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])

ITM to Announce Quality of Life Data from the Phase 3 COMPETE Trial in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) at ASCO 2026

On April 21, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that it will provide quality of life data from its Phase 3 COMPETE trial in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held from May 29 – June 2, 2026 in Chicago, Illinois.

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Poster Presentation Details
Title: Quality of life in patients with gastroenteropancreatic neuroendocrine tumors receiving 177Lu-edotreotide or everolimus: Results from the COMPETE study
Abstract Number: 4171
Poster Board Number: 154
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Date and Time: May 30, 2026, 9:00 AM – 12:00 PM CDT
Location: McCormick Place Convention Center, Chicago, IL, USA
Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, APR 21, 2026, View Source [SID1234664662])

Avenzo Therapeutics to Present Updated Results from the Phase 1 Study of AVZO-021, a Potential Best-in-Class CDK2 Inhibitor, at the 2026 American Society of Clinical Oncology Annual Meeting

On April 21, 2026 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, reported the acceptance of an abstract for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago, Illinois from May 29 – June 2, 2026.

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Avenzo will present updated safety and efficacy results from the Phase 1 portion of its ongoing Phase 1/2 clinical study of AVZO-021, its potential best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor.

Details of the poster presentation are as follows:

Abstract: 1094

Title: A phase 1/2, first-in-human study of AVZO-021, a selective cyclin-dependent kinase 2 inhibitor (CDK2i), as monotherapy and in combination for patients with advanced solid tumors, including hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) breast cancer (BC) and cyclin E1 (CCNE1)–amplified solid tumors: Updated safety and efficacy results.

Session Title: Breast Cancer—Metastatic

Poster Board: 208

Date and Time: June 1, 2026, 1:30 to 4:30 p.m. CT

(Press release, Avenzo Therapeutics, APR 21, 2026, View Source [SID1234664599])

Medicenna Presents Positive Data Demonstrating Superior Safety and Efficacy Potential of its First-in-Class anti-PD-1 x IL-2 Bifunctional Superkine MDNA113 at AACR 2026

On April 21, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of proprietary Superkines targeting cancer and autoimmune diseases, reported new positive preclinical data from MDNA113, its first-in-class tumor-anchored and conditionally activated anti-PD-1 x IL-2 bifunctional Superkine, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, California.

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The data demonstrate that MDNA113’s architecture delivers on the promise of a truly differentiated and highly tolerable PD-1 x IL-2 bifunctional. In a head-to-head non-human primate study, MDNA113 was well tolerated at doses up to 50 mg/kg while a representative anti-PD-1 x IL-2α-biased bispecific could not be administered a second dose at a fraction of that exposure due to severe toxicity, including evidence of vascular leak syndrome.

"Taken together, these data demonstrate that MDNA113 is a first-in-class PD-1 x IL-2 bifunctional with exquisite design that delivers superior tolerability and a significantly wider therapeutic window compared with first-generation approaches," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "This is exactly the kind of data we had hoped for on our design thesis: by combining tumor anchoring, dual conditional activation, and a β-enhanced not-α IL-2 Superkine, we can dose at levels comparable to approved anti-PD-1 therapies without the systemic toxicity that has forced competitors to compromise on potency by lowering the dose and attenuating activity of IL-2. With MDNA113, we have fused a blockbuster anti-PD-1 with our IL-2 Superkine, which has already demonstrated promising single-agent activity in immunotherapy-resistant patients, significantly de-risking clinical development. We look forward to advancing MDNA113 toward an IND submission later this year."

PD-1 bispecifics have emerged as a leading next-generation approach to enhancing the efficacy of PD-1 inhibitors, the best-selling class of oncology drugs in the world. The commercial potential of PD-1 x IL-2 bispecifics specifically has been validated by recent multi-billion-dollar transactions.

MDNA113 is built on the Company’s IL-2 and IL-13 Superkine platforms. The β-enhanced not-α IL-2 Superkine at the core of MDNA113 is shared with MDNA11, the Company’s clinical-stage IL-2 Superkine, which has demonstrated durable single-agent anti-tumor activity and a manageable safety profile in the ongoing Phase 1/2 ABILITY-1 study in patients with advanced solid tumors. Unlike competing PD-1 x IL-2 programs that utilize proprietary anti-PD-1 antibodies, MDNA113 incorporates variants of commercially validated, approved human anti-PD-1 antibodies.

MDNA113 is designed to address the safety and dosing limitations that have constrained first-generation molecules in this class by combining a commercially validated anti-PD-1 antibody with Medicenna’s clinically validated IL-2 Superkine, the only next-generation IL-2 with demonstrated durable single-agent anti-tumor activity, in a tumor-targeted, conditionally activated architecture.

Key highlights from the presentation:

MDNA113’s masking architecture achieved >10,000-fold attenuation of IL-2R agonism relative to the non-masked parent molecule while preserving full PD-1/PD-L1 blockade, and the masking domain demonstrated stability in serum for at least 8 days, confirming that IL-2 Superkine is effectively shielded from systemic exposure until activated within the tumor microenvironment
MDNA113 demonstrated two independent mechanisms of conditional activation: tumor-associated matrix metalloprotease (MMP) cleavage fully restored IL-2R signaling at the tumor site, and proximity-dependent unmasking upon engagement with PD-1-expressing T cells provided a second activation pathway independent of protease expression, a key differentiator versus competing masked programs that rely solely on MMP cleavage
MDNA113’s IL-13Rα2 tumor-targeting domain drove selective accumulation and prolonged residence at the tumor site for at least 3 days in IL-13Rα2-expressing tumors, with clearance from non-expressing tissue, a tumor-anchoring capability not incorporated by any other PD-1 x IL-2 bispecific in development
In syngeneic mouse tumor models, MDNA113 demonstrated significant tumor growth inhibition with preferential expansion of CD8+ T cells expressing Granzyme B over NK cells and regulatory T cells, and efficacy was compromised with an uncleavable version, confirming conditional activation within the tumor microenvironment is required for therapeutic effect
MDNA113 was well tolerated at doses of 10, 30 and 50 mg/kg in non-human primates with pharmacokinetics consistent with approved anti-PD-1 antibodies, expanded CD8+ T cells without significant regulatory T cell increase, and did not produce dose-limiting adverse findings at any dose level tested
In a head-to-head non-human primate comparison at molar-equivalent doses, an anti-PD-1 x IL-2α-biased bispecific (1.4 mg/kg) exhibited severe toxicity after a single dose, including evidence of vascular leak syndrome, significant body weight loss, decreased serum albumin, elevated blood urea and liver enzymes, and increased white blood cell counts, and could not receive a second dose due to ongoing adverse events
By contrast, MDNA113 was well tolerated at exposures more than 30-fold higher than the single tolerated dose of the α-biased comparator and received repeat dosing without treatment-limiting findings, demonstrating a fundamentally wider therapeutic window than competing first-generation anti-PD-1 x IL-2α-biased bispecifics
A copy of the poster is available on the "Scientific Presentations" page of Medicenna’s website.

About MDNA113

MDNA113 is a novel, first-in-class tumor-targeted and tumor-activated bifunctional anti-PD-1x IL-2 Superkine with exceptionally high affinity for IL-13Rα2 without binding to the functional IL-13Rα1. IL-13Rα2 is overexpressed in a wide range of solid tumors, including "immunologically cold" tumors, with minimal to no expression in normal tissues. IL-13Rα2-expressing tumors also have abundant matrix metalloproteases in the tumor microenvironment that may efficiently activate MDNA113. IL-13Rα2 expression is associated with poor clinical outcomes in multiple tumor types including prostate, pancreatic, ovarian, liver, breast and brain cancer, with an annual worldwide incidence of over 2 million.

(Press release, Medicenna Therapeutics, APR 21, 2026, View Source [SID1234664615])

Innovent to Present New Clinical Data of IBI363(PD-1/IL-2α-biased bispecific fusion protein) at the 2026 ASCO Annual Meeting

On April 21, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that clinical data for its first-in-class IBI363 (PD-1/IL-2α-biased bispecific fusion protein) * as well as TYVYT (sintilimab injection)** will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 to June 2, 2026, in Chicago, Illinois, U.S.

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Dr. Hui Zhou, Chief R&D Officer (Oncology) of Innovent, stated: "We are excited to announce that at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, we will present new PoC data of IBI363 in NSCLC, across both IO-resistant and first-line settings. With robust PoC data for IO-resistant NSCLC now in hand, we are moving IBI363 into MRCT pivotal development, an important step toward tackling a major global unmet medical need. At the same time, we are encouraged by the promising dose optimization data in first-line NSCLC, and we look forward to continued maturation of PoC full data to inform our next steps. Innovent will continue to push the boundaries of cancer care, as we are dedicated to delivering physicians and patients more innovative, effective, and life-saving treatment options."

Abstracts of IBI363(PD-1/IL-2α-biased bispecific fusion protein)

1. Presentation Title: IBI363 (TAK-928) plus chemotherapy as first line (1L) treatment for advanced non-small cell lung cancer (NSCLC).
Abstract Number: 8586
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Haiyan Tu, Guangdong Provincial People’s Hospital

2. Presentation Title: First-in-class PD-1/IL-2α-bias bispecific antibody IBI363 (TAK-928) in patients (pts) with advanced immunotherapy-resistant non-small cell lung cancer (NSCLC): updated results from a phase I study.
Abstract Number: 2618
Session Type: Poster
Session Title: Developmental Therapeutics/Immunotherapy
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Jianya Zhou, First Affiliated Hospital of Zhejiang University School of Medicine

3. Presentation Title: Randomized phase 3 study (MarsLight-11) evaluating IBI363 (TAK-928) versus docetaxel in patients (pts) with squamous non-small cell lung cancer (sqNSCLC) after prior chemotherapy (chemo) and immunotherapy (IO).
Abstract Number: TPS8673
Session Type: Poster
Session Title: Lung Cancer/Non-Small Cell Metastatic
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Roy S. Herbst, Yale School of Medicine

Abstracts of TYVYT(sintilimab)

1. Presentation Title: Adjuvant sintilimab plus bevacizumab following curative resection of spontaneously ruptured hepatocellular carcinoma: A prospective exploratory phase II study (CLEAR-2)
Abstract Number: TPS4254
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yongjun Chen, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

2. Presentation Title: Neoadjuvant chemoradiotherapy with or without PD-1 blockade in pMMR/MSS low rectal cancer patients (CHOICE II): A multi-center, open-label, randomized controlled trial.
Abstract Number: 3640
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Wei Zhang, Changhai Hospital

3. Presentation Title: Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC): A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study
Abstract Number: 4148
Session Type: Poster
Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Jia Fan, Zhongshan Hospital, Fudan University

4. Presentation Title: CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer.
Abstract Number: TPS3680
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026, 9:00 AM-12:00 PM CDT
Presenter: Dr. Yue Liu, The Second Affiliated Hospital of Zhejiang University School of Medicine.

5. Presentation Title: Long-term survival and biomarker analysis of neoadjuvant chemoradiotherapy with or without PD-1 antibody sintilimab in pMMR locally advanced rectal cancer: A randomized clinical trial.
Abstract Number: 3610
Session Type: Poster
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xiao Weiwei, Sun Yat-sen University Cancer Center

6. Presentation Title: Larynx preservation via chemotherapy-free neoadjuvant sintilimab-cetuximab-SBRT and response-adapted treatment in locally advanced laryngeal cancer: A phase II, single-arm clinical trial (The NeoVOICE study).
Abstract Number: 6095
Session Type: Poster
Session Title: Head and Neck Cancer
Session Date & Time: May 30, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Song Ming, Sun Yat-sen University Cancer Center

7. Presentation Title: Pathological complete response and ctDNA analyses in SCIENCE: Results from a randomized, phase III trial of neoadjuvant chemotherapy plus sintilimab and chemoradiotherapy plus sintilimab versus chemoradiotherapy in resectable locally advanced esophageal squamous cell carcinoma.
Abstract Number: LBA4082
Session Type: Poster
Session Title: Gastrointestinal Cancer-Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: May 30, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Xuefeng Leng, Sichuan Cancer Hospital

8. Presentation Title: Sintilimab (PD-1 antibody) Plus Gemcitabine and Docetaxel (GT) as First-line or Later-line Therapy in Patients with Advanced Epithelioid Sarcoma: A Prospective, Multicenter, Single-arm, Phase II Clinical Study.
Abstract Number: 11574
Session Type: Poster
Session Title: Sarcoma
Session Date & Time: June 1, 2026 1:30 PM-4:30 PM CDT
Presenter: Dr. Xiaowei Zhang, Fudan University Shanghai Cancer Center

9. Presentation Title: Sintilimab plus Anlotinib and Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma: A Prospective, Phase II Clinical Trial.
Abstract Number: 8050
Session Type: Poster
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Session Date & Time: May 31, 2026 9:00 AM-12:00 PM CDT
Presenter: Dr. Jianchun Duan, Cancer Hospital, Chinese Academy of Medical Sciences

(Press release, Innovent Biologics, APR 21, 2026, View Source [SID1234664631])