{"id":39411,"date":"2026-09-22T12:14:19","date_gmt":"2026-09-22T12:14:19","guid":{"rendered":"https:\/\/itbusinesstoday.com\/?p=39411"},"modified":"2026-09-22T12:14:19","modified_gmt":"2026-09-22T12:14:19","slug":"pharming-reports-positive-phase-ii-data-for-leniolisib","status":"publish","type":"post","link":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/pharming-reports-positive-phase-ii-data-for-leniolisib\/","title":{"rendered":"\u30d5\u30a1\u30fc\u30df\u30f3\u30b0\u3001\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u306e\u7b2cII\u76f8\u8a66\u9a13\u3067\u826f\u597d\u306a\u30c7\u30fc\u30bf\u3092\u5831\u544a"},"content":{"rendered":"

Pharming Group announced data from a Phase II clinical trial that assessed leniolisib in patients with genetically identifiable primary immunodeficiencies (PIDs) that show immune dysregulation. The Dutch biotechnology company said the data have been accepted as a late‑breaking abstract for presentation at the 22nd Biennial Meeting of the European Society for Immunodeficiencies (ESID). The meeting will take place on October 14–17 2026 in the Netherlands.<\/p>

This development expands the investigation of leniolisib beyond activated phosphoinositide 3‑kinase delta syndrome (APDS) the immune disorder for which leniolisib is already approved in several markets, including Japan.<\/p>

APDS\u3092\u8d85\u3048\u3066\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u3092\u62e1\u5927\u3059\u308b<\/h3>

Leniolisib is a PI3Kδ inhibitor designed to modulate a signaling pathway that is involved in immune‑cell function. Pharming is studying whether leniolisib can address dysregulation in a group of genetically identifiable PIDs.<\/p>

The Phase II program includes conditions that are associated with altered PI3Kδ signaling, such as ALPS‑FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency and PTEN deficiency. Pharming previously described these conditions as having a patient population than APDS.<\/p>

\u540c\u793e\u306f\u3001PID\u306b\u304a\u3051\u308b\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u3092\u8a55\u4fa1\u3059\u308b2\u3064\u306e\u7b2cII\u76f8\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3066\u3044\u308b\u30021\u3064\u306e\u8a66\u9a13\u306f\u7279\u5b9a\u53ef\u80fd\u306a\u514d\u75ab\u8abf\u7bc0\u7570\u5e38\u3092\u5bfe\u8c61\u3068\u3057\u3066\u304a\u308a\u3001\u3082\u30461\u3064\u306f\u6c4e\u5909\u7570\u578b\u514d\u75ab\u4e0d\u5168\u75c7\uff08CVID\uff09\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u308b\u3002\u4e21\u8a66\u9a13\u306e\u88ab\u9a13\u8005\u767b\u9332\u306f\u5b8c\u4e86\u3057\u305f\u30022026\u5e74\u5ea6\u306e\u56db\u534a\u671f\u4e2d\u306b\u7d50\u679c\u304c\u516c\u8868\u3055\u308c\u308b\u898b\u8fbc\u307f\u3060\u3002.<\/p>

\u4eca\u56de\u306e\u767a\u8868\u3067\u306f\u3001\u907a\u4f1d\u5b50\u7684\u306b\u7279\u5b9a\u53ef\u80fd\u306aPID\u7814\u7a76\u306b\u95a2\u3059\u308b\u6700\u65b0\u60c5\u5831\u304c\u63d0\u4f9b\u3055\u308c\u305f\u3002\u8a73\u7d30\u306a\u8abf\u67fb\u7d50\u679c\u306f\u3001\u767a\u8868\u306e\u4e2d\u3067\u660e\u3089\u304b\u306b\u3055\u308c\u308b\u898b\u8fbc\u307f\u3060\u3002.<\/p>

\u5e0c\u5c11\u75be\u60a3\u6cbb\u7642\u85ac\u306e\u958b\u767a\u306b\u304a\u3044\u3066\u3001\u306a\u305c\u3053\u306e\u7d50\u679c\u304c\u91cd\u8981\u306a\u306e\u304b<\/h3>

\u5e0c\u5c11\u75be\u60a3\u306f\u901a\u5e38\u3001\u3054\u304f\u5c11\u6570\u306e\u60a3\u8005\u306b\u767a\u75c7\u3057\u3001\u907a\u4f1d\u7684\u8981\u56e0\u3084\u75c7\u72b6\u306e\u73fe\u308c\u65b9\u306b\u5927\u304d\u306a\u9055\u3044\u304c\u898b\u3089\u308c\u308b\u3053\u3068\u304c\u3042\u308b\u3002\u3053\u3046\u3057\u305f\u75be\u60a3\u306e\u6cbb\u7642\u85ac\u3092\u958b\u767a\u3059\u308b\u306b\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u75be\u60a3\u3092\u7d50\u3073\u3064\u3051\u308b\u751f\u7269\u5b66\u7684\u7d4c\u8def\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>

The PI3Kδ pathway is one of those targets. By looking at leniolisib in PIDs that have immune dysregulation Pharming is checking if a therapy that works for APDS can also help other similar disorders.<\/p>

\u4eca\u56de\u306e\u65b0\u305f\u306a\u7d50\u679c\u306b\u3088\u3063\u3066\u3001\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u304c\u3053\u3046\u3057\u305f\u3088\u308a\u5e83\u7bc4\u306a\u9069\u5fdc\u75c7\u306b\u3064\u3044\u3066\u627f\u8a8d\u3055\u308c\u305f\u85ac\u3068\u306a\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002\u30d5\u30a1\u30fc\u30de\u30ea\u30f3\u30b0\u793e\u306f\u3001APDS\u4ee5\u5916\u306e\u8abf\u7bc0\u7570\u5e38\u3092\u4f34\u3046PID\u306b\u5bfe\u3057\u3066\u3001\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u304c\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u306f\u73fe\u6642\u70b9\u3067\u306f\u4e0d\u660e\u3067\u3042\u308b\u3068\u8ff0\u3079\u3066\u3044\u308b\u3002.<\/p>

\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u3092\u3088\u308a\u5e83\u304f\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u691c\u8a0e\u3059\u308b\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3084\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u5be9\u67fb\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002.<\/p>

\u7cbe\u5bc6\u533b\u7642\u306e\u91cd\u8981\u6027\u306e\u9ad8\u307e\u308a<\/h3>

\u3053\u306e\u7814\u7a76\u306f\u3001\u75c5\u6c17\u306e\u6cbb\u7642\u306b\u304a\u3044\u3066\u907a\u4f1d\u5b50\u8a3a\u65ad\u304c\u3044\u304b\u306b\u91cd\u8981\u3067\u3042\u308b\u304b\u3082\u793a\u3057\u3066\u3044\u308b\u3002PID\u306b\u304a\u3051\u308b\u5909\u5316\u3092\u7279\u5b9a\u3067\u304d\u308c\u3070\u3001\u514d\u75ab\u7cfb\u304c\u3069\u306e\u3088\u3046\u306b\u5909\u5316\u3057\u3066\u3044\u308b\u304b\u3092\u628a\u63e1\u3067\u304d\u308b\u3002\u305d\u308c\u306b\u3088\u308a\u3001\u79d1\u5b66\u8005\u306f\u75c7\u72b6\u3060\u3051\u3067\u306a\u304f\u3001\u751f\u7269\u5b66\u7684\u30e1\u30ab\u30cb\u30ba\u30e0\u306b\u57fa\u3065\u3044\u305f\u6cbb\u7642\u6cd5\u3092\u691c\u8a0e\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308b\u3002.<\/p>

\u3053\u306e\u624b\u6cd5\u306f\u3001\u7cbe\u5bc6\u533b\u7642\u306b\u304a\u3044\u3066\u307e\u3059\u307e\u3059\u91cd\u8981\u306b\u306a\u3063\u3066\u304d\u3066\u3044\u308b\u3002\u907a\u4f1d\u5b50\u691c\u67fb\u3001\u5206\u5b50\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3001\u60a3\u8005\u8a18\u9332\u306f\u3001\u6a19\u7684\u7642\u6cd5\u306b\u3088\u3063\u3066\u75c7\u72b6\u306e\u6539\u5584\u304c\u898b\u8fbc\u307e\u308c\u308b\u60a3\u8005\u7fa4\u3092\u7814\u7a76\u8005\u304c\u7279\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002.<\/p>

For drug makers this means they need skills in genomics, biomarker work, managing trial data and smart data analysis. Linking a patient’s genetics to how they respond to treatment is also vital when planning studies for diseases, with few patients.<\/p>

Implications for Japan’s Biotech Sector<\/h3>

\u3053\u306e\u958b\u767a\u306f\u3001\u7279\u306b\u65e5\u672c\u304c\u75be\u60a3\u3084\u7cbe\u5bc6\u533b\u7642\u3078\u306e\u53d6\u308a\u7d44\u307f\u3092\u62e1\u5927\u3057\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u3001\u540c\u56fd\u306e\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u304a\u3088\u3073\u30d8\u30eb\u30b9\u30b1\u30a2\u6280\u8853\u5206\u91ce\u306b\u3068\u3063\u3066\u91cd\u8981\u3060\u3002.<\/p>

Pharming has already received approval for Joenja, the brand name for leniolisib for the treatment of APDS in patients aged 4 years and older. The company describes it as a targeted treatment for APDS with its mechanism centered on PI3Kδ signaling.<\/p>

\u3057\u305f\u304c\u3063\u3066\u3001\u540c\u3058\u6cbb\u7642\u30e1\u30ab\u30cb\u30ba\u30e0\u304c\u6700\u7d42\u7684\u306b\u514d\u75ab\u75be\u60a3\u306b\u3082\u95a2\u9023\u3092\u6301\u3064\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u89e3\u660e\u3059\u308b\u7814\u7a76\u304c\u9032\u3081\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u304b\u3089\u3001\u3053\u306e\u3088\u308a\u5e83\u7bc4\u306a\u7b2cII\u76f8\u8a66\u9a13\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u3001\u65e5\u672c\u3067\u3082\u6ce8\u8996\u3055\u308c\u308b\u3053\u3068\u306b\u306a\u308b\u3060\u308d\u3046\u3002.<\/p>

\u88fd\u85ac\u4f1a\u793e\u3001\u5927\u5b66\u3001\u8a3a\u65ad\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u8005\u306b\u3068\u3063\u3066\u3001\u4eca\u56de\u306e\u9032\u5c55\u306f\u3001\u907a\u4f1d\u5b50\u691c\u67fb\u3068\u6a19\u7684\u3092\u7d5e\u3063\u305f\u533b\u85ac\u54c1\u958b\u767a\u3092\u7d44\u307f\u5408\u308f\u305b\u308b\u3053\u3068\u306e\u6f5c\u5728\u7684\u306a\u4fa1\u5024\u3092\u793a\u3057\u3066\u3044\u308b\u3002\u307e\u305f\u3001\u5e0c\u5c11\u75be\u60a3\u306e\u7814\u7a76\u306b\u304a\u3044\u3066\u3001\u5c02\u9580\u7684\u306a\u81e8\u5e8a\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u3084\u30c7\u30fc\u30bf\u30a4\u30f3\u30d5\u30e9\u3092\u6574\u5099\u3059\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u6539\u3081\u3066\u6d6e\u304d\u5f6b\u308a\u306b\u3057\u3066\u3044\u308b\u3002.<\/p>

AI\u3068\u30c7\u30fc\u30bf\u304c\u6b21\u306e\u6bb5\u968e\u3092\u652f\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/h3>

\u5e0c\u5c11\u75be\u60a3\u306e\u7814\u7a76\u304c\u30c7\u30fc\u30bf\u96c6\u7d04\u578b\u306b\u306a\u3063\u3066\u3044\u304f\u306b\u3064\u308c\u3001AI\u3084\u30b2\u30ce\u30e0\u89e3\u6790\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3068\u3044\u3063\u305f\u6280\u8853\u304c\u3001\u9069\u683c\u306a\u60a3\u8005\u306e\u7279\u5b9a\u3084\u6cbb\u7642\u53cd\u5fdc\u306e\u5206\u6790\u306b\u304a\u3044\u3066\u3001\u3088\u308a\u5927\u304d\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u3088\u3046\u306b\u306a\u308b\u3060\u308d\u3046\u3002.<\/p>

For diseases affecting populations finding suitable trial participants can be particularly challenging. Digital patient registries, genetic databases and clinical decision‑support systems could help researchers identify patients whose biological characteristics match research programs.<\/p>

\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\uff1a 4\u4eba\u306e\u65e5\u672c\u4eba\u7814\u7a76\u8005\u304c\u3001\u533b\u7642\u9769\u65b0\u5206\u91ce\u306e\u30e9\u30b9\u30ab\u30fc\u8cde\u3092\u53d7\u8cde\u3057\u305f<\/a><\/h4>

AI\u306f\u3001\u30b2\u30ce\u30e0\u30c7\u30fc\u30bf\u3084\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u5206\u6790\u3092\u652f\u63f4\u3059\u308b\u3053\u3068\u3082\u53ef\u80fd\u3060\u304c\u3001\u3053\u3046\u3057\u305f\u6280\u8853\u3092\u5275\u85ac\u306b\u6d3b\u7528\u3059\u308b\u969b\u306b\u306f\u3001\u81e8\u5e8a\u7684\u691c\u8a3c\u3068\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u76e3\u7763\u304c\u4f9d\u7136\u3068\u3057\u3066\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002.<\/p>

Pharmings<\/a> \u3057\u305f\u304c\u3063\u3066\u3001\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u306e\u6700\u65b0\u306e\u9032\u6357\u72b6\u6cc1\u306f\u3001\u5358\u4e00\u306e\u5e0c\u5c11\u75be\u60a3\u30d7\u30ed\u30b0\u30e9\u30e0\u306e\u9032\u5c55\u306b\u3068\u3069\u307e\u3089\u306a\u3044\u3002\u3053\u308c\u306f\u3001\u4f5c\u7528\u6a5f\u5e8f\u306b\u57fa\u3065\u304f\u6cbb\u7642\u3001\u907a\u4f1d\u5b66\u7684\u60a3\u8005\u9078\u5b9a\u3001\u305d\u3057\u3066\u7cbe\u5bc6\u533b\u7642\u3078\u3068\u5411\u304b\u3046\u88fd\u85ac\u696d\u754c\u306e\u8ee2\u63db\u3092\u5982\u5b9f\u306b\u793a\u3057\u3066\u3044\u308b\u3002.<\/p>

ESID 2026\u3067\u767a\u8868\u3055\u308c\u308b\u7b2cII\u76f8\u8a66\u9a13\u306e\u8a73\u7d30\u306a\u7d50\u679c\u306f\u3001\u81e8\u5e8a\u7d50\u679c\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3082\u306e\u3060\u3002\u3055\u3089\u306a\u308b\u30c7\u30fc\u30bf\u53ce\u96c6\u3068\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u8a55\u4fa1\u304c\u5b8c\u4e86\u3059\u308b\u307e\u3067\u306f\u3001\u3053\u308c\u3089\u306e\u539f\u767a\u6027\u514d\u75ab\u4e0d\u5168\u75c7\uff08PID\uff09\u306b\u304a\u3051\u308b\u30ec\u30cb\u30aa\u30ea\u30b7\u30d6\u306e\u6f5c\u5728\u7684\u306a\u4f7f\u7528\u306f\u3001\u78ba\u7acb\u3055\u308c\u305f\u6cbb\u7642\u9069\u5fdc\u3067\u306f\u306a\u304f\u3001\u3042\u304f\u307e\u3067\u81e8\u5e8a\u7814\u7a76\u306e\u6bb5\u968e\u306b\u3068\u3069\u307e\u308b\u3002.<\/p>","protected":false},"excerpt":{"rendered":"

Pharming Group announced data from a Phase II clinical trial that assessed leniolisib in patients with genetically identifiable primary immunodeficiencies (PIDs) that show immune dysregulation. The Dutch biotechnology company said the data have been accepted as a late‑breaking abstract for presentation at the 22nd Biennial Meeting of the European Society for Immunodeficiencies (ESID). The meeting will take place on October 14–17 2026 in the Netherlands.This development expands the investigation of leniolisib beyond activated phosphoinositide 3‑kinase delta syndrome (APDS) the immune disorder for which leniolisib is already approved in several markets, including Japan.Expanding Leniolisib Beyond APDSLeniolisib is a PI3Kδ inhibitor designed to modulate a signaling pathway that is involved in immune‑cell […]<\/p>\n","protected":false},"author":7,"featured_media":39427,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"wprm-recipe-roundup-name":"","wprm-recipe-roundup-description":"","postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[89,8098,182],"tags":[136,15761,15764,15763,15762],"ppma_author":[572],"class_list":["post-39411","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-tech","category-news-articles","category-pharma","tag-drug-development","tag-genomic-analysis","tag-leniolisib","tag-pharming","tag-primary-immunodeficiencies"],"yoast_head":"\nPharming Shares Positive Phase II Leniolisib Data<\/title>\n<meta name=\"description\" content=\"Pharming announces positive Phase II results for leniolisib, including improvements in measures of immune dysregulation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/pharming-reports-positive-phase-ii-data-for-leniolisib\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharming Shares Positive Phase II Leniolisib Data\" \/>\n<meta property=\"og:description\" content=\"Pharming announces positive Phase II results for leniolisib, including improvements in measures of immune dysregulation.\" \/>\n<meta property=\"og:url\" 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