On June 2, 2023 AskGene Pharma Inc. reported its participation in the prestigious 15th International Gastric Cancer Congress (IGCC 2023), scheduled to take place on June 14-17, 2023 in Yokohama, Japan (Press release, AskGene Pharmaceuticals, JUN 2, 2023, View Source [SID1234632384]). At the conference, AskGene will give an oral presentation on the latest clinical results of NCT04632108 for ASKB589, an anti-CLDN18.2 antibody, on June 16, 2023. The presenter will be the leading principal investigator Dr. Lin Shen, professor from Peking University Cancer Hospital.

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IGCC is a world renowned biennial global academic conference sponsored by the International Gastric Cancer Association (IGCA). IGCC 2023 will be a hybrid online/offline conference.

Presentation Details

Title: A phase I/II study of ASKB589 (Anti-Claudin 18.2 (CLDN18.2) monoclonal antibody) in patients with solid tumors
Session: Oral 26 – Clinical Study
Date and Time: Friday, June 16, 2023 16:50-17:22 Local Time
Abstract Number: 01074
Leading PI: Dr. Lin Shen, professor from Peking University Cancer Hospital.
About NCT04632108

The NCT04632108 study is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of ASKB589 as a monotherapy and in a combination chemotherapy in patients with advanced solid tumors. The study includes ASKB589 monotherapy dose escalation and expansion (Part A) and dose escalation and expansion of ASKB589 combined with CAPOX (capecitabine and oxaliplatin) (Part B). Patients in the dose escalation were enrolled regardless of the expression of CLDN18.2, while patients in the dose expansion were only enrolled if their tumors tested positive for CLDN18.2 by a central laboratory assay. Enrollment in dose escalation for ASKB589 as monotherapy and in combination with CAPOX chemotherapy was completed in 2022. Enrollment continues in expansion cohorts of first-line advanced or metastatic patients with CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma that is being treated with ASKB589 in combination with chemotherapy.

About ASKB589

ASKB589 is an innovative biological drug discovered and developed by AskGene. It is a recombinant humanized monoclonal antibody targeting claudin 18.2. The drug mediates antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) through high-affinity binding to cancer cells. In addition to gastric and gastroesophageal junction cancers, ASKB589 is being tested in clinical trials for other ClDN18.2-positive solid tumors such as pancreatic cancer. A pivotal Phase III study of ASKB589 in the treatment of gastric cancer is being planned.

On June 2, 2023 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported that it has completed the previously announced 1-for-20 reverse stock split of its outstanding and authorized shares of common stock (Press release, Acorda Therapeutics, JUN 2, 2023, View Source [SID1234632383]). The reverse stock split became effective at 4:01 p.m. Eastern Time today, and the Company’s common stock will begin trading on a split-adjusted basis at the market open on June 5, 2023. The reverse stock split was effected to enable the Company to regain compliance with the $1.00 per share minimum closing price required to maintain continued listing on The Nasdaq Global Select Market.

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On November 11, 2022, the Company’s stockholders authorized the board of directors to effect a reverse stock split by a ratio of any whole number in the range of 1-for-2 to 1-for-20 and a corresponding reduction in the number of authorized shares of common stock. The board of directors subsequently approved the reverse stock split and authorized the filing of the Company’s amended and restated certificate of incorporation, as previously announced on May 31, 2023.

The Company’s common stock will continue to trade under the symbol "ACOR," and the new CUSIP number for the Company’s common stock following the reverse stock split is 00484M700.

Stockholders owning shares of common stock via a bank, broker, or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to their brokers’ particular processes.

On June 2, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that members of the Aclaris management team will participate in two healthcare investor conferences in June (Press release, Aclaris Therapeutics, JUN 2, 2023, View Source [SID1234632382]).

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Management will participate in a fireside chat during the 2023 Jefferies Global Healthcare Conference on Thursday, June 8, 2023 at 4:30 PM ET, in New York, NY.

Additionally, management will be participating in a fireside chat during the 44th Annual Goldman Sachs Global Healthcare Conference on Wednesday, June 14, 2023 at 4:40 PM PT/7:40 PM ET, in Dana Point, CA.

Webcasts of the fireside chats may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcasts will be archived for at least 30 days on the Aclaris website.

On Jume 1, 2023 GI Biome, an affiliate of GI Innovation and a microbiome drug development company, reported that it has started administering GB-X01 to the first patient in the domestic phase 1 clinical trial for colorectal cancer microbiome treatment (Press release, GI Biome, JUN 1, 2023, View Source [SID1234633251]).

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This clinical trial will be conducted at Samsung Seoul Hospital for patients who have completed standard treatment after radical resection of colorectal cancer. It is planned to evaluate the safety and tolerability of GB-X01 and to confirm changes in the composition of the intestinal microflora before and after administration. It is expected to secure phase 1 results in the second half of this year, including a 4-week dosing period for a total of 9 patients (up to 18) and a 4-week follow-up period thereafter. GB-X01

, obtained through GI Biome’s platform, has a single strain isolated from an adult female as its main component. As an oral drug, the antitumor effect was confirmed in monotherapy and combination therapy. It was said that ‘5-FU’, the most commonly used chemical anticancer drug for the treatment of colorectal cancer, showed a synergistic effect in combination with target anticancer drugs such as bevacizumab and natural killer (NK) cells under development by GI Cell . Based on these preclinical results, we applied for domestic and international patents on materials and uses. The company also confirmed through preclinical studies that it relieves anticancer drug-induced diarrhea ( CID ), which is a typical side effect of anticancer treatment, leading to treatment delay, dose reduction, and treatment discontinuation. A phase 2 plan for mitigating gastrointestinal side effects caused by the toxicity of chemical anticancer drugs is also taking shape.

When phase 1 is completed in the second half of this year, the goal is to apply for phase 2 in Korea early next year. In phase 2, it plans to evaluate the anticancer efficacy through the improvement of side effects caused by chemotherapy and the combination therapy of immune cell therapy.

On June 1, 2023 Triumvira Immunologics presented its corporate presentation (Presentation, Triumvira Immunologics, JUN 1, 2023, View Source [SID1234632480]).

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