First Patient Has Been Dosed in China in RRx-001 Phase III Clinical Trial for the Third Line and beyond Small Cell Lung Cancer

On September 6, 2022] SciClone Pharmaceuticals (Holdings) Limited (the "Company", together with its subsidiaries, the "Group", stock code: 6600. HK) reported that the first patient has been successfully dosed in China in the Phase III clinical study (the "REPLATINUM") of its pipeline product RRx-001 for the third line and beyond small cell lung cancer ("SCLC") (Press release, SciClone Pharmaceuticals, SEP 6, 2022, View Source [SID1234621813]).

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The REPLATINUM, a controlled, open-label, randomized Phase III study, is conducted simultaneously in China and the United States, and is designed to enroll 292 patients in total. The REPLATINUM will evaluate the efficacy and safety of RRx-001 administered sequentially with platinum doublet for the third line and beyond SCLC by comparing to platinum doublet alone.

RRx-001 is a potential first-in-class ("FIC") small molecule with multiple mechanisms of action including CD47-SIRP α targeting, RONS generation, and epigenetic modulations. It can regulate a variety of tumor microenvironment abnormalities: downregulating CD47-SIRP α, repolarizing tumor-associated macrophages from protumor M2 to antitumor M1, activating tumor suppressor genes through epigenetic modulation to reverse chemoresistance, normalizing tumor blood vessels to enhance chemotherapeutic drugs penetration, and inducing the generation of RONs to cause tumor cell necrosis. The data from a Phase II clinical trial showed that RRx-001 has promising efficacy and safety profile in treating patients with various solid tumors such as SCLC. RRx-001 shows potential benefits of improve patients’ survivals in comparison with current standard cares.

In REPLATINUM, eligible patients of third line and beyond SCLC will be randomized 1:1 into 1 of 2 parallel arms. Patients in Arm 1 will receive RRx-001 followed by platinum doublet (platinum plus etoposide) chemotherapy for 4 cycles, and then alternating cycles of RRx-001 and single agent platinum (the "Platinum Stacking Phase") until progression. Patients in Arm 2 will receive the standard of care platinum doublet chemotherapy for 4 cycles. At radiologic progression in Arm 2, patients may "cross-over" to the Platinum Stacking Phase of Arm 1. The primary objectives of the REPLATINUM are progression free survival ("PFS") and overall survival ("OS") in Arm 1 comparing with Arm 2. The secondary objectives include the overall response rate ("ORR") and the duration of response ("DOR") between the two arms.

"There is a significant unmet medical need for the treatment of SCLC worldwide, and more effective treatment options are urgently needed in clinical practice. The current research data shows that RRx-001 can reverse chemoresistance and resensitize tumors to platinum-based therapy with a favorable safety profile. We look forward to positive results from the REPLATINUM, thereby offering SCLC patients with the opportunity to benefit from new treatment options,"said Professor Zhang Li, the global principal investigator of the REPLATINUM and Director of the Department of Medical Oncology, Sun Yat-sen University Cancer Center.

Dr. Mao Li, Vice President, General Manager of Research and Development and Chief Medical Officer of the Companysaid, "The completion of dosing in the first patient in China is a significant material progress of the REPLATINUM. The Company expects RRx-001, an innovative FIC small molecule with differentiated mechanisms of action, will be able to advance the clinical treatment of SCLC worldwide and offer new options to patients."

ReCode Therapeutics to Present at Morgan Stanley 20th Annual Global Healthcare Conference

On September 6, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Shehnaaz Suliman, M.D., M.B.A., M.Phil., Chief Executive Officer of ReCode Therapeutics, will present a corporate overview at 8:00 a.m. ET on Tuesday, September 13th at the upcoming Morgan Stanley 20th Annual Global Healthcare Conference being held in New York, NY (Press release, ReCode Therapeutics, SEP 6, 2022, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-present-at-morgan-stanley-20th-annual-global-healthcare-conference [SID1234619535]).

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Reata Pharmaceuticals Announces Participation in the Citi 17th Annual BioPharma Conference

On September 6, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," or "we"), a clinical-stage biopharmaceutical company, reported that management will participate in investor meetings at the Citi 17th Annual BioPharma Conference on September 7 – 8, 2022 in Boston, Massachusetts (Press release, Reata Pharmaceuticals, SEP 6, 2022, View Source [SID1234619175]).

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Cytokinetics to Participate in Upcoming Investor Conferences

On September 6, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that the company is scheduled to participate in the following investor conferences (Press release, Cytokinetics, SEP 6, 2022, View Source [SID1234619173]):

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Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 8:10 AM ET in a fireside chat with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, and Andrew Callos, Chief Commercial Officer, at the Sheraton New York.
H.C. Wainwright 24th Annual Global Investment Conference on Tuesday, September 13, 2022 at 12:30 PM ET in a presentation with Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, at the Lotte New York Palace Hotel.
Interested parties may access the live webcast of these presentations by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Equillium to Acquire Metacrine in All-Stock Transaction

On September 6, 2022 Equillium, Inc. (Nasdaq: EQ) and Metacrine Inc. (Nasdaq: MTCR), reported that the two companies have entered into a definitive merger agreement pursuant to which Equillium will acquire Metacrine in an all-stock transaction (Press release, Equillium, SEP 6, 2022, View Source [SID1234619165]). The transaction is anticipated to add $33 million in cash to Equillium’s balance sheet at closing, which is expected to extend the company’s cash runway into 2024. The transaction has been approved by the boards of directors of both companies.

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"The acquisition of Metacrine meaningfully strengthens Equillium’s cash position," said Bruce Steel, chief executive officer at Equillium. "As we continue to execute on our ongoing clinical development programs this cash runway extension is expected to see us through multiple data catalysts and operational milestones, including our interim data readout from the Type B portion of the EQUALISE study in lupus nephritis patients in the coming weeks followed by topline data in 2023; the initiation of a Phase 2 clinical study of EQ101 in alopecia areata; initiation of a Phase 1 SAD/MAD study of EQ102 in normal healthy volunteers and celiac patients; and interim data from both EQ101 and EQ102. While prioritizing our ongoing studies, we will carefully evaluate strategic partnership options to advance the acquired MET642 program, an orally delivered Phase 2 ready FXR agonist program in ulcerative colitis. Dr. Preston Klassen, president and CEO of Metacrine, is ideally suited to help us in this endeavor and we are pleased to announce his appointment to Equillium’s Board of Directors in conjunction with the closing of the transaction."

"I’m honored to be joining this experienced and talented team," said Preston Klassen, M.D., MHS, president and chief executive officer of Metacrine. "I look forward to working with the Equillium team to advance their exciting pipeline of clinical programs and explore strategic opportunities for MET642. I strongly believe that Metacrine shareholders will benefit from long-term value created by the combination of our companies."

Through the acquisition, Equillium adds Metacrine’s farnesoid X receptor (FXR) platform, including lead molecule MET642, an orally delivered FXR agonist that is a potential first-in-class, non-immunosuppressive treatment for inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease. MET642 is expected to address multiple aspects of IBD pathogenesis including maintenance of epithelial barrier function and reduction of bacterial translocation. Equillium will be seeking a strategic partner with which to advance this program.

Transaction Details

The transaction consideration will be comprised entirely of stock, where Equillium will issue stock valued at a 25% premium over the net cash delivered at closing, which is estimated to be approximately $26 million. Net cash is total cash, cash equivalents, and short-term investments, adjusted by certain factors including debt, which includes term debt with an outstanding principal of $15 million, and other liabilities, as defined in the merger agreement. The stock value will be based on Equillium’s 10-day volume weighted average closing price calculated ten trading days prior to closing, subject to a share price collar ranging from $2.70 to $4.50. In addition, Equillium has agreed to terms on an amended debt facility with Metacrine’s current lender, K2 HealthVentures LLC, whereby Equillium would assume Metacrine’s existing loan with an outstanding principal balance of $15 million, along with potential access to an additional $10 million of committed debt capital. Concurrent with the transaction closing, Equillium intends to retire its existing debt facility with Oxford Finance LLC and SVB, which currently has an outstanding principal balance of $10 million. After paying off its existing debt facility, Equillium expects to add an estimated $33 million of cash to its balance sheet at closing. Equillium is not planning to retain any current Metacrine employees and expects to assume minimal operating expenses while maintaining sole discretion over the timing and extent of advancing development of the Metacrine programs. The acquisition is anticipated to close late 2022 pending approval from both Equillium and Metacrine shareholders, Metacrine having minimum net cash of $23 million, and other customary closing conditions. Preston Klassen, M.D., MHS, has served as president and chief executive officer and as a member of the board of directors of Metacrine since June 2020. From March 2017 to June 2020, Dr. Klassen served as executive vice president, head of research and development and chief medical officer of Arena Pharmaceuticals, Inc. From June 2016 to March 2017, he was chief medical officer of Laboratoris Sanifit S.L., and from November 2009 to May 2016, was executive vice president, head of global development at Orexigen Therapeutics, Inc. Dr. Klassen also held several positions of increasing responsibility at Amgen Inc., including therapeutic area head for nephrology. Before joining Amgen, he was a faculty member in the Division of Nephrology at Duke University Medical Center. Dr. Klassen received his medical degree from the University of Nebraska College of Medicine, completed his residency in internal medicine, fellowship in nephrology, and Master of Health Sciences degree at Duke University and holds a B.S. in Chemistry from Central University of Iowa.

Webcast and Conference Call

Management will host a conference call accompanied by a slide presentation to discuss the acquisition of Metacrine for analysts and institutional investors, at 8:30 am ET tomorrow, September 7, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at View Source The webcast will be archived for 180 days.

MTS Securities LLC is serving as Metacrine’s financial advisor for the transaction.

Additional Information and Where to Find it

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed merger or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. In connection with Metacrine, Inc.’s pending acquisition by Equillium, Inc., Equillium will file a registration statement on Form S-4 containing a joint proxy statement/prospectus of Equillium and Metacrine and other documents concerning the proposed merger with the Securities and Exchange Commission (the "SEC"). EQUILLIUM URGES INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE OTHER MATERIALS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT EQUILLIUM, METACRINE AND THE PROPOSED MERGER. Investors may obtain free copies of the joint proxy statement/prospectus (when available) and other documents filed by Equillium and Metacrine with the SEC at the SEC’s website at www.sec.gov. Free copies of the joint proxy statement/prospectus (when available) and Equillium’s other SEC filings are also available on Equillium’s website at View Source
Equillium, Metacrine and their respective directors, executive officers, certain members of management and certain employees may be deemed, under SEC rules, to be participants in the solicitation of proxies with respect to the proposed merger. Information regarding Equillium’s officers and directors is included in Equillium’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 13, 2022 with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Equillium’s Investors page on its corporate website at View Source Information regarding Metacrine’s officers and directors is included in Metacrine’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 7, 2022 with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC’s website at www.sec.gov or by going to Metacrine’s Investors page on its corporate website at www.Metacrine.com. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed Merger, and a description of their direct and indirect interests in the proposed Merger, which may differ from the interests of Equillium’s stockholders or Metacrine’s stockholders generally, will be set forth in the joint proxy statement/prospectus when it is filed with the SEC.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Multi-Cytokine Platform: EQ101 & EQ102

Our proprietary multi-cytokine platform (MCP) generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach provides multi-cytokine inhibition at the receptor level and is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as JAK inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases. Current MCP assets include EQ101, a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, and EQ102, a first-in-class, selective inhibitor of IL-15 and IL-21.