JZP898 / Werewolf Therap, Jazz - LARVOL DELTA

A phase 1/1b first-in-human (FIH) study of JZP898 as monotherapy and in combination with pembrolizumab in adult patients with advanced or metastatic solid tumors. (ASCO 2024) - P1 | "Secondary endpoints include: PK parameters; incidence of antidrug antibodies; investigator-assessed duration of response; progression-free survival; disease control rate; investigator-assessed ORR (Part A); and overall survival (Part B). The study is actively enrolling patients with a planned enrollment of up to 177 patients."

Clinical • Combination therapy • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor • IFNA1

Jazz Pharmaceuticals to Present Data Across Growing Oncology Pipeline and Portfolio at ASCO 2024 (PRNewswire) - "Jazz Pharmaceuticals...announced that the company, along with its partners, will present or publish eight abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31-June 4, 2024 in Chicago. Presentations include data from trials of zanidatamab, Zepzelca (lurbinectedin), and Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). A poster featuring the study design for the JZP898 Phase 1 trial in progress will also be presented. Updated data with longer follow-up, including overall survival findings, will be presented from the Phase 2b HERIZON-BTC-01 trial of zanidatamab, a HER2-targeted bispecific, biparatopic antibody, in previously treated HER2-positive biliary tract cancer (BTC)."

Clinical data • P2b data • Trial status • B Acute Lymphoblastic Leukemia • Biliary Tract Cancer • Bladder Cancer • Leiomyosarcoma • Small Cell Lung Cancer • Synovial Sarcoma

JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Recruiting | Sponsor: Jazz Pharmaceuticals | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF • MSI

Jazz Pharmaceuticals Announces Third Quarter 2023 Financial Results and Updates Financial Guidance (PRNewswire) - "JZP898: JZP898 is an engineered IFNα cytokine pro-drug that is activated specifically within the tumor microenvironment where it can stimulate IFNα receptors on cancer-fighting immune effector cells....The Company expects to initiate a Phase 1 clinical trial by the end of the year."

New P1 trial • Oncology

JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Not yet recruiting | Sponsor: Jazz Pharmaceuticals

Combination therapy • Metastases • Monotherapy • New P1 trial • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRAF • MSI

Jazz Pharmaceuticals Announces Second Quarter 2023 Financial Results and Raises 2023 Full Year Financial Guidance (PRNewswire) - "In July 2023, JZP898 received Investigational New Drug (IND) application clearance. The Company expects to initiate a Phase 1 clinical trial by the end of the year."

IND • New P1 trial • Oncology

Jazz Pharmaceuticals Announces First Quarter 2023 Financial Results and Affirms 2023 Financial Guidance (PRNewswire) - "Key Pipeline Highlights:...JZP898:...The Company expects to file an Investigational New Drug (IND) application for JZP898 in the U.S. this year."

IND • Oncology

WTX-613, (JZP898) a selectively activated IFNα INDUKINE™ molecule, reprograms the tumor microenvironment and generates robust anti-tumor immunity as a monotherapy and in combination with checkpoint inhibitors (AACR 2023) - "Finally, the combination of mWTX-613 treatment with various checkpoint inhibitor molecules resulted in improved anti-tumor efficacy in syngeneic models. Together, these data support the advancement of this innovative IFNα therapy into clinical testing."

Biomarker • Checkpoint inhibition • Combination therapy • Monotherapy • Tumor microenvironment • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Oncology • Solid Tumor • CD8 • IFNA1

Jazz Pharmaceuticals to Present Data at 2023 AACR Annual Meeting Showcasing New Zepzelca (lurbinectedin) Data and Expanded Oncology Pre-Clinical and Clinical Pipeline (PRNewswire) - "Jazz Pharmaceuticals plc...announced that the company, along with its partners, will present five new abstracts at the American Association for Cancer Research (AACR) Annual Meeting from April 14-19, 2023. Research findings to be presented include data from company-sponsored and collaborative trials studying Zepzelca® (lurbinectedin), zanidatamab and JZP898."

P1 data • Preclinical • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Jazz Pharmaceuticals and Werewolf Therapeutics Announce Exclusive Global License and Collaboration Agreement to Develop WTX-613, a Differentiated, Conditionally-Activated IFNα INDUKINE Molecule (PRNewswire) - "Jazz Pharmaceuticals plc...and Werewolf Therapeutics, Inc...announced that the companies have entered into a licensing agreement under which Jazz has acquired exclusive global development and commercialization rights to Werewolf's investigational WTX-613...Jazz expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for WTX-613 in 2023....Under the terms of the transaction, Jazz has secured exclusive global rights to WTX-613. Jazz will make an upfront payment of $15 million to Werewolf, and Werewolf is eligible to receive development, regulatory and commercial milestone payments of up to $1.26 billion. Pending approval, Werewolf is eligible to receive a tiered, mid-single-digit percentage royalty on net sales of WTX-613."

IND • Licensing / partnership • Oncology

Conditionally Activated IL-12 or IFNα Indukine™ Molecules Inhibit Syngeneic Lymphoma Tumor Growth in Mice, Induce Anti-Tumor Immune Responses and Are Tolerated in Non-Human Primates (ASH 2021) - "The WTX-330 INDUKINE™ molecule, a wild-type IL-12 pro-drug, contains a half-life extension (HLE) domain to support infrequent dosing and a high affinity anti-IL-12 neutralizing antibody domain to maintain the molecule in its inactive state in the periphery. Similar studies for WTX-613 are on-going. Preclinical data obtained so far for both programs support the continued development and future evaluation of these innovative and differentiated therapies in hematologic malignancies, both as monotherapies and in multiple combinations with standard of care."

Preclinical • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Lymphoma • Melanoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • CD8 • IFNA1 • IFNAR1 • IL12A

Werewolf Therapeutics to Present Preclinical Data on INDUKINE Molecules at the 63rd American Society of Hematology (ASH) Annual Meeting (GlobeNewswire) - "WTX-330 and WTX-613 are systemically delivered, conditionally activated IL-12 and IFNα INDUKINE molecules, respectively, for the potential treatment of solid tumors. The study used surrogate WTX-330 and WTX-613 INDUKINE™ molecules, consisting of a mouse/human chimeric IL-12 or a mouse IFNα1, to explore anti-tumor responses in syngeneic hematologic cancer models, as human IL-12 and IFNα2b are not active in mice....The WTX-330 and WTX-613 surrogates also strongly activated NK and CD8+ cell responses and induced antigen-presenting cell and effector cell markers in the MC38 syngeneic tumor model, supporting a mechanism of action as described for wild-type IL-12 and IFNα."

Preclinical • Oncology

WTX-613, a conditionally activated IFNα INDUKINE™ molecule, induces anti-tumor immune responses resulting in strong tumor growth control in syngeneic mouse tumor models (SITC 2021) - "Specifically, the WTX-613 surrogate was better than native IFNα1 in inducing CD8+, NK, and DC cells. Conclusions Preclinical data obtained so far support the continued development of this innovative and differentiated engineered IFNα therapy and progression into clinical trials."

Preclinical • Breast Cancer • Hematological Malignancies • Leukemia • Lymphoma • Melanoma • Oncology • Solid Tumor • CD8 • IFNA1 • IFNAR1

Werewolf Therapeutics Reports Third Quarter 2021 Financial Results and Business Update (GlobeNewswire) - “Werewolf Therapeutics continues to make significant progress advancing and executing across our pipeline and we are on track to file INDs for our two lead INDUKINE™ product candidates, WTX-124 and WTX-330, in the first half of 2022…Upcoming preclinical presentations at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 10-14, 2021 in Washington, DC: Werewolf will present posters on its lead programs WTX-124 (Poster #718), WTX-330 (Poster #715) and WTX-613 (Poster #723) describing the design and preclinical evaluation of Werewolf’s IL-2, IL-12 and IFN-a INDUKINE™ molecules.”

Clinical • IND • Oncology