Abivax, a company whose ulcerative colitis drug is currently in late-stage clinical development, now has nearly $236 million to continue a pivotal study key to showing not only that its drug works, but also that it can differentiate itself in a crowded and competitive field of inflammation-fighting medicines.
Paris-based Abivax raised the new capital by making its U.S. stock market debut and striking a separate financing deal. The company last Friday priced its offering of more than 18.6 million American depositary shares at $11.60 apiece, which was the low end of the price range it had previously set. That U.S. IPO raised about $217 million. It’s an additional public listing for the company, which has traded on the Euronext Paris exchange since 2015. Abivax’s stock symbol on both exchanges is “ABVX.”
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Concurrent with the Nasdaq debut, Abivax also sold more than 1.6 million shares of its Euronext-traded securities in a private placement priced at €10.98 per share, raising about €17.8 million (about $19.05 million). Combined, the two stock transactions raised $235.8 million, before expenses and commissions.
Many of the drugs available (and some that are in clinical development) for inflammatory bowel disorders are injectable antibodies designed to block a target associated with inflammation. Chronic injections pose a burden to patients. Oral alternatives offer patients an easier dosing alternative, but inflammation-fighting oral drugs, such as JAK inhibitors, come with safety risks. Pfizer recently won FDA approval for Velsipity, a S1P-modulating small molecule hoped to be a safer alternative to JAK inhibitors.
Abivax aims to offer patients an orally dosed drug with a safety edge compared to other inflammatory disease therapies. The company says its approach to chronic inflammatory diseases involves harnessing the body’s natural regulatory mechanisms in order to modulate immune responses. Obefazimod is a small molecule designed to enhance expression of miR-124, a micro-RNA that plays a role in regulating the inflammatory response. In the IPO filing, Abivax said this target can control the progression of inflammation and restore homeostasis of the immune system without causing broader immunosuppression. Currently available therapies target a single cytokine or pathway. But Abivax says that through miR-124, obefazimod can modulate several cytokines and pathways.
“Modulating multiple inflammatory pathways simultaneously may lead to more durability of efficacy results over the long-term, which is critical in lifelong conditions such as IBD, potentially differentiating obefazimod from currently available IBD treatments,” Abivax said in the IPO filing.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The Phase 3 program for obefazimod consists of two induction trials, in which patients get the drug into their systems to eliminate symptoms of the disorder. The induction studies are followed by a Phase 3 maintenance study to see how well and how long the drug’s benefits hold up. Preliminary data from the induction studies are expected in the first quarter of 2025. The maintenance study is expected to have preliminary data in first quarter of 2026. Abivax also plans begin a Phase 2a clinical trial of obefazimod in Crohn’s disease in the first quarter of 2024.
According to the IPO filing, Abivax has budgeted about €170 million for continued clinical development of obefazimod for ulcerative colitis. Another €15 million is earmarked for development of the molecule for Crohn’s disease.
IPO research firm Renaissance Capital notes that Abivax is part of a cohort of new public listings reminiscent of the early part of the year, when biotech, energy, and financial firms drove the flow of large IPO deals.
“The deals that came out of that period are among the strongest performers now, so it makes sense to see those trends resurface,” Bill Smith, Renaissance’s co-founder and CEO, wrote in the firm’s weekly newsletter.
Shares of Abivax closed Monday at $8.10, down more than 30% from the IPO price. The company is still a long way away from posting any clinical data that could bump up the stock price. Preliminary results from the induction studies are expected in the first quarter of 2025. The maintenance study is expected to have preliminary data in first quarter of 2026. The Crohn’s disease study could have initial data in the second half of 2025.
Two more biotechs joined the IPO queue. Here’s a brief look at both of them:
Clinical-Stage Cargo Aims to Load Cell Therapies With More Features
Seven months after Cargo Therapeutics unveiled $200 million in financing for cell therapies that overcome ways that cancer develops resistance to drugs, the biotech filed IPO paperwork to raise even more cash. San Mateo, California-based Cargo did not set any pricing terms for its offering, but Renaissance Capital penciled in a $100 million figure for the planned IPO.
The first generation of CAR T-therapies are made by harvesting a patient’s T cells and engineering them to target a cancer protein called CD19. If, or when cancers become resistant to CD19-targeting drugs, they won’t work for patients. Lead Cargo program CRG-022 is an autologous CAR T-therapy engineered to address a different target called CD22.
A potentially pivotal Phase 2 study is evaluating this therapy in patients whose large B-cell lymphoma has relapsed or has not responded to a CD19-targeting cell therapy. Cargo also plans to evaluate its cell therapy in patients in earlier stages of their disease. In addition, the biotech is developing a pipeline of therapies engineered to carry multiple types of therapeutic cargo that help therapy better reach its tumor destination, last longer, safeguard against tumor resistance, and overcome T cell exhaustion.
Invea Aims to Turn Failed Daiichi Drug Into a New Inflammation Med
In other IPO filing news, Invea Therapeutics submitted paperwork for its planned stock market debut. The Guilford, Connecticut-based biotech is developing small molecules for immune-mediated inflammatory diseases. Invea’s drug discovery approach employs artificial intelligence and machine learning. Renaissance estimated Invea’s offering could raise $75 million.
The Invea pipeline is led by INV8001, a small molecule licensed from Daiichi Sankyo. In the hands of the Japanese drug company, INV8001 failed a mid-stage clinical trial in atopic dermatitis. But Invea said in its IPO filing that it has closely analyzed the trial data and has identified potential gaps in that trial’s design. Invea plans to seek FDA permission to try again with a Phase 2b study employing a new trial design that includes a different dosing regimen and enrollment of patients using well-defined selection criteria, such as high levels of antibodies that are an indicator for the activation of mast cells that drive allergic inflammation.
Photo: Getty Images
