ISA-101

SINGAPORE, May 12, 2024 /PRNewswire/ -- SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, announced first preclinical data of its novel human papillomavirus (HPV)-specific T cell receptor-engineered T (TCR T) cell therapy armored with an TGFβRII-41BB immunoswitch – SCG142 – in an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in Baltimore, Maryland. In preclinical studies, SCG142 demonstrated superior CD8+ and CD4+ TCR T cell proliferation and tumor inhibition both in-vitro and in-vivo compared to conventional TCR T without immunoswitch, including tumor rechallenge models. Importantly, SCG142 functionality is CD8 co-receptor independent, transferring desired effector functions also to CD4+ T cells and promoting longer persistence and improved proliferation of T cells. In addition, SCG142 exhibited high functional avidity and can recognize both genotypes HPV-16 and HPV-52, with a favorable safety profile with no alloreactivity or off-target toxicity in relevant toxicology models. "SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with preclinical efficacy in various tumor types with expression of HPV-16- and HPV-52 genotypes. We're excited to demonstrate that armoring the TCR-T cells with the chimeric switch receptor didn´t change the favorable safety profile but helped to overcome the immune inhibitory signal of TGF-β, which can be crucial for effective treatment of solid tumors", said Dr. Susanne Wilde, Head of Preclinical Research of SCG Cell Therapy. "These promising results underscore the potential of SCG142 to provide new solutions for patients in a variety of HPV-16- and HPV-52 expressing cancers. Based on these encouraging data, we are eagerly advancing SCG142 towards clinical trials", she added. About SCG142 SCG142, an autologous HPV-specific TCR T cell therapy holding the promise as the best-in-class product. Utilizing SCG's proprietary GianTCRTM technology, high affinity and high avidity natural TCRs can be isolated to target against intracellular antigens presented through major histocompatibility complex (MHC) in solid tumors. Study results showed that SCG142, a fully natural HPV specific TCR armoured with chimeric switch receptor, has the potential to specially target HPV-16 and HPV-52-positive tumor cells in various HPV-related tumor types, generating CD8 co-receptor independent T cell functionality and sustained anti-tur activity. About Human Papillomavirus and Cancers Human papillomavirus (HPV) infection is the most common sexually transmitted infection. Nearly all sexually active people are infected with HPV and around half of these infections occur with a high-risk HPV type, which can lead to cancer development.1 As such, HPV infection accounts for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharyngeal cancers, and it causes an estimated 630,000 cancers worldwide each year2x. About SCG Cell Therapy SCG is a leading biotechnology company focusing on the development of novel immunotherapies in infections and its associated cancers. The company targets the most common cancer-causing infections: helicobacter pylori, HPV, HBV and EBV, and develops a broad and unique pipeline of TCR-based cellular immunotherapy products against infection- associated cancers. With the proprietary GianTCRTM TCR screening platform, in house viral vector production and AutoCellTM, a fully closed and automatic cell therapy manufacturing system, the company covers the entire value chain from new target research and discovery, manufacturing, and clinical development. For more information about SCG, please visit us at . [1] HPV and cancer. National Cancer Institute. (2023, October 18) [2] Basic information about HPV and cancer. Centers for Disease Control and Prevent (2023, September 12) SOURCE SCG Cell Therapy Pte Ltd

Ultimovac’s UV1 works by inducing T cell response against telomerase reverse transcriptase (hTERT) – a protein that provides the limitless self-renewal hallmark in cancer progression. Image Credit: CI Photos / Shutterstock. Ultimovacs has implemented cash-saving strategies, including a 40% workforce reduction, to extend its reserves into Q4 2025. The operational adjustments are expected to provide a cash runway beyond the anticipated top-line readout from the next two Phase II trials – the FOCUS trial in Q3 this year, and the DOVACC trial in H1 2025. The UV1 cancer vaccine development programme has suffered some setbacks. The company has reported topline data from two Phase II trials, NIPU and INITIUM, for the vaccine used in combination with PD1 inhibitors in two cancer indications, with both trials failing to meet primary endpoints. The Phase II NIPU trial (NCT04300244) evaluated UV1 in combination with Bristol Myers Squibb’s checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) as a second-line treatment in mesothelioma patients. The study failed to meet its primary endpoint of progression-free survival (PFS). The Phase II INITIUM trial (NCT02275416) also evaluated the UV1, Opdivo and Yervoy combination but in patients with unresectable or metastatic malignant melanoma. The study also failed to meet primary endpoints, with the company deciding to stop pursuing the therapy in this indication. See Also: NIH team develops AI tool to predict cancer drug response SGN-1 by Guangzhou Huajin Pharmaceutical Technology for Peritoneal Cancer: Likelihood of Approval Despite this, Ultimovacs expects positive readouts from the next two trials. The Phase II FOCUS trial (NCT05075122) evaluates the combination treatment of UV1 vaccine with MSD’s Keytruda (pembrolizumab) as a first-line treatment in patients with PD-L1 positive head and neck squamous cell carcinoma. The combination has been successful in the Phase I trial (NCT03538314), with an observed 67% overall survival rate at a three-year follow-up. While the company expects positive data in Q3 this year, it is prepared to wait for data readout from the DUVACC trial before deciding on the fate of UV1 should the FOCUS trial fail, said Ultimovac’s CEO Carlos de Sousa in a business update webcast today. The Phase II DUVACC trial (NCT04742075) evaluates UV1 in combination with AstraZeneca’s checkpoint inhibitor Infinzi (duvalumab) and Lynparza (olaparib), a poly-ADP ribose polymerase (PARP) inhibitor, as a second line treatment in patients with BRCA negative ovarian cancer. The trial is currently recruiting patients, with 40% of the total expected enrolment completed as of Q4 2023. UV1 is also being evaluated in an investigator-led Phase II LUNGVAC trial (NCT05344209). The study investigates the combination therapy of UV1 and Sanofi and Regeneron’s Libtayo (cemiplimab) as a first-line therapy in patients with advanced or metastatic non-small cell lung cancer. The trial started recruitment in October 2022 and reached only 15% enrolment as of Q4 2023. The topline data from the trial is expected in H1 2026. GlobalData forecasts therapeutic cancer vaccines as the weakest immuno-oncology agent class with relatively low global sales of up to $4bn by 2028, compared to checkpoint modulators sales reaching $120bn by 2028. GlobalData is the parent company of Pharmaceutical Technology . Other cancer vaccines in development include Transgene and Japanese NEC Corporation’s cancer vaccine, TG4050 , for the treatment of head and neck cancers and ISA Pharmaceuticals’ cancer vaccine, ISA101b , for treating oropharyngeal cancer.