OriCell Therapeutics Co.,Ltd.

SHANGHAI and ROSELAND, N.J., June 5, 2024 /PRNewswire/ -- Oricell Therapeutics, a pioneering clinical-stage biopharmaceutical company, has presented the two-year long-term follow-up results of OriCAR-017, an open-label Phase I study evaluating GPRC5D-targeted CAR-T therapy in patients with relapsed/refractory multiple myeloma (RRMM), in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Efficacy & Durability of OriCAR-017 in RRMM Patients The updated data demonstrates that OriCAR-017 elicits deep and durable responses in RRMM patients as well as a favorable safety profile, including those refractory to anti-CD38 therapies, PIs, IMIDs, and those who have failed BCMA targeting CAR-T treatment. The long-term efficacy and safety follow-up results support OriCAR-017 as a promising therapeutic approach for RRMM. Currently, Oricell is smoothly advancing the clinical development of OriCAR-017 in both China (NCT06182696) and the United States (NCT06271252). As of January 16, 2024, all ten patients responded well to OriCAR-017, with the last patient having completed a 24-month follow-up. The overall response rate (ORR) was 100.0%, with a stringent complete response rate (sCR) of 80.0% and a very good partial response rate (VGPR) of 20.0%. All patients achieved 100% minimal residual disease negativity (MRD) at day 28, which was further confirmed as 100% negative at the 3-months follow-up. The median duration of response (mDoR) was 10.43 months (95% CI, 5.00-17.00), the median progression-free survival (mPFS) was 11.37 months (95% CI, 5.93-18.00), and the median overall survival (mOS) had not yet been reached (7 patients were still under survival follow-up, 1 patient died due to disease progression, and 2 patients died from COVID-19). In the high-dose group, where 67% of patients were previously treated with BCMA CAR-T, the mDoR was 17.23 months (95% CI, 7.33-NR), and the mPFS was 19.10 months (95% CI, 8.30-NR). Currently, a BCMA CAR-T-treated patient is still in remission (>24 months). Safety Profile of OriCAR-017 in the Treatment of RRMM The therapy was well-tolerated, with 9 out of 10 patients (90%) experiencing Grade 1 cytokine release syndrome (CRS) and only 1 patient (10%) experiencing Grade 2 CRS. No Grade 3 or higher CRS was observed. The median time to CRS onset was 2 days (range 1-9 days), with a median duration of 6 days (range 3-9 days). No immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs) were observed. There were no serious adverse events (SAEs) or treatment-related deaths, cerebellar disorders, or delayed infections reported. Pharmacokinetics (PK) of OriCAR-017 in RRMM Patients There were no pharmacokinetic differences between dose levels, with a Cmax of 7354.7 copies/μL and an AUC0-28 of 68587 copies•day/μg. At high doses, CAR-T cells were still detectable at 9 months, and after 21 months of follow-up, one patient had CAR-T cell expansion above the lower limit of quantitation (LLOQ). Patients with Tlast ≥ 9 months had a longer PFS compared to those with Tlast < 9 months. G5 Expression in Response to OriCAR-017 Treatment in RRMM No correlation was observed between antigen expression and therapeutic efficacy. Baseline data from all patients showed positive GPRC5D expression in bone marrow CD138+ plasma cells (MMPC), while 50% of relapsed patients showed downregulated expression detected by flow cytometry. OriCAR-017 Demonstrates Significant Potential in Severely Progressed RRMM Patients It's worth noting that the study included patients with complex and advanced disease characteristics. Among the ten R/R MM patients, 40% had extramedullary disease (EMD), 50% had undergone one or more BCMA-directed CAR-T treatments, 70% had high-risk cytogenetics, 70% were classified as ECOG 2 score status, and 80% were at International Staging System (ISS) stages II & III. OriCAR-017 demonstrates its potential as a safe and efficacious treatment option for RRMM patients, marking a substantial progress in the fight against multiple myeloma and offering hope to those facing demanding health conditions. Details for the presentation as below: Oral Presentation #7511 Title: OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS). Session Type:Rapid Oral Abstract Session Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia Link: About OriCAR-017 OriCAR-017, a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, is a groundbreaking innovation in the treatment of relapsed/refractory multiple myeloma (RRMM). Leveraging Oricell Therapeutics' cutting-edge proprietary technology platforms, OriCAR-017 exhibits clearly differentiated binding avidity, persistence, anti-tumor efficacy and safety profile. OriCAR-017 received IND approval from FDA in Jan 2024 after its approval by NMPA in 2023. Impressive clinical results from the POLARIS study continue to be released. Currently, Oricell has assembled a skilled team to operate in both the U.S. and China, collaboratively accelerating pipeline development globally. SOURCE OriCell Therapeutics Co., Ltd.

SHANGHAI, Aug. 10, 2023 /PRNewswire/ -- August 10, 2023, in a groundbreaking development, Oricell Therapeutics Co., Ltd. ("Oricell") has received the green light for its Investigational New Drug (IND) application of OriCAR-017, a cutting-edge CAR-T cell therapy targeting GPRC5D to combat relapsed or refractory multiple myeloma (R/R MM). This remarkable milestone not only marks the world's first tier GPRC5D-targeting CAR-T therapy approved in China but also underlines Oricells prowess as a frontrunner in the biotech industry. About GPRC5D target GPRC5D, a G protein-coupled receptor that boasts high expression on multiple myeloma cells while maintaining low levels in normal tissues, has emerged as a promising therapeutic target for multiple myeloma. The revolutionary approach of independently targeting GPRC5D, regardless of BCMA expression levels, opens up new possibilities for patients who have exhausted conventional treatments or shown limited response to BCMA-targeting therapies. Earlier, data from the investigator initiated trial of OriCAR-017 (POLARIS) were presented at the 2022 ASCO (American Society of Clinical Oncology Annual Meeting) and the 2022 EHA (European Hematology Association Annual Meeting), attracting widespread attention due to its efficacy and safety advantages. The study enrolled 10 patients, included f ive patients who were previously treated with BCMA-targeted CAR T-cell therapy and four patients with extramedullary disease (EMD). According to the latest data, at a median follow-up time of 280 days (217 ~ 459 days), OriCAR-017 is turning heads with an impressive overall response rate (ORR) of 100% and a stringent complete response rate (sCR) of 80%. Additionally, compared to other therapies targeting the same antigen, OriCAR-017 demonstrated significant safety advantages, with only one case of grade 2 cytokine release syndrome (CRS) observed after treatment, while the rest were grade 1. Notably, no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) and no grade 3 or higher skin toxicities or nail changes were reported, nor infection events were observed during long-term follow-up after treatment. Such reassuring safety data paves the way for reduced post-treatment clinical interventions, ultimately lightening the burden on healthcare providers and enhancing patient experiences. Oricell's Chairman and CEO, Helen Yang expressed, "OriCAR-017's approval as China's first and the world's leading GPRC5D-targeting CAR-T therapy is a pivotal moment for the biotech landscape. We are bridging the gap in late-line treatments for R/R MM, providing new hope to patients who have failed or responded poorly to different therapies targeting BCMA. The potential global impact of OriCAR-017 is undeniable, as we have been developing a global development plan for OriCAR-017 and are systematically advancing its registration for clinical trials in the United States. We have already obtained the 'Orphan Drug' designation from the Office of Orphan Products Development (OOPD) of the U.S. FDA." Helen is confident about the development prospects of this product and further stated, "with the IND clearance in China and seamless progress in overseas registrations and technology transfer, the stage is set for OriCAR-017 to become a game-changer in the fight against multiple myeloma. As Oricell continues to make strides in ground-breaking innovation, the future of cancer treatment looks more promising than ever before." SOURCE Oricell Therapeutics

SHANGHAI, Feb. 28, 2023 /PRNewswire/ -- Oricell Therapeutics Co., Ltd ("Oricell" or "the Company"), a China-based innovative pharmaceutical company committed to the development of tumor cellular immunotherapeutics, today announced the close of a $45M Series B1 investment round after the completion of a $125M Series B fund-raise in July 2022. The round was led by premier global industry investors RTW Investments, LP ("RTW") and Qatar Investment Authority ("QIA"), with participation from existing investors, including Qiming Venture Partners and C&D Emerging Industry Equity Investment. The new injection of capital will be utilized primarily to support the company's core product clinical development in the U.S. Oricell Chairman and CEO Helen Yang said, "We are thrilled with the momentum our team has built over the last several months and look forward to using this funding to further expand our platform and research. This round reflects our investors' recognition of Oricell's ongoing growth and the development of our robust pipeline of ground-breaking therapeutics. We look forward to continuing to help improving the lives of patients in need." Over the past year, Oricell's cell therapy pipeline and drug discovery platform have seen tremendous growth. Since the debut of Oricell's first key product Ori-C101 at the 2021 American Society of Clinical Oncology ("ASCO") Annual Meeting, the Company has been overcoming many difficulties and made unremitting efforts to achieve all the expected milestones, to attract widespread attention among investors worldwide with its increased presence in the global new drug market during 2022 and into 2023. The Company launched its red-chip restructuring in the fourth quarter of last year in parallel with series B round of financing. Ori-C101 received IND clearance from NMPA in September 2022. At 2022 ASCO annual meeting and European Hematology Association ("EHA") 2022 congress, Oricell presented the clinical research data of its proprietary CAR-T cell therapy targeting GPRC5D (OriCAR-017) for the treatment of Relapsed/Refractory Multiple Myeloma ("RRMM"). The oral presentation was very well received; subsequently, the product was granted an orphan drug designation by US FDA. Its follow-up data was published in Lancet Haematology on January 31 2023. With this new funding, the Company is now well-positioned to expand its products to the U.S., specifically OriCAR-017, a GPRC5D CAR-T therapeutic that treats relapsed and refractory multiple myeloma, which is a product currently on the stage of IND enabling both in the US and China. Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW, said "RTW continues to focus on advanced tumor cellular immunotherapeutics. As a long-term investor in the primary and secondary markets, we have been closely following Oricell and have been duly impressed by its milestone achievements over the past year. Today, we feel honored to have established a partnership with the company through the Series B1 financing. With our years of experience working in the U.S. market, we look forward to empowering Oricell and its team as they continue to provide cancer patients across the world with better therapies and create more value for the community." About RTW In vestment Headquartered in New York, with offices in Shanghai and London, RTW Investments, LP is a global life sciences investment and innovation firm that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to advance emerging medical therapies by building and supporting the companies and/or academics developing them. For further information about RTW, please visit About Qatar Investment Authority Qatar Investment Authority ("QIA") is the sovereign wealth fund of the State of Qatar. QIA was founded in 2005 to invest and manage the state reserve funds. QIA is among the largest and most active sovereign wealth funds globally. QIA invests across a wide range of asset classes and regions as well as in partnership with leading institutions around the world to build a global and diversified investment portfolio with a long-term perspective that can deliver sustainable returns and contribute to the prosperity of the State of Qatar. About Qiming Venture Partners Founded in 2006, Qiming Venture Partners is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Hong Kong, Seattle, Boston and the San Francisco Bay Area. Currently, Qiming Venture Partners manages eleven US Dollar funds and seven RMB funds with $9.4 billion in capital raised. Since our establishment, we have invested in outstanding companies in the Technology and Consumer (T&C) and Healthcare industries at the early and growth stages. About C&D Emerging Industry Equity Investment Xiamen C&D Emerging Industry Equity Investment Co., Ltd is a professional equity asset management company affliated to Xiamen C&D Corporation Limited, focusing on new economy sectors including healthcare, advanced manufacturing and innovative consumption. The subsidiary manages a fund of RMB18 billion to help more emerging enterprises flourish. About Oricell Therapeutics Oricell Therapeutics was founded in 2015 as an innovative biopharmaceutical company in China. It is committed to developing tumor cellular immunotherapeutics through its own innovative technology platforms. Oricell has applied for over 100 invention patents (including 6 PCT), with 10 already granted. Oricell Therapeutics' mission is to develop affordable drugs for unmet clinical needs worldwide. It has built several proprietary technology platforms based on tumor cell immunotherapy, including Ori®Ab and Ori®CAR. Oricell Therapeutics has made several achievements to overcome challenges to treat solid tumors including among others antibody engineering construction technology, tumor immune microenvironment regulation, T cell infiltration and killing ability. With over 10 cellular projects in its pipeline, Oricell Therapeutics is well positioned to develop novel cell therapies to treat liquid and solid tumors. Oricell focuses on indications with a wide range of therapeutic needs, including liver, ovarian, gastric, cervical and non-small cell lung cancer, as well as multiple myeloma. With the corporate goal of becoming an innovation-driven global leader in the creation of new tumor immunotherapeutics, Oricell Therapeutics has established an international product development and operations management team, GMP-compliant manufacturing facilities and quality testing and management systems. Oricell Therapeutics is continuing to explore and develop therapeutically effective, well differentiated and affordable drugs through its own innovative technology platforms. The company seeks to create new opportunities for the development of innovative China-made drugs. Oricell raised over $120 million USD in series B financing in July 2022. SOURCE Oricell Therapeutics