University of Salamanca

Assembles Global Dream Team and Establishes Scientific Advisory Board to Accelerate Myeloma ResearchSTUDIO CITY, Calif., July 03, 2024 (GLOBE NEWSWIRE) -- The International Myeloma Foundation (IMF) today announced that IMF Co-Founder Dr. Brian G.M. Durie‘s last day as IMF Chief Scientific Officer will be on July 8, 2024. Dr. Durie will continue to be a member of the IMF Board of Directors. In 1990, Dr. Durie, along with Brian Novis and Susie Novis Durie, founded the International Myeloma Foundation (IMF)—a non-profit that is dedicated to serving the global myeloma community. When the IMF was established, very little was known about multiple myeloma and the IMF founders set out to educate patients about the disease and the very limited available treatment options. As the organization grew, the four founding pillars of research, education, support, and advocacy became its foundation, for which it still stands. Due to Dr. Durie’s remarkable scientific and organizational leadership for the previous 35 years, the IMF continues to thrive, making advances in the field of myeloma, and dedicating to its mission of improving the quality of life for myeloma patients while working toward prevention and a cure. “We deeply appreciate Dr. Durie’s invaluable contributions, which have shaped the IMF and the myeloma community into what it is today,” said IMF President & CEO and 28-year myeloma patient Yelak Biru. “Dr. Durie’s reputation for innovation in the field of myeloma globally has allowed the IMF to develop in ways no one could have imagined. The IMF was the first of its kind in many arenas. That pioneering mindset contributed to groundbreaking research and the development of invaluable patient support services, offering a brighter future for those diagnosed with multiple myeloma,” continued Mr. Biru. On a personal note, Mr. Biru described how the IMF has made an impact on his life as a 28-year myeloma patient: "The IMF has empowered and continues to empower me in my 28-year myeloma journey. The IMF has been instrumental in providing information, connecting patients with a supportive community, and giving them hope for a brighter future." “I am incredibly grateful to Dr. Brian Durie for his major contributions and tireless commitment to the myeloma field and the IMF. This is a major transition point for us, and we will work hard as a team to ensure that the organization continues to grow and expand its reach in our quest to improve the lives of myeloma patients around the world through research, education, support, and advocacy. In this regard, I am glad that some of the best researchers in the myeloma field will be assisting us as members of the newly reconstituted Scientific Advisory Board,” said IMF Chairperson of the Board Dr. S. Vincent Rajkumar. Building on Dr. Durie’s more than three decades of hard work and legacy, the IMF will embark on a new scientific chapter while continuing with established IMF-funded research initiatives: the International Myeloma Working Group (IMWG); the Black Swan Research Initiative (BSRI); the iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma) Project; the Asian Myeloma Network (AMN); the i2TEAMM’s research work on minimal residual disease (MRD); the ASCENT and CESAR Cure Trials; and the IMF Immunotherapy Registry, to name a few. The IMF will keep innovating new opportunities to amplify patient voices in research and to double down on global collaboration. The IMF continues its collaborative work with patients, renowned researchers, industry partners, and other organizations in the global fight against the second most common blood cancer in the world. To undertake this endeavor, the IMF has established a new Scientific Advisory Board. The Scientific Advisory Board includes an esteemed group of global myeloma experts (led by IMF Chairperson of the Board Dr. S. Vincent Rajkumar), who will guide and prioritize IMF research initiatives as well as identify areas for investment and expansion. Members of the newly established IMF Scientific Advisory Board include IMF Chairperson Dr. Rajkumar (Mayo Clinic—Rochester, MN), and IMF President & CEO and 28-year myeloma patient Yelak Biru, MSc (IMF—Los Angeles, CA), as well as the following world-renowned myeloma researchers: Wee Joo Chng, MD (National University Cancer Institute—Singapore); Professor and Director, National University Cancer Institute; Group Director of Research, National University Health SystemVania Hungria, MD, PhD (Santa Casa de São Paulo— São Paulo Brazil); Associate Professor of Hematology and Oncology, Santa Casa Medical School; Clinical Director, Clinica São GermanoSigurður Yngvi Kristinsson, MD, PhD (University of Iceland— Reykjavík, Iceland); Professor, University of Iceland; Consultant, Landspitali University Hospital Shaji Kumar, MD (Mayo Clinic—Rochester, MN, USA); Professor and Research Chair, Division of Hematology, Department of Internal Medicine, Mayo Clinic; Vice Chair, International Myeloma SocietySagar Lonial, MD, FACP (Winship Cancer Institute, Emory University—Atlanta, GA, USA); Professor and Chair, Department of Hematology and Medical Oncology, Emory University School of Medicine; Chief Medical Officer, Winship Cancer Institute, Emory UniversityThomas G. Martin, MD (University of California, San Francisco, CA — Helen Diller Family Comprehensive Cancer Center—San Francisco, CA, USA); Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program, UCSF; Associate Director, Myeloma Program, UCSF; Co-Leader, Cancer immunology & Immunotherapy Program, Helen Diller Family Comprehensive Cancer CenterMaría-Victoria Mateos, MD, PhD (University of Salamanca—Salamanca, Spain); Head of Myeloma and Clinical Trials Unit, Hematology Department; Professor of Medicine, University of Salamanca; Coordinator, Spanish Myeloma Group (GEM); IMWG Smoldering MM Committee MemberJoseph Mikhael, MD (TGen, City of Hope Cancer Center—Phoenix, AZ, USA); IMF Chief Medical Officer; Professor, Applied Cancer Research and Drug Discovery Division, Translational Genomics Research Institute (TGen), City of Hope Cancer CenterPhilippe Moreau, MD (University Hospital of Nantes—Nantes, France); Head of the Hematology Department, University Hospital of Nantes; Professor, Clinical Hematology; President, International Myeloma Society; IMWG Scientific Committee Member Nikhil Munshi, MD (Dana-Farber Cancer Institute—Boston, MA, USA); Director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center; Director, Multiple Myeloma Immune Effector Cell Therapy; Professor of Medicine, Harvard Medical School; Kraft Family Chair; IMWG Scientific Committee Member Jesús San Miguel, MD, PhD (University of Navarra—Pamplona, Spain); Professor of Medicine-Hematology and Head of Clinical and Translational Medicine, University of Navarra; Medical Director and Vice-Dean of Research, Clinica Universidad de Navarra; CIMA Scientific Director; IMWG Scientific Committee MemberSaad Z. Usmani, MD, MBA, FACP, FASCO (Memorial Sloan Kettering Cancer Center—New York, NY, USA); Myeloma Specialist and Cellular Therapist; Chief, Myeloma Service, Memorial Sloan Kettering Cancer Center “This collective leadership model will expand our reach and lean into our values of global collaboration and innovation. Engagement with a diverse group of leaders will further advance our vision of enabling every myeloma patient to live life to the fullest, unburdened by disease,” said Mr. Biru. By assembling a remarkable global dream team of renowned myeloma experts in the newly established Scientific Advisory Board, the IMF can leverage the Scientific Advisory Board’s collective knowledge and experience, identify promising new areas of research, collaborate on international research initiatives, and strengthen the scientific rigor of ongoing projects. The IMF will continue to be inspired by the remarkable legacy of its founders—Dr. Brian G.M. Durie, Susie Novis Durie, and Brian D. Novis— in realizing its mission of improving the quality of life of myeloma patients while working toward prevention and a cure. ABOUT THE INTERNATIONAL MYELOMA FOUNDATION Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation's reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Follow the IMF on:X: @IMFmyelomaInstagram: @imfmyelomaFacebook: @myelomaLinkedIn: International Myeloma Foundation Media Contacts: Peter AntonPanton@myeloma.org Jason LondonJlondon@myeloma.org

LONDON, UK I February 05, 2024 I GSK plc (LSE/NYSE: GSK) today announced results from an interim analysis of the DREAMM-7 phase III head-to-head trial evaluating Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) versus daratumumab plus BorDex in second-line and later treatment of relapsed or refractory multiple myeloma. These data will be presented at the American Society of Clinical Oncology (ASCO) Plenary Series on 6 February 2024. In the primary endpoint of progression-free survival (PFS), a statistically significant and clinically meaningful improvement was observed with the belantamab mafodotin combination (n=243), showing a 59% reduction in the risk of disease progression or death (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001) compared to the daratumumab combination (n=251). With a median follow-up of 28.2 months, the median PFS was 36.6 months (95% CI: 28.4-not reached [NR]) with the belantamab mafodotin combination compared to 13.4 months (11.1-17.5) in the daratumumab combination. The PFS effect was observed across all prespecified subgroups, including those who were refractory to lenalidomide and those with high-risk cytogenetics. The safety and tolerability profile of the belantamab mafodotin combination was consistent with the known profile of the individual agents. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “The substantial progression-free survival benefit and strong overall survival trend compared to a daratumumab standard of care combination reinforce our belief in the potential for belantamab mafodotin used in combination to redefine the treatment of multiple myeloma at or after first relapse. We plan on sharing these results with health authorities worldwide.” The belantamab mafodotin combination also resulted in clinically meaningful improvements in all secondary efficacy endpoints including a doubling of complete response rate (stringent complete response plus complete response), minimal residual disease (MRD) negativity rate and median duration of response (DOR). A strong and clinically meaningful overall survival (OS) trend was observed at the interim analysis, with a 43% reduction in the risk of death (HR: 0.57 [95% CI: 0.40-0.80], p-value=0.00049), which has not yet reached the interim criteria for statistical significance of OS. OS follow-up continues and further analyses are planned. María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said : “These results from DREAMM-7 show how belantamab mafodotin in combination with BorDex represents a significant improvement over the daratumumab-based regimen in a second-line multiple myeloma treatment setting. Anti-BCMA therapies are helping to improve outcomes for patients with multiple myeloma, and having an off-the-shelf option, like belantamab mafodotin, that can be administered in a community oncology treatment centre where the majority of patients are treated has the potential to transform the way we treat myeloma at or after first relapse.” Key secondary endpoint summaries are listed below. * Measured in patients with a sCR or CR. ** An Intent-to-treat restricted mean DOR (RMDoR) analysis comparing DOR between arms showed a statistically significant benefit in favour of the belantamab mafodotin combination (p < 0.00001). *** Has not yet reached criteria for statistical significance (p ≤ 0.00037) of OS at this interim. Follow-up for OS is ongoing. # Nominal p-value Grade 3 or higher non-ocular adverse events of clinical interest in the belantamab mafodotin combination and daratumumab combination arms, respectively, included thrombocytopenia (55% and 35%; exposure-adjusted event rate: 40 and 29, per 100 person-years), neutropenia (12% and 6%), pneumonia (12% and 4%; exposure-adjusted event rate: 8 and 3, per 100 person-years), and anaemia (8% and 10%). Eye-related side effects, a known risk of treatment with belantamab mafodotin, were generally reversible, manageable with dose modification, and led to low (9%) treatment discontinuations. Grade 3 or higher ocular adverse events occurred in 34% of patients receiving the belantamab mafodotin combination and primarily included blurred vision (22%), dry eye (7%), eye irritation (5%), and visual impairment (5%). Eighty-two patients (34%) with a best corrected visual acuity (BCVA) score of 20/25 or better in at least one eye at baseline had a worsening in both eyes to 20/50 or worse. Almost all these patients’ events (98%) had resolved at the time of this analysis. The median time to resolution was 22 days. Global health status quality of life (QOL) as measured by the EORTC-QLQ-C30 indicated no difference in global QOL between different treatment arms over time. The DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical development programme continues to evaluate the potential of belantamab mafodotin in early lines of treatment and in combination with novel therapies and standard of care treatments. This includes the ongoing phase III DREAMM-8 trial evaluating belantamab mafodotin in combination with pomalidomide and dexamethasone versus bortezomib in combination with pomalidomide and dexamethasone. DREAMM-8 data are expected in the second half of 2024. About DREAMM-7 The DREAMM-7 phase III clinical trial is a multicentre, open-label, randomised trial evaluating the efficacy and safety of belantamab mafodotin in combination with bortezomib and dexamethasone (BorDex) compared to a combination of daratumumab and BorDex in patients with relapsed/refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. A total of 494 participants were randomised at a 1:1 ratio to receive either belantamab mafodotin in combination with BorDex or a combination of daratumumab and BorDex. Belantamab mafodotin was scheduled to be dosed at 2.5mg/kg intravenously every three weeks. The primary endpoint is PFS as per an independent review committee. The key secondary endpoints include OS, DOR, and MRD negativity rate as assessed by next-generation sequencing. About multiple myeloma Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. 1,2 There are approximately 176,000 new cases of multiple myeloma diagnosed globally each year. 3 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments. 4 About Blenrep Blenrep is an antibody-drug conjugate comprising a humanised B-cell maturation antigen monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group. Refer to the Blenrep EMA Reference Information ( https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep ) for a full list of adverse events and the complete important safety information in the EU. GSK in oncology Oncology is an emerging therapeutic area for GSK where we are committed to maximising patient survival with a current focus on haematologic malignancies, gynaecologic cancers and other solid tumours through breakthroughs in immuno-oncology and tumour-cell targeting therapies. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements References 1 Sung H, Ferlay J, Siegel R, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin . 2021;71(3):209-249. doi:10.3322/caac.21660. 2 Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681. doi:10.1053/j.seminoncol.2016.11.004. 3 Multiple Myeloma: Statistics. Cancer.net. Published February 2022. https://www.cancer.net/cancer-types/multiple-myeloma/statistics#:~:text=This%20year%2C%20an%20estimated%2034%2C470,with%20multiple%20myeloma%20in%202020. Accessed 19 October 2023. 4 Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood . 2015;125(20). SOURCE: GlaxoSmithKline

INCITE ES clinical study results suggest the Aliya™ PEF system may stimulate an immune response BOSTON, Nov. 10, 2022 /PRNewswire/ -- Galvanize Therapeutics, Inc., a commercial-stage biomedical platform company operating at the convergence of engineering, biology and healthcare delivery, today announced promising clinical data using its Aliya™ Pulsed Electric Field (PEF) system in patients with non-small cell lung cancer (NSCLC). Initial results from the INCITE-ES clinical study conducted outside of the U.S., presented at this week's Society for Immunotherapy of Cancer's (SITC) 37th Annual Meeting, indicate that the Aliya PEF system has the potential to stimulate an immune response in NSCLC patients. INCITE-ES is a prospective, two-arm, non-randomized, concurrently controlled, multi-center treat-and-resect study in patients with suspected or confirmed NSCLC stage IA2-IB. In 30 patients PEF energy was delivered to a solitary tumor either percutaneously or endoscopically at the time of biopsy, prior to surgical resection. Eight additional patients were enrolled in the non-treated control group. Data presented previously demonstrated safety and feasibility to deliver PEF with no device or procedure-related adverse events. In an initial cohort of 10 PEF treated patients, tertiary lymphoid structures (TLS) [average 43.1 ± 41.0, (range 5-113)] were observed within tumors post-PEF, whereas none were identified on pre-PEF biopsy. TLS accumulation was greater in the PEF treated group as compared to the non-treated control group. TLS formation, shown in other studies to generate anti-tumor immunity¹, is emerging as a strong prognostic and predictive biomarker2 associated with patient survival benefits in NSCLC3,4. "The five-year survival rate for NSCLC has only modestly improved from 13% in the 1970s to 21.7% in 20195, despite advances in surgery, radiation and advanced therapeutics," explained Marcelo Jimenez, MD, PhD, Professor of Surgery, Thoracic Surgery Department, Salamanca University Hospital, Spain, investigator in the INCITE ES clinical study. "New treatment approaches are critically needed in NSCLC, and early indications of the potential for pulsed- electric field energy to activate the patient's immune system are very encouraging. I look forward to future studies assessing this novel immuno-oncology approach in more patients." "These early clinical data build upon the recent U.S. Food and Drug Administration (FDA) 510(k) clearance for the Aliya system for soft tissue ablation and add to our confidence that PEF has the potential to mutually kill target cells and create immunogenic molecules," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "We are eager to expand our clinical program to further understand the opportunity for PEF to stimulate the immune system to activate against NSCLC and other solid tumors." About Aliya™ PEF System The Aliya PEF system delivers non-thermal, high-voltage, high-frequency electrical currents through a single monopolar electrode placed in the target tissue. The PEF energy destabilizes the cells, resulting in cell death. The non-thermal modality of the Aliya PEF system preserves surrounding healthy tissue, enabling ablation near critical structures, such as nerves and blood vessels. The Aliya waveform and electrode are designed to maximize the potential for releasing tumor antigens and may stimulate an immune response, potentially disrupting the immunosuppressive tumor microenvironment. The Aliya System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is not currently commercially available in any other geography. About Galvanize Therapeutics™ Galvanize Therapeutics aims to become the global leader in delivering medical technology innovations that drive biologic processes to treat a range of diseases, starting with treating chronic bronchitis symptoms, cardiac arrhythmias, and solid tumors. Formed by ATP (Apple Tree Partners) in 2022, Galvanize is based in San Carlos, Calif., and is researching and commercializing its revolutionary Aliya Pulsed Electric Field (PEF) energy platform in the United States and Europe. For more information, please visit . References: 1 Schumacher T N, Thommen D S. Tertiary lymphoid structures in cancer. Science. 2022; 375(6576):eabf9419. 2 Petitprez F, de Reynies A, Keung E. B cells are associated with survival and immunotherapy response in sarcoma. Nature. 2020;577(7791):556 - 560. 3 Sautès-Fridman C, Petitprez F, Calderaro J. Tertiary lymphoid structures in the era of cancer immunotherapy. Nat Rev Cancer. 2019; 19:307 - 325. 4 Cottrell T R, Thompson E D, Forde P M. Pathologic features of response to neoadjuvant anti-PD-1 in resected non- small-cell lung carcinoma: a proposal for quantitative immune-related pathologic response criteria (irPRC). Ann Oncol. 2018;29(8):1853-1860. 5 American Lung Association, State of Lung Cancer 2019 SOURCE Galvanize Therapeutics, Inc.