CG Invites Co., Ltd.

ORINDA, Calif., Jan. 23, 2025 /PRNewswire/ -- CG Pharmaceuticals (CG Pharma), a clinical biopharmaceutical company located in the San Francisco Bay Area, was established as an independent entity in 2024 after licensing ivaltinostat from CG Invites. The company has since been conducting various research projects on ivaltinostat in the U.S. including the metastatic pancreatic cancer (mPDAC) clinical trial (NCT05249101). The results of the completed Phase 1b study and the progress report of Phase 2 will be presented at the ASCO Gastrointestinal Symposium on Friday, January 24. In the Phase 1b study, a total of 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at 3 different dose levels (60, 125 and 250 mg/m² on days 1 and 8) in combination with capecitabine (1000 mg/m², administered twice daily on days 1-14) of a 21-day cycle. Treatment-emergent adverse event (TEAE) profile was similar across dose levels, with the most common TEAEs (primarily grade 1-2) including fatigue, nausea, palmar-plantar erythrodysesthesias, constipation, and diarrhea. No serious adverse events that were related to ivaltinostat occurred in any of the 3 dose cohorts. At the time of data cutoff (12/28/2024), there were 7 patients still alive, 18 deaths (all due to disease progression after discontinuation from study; no deaths directly related to study treatment), 1 patient lost to follow-up, and 2 study withdrawals. The longest-surviving patient has been alive for 27 months and the maximum duration of treatment was 20 months. Two thirds (65%) from a total of 28 patients showed stable disease or no evidence of disease, 14% experienced disease progression, and 22% were not evaluated. The safety and efficacy results of the Phase 1b clinical study demonstrated that ivaltinostat can be effectively combined with cytotoxic chemotherapy to treat mPDAC. With the RP2D of ivaltinostat established at 250 mg/m2 from Phase 1b, this combination is now being evaluated in the Phase 2 randomized portion of the study comparing ivaltinostat plus capecitabine versus capecitabine alone in the maintenance setting for patients with mPDAC who underwent first line fluoropyrimidine-based therapy for at least four months without disease progression in terms of Progression-Free Survival and Overall Survival. The ongoing Phase 2 trial began patient enrollment in January 2024 and has already achieved over 62% of its target enrollment across 17 U.S. clinical trial sites. CG Pharma anticipates completing Phase 2 patient enrollment and follow-ups this year, with a final clinical study report expected by mid-2026. Ivaltinostat: A Promising New Approach Ivaltinostat, an epigenetic-targeting HDAC inhibitor, has shown exceptional safety and pharmacokinetic profiles compared to other investigational agents in its class. Metastatic pancreatic cancer remains a deadly malignancy with limited treatment options, underscoring the urgent need for innovative therapies like ivaltinostat. Leadership Statements: Dr. Joong Myung Cho, founder of CrystalGenomics and majority shareholder of CG Pharma, highlighted the significance of addressing unmet medical needs through the development of new therapies like ivaltinostat: "For 40 years, I have been dedicated to developing innovative treatments for diseases with limited therapeutic options. Our Phase 2 trial for metastatic pancreatic cancer is progressing smoothly, and we look forward to sharing top-line results soon." Dr. Gene Cho, CG Pharma's Vice President of Global Strategy, remarked: "We are actively engaging with partners and investors to support CG Pharma's success. Exciting updates are forthcoming." Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ. The information in this release is provided only as of the written date, and CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. Contact: Gene Young Cho, Ph.D. Vice President of Global Strategy at CG Pharmaceuticals, Inc. Phone: 925-259-7333 Mobile: 925-899-9637 Email: [email protected] SOURCE CG Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SEONGNAM, South Korea--( BUSINESS WIRE )-- Huons Co., Ltd. (KRX:243070) (Co-CEOs : Song Soo-young and Yoon Sang-bae) announced on November 5 that it has decided to acquire 2,647,378 shares of PanGen Biotech Inc. (Co-CEOs : Yoon Jae-seung and Jung In-cheol) by investing KRW 14.3 billion. Huons will own PanGen shares through the acquisition of existing shareholders and a paid-in capital increase via third-party allocation. Huons also concluded a stock purchase agreement with CG Invites, the existing largest shareholder of PanGen, through a board of directors’ resolution. The company will also acquire new shares issued by PanGen. After the acquisition, Huons will own a total of 3,983,167 shares, representing a 31.53% stake to be PanGen’s largest shareholder. After the acquisition, Huons plans to secure management rights through an extraordinary shareholders’ meeting of PanGen and incorporate it as a subsidiary. Huons intends to strengthen its biopharmaceutical R&D expertise and contract development and manufacturing organization (CDMO) business through this acquisition. PanGen is equipped with Good Manufacturing Practice (GMP) facilities for biopharmaceutical production, and ‘PanGen CHO-TECH’, a cell line development source technology, and productization capabilities. In June, PanGen, a raw material producer of human hyaluronidase, signed an entrustment contract with Huonslab, a Huons subsidiary, to produce clinical samples for ‘human hyaluronidase’ and conduct validation for product approval. Human hyaluronidase is used as a substance that can conveniently convert intravenous (IV) formulations such as anticancer and antibody drugs into subcutaneous (SC) formulations. The patent currently held by Halozyme expired in Korea in March. The US patent will expire in 2027. In preparation, Huonslab received approval for the human hyaluronidase clinical trial plan (IND) from the Ministry of Food and Drug Safety in August based on the raw material (DS) produced by PanGen and is in the course of developing it. Huons evaluates it has secured a stable production site for development and commercialization of biopharmaceuticals including human hyaluronidase. A Huons official said, “Through this acquisition, we’ll incorporate PanGen as a subsidiary to boost sales and enter the new biopharmaceutical CDMO business. We intend to lead the healthcare market by maximizing synergy between affiliates.” Huons expects to create more synergies between affiliates following the latest move. Notably, it aims to expand its capabilities in biopharmaceuticals and ultimately enhance its global competitiveness.

Huons has announced the acquisition of biopharmaceutical company PanGen to expand its research and development (R&D) and contract development and manufacturing organization (CDMO) capabilities. Led by Song Sooyoung and Yoon Sangbae, Huons confirmed on Nov. 5 that it will invest 14.3 billion won ($10.3 million) in PanGen Biotech. PanGen, headed by CEOs Yoon Jae-Seoung and Jung In-cheol, was acquired by Huons for 2.6 million shares. The acquisition involved both a third-party allotment and the purchase of existing shares. Huons’ board of directors signed a stock purchase agreement with CG Invites, the former largest shareholder of PanGen. Following the purchase of new shares issued by PanGen, Huons will become the largest shareholder with a 31.53 percent stake, holding just under four million shares. Once the acquisition is finalized, Huons plans to secure management rights through an extraordinary meeting of PanGen shareholders, making the company a Huons subsidiary. The acquisition aims to strengthen Huons’ biopharmaceutical R&D and CDMO capabilities. Huons will leverage PanGen’s resources, including its good manufacturing practice (GMP) facilities for biopharmaceutical production, product commercialization and the proprietary PanGen CHO-TECH cell line development technology. In June, PanGen signed a validation consignment contract with Huons Global’s subsidiary Huons Lab for the clinical sample production and product approval of human-derived hyaluronidase, a pharmaceutical material used for subcutaneous delivery of oncology or antibody drugs. Halozyme’s patent for this enzyme expired in Korea this March, with the U.S. patent expiring in 2027. With this opportunity, Huons Lab has received Ministry of Food and Drug Safety (IND) approval for clinical trials, and development is ongoing. Through the PanGen acquisition, Huons has secured a stable production base to develop and commercialize human-derived hyaluronidase as well as other biopharmaceuticals. “With the acquisition of PanGen, we expect increased profits and a strong entry into the biopharmaceutical CDMO sector,” said a Huons representative. “We aim to lead the health care market by maximizing synergies among our subsidiaries.” With its expanded biopharmaceutical capacity, Huons is set to enhance its competitive edge in the global market.