On December 1, 2025 OncoPrecision Corporation ("OncoPrecision"), a translational therapeutics company developing novel antibody-based cancer therapies informed by large-scale patient-derived biology, reported that data from its development candidate, ONC001, has been selected for an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 6–9, 2025, in Orlando, Florida.

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ONC001 is a first-in-class antibody-drug conjugate (ADC) designed to uniquely target CD64, a myeloid-restricted receptor pervasively expressed in CMML and M4/M5 acute myeloid leukemia, including highly resistant subsets. The ADC was developed using OncoPrecision’s proprietary discovery engine, which integrates large-scale, patient-derived biology and AI-enhanced high-throughput screening to reveal the most actionable cellular vulnerabilities. This process enabled the identification of a lead antibody with high affinity against an overlooked target, alongside the optimal ADC payload and linker chemistry to minimize off-target toxicity and collateral damage to healthy hematopoiesis. ONC001 is advancing through IND-enabling studies and represents a differentiated approach to overcoming monocyte-driven resistance.

Preclinical data to be presented by Dr. Gastón Soria, Co-Founder and Chief Scientific Officer, will highlight:

Selective engagement of patient-derived CMML and AML cells
Robust activity in samples resistant to current standard-of-care therapies
Compelling in vivo efficacy across heterotopic and orthotopic models
"The selection of ONC001 for an oral presentation at ASH (Free ASH Whitepaper) underscores the strength of this fundamentally new therapeutic approach," said Tarek Zaki, Co-Founder & Chief Executive Officer of OncoPrecision. "ONC001 is designed to specifically target resistance mechanisms that drive certain aggressive blood cancers, offering a new way to overcome common treatment failures. We look forward to sharing this data with the global hematology community and to continuing discussions with prospective development and strategic partners."

"ONC001 is the direct result of our platform’s ability to integrate insights from patient-derived biology with rational target selection and payload matching," said Dr. Gastón Soria. "Although CD64 has long been acknowledged as a biomarker of monocytic leukemia, no approved or clinical-stage assets have successfully exploited it as a therapeutic target. Our platform unveiled that an ADC modality is the optimal path to achieve this."

Oral Presentation Details

Title: ONC001: A first-in-class ADC targeting CD64 for the treatment of monocytic leukemia developed through patient-guided target and payload selection
Presenter: Gastón Soria, PhD, Co-Founder & Chief Scientific Officer, OncoPrecision
Session: 604. Molecular Pharmacology and Drug Resistance: Myeloid Neoplasms: Novel strategies to overcome therapy resistance in AML
Date: Saturday, December 6, 2025
Session Time: 4:00 PM – 5:30 PM
Presentation Time: 5:15 PM – 5:30 PM
Location: OCCC – Valencia Room W415D

(Press release, OncoPrecision, DEC 1, 2025, View Source [SID1234661029])

On December 1, 2025 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, reported that management will participate in a fireside chat at the Bank of America CNS Therapeutics Conference, being held virtually on Monday, December 8, 2025, at 2:25 pm ET.

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A webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

(Press release, Alector, DEC 1, 2025, View Source [SID1234661014])

On December 1, 2025 Blood Cancer United—formerly The Leukemia & Lymphoma Society— reported it will celebrate new data presented by Blood Cancer United funded grantees at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (December 6-9, 2025).

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"We are excited to see firsthand at the ASH (Free ASH Whitepaper) Annual Meeting the scientific breakthroughs that provide life-changing benefits for more patients, helping to extend and improve their lives and move us closer to achieving durable remission for more patients with blood cancer," says Lore Gruenbaum, Ph.D., Chief Scientific Officer, Blood Cancer United.

Blood Cancer United will present findings from four sub-studies from its Beat AML Master Clinical Trial and Pediatric Acute Leukemia Master Clinical Trial (PedAL).

Data from Beat AML—the first ever collaborative precision medicine clinical trial in blood cancer—include an oral presentation of an analysis from over 2,000 venetoclax treated patients that incorporates clinical and genomic features to improve the assessment of patient prognosis, an important factor in clinical practice. A second oral presentation reports an analysis of the impact of mutations in RAS genes on the prognosis of patients who have acute myeloid leukemia (AML) with NPM1 mutations. A trial in progress poster presentation introduces a Beat AML sub-study assessing the efficacy of the combination of ficlatuzumab, a first-in-class anti-hepatocyte growth factor antibody, with azacytidine and venetoclax. The abstract from PedAL—the first integrated, global, pediatric acute leukemia master clinical trial—identifies opportunities to optimize treatments for children with AML.

On the heels of the FDA’s approval of ziftomenib for the treatment of adults with an advanced form of AML with a mutation in a gene called NPM1, we will see new data on the use of this and other menin inhibitors at ASH (Free ASH Whitepaper). The early drug discovery work that led to the development of ziftomenib was supported through the Therapy Acceleration Program (TAP). At the meeting, two oral presentations on combination studies of ziftomenib, venetoclax and azacitidine in newly diagnosed and relapsed/refractory AML will be presented.

Fifteen current and former TAP biotech partners will present more than 50 abstracts—including eight oral presentations—showcasing promising clinical results across blood cancers, including AML, myelodysplastic syndrome, large granular lymphocytic leukemia, myelofibrosis, blastic plasmacytoid dendritic cell neoplasm, T-cell lymphoma and more.

Studies funded through Blood Cancer United’s Academic Research Grant Program, Equity in Access Research Program, Influential Medicine Providing Access to Clinical Trials and Student Mentorship and Research Training (SMART) Program will be presented throughout the meeting.

This research evaluates opportunities to improve cancer care quality for patients with all types of blood cancer, including the impact of travel and insurance type on access to care.

Blood Cancer United leaders and experts are available to discuss Blood Cancer United supported studies and provide comments on other data at the meeting.

Lore Gruenbaum, Ph.D., Chief Scientific Officer
E. Anders Kolb, M.D., Chief Executive Officer
Gwen Nichols, M.D., Chief Medical Officer
Ashley Yocum, Ph.D., Master Trial Lead
Further information on Blood Cancer United’s research portfolio is available at bloodcancerunited.org/research.

Additional details on key presentations from Blood Cancer United funded researchers at ASH (Free ASH Whitepaper) are available below. The full ASH (Free ASH Whitepaper) Annual Meeting 2025 abstracts are available here.

Title

Date/Time

Presentation Type

Abstract ID

Beat AML

Prognostic risk integration for survival modeling (PRISM) in newly diagnosed acute myeloid leukemia treated with venetoclax: a multinational retrospective cohort study

December 7
10 to 10:15 a.m. ET

Oral Presentation

453

Phase 1b safety run-in study followed by Phase 2 study of ficlatuzumab, azacitidine and venetoclax in untreated Acute Myeloid Leukemia patients aged ≥ 60 years old

December 7
6 to 8 p.m. ET

Poster Presentation

3432

RAS mutations negate the favorable impact of NPM1 in older patients with newly diagnosed Acute Myeloid Leukemia treated with ven/HMA

December 8
5:30 to 5:45 p.m. ET

Oral Presentation

995

PedAL

ITCC-101/APAL2020D: A randomized Phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamycin with or without venetoclax in children with relapsed Acute Myeloid Leukemia

December 6
5:30 to 7:30 p.m. ET

Poster Presentation

1656

Therapy Acceleration Program

Efficacy, molecular and translational analysis of TP53-mutated HR-MDS with bexmarilimab and azacitidine: Updated results from the bexmab Phase 1/2 study

December 6
2:15 to 2:30 p.m. ET

Oral Presentation

236

γ9δ2 T-cell (γ9δ2TC) activation with ICT01 and azacitidine-venetoclax (Aza-Ven) induces high rates of remission and overall survival in patients with newly diagnosed (ND) acute myeloid leukemia (AML): Results from the phase 1/2 study eviction

December 7

5:15 to 5:30 p.m. ET

Oral Presentation

652

Initial clinical data from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with large granular lymphocytic leukemia

December 8

11 to 11:15 a.m. ET

Oral Presentation

777

Academic Research Grants

Circulating tumor cells (CTCs) for dynamic risk assessment of patients (Pts) with smoldering multiple myeloma (SMM)

December 7

9:30 to 9:45 a.m. ET

Oral Presentation

493

Rituximab and epcoritamab as first-line therapy for patients with high-tumor burden follicular lymphoma: Results of a multicenter phase II trial

December 7

9:45 to 10 a.m. ET

Oral Presentation

464

Humanized CD19 chimeric antigen receptor (CAR) T-cell therapy for high-risk and post-CAR relapse of B-cell acute lymphoblastic leukemia

December 7

5:15 to 5:30 p.m. ET

Oral Presentation

646

Interim Results of the CMML intercept study: A prospective observational study to evaluate the role of acute inflammation in CMML disease progression

December 8

10:45 to 11 a.m. ET

Oral Presentation

788

Evidence for pre-existing myeloma cells with a gene expression pattern associated with resistance to BCMA CAR T cells.

December 8

5:30 to 5:45 p.m. ET

Oral Presentation

1031

Novel Targets and Therapeutics for Optimizing HSCT and Cell Therapy

December 9

9:45 to 11:15 a.m. ET

Presidential Symposium

N/A

Equity in Access

Travel time and insurance status as determinants of specialized leukemia care access in adolescents and young adult (AYA) patients with acute lymphoblastic leukemia (ALL)

December 6
2 p.m. ET

Oral Presentation

283

Medicaid versus commercial insurance: Association with quality of end-of-life care among patients with blood cancers

December 6
2:30 p.m. ET

Oral Presentation

285

Real-world rates of tyrosine kinase inhibitor prescription approval, fill, and adherence and associated factors in a national sample of patients with chronic myeloid leukemia

December 6
5:30 p.m. ET

Poster Presentation

2651

Strengthening the referral pathway: Community oncology clinician perspectives on referring to academic cancer centers

December 8
11:30 a.m. ET

Oral Presentation

833

Characterizing Hodgkin lymphoma survivors’ shared decision making across the care continuum

December 8
6:00 p.m. ET

Poster Presentation

6424

Health Services

The impact of a clinical trial communication training workshop on hematology-oncology Fellows’ knowledge, attitudes and behaviors: A mixed-methods evaluation

December 8
11:45 a.m. ET

Oral Presentation

834

SMART

CBFA2T3::GLIS2 directly represses differentiation and is required for AMKL disease maintenance

December 6

5:30 to 7:30 p.m. ET

Poster Presentation

1473

(Press release, The Leukemia & Lymphoma Society, DEC 1, 2025, View Source [SID1234661030])

On December 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a peer-reviewed article in Nature communications, reporting data from the REACtiVe-2 clinical trial. REACtiVe-2 is a Phase 1 dose-escalation study evaluating the safety, tolerability and immunological effects of mitazalimab in combination with the dendritic cell-based vaccine MesoPher, developed by Amphera, in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) following standard of care chemotherapy. The study, conducted at Erasmus Medical Center in Rotterdam, underscores mitazalimab’s ability to activate anti-tumor immunity and support its proposed mode of action, including a reduction of tumor fibrosis, as well as increased T-cell infiltration and activation in the tumor.

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Key findings:

The combination therapy significantly decreased intratumoral collagen content, likely through mitazalimab-mediated macrophage activation and stromal degradation.
Treated tumors showed a clear rise in intratumoral T cells, indicating improved recruitment and immune access to the tumor.
The treatment activated central memory CD4+ T cells and triggered immune pathways related to antigen presentation.
Patients with stable disease after prior chemotherapy achieved a median OS of 12.1 months and a 1-year survival rate of 50%.
"These compelling translational data provide further support for the therapeutic potential of mitazalimab in reshaping the immunosuppressive microenvironment characteristic of pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "Furthermore, the data validates the immunological basis behind mitazalimab’s mechanism of action, thereby reinforcing it’s rational in mPDAC and other solid tumors, in combination with other treatment modalities.
The REACtiVe-2 study has been a part of Alligator’s broader clinical strategy to establish mitazalimab as a immunotherapy in hard-to-treat cancers such as mPDAC. The findings further highlight the synergistic potential of mitazalimab when combined with vaccines and chemotherapy.

(Press release, Alligator Bioscience, DEC 1, 2025, View Source [SID1234661015])

On December 1, 2025 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE034, a potential first-in-class bispecific B7H3/PTK7 TOP1 antibody-drug conjugate (ADC). IDEAYA expects to begin enrolling the study in Q1 2026, initially evaluating patients with solid tumors known to express B7H3 and PTK7, including lung, colorectal, head and neck and ovarian/gynecological cancers. Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.

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"IND clearance for IDE034 is an important step in expanding our potential first-in-class TOP1 ADC clinical pipeline into bispecific, precision-guided approaches," said Darrin M. Beaupre, M.D., Ph.D., Chief Medical Officer of IDEAYA Biosciences. "IDE034 has demonstrated robust antitumor activity and selective targeting of B7H3- and PTK7-expressing solid tumor models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscores its broad indication potential."

"We are excited to advance our differentiated clinical strategy with now three potentially first-in-class clinical-stage programs focused on enhancing the efficacy of TOP1 ADCs through the PARG DDR combination mechanism. We believe this approach addresses a key unmet need by improving the durability of response to TOP1 payload-based ADC therapies. We are targeting to share additional preclinical data to support the PARG and TOP1 ADC combination rationale at a major medical conference in H1 2026," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Preclinical studies have demonstrated strong anti-tumor activity in B7H3/PTK7-positive tumor models, including deep and durable tumor regressions with IDE034 monotherapy, supporting advancement into clinical development. This co-expression pattern supports the potential for broad monotherapy activity, while the TOP1 payload provides a strong mechanistic rationale for combining IDE034 with IDEAYA’s PARG inhibitor, IDE161. TOP1 inhibition induces replication stress and DNA damage, which can increase reliance on the PARG pathway; therefore, a IDE034 and IDE161 combination approach may enhance anti-tumor activity in patients with solid tumors that co-express B7H3 and PTK7, consistent with the results that were observed preclinically with this combination.

(Press release, Ideaya Biosciences, DEC 1, 2025, View Source [SID1234661031])