Hematology Today—November 10, 2025

This week’s Hematology update spotlights fresh breakthroughs, regulatory milestones, and trends redefining patient care.

In Today’s Newsletter

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🧬 Indapta Therapeutics Presents IDP-023 Data in Multiple Myeloma [1] [US • 07 Nov 2025]

https://finance.yahoo.com/news/indapta-therapeutics-presents-data-demonstrating-140000295.html
Context: Data presented at SITC Annual Meeting showing IDP-023’s potential in relapsed/refractory multiple myeloma patients.
Key point: Marked tumor reduction with no dose-limiting toxicities observed.
Implication: Data could shift clinical practices and influence prescriber choices.

💉 Heidelberg Pharma’s HDP-101 Shows Progress in Myeloma [2] [EU • 06 Nov 2025]

https://heidelberg-pharma.com/en/press-investors/announcements/press-releases-and-ad-hoc-announcements/pr-heidelberg-pharmas-lead-atac-candidate-hdp-101-shows-progress-in-phase-i-iia-trial-in-multiple-myeloma
Context: Latest results from Phase I/IIa study show stringent complete remission in multiple myeloma patients.
Key point: HDP-101 achieves rapid responses in Cohort 8 with no dose-limiting toxicities.
Implication: Encouraging data could influence market perception and accelerate clinical development.

💉 Moderna Doses First Patient in mRNA-2808 Trial for Multiple Myeloma [3] [US • 03 Nov 2025]

https://feeds.issuerdirect.com/news-release.html?newsid=8697748208320019&symbol=MRNA
Context: Moderna’s first T-cell engager mRNA-2808 targets multiple myeloma.
Key point: Phase 1/2 study aims to tackle tumor heterogeneity.
Implication: Represents a novel treatment modality for difficult-to-treat cancers.

🧬 Kura Oncology Receives Second Milestone in AML Program [4] [US • 03 Nov 2025]

https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-receives-second-30-million-development-milestone
Context: Kura Oncology’s menin inhibitor program for AML progresses with second milestone payment.
Key point: KOMET-017 Phase 3 trial continues with promising early data.
Implication: Positive momentum for Kura’s AML treatment options.

💡 Leukogene Therapeutics Awarded FDA Orphan Drug Designation for LTI-214 in AML [5] [US • 05 Nov 2025]

https://www.morningstar.com/news/business-wire/20251105454890
Context: FDA Orphan Drug Designation granted to LTI-214 for acute myeloid leukemia (AML).
Key point: LTI-214 targets CD33 for selective elimination of leukemic cells.
Implication: Opens doors for accelerated development and market exclusivity.

💊 Otsuka Files for EMA Authorization of Inaqovi for AML [6] [EU • 05 Nov 2025]

https://www.thepharmaletter.com/pharmaceutical/otsuka-files-for-ema-authorization-of-inaqovi
Context: Otsuka applies for EMA approval of Inaqovi, an oral treatment for AML.
Key point: Combination of decitabine and cedazuridine shown to improve remission rates in AML patients.
Implication: Expected to expand treatment options in the European market.

🧫 Oryzon’s RESTORE Trial for Sickle Cell Disease [7] [EU • 03 Nov 2025]

https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-fpi-restore-phase-ib-trial-iadademstat-sickle-cell
Context: First patient dosed in RESTORE Phase Ib trial evaluating iadademstat for sickle cell disease.
Key point: Investigating impact of iadademstat on fetal hemoglobin expression.
Implication: Could offer new therapeutic options for sickle cell patients.

💸 Zydus Receives US FDA Orphan Drug Designation for Desidustat in Beta-Thalassemia [8] [IN • 06 Nov 2025]

https://www.msn.com/en-in/health/other/zydus-gets-usfdas-orphan-drug-designation-for-beta-thalassemia-product/ar-AA1PUsbh
Context: Zydus Lifesciences awarded Orphan Drug Designation for Desidustat in beta-thalassemia.
Key point: Desidustat increases hemoglobin levels, potentially reducing reliance on transfusions.
Implication: Could help redefine treatment strategies in beta-thalassemia.

💉 AstraZeneca & Leukemia & Lymphoma Society Announce 2025 Blood Cancer Grant Winners [9] [CA • 05 Nov 2025]

https://www.newswire.ca/news-releases/astrazeneca-canada-amp-the-leukemia-amp-lymphoma-society-of-canada-announce-winners-of-the-2025-operating-grants-in-blood-cancer-897134703.html
Context: Grants awarded to support research in leukemia and lymphoma.
Key point: Focus on precision diagnostics and gene editing in blood cancers.
Implication: Will likely drive new therapies and inform clinical strategies.

🩸 Regeneron’s Phase 2 Data on Factor XI Antibodies for Clotting Prevention [10] [US • 08 Nov 2025]

https://investor.regeneron.com/news-releases/news-release-details/phase-2-trials-demonstrating-antithrombotic-effect-two-novel
Context: Regeneron presents Phase 2 results for two novel factor XI antibodies.
Key point: One antibody showed strong anti-clotting effects with lower bleeding risk.
Implication: Offers potential new therapies for patients needing anticoagulation therapy.

💉 CERo Therapeutics Initiates Second Cohort of Phase 1 Trial of CER-1236 in AML [11] [US • 05 Nov 2025]

https://www.cero.bio/press-release?storyId=8566145122135553
Context: CERo Therapeutics starts second cohort of Phase 1 trial for CER-1236 in AML patients.
Key point: No dose-limiting toxicities observed, allowing for dose escalation.
Implication: Promising early safety and efficacy data could pave the way for Phase 2 trials.

Why it matters

Next-Gen Immunotherapies: Indapta’s allogeneic NK cells and Heidelberg Pharma’s ADCs signal continued innovation in hematologic cancers.
Targeted AML Therapies: The progression of menin inhibitors and novel combinations like Moleculin’s Annamycin highlight the shift toward more personalized AML treatments.
Gene Therapy & SCD: Oryzon’s iadademstat and Zydus’ Desidustat offer potentially transformative treatments for inherited hematological conditions.
FDA Orphan Drug Designations: Increased regulatory support for rare diseases such as AML and beta-thalassemia continues to drive drug development.

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FAQ

What is IDP-023, and how does it work?

IDP-023 is an allogeneic NK cell therapy developed by Indapta Therapeutics. It targets cancer cells using natural killer (NK) cells, offering a potentially safer and more effective treatment option for relapsed/refractory multiple myeloma.

How does Heidelberg Pharma’s HDP-101 target multiple myeloma?

HDP-101 is an antibody-drug conjugate (ADC) that delivers a cytotoxic payload directly to BCMA-expressing plasma cells, a key feature of multiple myeloma.

What is the significance of Regeneron’s factor XI antibodies?

Regeneron’s antibodies offer a new approach to preventing blood clots, providing a tailored solution for patients with different bleeding risks, which could lead to improved patient outcomes in surgeries.

Why did BioMarin decide to divest Roctavian?

BioMarin’s decision to divest Roctavian was driven by disappointing sales performance and limited market traction. The company is seeking a partner to continue patient access while focusing on other therapeutic areas.

What is iadademstat’s role in sickle cell disease?

Iadademstat works by promoting fetal hemoglobin production, a key component in reducing sickle cell disease symptoms. The RESTORE trial is investigating its ability to provide a scalable treatment option for adult patients.

Entities / Keywords

Indapta Therapeutics • IDP-023 • Multiple Myeloma • Heidelberg Pharma • HDP-101 • Moleculin Biotech • Annamycin • Kura Oncology • Menin Inhibitors • Leukogene Therapeutics • LTI-214 • Otsuka • Inaqovi • Oryzon • iadademstat • Sickle Cell Disease • Zydus Lifesciences • Desidustat • Regeneron • Factor XI Antibodies • CERo Therapeutics • CER-1236.