Hematology Today—November 3, 2025

LucidQuest

2 months ago

Catch the latest hematology news, featuring industry updates, clinical progress, and biopharma innovations

In Today’s Newsletter

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🧬 Lantern Pharma LP-284 shows complete response in post-CAR-T DLBCL [1] [US • 28 Oct 2025]

http://ir.lanternpharma.com/news-1/news/news-details/2025/Lantern-Pharma-Presents-LP-284-Clinical-Data-at-25th-LLM-Congress-Highlighting-Complete-Response-in-Therapeutically-Exhausted-DLBCL-Patient–Therapeutic-Potential-in-Advanced-B-Cell-Cancers-/default.aspx
Context: Phase 1 study (NCT06132503) of LP-284 in relapsed/refractory B-cell NHL.
Key point: Achieved complete metabolic response after two cycles in DLBCL patient refractory to CAR-T and bispecifics.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 Glofitamab + Polatuzumab yields durable remissions in R/R LBCL [2] [US • 29 Oct 2025]

http://www.bloodcancerstoday.com/post/glofitamab-polatuzumab-combo-yields-durable-responses-in-relapsed-large-b-cell-lymphoma
Context: Phase 1b/2 (NCT03533283) trial in 129 R/R LBCL patients.
Key point: 78% overall response, 60% complete response, median OS 33.8 months; manageable CRS profile.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Moleculin Biotech highlights MIRACLE Phase 3 AML trial [3] [EU • 30 Oct 2025]

http://moleculin.com/moleculin-to-highlight-its-ongoing-phase-3-acute-myeloid-leukemia-miracle-clinical-trial-at-the-14th-annual-acute-leukemia-meeting/
Context: Global pivotal Phase 2B/3 AnnAraC trial (NCT06788756) of Annamycin + cytarabine in relapsed/refractory AML.
Key point: Annamycin, a non-cardiotoxic anthracycline, holds FDA and EMA Orphan Drug status.
Implication: May influence prescriber choice and payer reviews pending full data.

💰 Adaptam Therapeutics raises €3 M for myeloid-targeted immunotherapies [4] [EU • 27 Oct 2025]

http://adaptamtx.com/adaptam-therapeutics-raises-e3-million-to-pioneer-cancer-immunotherapies-against-immunosuppressive-myeloid-cells/
Context: Pre-seed financing led by Criteria Bio Ventures.
Key point: Funds ADC and bispecific antibody programs against glyco-immune checkpoints on myeloid cells.
Implication: Signals pipeline investment and modality expansion.

🧫 Alethio Therapeutics launches to target MPNs with ADCs [5] [UK • 30 Oct 2025]

http://www.globenewswire.com/news-release/2025/10/30/3177111/0/en/Alethio-Therapeutics-Launches-with-New-CEO-and-Chair-to-Advance-Two-Targeted-Medicines-for-Myeloproliferative-Neoplasms-Chronic-Blood-Cancers.html
Context: Company re-emerges from Alethiomics with AT-01 and AT-02 programs for myeloproliferative neoplasms.
Key point: AT-01 and AT-02 are first-in-class ADCs targeting MPN stem cells and mutant CALR respectively.
Implication: Signals pipeline investment and modality expansion.

🧫 GeneVentiv gains FDA INTERACT support for GENV-HEM gene therapy [6] [US • 29 Oct 2025]

http://www.geneventiv.com/2025/10/30/geneventiv-therapeutics-announces-positive-fda-interact-feedback-supporting-advancement-of-genv-hem-gene-therapy-for-hemophilia-a-with-or-without-inhibitors/
Context: Pre-IND AAV gene therapy for Hemophilia A (with/without inhibitors).
Key point: FDA alignment on IND-enabling plan and CMC strategy for GENV-HEM.
Implication: May influence prescriber choice and payer reviews pending full data.

💸 BioMarin to divest Roctavian hemophilia A gene therapy [7] [US • 28 Oct 2025]

http://www.fiercepharma.com/pharma/biomarin-resigned-ending-journey-hemophilia-gene-therapy-roctavian-seeking-divestiture-amid
Context: Roctavian gene therapy generated only $3 million in Q3 sales.
Key point: Company pursuing out-licensing to maintain patient access while refocusing portfolio.
Implication: Introduces competition that may affect pricing and formulary access.

🧫 Gamida Cell reports 92.9% neutrophil recovery with omidubicel in SAA [8] [UK • 28 Oct 2025]

http://www.biospace.com/press-releases/gamida-cell-presents-positive-initial-results-on-treating-severe-aplastic-anemia-saa-with-omidubicel
Context: NIH-led study presented at AABB 2025.
Key point: 13 of 14 patients achieved rapid neutrophil recovery (median 7 days); no severe GvHD observed.
Implication: May influence prescriber choice and payer reviews pending full data.

🩸 AABB 2025: Blood storage age impacts SCD transfusion outcomes [9] [US • 29 Oct 2025]

http://www.aabb.org/news-resources/news/article/2025/10/29/aabb2025–the-impact-of-blood-storage-age-and-red-cell-quality-for-patients-with-sickle-cell-disease
Context: Randomized Age of Blood Trial (2017–2024) in SCD patients.
Key point: Older (30-day) units linked to higher inflammation, iron load and pain crises vs fresh (<10-day) blood.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 Fulcrum Therapeutics completes high-dose pociredir enrollment in SCD [10] [US • 30 Oct 2025]

http://www.globenewswire.com/de/news-release/2025/10/29/3176248/0/en/Fulcrum-Therapeutics-Announces-Recent-Business-Highlights-and-Financial-Results-for-Third-Quarter-2025.html
Context: Phase 1b PIONEER trial (NCT05169580); 20 mg cohort over-enrolled.
Key point: Pociredir (FTX-6058) induces fetal hemoglobin and shows favorable safety; data expected end 2025.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

AI-guided design (Lantern LP-284) and targeted biologics (Glofitamab + Polatuzumab) illustrate growing precision in post-CAR-T lymphoma care.
Adaptive Phase 3 AML programs (Moleculin) and preclinical ADC ventures (Adaptam, Alethio) show renewed appetite for differentiated oncology assets.
Gene therapy momentum continues with GeneVentiv’s FDA alignment, despite BioMarin’s Roctavian exit.
Cell and transfusion innovations (Gamida Cell, AABB 2025) underscore evidence-based approaches to hematologic support.
Fulcrum’s pociredir advances oral alternatives to gene editing in SCD, expanding patient options.

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FAQ

What is LP-284 and how is Lantern Pharma developing it?

LP-284 is a synthetic-lethal anticancer agent targeting DNA repair deficiencies, developed using Lantern’s RADR AI platform. It is in Phase 1 testing for relapsed/refractory B-cell lymphomas [1].

How does the Glofitamab–Polatuzumab regimen differ from single-agent therapy?

It pairs a bispecific antibody with an ADC to drive T-cell killing and deliver cytotoxic payloads, achieving durable remissions in R/R LBCL [2].

What is the goal of Moleculin’s MIRACLE trial?

To evaluate Annamycin plus cytarabine (AnnAraC) in relapsed AML and support potential global approval for a non-cardiotoxic anthracycline [3].

Why is BioMarin exiting the Roctavian program?

Limited sales and reimbursement uptake led to divestiture plans; the company will retain supply for existing patients while seeking a partner [7].

How is Fulcrum’s pociredir intended to help SCD patients?

Pociredir blocks EED to increase fetal hemoglobin, potentially reducing pain crises and offering an oral alternative to gene therapy [10].

What clinical impact might the AABB 2025 data have?

They suggest blood storage age affects SCD outcomes, prompting calls for tailored transfusion policies and further observational work [9].

Entities / Keywords

Lantern Pharma • LP-284 • DLBCL • Glofitamab • Polatuzumab Vedotin • Moleculin Biotech • Annamycin • AML • Adaptam Therapeutics • Alethio Therapeutics • MPN • GeneVentiv Therapeutics • GENV-HEM • BioMarin • Roctavian • Gamida Cell • Omidubicel • AABB 2025 • Sickle Cell Disease • Fulcrum Therapeutics • Pociredir (FTX-6058).