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Equillium announced that an abstract was accepted for oral presentation at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy, ASTCT, and the Center for International Blood & Marrow Transplant Research, CIBMTR. The Hybrid meetings will take place virtually and in person at the Orlando World Center Marriott, Orlando, Florida, February 15 - 19, 2023. The abstract highlights positive final study results, including long-term follow-up data for up to one year, from EQUATE, a Phase 1b study of itolizumab in combination with corticosteroids to treat subjects with newly diagnosed severe acute graft-versus-host disease. The data demonstrate promising outcomes in subjects with severe aGVHD, and Equillium has since initiated EQUATOR, a Phase 3 study of itolizumab as a potential initial therapy for aGVHD in combination with CS.

Equillium (EQ) and Metacrine (MTCR) announced the mutual termination of their previously announced definitive merger agreement. "Equillium first set out to acquire Metacrine in an all-stock transaction in early 2022, with the intent of adding cash runway in a very difficult financing market," said Bruce Steel, CEO of Equillium. "However, our recent strategic partnership with Ono Pharmaceutical is expected to extend our cash runway into 2025, and possibly further with potential option exercise and milestone payments. We therefore find ourselves in a strong financial position, and with our pipeline of wholly-owned multi-cytokine inhibitors in the clinic we are excited about the opportunity to unlock value in our programs during 2023 and beyond."

Equillium announced that Biocon, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis, or UC. The Phase 2 double-blinded placebo-controlled clinical study is evaluating the safety and efficacy of itolizumab for biologics-naive patients with moderate to severe active UC, where patients are randomized 1:1:1 to receive a fixed dose of 140 mg of itolizumab, adalimumab, or placebo every two weeks for a 12-week treatment period, with adalimumab non-responders able to cross over to itolizumab. The study is expected to enroll up to 90 patients in multiple clinical trial sites in India. The trial design and initiation have been a collaborative effort, with help from the gastroenterologist community and leading global clinical and scientific experts in the field of inflammatory bowel disease, or IBD.

Braden Leonard's BML Investment Partners disclosed a 15.2% stake in Metracrine (MTCR), which represents over 6.4M shares. The filing with the SEC allows for activism. BML said it plans to vote against the company's proposed merger with Equillium (EQ) "unless the collar is adjusted to reflect the current Equillium share price."

Equillium and Ono Pharmaceutical announced an option and asset purchase agreement through which Ono gains the exclusive option to purchase Equillium's rights to itolizumab, a first-in-class monoclonal antibody targeting CD6. These rights include all therapeutic indications and the rights to commercialize itolizumab in the United States, Canada, Australia, and New Zealand. Under the terms of the agreement, Equillium will receive a non-refundable upfront payment of approximately $26M and will also be eligible to receive up to an aggregate of approximately $138.5M for exercise of the option and milestone payments from development through first commercial sale. Equillium will be responsible for the conduct of all research and development of itolizumab, which will be fully funded by Ono on a quarterly basis commencing July 1 through the option period. The option period will expire three months following delivery of topline data from the EQUALISE study in lupus nephritis and interim data from the EQUATOR Phase 3 study in acute GVHD.