Pfenex and Arcellx Announce a Development, Evaluation and License Agreement
August 01 2019 - 7:10AM
Pfenex Inc. (NYSE American: PFNX) and Arcellx, Inc. today announced
a Development, Evaluation and License agreement under which Arcellx
gains access to the proprietary Pfenex Expression Technology®
platform to advance multiple proprietary sparX proteins that
activate, silence and reprogram Antigen- Receptor Complex T cell
based therapies. Pfenex has successfully completed expression
screening and process development activities for the first sparX
program. Technology transfer of the program to a cGMP manufacturing
facility is underway. The success of the first program has
encouraged both parties to initiate a second sparX program, both
programs are focused on the treatment of hematologic malignancies.
Under the terms of the agreement, Pfenex is
eligible to receive development funding in addition to development,
regulatory and commercial milestones ranging from $2.6M up to $18M
for each product incorporating a SparX protein expressed using the
Pfenex Expression Technology® as well as royalties on worldwide
sales of any such products.
“Our collaboration with Arcellx fits our
strategy of leveraging the Pfenex protein production platform to
advance our products and those of our collaborators. Pfenex’s
success with the first sparX program further validates the
versatility of our proprietary protein expression platform and the
quality of our development capabilities. We look forward to
collaborating with Arcellx through the combination of our
respective platforms in support of developing new therapies for
patients in need.” said Eef Schimmelpennink, chief executive
officer of Pfenex.
“The uniquely efficient protein expression
technologies and process expertise developed by Pfenex have been
critical in accelerating development of our first sparX program,”
said David Hilbert, chief executive officer of Arcellx. “Our
continued development of new sparX programs provides the basis for
a forward looking Pfenex collaboration involving multiple sparX
proteins with the potential to revolutionize immune cell
therapies.”
About Pfenex Inc.Pfenex is a
clinical-stage development and licensing biotechnology company
focused on leveraging its Pfēnex Expression Technology® to develop
and improve protein therapies for unmet patient needs. Using the
patented Pfēnex Expression Technology platform, Pfenex has created
an advanced pipeline of therapeutic equivalents, vaccines,
biologics and biosimilars. Pfenex also uses its Pfēnex Expression
Technology platform to produce CRM197, a diphtheria toxoid carrier
protein used in prophylactic and therapeutic vaccines. Pfenex’s
lead product candidate is PF708, a therapeutic equivalent candidate
to Forteo® (teriparatide) for the treatment of osteoporosis. In
addition, Pfenex is developing hematology/oncology products,
including PF743, a recombinant crisantaspase, and PF745, a
recombinant crisantaspase with half-life extension technology, in
collaboration with Jazz Pharmaceuticals.
Pfenex investors and others should note that
Pfenex announces material information to the public about Pfenex
through a variety of means, including its website
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(http://pfenex.investorroom.com/), press releases, SEC filings,
public conference calls, corporate Twitter account
(https://twitter.com/pfenex), Facebook page
(https://www.facebook.com/Pfenex-Inc- 105908276167776/timeline/),
and LinkedIn page (https://www.linkedin.com/company/pfenex-inc) in
order to achieve broad, non-exclusionary distribution of
information to the public and to comply with its disclosure
obligations under Regulation FD. Pfenex encourages its investors
and others to monitor and review the information Pfenex makes
public in these locations as such information could be deemed to be
material information. Please note that this list may be updated
from time to time.
About Arcellx, Inc. Arcellx is
a privately held development-stage company devoted to providing
patients with superior immune cell therapies through scientific
innovation, accelerated development, and responsible patient
care. Our lead programs target cancer with first-in-class
adaptive immune cells called Antigen-Receptor Complex T cells
(ARC-T) that are readily silenced, activated, and reprogrammed by a
sparX protein therapeutic. Although our initial clinical
focus is cancer therapy, we are committed to extending our
therapies across a broad spectrum of human disease.
Cautionary Note Regarding Forward-Looking
StatementThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements generally relate to
future events or Pfenex's future financial or operating
performance. In some cases, you can identify forward-looking
statements because they contain words such as "may," "will,"
"should," "expects," "plans," "anticipates," "could," "intends,"
"target," "projects," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negative of these
words or other similar terms or expressions that concern Pfenex's
future expectations, strategy, plans or intentions. Forward-looking
statements in this press release include, but are not limited to,
statements regarding Pfenex's expectations with regard to future
development funding, milestones, and royalty payments from Pfenex’s
collaborations with Arcellx; the potential to develop new therapies
and revolutionize immune cell therapies; and the expectation that
Arcellx will initiate additional sparX protein programs under the
agreement. Pfenex's expectations and beliefs regarding these
matters may not materialize, and actual results in future periods
are subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of the uncertainties inherent in the protein
development process; Pfenex's ability to obtain additional funding
to support its business activities and establish and maintain
strategic business alliances and new business initiatives; Pfenex's
dependence on third parties for development, manufacture,
marketing, sales and distribution of products; unexpected
expenditures; litigation and other proceedings regarding
intellectual property rights; and difficulties in obtaining and
maintaining intellectual property protection for its product
candidates. Information on these and additional risks,
uncertainties, and other information affecting Pfenex's business
and operating results is contained in Pfenex’s Quarterly Report on
Form 10-Q for the period ended March 31, 2019 and in its
other filings with the Securities and Exchange Commission.
The forward-looking statements in this press release are based on
information available to Pfenex as of the date hereof, and Pfenex
disclaims any obligation to update any forward-looking statements,
except as required by law.
Company Contact: Susan A. KnudsonChief
Financial Officer(858) 352-4324sknudson@pfenex.com
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