Imlifidase

Hansa Biopharma’s phase 3 study evaluated kidney function over a year in highly sensitized patients who received either imlifidase prior to their transplant or a range of control treatment options. With a late-stage win in hand, Sweden’s Hansa Biopharma is one step closer to bringing its kidney transplant drug to the U.S.Thursday, the company reported positive top-line results from a U.S. phase 3 trial of its antibody-cleaving enzyme imlifidase, which boasts conditional nods in the EU and several other countries to ease the kidney transplant process for certain patients with end-stage renal disease.Kidney transplantation is preferred over dialysis for patients in that stage of disease, but the waitlist for an organ match in the U.S. is long and growing each year, executives at Hansa said on a call with analysts Thursday. Additionally, highly sensitized patients have even more difficulty finding a kidney match, due to their bodies producing high levels of antibodies that are meant to attack foreign tissues.In turn, Hansa has developed imlifidase to rapidly cleave Immunoglobulin G (IgG) antibodies and inhibit their activity within hours, theorizing that the suppressed IgG activity might prevent those patients’ bodies from fighting back against a donor organ.Hansa’s phase 3 study evaluated kidney function over a year in highly sensitized patients who received either imlifidase prior to their transplant or a range of control treatment options. The efficacy of Hansa’s candidate was assessed using the estimated glomerular filtration rate (eGFR) measure, the company’s chief medical officer, Richard Philipson, M.D., said on Thursday’s call.Those in the control arm received care options such as remaining on dialysis while awaiting a more compatible organ offer, transplantation using off-label desensitization approaches or transplantation with a compatible organ, Hansa noted in a press release.The U.S. trial included a total of 64 participants, split evenly between those receiving imlifidase and a control treatment, Philipson explained.Patients on imlifidase achieved statistically significant improvements in kidney function on the eGFR measure at the trial’s 12-month mark, satisfying the study’s primary endpoint.Hansa’s drug was well tolerated and yielded a low incidence of infusion reactions, Philipson said. Other side effects tracked with the kidney transplant population more broadly and were generally considered unrelated to imlifidase, according to the CMO.  Hansa aims to seek an accelerated review of imlifidase at the FDA by the end of the year, the company’s chief executive, Renée Aguiar-Lucander, said Thursday. If all goes to plan, the company could expect to see a U.S. approval decision on its drug in the third quarter of 2026, she said. Laying out the opportunity for a drug like imlifidase in the U.S., Hansa’s chief operating officer and U.S. chief, Maria Törnsén, noted that “[t]he unmet needs in the U.S. kidney transplant market are significant.” The highly sensitized patients Hansa is targeting make up about 10% to 15% of the roughly 100,000 people on the U.S. kidney transplant list, she added.As Hansa eyes a potential launch, the company is focusing its attention on the roughly 200 centers offering kidney transplants around the U.S. Meanwhile, the company has already worked with about 25% of the U.S. transplant market through its clinical trials, providing a strong base to debut imlifidase in the event of an FDA approval, Törnsén said.As Hansa gets closer to a potential launch, the company also plans to recruit a field team of about 20 account managers, the COO added.“We are very confident that we have the right professionalization strategy in place to enable a successful launch in the U.S., assuming FDA approval,” she said.

An immune antibody-cleaving drug from Hansa Biopharma could soon make it easier for some patients to get kidney transplants in the US. The Swedish biotech reported Wednesday that its drug imlifidase delivered in a Phase 3 US study for highly sensitized adult kidney transplant patients. These are patients who have antibodies that react to certain proteins from most donor kidneys, which means that they likely need to wait longer for a match or often face challenges finding one. Imlifidase is an enzyme that cleaves IgG antibodies, which are immune antibodies that are meant to fight foreign invaders. In this case, the hope is that culling them could stop the immune system from attacking the newly transplanted organ. At one year, kidney transplant patients who received imlifidase had significantly better results on a blood test for kidney function compared to those in the control group. Imlifidase has conditional approval to treat highly sensitized adult kidney transplant patients in the EU and other countries, where it is marketed as Idefirix. Now, Hansa will be seeking accelerated approval in the US using the results from the late-stage trial. “The chances of them getting a natural cross-match is obviously there, but still quite elusive for a lot of these patients,” Hansa CEO Renée Aguiar-Lucander said. “Having a procedure that can actually give some consistency, predictability of an outcome — where you can use organs that previously have not really been able to be allocated to this patient population — it’s actually quite a breakthrough solution,” Aguiar-Lucander added. She joined Hansa in April as its new CEO after she sold her previous company Calliditas, where she was CEO for seven years, to Japan’s Asahi Kasei for over $1 billion. Hansa’s stock price is up by as much as 25% on the Stockholm exchange on Thursday. The Phase 3 study compared a measure of kidney function called eGFR in patients who received a kidney transplant with imlifidase and those who received one using each institution’s specific desensitization protocol, according to a federal clinical trials database. For patients in the control arm, if the desensitization protocol isn’t successful, then the kidney would be turned down. Aguiar-Lucander noted that as a result, the number of patients in the control arm who accepted a kidney transplant at randomization was lower than in the imlifidase arm. Hansa reported that the mean eGFR was 51.5 in the imlifidase arm versus 19.3 in the control arm, where a higher number indicates better kidney function. (eGFR measures are reported in mL/min/1.73m2.) The p-value was <0.0001. The company also said imlifidase was “generally well-tolerated,” and that full results of the late-stage trial would be shared at a medical meeting next year. Hansa plans to submit an application at the end of the year to ask the FDA for accelerated approval of imlifidase based on the trial outcomes. Aguiar-Lucander said it’s estimated that about 10% to 15% of the patients on the waitlist are highly sensitized. In the US, there are around 90,000 people waiting for a kidney, according to UNOS . Unlike the class of IgG antibody-recycling drugs being developed primarily for autoimmune diseases, such as argenx’s Vyvgart, imlifidase works more rapidly in cleaving the antibodies and with a more potent effect. Aside from kidney transplantation, Hansa is also studying imlifidase to help more patients receive gene therapy. There, it’s looking at imlifidase in patients who’ve developed antibodies against the viral delivery packages for the gene therapies. Hansa is partnered with Sarepta Therapeutics, the maker of the Duchenne muscular dystrophy gene therapy Elevidys. However, the study of Elevidys and imlifidase is one of several paused in Europe after Sarepta reported the first patient death following its gene therapy. The biotech also expects to report data next month on imlifidase being used alongside a gene therapy developed by Genethon for a rare disease called Crigler-Najjar syndrome.