Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025
Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025
TAMPA, FL, USA I June 9, 2025 I TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company’s Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.
“We are grateful for the collaborative interaction with the reviewers at the Office of Therapeutic Products (OTP) and the Oncology Center of Excellence (OCE), including their quick response time and, importantly, their helpful recommendations going forward,” stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.
“The removal of the partial clinical hold allows TuHURA to begin the trial’s initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0,” continued Dr. Bianco. “We are also pleased that the removal of the partial clinical hold represents the achievement of the second milestone funding condition under our recently announced private placement, thereunder trigging the payment to the Company of an additional $2.23 million under the financing.”
The Company’s Phase 3 accelerated approval trial of IFx-2.0, will be conducted under an SPA Agreement with the U.S. FDA, and will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda® compared to Keytruda® plus placebo in the first line treatment of patients with advanced or metastatic MCC. Keytruda® is currently approved in MCC under accelerated approval based on Overall Response Rate (ORR). The pivotal trial for IFx-2.0 is expected to enroll 118 across approximately 22 to 25 U.S. sites. Trial participants will be randomized on a 1:1 basis and receive Keytruda® in both arms, for up to two years, or until disease progression or Keytruda® related toxicities. The primary endpoint for the trial is ORR with a key secondary endpoint of Progression Free Survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival. Accelerated approval is based on the successful achievement of the ORR primary endpoint. PFS, the key secondary endpoint, if successfully achieved, without a detrimental effect on overall survival, could satisfy the requirement for regular approval without the requirement for a post approval confirmatory trial (in contrast to most accelerated approval trials).
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA’s lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
Following its proposed merger with Kineta, Inc., if completed, the Company expects to advance Kineta’s novel VISTA inhibiting antibody into a randomized Phase 2 trial in NPM1 mutated r/r AML in combination with a menin inhibitor.
In addition to its innate immune agonist product candidate, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
SOURCE: TuHURA
Post Views: 826
Company anticipates initiating its Phase 3 accelerated approval trial of IFx-Hu2.0 as adjunctive therapy with Keytruda® (pembrolizumab) as first-line treatment for advanced and metastatic Merkel cell carcinoma (MCC), conducted under Special Protocol Assessment (SPA) Agreement with U.S. Food and Drug Administration (FDA), later in June 2025
Resolution of partial clinical hold unlocks second tranche of funds from $12.5 million PIPE financing announced on June 3, 2025
TAMPA, FL, USA I June 9, 2025 I TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA” or the “Company”), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced that the FDA has removed the manufacturing-related partial clinical hold on the Company’s Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA.
“We are grateful for the collaborative interaction with the reviewers at the Office of Therapeutic Products (OTP) and the Oncology Center of Excellence (OCE), including their quick response time and, importantly, their helpful recommendations going forward,” stated James Bianco, M.D., President and Chief Executive Officer of TuHURA Biosciences.
“The removal of the partial clinical hold allows TuHURA to begin the trial’s initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0,” continued Dr. Bianco. “We are also pleased that the removal of the partial clinical hold represents the achievement of the second milestone funding condition under our recently announced private placement, thereunder trigging the payment to the Company of an additional $2.23 million under the financing.”
The Company’s Phase 3 accelerated approval trial of IFx-2.0, will be conducted under an SPA Agreement with the U.S. FDA, and will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda® compared to Keytruda® plus placebo in the first line treatment of patients with advanced or metastatic MCC. Keytruda® is currently approved in MCC under accelerated approval based on Overall Response Rate (ORR). The pivotal trial for IFx-2.0 is expected to enroll 118 across approximately 22 to 25 U.S. sites. Trial participants will be randomized on a 1:1 basis and receive Keytruda® in both arms, for up to two years, or until disease progression or Keytruda® related toxicities. The primary endpoint for the trial is ORR with a key secondary endpoint of Progression Free Survival (PFS). Other secondary endpoints are safety, duration of response, and overall survival. Accelerated approval is based on the successful achievement of the ORR primary endpoint. PFS, the key secondary endpoint, if successfully achieved, without a detrimental effect on overall survival, could satisfy the requirement for regular approval without the requirement for a post approval confirmatory trial (in contrast to most accelerated approval trials).
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA’s lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma.
Following its proposed merger with Kineta, Inc., if completed, the Company expects to advance Kineta’s novel VISTA inhibiting antibody into a randomized Phase 2 trial in NPM1 mutated r/r AML in combination with a menin inhibitor.
In addition to its innate immune agonist product candidate, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune-suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
SOURCE: TuHURA
Post Views: 826
