Diabetes Mellitus, Type 1

Sionna Therapeutics and Odyssey Therapeutics have joined Metsera and Maze in an attempt to go public via the still rocky IPO route. The biotechs, focused on cystic fibrosis and immunology respectively, filed for their initial public offerings on Friday evening. Sionna and Odyssey departed last week’s annual JP Morgan Healthcare Conference with plans for public life as $SION and $ODTX . They join the Nasdaq queue alongside obesity drug developer Metsera and kidney disease startup Maze , which has spun out other companies and formed joint ventures over the years. None of the IPO hopefuls have yet outlined the size of their planned debuts. If all four biotechs follow through with their plans, they’d create a buzzy start to 2025 compared to the relatively dry IPO market of the past few years. The new entrants Sionna and Odyssey are both well-funded, clinical-stage biotechs with experienced management teams, ticking most of the boxes that public market investors seek for drug development startups in the current IPO environment. Last year, Boston-based Sionna in-licensed three cystic fibrosis drug candidates from AbbVie, just months after disclosing a $182 million Series C that would take it through 2026, CEO Mike Cloonan told Endpoints News last July. Cloonan was a long-time Biogen executive and Sage Therapeutics operating chief before joining Sionna in spring 2021. New details on the AbbVie deal were revealed in Sionna’s S-1 paperwork, which was filed on 17 January. AbbVie got $5 million upfront and $8.6 million worth of common stock. The pharma giant could also get up to $360 million in development and commercial biobucks, plus up to $130 million in commercial and sales-based milestones, according to the S-1 filing . Sionna had $180 million in cash, equivalents and marketable securities at the end of September, according to the filing. The mid-stage biotech spent about $43 million on R&D in the first nine months of 2024, a $12 million jump over the same period the prior year, per the S-1. Sionna has raised about $330 million since its 2019 founding. RA Capital owns the largest chunk of the biotech at 29.2%. TPG Growth holds 17.4%, Atlas Venture owns 11.4% and OrbiMed maintains a 9.9% stake. OrbiMed is also one of the largest stakeholders in Odyssey. SR One is the biggest shareholder at 16.2% followed by OrbiMed (14.3%), Fidelity (6.7%) and Foresite Capital (6%), according to Odyssey’s S-1 filing . Odyssey is developing small molecule therapies for ulcerative colitis, Crohn’s disease, atopic dermatitis, systemic sclerosis and other indications. It’s also creating protein therapeutics for vitiligo, type 1 diabetes, systemic lupus erythematosus and asthma. The preclinical asthma program is part of the burgeoning TSLP arena. Gary Glick, a chemistry professor-turned-serial entrepreneur, leads Odyssey. The biotech startup formed in 2021 and quickly disclosed three successive megaround financings, most recently a $101 million Series C in December 2023. Glick is also a co-founder of Scorpion Therapeutics. During last week’s JPM, Eli Lilly said it would buy Scorpion for up to $2.5 billion . Odyssey spent $81 million on R&D in the first nine months of 2024, a $5 million decrease compared with the same period of 2023. The company had about $155 million in cash, equivalents and marketable securities at the end of September.

Jan. 10, 2025 -- InflammX Therapeutics Inc., a clinical-stage biotechnology company focused on developing innovative therapies for retinal diseases with significant unmet needs, announced today that it has entered into an option agreement granting leading global eye health company Bausch + Lomb the right to acquire the company. This strategic move aligns with a shared goal of advancing groundbreaking treatments addressing unmet medical needs in ophthalmology. InflammX’s pipeline includes a cutting-edge, orally dosed, therapeutic candidate targeting a form of macular degeneration known as intermediate age-related macular degeneration (iAMD) and diabetic retinal eye disease. “We see tremendous potential in combining our resources and expertise with InflammX’s innovative approach to retinal disease treatment,” said Yehia Hashad, chief medical officer and executive vice president of Research & Development, Bausch + Lomb. Under the terms of the option agreement, which was signed in December 2024, Bausch + Lomb has secured the exclusive option to acquire InflammX Therapeutics during an agreed-upon option period based on the achievement of specified development milestones. “Partnering with Bausch + Lomb offers a unique opportunity to accelerate the development of our pipeline and bring our therapies to patients worldwide,” said Brian Levy, chief executive officer, InflammX Therapeutics. “We share a common vision of improving outcomes for individuals affected by retinal disease, such as iAMD, which represents a majority of patients diagnosed with AMD, and for which there is no currently approved treatment.” The agreement marks a milestone in InflammX’s strategy to enhance its innovation-driven retinal portfolio. No financial terms have been disclosed. InflammX is a clinical stage company with an orally dosed drug (Xiflam), which targets the activated, inflammatory recycling innate immune system, known as the NLRP3 Inflammasome. The drug target for Xiflam is the Connexin43 (Cx43) hemichannel, which when pathological allows ATP to escape from the cell signaling activation of the NLRP3 inflammasome and associated perpetuated, inflammation. Xiflam acts directly on the pathological Cx43 hemichannel reverting it back to a physiological state, shutting down the recycling inflammation. The retinal disease states being targeted by InflammX, have been shown to be mediated by inflammasome driven autoinflammation. InflammX Therapeutics has filed an IND with the FDA and is currently in a Phase 2 Randomized Clinical Trial treating patients with early-stage Diabetic Macular Edema (DME). The study is supported by the DRCR Retina Network of the National Eye Institute and Breakthrough T1D, formerly known as the Juvenile Diabetic Research Foundation. InflammX is in the process of beginning a second Clinical Trial treating patients diagnosed with iAMD, the early stage of macular degeneration, which is the precursor to vision loss. The content above comes from the network. if any infringement, please contact us to modify.

ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- Rise Therapeutics, a biotechnology company engaged in developing novel oral Immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a cancer Phase 1 clinical trial for its program candidate, R-5780. This is Rise Therapeutics' fourth clinical program to enter patient clinical testing. For separate products, other clinical studies are ongoing for the treatment of ulcerative colitis, rheumatoid arthritis, and type 1 diabetes. Continue Reading R-5780 is an orally delivered immune oncology drug candidate being developed for the treatment of cancer. R-5780 has demonstrated a pronounced ability to engage immune pathways that enhance the effectiveness immune checkpoint inhibitor therapy. This drug candidate builds upon the growing understanding of how certain gut-regulated immune pathways can help promote efficacy of immune oncology drugs. R-5780 is a precision-directed synthetic biology medicine that engages selective immune pathways that can support a robust anti-tumor T cell response. This revolutionary immune oncology drug candidate is one of the first of its kind in the context of mechanism of action and potential for success in the context of cancer treatment. Rise Therapeutics Receives FDA IND Clearance to Initiate Clinical Testing of R-5780 in Cancer Post this "The FDA's clearance for R-5780 is a testament to the innovation and dedication of our team at Rise Therapeutics driving novel immunotherapies forward into human proof-of-concept" states Christian Furlan Freguia, Senior Vice President of Research at Rise Therapeutics. "R-5780 represents a pioneering approach that leverages the power of gut-regulated immune pathways to enhance the effectiveness of immune checkpoint inhibitors... We believe R-5780 has the potential to expand responses in patients that become refractory to immune checkpoint inhibitors and increase responsiveness in tumors initially unresponsive to these medications". The Phase I clinical trial (NCT06398418) will be a multi-dose clinical trial assessing the safety, drug exposure, and clinical activity of R-5780 in patients with cancer. The study will enroll up to 33 participants. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . Contact: [email protected] SOURCE Rise Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED