RWTH Aachen University

Patients receiving nine-dose regimen over five months experienced deep and durable reduction in proteinuria, reaching up to ~50% mean reduction in UPCR at end of study at month 24 and over 18 months after last dose Patients across treatment arms exhibited stabilization in eGFR through 24 months, while patients in placebo arm showed a rapid decline in eGFR Prolonged IgA reductions observed out to 24 months while IgG and IgM recovered to baseline shortly after last dose, potentially enabling a sustained treatment benefit without the need for chronic immunosuppression SOUTH SAN FRANCISCO, May 24, 2024 /PRNewswire/ -- Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced positive interim results from the randomized, placebo-controlled Phase 2 IGNAZ study of the investigational CD38 antibody felzartamab in the treatment of IgA nephropathy (IgAN). Patients receiving a nine-dose regimen over five months experienced a deep and durable decrease in proteinuria levels, reaching up to ~50% mean reduction in UPCR at month 24, which was more than 18 months after the last dose. In addition, patients exhibited stabilization of kidney function as measured by eGFR through 24 months. Administration of felzartamab was generally well tolerated with a safety profile consistent with prior studies. "Demonstrating a treatment effect that persists for more than 18 months after last dose of felzartamab represents a potential departure from plasma- or B-cell-modulating agents that require chronic dosing," commented Study Investigator and lead author Jürgen Floege, M.D., RWTH Aachen University, Germany. "The reduction in proteinuria and stabilization of eGFR we are seeing represent clinically meaningful outcomes for patients with IgA nephropathy. The results also suggest the potential for felzartamab in helping to preserve kidney function while avoiding the need for chronic immunosuppression. In addition, we are seeing selective and durable reductions in IgA antibody levels with the recovery of IgG and IgM, which represents a potential safety profile advantage for patients, as felzartamab may allow maintenance of important immune functions that protect against infection. The results of this study highlight felzartamab's promise as a durable therapy and support its continued investigation in IgA nephropathy." "The results of the IGNAZ study are the first data investigating the application of felzartamab in the treatment of IgA nephropathy and the effects we have seen are highly encouraging," said Uptal Patel, M.D., Chief Medical Officer at HI-Bio. "Because felzartamab can selectively deplete CD38+ plasma cells, upstream contributors to disease progression and producers of Gd-IgA1 and anti-Gd-IgA1 antibodies, we believe treatment with felzartamab may represent a potentially disease-modifying approach that could help preserve kidney function. We look forward to receiving final data from the IGNAZ study later this year, which we expect to submit for presentation in an appropriate peer-reviewed forum, and are evaluating next steps in development for felzartamab in this indication." Patients in the nine-dose group experienced a prolonged pharmacodynamic effect of IgA reduction while IgG and IgM levels showed recovery, with selective and durable reductions in IgA levels maintained for more than 18 months following the last dose. Felzartamab was generally well tolerated with no dose-dependent adverse events and no exposure-safety relationship. Most adverse events (AEs) were mild, and the most common type of AE was infusion-related reactions (IRRs). There were two (5%) serious adverse events in felzartamab-treated subjects (IRR, tendon rupture) and infections were mostly mild and balanced across the active treatment groups. Of the total number of patients treated with felzartamab, five patients discontinued treatment due to IRRs or hypersensitivity; for four of five patients, the infusion rate was higher than protocol-specified or had an error in pre-medication. The Phase 2 IGNAZ study (NCT05065970) is a randomized, placebo-controlled, multi-center, proof-of-concept and dose evaluation study designed to assess safety and efficacy in adult patients with high-risk IgAN. Patients were enrolled with proteinuria (UPCR) of at least 1.0 g/d and eGFR of at least 30 ml/min/1.73 m2 and were assigned to one of four groups receiving either placebo, two doses, five doses or nine doses over a 24-week treatment phase of 16 mg/kg of felzartamab provided by intravenous infusion. The study also included an open-label treatment arm in Japan provided with the nine-dose schedule. The study enrolled 54 patients in total and data were analyzed on a per-protocol basis. Data from the IGNAZ study were presented today at the 61st European Renal Association (ERA) Congress in Stockholm. The full presentation from the ERA Congress will be made available on HI-Bio's website. About IgA Nephropathy Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis worldwide. It is a leading cause of chronic kidney disease with up to 40% of IgAN patients progressing to end stage kidney disease about 20 years after diagnosis. IgAN accounts for about 40% of all native-kidney biopsies in Japan, 25% in Europe, 12% in the United States, but less than 5% in central Africa.1 About Felzartamab Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG for multiple myeloma. HI-Bio exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan), where TJ Biopharma retains the rights. Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority. About HI-Bio Human Immunology Biosciences, Inc. (HI-Bio™), was incubated by ARCH Venture Partners and Monograph Capital to develop precision therapies for immune-mediated diseases and to bring clinical immunology into its next chapter. Inspired by the rise of targeted therapies in clinical oncology, the company pursues a therapeutic strategy of targeting and depleting the immune cell types that drive IMDs. The company's most advanced candidate, felzartamab, is a CD38-targeted antibody shown in clinical studies to deplete CD38+ cells, including plasma and natural killer (NK) cells, which are implicated in a range of indications including antibody-mediated rejection (AMR), IgA nephropathy (IgAN), lupus nephritis (LN) and primary membranous nephropathy (PMN). Other investors include Alpha Wave Global, Arkin Bio Capital, Jeito Capital and Viking Global Investors. To learn more about HI-Bio, visit or follow the company on LinkedIn and X. References: Rajasekaran et al. (2021) IgA nephropathy: An interesting autoimmune kidney disease. Available at . Hastings et al. (2018) Clinical Research, Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy. Available at (17)30362-5/fulltext SOURCE HI-Bio

Rice University hosts world's largest and richest student startup competition HOUSTON, April 8, 2024 /PRNewswire/ -- Ice cream company Protein Pints took home the grand prize at the 2024 Rice Business Plan Competition (RBPC) April 6 as the best student ventures from top universities across the world competed for prizes in front of nearly 350 angel, venture capital and corporate investors and members of the business community. Continue Reading The best student ventures from top universities across the world competed in the 2024 Rice Business Plan Competition. Post this (Left to right) Alexa Stachowiak, Eric Pulaski, David Klein, Andrew Nicholson and Ashok Rao of Goose Capital; Paul Reiss, CEO, and Jordan Emmer, director of analytics, Protein Pints; Jeff Smisek, (Trustee emeritus/Rice Board of Trustees), John Chaney and Jim Compton of Goose Capital; and from Rice University Paul Cherukuri, vice president for innovation; Kelly Fox, executive vice president for operations, finance and support; Peter Rodriguez, dean, Jones Graduate School of Business During his acceptance speech, Founder and CEO of Protein Pints Paul Reiss said, "The love and support that we've been shown during our time here at Rice, and the relationships and the friends that we've made, is something that I know I and every other student here is going to remember for the rest of our lives." Hosted annually by the Rice Alliance for Technology and Entrepreneurship and Rice University's Jones Graduate School of Business, the RBPC is the world's largest and richest student startup competition. The RBPC offers real-world opportunities to learn what's required to successfully launch a new business. In addition to the substantial cash, investment and in-kind prizes, the heart of the competition is the mentoring from investors and experienced entrepreneurs. RBPC alumni have raised more than $6.1 billion in capital and 288 are in business or have had successful exits. The winners were announced at the conclusion of the three-day pitching, mentoring and networking event, which included an elevator pitch competition, practice round, semifinals, wildcard and final round. At the award celebration, more than 80 prizes were announced totaling $1.5 million in investment and non-dilutive cash prizes. Every team took home cash. "We award the competitors $1 million in prizes, prizes that serve as foundational capital to launch their startup," said RBPC Director Catherine Santamaria in her welcome speech at the awards gala April 6. "That's a large number of prizes, but the biggest thing our startups leave with is a feeling of generosity and community from this room. This community is always ready and willing to help our founders and support our vision for the competition by investing time, money and resources in these student innovators." The 42 competing startups represented 35 universities from four countries. They were chosen from more than 450 applicants to compete in one of five categories: energy, cleantech and sustainability; life sciences and health care solutions; consumer products and services; hard tech; and digital enterprise. Learn more about all of the startups here. The seven finalists based on the judges' overall scores were: Protein Pints, Michigan State University — first place and the $150,000 GOOSE Capital Investment Grand Prize. Protein Pints is a high-protein, low-sugar, ice cream product designed for people who would benefit from having access to a functional ice cream and/or better tasting and more enjoyable protein options. Somnair, Johns Hopkins University — second place and the $100,000 Investment Prize, sponsored by David Anderson, Jon Finger, Anderson Family Fund, Finger Interests, Greg Novak and Tracy Druce. Somnair is a Novel Non-Invasive Neurostimulation device for the treatment of obstructive sleep apnea. Power2Polymers, RWTH Aachen University — third place and the $50,000 Rice University investment, provided by the Rice Alliance for Technology and Entrepreneurship and sponsored by Finger Interests, the Anderson Family Fund at the Greater Houston Community Foundation, Greg Novak and Tracy Druce. Power2Polymers tackles the pressing issue of "forever chemicals," which have been linked to over 6.5 million deaths in the U.S. alone, by offering safe alternatives free of forever chemicals. Informuta, Tulane University — fourth place and the $5,000 prize, sponsored by Norton Rose Fulbright. Informuta's proprietary technology leverages DNA sequencing to predict if bacteria will respond to different antibiotics or, for the very first time, develop future resistance thus causing treatment failure. Icorium Engineering Company, University of Kansas — fifth place and the $5,000 prize, sponsored by EY. Icorium Engineering Company is a chemical engineering startup and University of Kansas spinout developing technologies to make sustainable, circular economies a reality for refrigerants and other complex chemical mixtures. EndoShunt Medical, Harvard University — sixth place and the $5,000 prize, sponsored by Chevron Technology Ventures. EndoShunt is transforming trauma surgery with a rapid, targeted blood flow control device. D.Sole, Carnegie Mellon University — seventh place and the $5,000 prize, sponsored by Shell Ventures. D. Sole is advancing the development of remote patient monitoring in podiatry with foot insoles designed for the early detection and monitoring of diabetic foot complications, such as ulcers and deformities. The fourth through seventh place startups were also awarded an additional investment prize of $25,000 each provided by Rice Alliance and sponsored by David Anderson, Jon Finger, Anderson Family Fund, Finger Interests, Greg Novak and Tracy Druce, bringing their finalist prize totals up to $30,000. Other significant prizes this year and the teams that won them include: $200,000 Goose Capital Investment Prize — Osphim, RWTH Aachen University $250,000 OWL Investment Prizes — MesaQuantum, Harvard University $100,000 OWL Investment Prizes — Icorium Engineering Company, University of Kansas $100,000 Houston Angel Network Investment Prize — Somnair, Johns Hopkins University $100,000 The Indus Entrepreneurs (TiE) Texas Angels Investment Prize — Protein Pints, Michigan State University $60,000 nCourage Courageous Women Entrepreneur Investment Prize — MesaQuantum, Harvard University $40,000 nCourage Courageous Women Entrepreneur Investment Prize — Icorium Engineering Company, University of Kansas $40,000 Pearland EDC Spirit of Entrepreneurship Cash Prize — Informuta, Tulane University $25,000 New Climate Ventures Sustainable Investment Prize — Oxylus Energy, Yale University $25,000 Dream Big Ventures Latino Entrepreneur Investment Prize — Dendritic Health AI, Northwestern University $25,000 NOV Energy Technology Innovation Cash Prize — LiQuidium, University of Houston $25,000 Urban Capital Network Diversity Investment Prize in Partnership with South Loop Venture Investment Prize — TouchStone, University of California, Berkeley $25,000 Southwest National Pediatric Device Consortium Pediatric Device Cash Prize — EndoShunt Medical, Harvard University $25,000 Jacobs, Intuitive Machines and WRX Companies Rising Stars Space Technology and Commercial Aerospace Cash Prize — MesaQuantum, Harvard University For more information about the 2024 Rice Business Plan Competition, visit rbpc.rice.edu. About Rice Located on a 300-acre forested campus in Houston, Rice University is consistently ranked among the nation's top 20 universities by U.S. News & World Report. Rice has highly respected schools of architecture, business, continuing studies, engineering, humanities, music, natural sciences and social sciences and is home to the Baker Institute for Public Policy. With 4,574 undergraduates and 3,982 graduate students, Rice's undergraduate student-to-faculty ratio is just under 6-to-1. Its residential college system builds close-knit communities and lifelong friendships, just one reason why Rice is ranked No. 1 for lots of race/class interaction, No. 2 for best-run colleges and No. 12 for quality of life by the Princeton Review. Rice is also rated as a best value among private universities by Kiplinger's Personal Finance. SOURCE Rice University

– Industry veteran brings extensive clinical development experience to AVEO Oncology leadership team as Chief Medical Officer – – Formation of a Scientific Advisory Committee from world-renowned cancer institutions – BOSTON, March 25, 2024 (GLOBE NEWSWIRE) -- AVEO Oncology (also known as AVEO Pharmaceuticals, Inc.) (“AVEO”), an LG Chem company, today announced the appointment of Edgar E. Braendle, MD, PhD as AVEO Oncology’s new Chief Medical Officer. Dr. Braendle is a life sciences executive with experience spanning from early drug discovery to the launch of small molecules, biologics, radiopharmaceuticals, gene and cell therapies, and medical device development. Dr. Braendle brings more than twenty years of clinical research experience to AVEO Oncology, most recently serving as Chief Development Officer of Autolus Therapeutics Plc since July 2021, where he was responsible for all development functions and the conduct of the pivotal program of AUCATZYL™ (a CD-19 directed genetically modified autologous T cell immunotherapy) in adult acute lymphoblastic leukemia, and the respective filing to the U.S. Food & Drug Administration and European Medicines Agency. “We are delighted to have Dr. Braendle join the AVEO Oncology team particularly at this important juncture as we seek to become a global top 20 oncology leader,” said Michael P. Bailey, President and Chief Executive Officer of AVEO Oncology, an LG Chem company. “Dr. Braendle’s significant experience will be instrumental in our efforts to develop and diversify our pipeline.” Prior to his time at Autolus, Dr. Braendle held the role of Executive Vice President, Chief Medical Officer and Global Head of Development at Sumitomo Dainippon Pharma Oncology, where he was responsible for a full range of development functions and progressed several early-stage, first in human programs and late-stage programs. Prior to this, Dr. Braendle served as President and CEO of ARUP Laboratories, a national clinical and anatomic reference laboratory. Dr. Braendle also spent over a decade at Novartis AG, where he served as Senior Vice President and Global Head of Companion Diagnostics and led the company's precision medicine approach. Dr. Braendle received his medical degree at RWTH Aachen University in Germany, followed by specialty training in medical oncology, urology and pharmacology. Dr. Braendle is also an associate professor at the University of Ulm, Germany. Today, AVEO Oncology, an LG Chem company, and LG Chem Life Sciences also announced the formation of its Scientific Advisory Committee (“Committee”). This esteemed group of experts in oncology research and clinical development were selected to advise and bring unique perspectives to AVEO and LG Chem’s clinical strategy and business development initiatives. "We are excited and privileged to have the opportunity to work with this group of top oncology experts to help guide our drug development initiatives from discovery through commercialization. Notably, the Committee represents key areas of interest including gastrointestinal, genitourinary, ovarian, lung and head and neck cancers," said Mr. Bailey. The Scientific Advisory Committee is comprised of several leading cancer experts, including: Al B. Benson III, MD, FACP, FACCC, FASCO Professor of Medicine Associate Director from Cooperative Groups Robert H. Lurie Comprehensive Cancer Center of Northwestern University Scott Kopetz, MD, PhD Professor and Deputy Chair for Translational Research, Department of Gastrointestinal Medical Oncology Division of Cancer Medicine University of Texas MD Anderson Cancer Center D. Ross Camidge, MD, PhD Professor of Medicine/ Oncology Joyce Zeff Chair in Lung Cancer Director, Thoracic Oncology Faculty, Developmental Therapeutics Program University of Colorado Cancer Center, Aurora John L. Marshall, MD Chief, Hematology and Oncology Professor of Medicine and Oncology Director, Otto J Ruesch Center for the Cure of Gastrointestinal Cancers Georgetown Lombardi Comprehensive Cancer Center Edward Chu, MD, MMS Director, Montefiore Einstein Cancer Center Albert Einstein College of Medicine Tony S.K. Mok, BBS, FASCO Chairman, Department of Clinical Oncology LiShu Fan Professor of Clinical Oncology The Chinese University of Hong Kong Ezra Cohen, MD, FRCPSC, FASCO Chief Medical Officer of Oncology Tempus University of California- San Diego Paul G. Richardson, MD Director, Clinical Research Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Kevin J. Cullen, MD Professor of Oncology University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center University of Maryland School of Medicine Joseph Tabernero, MD, PhD Head, Medical Oncology Department Director, Vall d’Hebron Institute of Oncology Professor of Medicine, UVic-UCC Enrique Grande, MD, PhD, Msc Director, Medical Oncology Program and Clinical Research lead MD Anderson Cancer Center Madrid Jan Vermorken, MD, PhD Emeritus Professor of Oncology Department of Medical Oncology Antwerp University Hospital For more information about the Scientific Advisory Committee, please visit About AVEO Pharmaceuticals, Inc. AVEO is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immunooncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. For more information, please visit About LG Chem, Ltd. and LG Chem Life Sciences LG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversified business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting-edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people’s lives through inspiring science and leading innovation. For more information, please visit ContactsMedia: John F. Kouten JFK Communications, Inc. jfkouten@jfkhealth.com (908) 227-4714 Source: AVEO Pharmaceuticals, Inc.