Core Points - TuHURA Biosciences, Inc. has been added to the Russell 3000® Index and automatically included in the Russell 2000® Index as part of the 2025 annual reconstitution, effective June 27, 2025 [1][2] - The inclusion in the Russell indexes signifies the company's progress in its first year as a publicly traded entity and reflects its potential for continued development [2] - TuHURA is currently enrolling patients in a Phase 3 accelerated approval trial of its lead product IFx-2.0, which is being tested as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel cell carcinoma [2][11] - The company has also acquired a novel anti-VISTA antibody from Kineta, Inc. and plans to advance it into a Phase 2 clinical trial for treating NMPL1-mutated Acute Myeloid Leukemia [2] Company Overview - TuHURA Biosciences, Inc. is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing both primary and acquired resistance [10] - The company's lead product, IFx-2.0, is designed to enhance the effectiveness of checkpoint inhibitors [11] - TuHURA is also leveraging its Delta Opioid Receptor technology to create bi-specific antibody drug conjugates aimed at inhibiting immune suppression in the tumor microenvironment [12]

Core Insights - Aethlon Medical has achieved a significant milestone by treating the second patient with the Hemopurifier in its clinical trial for solid tumors not responding to anti-PD-1 antibodies [1][2] - The trial aims to assess the safety and feasibility of the Hemopurifier, with the first cohort consisting of approximately 18 patients [6] - The Hemopurifier is designed to remove tumor-derived extracellular vesicles (EVs) from the bloodstream, potentially improving responses to anti-PD-1 therapies [5][7] Group 1: Clinical Trial Progress - The second patient was treated on June 11, 2025, at the Royal North Shore Hospital/University of Sydney, following the first patient treated on January 29, 2025 [1][2] - Both patients completed the 4-hour Hemopurifier treatment without device deficiencies or immediate complications, and have finished the 7-day safety follow-up period [2][4] - The Data Safety Monitoring Board (DSMB) will review the safety data after the third patient is enrolled, which is expected to occur soon [3][4] Group 2: Device and Mechanism - The Hemopurifier is an investigational device that utilizes plasma separation and affinity binding to remove enveloped viruses and EVs from circulation [7][8] - Preclinical studies indicate that the Hemopurifier can reduce the number of exosomes in cancer patient plasma, which may enhance the effectiveness of anti-PD-1 therapies [5][6] - The device holds FDA Breakthrough Device designation for treating advanced or metastatic cancer patients who are unresponsive to standard therapies [8] Group 3: Future Directions - The primary endpoint of the trial is to monitor adverse events and significant changes in safety lab tests among treated patients [6] - The study will also explore the number of Hemopurifier treatments required to decrease EV concentrations and whether this improves the immune response against tumor cells [6] - Data on the effects of the Hemopurifier on anti-tumor T cell activity is anticipated approximately three months after the enrollment of the third patient [3]

Core Viewpoint - Alvotech and Dr. Reddy's Laboratories have entered a collaboration to co-develop a biosimilar candidate to Keytruda® (pembrolizumab), which had worldwide sales of US$29.5 billion in 2024, aiming to enhance the availability of cost-effective biologic medications for cancer treatment globally [1][2][3][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, with a goal to be a leader in the biosimilar space by providing high-quality, cost-effective products [7]. - Dr. Reddy's Laboratories is a global pharmaceutical company committed to providing access to affordable and innovative medicines, with a focus on various therapeutic areas including oncology [10][11]. Collaboration Details - The collaboration agreement stipulates that both companies will share responsibilities and costs in the development and manufacturing of the biosimilar candidate, with each party having the right to commercialize the product globally [2]. - This partnership is expected to leverage the strengths of both companies in biosimilars, accelerating the development process and expanding market reach [1][3][4]. Market Context - Keytruda® is a critical therapy in immuno-oncology, and the collaboration aims to enhance the capabilities of both companies in this therapeutic area [4]. - The biosimilars market is growing, and this collaboration positions both companies to capitalize on the increasing demand for affordable cancer treatments [3][4].

Core Insights - TuHURA Biosciences is advancing its clinical programs, including the initiation of a Phase 3 trial for IFx-Hu2.0 in combination with Keytruda for advanced Merkel cell carcinoma (MCC) [1][3] - The company is targeting the acquisition of Kineta, Inc. and plans to initiate a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated acute myeloid leukemia (AML) [2][3] Clinical Development - TuHURA has initiated a Phase 1b/2a trial of IFx-Hu2.0 as adjunctive therapy with pembrolizumab in patients with Merkel cell carcinoma of unknown primary origin (MCCUP) [1][4] - The Phase 3 trial for IFx-Hu2.0 is expected to begin in Q2 2025, pending the lifting of a partial clinical hold by the FDA [3][10] - The Phase 1b/2a trial will include patients with deep-seated tumors who are not eligible for the Phase 3 trial, addressing a significant patient population [3][4] Financial Overview - For the first quarter ended March 31, 2025, research and development expenses were $4.6 million, compared to $3.6 million for the same period in 2024 [6] - General and administrative expenses increased to $2.4 million in Q1 2025 from $1.0 million in Q1 2024 [6] Corporate Updates - TuHURA is in the process of acquiring Kineta, Inc., with the deal expected to close in Q2 2025, subject to financing and other conditions [2][8] - The company appointed Dr. Bertrand Le Bourdonnec as Head of Drug Discovery and Dr. Craig L. Tendler to its Board of Directors, enhancing its leadership team [10] Upcoming Milestones - Q2 2025: Anticipated initiation of the Phase 3 trial for IFx-Hu2.0 and closing of the Kineta acquisition [10] - Q3 2025: Planned initiation of a Phase 2 trial for Kineta's VISTA inhibiting monoclonal antibody in NPM1-mutated AML [10]

Core Viewpoint - TuHURA Biosciences has initiated a Phase 1b/2a trial for IFx-Hu2.0 in combination with Keytruda® to evaluate safety and feasibility in patients with deep-seated tumors, expanding the potential patient population for this treatment [1][2][4]. Group 1: Trial Details - The Phase 1b/2a trial is designed to assess the safety and feasibility of IFx-Hu2.0 as an adjunctive therapy to Keytruda® in adult patients with non-cutaneous Merkel cell carcinoma (MCC) [4]. - The trial will enroll a total of nine patients with hepatic, pulmonary, or retroperitoneal lesions, administering IFx-Hu2.0 (0.1 mg) weekly for three weeks, followed by pembrolizumab [4]. - The primary endpoint is the safety and feasibility of IFx-Hu2.0 evaluated 28 days after the last dose, with secondary endpoints including efficacy assessed at three and six months [4]. Group 2: Future Plans - If the trial demonstrates safety and feasibility, TuHURA plans to extend enrollment to other non-MCC cancers that poorly respond to checkpoint inhibitors [3]. - The company is preparing to initiate a Phase 3 accelerated approval trial of IFx-Hu2.0 as an adjunctive therapy to Keytruda® for first-line treatment of advanced or metastatic MCC [5][9]. - The FDA has agreed to the trial's design under the accelerated approval pathway, with overall response rate (ORR) as the primary endpoint [6][7]. Group 3: Company Overview - TuHURA Biosciences is focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [8]. - The lead product candidate, IFx-Hu2.0, is designed to overcome primary resistance to checkpoint inhibitors, with prior trials showing promise in various skin cancers [9][10].

Core Insights - TuHURA Biosciences, Inc. is advancing its Phase 3 immune-oncology initiatives, focusing on overcoming resistance to cancer immunotherapy [5][6] - The company announced that abstracts from Kineta Inc. and Moffitt Cancer Center will be presented at the AACR Annual Meeting 2025, showcasing novel therapies for advanced melanoma [1][2] Group 1: Company Developments - TuHURA is set to present initial results from a Phase 1 study of KVA12123, an anti-VISTA antibody, in combination with pembrolizumab for advanced solid tumors [2] - The company is preparing to initiate a Phase 3 trial for its lead product, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced Merkel Cell Carcinoma [6] - TuHURA has entered into a merger agreement with Kineta, Inc. to acquire the rights to KVA12123, with the merger expected to close in Q2 2025 [4] Group 2: Research and Presentations - The accepted abstracts for the AACR Annual Meeting include mechanistic insights into IFx-Hu2.0 responses after prior anti-PD-1 therapy failure [2] - Presentations will take place on April 28, 2025, with specific sessions dedicated to experimental therapeutics and immunology [2][3]

Core Insights - TuHURA Biosciences, Inc. has appointed Dr. Bertrand Le Bourdonnec as Executive Vice President, Head of Drug Discovery, Early Development, and Program Management, bringing extensive experience in drug discovery and development [1][3][4] Company Overview - TuHURA is a Phase 3 registration-stage immuno-oncology company focused on developing novel technologies to overcome resistance to cancer immunotherapy, addressing a significant challenge in cancer treatment [6][8] - The company is preparing to initiate a Phase 3 trial for its lead candidate, IFx-2.0, as an adjunctive therapy to Keytruda® for advanced or metastatic Merkel Cell Carcinoma [7] Leadership and Expertise - Dr. Le Bourdonnec has a proven track record in leading R&D programs across various therapeutic areas, including oncology and pain management, and is an expert in the biochemistry and pharmacology of the Delta Opioid Receptor (DOR) [2][4] - His previous roles include Chief Scientific Officer at HDAX Therapeutics and VP at Deciphera Pharmaceuticals, where he managed significant teams and contributed to the development of novel therapeutics [4][5] Technology and Innovation - TuHURA is leveraging its DOR technology to develop first-in-class bi-specific Antibody Drug Conjugates (ADCs) and Antibody Peptide Conjugates (APCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to enhance the immune response in the tumor microenvironment [8] - The company aims to address unmet medical needs and transform treatment paradigms for cancer patients through innovative drug development [4][6]