Extensive stage Small Cell Lung Cancer

SHANGHAI, April 25, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“NDA”) for toripalimab (trade name: TUOYI®) as the first-line treatment for unresectable or metastatic melanoma has been approved by the National Medical Products Administration (“NMPA”). This marks the approval of toripalimab’s 12th indication in the Chinese mainland. Melanoma is the most malignant type of skin cancer. According to GLOBOCAN 2022 statistics, approximately 332,000 new melanoma cases and 59,000 deaths were recorded globally that year. Though melanoma is relatively uncommon in China, its mortality rate is high (approximately 5,000 deaths amongst approximately 9,000 new cases in 2022) and its incidence rate is rising year by year. Since 2018, anti-PD-1 monoclonal antibodies have been approved for the second-line or later treatment of advanced melanoma in China and are widely used clinically. However, the first-line standard treatment for advanced melanoma is still dominated by traditional chemotherapy or targeted therapy (limited to patients with BRAF V600 mutation). Until now, no domestic anti-PD-1 monoclonal antibody had been approved for advanced melanoma in China, creating an urgent clinical need for first-line immunotherapy options. The supplemental NDA approval is based on data from the MELATORCH study (NCT03430297). MELATORCH is a multicenter, randomized, open-label, positive-controlled Phase 3 clinical study, and is also the first pivotal registrational clinical study of a PD-(L)1 inhibitor as the first-line treatment for advanced melanoma that has yielded positive results. Led by Professor Jun GUO from Peking University Cancer Hospital as the Principal Investigator, the study was conducted in 11 clinical centers across the country. The study was designed to compare the efficacy and safety of toripalimab versus dacarbazine for the systemic anti-tumor treatment-naive patients with unresectable or metastatic melanoma. Prior to this, the results of the MELATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Annual Meeting. The results showed that compared with the dacarbazine group (N=128), the progression-free survival (“PFS”) assessed by Blinded Independent Central Review (BICR) of the toripalimab group (N=127) was significantly prolonged, with the median PFS of the two groups being 2.3 months vs. 2.1 months respectively, and the disease progression or mortality risk was reduced by 29.2% (hazard ratio [HR]=0.708, 95% CI: 0.526-0.954; P=0.0209). The sensitivity analysis of median overall survival (“OS”), corrected for the impact of subsequent anti-tumor treatment, showed that compared with the dacarbazine group, the toripalimab treatment group showed a significant trend towards survival benefit, with the median OS being 15.1 months vs. 9.4 months (HR=0.680, 95% CI: 0.486-0.951) respectively. Toripalimab has a good safety profile that is consistent with previous studies with no new safety signals identified. Professor Jun GUO from Peking University Cancer Hospital said, “Melanoma is a highly aggressive cancer. Due to its low sensitivity to traditional radiotherapy and chemotherapy, patients are often faced with poor survival outcomes. However, thanks to melanoma’s high immunogenicity, immunotherapies such as toripalimab have significantly improved patient survival in recent years. In China, advanced melanoma patients—including those in second-line and later—have gained broad access to these treatments through national medical insurance. Now, toripalimab has been extended to first-line treatment of advanced melanoma. Compared to traditional chemotherapy, toripalimab has demonstrated significant advantages in PFS, ORR, and DoR, as well as a clear trend toward improved OS. Notably, this approval was based on the MELATORCH study, which exclusively enrolled Chinese patients. The trial design aligned closely with clinical practice in China, and thus the findings were more relevant to Chinese melanoma patients. We hope that China’s independently developed immunotherapies like toripalimab can provide a comprehensive treatment solution for advanced melanoma and offer new hope to more patients.” Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, also shared her enthusiasm: “Within a month, toripalimab has secured approvals for two new indications—liver cancer and melanoma. This milestone achievement was, without a doubt, made possible by the selfless and dedicated collaboration of researchers, participating patients, and R&D teams. Seven years ago, toripalimab had just pioneered breakthroughs in second-line melanoma treatment, becoming China’s first domestically developed anti-PD-1 monoclonal antibody and starting a new era of immunotherapy in China; today, toripalimab is again reaching new heights as it becomes the first Chinese-developed first-line immunotherapy for melanoma. Not only does this demonstrate toripalimab’s exceptional clinical value, it also reflects China’s growing strength and innovation in immuno-oncology. Moving forward, we will remain committed to advancing world-class therapies to benefit patients across the world!” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;first-line treatment for unresectable or metastatic melanoma. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

In combination with atezolizumab or durvalumab Study conducted under the CRADA agreement between NCI and Oryzon April 15, 2025 -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the first patient has been dosed in a Phase I/II trial of iadademstat, Oryzon’s potent and selective LSD1 inhibitor, in combination with immune checkpoint inhibitors (ICI) in first line small cell lung cancer (SCLC) patients with extensive disease, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. This is the first clinical trial testing the combination of iadademstat with ICI. The trial (NCT06287775), titled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”, will evaluate the safety, tolerability, dose finding and efficacy of iadademstat in combination with an ICI, either atezolizumab or durvalumab, in patients with extensive-stage SCLC who have initially received standard of care chemotherapy and immunotherapy. This Phase I/II clinical study is conducted and sponsored by the NCI, with Dr. Charles Rudin, from the Memorial Sloan Kettering Cancer Center (MSKCC) as the Principal Investigator. The trial will be conducted at a number of prestigious cancer centers in the US, including the MSKCC, the JHU Sidney Kimmel Comprehensive Cancer Center and many others. The trial plans to enroll 45-50 patients and will be carried out under a Cooperative Research and Development Agreement (CRADA) that Oryzon has in place with the NCI. Dr. Carlos Buesa, Oryzon’s CEO, stated: “We are very excited to have the first patient dosed in this study. The biology underlying iadademstat’s ability to make SCLC cells visible to the immune system and to boost significantly the number and the activation of cytotoxic CD8+ T cells is fascinating. Moreover, prior analyses of several Phase III trials in SCLC indicate that low LSD1 expression is a key factor in determining patients' likelihood of responding and surviving. If this trial confirms the preliminary findings reported by researchers at MSKCC and others, it would reinforce the rationale for this combination as a therapeutic option for this critically underserved patient population. In the event of positive results, the company could also initiate a complementary trial to generate additional data in support of a potential accelerated registration strategy.” Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS (Phase III-ready) and iadademstat in oncology (Phase II). The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and strong clinical activity in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7):e487-e498). Iadademstat is currently being evaluated in combination with gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations, and in combination with azacitidine and venetoclax in 1L AML in an investigator-initiated study led by OHSU and in a trial sponsored by the U.S. National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) signed between Oryzon and the NCI to collaborate on further clinical development of iadademstat in different types of hematologic and solid cancers. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in a collaborative Phase II trial with the Fox Chase Cancer Center (FCCC) in combination with paclitaxel in R/R neuroendocrine carcinomas, and in a Phase I/II randomized trial in 1L ED-SCLC in combination with ICI sponsored by NCI and led by the Memorial Sloan Kettering Cancer Center. Oryzon is further expanding the clinical development of iadademstat through additional investigator-initiated studies. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. 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In combination with atezolizumab or durvalumab Study conducted under the CRADA agreement between NCI and Oryzon MADRID, SPAIN and CAMBRIDGE, MA, UNITED STATES, April 15th, 2025 - Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the first patient has been dosed in a Phase I/II trial of iadademstat, Oryzon’s potent and selective LSD1 inhibitor, in combination with immune checkpoint inhibitors (ICI) in first line small cell lung cancer (SCLC) patients with extensive disease, sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. This is the first clinical trial testing the combination of iadademstat with ICI. The trial (NCT06287775), titled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”, will evaluate the safety, tolerability, dose finding and efficacy of iadademstat in combination with an ICI, either atezolizumab or durvalumab, in patients with extensive-stage SCLC who have initially received standard of care chemotherapy and immunotherapy. This Phase I/II clinical study is conducted and sponsored by the NCI, with Dr. Charles Rudin, from the Memorial Sloan Kettering Cancer Center (MSKCC) as the Principal Investigator. The trial will be conducted at a number of prestigious cancer centers in the US, including the MSKCC, the JHU Sidney Kimmel Comprehensive Cancer Center and many others. The trial plans to enroll 45-50 patients and will be carried out under a Cooperative Research and Development Agreement (CRADA) that Oryzon has in place with the NCI. Dr. Carlos Buesa, Oryzon’s CEO, stated: “We are very excited to have the first patient dosed in this study. The biology underlying iadademstat’s ability to make SCLC cells visible to the immune system and to boost significantly the number and the activation of cytotoxic CD8+ T cells is fascinating. Moreover, prior analyses of several Phase III trials in SCLC indicate that low LSD1 expression is a key factor in determining patients' likelihood of responding and surviving. If this trial confirms the preliminary findings reported by researchers at MSKCC and others, it would reinforce the rationale for this combination as a therapeutic option for this critically underserved patient population. In the event of positive results, the company could also initiate a complementary trial to generate additional data in support of a potential accelerated registration strategy.”