Pembrolizumab

Safety Review Committee (SRC) approves single 3mg dose for the third cohort in Phase 1 trial of PMC-403 DAEJEON, South Korea, July 2, 2024 /PRNewswire/ -- PharmAbcine, Inc. ("PharmAbcine" or the "Company") (KOSDAQ: 208340), a clinical-stage public company developing next generation therapeutics to treat medical unmet needs, announced today the decision to advance PMC-403, its candidate treatment for neovascular age-related macular degeneration (nAMD), to the fourth single-dose group of 4mg and first multiple-dose group of 3mg in Phase 1 clinical trial. PMC-403 is a novel TIE2-activating antibody with the mechanism of stabilizing pathological and leaky blood vessels. TIE2 receptors, expressed on endothelial cells, are involved in vessel normalization processes such as angiogenesis and intercellular adhesion. This Phase 1 trial targets patients with neovascular age-related macular degeneration who are no longer responding to anti-VEGF standard therapeutics. With the SRC's decision, the trial will advance to the highest single dose cohort (4mg) and the first multiple ascending dose cohort (3mg), potentially providing more advanced data from this Phase 1 study. Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, "Despite standard anti-VEGF treatments, many patients with neovascular age-related macular degeneration continue to experience vision loss and retinal vascular leakage. We are committed to delivering an innovative new drug with differentiated mode of action for these patients." He added, "If final safety is confirmed in this Phase 1 trial, the likelihood of advancing to Phase 2 will increase, paving the way for the commercialization of this treatment." Macular degeneration is a leading cause of blindness caused by aging-related damage to the retina, particularly due to abnormal blood vessels in the macula. The global aging population has led to a rapid increase in macular degeneration cases, and current standard treatments with anti-VEGF inhibitors are insufficient for complete treatment. Consequently, there is a growing demand for new mechanism therapies. Once PharmAbcine's PMC-403 secures safety at the highest dose cohort (4mg), it could play a crucial role in treating macular degeneration. As the likelihood of moving to Phase 2 clinical trials increases, PMC-403 is expected to provide a new treatment option for macular degeneration patients worldwide. About PharmAbcine Inc. PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs. The Company's main pipeline include clinical assets olinvacimab, PMC-403, and PMC-309. Olinvacimab, the Company's lead asset, is ongoing a Phase II trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging result from Phase Ib olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile. PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration). PMC-403 is currently undergoing Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is also being explored to expand into wider therapeutic areas related to pathological vessels including vessel-related rare diseases and non-rare diseases. PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH conditions, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment). Phase I is ongoing at multicenter in Australia and Phase Ib/II in combination with MSD's pembrolizumab PMC-309 + Pembrolizumab combo is in plan. PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy. For additional information about PharmAbcine, visit or follow on YouTube and LinkedIn. For licensing deals, joint venture, co-development, and collaboration in research or antibody discovery inquiries, please contact: Business Development Team E-mail: [email protected] Office line: +82 70 4279 5100 For investor relations and public relations inquiries, please contact: IR/PR Team E-mail: [email protected] SOURCE PharmAbcine

SAN FRANCISCO and SUZHOU, China, July 1, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the ESMO Gastrointestinal Cancers (ESMO GI) Congress 2024 (NCT05458219). The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2. Gastric cancer is one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics[1], gastric cancer ranks as the 5th most common malignant tumor and the 5th leading cause of cancer death around the world. It accounts for an estimated 970,000 cases and 660,000 deaths worldwide. Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of the global totals, respectively, highlighting a significant unmet medical need. The data presented at this conference is from a Phase 1 study conducted in China and Australia with IBI343 and are as follows: In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%. With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months. The majority of treatment emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% patients had ≥ Grade 3 treatment-related adverse events (TRAEs). ≥ Grade 3 gastrointestinal toxicities were extremely low (<5%). No interstitial lung disease (ILD) occurred. Dr Jia (Jenny) Liu, translational lead of early phase clinical trials at The Kinghorn Cancer Centre, St Vincent's Hospital Sydney, said : "As a next generation anti-CLDN18.2 antibody-drug conjugate that is Fc silenced, IBI343 has shown encouraging tolerability and clinical benefit in patients with advanced gastric and gastroesophageal junction adenocarcinomas that had moderate to high expression of CLDN18.2. Furthermore, the gastrointestinal toxicity of the drug we observed in the Phase 1 trial appears lower than that of other drugs targeting CLDN18.2, and there were no cases of interstitial lung disease. We look forward to seeing the results of ongoing Phase 3 trials comparing the efficacy and tolerability of IBI343 with standard-of-care treatments." Dr. Hui Zhou, Senior Vice President of Innovent Biologics, said, "With a unique ADC platform designed to deliver effective and more tolerable therapeutics, the data in gastric cancer is a testimony to the molecular design of IBI343. We will further explore IBI343 in combination with other treatments, including immunotherapies, across different tumor types in order to benefit cancer patients worldwide. As a pioneer company in the field of oncology, Innovent is committed to advancing and promoting global innovation to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people." Apart from gastric cancer, Innovent is also exploring IBI343's therapeutic potential in solid tumors such as pancreatic cancer. Earlier this month, the data from the Phase 1 clinical study of IBI343 in the treatment of patients with pancreatic cancer were presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, demonstrating encouraging efficacy and a favorable safety profile. [details link] About Gastric/ Gastroesophageal Junction Adenocarcinoma Gastric cancer is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[2]. China and Japan have the highest incidence rates of gastric cancer[3]. Currently, the standard-of-care treatments for patients with advanced metastatic gastric cancer include a chemotherapy combination of fluoropyrimidine and platinum, as well as immune checkpoint inhibitor therapy. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[4]. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[5]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer. About IBI343 （ Anti CLDN18.2 ADC ） IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect". As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in this Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer. In May 2024, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment. The multi-center Phase 3 trial of IBI343 for this indication is in preparation. In June 2024, IBI343 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Disclaimer: Innovent does not recommend any unapproved drugs/indications. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References SOURCE Innovent Biologics