Pennsylvania: Jubilant Therapeutics has announced that preliminary clinical data from its Phase 1/2 study of JBI-802, an investigational first-in-class oral dual LSD1/HDAC6 inhibitor, have been selected for an oral presentation at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, scheduled for December 12-15, 2026, in New Orleans and online.

The findings highlight encouraging early evidence of rapid platelet reduction and sustained hematologic control in patients with essential thrombocythemia (ET) and other related myeloproliferative neoplasms (MPNs). Additional efficacy, safety and molecular data from the ongoing study will be presented at the meeting.

"We are pleased to have the preliminary clinical data for JBI-802 selected for oral presentation at ASH," said Daniel O’Connor, President and Chief Executive Officer of Jubilant Therapeutics. "The abstract data from this ongoing Phase 1/2 study show encouraging early evidence of rapid platelet reductions and hematologic control in patients with ET and related MPNs. We look forward to presenting additional efficacy, safety and molecular data at ASH as we continue to evaluate JBI-802 in these patients."

The oral presentation will feature results from the Phase 1 portion of an open-label, multicenter clinical trial evaluating the safety, tolerability and preliminary efficacy of JBI-802. The study enrolled patients with essential thrombocythemia, polycythemia vera (PV) and myelodysplastic/myeloproliferative neoplasms (MDS/MPN) with thrombocytosis who had relapsed, were refractory to treatment or were intolerant to standard therapies.

According to the abstract, based on data available as of June 30, 2026, all eight patients who initiated treatment at the 15 mg dose achieved either a greater than 50% platelet reduction or platelet normalization (below 400 × 10⁹/L) by Week 3. The median time to platelet response was 15 days. Platelet normalization was maintained for 33, 44 and 46 weeks in patients receiving the 15 mg dose who had more than 12 weeks of follow-up. Additionally, seven of 11 patients with leukocytosis receiving the 15 mg dose achieved a complete hematologic response. No dose-limiting toxicities were observed at the 5 mg, 7 mg or 15 mg dose levels.

The company said additional efficacy, safety and molecular findings will be shared during the ASH oral presentation. The study is registered under JBI-802-02 (ACTRN12624000478516).

The oral presentation is titled "Safety and preliminary efficacy results from a Phase 1/2 multicenter open-label study evaluating JBI-802, a first-in-class oral CoREST inhibitor, in myeloproliferative and myelodysplastic/myeloproliferative neoplasms." Andrew McQuillan, MBBS, FRACP, FRCPA, will deliver the presentation on December 14, 2026, at 5:15 p.m. CT (6:15 p.m. ET) during the Myeloproliferative Syndromes: Clinical and Epidemiological session. The presentation is listed under Abstract 1036.

Jubilant Therapeutics will also present a poster titled "Pharmacokinetics, active-metabolite contribution, and pharmacokinetic/pharmacodynamic correlation of JBI-802, a first-in-class oral dual LSD1/HDAC6 (CoREST) inhibitor, in patients with MPN and MDS/MPN." Sridharan Rajagopal, Ph.D., will present the findings on December 14, 2026, from 6:00 p.m. to 8:00 p.m. CT (7:00 p.m. to 9:00 p.m. ET) during the Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III session. The poster is listed under Abstract 5540.

Following the oral presentation, Jubilant Therapeutics will host a scientific and corporate event titled "Dual LSD1/HDAC6 Inhibition with JBI-802 in Thrombocytosis-Predominant MPN: Clinical Data and Emerging Perspectives" on December 14, 2026. The event will review the Phase 1 findings presented at ASH and explore their potential clinical implications. It will be livestreamed, with a replay made available on the company's website. Further details are expected to be announced.

The ASH presentations will also be published in the Publications section of Jubilant Therapeutics' website following the sessions.

JBI-802 is an investigational, orally administered dual inhibitor of lysine-specific demethylase 1 (LSD1) and histone deacetylase 6 (HDAC6), targeting the CoREST complex. The drug candidate is designed to influence multiple disease-related processes, including abnormal megakaryocyte differentiation, platelet production, leukocyte proliferation and inflammatory signaling. JBI-802 is currently being evaluated in an ongoing Phase 1/2 clinical study involving patients with essential thrombocythemia and other thrombocytosis-predominant myeloid malignancies (JBI-802-02; ACTRN12624000478516).

Jubilant Therapeutics is a clinical-stage biopharmaceutical company focused on developing precision therapeutics for myeloproliferative neoplasms and other diseases with significant unmet medical needs. The company combines expertise in medicinal chemistry, structure-based drug design, translational science and clinical development to discover and advance differentiated small-molecule medicines.

Its lead clinical candidate, JBI-802, is a first-in-class dual LSD1/HDAC6 (CoREST) inhibitor being investigated in essential thrombocythemia, MPNs and other indications. Its pipeline also includes JBI-3041, a selective first-in-class PAD4 inhibitor with potential applications in autoimmune diseases. Headquartered in Yardley, Pennsylvania, Jubilant Therapeutics is a step-down subsidiary of Jubilant Pharmova Limited and is committed to developing innovative therapies to improve patient outcomes worldwide.

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