Forlong Biotechnology to Present Clinical Data from the First-in-human Study for FL115 (IL-15 Superagonist) in US Patients with Advanced Solid Tumors at 2026 ASCO Annual Meeting

On April 21, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported a poster presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held from May 29 to June 2, 2026, at the McCormick Place in Chicago, IL.

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The presentation will detail safety, pharmacokinetics, pharmacodynamics and antitumor activities of FL115 from the first-in-human FL115-101 study conducted at 3 investigational sites in US. First patient was dosed in December 2023, and the study was completed in September 2025 with total of 11 patients treated. One patient received the 1st dose in Jul 2024, remained progression-free at the study completion, and afterwards has continued to receive FL115 treatment under a Single Patient IND Protocol/Treatment Plan.

Details of the poster presentation are as follows:

Poster Board: 291
Poster Title: Safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activities of FL115, a novel IL-15 superagonist, from the first-in-human study in patients with locally advanced/metastatic solid tumors.
Session Type/Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
About FL115

FL115 is an engineered IL-15/IL15Rα-Fbody fusion protein, aiming to enhance anti-tumor immunity via IL-15-mediated signaling on NK and CD8+ T cells while minimizing complexity from Fc. FL115 has demonstrated significant anti-tumor activities as a monotherapy or as part of combination therapy in vivo, and can be manufactured by a robust and efficient process with excellent product stability. Clinically, FL115 has demonstrated favorable safety profile and preliminary clinical responses as a monotherapy, and has the best-in-class potential to synergize with current and emerging T cell-targeting immunotherapies through combination therapy to significantly improve the treatment outcome for patients. It is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase 2 clinical trial to evaluate safety and preliminary efficacy in patients with nonmuscle invasive bladder cancer (NMIBC) and in combination with an anti-PD1 monoclonal antibody in a Phase 1b/2 clinical trial to evaluate safety and preliminary efficacy in patients with advanced solid tumors.

(Press release, Forlong Biotechnology, APR 21, 2026, View Source [SID1234664648])

Incyte Highlights New Phase 3 Tafasitamab Data at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2026 Incyte (Nasdaq:INCY) reported that full results from the Phase 3 pivotal study evaluating tafasitamab (Monjuvi/Minjuvi) in first-line diffuse large b-cell lymphoma (DLBCL) will be featured as an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 29 – June 2, 2026, in Chicago.

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"The positive Phase 3 frontMIND results for tafasitamab in patients with newly diagnosed diffuse large B-cell lymphoma highlight Incyte’s continued focus on advancing novel differentiated approaches with the potential to meaningfully impact patients," said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. "We look forward to sharing the full data at ASCO (Free ASCO Whitepaper), and to progressing our pipeline."

Presentation details:

frontMIND: Phase 3 Study of tafasitamab (Tafa) Plus lenalidomide (Len) and R-CHOP for Patients (pts) with Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
(Abstract #7000. Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia. May 30, 4:00 – 7:00 p.m. ET (3:00 – 6:00 p.m. CDT))

More information regarding the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting can be found at: View Source

About Tafasitamab (Monjuvi/Minjuvi)

Tafasitamab (Monjuvi/Minjuvi) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

(Press release, Incyte, APR 21, 2026, View Source [SID1234664647])

Obsidian Therapeutics to Present OBX-115 Phase 2 Clinical Data in Advanced Melanoma in Oral Presentation at 2026 ASCO Annual Meeting

On April 21, 2026 Obsidian Therapeutics, Inc., a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported an oral presentation of Phase 2 results in patients with advanced melanoma from the Phase 1/2 Agni-01 multicenter study of OBX-115, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, May 29–June 2, 2026.

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Oral Presentation Details:

Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors (ICI): Phase 2 results
Session Type/Title: Oral Abstract Session – Melanoma/Skin Cancers
Date: Monday, June 1
Abstract Number: 9507
Speaker/Lead Author: Allison S Betof, Division of Oncology, Stanford University School of Medicine, Stanford, CA
Clinical Trial Identifier: NCT06060613

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

(Press release, Obsidian Therapeutics, APR 21, 2026, View Source [SID1234664646])

Tubulis to Present Phase I/IIa Trial Data for ADC Candidate TUB-040 in Platinum-resistant Ovarian Cancer in Rapid Oral Presentation at ASCO 2026

On April 21, 2026 Tubulis reported that an abstract covering current clinical trial data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for a rapid oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting, being held May 29 – June 2, 2026, in Chicago. The presentation by Prof. Dr. Toon Van Gorp, clinical investigator of the study, will provide an update of maturing data from the ongoing dose escalation part of the ovarian cancer cohort.

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Details of the oral presentation:

Title: NAPISTAR 1-01: Results of phase 1 dose escalation of monotherapy with TUB-040, a novel NaPi2b-targeting exatecan ADC, in patients (pts) with platinum-resistant ovarian cancer (PROC)
Presenter: Dr. Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven, Belgium
Session Category and Title: Rapid Oral Abstract Session: Gynecologic Cancer
Session Date and Time: May 30, 2026; 08:00 – 09:30 AM CDT
Location: McCormic Place, E450a
Abstract Number: 5513

About TUB-040 and the Tubutecan Technology

Tubulis’ lead antibody-drug conjugate (ADC) TUB-040 is directed against NaPi2b, an antigen highly overexpressed in ovarian cancer, lung adenocarcinoma, and endometrial cancer. It consists of an IgG1 antibody targeting NaPi2b equipped with Tubulis’ proprietary Tubutecan technology, connecting the Topoisomerase I inhibitor, exatecan, through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous DAR of 8. Based on novel chemistry for cysteine-selective conjugation, the technology enables the development of stable, highly targeted ADCs optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. The candidate has already demonstrated robust clinical activity with a favorable safety profile as monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC), reported at ESMO (Free ESMO Whitepaper) 2025. It is currently being further investigated in a multicenter Phase I/IIa study (NAPISTAR1-01, NCT06303505) in PROC and relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC).

(Press release, Tubulis, APR 21, 2026, View Source [SID1234664645])

Immunome Announces Oral Presentation of Phase 3 RINGSIDE Data at 2026 ASCO Annual Meeting

On April 21, 2026 Immunome, Inc. ("Immunome") (Nasdaq: IMNM), a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies, reported that data from RINGSIDE, its global, Phase 3, randomized, placebo-controlled trial of varegacestat in patients with progressing desmoid tumors, has been selected for presentation in an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29–June 2, 2026, in Chicago.

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"The selection of the Phase 3 RINGSIDE trial for oral presentation at ASCO (Free ASCO Whitepaper) reflects the importance of advancing new treatment options for patients with desmoid tumors," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "We look forward to sharing detailed results that build on the positive topline data reported in December 2025."

Oral Presentation Details

Abstract Title

RINGSIDE: A phase 3 randomized, placebo-controlled trial of varegacestat for treatment of progressing desmoid tumors

Session Type/Title

Oral Abstract Session – Sarcoma

Date and Time

May 30, 2026, 3:00 PM–6:00 PM CDT

Presenter

Mrinal M. Gounder, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number

11506

About the RINGSIDE Trial

The global, randomized, double-blind, placebo-controlled Phase 3 RINGSIDE trial (NCT04871282) evaluated the efficacy and safety of varegacestat in patients with progressing desmoid tumors. A total of 156 patients were randomized to receive varegacestat 1.2 mg daily or placebo until disease progression or death, representing the largest randomized study in this population. The primary endpoint of the trial was progression-free survival as assessed by blinded independent central review. Statistically controlled secondary endpoints were confirmed ORR using RECIST v1.1 and change in tumor volume at week 24, both determined by blinded independent central review, as well as change in pain intensity at week 12 as determined using a patient reported outcome instrument. Additional secondary endpoints included duration of response, best reduction in tumor volume, patient-reported outcomes, and safety and tolerability. RINGSIDE includes an open-label extension phase, which is ongoing.

About Varegacestat

Varegacestat (formerly AL102) is an investigational, oral, once-daily gamma secretase inhibitor. In December 2025, Immunome reported positive topline results for the Phase 3 RINGSIDE trial of varegacestat in adults with progressing desmoid tumors. Immunome plans to submit a New Drug Application for varegacestat to the U.S. Food and Drug Administration in Q2 2026.

(Press release, Immunome, APR 21, 2026, View Source [SID1234664644])