NVG-111

- Updated clinical data for ROR1xCD3 targeting TCE NVG-111 in hematological malignancies focussed on relapsed / refractory CLL and MCL- - Pre-clinical data for NVG-222, a first-in-class half-life extended Autoregulated T Cell engager targeting ROR-1- LONDON, Nov. 02, 2023 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough immunotherapies, alongside an Autoregulation platform, today announces the online publication of two abstracts submitted to the American Society of Hematology Annual meeting, to be held December 9-12, 2023 in San Diego, USA. “We are pleased to announce our forthcoming oral presentation on the hematological arm of the NVG-111-01 Phase I clinical study (NCT04763083). Our comprehensive findings reveal highly favorable safety and efficacy outcomes among patients with relapsed/refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL), with patients demonstrating encouraging activity in both monotherapy and combination therapy groups. Building upon these achievements, we are advancing the development of NVG-111 into solid tumor indications,” said Professor Amit Nathwani, Founder and CEO of NovalGen. “We are also presenting a poster detailing the development of NVG-222, our next-generation T cell engager that will enter clinic in 2024 and carries our proprietary Autoregulation or ‘AR’ platform. NVG-222 unlocks the potential of AR in clinic with its ability to automatically deactivate when there is risk of toxicity at the site of action. This mitigates adverse events but also facilitates the administration of higher doses over extended durations, thereby expanding the therapeutic index. We firmly believe AR can be a paradigm-shifting development for a range of immunotherapies.” Oral Presentation: Abstract Title:Time Limited Exposure to a ROR1 Targeting Bispecific T cell Engager (NVG-111) Leads to Durable Response in Subjects with Relapsed Refractory Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) Link to abstract Session Title: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: New Inhibitors and Cellular Therapies for Treatment of Relapsed CLL Session Date: Saturday, December 9, 2023 Presentation Time: 4:00 PM - 5:30 pm PT Location: Manchester Grand Hyatt San Diego, Grand Hall D Publication Number: 329 Presenting Author: Dr Parag Jasani Summary: Between May 2021 and July 2023 12 subjects (10 males and 2 females, median age 60 years) completed a maximum of 6 cycles of NVG-111 treatment, with all evaluable for toxicity and 11 evaluable for efficacy. Grade 1 or 2 CRS occurred in 58% of subjects, mainly in week 1 cycle 1. Objective clinical responses were observed in 55% of subjects, including two with clear evidence of single agent activity. Amongst these, three CLL subjects were rendered MRD negative in peripheral blood and one MCL subject achieved complete metabolic response by the Lugano criteria. These data provide clinical proof of concept for objective antitumor activity by ROR1 targeting TCE NVG-111, even in CLL patients known to have defective T cell function, with a safety pro with the mechanism of action. Further evaluation of this promising molecule is now progressing into solid tumors. Poster Presentation: Abstract Title:NVG-222: A First-in-Class Autoregulating Half-Life Extended ROR1xCD3 T Cell Engager Heralding a New Class of Safer Drugs Link to abstract Session Title: 605. Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II Session Date: Sunday, December 10, 2023 Presentation Time: 6:00 PM - 8:00 pm PT Location: San Diego Convention Center, Halls G-H Publication Number: 2820 Presenting Author: Dr Vincent Muczynski Summary: Building on the success of lead clinical programme of NVG-111, NovalGen’s proprietary Autoregulation (AR) platform has been applied to next-generation half-life extended T cell engager NVG-222. This groundbreaking technology aims to improve the safety pro extend the therapeutic window to improve patient outcomes. NovalGen have shown that applying AR to TCEs does not affect the potency, but significantly reduces toxicity in pre-clinical models. Furthermore, modelling from preclinical PK suggests NVG-222 will support dosing once every two weeks in clinic, and is due to enter trials in 2024. About NovalGen NovalGen is a privately held clinical stage immunology company developing breakthrough bispecific therapies, with the aim of creating life-saving new treatments for people with immunologically driven diseases. Our Autoregulation (AR) platform can be applied to multiple drug modalities for a wide range of indications in oncology, hematology, inflammation and other areas in the immunology space. Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated products tailored to the needs of the patient. The company’s lead program, NVG-111, is an ROR1-targeting bispecific antibody T-cell engager for the treatment of both hematological malignancies and solid tumors using our breakthrough bispecifics technology. Our lead AR programme, NVG-222, builds on the success of NVG-111 and is primed for entry into the clinic in 2024. About Autoregulation (AR) AR is NovalGen’s proprietary platform for next-generation therapeutics that has the potential to transform the treatment paradigm across multiple indications. AR therapies harness a response-mediated negative-feedback loop that detects when there is the risk of severe toxicities arising from the drug’s mechanism of action. When this occurs, the drug is deactivated at the site of action to prevent serious side effects. As the risk of toxicity reduces the drug is replenished from circulating active drug and treatment continues. AR enables the potential for therapies to be safely given at higher doses and for longer, widening the therapeutic index and resulting in better outcomes for patients. About Chronic Lymphocytic Leukemia (CLL) CLL is the most common form of leukemia in the Western world and is a type of cancer that affects a specific type of white blood cell called B-lymphocytes. These abnormal lymphocytes accumulate in the blood, bone marrow, lymph nodes, spleen and other tissues. Common symptoms of CLL can include fatigue, enlarged lymph nodes, and susceptibility to infections. However, not everyone with CLL will experience these symptoms. Treatment options for CLL can vary and may include watchful waiting, chemotherapy, immunotherapy, targeted therapy, or stem cell transplantation, depending on the individual's specific situation and stage of the disease. About Mantle Cell Lymphoma (MCL) MCL is an aggressive but rare cancer that affects white blood cell called B-lymphocytes located in the mantle zone the body's lymphatic system. Typical symptoms include swollen lymph nodes, fatigue, and digestive problems. It can be treated with different therapies, including chemotherapy, targeted drugs, and stem cell transplantation depending on the stage of disease and individual factors. Further information JW Communications Julia Wilson Tel. +44 (0) 7818 430877 Email: juliawilsonuk@gmail.com

Two highly experienced industry executives who bring a wealth of leadership and drug development experienceLONDON, Jan. 09, 2023 (GLOBE NEWSWIRE) -- NovalGen Ltd (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies, alongside a disruptive auto-regulation platform, today announces the appointment of Dr Michael Owen and Mr Scott Clark as Non-Executive Directors to its Board, effective January 2023. “Both Mike and Scott are highly experienced industry executives who bring a wealth of leadership and drug development experience, and they will be an asset to our Board of Directors,” said Professor Amit Nathwani, Founder and CEO of NovalGen. “NovalGen is at a transformational stage in its development as we progress our lead product through the clinic as well as drive our pre-clinical programmes, including our first-in-class half-life extended T cell engager targeting ROR-1 with autoregulation capability, which demonstrates the inherent value in both our pipeline and our technology base.” Dr Michael Owen has worked in biomedical research, and in the pharmaceutical and biotechnology industries for over 40 years. He currently serves as a director on four boards. He is the Chairman of Ossianix Inc, a privately held biotechnology company, and is also on the boards of Zealand Pharma A/S, ReNeuron plc and Sareum Holdings plc. Dr Owen is also an advisor to several Venture Capital LPs and is Chairman of Avacta plc’s SABs. Prior to board services, Dr Owen co-founded and served as the first CSO of Kymab Ltd, a biopharmaceutical company recently acquired by Sanofi. Prior to co-founding Kymab, he worked for GSK where he was SVP and Head of Research for Biopharmaceuticals R&D. Prior to joining the Pharma industry, Dr Owen was a Principal Scientist at the ICRF London laboratories (now CRUK) where he was noted for his work on lymphocyte development and on the molecular basis of diversity in the adaptive immune system. He received a BA degree from Oxford University and a PhD from Cambridge University. He was elected a member of the European Molecular Biology Organisation and a Fellow of the Academy of Medical Sciences. Mr Scott Clarke brings more than 25 years of experience in the biotechnology and pharmaceutical industry. He is currently the CEO of Ambagon Therapeutics, and serves on the board of Trishula Therapeutics, where he was previously CEO. Prior to that, Mr Clarke was CEO of Tizona Therapeutics. Under his leadership, Tizona’s two lead programs advanced into clinic, and the company built out its preclinical portfolio, culminating in the spinout of Tizona’s lead program into Trishula and Gilead’s acquisition of rights to the rest of Tizona’s pipeline for $300 million up front and $1.25 billion in milestones. Prior to Tizona, Mr Clark was the Global Head of Oncology Partnering and Head of Asia and Emerging Markets Partnering at Roche. Earlier in his career, he held senior roles at BioMarin, including the Senior Vice President of Product Development, responsible for advancing its portfolio of clinical and late preclinical product candidates through approval. He holds a BS in Chemical Engineering from the University of California, Berkeley, an MSc in Biotechnology at Northwestern University, and an MBA from London Business School. Further informationJW CommunicationsJulia WilsonTel. +44 (0) 7818 430877Email: juliawilsonuk@gmail.com About NovalGenNovalGen is a privately held clinical stage immuno-oncology company developing breakthrough bispecific therapies that can safely harness the immune system to fight cancer, with the aim of creating life-saving new treatments for people with cancer. Alongside this, we are building out our auto-regulation platform that can be applied to a range of therapeutic indications outside of oncology, such as haematology as well as other immunotherapy indications, including cell-based therapies such as Chimeric Antigen Receptors (CAR-Ts). Our dedicated team of experienced scientists, physicians and professionals are passionate about building a pipeline of disruptive and differentiated products tailored to the needs of the patient. The company’s lead program, NVG-111, is an ROR1-targeting bispecific antibody T-cell engager for the treatment of both hematologic malignancies and solid tumors using our breakthrough bispecifics technology.