On November 24, 2025 IN8bio, Inc. (the "Company") reported consolidated data, a summary of which is located below, from its investigator-sponsored Phase 1 single-center clinical trial of INB-200 and its Company-sponsored Phase 2 multi-center clinical trial of INB-400 for the treatment of patients with newly diagnosed glioblastoma ("GBM") in poster and oral presentations at the 2025 Society for Neuro-Oncology ("SNO") Annual Meeting on November 21 and 22, 2025.

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Summary of Clinical Update from Phase 1 Trial of INB-200 and Phase 2 Trial of INB-400

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Across the two trials, 17 patients were treated with the Company’s DeltExTM Drug Resistant Immunotherapy ("DeltEx DRI") gamma-delta T cells, with 14 patients receiving repeated (3 up to 6) doses. 10 additional patients were consented contemporaneously but received only the standard-of-care Stupp protocol ("SOC") and were monitored for progression and survival.

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Patients treated with repeated doses of DeltEx DRI cells achieved a median progression-free survival ("mPFS") of 13.0 months (n=14), compared to the mPFS of 6.6 months for patients receiving only SOC (n=10).

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Patients receiving repeated doses of DeltEx DRI cells have not yet reached median overall survival ("mOS"), which continues to climb at 16.4+ months as of October 31, 2025, while SOC patients attained a mOS of 11.0 months.

(Press release, In8bio, NOV 24, 2025, View Source [SID1234660898])

On November 24, 2025 Phrontline Biopharma ("Phrontline"), a next-generation antibody–drug conjugate (ADC) company, reported the closing of a $60 million Pre-A+ financing round. The round was led by Lapam Investment, with participation from Samsung Venture Investment Corporation (SVIC), Guofang Innovation, Hankang Venture Capital, Songqing Capital, Jifeng Ventures, and Sino Biopharmaceutical Limited. Existing shareholders — Decheng Capital, Medfine Health Fund, and C&D Emerging Investment — also participated and increased their investment in the company. This financing reflects strong investor confidence in Phrontline’s differentiated bispecific and dual-payload ADC platforms, its strategically designed pipeline, and its rapidly expanding global development capabilities. Proceeds will support advancement of the company’s clinical-stage and preclinical ADC programs, expansion of global clinical operations, and strengthening of key strategic partnerships.

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Building a Leading Bispecific and Dual-Payload ADC Platform

Founded in 2022, Phrontline is among the first biotechnology companies globally to focus on bispecific antibody ADCs (BsAb-ADCs) and dual-payload ADCs. The company has built an end-to-end ADC platform spanning antibody discovery, linker–payload engineering, site-specific conjugation, and functional characterization — resulting in a proprietary, highly differentiated technology engine.

Leveraging this platform, Phrontline has designed multiple dual-target combinations and complementary payload strategies tailored to specific tumor indications and has advanced nearly ten innovative ADC programs. Among them, TJ101, a bispecific ADC targeting EGFR and B7-H3, is currently enrolling patients in parallel first-in-human clinical trials in China and the United States. Preclinical data demonstrate superior efficacy and safety relative to peer programs, positioning TJ101 as one of the leading next-generation EGFR/B7-H3 bispecific ADC candidates worldwide.

Strategic Collaborations Accelerating Global Expansion.

On October 20, 2025, Phrontline announced a global strategic collaboration with Samsung Bioepis. Under the terms of the agreement, the companies will jointly develop two next-generation bispecific, dual-payload ADC candidates with differentiated mechanisms of action, leveraging Phrontline’s proprietary BsAb and dual-payload ADC platforms.

On October 31, 2025, Phrontline entered into an exclusive license agreement with Sino Biopharmaceutical Limited for TJ101 in Mainland China and the Hong Kong SAR. Sino Biopharmaceutical will make an upfront payment of an undisclosed amount, along with potential development and commercial milestone payments and sales-based royalties. This collaboration represents a key inflection point for Phrontline’s lead asset as it transitions into accelerated global clinical development.

Advancing Next-Generation ADCs Through Science and Conviction

"From the beginning, our strategy has been guided by biology and translational science. We believe that dual-target synergy and complementary payload mechanisms can unlock new therapeutic options for patients whose tumors are resistant to current therapies," said Tony Chen, Ph.D., Founder and Chief Executive Officer of Phrontline Biopharma. "Our preclinical and emerging clinical data are beginning to validate this vision." "We are deeply grateful to both our new and existing investors for their continued confidence in Phrontline," Dr. Chen added. "This financing marks an important milestone for the company and will allow us to accelerate our clinical programs and global expansion as we work to deliver truly innovative ADC medicines to patients around the world."

Investor Perspective

"Phrontline is a highly execution-focused and resilient team," said Ji Wang, Investment Lead at Lapam Investment. "By leveraging its proprietary bispecific antibody and dual-payload ADC platforms, the company has built a differentiated pipeline aimed at major unmet medical needs. Its preclinical data show compelling efficacy and safety and demonstrate the strong scalability of its platform.

"We look forward to supporting Phrontline as its programs advance through clinical development and as the company continues to drive innovation in next-generation ADC therapeutics," Wang added.

(Press release, Phrontline Biopharma, NOV 24, 2025, View Source [SID1234660914])

On November 24, 2025 Lineage Cell Therapeutics, Inc. reported it had achieved the first milestone available under its worldwide collaboration with Roche and Genentech, a member of the Roche Group, for OpRegen (RG6501), a suspension of human allogeneic retinal pigment epithelial (RPE) cells, currently in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The milestone was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program.

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"We are excited to have achieved the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech. The achievement of this milestone is rooted in our manufacturing expertise, which we deployed with the OpRegen cell therapy program, and reflects years of investment to optimize our in-house production processes and highlights the importance of having in-house control of complex manufacturing processes," stated Brian M. Culley, Lineage CEO. "Roche and Genentech are established leaders in ophthalmology, with a demonstrated and longstanding commitment to patients, innovative research, and successful product development, and we are proud to have reached this manufacturing milestone to support the Genentech team’s clinical efforts."

"Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the view that GA causes irreversible damage. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients with less advanced disease. Notably, five patients who received significant coverage of OpRegen cell therapy across their GA lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement," added Mr. Culley.

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114).

(Press release, Lineage Cell Therapeutics, NOV 24, 2025, View Source [SID1234660899])

On November 24, 2025 The Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, reported that the company will present new data related to ELZONRIS (tagraxofusp-erzs) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, December 6-9th.

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The presentations include an oral session highlighting results from a triplet therapy combining tagraxofusp, azacitidine, and venetoclax, which demonstrated both efficacy (high response and bridge to transplant rates) and tolerability in individuals with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

"At Menarini Stemline, our commitment to transforming the lives of people living with difficult-to-treat cancers is unwavering," said Elcin Barker Ergun, CEO of the Menarini Group. "These data demonstrate that tagraxofusp plays an important role in both monotherapy and combination settings for the treatment of BPDCN, and that it also has potential to help patients living with other aggressive hematologic malignancies, where more effective treatment options are desperately needed."

See below for full details of the Menarini Group/Stemline Therapeutics’ upcoming presentations and publication:

American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025

Lead Author

Title and Publication Number

Session Name

Presentation Details

Navarro Vicente I, et al.

Disease Presentation and Immunophenotype Characteristics in 257 Patients with
Blastic Plasmacytoid Dendritic Cell Neoplasm: a PETHEMA/PALG Study*

Publication Number: 218

618. Acute Myeloid Leukemias:
Biomarkers and Molecular Markers
in Diagnosis and Prognosis:
Redefining AML: Genetic, Phenotypic
and Response-Based Insights

Oral Presentation

December 6, 2025

2:15 PM – 2:30 PM

OCCC – W414AB

Lane A, et al.

Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows
efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid
dendritic cell neoplasm (BPDCN): Results of a phase 2 trial*

Publication Number: 653

616. Acute Myeloid Leukemias:
Investigational Drug and Cellular
Therapies: Immunotherapy and
chemotherapy combinations in AML

Oral Presentation

December 7, 2025

5:30 PM – 5:45 PM

OCCC – Chapin Theater (W320)

Stein A, et al.

Longer Survival with Tagraxofusp versus Venetoclax in Patients with Blastic
Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Results of A Real-World Analysis

Publication Number: 4612

908. Outcomes Research:
Myeloid Malignancies: Poster II

Poster Presentation

December 7, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Wang E, et al.

Favorable outcomes including post-transplant survival are seen independent
of baseline skin burden in treatment-naïve patients (pts) with blastic
plasmacytoid dendritic cell neoplasm (BPDCN) treated with tagraxofusp (TAG): Subgroup analysis of a pivotal trial

Publication Number: 5221

617. Acute Myeloid Leukemias:
Commercially Available
Therapies: Poster III

Poster presentation

December 8, 2025

6:00 PM – 8:00 PM

OCCC – West Halls B3-B4

Cho W, et al,

Tagraxofusp and Low-Intensity Chemotherapy for the Treatment of CD123-Positive
Relapsed or Refractory Acute Myeloid Leukemia*

Online-only publication

*Denotes investigator sponsored research or collaborative research.

ELZONRIS was approved by the FDA in December 2018 for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. In January 2021, ELZONRIS was approved by the European Commission.

About BPDCN

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), is a highly aggressive, orphan hematologic malignancy that primarily affects skin, bone marrow and blood. It can also affect other parts of the body, such as the lymph nodes, spleen, liver and central nervous system. Approximately 85% to 90% of patients develop skin lesions as a first sign of BPDCN. BPDCN affects all people of all races and geographic locations, with the global prevalence likely in the range of 0.4 – 0.5 per 100,000 people annually. While BPDCN affects both men and women of all ages, 75% of cases occur in men, with a median age at onset of 60-70 years. A key characteristic of BPDCN cancer cells is their high expression of a protein called CD123, which can be observed on the surface of the cells. This makes CD123 a crucial diagnostic marker as well as a prime target for precision therapies to strike the cancer directly.

About ELZONRIS (tagraxofusp-erzs)

U.S. Indication: ELZONRIS (tagraxofusp-erzs) is a prescription medicine used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients 2 years and older.

Full prescribing information for the U.S. can be found at www.elzonris.com.

IMPORTANT SAFETY INFORMATION, ELZONRIS

Boxed WARNING: CAPILLARY LEAK SYNDROME

Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended.
Warnings and Precautions

Capillary Leak Syndrome

Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with ELZONRIS. In patients receiving ELZONRIS in clinical trials, the overall incidence of CLS was 53% (65/122), including Grade 1 or 2 in 43% (52/122) of patients, Grade 3 in 7% (8/122) of patients, Grade 4 in 1% (1/122) of patients, and four fatalities (3%). The median time to onset was 4 days (range – 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.

Before initiating therapy with ELZONRIS, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with ELZONRIS, monitor serum albumin levels prior to the initiation of each dose of ELZONRIS and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.

Hypersensitivity Reactions

ELZONRIS can cause severe hypersensitivity reactions. In patients receiving ELZONRIS in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with ELZONRIS and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment with ELZONRIS. Interrupt ELZONRIS infusion and provide supportive care as needed if a hypersensitivity reaction should occur.

Hepatotoxicity

Treatment with ELZONRIS was associated with elevations in liver enzymes. In patients receiving ELZONRIS in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption.

Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with ELZONRIS. Withhold ELZONRIS temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.

Adverse Reactions

Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST.

Please see full Prescribing Information, including Boxed WARNING.

(Press release, Menarini, NOV 24, 2025, View Source [SID1234660915])

On November 24, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that new data across multiple hematologic malignancies will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Fla. from Dec. 6-9. The data shared at the meeting will highlight the company’s ongoing commitment to advancing clinical research in hematology across Merck’s expanding and diverse pipeline of investigational candidates, with more than 20 abstracts being presented.

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"The data we’re sharing at ASH (Free ASH Whitepaper) 2025 reflect the continued growth and evolution of our promising hematology pipeline," said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. "We continue to build on our leadership in oncology by advancing a diverse portfolio of investigational candidates and exploring novel modalities with the goal of improving outcomes and helping to address significant unmet needs for patients with hematologic neoplasms and malignancies."

Data presentations will feature Merck’s pipeline candidates, including: MK-1045, an investigational CD19xCD3 T-cell engager; bomedemstat (MK-3543), an investigational, orally available lysine-specific demethylase 1 (LSD1) inhibitor; and nemtabrutinib (MK-1026), an investigational, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. Additionally, Merck will present new and updated results highlighting zilovertamab vedotin (MK-2140), an investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1).

Key data from Merck’s pipeline to be presented at the ASH (Free ASH Whitepaper) 2025 Annual Meeting and Exposition:

– First presentation by Merck of updated results from the dose escalation and expansion portion of a Phase 1b/2 study assessing the efficacy and safety of MK-1045 in adults with relapsed or refractory B-cell acute lymphoblastic leukemia (Abstract #647)
– First-time results from the Phase 2 Shorespan-004 study evaluating bomedemstat for patients with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy (Abstract #83)
– Initial results from an exploratory analysis of the BELLWAVE-003 study of acquired resistance and prognostic mutations in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) treated with nemtabrutinib (Abstract #797)

Details on abstracts listed above and additional key abstracts for Merck:

Acute lymphoblastic leukemia

Updated results from the Phase 1b/2 study of MK-1045, a novel CD19xCD3 T-cell engager, in adult participants with relapsed or refractory B-cell acute lymphoblastic leukemia. Y. Wang.

Abstract #647, Oral session, Acute Lymphoblastic Leukemias: Therapies Excluding Allogeneic Transplantation

Polycythemia vera

Efficacy and safety of the LSD1 inhibitor bomedemstat in participants with polycythemia vera (PV) resistant or intolerant to cytoreductive therapy: the Phase 2 Shorespan-004 study. L. Rein.

Abstract #83, Oral session, Myeloproliferative Syndromes: Clinical and Epidemiological

Essential thrombocythemia

Shorespan-017: Phase 3 extension study for safety of bomedemstat in participants with essential thrombocythemia who received bomedemstat from a prior clinical study. M. Marchetti.

Abstract #2033, Poster session, Myeloproliferative Syndromes: Clinical and Epidemiological

Chronic lymphocytic & small lymphocytic lymphoma

Genomic assessment of acquired mutations in participants with CLL/SLL treated with nemtabrutinib in the Phase 2 BELLWAVE-003 study. T. Kipps.

Abstract #797, Oral session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Nemtabrutinib plus venetoclax in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the dose escalation and confirmation segment of the Phase 3 BELLWAVE-010 study. P. Ghia.

Abstract #2119, Poster session, Chronic Lymphocytic Leukemia: Clinical and Epidemiological

Marginal zone lymphoma

Phase 2 BELLWAVE-003 Cohort F: Updated clinical outcomes of nemtabrutinib in participants with relapsed or refractory marginal zone lymphoma. M. Ozcan.

Abstract #1801, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Follicular lymphoma

Nemtabrutinib in participants with relapsed or refractory follicular lymphoma: updated efficacy and safety from Cohort G of the Phase 2 BELLWAVE-003 study. W. Jurczak.

Abstract #3570, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory follicular lymphoma. Y. Song.

Abstract #5372, Poster session, Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological

Diffuse large B-cell lymphoma

Phase 2/3 trial of zilovertamab vedotin plus standard of care in relapsed/ refractory diffuse large B-cell lymphoma: updated analysis of waveLINE-003. P. Armand.

Abstract #3745, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 2 trial of zilovertamab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone plus rituximab in diffuse large B-cell lymphoma: updated analysis of waveLINE-007. M. Ladetto.

Abstract #5516, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

Phase 1 study of MK-1045, a novel CD19xCD3 T-cell engager, in participants with relapsed or refractory diffuse large B-cell lymphoma. Y. Song.

Abstract #3740, Poster session, Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies

(Press release, Merck & Co, NOV 24, 2025, View Source [SID1234660900])