EpicentRx Inc. and SciClone Pharmaceuticals Establish Licensing Agreement for RRx-001 in Greater China

Jul 1, 2020

SciClone granted exclusive license to co-develop and commercialize RRx-001 upon approval in the Greater China Region

LA JOLLA, Calif., July 1, 2020 — EpicentRx Inc. (“EpicentRx”), a San Diego-based clinical cancer immunotherapy company and SciClone Pharmaceuticals International Ltd., (“SciClone”) today announced that they have entered into a licensing agreement for RRx-001, a small molecule immunotherapy targeting CD47 – SIRPα with ongoing Phase III trial in Small Cell Lung Cancer (“SCLC”).

Under the terms of the agreement, SciClone will obtain exclusive licensing rights to co-develop and commercialize RRx-001, for the treatment of cancer in humans, within Greater China territory, including mainland China, Hong Kong, Macau and Taiwan. SciClone will be responsible for development, product registration and commercialization in these territories. Per the agreement, SciClone will pay EpicentRx an undisclosed upfront payment and conditionally agrees to invest in EpicentRx this year. EpicentRx will be eligible to receive an aggregate amount of up to $120 million upon achieving certain development, approval, and commercial milestones. In addition, EpicentRx is eligible to receive double-digit royalties in the Greater China territory. SciClone has the option to solely develop RRx-001 for Hepatocellular Carcinoma indication in Greater China, and is eligible to receive royalties from EpicentRx upon the approval of such indication in EpicentRx’s territory.

“SciClone is a dynamic, innovative and forward-thinking company with whom we have excellent personal chemistry and are fully aligned as we seek to improve cancer outcomes in the US, China and around the world,” said >Tony Reid, CEO of EpicentRx.

“This agreement marks our next phase of growth, expanding development of our Phase 3 study as a global trial and strengthening the company financially to support a number of exciting programs,” added EpicentRx’s CFO, Franck Brinkhaus.

“RRx-001 was initially identified and sourced from the aerospace industry and has been developed by EpicentRx as a novel first-in-class therapy. This small molecule drug acts to normalize the tumor microenvironment, activate the tumor associated macrophages (TAMs) of the innate immune system, and sensitize solid tumors to standard therapies,” said Hong Zhao, President and Chief Executive Officer of SciClone. “We are excited to partner with EpicentRx team to develop and commercialize RRx-001 for the treatment of various types of cancer. This strategic partnership recognizes SciClone’s capability as a leading biotech company with integrated platform of development and commercialization.”

RRx-001 is a well-tolerated next generation small molecule immunotherapeutic that targets the CD47 – SIRPα axis and repolarizes tumor associated macrophages (TAMs) and other immunosuppressive cells in the tumor microenvironment to an immunostimulatory phenotype as well as improves tumor blood flow to enhance oxygen supply and drug delivery. As an immunotherapeutic with a non-overlapping mechanism of action and the potential to convert “treatment-resistant” tumors into “treatment sensitive” tumors, RRx-001 may be used as monotherapy or in combination with chemotherapy, immunotherapy, radiation and targeted agents. RRx-001 is currently a Phase 3 trial called REPLATINUM trial for the treatment of third-line and beyond SCLC. Clinical studies for the drug have also been conducted for the treatment of colorectal cancer, brain metastases and glioblastoma and are planned in leukemia and myelodysplastic syndrome.

About EpicentRx Inc.

EpicentRx is an immuno-oncology company whose focus is to identify and develop less toxic and more effective immunotherapy-based anti-cancer treatments that are active not only as single agents, but that also sensitize tumors to the cytotoxic effects of chemotherapy, radiation and immune checkpoint blockade. EpicentRx’s lead program is among a portfolio of novel dinitroazetidine-based drugs that downregulate CD47 – SIRPα to alter the tumor microenvironment and optimize immune responses as well as normalize the tumor vasculature for better drug and oxygen delivery, and has been tested in several clinical trials including an ongoing Phase 3 study in SCLC. The company is also advancing multiple programs through its smart virus AdAPT platform, including three anti-SARS-CoV-2 vaccines, a TGF-beta “trap” starting Phase 1, and various personalized cancer vaccines that have shown to be effective in both chemotherapy and immune resistant tumors. For more information regarding EpicentRx, go to: https://www.epicentrx.com.

About SciClone Pharmaceuticals International Ltd.

SciClone Pharmaceuticals is a privately-owned specialty pharmaceutical company with a substantial commercial business in Greater China and a product portfolio focusing on oncology and infectious diseases. SciClone is dedicated to improving patients’ health by providing top-tier healthcare products and services with global standards of care. SciClone’s proprietary lead product, ZADAXIN® (Thymalfasin), has been approved in multiple countries and may be used for the treatment of certain cancers, hepatitis, and as a vaccine adjuvant, according to the local regulatory approvals and treatment guidelines. In addition, SciClone currently markets a number of oncology products as commercial partner for Baxter and Pfizer in China. The Company also has a robust product pipeline aiming to address the unmet needs in severe and specialized disease areas, especially oncology. For more information regarding to SciClone, go to: http://www.sciclone.com/.

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include statements about the clinical activity of RRx-001, any additional equity investment by SciClone, or the receipt of future milestones and royalties from SciClone. Although EpicentRx believes that it has a reasonable basis for forward-looking statements contained herein, they are based on current expectations about future events affecting EpicentRx and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, and other risks applicable to clinical-stage biopharmaceutical companies, such as whether or not RRx-001 will be approved and whether EpicentRx will receive any development or commercial milestones or royalties under the SciClone agreement. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EpicentRx does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

SOURCE EpicentRx, Inc.; SciClone Pharmaceuticals International Ltd.