Paragon Therapeutics, Inc.

NEWS: Galecto is proud to announce the acquisition of Damora Therapeutics, uniting powerful science and expertise to advance targeted therapies that improve outcomes for people living with blood cancers.   Alongside an oversubscribed $285 million private placement, the acquisition expands Galecto’s pipeline to include Damora’s portfolio of anti-mutant calreticulin-targeted therapies. Its lead asset, DMR-001, is a potentially best-in-class monoclonal antibody against mutCALR, for which Phase 1 POC data is expected in 2027. Together, we will strive to redefine the standard‑of‑care for chronic blood disorders. Read the release: https://lnkd.in/empDe5xW #Acquisition #MutCALR #BloodCancer #Financing #Biotech

Today, we're excited to share positive interim Phase 1 results for ORKA-001, our long-acting anti-IL-23p19 antibody, in a late-breaking abstract at the EADV Congress in Paris, France. These results, including a half-life of ~100 days, support the potential for ORKA-001 to redefine the standard of care in psoriasis with annual dosing, higher rates of skin clearance, and extended off-treatment remissions in some patients. We also announced $180M in new financing, extending our runway >1 year beyond the ORKA-001 Phase 2b and ORKA-002 Phase 2 readouts in 2027. See more information on the Phase 1 results here https://lnkd.in/egDCPBji and the financing here https://lnkd.in/eKnMnfqd.

Today, we announced the first patient has been dosed in our SKYWAY Phase 2 basket study to evaluate SPY072 in #rheumatoidarthritis, #psoriaticarthritis, and #axialspondyloarthritis. These sub-studies are designed to assess SPY072’s potential to deliver meaningful improvements for patients living with moderate-to-severe disease, with endpoints evaluating joint, skin, and spinal inflammation. “We are excited that Spyre is pioneering a potential new therapeutic class for rheumatic diseases. SKYWAY is our second Phase 2 trial launch this year alongside the SKYLINE study that will evaluate three monotherapies and three combinations in IBD patients,” said Cameron Turtle, Chief Executive Officer of Spyre. “Together, we expect these two trials to deliver nine placebo-controlled proof-of-concept readouts over the next two years. These trials aim to efficiently identify multiple products with indication-leading profiles in commercial markets totaling over $60B in annual revenue.” Read our forward-looking statement and more: https://lnkd.in/ebKeA2Ny

We’ve reached an important milestone — Jade’s first clinical trial is now underway for our lead candidate JADE101.    JADE101 is an investigational monoclonal antibody designed to selectively inhibit the activity of APRIL for the treatment of IgA nephropathy or IgAN.    This Phase 1 study in healthy adult volunteers marks Jade’s transition to a clinical-stage company and represents a meaningful step toward our goal to deliver differentiated therapies for people living with autoimmune diseases.    Read the full announcement: https://lnkd.in/gTsYgkhg   #JBIO #IgAN #Autoimmune 

Apogee will report Part A 16-week data from the Phase 2 APEX trial of APG777 in patients with moderate-to-severe atopic dermatitis on July 7, 2025. Following the announcement, we will host a conference call and webcast to discuss the results. Visit the link below to access the live and archived webcast. https://lnkd.in/eQMpxeq6

Today, we’re pleased to share positive interim results from our Phase 1 trials of SPY002 and SPY072, two novel, extended half-life anti-TL1A antibodies. Each trial was a first-in-human, randomized, double-blind, placebo-controlled study evaluating safety, PK and PD. Additionally, interim data for both programs through 20 weeks of follow up: ·       Showed both antibodies were well tolerated across all dose levels ·       PK supports quarterly or less frequent dosing ·       Showed full TL1A target engagement for up to 20 weeks ·       Met key Phase 1 objectives and are advancing to Phase 2, SPY002 in #IBD and SPY072 in #rheumatology We are also proud to become a Phase 2 biotech company with the initiation of our SKYLINE-UC platform trial evaluating three monotherapies and three combinations in ulcerative colitis and the introduction of our planned SKYWAY-RD basket trial, which will evaluate SPY072 in three rheumatologic indications. We anticipate nine Phase 2 readouts between 2026 and 2027. Read more in the PR, including our forward-looking statements legend, and join us for a webcast for more details today at 8AM ET. https://lnkd.in/eFfMYnEY

We’re excited to announce that the first participants have been dosed in a Phase 1 trial of ORKA-002, our novel, half-life extended monoclonal antibody targeting IL-17A/F. Read the full press release here: https://lnkd.in/e9KqHahh.

The Spyre team is excited to be at Digestive Disease Week® (DDW) 2025, where we’re presenting two posters featuring up to eight months of follow-up from our ongoing Phase 1 trial of SPY001, as well as new preclinical data on dual inhibition of α4β7 and TL1A in murine colitis models. We’re proud to share these updates with the GI community. Learn more: https://lnkd.in/eKptznXj

The Spyre team is thrilled to share news of the first participant dosed in the Phase 1 trial of SPY003, a novel, half-life extended anti-IL-23 monoclonal antibody CANDIDATE – a potential best-in-class molecule for the treatment of #IBD.     We anticipate interim pharmacokinetic and safety data from healthy volunteers in the second half of this year and will incorporate SPY003 in our planned Phase 2 study in #ulcerativecolitis to explore three investigational monotherapies and three investigational combinations. To discover more, including our forward-looking statement legend: https://lnkd.in/eTGv-P93