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Angiex Joins the Leaders in the Field of Antibody-Drug Conjugates at 13th Annual World ADC Meeting in San Diego

On September 6, 2022 Angiex, developer of Nuclear-Delivered Antibody-Drug Conjugate (ND-ADC) therapies for solid cancers, reported in the 13th Annual World ADC Meeting in San Diego, California. During the meeting, the company provided an overview of its technology and near-term plans for its lead asset, AGX101, in its poster "AGX101 – A novel TM4SF1-directed ADC for the treatment of all solid tumors (Press release, Angiex, SEP 6, 2022, View Source [SID1234621829])."

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Angiex is developing a TM4SF1-directed ADC, AGX101, which is entering Phase 1 trials. TM4SF1 is a novel ADC antigen that is highly expressed in tumor cells and tumor associated vascular endothelium, and is differentiated by its internalization to the nucleus. AGX101 has been shown to be potent both in vitro and in vivo, with an IC50 between 10-100 pM against various cell lines, and complete tumor regressions in multiple human tumor xenograft models in mice. AGX101 is the first in Angiex’s pipeline of Nuclear Delivery Antibody-Drug ConjugatesTM, and proof of concept for Angiex’s Nuclear Delivery PlatformTM

"We couldn’t be more excited about where we are today at Angiex," said Marty J. Duvall, CEO of Angiex. "The advances and excitement being made in the field of antibody-drug conjugates was on full display at the World ADC Conference. With our impressive pre-clinical data, our potential to improve efficacy and therapeutic margin compared to traditional ADCs is clear, and we are now moving AGX101, our lead ND-ADC product, into clinical development."

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]).

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]).

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]).

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]):

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.