Articles from Celldex Therapeutics, Inc.

HAMPTON, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that the Company has initiated a Phase 2 study of barzolvolimab in atopic dermatitis (AD) and that the study is actively enrolling patients. AD is one of the most common chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of life1. Mast cells are strongly implicated in all facets of AD pathophysiology and the fundamental processes that characterize AD, including epithelial barrier dysfunction, immune cell recruitment, neuroinflammation2 and multiple other mast cell-associated factors that correlate with disease severity. Activated mast cells are also found in increased numbers in lesional biopsies. Barzolvolimab is a humanized monoclonal antibody that specifically binds and blocks the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell.

HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation.

HAMPTON, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in fireside chats at two upcoming conferences:

HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024.

- 71% of patients (150 mg Q4W) achieved complete response at Week 52 -- Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks -- Robust improvement across omalizumab-experienced/refractory/naïve disease -- Well tolerated through 52 weeks -- Enrollment to Global Phase 3 CSU trials underway -- Company to host webcast today at 12:00 pm ET/6:00 pm CEST -

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Amsterdam on September 25-28, 2024.

HAMPTON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in fireside chats at two upcoming conferences:

HAMPTON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today reported financial results for the second quarter ended June 30, 2024 and provided a corporate update.

HAMPTON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today positive topline results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD.

- EMBARQ-CSU1 and EMBARQ-CSU 2 will enroll more than 1800 patients suffering from CSU -- Studies include both biologic naïve and experienced patients -

HAMPTON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 6th at 10:00 am ET. A webcast of the presentation will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

- Clinically meaningful and statistically significant improvements across multiple angioedema measurements and barzolvolimab dose groups -- Sustained activity with rapid onset within 2 weeks -- Data further support barzolvolimab clinical benefit to patients with CSU -

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. Mast cells are believed to play an important role in amplifying chronic itch and neuroinflammation, including in PN where mast cells are associated with pruritic sensory neurons in PN lesions.

- Phase 3 CSU studies expected to initiate in summer 2024 -- Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 -- Enrollment completed in Phase 2 CIndU study; 12 week data expected 2H 2024 -- Phase 2 PN study initiated; enrollment progressing in Phase 2 EoE study -- Atopic dermatitis selected as next indication; Phase 2 study to initiate by YE 2024 -

HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—temperatures below skin temperature in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. In February 2024, the Company presented positive 12 week primary endpoint results from its ongoing Phase 2 study of barzolvolimab in the most common form of chronic urticaria—chronic spontaneous urticaria (CSU).

HAMPTON, N.J., March 08, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the Leerink Partners Global Biopharma Conference on Monday, March 11, 2024 at 10:00 a.m. ET.

HAMPTON, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that Anthony S. Marucci, President and Chief Executive Officer will participate in an “Inflammation & Immunology Corporate Panel Discussion” at TD Cowen’s 44th Annual Health Care Conference. The panel will be held on Tuesday, March 5, 2024 from 2:10 to 3:10 PM ET.

HAMPTON, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the closing of its previously announced underwritten public offering of 9,798,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 1,278,000 shares of common stock at a public offering price of $47.00 per share. All of the shares sold in the offering were sold by Celldex. The gross proceeds to Celldex from this offering were approximately $460.5 million, excluding underwriting discounts and commissions and other offering-related expenses.

HAMPTON, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an upsized underwritten public offering of 8,520,000 shares of its common stock at a public offering price of $47.00 per share. All of the shares to be sold in the offering are to be sold by Celldex. In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 1,278,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $400.4 million, excluding underwriting discounts and commissions and other offering-related expenses. The offering is expected to close on or about March 5, 2024, subject to customary closing conditions.

HAMPTON, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, $250.0 million of shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of the shares of common stock are being offered by the Company. The final terms of the offering will depend on market and other conditions at the time of pricing, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

- Phase 3 CSU studies expected to initiate in summer 2024 -- Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 -- Enrollment nearing completion in Phase 2 CIndU study; Data expected 2H 2024 -- Phase 2 PN study expected to start in early 2024; Positive Phase 1 PN data reported in oral presentation at WCI 2023 -

- Primary and secondary endpoints met with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups -- Sustained activity with rapid onset within 2 weeks -- Similar improvement in omalizumab-experienced/refractory and omalizumab-naïve disease consistent with unique mechanism of action -- Favorable safety profile -- 52 week results and Phase 3 CSU trial initiations anticipated in 2024 -- Company to host webcast February 25th at 9:45 am ET-

HAMPTON, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that management will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 9:00 a.m. ET.

HAMPTON, N.J., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that an abstract describing 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2024 being held in Washington, DC on February 23-26, 2024. Abstracts will be available on the meeting website today, February 5, 2024.

HAMPTON, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Tuesday, November 28th at 5:05 pm ET. A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

HAMPTON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an underwritten public offering of 7,425,000 shares of its common stock at a public offering price of $27.00 per share. In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 1,113,750 shares of common stock at the public offering price, less underwriting discounts and commissions.

HAMPTON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares of common stock are being offered by the Company. Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of barzolvolimab, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes. The final terms of the offering will depend on market and other conditions at the time of pricing, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

-Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups--Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group--Barzolvolimab was generally well tolerated with a favorable safety profile--Treatment will continue to 52 weeks; results support further development of barzolvolimab in Phase 3 CSU studies-- Company to host webcast call today at 8:00 am ET-

- Response observed as early as week 1 and durable for up to 16 weeks -- Data support important role for mast cells in the pathogenesis of PN and potentially other chronic itch indications -- Phase 2 PN study to initiate in early 2024 -- Conference call to be held on Monday, November 6th at 8:00 am ET to discuss study results -

- Phase 2 CSU enrollment complete; topline data by YE 2023 -- Phase 1b PN data accepted at World Congress on Itch -

HAMPTON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that an abstract describing the Phase 1b study of barzolvolimab in patients with prurigo nodularis (PN) has been accepted as an oral presentation at the 12th World Congress on Itch (WCI), being held in Miami on Nov 5-7, 2023.

HAMPTON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the Cantor Global Healthcare Conference on Tuesday, September 26th at 1:00 pm ET. A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

- Phase 2 CSU enrollment completed; topline data by YE 2023 - - Phase 1b PN data in Q4 2023 -- First patient dosed in Phase 2 EoE study -

HAMPTON, N.J., July 11, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. Treatment options for patients with CSU are limited and there are no approved therapies for patients who do not respond to omalizumab.

HAMPTON, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in eosinophilic esophagitis (EoE). EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus. Several studies have suggested that mast cells may be an important driver in this disease. Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival of the mast cell.

- Data updates at EAACI 2023 continue to position barzolvolimab as a potential best-in-class addition to a historically limited treatment landscape -- At week 24, 55% of all patients with CSU in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response (UAS7) and 69% had well-controlled disease (UCT) -- Patients in the CSU study with angioedema treated at these doses had profound and durable angioedema symptom improvement -- Single 3.0 mg/kg dose of barzolvolimab was well tolerated and demonstrated impressive clinical activity in difficult to treat cholinergic urticaria with a 56% complete response rate and patients reporting clinically significant improvement in quality of life -- Phase 2 CSU study nearing enrollment completion with topline data by year-end; Phase 2 CindU study enrolling as planned -

HAMPTON, N.J., June 08, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that data from the Company’s barzolvolimab program will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2023 being held June 9-11 in Hamburg, Germany.

HAMPTON, N.J., June 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday, June 7th at 9:00 am ET. A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

HAMPTON, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. Celldex plans to develop CDX-585 for the treatment of solid tumors either as monotherapy or in combination with other oncologic treatments. CDX-585 is the first compound from Celldex’s research and collaboration agreement with Biosion, Inc. and combines Celldex’s ILT4 mAb with Biosion’s PD-1 mAb.

HAMPTON, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced preclinical data from CDX-622, the Company’s bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF have been shown to contribute to the pathophysiology of various inflammatory, fibrotic and allergic disorders. These data were presented in a poster session as part of IMMUNOLOGY2023™, the annual meeting of the American Association of Immunologists (AAI).

- Phase 2 CSU enrollment completion expected in Q3 2023 -- Phase 1b CSU study and Phase 1 cholinergic cohort both accepted for oral presentation at EAACI 2023 -- Phase 2 EoE study expected to initiate in June 2023 -

HAMPTON, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in a fireside chat at the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on Thursday, March 30th at 11:30 am ET. A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

- Phase 1b multi-dose CSU data presented at AAAAI on February 26 - - Phase 2 CSU enrollment completion expected by Q3 2023 -

- Rapid, profound and durable responses across multiple dosing groups with favorable safety profile observed—positioning barzolimab as a potential best-in-class addition to a historically limited treatment landscape - - At week 12, 56% of all patients in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response and 76% had well-controlled disease (UAS7/UCT) - - At week 24, 53% of all patients in the 1.5 mg/kg and 3.0 mg/kg dose groups had complete response and 70% experienced well-controlled disease (UAS7/UCT); additional follow up ongoing in 4.5 mg/kg dose - - 37% of treated patients had prior omalizumab therapy and still had similar clinical benefit improvement as the overall population - - Company to host webcast on Sunday, February 26 at 4:00 pm CT/5:00 pm ET -

HAMPTON, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that it has appointed Rita Jain, M.D. to the Company’s Board of Directors.

HAMPTON, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) announced today that management will participate in fireside chat at the SVB Securities Global Biopharma Conference today at 9:20 am ET. A webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for 90 days following the event.

Company to host webcast on Sunday, February 26 at 4:00 pm CT/5:00 pm ET

- 100% complete response rate in cold urticaria after single dose of barzolvolimab at 1.5 mg/kg, including in omalizumab refractory patients -- Long term follow up of patients with chronic inducible urticaria treated at 3.0 mg/kg confirm that barzolvolimab-induced responses and mast cell suppression are durable and linked -- Company to host webcast conference call on Tuesday, December 6 at 8:00 a.m. ET -

- Includes oral presentation for 1.5 mg/kg cold urticaria cohort -

HAMPTON, N.J., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQCLDX) today announced that management will participate in fireside chats at the following investor conferences in November:

- Multiple clinical-stage programs on track for data updates in upcoming months -