BK virus infection

WUPPERTAL, Germany I October 31, 2024 I AiCuris Anti-infective Cures AG today announced the initiation of its Phase 1, first-in-human trial of AIC468, a novel antisense oligonucleotide. AIC468 is an antiviral agent which aims to treat BK virus (BKV) infections in kidney transplant (KT) recipients. BKV reactivation in KT recipients is an area of high unmet medical need with no approved drug treatments. This Phase 1 trial ( 2023-510074-13-00 ) will evaluate the safety, tolerability and pharmacokinetics of AIC468 in healthy volunteers. “BK virus infections remain an urgent threat to transplant recipients, leading to graft loss and other serious complications,” said Cynthia Wat, MD, CMO of AiCuris . “Advancing AIC468 into clinical trials brings us one step closer to providing a targeted therapeutic option that directly inhibits BK virus replication, that addresses this critical unmet medical need. Our team remains committed to improving outcomes for patients dealing with the challenges of post-transplant viral infections.” “This trial marks another significant milestone in our mission to develop innovative therapies for patients with weakened immune systems, who are particularly vulnerable to serious viral infections like BK virus infections,” said Larry Edwards, CEO of AiCuris . “The initiation of this trial demonstrates the strength and diversity of our pipeline as we continue to advance cutting-edge solutions for high-risk patient populations. With multiple programs now in the clinic, we are confident that our approach can make a meaningful impact on the lives of immunocompromised patients.” The randomized, double-blind, placebo-controlled first-in-human trial will assess the safety, tolerability, and pharmacokinetics of AIC468 in 72 healthy volunteers. Conducted in Germany, the trial includes both single and multiple ascending doses of AIC468. Topline data readout from the single ascending dose part of the study is expected in 2025. About BKV BK virus (BKV) is a common polyomavirus that infects most people in early childhood, typically without symptoms. In immunocompromised individuals, such as organ transplant recipients, BKV can reactivate, leading to serious health issues. In kidney transplant (KT) patients, BKV reactivation can cause BK virus-associated nephropathy (BKVAN), affecting up to 10% 1 of recipients and potentially resulting in graft loss. Current management involves reducing immunosuppressive therapy, which increases the risk of graft rejection. Despite its prevalence, there is no approved antiviral treatment specifically for BKV. About AiCuris AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future. 1 Imlay H. et al., Consensus Definitions of BK Polyomavirus Nephropathy in Renal Transplant Recipients for Clinical Trials, Clinical Infectious Diseases , 2022, https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciac071 SOURCE: AiCuris

WUPPERTAL, Germany--( BUSINESS WIRE )-- AiCuris Anti-infective Cures AG , announced today multiple milestone achievements for letermovir (marketed by MSD as PREVYMIS ® ) and across its pipeline of anti-viral therapeutics serving the growing population of people whose immune systems are impacted due to disease or immunosuppressive therapies. These achievements recognize AiCuris’ rapid progress in developing a clinical pipeline of precise therapies to effectively treat infections in a population for whom an otherwise manageable infection, can mean life or death. “Our mission is to make a difference for people with weakened immune systems, by giving them options in preventing or treating infections that are life-threatening for them. The expanded approval of PREVYMIS ® in Japan highlights its unique drug profile in diverse transplant settings where CMV infections pose a significant risk to adult patients on immunosuppressive therapies. Combined with the existing approvals in the U.S. and Europe, it provides further validation for the outstanding drug development capabilities of the AiCuris team and the benefit PREVYMIS ® can provide for immunocompromised patients,” said Larry Edwards, CEO of AiCuris. “It is our goal to achieve the same level of success for patients with our two follow-on pipeline programs pritelivir, which is close to pivotal Phase 3 read-out, and AIC468’s first-in-human study starting in the near-term.” PREVYMIS ® Update In May, PREVYMIS ® (letermovir) achieved approval in Japan for the use in adult patients receiving solid organ transplants (SOT). This significant milestone represents the first pan transplant indication approval for PREVYMIS ® , a first-in-class antiviral agent commercialized by our partner MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA) for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). PREVYMIS ® is marketed in over 60 countries. Following this achievement, AiCuris will receive a milestone payment of EUR €7.5 million from MSD. Pipeline Updates AiCuris published pharmacokinetic data for its lead candidate pritelivir (AIC316), an innovative therapeutic candidate targeting HSV replication, in May 2024. Pritelivir is currently being evaluated in a Phase 3 trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. The study expects to complete patient enrollment in 1H 2025. The study titled “ Evaluation of the Clinical Drug-Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach ” was recently published in the journal Clinical Pharmacology in Drug Development and provides data on the drug-drug interaction profile of pritelivir. The results demonstrated that pritelivir has a low risk of drug-drug interaction, as there was no effect on intestinal uptake and efflux transporters. These findings are crucial for ensuring the safety and efficacy of pritelivir as a treatment option for patients with resistant HSV infections, who are often receiving a range of additional treatments. In addition, AiCuris’ third pipeline candidate AIC468 is rapidly nearing the clinic after the regulatory approval of its clinical trial application by the German national authority. AIC468, an antisense RNA therapeutic candidate, is designed to treat BK virus (BKV) infection, which can lead to BKV-associated nephropathy, increasing the risk of chronic kidney failure or graft loss. AIC468 will be investigated in a first-in-human Phase 1 trial in healthy volunteers starting in Q3 of 2024. Up to 88 healthy individuals are expected to be enrolled in multiple single and multi-ascending dose cohorts with the objective to investigate safety and tolerability of AIC468. AIC468 specifically inhibits BKV replication, addressing the critical need to target the virus directly. By not compromising ongoing immunosuppressive treatments - the current standard of care – it helps to reduce the risk of graft loss. Preclinical studies have shown AIC468's mechanism of action effectively inhibits BKV replication in human kidney cells and achieved efficacious concentrations in kidney tissues in vivo . Additionally, a favorable pharmacokinetic and safety profile as well as a broad therapeutic window could be demonstrated preclinically warranting the start of clinical development. “AiCuris is driving innovation in antiviral therapies with our pipeline candidates pritelivir and AIC468. The recent publication on pritelivir underscores its potential as a breakthrough treatment for acyclovir-resistant HSV infections for immunocompromised patients,” said Larry Edwards . “Additionally, achieving Phase 1 approval for AIC468 marks a significant milestone in our efforts to address BK virus infections, showcasing promising preclinical efficacy data. We look forward to the upcoming data from these programs which will be important steppingstones in developing novel therapies for immunocompromised people.” About Prevymis ® PREVYMIS ® (letermovir), developed by AiCuris and marketed by MSD, is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant and prophylaxis of CMV in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]. The drug is marketed in more than 60 countries outside the U.S., including in the E.U., Canada, Japan and China, and has received approval for prevention of CMV infections in adult solid organ transplant (SOT) recipients in Japan in 2024. The recent approval for SOT in Japan is supported by robust clinical trials demonstrating its efficacy and safety in preventing CMV disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative). About Pritelivir Pritelivir, a novel helicase-primase inhibitor developed by AiCuris, targets both HSV-1 and HSV-2. These viruses are responsible for genital, oral or disseminated infections with increasing severity and resistance development in immunocompromised people. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, a mechanism distinct from nucleoside analogues like acyclovir. Earlier Phase 1 and Phase 2 trials in immune competent and immune compromised individuals showed a favorable safety profile and an improved clinical efficacy compared with standard of care treatments like valaciclovir and Foscarnet (including resistant or intolerant infections). Recognized with Breakthrough Therapy designation by the FDA for immunocompromised patients, pritelivir is currently advancing through a pivotal Phase 3 trial. The results of this trial will serve as a basis for filing for marketing authorization in 2026. About AIC468 AIC468 is a pioneering RNA-based therapy designed to treat BK virus (BKV) reactivation in kidney transplant patients. BKV infections prove to be a significant clinical challenge, particularly for kidney transplant recipients, as they can lead to BKV-associated nephropathy, resulting in chronic kidney failure or graft loss. To date, there are no approved antiviral treatments for BKV; the only option is to reduce immunosuppression therapy, increasing the risk of graft rejection. AIC468 is an antisense oligonucleotide that targets viral replication within infected cells by inhibiting the splicing of mRNA coding for the BKV master regulator large T-antigen. This innovative approach has demonstrated favorable pharmacokinetics and significant inhibition of BKV replication in preclinical studies. AiCuris expects to initiate the first human trial for AIC468 in Q3 of 2024, aiming to provide a much-needed therapeutic option for kidney transplant patients at risk of BKV reactivation. About Herpes Simplex Virus Herpes Simplex Virus (HSV) includes two types, HSV-1 and HSV-2, both of which cause lifelong infections. HSV-1 typically leads to oral herpes, resulting in cold sores around the mouth, while HSV-2 is commonly associated with genital herpes. These viruses can cause recurrent painful blisters and sores, and in severe cases, complications such as encephalitis, disseminated disease and neonatal herpes. HSV infections are widespread globally, with a significant impact on public health, especially immunocompromised patients, due to their high prevalence, more severe and more frequent manifestations and increased potential for drug resistance. About BK Virus BK virus (BKV) is a polyomavirus that commonly infects the urinary tract. While it remains latent in most healthy individuals, it can reactivate in immunocompromised patients, such as those undergoing organ transplantation. Reactivation of BKV can lead to serious complications, including BK virus-associated nephropathy (BKVN), which can cause kidney dysfunction and graft loss in transplant recipients. Managing BKV infections is essential in immunocompromised patients to prevent significant morbidity and improve transplant outcomes. About AiCuris AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. AiCuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future.

PRESS RELEASE Memo Therapeutics increases Series C financing to CHF 45 million Additional CHF 20 million raised from new investors Ysios Capital and Kurma Partners as well as from existing investors Proceeds will be used to expand Phase II of best-in-class anti-BK Virus antibody to become the largest study ever conducted for BK virus infection in kidney transplantation Schlieren / Zurich, Switzerland, 7 May, 2024 – Memo Therapeutics AG (or “MTx”), a late-stage biotech company developing a best-in-class BKV-neutralizing antibody for BKV infection in kidney transplantation, today announces that it has successfully raised CHF 20 million as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45 million. The new funding will be used to bolster the clinical advancement of MTx’s lead asset, AntiBKV, expanding the Phase II trial with a dose evaluation extension to be the largest BK viremia therapeutic study ever conducted in kidney transplant recipients. The disease represents a potential market in excess of $1 billion and is caused by the BK virus, which can become reactivated in immunosuppressed kidney transplant patients leading to severe complications. Initial data from the Phase II trial is expected in the first half of 2025. The funding will further support the development of MTx’s pipeline by leveraging its B-cell screening platform to select best-in-class humanized antibodies in other viral infections and oncology. Erik van den Berg, CEO of Memo Therapeutics, commented: “This financing provides further external endorsement of the potential of our highly potent anti-BK virus mAb and our clinical strategy to bring it to patients as quickly as possible. There are more than 100,000 kidney transplants worldwide each year and 20,000 of these are at risk from developing BK virus associated nephropathy. With no disease modifying therapies available, there is an urgent need for a treatment. With FDA fast track status already obtained for the product, we look forward to rapidly progressing the development of AntiBKV.” New investors Ysios Capital and Kurma Partners participated in the extension round, joining existing Series C round investors including Pureos Bioventures, Swisscanto, Vesalius Biocapital, Adjuvant Capital, Verve Ventures, Schroders Capital, GF Group, Fresenius Medical Care Ventures and Red Alpine. Thomas Harth, Principal at Ysios Capital stated: “We believe Memo Therapeutics has developed a very powerful antibody that can address the growing concern of BKV infections in kidney transplant recipients. By being able to preserve the kidney and ensure graft outcome, this antibody could offer a tremendous benefit to patients. Deriving antibodies in screening of the B-cell repertoire offers a route to best-in-class antibody medicines for multiple diseases. We believe MTx has one of the best engines to do so within the industry. We are encouraged to support MTx in its mission to address the unmet medical need of BK viremia and beyond. MTx fits strongly with the investment strategy at Ysios to support breakthrough medicines.” Hadrien Bouchez, Partner at Kurma Partners added: “MTx has an exceptional leadership team with a proven track record of success. We are very excited to support the development of AntiBKV, an agent which has a unique efficacy and safety profile. Our investment underscores our commitment to supporting companies that are poised to make a significant impact on global healthcare.” Thomas Harth, Principal at Ysios Capital and Hadrien Bouchez, Partner at Kurma Partners will join the Memo Therapeutics Board of Directors. Alongside AntiBKV, Memo Therapeutics is developing a panel of pre-clinical assets in cancer and viral infections. These are based on the ability of MTx’s antibody discovery platform DROPZYLLA®, to interrogate the antibodyomes of elite controllers of infection and cancer. -Ends- Contacts Memo Therapeutics AG info@memo-therapeutics.com ICR ConsiliumAmber Fennell, Ashley Tappmemotx@consilium-comms.com+44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG (“MTx”) is a late-stage biotech company developing best-in-class therapeutic antibodies to transform the lives of patients with viral infections and cancer. MTx’s lead program, AntiBKV, is a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients. This infection can lead to nephropathy, loss of kidney function, as well as organ failure and rejection. MTx’s pipeline consists of additional candidate therapeutic antibodies focusing on infectious diseases, such as cytomegalovirus (“CMV”), immuno-oncology targets alone and in partnership with Ono Pharmaceutical. MTx is a private company located in Schlieren / Zurich, Switzerland. About BK VirusBKV infection occurs mostly in childhood and remains dormant in healthy individuals. However, BKV infection poses a significant threat following kidney transplantation, with serious adverse effects on graft function, kidney failure and ultimately patient survival. Due to the immunosuppressive drug regimen transplant patients receive, reactivation of BKV is triggered in approx. 40% of kidney transplant recipients, with 20% experiencing systemic virologically exposure. Up to 10% then progress to BKV associated nephropathy, which is the leading cause of graft loss. There is currently no disease modifying therapy available to treat BKV infection; it can only be addressed by lowering immunosuppression. However, this significantly increases the risk of a graft rejection reaction, also leading to impaired functionality and longevity, or graft failure. About Ysios Capital Ysios Capital is a leading Spanish venture capital firm that provides private equity financing to early- and mid-stage, highly innovative life science companies bringing life-changing treatments to patients, with a focus on indications with high unmet need. They have a diverse international team in San Sebastián and Barcelona, driven by science, with the ambition to transform capital into medical breakthroughs. Ysios Capital was founded in 2008 and has over $450 million in assets under management through its three funds. About Kurma Partners Kurma Partners is a key European player in the financing of innovation in Healthcare and Biotechnology, from pre-seed to growth capital, in particular through its funds Kurma Biofund I, II, III, IV, Kurma Growth, Kurma Diagnostics and Kurma Diagnostics 2, as well as the links the company has forged with a network of prestigious research institutes and hospitals. Kurma Partners was founded in July 2009 and is based in Paris and in Munich.