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Celldex Therapeutics, Inc. reports developments as a clinical-stage biotechnology company focused on mast cell biology and antibody-based therapeutics for allergic, inflammatory, autoimmune and other mast cell-mediated diseases. Company updates center on barzolvolimab, a humanized monoclonal antibody being studied across chronic spontaneous urticaria, cold urticaria and symptomatic dermographism, as well as pipeline work that includes CDX-622 in asthma.
Recurring news themes include clinical data presentations at allergy and dermatology meetings, financial results, corporate updates and capital actions. Celldex also reports financing activity tied to its common stock and development priorities for its antibody-based immunology pipeline.
Celldex Therapeutics (NASDAQ:CLDX) announced preliminary results from its Phase 1 trial of CDX-527, a bispecific antibody targeting advanced malignancies. Presented at ASCO 2021, the data include 11 patients in dose escalation cohorts ranging from 0.03 to 3 mg/kg. Key findings show CDX-527 has a favorable safety profile, with no serious adverse events or dose-limiting toxicities. Notably, pharmacodynamic activity indicates immune system engagement. The trial continues with plans for higher dose cohorts and further evaluations in 2022.
Celldex Therapeutics (NASDAQ:CLDX) announced that the abstract detailing Phase 1b results of CDX-0159 for treating antihistamine refractory cold contact urticaria and symptomatic dermographism has been accepted for presentation at the EAACI Annual Congress 2021, scheduled for July 10-12, 2021. The late-breaking electronic Poster Discussion Session will include a pre-recorded presentation followed by a Q&A. Results will highlight disease activity reduction and treatment's effect on tryptase levels.
Celldex Therapeutics (NASDAQ:CLDX) announced participation in the Jefferies 2021 Virtual Healthcare Conference on June 2, 2021, at 1:30 p.m. ET. Senior management will engage in a fireside chat during the event. Interested parties can access the webcast through the Events & Presentations page on their website. A replay of the chat will be available for 30 days post-event.
Celldex Therapeutics (NASDAQ:CLDX) reported Q1 2021 financial results, highlighting positive interim data from the Phase 1b study of CDX-0159, which showed an 80% complete response rate in chronic inducible urticaria. The company is expanding the study to include cholinergic urticaria and plans to present more results this summer. Total revenue was $0.7 million, down from $2.7 million in the prior year, while R&D expenses increased to $12.7 million. Net loss for Q1 was $16.5 million, representing a loss of $0.42 per share. Celldex expects sufficient cash to fund operations through 2023.
Celldex Therapeutics (Nasdaq:CLDX) presented promising data on its bispecific platform at the AACR Annual Meeting 2021. The focus was on ILT4 inhibitory monoclonal antibodies for developing bispecific antibodies that counter myeloid cell suppression and activate T-cell responses. Preclinical studies demonstrated the efficacy of these antibodies in enhancing immune response against tumors. The company aims to advance bispecific candidates targeting ILT4 and PD-(L)1, with existing programs such as CDX-527 undergoing clinical trials.
Celldex Therapeutics (NASDAQ:CLDX) reported significant advances in their clinical pipeline during the fourth quarter and year ended December 31, 2020. The Phase 1b study of CDX-0159 in chronic inducible urticaria showed an 80% complete response rate, prompting an expansion to include cholinergic urticaria patients. Financial highlights included a net loss of $21.9 million for Q4 2020, though total revenue increased to $3.8 million, driven by milestone payments. The company maintains a robust cash position with $194.4 million to support operations through 2023.
Celldex Therapeutics (NASDAQ:CLDX) announced interim data from its clinical trial of CDX-0159, aimed at treating antihistamine refractory cold contact urticaria and symptomatic dermographism. Out of 10 patients assessed after treatment, 80% achieved a complete response, indicating a significant efficacy of the drug. CDX-0159 was generally well tolerated, with mild infusion reactions reported. Plans to expand the study to include cholinergic urticaria are underway, and upcoming results from related studies are anticipated.
Celldex Therapeutics (Nasdaq:CLDX) announced its participation in the H.C. Wainwright Global Life Sciences Conference, where a prerecorded fireside chat will be accessible to attendees starting March 9, 2021, at 7:00 a.m. ET. The presentation will be available via webcast on the company's website for fourteen days post-event. Celldex is focused on developing monoclonal and bispecific antibodies aimed at serious diseases, enhancing immune responses, and addressing areas with limited treatment options.
Celldex Therapeutics (Nasdaq: CLDX) announced an expansion of clinical development for CDX-0159 into prurigo nodularis (PN), a chronic skin condition causing intense itch and lesions. The drug, a humanized monoclonal antibody, shows promise by targeting the KIT receptor involved in mast cell activation. CDX-0159 has demonstrated significant plasma tryptase reduction in earlier trials. Celldex aims to initiate the PN study in Q4 2021, responding to a significant unmet medical need as there are currently no FDA-approved therapies for PN, potentially expanding into other itch-driven conditions.
Celldex Therapeutics (Nasdaq: CLDX) announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference on February 24, 2021, at 2:20 p.m. ET. A webcast will be accessible on the 'Events & Presentations' page of the company’s website, with a replay available for 14 days post-event.
Celldex is focused on developing monoclonal and bispecific antibodies to treat serious diseases, aiming to enhance the lives of patients suffering from inflammatory diseases and various cancers.