Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company
developing next-generation therapeutics for difficult-to-treat
cancers, today announced significant progress in its clinical
program for PYX-201, a first-in-concept antibody-drug conjugate
(ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a
non-cellular structural component within the tumor extracellular
matrix (ECM), which is highly expressed in various tumor types.
Two PYX-201 trials are now actively recruiting and are designed
to evaluate PYX-201 as monotherapy in patients with
recurrent/metastatic (R/M) head and neck squamous cell carcinoma
(HNSCC) and PYX-201 in combination with Merck’s anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other
advanced solid tumors. The combination trial is part of a recently
announced Clinical Trial Collaboration Agreement with Merck (known
as MSD outside of the US and Canada).
The Phase 1/2 combination study, PYX-201-102, is now actively
recruiting and is on track to initiate dosing patients in Q1 2025
as planned. This Pyxis Oncology sponsored trial is investigating
the novel extracellular targeting ADC PYX-201 in combination with
pembrolizumab in multiple indications including but not limited
to:
- First-line (1L) and second line + (2L+) R/M HNSCC
- Hormone receptor-positive (HR+) and human epidermal growth
factor receptor 2 negative (HER2- BC) breast cancer
- Advanced or metastatic triple-negative breast cancer
(TNBC)
"PYX-201 is designed to specifically deliver its AUR-0101
payload within the tumor microenvironment (TME) and has been shown
to induce immunogenic cell death. When combined with pembrolizumab,
PYX-201 may have the potential to enhance the oncologic responses
observed with pembrolizumab, by allowing activated T cells to
infiltrate TMEs that are often inaccessible and inhospitable," said
Lara S. Sullivan, M.D., President and Chief Executive Officer of
Pyxis Oncology. Dr. Sullivan continued, “Treatment options for many
patients with advanced solid tumors remain limited, and we are
eager to explore this promising therapeutic approach.”
In addition, the Part 2 monotherapy expansion cohorts of the
ongoing Phase 1 PYX-201-101 study have begun enrolling
patients. The expansion phase includes the following
cohorts across sites in the US, EU and other countries:
- PYX-201 monotherapy for 2L and third line (3L) R/M HNSCC
patients who have received prior platinum and PD-1 inhibitor
therapy
- PYX-201 monotherapy for 2L and 3L R/M HNSCC patients who have
received prior EGFR and PD-1 inhibitor therapy
Pyxis Oncology is committed to delivering innovative therapies
for cancer patients with limited treatment options. These ongoing
trials represent a critical step forward in advancing PYX-201 as a
potential breakthrough treatment for a broad range of cancers.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About PYX-201-101 Clinical StudyPYX-201-101
(NCT05720117) is an ongoing Phase 1 dose escalation (Part 1) and
dose expansion (Part 2) study evaluating PYX-201 monotherapy in
participants with advanced solid tumors predicted to express
EDB+FN, an extracellular matrix protein that is highly expressed in
tumor stroma across several human cancer types.
About PYX-201-102 Clinical StudyPYX-201-102
(NCT06795412) is a Phase 1/2, open-label, global, multicenter,
dose-escalation and dose-expansion study to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics, and preliminary
efficacy of PYX-201 in combination with pembrolizumab in
participants with advanced solid tumors. Patients with
histologically or cytologically confirmed advanced solid tumors,
including first-line (1L) R/M head and neck squamous cell carcinoma
(HNSCC), advanced or metastatic triple-negative breast cancer
(TNBC), hormone receptor-positive (HR+) and human epidermal growth
factor receptor 2 negative breast cancer (HER2- BC), gastric cancer
(GC), cervical cancer, and second-line and higher (2L+) R/M HNSCC
are eligible to enroll.
About PYX-201PYX-201, an antibody-drug
conjugate (ADC) with a microtubule inhibitor (optimized auristatin)
payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a
non-cellular structural component of the tumor extracellular matrix
(ECM), is the company’s lead clinical drug candidate.
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 monotherapy and
combination indications. PYX-201, an antibody-drug conjugate (ADC)
that uniquely targets EDB+FN, a non-cellular structural component
of the tumor extracellular matrix, is being evaluated in ongoing
Phase 1 clinical studies in multiple types of solid tumors. Pyxis
Oncology’s therapeutic candidates are designed to directly kill
cancer cells and to address factors in the microenvironment that
enable the uncontrolled proliferation and immune evasion of
malignant tumors. Pyxis Oncology’s ADC and immuno-oncology (IO)
programs employ novel and emerging strategies to target a broad
range of solid tumors resistant or refractory 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 StatementsThis press release
contains 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. These statements are
often identified by the use of words such as “anticipate,”
“believe,” “can,” “continue,” “could,” “estimate,” “expect,”
“intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,”
“potential,” “predict,” “project,” “should,” “to be,” “will,”
“would,” or the negative or plural of these words, or similar
expressions or variations, although not all forward-looking
statements contain these words. We cannot assure you that the
events and circumstances reflected in the forward-looking
statements will be achieved or occur and actual results could
differ materially from those expressed or implied by these
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to, those
identified herein, and those discussed in the section titled “Risk
Factors” set forth in Part II, Item 1A. of the Company’s Quarterly
Report on Form 10-Q filed with SEC on November 12, 2024, and our
other filings, each of which is on file with the Securities and
Exchange Commission. These risks are not exhaustive. New risk
factors emerge from time to time, and it is not possible for our
management to predict all risk factors, nor can we assess the
impact of all factors on our business or the extent to which any
factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking
statements. In addition, statements that “we believe” and similar
statements reflect our beliefs and opinions on the relevant
subject. These statements are based upon information available to
us as of the date hereof and while we believe such information
forms a reasonable basis for such statements, such information may
be limited or incomplete, and our statements should not be read to
indicate that we have conducted an exhaustive inquiry into, or
review of, all potentially available relevant information. These
statements are inherently uncertain, and investors are cautioned
not to unduly rely upon these statements. Except as required by
law, we undertake no obligation to update any forward-looking
statements to reflect events or circumstances after the date of
such statements.
Pyxis Oncology ContactPamela Connealy CFO and
COO ir@pyxisoncology.com
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