Clinical-stage biopharmaceutical company Pandion Therapeutics Inc. (PAND:NASDAQ), which focuses on developing modular therapeutics for treating autoimmune and inflammatory diseases, today announced "positive top-line data from its Phase 1a single-dose, healthy volunteer clinical trial, demonstrating proof of mechanism of PT101, an engineered IL-2 mutein fused to a protein backbone, in development for ulcerative colitis (UC), systemic lupus erythematosus (SLE), and other autoimmune diseases."
Pandion Therapeutics stated that in the Phase 1b clinical trial "PT101 selectively expanded total regulatory T cells (Tregs), with a mean maximal increase up to of 3.6-fold over baseline and that a subset of activated Tregs with high CD25 expression, known as CD25 bright Tregs, expanded, with a mean maximal increase of up to 72.5-fold over baseline."
The company reported that PT101 was observed to be well tolerated in the Phase 1a clinical study and that no serious adverse events were observed and pointed out further that there was no evidence of expansion of natural killer T (NK) cells and pro-inflammatory conventional T (Tconv) at any dose studied.
Scott Snapper, M.D., Ph.D., chief of the Division of Gastroenterology, Hepatology and Nutrition and director of the Inflammatory Bowel Disease Center at Boston Children's Hospital and professor of medicine at Harvard Medical School, commented, "Native IL-2 has been the subject of several clinical trials across a range of autoimmune diseases due to its ability to activate a normal immune regulatory response and improve disease activity. However, its therapeutic use has been hampered by native IL-2's undesired activation of the pro-inflammatory side of the immune system...PT101's high selectivity for and expansion of Tregs could allow for a fulsome exploration of the potential of this mechanism in autoimmune diseases, and I look forward to seeing its continued clinical development by Pandion."
The firm advised that the Phase 1a randomized trial studied 56 healthy volunteers who were split into seven cohorts who each received a single doses of PT101 ranging from 1-10 mg or a placebo. Patients were observed for 28 days with the objective of assessing the potency and selectivity of PT101 in order to establish proof of mechanism. Pandion stated that at dosage levels of 3.5 mg and above it observed the expansion of both total Tregs and the CD25 bright Treg subset after 8-10 days. The company explained that PT101 maintained selectivity for regulatory T cells at all doses tested during the Phase 1a blind study.
Pandion Therapeutics' Chief Medical Officer John Sundy, M.D., Ph.D., remarked, "These data show PT101 meaningfully expanded regulatory T cells while maintaining a high degree of selectivity...We believe this combined potency and selectivity could provide meaningful clinical benefit for patients with many different autoimmune diseases. Therefore, following the completion of the regulatory process, we plan to initiate a Phase 1b/2a clinical trial in patients with UC in mid-2021 and a Phase 2 clinical trial in patients with SLE in H2/21."
Pandion Therapeutics is a clinical-stage biopharmaceutical company headquartered in Watertown,, Mass. The firm is engaged in creating novel innovative modular therapeutics to meet unmet needs of patients with autoimmune and inflammatory diseases. The company noted that its "TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform enables the company to create a pipeline of product candidates using immunomodulatory effector modules, with the ability to also combine an effector module with a tissue-targeted tether module in a bifunctional format."
The firm stated that PT101, its lead product candidate, is "a combination of an interleukin-2 mutein effector module with a protein backbone, is designed to selectively expand regulatory T cells systemically, without activating proinflammatory cells, such as conventional T cells and natural killer cells."
Pandion Therapeutics started the day with a market cap of around $438.4 million with approximately 29.5 million shares outstanding. PAND shares opened slightly lower today at $14.75 (-$0.10, -0.67%) compared to the previous trading day's $14.85 closing price. The stock has traded today between $14.75 and $21.99 per share and is currently trading at $20.12 (+$5.27 +35.49%).[NLINSERT]
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