Core Viewpoint - Pyxis Oncology is prioritizing its lead asset, PYX-201, a novel antibody-drug conjugate (ADC) targeting difficult-to-treat cancers, particularly head and neck squamous cell carcinoma (HNSCC) [1][8] Group 1: PYX-201 Development - PYX-201 has shown significant RECIST responses in HNSCC, with a confirmed 50% objective response rate (ORR) in a Phase 1 trial [2] - The drug achieved a disease control rate (DCR) of 100% in a small cohort of heavily pretreated patients [2] - Across six solid tumor types, PYX-201 achieved a 26% ORR, indicating potential for further development in both monotherapy and combination therapy settings [3] Group 2: Clinical Trials and Future Plans - The company plans to initiate patient dosing for both monotherapy and combination therapy trials in early 2025, including a frontline HNSCC study in combination with pembrolizumab [3][4] - Preliminary data from ongoing dose expansion studies is expected in the second half of 2025 and the first half of 2026 [4] Group 3: Financial Outlook - The current cash position is projected to fund the development of PYX-201 into the second half of 2026 [9] Group 4: Pipeline Prioritization - The company has deprioritized its second clinical program, PYX-106, to focus resources on advancing PYX-201 [6][8] - PYX-106 was observed to be generally safe and well-tolerated, but further clinical investment has been suspended [7][8]

On Wednesday, Pyxis Oncology, Inc. PYXS released preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple solid tumors.Among evaluable Head and Neck Squamous Cell Carcinoma (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).The company additionally announced a Clinical Trial ...

— 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40881 | --- | --- | |----------------------------------------------------------------------------|------------------------------------------| | Pyxis Oncology, ...

Core Insights - Stephens has initiated coverage on Pyxis Oncology Inc, emphasizing the company's technology platform for next-gen antibody-drug conjugates (ADCs) with improved potency, stability, and tolerability [1] - The lead drug, PYX-201, targets Extradomain-B Fibronectin (EDB+FN) in tumor stroma and delivers a toxic payload into the tumor microenvironment [1] - The analyst has given an Overweight rating with a price target of $13 [1] ADC Technology Potential - The ADC technology has demonstrated strong potential, with recent successes enhancing confidence in market growth [2] - Pyxis has shown that proteases and acidic conditions in the tumor stroma can effectively break down the payload linker, similar to cellular absorption processes [2] Clinical Trial Updates - The company is set to announce results from the first phase of its human clinical trial for PYX-201, which targets various solid tumors, with updates expected this month [3] - Positive results, including partial or complete responses and a favorable safety profile at doses above 3.6 mg/kg, are anticipated [3] Financial Position - As of June 30, 2024, Pyxis Oncology reported cash and cash equivalents of $157.2 million, which includes restricted cash and short-term investments [4] - The current financial resources are projected to fund operations into the second half of 2026 [4] - The stock price of PYXS was noted at $4.42, reflecting a 12.2% change at the last check [4]

NEW YORK, Sept. 25, 2024 /PRNewswire/ -- Levi & Korsinsky announces that it has commenced an investigation of Pyxis Oncology, Inc. (NASDAQ:PYXS) concerning possible breaches of fiduciary duty. To obtain additional information, go to: https://zlk.com/compensation2/pyxis-oncology-inc-lawsuit-submission-form or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212) 363-7500. There is no cost or obligation to you. Levi & Korsinsky is a nationally recognized firm with offices ...

RapidEye/iStock via Getty Images Pyxis Oncology (NASDAQ:PYXS) is an antibody and antibody-drug conjugate (ADC) developer that I covered back in March. At that time, I rated it a hold, as the company had the funds it needed to run its trials, but there was no near-term clinical catalyst. This article looks at updates from the company and the near-term catalyst of PYX-201 data. The clinical timeline While I lamented slippage to the timeline of clinical readouts in my previous article on PYXS, the timeline for ...

BOSTON, Aug. 29, 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 that Lara S. Sullivan, M.D., President and Chief Executive Officer, will participate in fireside chats and members of management will participate in one-on-one meetings at the following two upcoming investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference in New York, NY, on Septem ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40881 | --- | --- | |----------------------------------------------------------------------------|------------------------------------------| | | | | | | | Pyxis On ...

Pyxis Oncology Provides Corporate Update and Reports Financial Results for Second Quarter 2024 - Preliminary data from the Phase 1 trial of PYX-201 remains on track to be announced in the fall of 2024 - Preliminary data from the Phase 1 trial of PYX-106 is expected to be reported by year-end 2024 - Expected cash runway into 2H 2026 BOSTON, Mass., August 14, 2024 – Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat can ...