30 of a projected 39 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab)
Kineta anticipates the trial to be fully enrolled by the end of 2024
TAMPA, FL & SAN DIEGO, CA, USA I August 19, 2024 I TuHURA Biosciences, Inc. (“TuHURA”), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that Kineta, Inc. (Nasdaq: KA) (“Kineta”), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, has reopened enrollment in its ongoing VISTA-101 Phase 1/2 clinical trial. As previously announced on July 8, 2024, TuHURA entered into an Exclusivity and Right of First Offer Agreement (the “Agreement”) with Kineta for the potential acquisition of Kineta’s KVA12123 VISTA blocking antibody and related rights and assets associated with and derived from the asset. Kineta and TuHURA are cooperating on the reinitiation of patient enrollment into this trial during TuHURA’s due diligence period with respect to the KVA12123 assets.
To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab). Initial results demonstrating partial response and stable disease in the combination cohorts, and durable stable disease observed in monotherapy cohorts, were reported earlier this year at the American Association of Cancer Research (AACR) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of cytokine release syndrome (CRS)-associated cytokines at any dose level.
Dr. James Bianco, Chief Executive Officer of TuHURA commented, “We believe KVA12123 has the potential to be a promising new treatment alternative for patients with cancer. Importantly, KVA12123 has demonstrated multiple synergies with both of our IFx and Delta receptor technologies and could be a promising addition to our pipeline, bringing in a potential Phase 2 ready, novel checkpoint inhibitor. The expected completion of the enrollment in the Phase 1 portion of the VISTA-101 trial this year is an important milestone in the continued advancement of this program, and we are pleased to work closely with the Kineta team to get patient enrollment underway again as we continue to investigate the possibility of acquiring this asset under the Agreement.”
“We have made noteworthy progress with the trial, and the data seen to date have demonstrated KVA12123 has been well tolerated with no dose limiting toxicities and no cytokine release syndrome. We are very pleased to resume enrollment for VISTA-101 and are focused on the successful execution and working towards completing enrollment which we expect to do by the end of 2024,” said Thierry Guillaudeux, Chief Scientific Officer of Kineta.
As previously announced, under the terms of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA. Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to discuss and negotiate with Kineta the potential acquisition of Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123. This exclusive right shall continue through the first to occur of (a) the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension for an additional 20 days. TuHURA is currently engaging in due diligence under the Agreement.
About KVA12123
KVA12123 is a VISTA blocking immunotherapy in development as an infusion dosed every two weeks being evaluated in an ongoing Phase 1/2 clinical trial both as a monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced treatment refractory, solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer and represents the introduction of a new class of checkpoint inhibitors.
VISTA (V-domain Ig suppressor of T-cell activation) is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.
As previously announced, TuHURA entered into a definitive agreement for an all-stock transaction with Kintara to form a company combining expertise and resources to advance a risk diversified late-stage oncology pipeline. The combined company will focus on advancing TuHURA’s personalized cancer vaccine(s) and first-in-class bi-functional ADCs, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name “TuHURA Biosciences, Inc.” and to trade on The Nasdaq Capital Market under the ticker “HURA.” The transaction is subject to customary closing conditions, including stockholder approval of both companies, and is expected to close in the third quarter of 2024.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA’s lead personalized cancer vaccine candidate, 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) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its cancer vaccine product candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-functional ADCs, 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 tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
About Kintara
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. Kintara’s lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC).
Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications.
For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and LinkedIn.
SOURCE: Kintara Therapeutics
Post Views: 1,763
30 of a projected 39 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab)
Kineta anticipates the trial to be fully enrolled by the end of 2024
TAMPA, FL & SAN DIEGO, CA, USA I August 19, 2024 I TuHURA Biosciences, Inc. (“TuHURA”), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara”), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that Kineta, Inc. (Nasdaq: KA) (“Kineta”), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, has reopened enrollment in its ongoing VISTA-101 Phase 1/2 clinical trial. As previously announced on July 8, 2024, TuHURA entered into an Exclusivity and Right of First Offer Agreement (the “Agreement”) with Kineta for the potential acquisition of Kineta’s KVA12123 VISTA blocking antibody and related rights and assets associated with and derived from the asset. Kineta and TuHURA are cooperating on the reinitiation of patient enrollment into this trial during TuHURA’s due diligence period with respect to the KVA12123 assets.
To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab). Initial results demonstrating partial response and stable disease in the combination cohorts, and durable stable disease observed in monotherapy cohorts, were reported earlier this year at the American Association of Cancer Research (AACR) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of cytokine release syndrome (CRS)-associated cytokines at any dose level.
Dr. James Bianco, Chief Executive Officer of TuHURA commented, “We believe KVA12123 has the potential to be a promising new treatment alternative for patients with cancer. Importantly, KVA12123 has demonstrated multiple synergies with both of our IFx and Delta receptor technologies and could be a promising addition to our pipeline, bringing in a potential Phase 2 ready, novel checkpoint inhibitor. The expected completion of the enrollment in the Phase 1 portion of the VISTA-101 trial this year is an important milestone in the continued advancement of this program, and we are pleased to work closely with the Kineta team to get patient enrollment underway again as we continue to investigate the possibility of acquiring this asset under the Agreement.”
“We have made noteworthy progress with the trial, and the data seen to date have demonstrated KVA12123 has been well tolerated with no dose limiting toxicities and no cytokine release syndrome. We are very pleased to resume enrollment for VISTA-101 and are focused on the successful execution and working towards completing enrollment which we expect to do by the end of 2024,” said Thierry Guillaudeux, Chief Scientific Officer of Kineta.
As previously announced, under the terms of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA. Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to discuss and negotiate with Kineta the potential acquisition of Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123. This exclusive right shall continue through the first to occur of (a) the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension for an additional 20 days. TuHURA is currently engaging in due diligence under the Agreement.
About KVA12123
KVA12123 is a VISTA blocking immunotherapy in development as an infusion dosed every two weeks being evaluated in an ongoing Phase 1/2 clinical trial both as a monotherapy and in combination with Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced treatment refractory, solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 has been shown to de-risk the VISTA target and provides a novel approach to address immune suppression in the TME with a mechanism of action that is differentiated and complementary with T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer and represents the introduction of a new class of checkpoint inhibitors.
VISTA (V-domain Ig suppressor of T-cell activation) is a negative immune checkpoint that suppresses T cell function in a variety of solid tumors. High VISTA expression in tumor correlates with poor survival in cancer patients and has been associated with a lack of response to other immune checkpoint inhibitors. Blocking VISTA induces an efficient polyfunctional immune response to address immunosuppression and drives anti-tumor responses.
As previously announced, TuHURA entered into a definitive agreement for an all-stock transaction with Kintara to form a company combining expertise and resources to advance a risk diversified late-stage oncology pipeline. The combined company will focus on advancing TuHURA’s personalized cancer vaccine(s) and first-in-class bi-functional ADCs, two technologies that seek to overcome the major obstacles that limit the effectiveness of current immunotherapies in treating cancer. The combined company is expected to operate under the name “TuHURA Biosciences, Inc.” and to trade on The Nasdaq Capital Market under the ticker “HURA.” The transaction is subject to customary closing conditions, including stockholder approval of both companies, and is expected to close in the third quarter of 2024.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. TuHURA’s lead personalized cancer vaccine candidate, 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) in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its cancer vaccine product candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-functional ADCs, 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 tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
About Kintara
Located in San Diego, California, Kintara is dedicated to the development of novel cancer therapies for patients with unmet medical needs. Kintara is developing therapeutics for clear unmet medical needs with reduced risk development programs. Kintara’s lead program is REM-001 Therapy for cutaneous metastatic breast cancer (CMBC).
Kintara has a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 Therapy, which consists of the laser light source, the light delivery device, and the REM-001 drug product, has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. In CMBC, REM-001 has a clinical efficacy to date of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications.
For more information, please visit www.kintara.com or follow us on X at @Kintara_Thera, Facebook and LinkedIn.
SOURCE: Kintara Therapeutics
Post Views: 1,763
