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."
Clinical Trial Collaboration Agreement with Merck’s KEYTRUDA®
(pembrolizumab)
The Company additionally announces that it has entered into a
Clinical Trial Collaboration Agreement with Merck (known as MSD
outside of the US and Canada), for a Pyxis Oncology-sponsored study
of PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab) in patients with 1L and 2L head and neck squamous
cell carcinoma (HNSCC), HR+/HER2- breast cancer, and
triple-negative breast cancer (TNBC) and sarcoma.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Pyxis
Oncology and Merck each retain all commercial rights to their
respective compounds, including as monotherapy or as combination
therapies.
PYX-201 Development Plans in Head and Neck Squamous Cell
Carcinoma (HNSCC)
The Company expects to initiate the following HNSCC Phase 1
expansion studies:
- PYX-201 and KEYTRUDA® combination dose escalation and expansion
study in 1L and 2L HNSCC with preliminary clinical data readout
expected in the second half of 2025;
- PYX-201 monotherapy study in 2L and 3L HNSCC patients who are
platinum and PD-1 inhibitor experienced, with preliminary clinical
data readout expected in the second half of 2025; and
- PYX-201 monotherapy study in 2L and 3L HNSCC patients who are
EGFR and PD-1 inhibitor experienced, with preliminary clinical data
readout expected in first half of 2026.
Preliminary Phase 1 Clinical Response Data in Additional
Solid Tumor Types:
Encouraging confirmed and unconfirmed responses were observed in
five additional solid tumor types: ovarian cancer, non-small cell
lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative
breast cancer (TNBC), and sarcoma.
PYX-201 Development Plan in Additional Tumor Types
Exploratory PYX-201 Phase 1 monotherapy expansion cohorts are
planned in ovarian cancer, NSCLC, HR+/HER2- breast cancer, TNBC,
and sarcoma, with preliminary clinical data expected in the second
half of 2025.
The Company also expects to initiate the following clinical
combination studies:
- PYX-201 and KEYTRUDA® combination study in HR+/HER2- breast
cancer, TNBC, and sarcoma with preliminary clinical data expected
in the second half of 2025 and the first half of 2026.
- Preclinical studies of PYX-201 in combination with other agents
in ovarian cancer and NSCLC to commence in 2025 to be followed by
clinical studies with preliminary clinical data expected in
2026.
Summary of Preliminary Phase 1 Safety and
Pharmacokinetics (PK) Data:
PYX-201 demonstrated favorable preliminary tolerability profile
data with low incidence of dose discontinuation, interruptions or
delays due to treatment-related adverse events (TRAE). Low
incidence of Grade 3 or Grade 4 payload-related TRAEs within the
identified dose range reinforce PYX-201’s differentiated construct
enabling enhanced molecular stability and differential expression
of Extradomain-B (EDB) in tumor tissue with negligible expression
in normal tissues. The low incidence of Grade 1 or Grade 2 adverse
events points to an attractive safety, given that it has been well
tolerated and suitable for both monotherapy and combination therapy
development.
With respect to PK data, PYX-201 demonstrated increased
stability in circulation, which we believe is due to its
proprietary design of site-specific conjugation chemistry as
compared to certain approved val-cit-monomethyl auristatin E (MMAE)
ADCs with non-site-specific conjugation chemistry.
"PYX-201 is an innovative investigational therapy designed with
a unique extracellular mechanism of action, unlike any other ADC
currently on the market or in development. These initial clinical
data, demonstrating tumor shrinkage across a broad range of solid
tumors with a differentiated safety profile indicate a significant
opportunity to further develop PYX-201 across a variety of tumor
types in both the mono and combo therapy settings," said Anthony
Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive Officer of
NEXT Oncology and PYX-201 Study Investigator. "Additionally, the
encouraging safety data support the potential for PYX-201 to be
safely combined with other agents, including checkpoint inhibitors,
to drive further patient responses."
Additional details and analyses beyond what have been included
in this press release will be presented during the Company's
preliminary PYX-201 Phase 1 data investor event today.
In-person and Virtual Investor Event
Information
Pyxis Oncology will host a virtual and in-person investor event
to discuss the preliminary Phase 1 data today, Wednesday, November
20, 2024, at 4:30 p.m. ET at Venue 42 by Convene, located at 5
Times Square in New York City. Anyone interested in attending the
live event should RSVP to pyxis.oncology.data.event.
Pyxis Oncology’s members of executive management team will be
joined by the following physician thought leaders to discuss
preliminary data from the Phase 1 trial:
- Anthony Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive
Officer, NEXT Oncology
- 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
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical stage company focused on
defeating difficult-to-treat cancers. The company is efficiently
building next generation therapeutics that hold the potential for
mono and combination therapies. PYX-201, an antibody-drug conjugate
(ADC) that uniquely targets EDB+FN, a non-cellular structural
component of the tumor extracellular matrix, and PYX-106, a fully
human Siglec-15-targeting antibody designed to block suppression of
T-cell proliferation and function, are being evaluated in ongoing
Phase 1 clinical studies in multiple types of solid tumors. Pyxis
Oncology’s therapeutic candidates are designed to directly kill
tumor cells and to address the underlying pathologies created by
cancer that enable its uncontrollable proliferation and immune
evasion. Pyxis Oncology’s ADC and immuno-oncology (IO) programs
employ novel and emerging strategies to target a broad range of
solid tumors resistant to current standards of care. To learn more,
visit www.pyxisoncology.com or follow us on X (formerly
known as Twitter) and LinkedIn.
Forward Looking Statements
This press release contain forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
All statements other than statements of historical facts contained
in this presentation and press release, including without
limitation statements regarding the Company's plans to develop,
manufacture and commercialize its product candidates, including
PYX-201; initial results, timing and progress of the Company's
ongoing clinical trials; the expected results of the Company's
clinical trials; the ability of initial and topline clinical data
to de-risk PYX-201 and be confirmed with clinical trial
progression, including the safety, tolerability, and potential
efficacy of PYX-201; the potential differentiation, advantage or
effectiveness of PYX-201 compared to other approved products
or products in development; the dosage and treatment potential of
PYX-201; the size and future of the market; the plans and
objectives of management, and the future results of operations and
financial position of the Company, are forward-looking statements.
These statements are neither promises nor guarantees, but are
statements that involve known and unknown risks, uncertainties and
other important factors that are in some cases beyond the Company's
control that may cause actual results, performance or achievements
to be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the risks
inherent in drug research and development, the Company's projected
cash runway and potential needs for additional funding; the
lengthy, expensive, and uncertain process of clinical drug
development, including potential delays in or failure to obtain
regulatory approvals; the Company's reliance on third parties and
collaborators to conduct clinical trials, manufacture their product
candidates, and develop and commercialize their product candidates;
and the Company's ability compete successfully against other drug
candidates. Accordingly, investors should not rely upon
forward-looking statements as predictions of future events. Except
as required by applicable law, the Company undertakes no obligation
to update publicly or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Pyxis Oncology ContactPamela Connealy CFO
and COO ir@pyxisoncology.com
Grafico Azioni Pyxis Oncology (NASDAQ:PYXS)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Pyxis Oncology (NASDAQ:PYXS)
Storico
Da Dic 2023 a Dic 2024