Pexastimogene devacirepvec

SEOUL, South Korea, April 22, 2024 /PRNewswire/ -- OSR Holdings, a global healthcare holding company, announced that it has signed a memorandum of understanding (MOU) with SillaJen, a Kosdaq-listed biotech firm with a pipeline of immuno-oncology drug candidates, to share technology and clinical development resources and launch a strategic collaboration between the two companies. Through the MOU, the two companies will explore various ways to collaborate to create synergies between current platform technologies and new drug candidates. OSR Holdings was established in 2019 in South Korea as a "hub-and-spoke" business model, which has become more visible in the biopharma space over the past decade. The "hub-and-spoke" model, exemplified by companies like Roivant Sciences, PureTech Health and BridgeBio Pharma, enables centralized management of drug development strategies, clinical plans, and resource allocation by the holding company. The model allows the holding companies' subsidiaries to concentrate on the advancement of new drug assets and technological innovations. The model's scalability and resource efficiency are notably enhanced, especially as clinical phases of drug development progresses. OSR Holdings' current portfolio includes Vaximm AG, a Swiss entity developing immuno-oncology therapeutics; Darnatein, a South Korean drug developer of osteoarthritis therapeutics; and RMC, a distributor of specialized medical devices. Vaximm AG, a venture spun out from Merck KGaA, has completed Phase 2a clinical trials for glioblastoma. Darnatein, established by Dr. Seung-Hyun Choi, a former researcher at one of the leading research institutes in the U.S., Salk Institute for Biological Studies, boasts a robust platform for cartilage and bone regeneration and is developing new drugs for other diverse disease indications based on this foundational technology. SillaJen boasts a diverse pipeline of new drugs, including the SJ-600 series and BAL0891, and is leading the way in developing anti-cancer viruses based on its GEEV® platform. Known for its immune-evasion capabilities, GEEV® enables anti-cancer viruses to efficiently target affected areas. The SJ-600 series is an anti-cancer pipeline based on SillaJen's GEEV® platform. BAL0891, a mitotic checkpoint inhibitor, has advanced to Phase 1 clinical trials targeting solid tumors and will be conducted in the United States. Sung Jae "Alex" Yu, COO of OSR Holdings, stated, "the signing of this MOU marks the two companies transitioning into strategic partners for the development of innovative drug technologies in the global immuno-oncology market. We eagerly anticipate exploring a variety of opportunities to further our relationship and collaborations with SillaJen, particularly in the U.S., the largest pharmaceutical market in the world." A representative of SillaJen stated, "We can anticipate synergies by collaborating between a company that possesses original anti-cancer drug development technology and a company with global business expertise," and added, "Aside from our cooperation with existing partners, we will have the opportunity to present SillaJen's exceptional pipeline in the U.S. market." About OSR Holdings OSR Holdings, headquartered in Korea, is a global healthcare holding company with biopharma and medical device subsidiaries in areas with high unmet medical needs such as certain cancer indications. The biopharma subsidiaries are developing novel drug candidates based on differentiated technologies. The medical device subsidiary operates as an exclusive distributor of neuro-intervention devices to nationwide hospitals in Korea. In November 2023, OSR Holdings announced a business combination with Bellevue Life Sciences Acquisition Corp (Nasdaq: BLAC), a SPAC that completed a $69M IPO in February 2023. About SillaJen SillaJen, Inc. (KOSDAQ: 215600) is a publicly held biotech company developing anti-cancer therapies, with its clinical-stage products, Pexa-Vec, an oncolytic viral immunotherapy, and BAL0891, a mitotic checkpoint inhibitor. The company is also developing a unique CD-55 expressing vaccinia virus platform, GEEV®, which can be delivered to tumors via intravenous injection while evading the complement system and neutralizing antibodies against oncolytic viruses. Additional information about SillaJen is available at . Disclaimer Language: This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the Company's financial position, results of operations, market position, product development and business strategy. 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 materially from such statements. The information in this release is provided only as of the date of this release, and OSR Holdings undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. SOURCE OSR Holdings

SEOUL, South Korea--(BUSINESS WIRE)-- SillaJen, Inc. (KOSDAQ: 215600) has submitted CSR to the US FDA on 06 Feb 2024 for REN026, a phase 1b/2a dose escalation and safety/efficacy evaluation study of Pexa-Vec in combination with cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The study demonstrated an acceptable safety pro encouraging efficacy of the combination therapy of Pexa-Vec, an engineered oncolytic vaccinia virus, and Libtayo (cemiplimab), anti-PD-1 monoclonal antibody developed by Regeneron Pharmaceuticals Inc. (NASDAQ: REGN). In 2017, SillaJen began a collaboration agreement with Regeneron for the clinical study of Pexa-Vec in combination with cemiplimab in patients with RCC. Following the U.S. FDA IND approval in November 2017, SillaJen initiated the trial and 95 patients were enrolled from total of 21 clinical sites in the U.S., South Korea, and Australia. The study ended in February 2023. The study was conducted in four study arms (A to D) to assess the safety and efficacy of the Pexa-Vec in combination with cemiplimab. In Arm C, consisting of patients naïve to Immune checkpoint inhibitors (ICIs), Pexa-Vec in combination with cemiplimab showed the overall response rate (ORR) of 23.3% and the median overall survival (OS) of 25.13 months. Both ORR and OS were the highest compared to other study arms. In Arm D, patients with prior ICI treatment demonstrated ORR of 17.9 %, the second highest of the four arms. In particular, Arm D included 22 out of 28 patients (78.57%) with the three or more prior systemic regimens in metastatic setting and 5 patients (17.86%) with two prior treatments. Given the typically lower response rates in patients with more prior extensive treatments, the results are considered highly encouraging. About REN026 1) Background Pexa-vec (PV) is an oncolytic and immunotherapeutic vaccinia virus engineered to express GM-CSF. The REN026 study assessed the antitumor activity and safety of intravenous (IV) or intratumoral (IT) PV in combination with cemiplimab, anti-PD-1monoclonal antibody, in patients with metastatic or unresectable renal cell carcinoma (RCC). 2) Methods The study enrolled 95 patients in total, including 6 patients in dose-escalation phase and 89 patients with measurable histologically or cytologically confirmed metastatic or unresectable RCC were randomly assigned to one of four study arms. Patients naïve to immune checkpoint inhibitors (ICIs) with accessible tumors were randomized into Arm A (IT PV and cemiplimab) or Arm B (cemiplimab monotherapy, addition of IT PV upon disease progression). Patients naïve to ICIs with non-accessible tumors were placed in Arm C with IV PV and cemiplimab, and those with prior ICIs treatment were assigned to Arm D with IV PV and cemiplimab. PV was given IT (Arms A and B) administered every 2 weeks or IV (Arms C and D) weekly for 3 or 4 treatments as 1× 109 pfu. cemiplimab IV infusion (all study arms) was administered every 3 weeks, at a dose of 350 mg. 3) Results Between June 2018 and February 2023, 89 patients were assigned to the study arms as follows: 15 in Arm A, 16 in Arm B, 30 in Arm C, and 28 in Arm D. The overall response rate (by RECIST 1.1) across the arms were as follows: Arm A – 13.3% (2PR), Arm B – 12.5% (2 PR), Arm C – 23.3% (1 CR, 6 PR) and Arm D – 17.9% (5 PR). Median progression-free survival and overall survival for the arms were 4.27/22.0 months, 5.65/20.8 months, 4.57/25.1 months and 6.31/18.5 months, respectively. All patients experienced treatment-related AEs (any grade); 40 (45.5 %) experienced a grade 3 or 4 event. Pyrexia was the most common treatment-related AE. No Grade 5 events occurred in any of the study arms. 4) Summary of efficacy results A (n=15) B (n=16) C (n=30) D (n=28) ORR (95% CI)-% 13.3 (1.7-40.5) 12.5 (1.6-38.3) 23.3 (9.9-42.3) 17.9 (6.06-36.9) DCR (95% CI)-% 60.0 (32.3-83.7) 56.3 (29.9-80.2) 63.3 (43.9-80.1) 67.9 (47.6-84.1) PFS median (mo) (80% CI) 4.27 (2.37-NR) 5.65 (2.07-NR) 4.57 (4.34-15.44) 6.31 (3.29-NR) OS median (mo) (80% CI) 21.98 (21.98-NR) 20.83 (19.52-NR) 25.13 (22.01-NR) 18.53 (14.75-NR) 5) Conclusions The combination of IV Pexa-Vec and cemiplimab demonstrated an acceptable safety pro encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment. About Pexa-Vec and the SOLVE Platform Pexa-Vec is SillaJen’s representative investigational product from the company’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. 595 cancer patients have been treated with Pexa-Vec as of 31 March, 2023, in multinational clinical trials. Pexa-Vec is engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. About SillaJen SillaJen, Inc. (KOSDAQ: 215600) is a publicly held biotech company developing anti-cancer therapies, with its clinical-stage products, Pexa-Vec, an oncolytic viral immunotherapy, and BAL0891, a mitotic checkpoint inhibitor. The company is also developing a unique CD-55 expressing vaccinia virus platform, GEEV®, which can be delivered to tumors via intravenous injection while evading the complement system and neutralizing antibodies against oncolytic viruses. Additional information about SillaJen is available at .