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This is the complete Preliminary PYX-201 Trial. There was NO death reported in this trial
This is the PYXS entire press release from its website
pyxisoncology.c...
Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data
PDF Version
— PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25
— Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting ADC
— New Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of novel extracellular PYX-201 ADC and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) to begin dosing 1Q25 in patients with HNSCC, HR+/HER2- breast, TNBC, and sarcoma
— PYX-201 generally well-tolerated with a favorable safety profile
— Multiple data updates expected in 2025
— Company to host in-person and virtual investor event today at 4:30 p.m. ET
BOSTON, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM).
"These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma. The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25."
In this ongoing open-label, multicenter, dose-escalation Phase 1 trial of PYX-201, 80 patients have been enrolled and dosed across multiple solid tumor types to receive doses of PYX-201 ranging from 0.3 mg/kg up to 8.0 mg/kg. The trial's main objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. The current identified dose range for PYX-201 is 3.6 mg/kg to 5.4 mg/kg. The number of prior lines of cancer therapies for patients enrolled is a median of 4 lines and up to 10 lines in some patients. The data cutoff date for this data announcement was October 4, 2024.
Preliminary Phase 1 Clinical Response Data in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC):
Significant clinical responses were observed in HNSCC. Among evaluable HNSCC patients treated at an identified dose range of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed 50% objective response rate (ORR) was observed, including one confirmed complete response (CR) and two confirmed partial responses (PR) by RECIST 1.1.
"These encouraging preliminary clinical data demonstrate the potential for PYX-201 to yield meaningful responses in heavily pretreated patients with head and neck cancer along with several additional solid tumor types," said Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "The patients in the study have endured multiple rounds of therapy before treatment with PYX-201. We believe the quantity and quality of the responses, including a complete response and PYX-201's tolerability profile, highlight its promising potential across multiple indications with high unmet medical need, particularly in head and neck cancer."
Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data
PDF Version
— PYX-201 achieved a confirmed 50% ORR by RECIST 1.1 including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients, supporting differentiated mono and front-line combo therapy expansion trials to begin dosing 1Q25
— Overall, 26% ORR across all six Solid Tumor Types of Interest (n=31) with Dose Dependent Responses Observed, Supporting First-In-Concept Mechanism with Novel Extracellular Targeting ADC
— New Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of novel extracellular PYX-201 ADC and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) to begin dosing 1Q25 in patients with HNSCC, HR+/HER2- breast, TNBC, and sarcoma
— PYX-201 generally well-tolerated with a favorable safety profile
— Multiple data updates expected in 2025
— Company to host in-person and virtual investor event today at 4:30 p.m. ET
BOSTON, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, today announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM).
"These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma. The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25."
In this ongoing open-label, multicenter, dose-escalation Phase 1 trial of PYX-201, 80 patients have been enrolled and dosed across multiple solid tumor types to receive doses of PYX-201 ranging from 0.3 mg/kg up to 8.0 mg/kg. The trial's main objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. The current identified dose range for PYX-201 is 3.6 mg/kg to 5.4 mg/kg. The number of prior lines of cancer therapies for patients enrolled is a median of 4 lines and up to 10 lines in some patients. The data cutoff date for this data announcement was October 4, 2024.
Preliminary Phase 1 Clinical Response Data in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC):
Significant clinical responses were observed in HNSCC. Among evaluable HNSCC patients treated at an identified dose range of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed 50% objective response rate (ORR) was observed, including one confirmed complete response (CR) and two confirmed partial responses (PR) by RECIST 1.1.
"These encouraging preliminary clinical data demonstrate the potential for PYX-201 to yield meaningful responses in heavily pretreated patients with head and neck cancer along with several additional solid tumor types," said Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "The patients in the study have endured multiple rounds of therapy before treatment with PYX-201. We believe the quantity and quality of the responses, including a complete response and PYX-201's tolerability profile, highlight its promising potential across multiple indications with high unmet medical need, particularly in head and neck cancer."
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