PYX-106 / Biosion, Pyxis Oncology - LARVOL DELTA

Study of PYX-106 in Solid Tumors (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: Pyxis Oncology, Inc | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2024 ➔ Aug 2025

Enrollment closed • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Pyxis Oncology shelves antibody to focus on sole clinical asset, an ADC licensed from Pfizer (FierceBiotech) - P1 | N=60 | NCT05718557 | Sponsor: Pyxis Oncology, Inc | "The Boston biotech is suspending clinical investments for PYX-106, a candidate Pyxis in-licensed from China-based Biosion in 2022 for $10 million upfront, according to a release shared after market close Dec. 19. Biosion retained rights in China to the anti-Siglec-15 antibody...The study, which was still listed as recruiting on ClinicalTrials.gov as of Nov. 25, found the candidate to be generally safe and well tolerated across all tested doses, which range from 0.5 mg/kg to 22.5 mg/kg. A maximum tolerated dose wasn’t established...Pyxis didn't mention an objective response from the study, an omission William Blair analysts interpret as 'PYX-106 not providing any meaningful clinical benefit,' according to a Dec. 19 note. Given that interpretation, the analyst agrees with the company's decision to discontinue the program."

Discontinued • P1 data • Solid Tumor

Associations of the immunomodulatory molecule Siglec-15 gene and protein expression to immune gene signatures as a potential biomarker for Siglec-15 targeted therapy in non-small cell lung cancer (SITC 2024) - P1 | "Siglec-15 is a novel immunosuppressive protein expressed on tumor associated macrophages (TAMs) and tumor cells in many indications and is currently under clinical investigation (PYX-106, NCT05718557)...The co-expression of Siglec-15 and PD-L1 in tumors may inform indication selection for combination therapies. Future studies will expand this data set for NSCLC and evaluate other indications."

Biomarker • Gene Signature • Immunomodulating • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • SIGLEC15

PYX-106, a highly differentiated anti-Siglec-15 monoclonal antibody, reverses Siglec-15 mediated immune suppression and enhances cytotoxic activity in human lymphocytes (SITC 2024) - P1 | "Conclusions These findings support that PYX-106 could serve as a potent therapeutic antibody for a broad array of cancer indications, including those non-responsive to conventional immunotherapies. PYX-106 is a promising immunotherapy which is currently under investigation in a Phase I clinical trial (NCT05718557)."

IO biomarker • Oncology • IFNG • SIGLEC15 • TNFA

Pyxis Oncology Provides Corporate Update and Reports Financial Results for Third Quarter 2024 (GlobeNewswire) - "PYX-106: Dose escalation of PYX-106 and safety monitoring is ongoing with 45 subjects dosed to date in the Phase 1 trial; The Company expects to report preliminary data from the Phase 1 trial of PYX-106, including PK/pharmacodynamic results, by year-end 2024."

P1 data • Trial status • Oncology • Solid Tumor

Pyxis Oncology Provides Corporate Update and Reports Financial Results for Second Quarter 2024 (GlobeNewswire) - "Recent Clinical Program Updates:...PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, is being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors. Dose escalation of PYX-106 and safety monitoring is ongoing with 33 subjects dosed to date in the Phase 1 trial. The Company expects to report preliminary data from the Phase 1 trial of PYX-106, including PK/pharmacodynamic results, by year-end 2024."

P1 data • Trial status • Solid Tumor

Study of PYX-106 in Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Pyxis Oncology, Inc | N=45 ➔ 60 | Trial primary completion date: Apr 2024 ➔ Dec 2024

Enrollment change • Metastases • Trial primary completion date • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Pyxis Oncology Provides Corporate Update and Reports Financial Results for First Quarter 2024 (GlobeNewswire) - "Research and development expenses were $13.0 million for the quarter ended March 31, 2024, compared to $11.9 million for the quarter ended March 31, 2023. The period-over-period increase was primarily due to increased clinical trial-related expenses for our ongoing Phase 1 clinical trials of PYX-201 and PYX-106."

Commercial • Oncology • Solid Tumor

Pyxis Oncology Provides Corporate Update and Reports Financial Results for Fourth Quarter and Full Year 2023 (GlobeNewswire) - "PYX-106 in the PYX-106-101 trial: Phase 1 trial focusing on NSCLC and other tumor types. Study dosing is ongoing with 21 subjects dosed to date and Cohort 5 is fully enrolled at 8 mg/kg administered once every two weeks. Preliminary data is anticipated in 2H 2024."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pyxis Oncology to Present New PYX-201, PYX-106 and PYX-102 Preclinical Data at AACR Annual Meeting (GlobeNewswire) - '"Data from PDX tumor preclinical models has shown potent anti-tumor activity in multiple human cancer indications. We will also demonstrate that the overexpression of EDB+FN, the molecular target of PYX-201, is consistently observed in various human tumor types, with minimal expression observed in healthy tissue. For our PYX-106 program, we will also present encouraging preclinical data supporting the clinical opportunity of this immune-oncology therapeutic candidate to potentially demonstrate clinical activity in individuals that are not candidates for anti-PD-(L)1 approaches. Finally, we will present anti-tumor efficacy data supporting the potential for PYX-102 as a therapeutic candidate, and remain open to out-licensing opportunities for future development.'"

Preclinical • Oncology • Solid Tumor

First-in-human, open-label, multicenter, phase 1 clinical study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of anti Siglec-15 PYX-106 in subjects with advanced solid tumors (SITC 2023) - P1 | "1 criteria and safety findings are reviewed by the dose escalation steering committee, which monitors the safety and recommends dose(s) for Part 2. The study population includes participants with histologically or cytologically confirmed solid tumors including non-small cell lung cancer (without driver mutations/translocations), breast cancer, endometrial cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder cancer, colorectal cancer, and head and neck squamous cell carcinoma."

Clinical • IO biomarker • Metastases • P1 data • PK/PD data • Biliary Cancer • Bladder Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • CD4 • CD8 • IFNG • SIGLEC15

Pyxis Oncology Announces Four Abstracts Accepted for Poster Presentation at Society for Immunotherapy of Cancer (SITC) 2023 (GlobeNewswire) - "Pyxis Oncology, Inc...announced four abstracts for four different assets have been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting to be held November 1-5, 2023, in San Diego....'We continue to expect to see preliminary data from this study, including biomarker results and early signs of potential clinical activity, in early 2024.'"

P1 data • Preclinical • Oncology • Solid Tumor

Pyxis Oncology Successfully Completes Acquisition of Apexigen (GlobeNewswire) - "Cash runway maintained into 1H 2025, enabling the Company to evaluate early signs of potential clinical activity for PYX-201 and PYX-106; Guidance on development strategy, timelines and milestones for the newly acquired Phase 2 sotigalimab CD40 agonist to be shared in 4Q23....Pyxis Oncology, Inc...announced the successful completion of its acquisition of Apexigen, Inc. ('Apexigen'), a clinical-stage biopharmaceutical company focused on discovering and developing innovative antibody therapeutics for oncology, in an all-stock transaction valued at approximately $10.7 million. The combined company is positioned at the forefront of ADC innovation with a platform that now includes four key components: novel humanized antibody generation capabilities, an expanded library of linkers with improved stability, site specific conjugation chemistries, and optimized payloads."

M&A • Oncology

Pyxis Oncology Advances PYX-106 and PYX-201 Clinical Programs (GlobeNewswire) - "Pyxis Oncology, Inc...announced dosing of the first subject in the Phase 1 trial of PYX-106....The Company also announced that the second dose level has been initiated in the ongoing Phase 1 trial of PYX-201, a novel antibody-drug conjugate (ADC) product candidate licensed from Pfizer targeting extradomain-B (EDB) of fibronectin, a non-internalizing antigen that is an integral component of the extracellular matrix in tumors....'We expect to see preliminary data from each of our ongoing Phase 1 trials of PYX-106 and PYX-201, including biomarker results and potential early signs of clinical activity, in the late-2023 to early-2024 timeframe'."

Biomarker • P1 data • Trial status • Oncology • Solid Tumor

Pyxis Oncology Reports Financial Results for the First Quarter 2023 and Provides Corporate Update (GlobeNewswire) - "Clinical sites are active and patient screening continues in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin during the second quarter of 2023. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for PYX-201 in pancreatic cancer, and subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101....'We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from both trials in the late-2023 to early-2024 timeframe'."

Orphan drug • P1 data • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Pyxis Oncology Reports Financial Results for the Fiscal Year Ended December 31, 2022, and Provides Corporate Update (GlobeNewswire) - "Two Phase 1 trials initiated: Clinical sites are being activated and patient screening is ongoing in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin early in the second quarter of 2023. Subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101. Preliminary data are anticipated from both trials in the late-2023 to early-2024 timeframe."

Enrollment status • P1 data • Trial status • Oncology • Solid Tumor

Study of PYX-106 in Solid Tumors (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Pyxis Oncology, Inc

Metastases • New P1 trial • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Pyxis Oncology Announces FDA Clearance of Two IND Applications (GlobeNewswire) - "Pyxis Oncology...announced today that it has received clearance for its two Investigational New Drug (IND) applications from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-201, a novel antibody-drug conjugate (ADC) product candidate, will be investigated for the potential treatment of several solid tumors, including breast, head and neck, lung, and thyroid cancer. PYX-106, an immunotherapy product candidate, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer....'We look forward to beginning both clinical trials in early 2023'."

IND • New P1 trial • Biliary Cancer • Biliary Tract Cancer • Bladder Cancer • Breast Cancer • Cholangiocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Thyroid Gland Carcinoma

Pyxis Oncology Reports Financial Results for the Quarter Ended September 30, 2022 and Provides Corporate Update (GlobeNewswire) - "Pyxis Oncology remains on track with its IND plans for PYX-106 and PYX-201 by the end of this year. The company remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer, breast cancer, and other solid tumors. PYX-106 is a highly potent immunotherapy that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors."

IND • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Pyxis Oncology Reports Financial Results for the Second Quarter Ended June 30, 2022 and Provides Pipeline Update (GlobeNewswire) - "Pyxis Oncology is on track to file Investigational New Drug applications (INDs) for PYX-201 and PYX-106 in 2022; The Company will pause the preclinical development of PYX-203 and PYX-102."

IND • Preclinical • Oncology

Pyxis Oncology Reports Financial Results for the Quarter Ended March 31, 2022 and Provides Business Update (GlobeNewswire) - "Pyxis Oncology, Inc...today reported financial results for its first quarter ended March 31, 2022. The Company ended the quarter with approximately $247 million in cash and cash equivalents. Pyxis Oncology remains on target to file INDs for anti-EDB, PYX-201, and anti-Siglec-15, PYX-106, in the second half of 2022 and INDs for anti-CD123, PYX-203, and anti-KLRG1, PYX-102, in the second half of 2023. Further, as previously disclosed, the Company expects to provide an update on its anti-DLK1 ADC, PYX-202, in mid-2022."

IND • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Ovarian Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thoracic Cancer • Triple Negative Breast Cancer • Uterine Cancer

BSI-060T, a high affinity, fully human anti-siglec-15 antibody as an alternative immune checkpoint blocker (AACR 2022) - "BSI-060T exhibits best-in-class biophysical properties and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies."

Checkpoint inhibition • IO biomarker • IO Companion diagnostic • PD(L)-1 companion diagnostic • Oncology • Solid Tumor • CD4 • CD8 • IFNG • PD-L1 • SIGLEC15

Pyxis Oncology Announces Preclinical Data on Anti-Siglec-15 BSI-060T (PYX-106) Presented by Biosion, Inc. at the 2022 American Association for Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Preclinical data support IND filing in 2H 2022...Key findings from the presentation include: PYX-106 binds to Siglec-15 with high affinity and blocks the interaction between Siglec-15 and its putative receptor in vitro. PYX-106 shows cross-reactivity to monkey and mouse Siglec-15 in vitro. In ex vivo T cell response assays, PYX-106 relieves Siglec-15-mediated inhibition of CD8+ and CD4+ T cell proliferation and interferon-γ release. In a humanized Siglec-15 mouse syngeneic tumor model, PYX-106 shows significant inhibition of tumor growth and was well-tolerated. PYX-106 also exhibits excellent pharmacokinetics in a non-human primate study."

IND • Preclinical • Oncology

"#Biosion licenses #BSI060T (#AntiSiglec15) to #PyxisOncology $PYXS https://t.co/9TC4aNZRIZ" (@1stOncology)

Oncology • SIGLEC15

Pyxis Oncology Provides Corporate and Financial Update (GlobeNewswire) - "The American Academy for Cancer Research (AACR) has accepted an abstract submitted by Biosion for PYX-106. The poster will be made available at the start of the AACR Annual Meeting on April 8, 2022....The Company will continue to monitor the progress of its PYX-202 program and expects to provide an update about PYX-202 in mid-2022....Pyxis Oncology expects to file INDs for anti-EDB, PYX-201, and anti-CD123, PYX-203, in the second half of 2022 and in the second half of 2023, respectively."

Preclinical • Oncology • Solid Tumor