SAN DIEGO, August 1, 2019 —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.
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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 Statement
This 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.
Susan A. Knudson
Chief Financial Officer