Version 22 of the AIRR Community Governance document has passed our internal review and the community feedback process and is now ready for formal ratification by the AIRR Community. A brief summary of the changes to the governance document are outlined in the V20 – V22 comparison document for your reference. AIRR Community Members are invited to login to the Members-only section of the AIRR-C website to access these documents, and then complete the voting survey on the Voting Page. For questions, please contact info@airr-community.org. Please vote today!
On AIRR Podcast Episode 15 Now Available!
In the latest episode of the On AIRR – An AIRR-C Podcast Series, Dr. Ulrik Stervbo and Dr. Zhaoqing Ding speak with Dr. Corey Watson and Dr. William Lees about the recent work by the Germline Database Working Group of the AIRR-Community. We discuss the challenges in creating a database to hold all relevant and potentially relevant germline information, especially in the light of increased discovery rate through technological advances and improved analysis pipelines. We also reflect on the complexity in handling personalized germline reference sets.
You can subscribe and listen in your favorite podcasting app or check out all of the On AIRR episodes here at http://onairr.airr-community.org or on the AIRR YT Channel. If you share podcast-related content in social media, please remember to use the hashtag #onairr!
Join us for the next AIRR-C webinar on Nov 7th!
Drs. Encarnita Mariotti-Ferrandiz and Nina Luning Prak, members of the Adaptive Immune Receptor Repertoire (AIRR) Community Biological Resources Working Group, will describe quality control (QC) procedures for immune repertoire profiling. Dr. Mariotti-Ferrandiz will describe QC pipelines for sequencing of T cell receptor gene rearrangements that are in use in her laboratory in the Department of Immunology, Immunopathology and Immunotherapy at the Sorbonne. Next, Dr. Luning Prak will describe QC pipelines for sequencing of B cell receptor gene rearrangements that are in use in her laboratory and in the Human Immunology Core facility at the University of Pennsylvania. They will then focus on frequently asked questions and respond to other questions posed by attendees during a Q&A period.
Registration is open. Visit the AIRR Community Webinar Series website to learn more about this series, and access the recordings of past sessions.
FDA approves Omvoh™ (mirikizumab-mrkz)
On October 26, 2023, Eli Lilly and Company announced that the U.S. Food and Drug Administration approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment.
Mirikizumab (LY3074828) is a humanized IgG4ҡ monoclonal antibody that blocks the activity of interleukin 23 by targeting the p19 subunit the cytokine. The antibody is engineered with the following mutations: S228P for hinge stabilization, F234A and L235A to abrogate effector function, and K447> del to reduce IgG4 C-terminal heterogeneity.
The recommended induction dosage is 300 mg administered by intravenous infusion over at least 30 minutes at Weeks 0, 4, and 8. The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter. Lilly received approval for Omvoh in Japan and the European Union earlier in 2023.
FDA approves LOQTORZI™ (toripalimab-tpzi)
On October 27, 2023, Coherus BioSciences, Inc. and Shanghai Junshi Biosciences Co., Ltd. announced that the U.S. Food and Drug Administration approved LOQTORZI™ (toripalimab-tpzi) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
Toripalimab (marketed as Tuoyi® in China) is an IgG4k anti-PD-1 monoclonal antibody developed by Shanghai Junshi Bioscience Co., Ltd. Coherus partnered with the company to co-develop toripalimab, with Coherus responsible for the development and commercialization of toripalimab in the US and Canada. In 2018, toripalimab became the first anti-PD1 approved in China, and the product is now approved there for multiple types of cancer.
Toripalimab was granted Orphan Drug designations by the FDA for the treatment of NPC, mucosal melanoma, soft tissue sarcoma, esophageal cancer, and SCLC. FDA also granted Breakthrough Therapy designation to toripalimab for the treatment of recurrent or metastatic NPC with disease progression on or after platinum-containing chemotherapy and in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC.
FDA’s approval was based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study and is irrespective of a patient’s PD-L1 status. The recommended LOQTORZI dose with cisplatin and gemcitabine is 240 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months. The recommended LOQTORZI dose as a single agent for previously treated NPC is 3 mg/kg every two weeks until disease progression or unacceptable toxicity.
The Phase 3 JUPITER-02 (NCT03581786) study included patients with recurrent or metastatic NPC and no previous chemotherapy for recurrent or metastatic disease. Patients (n=289) were randomized (1:1) to receive either toripalimab (240 mg) or placebo in combination with gemcitabine-cisplatin therapy every 3 weeks for up to six cycles, followed by monotherapy with toripalimab or placebo. The primary endpoint was PFS as assessed by a blinded independent review committee according to RECIST v.1.1. The combination of toripalimab and gemcitabine-cisplatin improved the median progression-free survival compared to the chemotherapy arm (11.7 vs 8 months, respectively), the overall response rate (77.4% vs. 66.4% (P = 0.033), respectively) and the median duration of response (10.0 vs. 5.7 months, respectively).
In the POLARIS-02 clinical study, LOQTORZI demonstrated durable antitumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate (ORR) of 20.5%, a disease control rate (DCR) of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.
