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Werewolf Therapeutics Presents Data Expanding Its PREDATOR® Platform at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting
Globenewswire· 2025-11-07 14:00
Core Insights - Werewolf Therapeutics presented preclinical data at the 2025 Society for Immunotherapy of Cancer's Annual Meeting, showcasing advancements in their INDUCER™ T Cell Engager Platform designed to enhance safety and efficacy in cancer treatment [1][2][3] Group 1: Technology and Platform - The proprietary PREDATOR platform utilizes clinically validated protease-cleavable linkers for tumor-selective activation, leading to the development of three clinical-stage INDUKINE candidates [2][6] - The INDUCER molecules employ a novel masking strategy that prevents systemic T cell activation and cytokine release, activating only in the presence of human tumor tissue [5][6] Group 2: Preclinical Findings - A sequential dosing regimen of mWTX-330 (IL-12) followed by WTX-124 (IL-2) demonstrated superior tumor-killing ability in preclinical models, suggesting enhanced immune response and tolerability [5][6] - Real-time pharmacokinetic data confirmed that WTX-124 selectively activates within tumors, with minimal active cytokine released into the plasma, validating the prodrug design [5][6] Group 3: Company Overview - Werewolf Therapeutics focuses on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions, with advanced candidates WTX-124 and WTX-330 targeting solid tumors [6]
Werewolf Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-04 12:00
Core Insights - Werewolf Therapeutics is advancing its proprietary PREDATOR® platform, focusing on conditionally activated immune therapeutics for cancer treatment, with significant progress in its lead clinical programs WTX-124 and WTX-330, as well as the first INDUCER T-cell engager candidate, WTX-1011 [2][9] Clinical-Stage INDUKINE Molecules - WTX-124 has received Fast Track Designation from the FDA for treating locally advanced or metastatic cutaneous melanoma, with updates on clinical trial data and regulatory feedback expected in Q4 2025 [6][5] - WTX-330 is currently in a Phase 1b/2 clinical trial for advanced or metastatic solid tumors, with further development plans to be announced later in Q4 2025 [5][6] - WTX-1011 is undergoing IND-enabling studies, targeting STEAP1 for prostate cancer, with a differentiated target candidate expected to be nominated by year-end 2025 [11][5] Preclinical-Stage INDUCER Molecules - The company has development candidates available for partnering, including WTX-712 (IL-21), WTX-518 (IL-18), and WTX-921 (IL-10), aimed at treating various cancers and inflammatory diseases [7] Financial Results for Q3 2025 - Cash and cash equivalents as of September 30, 2025, were $65.7 million, down from $77.6 million as of June 30, 2025, expected to fund operations into Q4 2026 [12] - Research and development expenses were $11.6 million for Q3 2025, a decrease from $12.5 million in Q3 2024 [12] - General and administrative expenses were $4.1 million for Q3 2025, down from $4.6 million in Q3 2024 [12] - The net loss for Q3 2025 was $16.4 million, compared to a net loss of $16.7 million in Q3 2024 [12][15]
Werewolf Therapeutics to Present Posters at the Society for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting
Globenewswire· 2025-10-03 13:00
Core Insights - Werewolf Therapeutics, Inc. is set to present three posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting, highlighting its innovative biopharmaceutical developments aimed at stimulating the immune system for cancer treatment [1][2]. Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics designed to enhance the body's immune response against cancer and other immune-mediated conditions [3]. - The company utilizes its proprietary PREDATOR platform to create INDUKINE™ and INDUCER™ molecules that selectively activate in the tumor microenvironment while remaining inactive in peripheral tissues [3]. - The lead clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3]. Upcoming Presentations - The first poster will discuss the sequential administration of WTX-124 and mWTX-330, demonstrating enhanced antitumor activity in mice with poorly immunogenic EMT6 tumors without systemic toxicity [2]. - The second poster will focus on the development of conditional T cell engagers (INDUCER™ molecules) that utilize a masking approach to minimize dose-limiting cytokine release and off-target toxicity [2]. - The third poster will provide pharmacokinetic insights into the IL-2 INDUKINE prodrug WTX-124, assessing tumor-specific activation and immune modulation in real-time [2].
Werewolf Therapeutics to Present Posters at the Society for Immunotherapy of Cancer's (SITC) 40th Annual Meeting
Globenewswire· 2025-10-03 13:00
Core Insights - Werewolf Therapeutics, Inc. is set to present three posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting, highlighting its innovative biopharmaceutical developments aimed at stimulating the immune system for cancer treatment [1][2]. Group 1: Poster Presentations - The first poster will discuss the sequential administration of WTX-124 and mWTX-330, showcasing enhanced antitumor activity in mice with poorly immunogenic EMT6 tumors without systemic toxicity [2]. - The second poster will focus on the development of conditional T cell engagers (INDUCER™ molecules) that utilize a masking approach to minimize dose-limiting cytokine release and off-target toxicity [2]. - The third poster will provide pharmacokinetic insights into the IL-2 INDUKINE prodrug WTX-124, emphasizing real-time assessment of tumor-specific activation and immune modulation [2]. Group 2: Company Overview - Werewolf Therapeutics is pioneering the development of therapeutics designed to stimulate the immune system for treating cancer and other immune-mediated conditions, leveraging its proprietary PREDATOR® platform [3]. - The company is advancing its most clinical-stage product candidates, WTX-124 and WTX-330, which are conditionally activated Interleukin-2 and Interleukin-12 INDUKINE molecules, respectively, for solid tumor treatment [3]. - Werewolf is also developing INDUCER molecules, with the first candidate, WTX-1011, targeting STEAP1 for prostate cancer, building on positive data from its INDUKINE molecules [3].
Werewolf Therapeutics to Participate in the Upcoming H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-02 12:00
Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer and immune-mediated conditions [3] Group 1: Company Overview - Werewolf Therapeutics is leveraging its proprietary PREDATOR platform to design INDUKINE™ and INDUCER™ molecules that enhance both adaptive and innate immunity [3] - The company's advanced clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3] - WTX-124 is being advanced in multiple tumor types both as a single agent and in combination with immune checkpoint inhibitors, while WTX-330 is also being explored in various solid tumor types [3] Group 2: Upcoming Events - Daniel J. Hicklin, Ph.D., President and CEO, and Randi Isaacs, M.D., Chief Medical Officer, will participate in a fireside chat at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 [1] - A live webcast of the presentation will be available, with an archived replay accessible for approximately 90 days post-event [2]
Werewolf Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-14 11:00
Core Insights - Werewolf Therapeutics is advancing its clinical trials for WTX-124 and WTX-330, with significant milestones expected in 2025, including interim data readouts and FDA engagement [1][2][5] Clinical Development - WTX-124 is a conditionally activated Interleukin-2 (IL-2) INDUKINE molecule, currently in a Phase 1/1b clinical trial for cutaneous melanoma and renal cell carcinoma, with interim data expected in Q4 2025 [1][5] - WTX-330, an Interleukin-12 (IL-12) INDUKINE molecule, is in a Phase 1b/2 clinical trial for advanced solid tumors, with dosing regimen determination anticipated by the end of 2025 [1][5] - The company has introduced WTX-1011, its first INDUCER T-cell engager targeting STEAP1 for prostate cancer, which has shown promising preclinical data [2][5] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of $77.6 million, down from $92.0 million as of March 31, 2025, indicating a need for careful cash management [11][15] - Research and development expenses for Q2 2025 were $13.1 million, a decrease from $15.3 million in Q2 2024, while general and administrative expenses also saw a decline [11][14] - The net loss for Q2 2025 was $18.0 million, slightly higher than the $17.2 million loss reported in the same period of 2024 [11][14]
Werewolf Therapeutics to Participate in the BIO International Convention
GlobeNewswire News Room· 2025-06-12 12:00
Core Insights - Werewolf Therapeutics, Inc. is focused on developing conditionally activated therapeutics aimed at enhancing the immune system for cancer treatment and other immune-mediated conditions [1][3] - The company will participate in a panel discussion at the BIO International Convention, highlighting the potential of its biologics to redefine oncology treatment paradigms [2] Company Overview - Werewolf Therapeutics utilizes its proprietary PREDATOR® platform to create therapeutics that stimulate both adaptive and innate immunity, addressing limitations of traditional immune therapies [3] - The company's leading clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, targeting solid tumors and Non-Hodgkin Lymphoma [3] Clinical Trials and Initiatives - The "Full Moon Moment" initiative aims to raise awareness of ongoing clinical trials, including one for WTX-124, which has shown promising results, including a patient with cutaneous squamous cell carcinoma in remission for over a year [2] - WTX-124 is being evaluated as a single agent and in combination with immune checkpoint inhibitors across multiple tumor types [3]
Werewolf Therapeutics to Participate in the Upcoming Jefferies Global Healthcare Conference
Globenewswire· 2025-05-29 12:00
Core Insights - Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company focused on developing conditionally activated therapeutics to stimulate the immune system for cancer treatment [3] - The company will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, featuring CEO Daniel J. Hicklin and CMO Randi Isaacs [1][2] Company Overview - Werewolf Therapeutics leverages its proprietary PREDATOR® platform to create therapeutics that activate selectively in the tumor microenvironment while remaining inactive in peripheral tissues [3] - The company's advanced clinical candidates include WTX-124 and WTX-330, which are conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) molecules, respectively, aimed at treating solid tumors [3] - WTX-124 is being advanced in multiple tumor types both as a single agent and in combination with immune checkpoint inhibitors, while WTX-330 is being explored for various tumor types and Non-Hodgkin Lymphoma [3]
Werewolf Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 11:00
Core Insights - Werewolf Therapeutics is advancing its clinical-stage programs, particularly WTX-124 and WTX-330, with significant milestones expected in the second half of 2025 [2][6][4] - The company is also developing proprietary INDUCER T cell engager molecules, with a candidate expected to be nominated by the end of Q2 2025 [2][7] - Financial guidance indicates sufficient cash runway into Q4 2026, with cash and cash equivalents reported at $92.0 million as of March 31, 2025 [11][17] Clinical Development - WTX-124 is a conditionally activated Interleukin-2 (IL-2) molecule being evaluated as a monotherapy and in combination with pembrolizumab for various solid tumors [3][9] - WTX-330, an Interleukin-12 (IL-12) molecule, has initiated patient dosing in a Phase 1b/2 trial to optimize its exposure in the tumor microenvironment [4][6] - The company plans to present interim data from the WTX-124 trial in the second half of 2025, focusing on tolerability and response rates [6] Financial Performance - For Q1 2025, research and development expenses were $13.1 million, slightly up from $12.9 million in Q1 2024 [11][15] - General and administrative expenses decreased to $4.9 million in Q1 2025 from $5.0 million in Q1 2024 [11][15] - The net loss for Q1 2025 was $18.1 million, compared to a net loss of $16.2 million in the same period of 2024 [11][15] Strategic Initiatives - The company is launching an educational campaign in May to raise awareness about skin cancer and the differentiation of its therapeutics [2][6] - Werewolf's proprietary PREDATOR masking technology is designed to enhance the safety and efficacy of its T cell engagers by silencing peripheral activity [2][7]
Werewolf Therapeutics Presents New Preclinical Data Further Characterizing its IL-10 INDUKINE Molecule, WTX-921, for the Treatment of Inflammatory Bowel Disease (IBD) at AAI Annual Meeting
Globenewswire· 2025-05-05 12:05
Core Insights - Werewolf Therapeutics, Inc. announced the efficacy of its IL-10 INDUKINE molecule, WTX-921, in reducing tissue damage and inflammatory cytokine production in a mouse colitis model [1][3] - The findings provide a deeper understanding of WTX-921's anti-inflammatory effects on the immune landscape in the inflamed colon [1] Company Overview - Werewolf Therapeutics is focused on developing conditionally activated therapeutics aimed at stimulating the immune system for cancer and immune-mediated conditions [1][7] - The company utilizes its proprietary PREDATOR platform to design molecules that activate selectively in the tumor microenvironment, addressing limitations of conventional therapies [7] Product Development - WTX-921 is engineered to selectively deliver IL-10 to inflamed tissues, minimizing systemic toxicity while providing therapeutic exposure [6] - The molecule has shown potential in blocking disease-driving effector molecules and cytokines, impacting both innate and adaptive immune responses [6] Clinical Findings - The data presented at the AAI Annual Meeting indicate that WTX-921 effectively masks IL-10, preventing off-tissue effects and demonstrating efficacy in preventing weight loss and reducing Disease Activity Index (DAI) scores in a colitis model over four weeks [4][3] - The treatment resulted in decreased immune cell infiltration and reduced RNA levels of inflammatory cytokines in treated animals [4] Market Context - The CDC estimates that 7 million people worldwide had Inflammatory Bowel Disease (IBD) in 2024, highlighting the need for improved treatment options [3]