CD22

Octagon Therapeutics formed a research alliance with Novo Nordisk in 2022.\n Octagon Therapeutics has thrown in the towel. The Novo Nordisk-allied autoimmune disease biotech is winding down after deprioritizing its lead program and running into unresolved biology questions.Isaac Stoner, the co-founder and CEO of Octagon, disclosed the decision to close the biotech on LinkedIn Monday. Stoner said the action followed “the deprioritization of a lead B cell immunomodulator program and unresolved biology questions around a high-potential pipeline effort.”Octagon initially focused on developing antibiotics for multidrug-resistant infections but later shifted its attention to autoimmune and inflammatory diseases. The pivot was built on evidence that the biotech could suppress cells that cause autoimmune disease—without disrupting healthy immune activities—by restoring the activity of immune checkpoint receptors.  OCT50 was the most advanced manifestation of that idea. Octagon designed the molecule to suppress autoreactive B cells that drive autoimmune conditions such as lupus and multiple sclerosis by restoring the natural regulatory role of Siglec-2.  Octagon got as far as selecting a development candidate for the OCT50 program before calling it quits, according to the biotech’s public pipeline. The next most advanced asset was OCT102, which was back at the target validation stage. Octagon designed OCT102 to suppress secretion of inflammatory cytokines involved in certain inflammatory diseases by acting on an undisclosed checkpoint. The biotech raised $11 million last year, adding to the smaller sums it pulled in across earlier financings. Octagon formed a research alliance with Novo in 2022. The company took part in Novo’s Co-creation Greenhouse accelerator program, demonstrating its ability to discover therapeutic targets and landing a chance to collaborate with the Danish drugmaker on cardiometabolic diseases. 

Century Therapeutics has decided it\'s time to join a burgeoning trend, discarding a cancer trial to jump on the autoimmune bandwagon.\n Century Therapeutics has joined the onslaught of cell therapy biotechs taking hits, discontinuing a phase 1 cancer study to turn its focus toward autoimmune diseases.The move isn’t shocking, as it follows Century’s acquisition of autoimmune cell therapy biotech Clade Therapeutics last year and mirrors an industrywide pattern as numerous other companies turn from cancer to autoimmune.For Century, the change means ending a study of CNTY-101, the company’s first allogeneic cell therapy candidate that was being tested among patients with late-stage relapsed-refractory non-Hodgkin lymphoma, according to an annual financial report shared after market close March 19.The program, dubbed Elipse-1, launched in the beginning of 2023 and had an estimated enrollment of 75 patients, according to ClinicalTrials.gov. While Century called the therapy’s clinical activity and tolerability profile encouraging, the data didn’t meet the company’s standard to be considered “transformational” for the patient population, according to the release.The Philadelphia-based biotech said it was “committed to providing continued treatment access in the Elipse-1 trial for patients showing benefit.”Century is pointing to the Elipse-1 data as reason to move CNTY-101 into autoimmune diseases, citing deep B-cell depletion and evidence of the therapy trafficking to lymph nodes. The company plans to share more data from the trial later this year, it said in a statement.  The cell therapy company is now launching a new trial for its sole clinical asset, this time for patients with B-cell-mediated autoimmune diseases. The early-stage study, called Calipso-1, is slated to start dosing this month at U.S. sites, with plans to expand to certain European countries later this year.“We believe CNTY-101 is well-positioned to potentially impact the standard of care meaningfully in B-cell-mediated autoimmune diseases,” Century CEO Brent Pfeiffenberger said in the release.The company also expects further insights on the CD19 CAR-iNK cell therapy candidate to come from a phase 1/2 investigator-initiated clinical trial, dubbed Caramel.The study will be sponsored by the Friedrich-Alexander University Erlangen-Nürnberg in Germany and will enroll patients with systemic lupus erythematosus, lupus nephritis, idiopathic inflammatory myopathy and diffuse cutaneous systemic sclerosis. The study is expected to launch in mid-2025.Analysts with William Blair view the discontinuation as \"as unfortunate but necessary,\" citing a competitive treatment landscape for non-Hodgkin lymphoma in a March 20 note. Leerink Partners echoed the sentiment, citing a challenging financing environment for early-stage cell therapy companies. The analyst said it supported Century\'s decision to continue development of CNTY-101 in autoimmune diseases. Meanwhile, the biotech is prioritizing its preclinical pipeline to feature four programs, led by CNTY-308, a CD19-targeted CAR-iT cell therapy. The therapy is being developed for B-cell-mediated autoimmune diseases and malignancies.Another of Century’s candidates is CNTY-341, a CD19/CD22 dual-targeted CAR-iT cell therapy. The prioritized preclinical programs all use induced-pluripotent-stem-cell-derived “tunable” CD4+/CD8+ ab T cells, according to Century.“In the case of CNTY-308 and CNTY-341 in B-cell-mediated diseases, we are aiming for comparable or better performance to approved autologous CAR-T therapies,” Century Chief Scientific Officer Chad Cowan, Ph.D., said in the release. “With our combined expertise in protein engineering, cell differentiation and manufacturing, we aim to launch allogeneic cell therapies at antibody-like scale and cost. For our solid tumor and non-immune cell programs, this brings the potential to expand access to cell therapies much more broadly.”The company will host a live webcast April 22 to discuss each of the programs in more detail. The biotech’s pipeline pivot follows Bristol Myers Squibb’s own “portfolio prioritization efforts” that eliminated a pact with Century in December.Century had entered a collaboration with BMS back in 2022 in which the partners were working to develop stem-cell-derived, engineered natural killer cell and gamma delta T-cell candidates for blood cancers. The Big Pharma paid out $150 million in cash and an equity investment and offered up more than $3 billion in biobucks.After reviewing its own portfolio, BMS axed the entire deal “without cause,” a dissolution that became effective March 12.Century still lists two preclinical cancer candidates—named CNTY-104 and CNTY-106—that were being developed with BMS on its site.As of Dec. 31, 2024, Century had $220 million in cash and marketable securities, a runway expected to bring the biotech into the final quarter of 2026.  Editor\'s note: This story was updated at 10 a.m. ET on March 20 to include analyst commentary.

EMERYVILLE, CA, USA I February 21, 2025 I Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19-targeted ARTEMIS ® T-cell therapies to treat cancer and autoimmune diseases, today announced the successful completion of the first dose cohort in its ongoing STARLIGHT-1 Phase I/II clinical trial. Following a review of safety and efficacy data, the Data and Safety Monitoring Board (DSMB) has approved the initiation of the second dose cohort, which will administer 5 million receptor-positive T cells per kilogram of body weight of EB103 CD19-Redirected ARTEMIS ® T-cell therapy. The first dose cohort included patients with relapsed/refractory B-cell non-Hodgkin lymphoma (“NHL”) who have failed multiple prior lines of therapy. Preliminary data from this cohort demonstrated a favorable safety profile, with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs) observed. Additionally, tumor response, were noted in all patients at Month 1. The STARLIGHT-1 trial is an open-label, dose-escalation, multi-center study designed to evaluate the safety, tolerability, and preliminary efficacy of EB103 in adult patients with relapsed/refractory B-cell NHL. The trial follows a standard 3+3 dose-escalation design, with the goal of evaluating the safety profile, the pharmacokinetics of EB103 and determining the Recommended Phase II Dose (RP2D). “The safety and early efficacy data from the first dose cohort are encouraging. We look forward to evaluating the higher dose cohort to further understand the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell NHL.” said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma. About EB103 EB103, a T-cell therapy, also referred to as Estrella’s “CD19-Redirected ARTEMIS ® T-Cell Therapy,” utilizes ARTEMIS ® technology licensed from Eureka Therapeutics, Inc. (“Eureka”), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS ® T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them. About Estrella Immunopharma Estrella is a clinical-stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS ® T-cell therapies to treat cancers and autoimmune diseases. Estrella’s mission is to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer and other diseases. To accomplish this mission, Estrella’s lead product candidate, EB103, utilizes Eureka’s ARTEMIS ® technology to target CD19, a protein expressed on the surface of almost all B-cell leukemias and lymphomas. Estrella is also developing EB104, which also utilizes Eureka’s ARTEMIS ® technology to target not only CD19, but also CD22, a protein that, like CD19, is expressed on the surface of most B-cell malignancies. For more information about Estrella, please visit www.estrellabio.com . SOURCE: Estrella Immunopharma