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PolTREG plans to start a pivotal Phase II/III trial of PTG-007 for the treatment of type 1 diabetes and is pursuing partnership funding. Image Credit: Anatoliy Cherkas / Shutterstock. PolTREG’s has presented positive long-term data for its cell therapy, PTG-007, showing that the therapy induced clinical remission for type 1 diabetes for up to 12 years. The follow-up data from 54 patients with early-onset type 1 diabetes who took part in Phase I and II trials was presented at the European Association for the Study of Diabetes (EASD) taking place from 9-13 September in Spain. In light of the positive data, the Polish company will start a pivotal Phase II/III trial of PTG-007 for the treatment of type 1 diabetes and is pursuing partnership funding. “Today’s results are extremely encouraging and show that some patients remain in clinical remission for up to 12 years after initial treatment,” said Professor Piotr Trzonkowski, PolTREG’s CEO. “This makes us very eager to launch a pivotal study of PTG-007 as soon as we find a suitable partner.” The 54 patients with early-onset type 1 diabetes were followed for 7-12 years after receiving initial treatment as part of Phase I and Phase II trials. The study showed that a “proportion of patients” remained insulin-independent up to 18 to 24 months after treatment. See Also: LACTIN-V by Osel for Human Papillomavirus Infections: Likelihood of Approval Cadisegliatin by VTv Therapeutics for Type 1 Diabetes (Juvenile Diabetes): Likelihood of Approval Additionally, some of the patients remained in clinical remission for 7-12 years after being treated with PTG-007. The trial defined clinical remission as having a low need for external insulin, while retaining proper metabolic/glycaemia control. The study also found that the “best results” were seen in patients who received the combination therapy of Treg therapy and Roche and Biogen ’s anti-CD20 treatment Rituxan (rituximab). The company plans to release detailed data and publish the results in a peer-reviewed scientific publication. PolTREG plans to initiate a Phase II trial evaluating PTG-007 in patients with presymptomatic type 1 diabetes. Cell therapies as a treatment for type 1 diabetes are gaining popularity. Last year saw the US Food and Drug Administration (FDA) approving the first cell therapy, CellTrans’s Lantidra (donislecel) for the treatment of type 1 diabetes. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy

The funds will support the trial of MOv18 IgE to potentially treat platinum-resistant ovarian cancer. Credit: Jo Panuwat D/Shutterstock. Epsilogen has completed a Series B expansion financing round, raising £12.5m ($16.4m) to progress the development of its immunoglobulin E (IgE) antibodies for cancer treatment. The investment was sourced entirely from existing backers British Patient Capital, the Novartis Venture Fund, Epidarex Capital, the 3B Future Health Fund and ALSA Ventures. The latest funding takes the total raised in the Series B financing round to £43.25m. The funds will primarily support the clinical proof of concept for MOv18 IgE, the company’s leading asset, in a Phase Ib trial targeting platinum-resistant ovarian cancer. MOv18 IgE, a therapeutic IgE antibody, is designed to target the folate receptor alpha (FRα) which is prevalent in various cancers. See Also: LACTIN-V by Osel for Human Papillomavirus Infections: Likelihood of Approval Cadisegliatin by VTv Therapeutics for Type 1 Diabetes (Juvenile Diabetes): Likelihood of Approval The Phase Ib trial of MOv18 IgE will have dose escalation and expansion parts, enrolling patients with FRα-positive PROC who have undergone up to four previous treatments. The trial follows a Phase I study where MOv18 IgE showed safety, tolerability and initial signs of clinical activity. MOv18 IgE’s unique mechanism of action is different from that of other clinical agents, due to its high-affinity binding to FcεR1 that promotes immunosurveillance and robust tumour cell destruction by myeloid cells. IgE antibodies have the potential to alter the tumour immune microenvironment, making it more pro-inflammatory, which results in higher levels of activated T cells and macrophages within the tumour, enhancing its destruction. Established in 2017, Epsilogen is a spin-out from King’s College London, UK. Its CEO Tim Wilson stated: “We are delighted to have received strong continued support from our existing investors, and we thank them. “The promise of IgE to treat cancer is based upon its unique mechanism of action and MOv18 IgE is the first ever to be tested in man. Everything is ready for phase Ib initiation which will occur shortly and we look forward to reporting progress from the trial.”