Solitumomab

Clinically validated pH-sensitive nanomedicine platform allows for tumor specific delivery of protein therapeutics and increased tolerability SOUTHLAKE, Texas--(BUSINESS WIRE)-- OncoNano Medicine, Inc. today announced the presentations of positive preclinical data on the company’s ON-BOARD™ pH-activatable delivery platform at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts. The data presented at SITC 2022 demonstrated the capability of the ON-BOARD™ platform for effective encapsulation and improvement of the therapeutic index of a variety of therapeutic payloads, including bispecific T cell engagers (TCE) and a therapeutic cytokine – IL-2-Fc, using relevant animal models. The ON-BOARD™ platform is designed to protect oncology intervention payloads systemically and release them in the acidic tumor microenvironment, minimizing systemic exposure and toxicity. OncoNano’s lead clinical candidate, pegsitacianine, currently in Phase 2 clinical trials, is formulated with ON-BOARD™, and the clinical data has validated its pH-activated tumor specificity. In the two separate presentations, a variety of TCEs including solitomab, runimotamab and several TCEs with undisclosed targets as well as a human IL-2 fused with IgG Fc were encapsulated using the ON-BOARD™ platform. The data demonstrated that: ON-BOARD™ successfully encapsulated TCEs across a range of different targets and structural configurations without any protein engineering involved ON-BOARD™-encapsulated TCEs demonstrated rapid release and high pH specificity as well as pH-activated cytotoxicity against various cancer cell lines in vitro ON-BOARD™ encapsulation of an undisclosed TCE significantly improved its tolerability in vivo compared to the unencapsulated molecule and inhibited the growth of a poorly immunogenic “cold” tumor model with in-tumor payload activation confirmed by PD markers ON-BOARD™-encapsulated IL-2-Fc showed robust anti-tumor efficacy in both the "hot" MC38 and the "cold" B16F10 tumors and greatly suppressed systemic toxicity compared to unencapsulated IL-2-Fc “We were excited to share the positive data on the encapsulation of a variety of bispecific T cell engagers and a therapeutic cytokine and the significant improvement of therapeutic index without complicated protein engineering,” said Tian Zhao, PhD, Vice President of Research and Development at OncoNano. “We look forward to developing this technology for clinical translation with these types of payload molecules in the near future.” Presentation Overview Title: A Clinically Validated pH-Sensitive Nanomedicine Platform for Encapsulating Therapeutic Bispecific T Cell Engagers for Tumor Specific Delivery and Activation Date: November 10 – 11, 2022 Time: 9:00 am - 9:00 pm EST Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA Title: Ultra-pH Sensitive Nanoparticles Increase Therapeutic Index of IL-2-Fc Date: November 12, 2022 Time: 10:40 am – 10:50 am EST Location: Session 302: Thomas Waldmann Memorial Plenary Session: New Immunotherapies, Boston Convention and Exhibition Center, Boston, MA About OncoNano Medicine OncoNano Medicine is developing a new class of products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat cancer with high specificity. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, agents for real-time image guided surgery and a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer. OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARD™ platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at .

BioFlorida's Annual Conference Spotlights Industry Success & Fuels Collaboration MIAMI, Nov. 7, 2022 /PRNewswire/ -- BioFlorida's 25th Annual Conference united statewide leaders of Florida's life sciences industry representing biopharmaceutical, medical technology, and digital health companies, globally recognized research universities and research institutions, and the state's health systems to spotlight the continued momentum and success in science, business, and public policy and spur collaboration and future growth. "For 25 years, BioFlorida has convened our state's champions for the life sciences – those leaders from Florida-based companies, research institutions, and health systems – to spotlight success, to foster collaboration, and to explore policy solutions to fuel continued industry growth and innovation," said Nancy K. Bryan, President and CEO of BioFlorida. "The Conference provided an opportunity to reflect on the role we've played to collectively establish Florida as a leading life science destination that today represents 8,600 establishments and research organizations that employ nearly 107,000 Floridians. But our focus remains on the patient, and we're excited to continue the unprecedented collaboration to develop new, innovative treatments and cures over the next 25 years." The Conference explored topics ranging from emerging therapies and breakthrough research in cancer care, rare disease, neurology and movement disorders, and gene and cell therapy to innovations in manufacturing, financing strategies, commercialization considerations, and other emerging trends, like AI and machine learning applications and leveraging MedTech to improve the patient, physician, and clinical experience. All conversations were led by CEOs, executives and top scientists and researchers from Florida-based companies, universities, research organizations, and health systems. Panels also explored opportunities to fuel Florida's life sciences ecosystem by attracting companies and talent to the state and policy discussions on the future of healthcare in Florida with Senator Ana Maria Rodriguez and Representative Tom Fabricio. Speaker of the Florida House of Representatives Chris Sprowls shared the impact of the life sciences industry as a cancer survivor and the Florida Legislature's role in helping to grow the industry. The keynote speaker at the Conference was Fred Hassan, a director with the private equity firm, Warburg Pincus, and board member of Precigen, IntegraConnect, Prometheus Biosciences, and BridgeBio. The industry titan drew on his years of success leading companies like Schering-Plough Corporation, where he served as Chairman and CEO from 2003 until its merger with Merck & Co. in 2009, and Pharmacia Corporation, where we served as Chairman and CEO from 2001 to 2003 until its acquisition by Pfizer Inc. to share strategies for success in today's environment. Jeffrey Duerk, PhD, Executive Vice President for Academic Affairs and Provost for the University of Miami, spurred collaborative solutions to connect academics, research, and industry in Florida to spotlight state efforts on a global level. The Spotlight on Innovation session showcased four companies that have exhibited transformational growth: Veru, Inc. (Miami); Accelus (Palm Beach Gardens); Catalyst Pharmaceutical Inc. (Coral Gables); and ILiAD Biotechnologies (Weston). Seed and early-stage companies competed in BioPitch, an opportunity for some of the state's most innovative companies to pitch to 25+ life science investors. A record-breaking 55 companies entered BioPitch with InnoCare Urologics LLC (Miami), a company developing the InnoCare Egress Catheter, the only indwelling urinary catheter designed to rapidly deflate if accidentally removed, winning the competition and receiving $10,000. Runners-up included Andante Biologics (Gainesville); FoxSeq LLC (Alachua); and, VuEssence (Tampa). BioFlorida recognized individuals and organizations throughout six unique categories for their incredible achievements. This year's award recipients include: Researcher of the Year Award The Researcher of the Year award recognizes distinguished researchers whose achievements have significantly advanced scientific knowledge with a proven impact on innovation and public health. This years' award was presented to Dr. James J. Hickman, Chief Scientist and Chairman of the Board at Hesperos, Inc., a global contract research organization he co-founded that is providing safety and efficacy testing services for novel therapeutics using its Human-on-a-Chip® platform – the most advanced, multi-organ microphysiological system available today. By developing human-based, clinically relevant disease models, Hesperos is accelerating drug discovery for a range of indications by providing unprecedented visibility into how those diseases and potential therapeutics impact the body over time, especially for rare diseases. This includes neurodegenerative and rare diseases such as Alzheimer's and ALS, as well as investigating the effects of opioid overdose and recovery, among others. The exciting new technology continues gaining industry adoption from commercial partners and regulators alike. This was most recently evidenced by the FDA authorizing a Phase II clinical trial (#NCT04658472) for a repurposed drug for a rare neurodegenerative disease using safety data from another indication but using efficacy data only from the Hesperos platform. This was a first-of-its-kind achievement and a significant milestone in the evolution of drug discovery for human-on-a-chip systems. In addition to his role at Hesperos, Dr. Hickman is the Founding Director of the NanoScience Technology Center, and Professor of NanoScience Technology and Electrical Engineering at the University of Central Florida. Hesperos was initiated in the UCF incubator before moving to its current facility. Previously, he was the Hunter Endowed Chair in the Bioengineering Department at Clemson University where he and Tom Boland invented the bioprinting of cells. Dr. Hickman earned his Ph.D. in Chemistry from MIT and has spent the past 30 years studying the interaction of biological species with modified surfaces in both industry and academia, including stints at NSF and DARPA in the area of biological computation. He has more than 31 issued patents, 164 publications, and 20 book chapters. He is a Fellow of the American Institute of Medical and Biomedical Engineers, the American Vacuum Society, International Academy of Nanobiotechnology, and most recently, the National Academy of Inventors. Deal of the Year Award The Deal of the Year Award recognizes a deal, whether it be an equity investment, key license agreement, significant grant award, or other agreement, with a significant impact on innovation, public health, and the deal-flow ecosystem within Florida's life sciences industry. The Deal of the Year Award was presented to Dr. Edgardo Rodriguez-Lebron, Co-founder, President and Chief Executive Officer of Lacerta Therapeutics, a biotechnology company focused on adeno-associated virus (AAV) technologies and founded in 2017 in Alachua. The Deal of The Year is Lacerta's capsid licensing and collaborative research agreement with Prevail Therapeutics, a wholly owned subsidiary of Eli Lilly and Company. The collaboration will leverage Lacerta's established expertise in AAV technologies and Prevail's development and clinical capabilities, with the goal of accelerating development of gene therapies for patients with neurodegenerative disorders. Lacerta will lead capsid discovery, screening, and validation, while Prevail will complete preclinical and investigational New Drug-enabling studies. Prevail will oversee manufacturing, clinical development, and commercialization. Dr. Rodriguez-Lebron has been a leader at Lacerta from its foundation and has over two decades of research experience in neurodegenerative diseases and adeno-associated viruses (AAV). An active contributor to the gene therapy community, he is an ASGCT member and serves as the CSO of NF2Biosolutions, a nonprofit focused on the development of a gene therapy approach to neurofibromatosis type 2 (NF2). He has co-founded and helped launch multiple startups in the Gainesville, Florida area. Weaver H. Gaines Entrepreneur of the Year Award The Weaver H. Gaines Entrepreneur of the Year Award honors an individual who has made extraordinary contributions to the growth of Florida's life sciences industry. The 2022 Weaver H. Gaines Entrepreneur of the Year Award was presented to Courtney A. Miller, Ph.D., Co-Founder and acting CEO of Myosin Therapeutics, a Jupiter-based biopharmaceutical company focused on developing first-in-class therapies for the treatment of cancer and psychiatric disorders, targeting an untapped superfamily of proteins known as molecular nanomotors. Together with her co-founders, Drs. Pat Griffin and Ted Kamenecka, the team developed nMOTOR, a high-throughput screening platform to identify selective modulators of any one of the hundred different nanomotors encoded by the human genome. Myosin is currently advancing the development of MT-110 and MT-125, two CNS-penetrant small molecule inhibitors with novel nanomotor targets. Myosin was born out of more than a decade of work by the team in their labs at UF Scripps Biomedical Research, with $15 million in NIH support to help bring their compounds to the clinic. Under Dr. Miller's leadership, the company was founded in August 2020 and awarded a $2.5 million-dollar Fast Track SBIR from NIH just six months later to support completion of IND-enabling studies and a Phase I clinical trial of MT-110 for stimulant use disorder, for which there are currently no FDA-approved treatments. In parallel, the team has been working with physician-scientist, Dr. Steven Rosenfeld, Director of Neuro-Oncology at the Mayo Clinic in Jacksonville, on development of MT-125 for the treatment of glioblastoma, an aggressive form of brain cancer with no cure. MT-125 is safe and effective in preclinical studies, blocking both growth of the tumor and its invasion of healthy brain tissue, and shows potentially curative effects when combined with existing FDA-approved therapies. David J. Gury Company of the Year Award The David J. Gury Company of the Year Award honors a company that has achieved significant milestones and has contributed to the growth of Florida's life sciences industry. The 2022 David J. Gury Company of the Year Award was presented to Patrick J. McEnany, CEO of Catalyst Pharmaceuticals, a commercial-stage biotechnology company dedicated to making a meaningful difference in the lives of patients suffering from rare diseases. Based in Coral Gables, Catalyst was granted breakthrough therapy designation by the FDA in treating the rare disease Lambert-Eaton Myasthenic Syndrome (LEMS) in 2013. The product was approved in November 2018 and successfully launched FIRDAPSE in 2019. In 2022, the company received an sNDA approval for FIRDAPSE extending the patient population to include pediatric patients six years and older for the treatment of LEMS, and was named by Forbes as one of the 2022 Top Small Companies in America and South Florida Business Journal's 2022 Top 50 Public Companies. With a proven track record in development and commercialization, Catalyst continues to attain several significant milestones while generating yearly organic revenue growth. The company has $220 million in cash and short-term investments as of June 30, 2022, and no funded debut. BioFlorida Leadership Award The BioFlorida Leadership Award recognizes the BioFlorida volunteer who has taken on a leadership role within the organization, dedicated significant time to BioFlorida's mission, and has acted as a true ambassador to BioFlorida and the industry. The 2022 recipient of the BioFlorida Leadership Award is Kathy Chiu, a Founding Partner of DeepWork Capital, which manages venture capital funds investing in Florida startups. This year DeepWork Capital was selected to be the investment manager of Florida Opportunity Fund (FOF), a series of the state's venture capital investment program. Chiu co-founded DeepWork Capital, an Orlando-based company, in 2015 to help close the funding gap in Florida's innovation economy. DeepWork Capital is a rare multi-disciplinary early-stage venture capital fund in the state with life science capabilities. Its selection as the investment manager enables FOF to process life science investments, a development welcomed by BioFlorida. Chiu was instrumental in building up DeepWork's Life Science capabilities and led the firm in its investment in HCW Biologics (NASD: HCWB), which went public in 2021. At the 2022 BioFlorida Annual Conference, Chiu served as of BioPitch, a pitch competition that connects life science companies to investors. Chiu's dedication helped the organization expand its network to include a record-breaking 25+ investors and 55 applicants, as well as using her experience to implement key improvements to the BioPitch competition to address the needs of participants. BioFlorida Lifetime Achievement Award The BioFlorida Lifetime Achievement Award recognizes an individual's outstanding career achievements, leadership and contributions that have significantly contributed to the growth of his or her respective industry. The 2022 recipient of the BioFlorida Lifetime Achievement Award is Dr. Leonard Pinchuk. Over a forty-year career in biomedical engineering, Dr. Pinchuk's achievements include 137 issued U.S. patents, more than 100 publications and the founding of 10 companies. His major inventions are the Nylon 12 angioplasty balloon (used by all interventional cardiology companies), the helical undulating wire stent (Johnson and Johnson/Cordis, FL and Medtronic, MN), the modular stent-graft for bypassing aortic aneurysms (Boston Scientific Corporation, MA), a drug-eluting coronary stent (TAXUS®, Boston Scientific, MA), radiation oncology catheters (TriSalus, CO), a novel glaucoma treatment device (the PRESERFLO® MicroShunt, InnFocus/Santen, Osaka, JP), the next generation intraocular lens (Eyedeal, Xi'an China), a pull-out injury safe urinary drainage catheter (InnoCare, Miami, FL) and two important biomaterials; Bionate® polycarbonate urethane (Covestro AG, Germany) and SIBS® (Innovia LLC, Miami, FL), used in hundreds of medical devices world-wide. Dr. Pinchuk's inventions are used in over a billion patients worldwide with a financial impact of well over $100 billion. He was inducted into the U.S. National Academy of Engineering (NAE) in 2012 and, among other prestigious awards, received the National Academy of Engineering 2019 Fritz J. and Dolores H. Russ Prize, the world's top prize in bioengineering, for innovations in medical devices that enable minimally invasive angioplasty treatment of advanced coronary artery disease. About BioFlorida BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in BioPharma, MedTech, Digital Health, and Health Systems that collectively employ nearly 107,000 Floridians (Source: TEConomy/BIO). BioFlorida's member driven initiatives provide a strong business climate for the advancement of innovative products and technology that improve lives and promote economic benefits to the state. SOURCE BioFlorida