Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company
focused on developing next-generation therapeutics to target
difficult-to-treat cancers, today announced dosing of the first
subject in the Phase 1 trial of PYX-106. PYX-106 is a fully human
immunotherapy antibody candidate that is designed to block the
activity of Siglec-15, an immune suppressor expressed across a
broad range of tumors. 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 are excited to announce dosing of the first
subject in the Phase 1 trial of PYX-106 and we are enthusiastic
about the potential PYX-106 may hold for patients, particularly
those not well served by currently available immunotherapies,” said
Lara S. Sullivan, M.D., President and Chief Executive Officer of
Pyxis Oncology. “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.”
Webcast Presentation at Jefferies Healthcare Conference,
June 7, 2023Pyxis Oncology will present a corporate
overview at the Jefferies Healthcare Conference at 4:00 pm ET on
June 7, 2023. Lara S. Sullivan, M.D., President and Chief Executive
Officer, and Pyxis Oncology management team members will be
available during the conference for one-on-one meetings with
investors. A live webcast of the presentation can be accessed on
the Investors section of the Pyxis Oncology website at
ir.pyxisoncology.com. Following the live event, a replay of the
webcast will be archived for up to 90 days.
About PYX-106-101 PYX-106-101
(NCT05718557) is an open-label, multicenter, Phase 1 dose
escalation trial designed to evaluate the safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of
PYX-106 in patients with advanced solid tumors in order to
determine the recommended dose(s) for future study. Patients with
relapsed or refractory solid tumors known to have significant
infiltration of M2 macrophages and expression of Siglec-15,
including non-small cell lung cancer, breast cancer, endometrial
cancer, thyroid cancer, kidney cancer, cholangiocarcinoma, bladder
cancer, colorectal cancer, and head and neck squamous cell
carcinoma, are eligible to enroll.
About PYX-201-101PYX-201-101
(NCT05720117) is an open-label, multicenter, Phase 1
dose-escalation trial designed to evaluate the safety,
tolerability, pharmacokinetics, pharmacodynamics, and preliminary
efficacy of PYX-201. Patients with relapsed or refractory solid
tumors known to have significant expression of EDB of fibronectin,
including with relapsed or refractory solid tumors, including
non-small cell lung cancer, hormone receptor positive breast
cancer, ovarian cancer, thyroid cancer, pancreatic ductal
adenocarcinoma, soft tissue sarcoma, hepatocellular carcinoma or
kidney cancer are eligible to enroll.
About PYX-106PYX-106 is a fully
human immunotherapy antibody candidate in development that blocks
the activity of Siglec-15, an emerging immune suppressor expressed
across a broad range of tumors. Siglec-15 expression does not
overlap with one of the most common targets in immuno-oncology,
PD-1, supporting its potential use alone and in combination with
current immunotherapies. PYX-106 may benefit patients who do not
respond to current standards of care. In preclinical studies,
PYX-106 has demonstrated broad immune activation, strong binding
affinity, and a 7-day half-life. Cumulatively, these advantages may
translate to superior anticancer activity and more flexible dosing
regimens.
About PYX-201PYX-201 is 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. EDB fibronectin is overexpressed in
many solid tumors and minimally expressed in most normal adult
tissues.
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. 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 antibody-drug
conjugates (ADCs) 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 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 May 11,
2023, and in our other filings with the SEC. Among other
things, there can be no guarantee that the proposed business
combination will be completed in the anticipated timeframe or at
all, that the conditions required to complete the proposed
combination will be met, that the combined company will realize the
expected benefits of the proposed business combination, if any,
that the clinical stage assets will progress on anticipated
timelines or at all, that the combined company will be successful
in progressing its pipeline through development and the regulatory
approval process. 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.
No Offer or Solicitation
This press release is not a proxy statement or
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the proposed business combination
and shall not constitute an offer to sell or a solicitation of an
offer to buy any securities nor shall there be any sale of
securities in any state or jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction. No offer of securities shall be made except by means
of a prospectus meeting the requirements of the Securities Act.
Important Additional Information Will Be
Filed with the SEC
Pyxis Oncology plans to file with the SEC a
Registration Statement on Form S-4 in connection with the
transactions and Apexigen plans to file with the SEC and mail to
Apexigen stockholders a Proxy Statement/Prospectus in connection
with the transactions. Investors and security holders are urged to
read the Registration Statement and the Proxy Statement /
Prospectus carefully when they are available before making any
voting or investment decision with respect to the proposed
transactions. The Registration Statement and the Proxy statement /
Prospectus will contain important information about Pyxis Oncology,
Apexigen, the transactions and related matters. Investors and
security holders will be able to obtain free copies of the
Registration Statement and the Proxy Statement / Prospectus and
other documents filed with the SEC by Pyxis Oncology and Apexigen
through the web site maintained by the SEC at www.sec.gov. In
addition, investors and security holders will be able to obtain
free copies of the Registration Statement and the Proxy Statement /
Prospectus from Pyxis Oncology by contacting ir@pyxisoncology.com
or from Apexigen by contacting ir@apexigen.com.
Participants in the
Solicitation
Pyxis Oncology and Apexigen and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies in respect of the transactions
contemplated by the merger agreement. Information regarding Pyxis
Oncology’s directors and executive officers is contained in Pyxis
Oncology’s proxy statement dated April 28, 2023, which is filed
with the SEC. Information regarding Apexigen’s directors and
executive officers is contained in Apexigen’s Annual Report dated
February 22, 2023, which is filed with the SEC. Additional
information regarding the persons who may be deemed participants in
the proxy solicitation and a description of their direct and
indirect interests in the proposed business combination will be
available in the Registration Statement and the Proxy Statement /
Prospectus.
Pyxis Oncology ContactJennifer
Davis Ruffir@pyxisoncology.com
Media ContactJason Braco,
Ph.D.jbraco@lifescicomms.com
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