CEO, tel +4670 - 575 50 37 About Annexin Pharmaceuticals AB Annexin Pharmaceuticals AB is a leading biotechnology company in the Annexin A5 field for the treatment of various diseases. The company's biological drug candidate ANXV – a human recombinant protein, Annexin A5 – is primarily intended for treatment of patients with injuries and inflammation of the blood vessels, but also for cancer. The company has an extensive patent portfolio for the treatment of diseases with Annexin A5 and for production of Annexin A5. The Company is based in Stockholm, Sweden and listed on Nasdaq First North Growth Market, under the ticker ANNX. Redeye is the company's Certified Adviser. CONTACT: susanne.andersson@annexinpharma.com Susanne Andersson CFO/IR @ Annexin Pharmaceuticals AB The following files are available for download: View original content: SOURCE Annexin Pharmaceuticals AB Company Codes: ISIN:SE0009664154, Stockholm:ANNX

STOCKHOLM, Sept. 29, 2023 /PRNewswire/ -- Annexin Pharmaceuticals today announces important progress in the company's preclinical cancer research where the drug candidate ANXV has shown promising results as a transporter of chemotherapy drugs to kill cancer cells. Within the framework of Annexin's cancer initiative, the company has successfully produced a so-called conjugate where the drug candidate ANXV is chemically bound to a chemotherapy agent and together forms a new composite molecule. In cell systems outside the body, this ANXV conjugate has been shown to kill a type of cancer cell taken from a person with triple-negative breast cancer, a very difficult-to-treat form of breast cancer. The chemotherapy agent alone was not effective on this highly resistant cell type and with no immune cells present in the cell system ANXV was, as expected, also not effective. "The results we have seen are very exciting as it means that our drug candidate ANXV has the potential to be used together with known chemotherapy drugs to develop new cancer drugs in areas where there are currently no effective treatments. In addition, fewer and milder side effects are expected because the ANXV conjugate is expected to be specifically targeted to the cancer," says Anna Frostegård, CSO and CMO of Annexin Pharmaceuticals. "Much work remains to be done before treatment of patients can take place, but an important milestone within our cancer initiative that was set in December 2022, at the time of the directed share issue, has now been achieved," says Anders Haegerstrand, CEO of Annexin Pharmaceuticals. Annexin has chosen to drive development towards new cancer treatments based on the fact that many different cancer cells expose the substance phosphatidylserine (PS), ANXV's target molecule, on their surface. One part of the company's cancer initiative involves the development of ANXV conjugates. In a process of conjugation, a cytotoxic agent is chemically bound to ANXV and the expected therapeutic effect will be achieved when cancer cells exposing PS on the surface, transports the conjugate into the cell where the chemotherapy drug gets separated from ANXV and then exerts its cytotoxic effect. The principle of linking chemotherapy drugs to proteins that target cancer cells is well known and used in many approved drugs. The market for conjugate drugs in oncology is expected to reach more than USD 10 billion within a few years. An ANXV conjugate may become the first conjugate drug that takes advantage of the presence of PS on the surface of cells in many difficult-to-treat type of cancers. For further information, please contact: Anders Haegerstrand, CEO, tel +4670 - 575 50 37 About Annexin Pharmaceuticals AB Annexin Pharmaceuticals AB is a leading biotechnology company in the Annexin A5 field for the treatment of various diseases. The company's biological drug candidate ANXV - a human recombinant protein, Annexin A5 - is primarily intended for treatment of patients with injuries and inflammation of the blood vessels, but also for cancer. The company has an extensive patent portfolio for the treatment of diseases with Annexin A5 and for production of Annexin A5. The Company is based in Stockholm, Sweden and listed on Nasdaq First North Growth Market, under the ticker ANNX. Redeye is the company's Certified Adviser. The following files are available for download: SOURCE Annexin Pharmaceuticals AB

STOCKHOLM, Aug. 11, 2023 /PRNewswire/ -- Annexin Pharmaceuticals AB today announces that an independent evaluation of potential signals of effect has been carried out in the company's Phase 2-study in retinal vein occlusion with the investigational new drug ANXV. Positive findings justify an extended follow-up period. A group of leading independent US ophthalmologists has conducted an evaluation of the available information from patients treated so far in the placebo-controlled study. The evaluation confirmed an unexpectedly long duration of effect with a single dose of standard of care anti-VEGF treatment in two of five treated patients. These two patients also had some positive effects on visual acuity and the retina already during the four weeks before standard of care treatment was used. The expert group recommended unmasking the treatment to clarify whether the treated patients received placebo or ANXV. The unmasking showed that the two patients with potential signals of effect had received ANXV. No clear signals of effect were observed in the other patients in the study where two had received ANXV and one had received placebo. The experts also recommended that the study should continue with a longer follow-up time and without a placebo group, since ANXV treatment has not raised safety concerns. "The observations are interesting and indicate that ANXV may have a positive effect on the course of the disease in RVO, which is in line with our hypothesis. It is not possible to draw any firm conclusions from two patients, but it is unusual for such patients to respond to just a single anti-VEGF injection in the first six months after diagnosis. We intend to recruit and treat two more patients at the current dose and up to ten patients at a higher dose to gather more safety and tolerability data and to possibly confirm signals of effect", says Dr Anna Frostegård, Chief Scientific and Medical Officer at Annexin. "With these early signals in the RVO study, a favorable safety profile and the imaging data that we reported last spring, we have several interesting clinical findings. In the simplified study design we are removing the placebo group and altogether we believe the changes will accelerate patient enrolment", says Anders Haegerstrand, CEO in a comment. About the study Annexin's phase 2 study includes patients who have recently received their RVO diagnosis, but have not been treated with the standard anti-VEGF therapy. After the protocol update, the study will be an open-label study where patients receive the investigational new drug ANXV followed by anti-VEGF (as needed) and will be followed up to four months with examinations to evaluate safety, tolerability and any signals of effect that may be related to ANXV. The company plans to include up to sixteen patients treated with ANXV, including the four already treated patients. About Retinal vein occlusion (RVO) RVO is a vascular disease of the eye in which blood flow in the veins of the retina is blocked. The disease often leads to severe visual impairment or blindness and the need for long-term treatment. The treatments of RVO available today are injected directly into the eye, usually monthly, and have no effect on the blockage of blood vessels that causes RVO. According to a report by Transparency Market Research in 2021, the value of the RVO market in 2025 is estimated to reach about USD 20 billion, and it is expected to grow by about 7 percent annually for the next 10 years. For further information, please contact: Anders Haegerstrand, CEO, tel +4670 - 575 50 37 This disclosure contains information that Annexin Pharmaceuticals AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person on 11 August 2023, 10:15 CET. This document has been prepared in both a Swedish and English version. In the event of any deviations, the Swedish version shall prevail. About Annexin Pharmaceuticals AB Annexin Pharmaceuticals AB is a leading biotechnology company in the Annexin A5 field for the treatment of various diseases. The company's biological drug candidate ANXV - a human recombinant protein, Annexin A5 - is primarily intended for treatment of patients with injuries and inflammation of the blood vessels, but also for cancer. The company has an extensive patent portfolio for the treatment of diseases with Annexin A5 and for production of Annexin A5. The Company is based in Stockholm, Sweden and listed on Nasdaq First North Growth Market, under the ticker ANNX. Redeye is the company's Certified Adviser. The following files are available for download: SOURCE Annexin Pharmaceuticals AB