Deciphera Pharmaceuticals Announces First Patient Dosed in Pivotal Phase 3 INTREPID Study of Sapablursen in Polycythemia Vera

On June 17, 2026 Deciphera Pharmaceuticals, LLC, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported the first patient was dosed in the global pivotal Phase 3 INTREPID study evaluating sapablursen for the treatment of polycythemia vera (PV). Sapablursen is an investigational drug that has the potential to offer a once-monthly treatment option for patients with PV, a rare and potentially life-threatening hematologic disease.

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"We look forward to building upon the positive efficacy and safety results from the Phase 2a IMPRSSION study, which demonstrated the ability of sapablursen to reduce the frequency of phlebotomy, control hematocrit, and improve PV symptoms in patients treated with phlebotomy alone and those on cytoreductive therapies," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "Sapablursen has the potential to be an important new treatment option for patients with PV, and we are excited to begin our Phase 3 INTREPID study, which brings us one step closer to addressing the unmet needs of these patients."

INTREPID is a pivotal global Phase 3 study in patients with phlebotomy-dependent PV designed to compare the efficacy and safety of sapablursen to placebo over a 32-week double-blind treatment period followed by up to 124 weeks of open label treatment. The primary endpoint is response, defined by the absence of phlebotomy eligibility. Key secondary endpoints are number of phlebotomies, which is the primary endpoint for the European Medicines Agency for potential regulatory approval, hematocrit control, and improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Total T-score and the Myelofibrosis Symptom Assessment Form (MFSAF) Total Symptom Score. Durability of response will be evaluated in patients randomized to sapablursen over 52 weeks of study treatment, including 32 weeks of blinded treatment and 20 weeks of open-label treatment.

The INTREPID clinical trial has initiated in the United States and is planned in additional regions including North America, Latin America, Asia Pacific and Europe. For more information on the INTREPID study, please visit View Source

Sapablursen received Fast Track designation and Orphan Drug Designation in 2024 and Breakthrough Therapy Designation in 2025 by the U.S. Food and Drug Administration (FDA).

Sapablursen was discovered and advanced through Phase 2 clinical development by Ionis Pharmaceuticals. Ono obtained exclusive global rights for the development and commercialization of sapablursen after entering into a license agreement with Ionis in March 2025.

About Sapablursen

Sapablursen is designed to reduce the production of TMPRSS6 resulting in increased expression of hepcidin, the key regulator of iron homeostasis. By increasing the production of hepcidin, sapablursen has the potential to positively impact PV by decreasing hematocrit, reducing the need for phlebotomy, and improving quality of life.

About Polycythemia Vera

Polycythemia vera (PV) is a rare and potentially life-threatening hematologic disease characterized by the overproduction of red blood cells, which significantly increases the risk of serious blood clots, heart attack, stroke, and death. The primary treatment goal in PV is to maintain blood hematocrit levels <45% to prevent thrombotic events and alleviate burdensome symptoms, such as severe fatigue, difficulty concentrating, night sweats, and pruritus. Current treatment options often worsen symptoms and inadequately maintain hematocrit control.

(Press release, Deciphera Pharmaceuticals, JUN 17, 2026, View Source [SID1234668788])

LabGenius Therapeutics and LG Chem Enter a Research Collaboration, Option and License Agreement to Develop an AI/ML-Designed Tumour-Targeting Antibody

On June 17, 2026 LabGenius Therapeutics ("LabGenius"), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, reported a multi-year research collaboration, option and licensing agreement with LG Chem. The collaboration aims to identify next-generation multispecific antibodies designed to overcome the key limitations of existing immunotherapies, including on-target, off-tumour toxicities. Together, the companies will aim to develop a novel, tumour-selective therapeutic targeting a solid tumour antigen expressed across multiple difficult-to-treat cancer types.

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"Partnering with LG Chem represents a very important moment for LabGenius and provides further validation of our platform’s ability to design highly optimised multispecific antibodies," said Dr. James Field, CEO of LabGenius. "We welcome this opportunity to leverage our proprietary discovery capabilities to advance the development of safer and more effective immunotherapies for patients with solid tumours."

Jineon So, Head of R&D, Life Sciences Division at LG Chem, commented: "LabGenius possesses a highly capable and systematic platform that enables rapid candidate exploration and early evaluation through a closed-loop structure integrating automated wet labs and computational dry labs. Through this collaboration, we aim to quickly identify novel oncology drug candidates with improved efficacy and reduced toxicity in areas of high unmet medical need."

Science Minister Lord Vallance said: "Cancer will touch many of us or our families over the course of our lives, but from drug discovery to faster diagnoses, emerging technologies like AI are transforming our ability to treat and cure this awful disease. By bringing together the power of machine learning and research expertise, this collaboration has the potential to deliver new treatments which are more efficient and have fewer side-effects – potentially improving outcomes for patients all over the world."

Under the terms of the licensing agreement, LabGenius will advance the programme through preclinical research, including in vitro efficacy studies, after which LG Chem will perform further pre-clinical development work, including in vivo studies, and then have the option to in-license the asset. LabGenius will receive an undisclosed upfront payment and potential early milestones, plus, if the option is exercised, potential triple-digit million clinical, regulatory and commercial milestones, along with royalties on net sales. LG Chem will fund all research and development activities conducted under the collaboration.

(Press release, LabGenius Therapeutics, JUN 17, 2026, View Source [SID1234668787])

Ligufalimab (CD47)-Based Combination Achieves Deep Responses and Survival Benefit in Frontline AML: Phase II Results Presented in Oral Session at EHA 2026

On June 17, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) were presented as an oral presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress. Ligufalimab is Akeso’s proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.

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Ligufalimab-based combination therapy demonstrates a significant trend toward survival benefit

At a median follow-up of 10 months in the ligufalimab group and 8.8 months in the control group, median event-free survival (EFS) was 9.1 months in the ligufalimab group versus 6.9 months in the control group (hazard ratio [HR] = 0.46). The 6-month EFS rate was 67.8% versus 55.5% in the control group, and the 9-month EFS rate was 53.2% versus 14.1%.
Median overall survival (mOS) was not reached in the ligufalimab group versus 8.3 months in the control group (HR = 0.46). The 6-month OS rate was 83.3% versus 73.2%, and the 9-month OS rate was 78.7% versus 43.1% in the control group.
Ligufalimab-based combination therapy yields deep tumor responses

The objective response rate (ORR) was 80.0% in the ligufalimab group versus 66.7% in the control group, and the composite complete response (CRc) rate was 56.7% versus 53.3%; the proportion of patients achieving CRc with minimal residual disease (MRD) negativity was higher in the ligufalimab group than in the control group (46.7% vs. 36.7%).
The median duration of CRc was 10.4 months in the ligufalimab group, which was markedly superior to 5.6 months in the control group.
Favorable Safety Profile With No New Safety Signals Observed

The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy.
Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm.
Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors.

(Press release, Akeso Biopharma, JUN 17, 2026, View Source [SID1234668786])

Jazz Pharmaceuticals and AbCellera Announce Collaboration to Discover Next-Generation T-cell Engaging Multispecific Antibodies

On June 17, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and AbCellera (Nasdaq: ABCL) reported a preclinical research collaboration, option and license agreement to discover and develop next-generation T-cell engaging (TCE) multispecific antibodies. The collaboration will leverage AbCellera’s antibody discovery engine to deliver optimized development candidates for multiple gastrointestinal (GI) cancers and other solid tumors.

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"This research collaboration with AbCellera directly aligns with Jazz’s rare disease strategy, expanding our focus on GI cancers and building on our existing expertise in oncology," said Josh Allen, Ph.D., chief scientific officer, oncology, Jazz Pharmaceuticals. "We look forward to collaborating with AbCellera to progress potential best-in-class TCE multispecific antibodies for GI cancers and other solid tumors into clinical development and to develop meaningful innovation for patients."

AbCellera’s T-cell engager platform is a fully integrated capability, from discovery to clinical manufacturing, for developing multispecific TCEs for difficult-to-treat cancers. The platform includes novel and proprietary panels of CD3-binding antibodies, costimulatory targeting arms, multispecific protein engineering technology, and a suite of high-throughput functional assays.

"Building on years of experience in TCEs, we are pleased to partner with Jazz Pharmaceuticals to leverage AbCellera’s differentiated TCE platform to bring forward novel cancer treatments for GI cancers and other solid tumors," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "TCEs drive highly targeted immune activation, which has the potential to significantly advance outcomes relative to existing treatments in these cancers."

Transaction Terms
Under the terms of the agreement, AbCellera will perform discovery and early-stage research activities for two initial programs with a commitment to start a third discovery program within 12 months. Jazz is granted an option in connection with each research program and, following exercise of its option and payment of an option fee, will have the exclusive, worldwide right to develop and commercialize each program. AbCellera will receive $56 million in total upfront payments for the first two research programs plus an additional $28 million due upon initiation of the third program. Should Jazz exercise its option for development, AbCellera is eligible to receive up to $792 million per program in option fees and development, regulatory, and commercial sales milestone payments along with tiered royalties on net sales ranging from mid-single digits to low double-digits. In addition, Jazz and AbCellera may mutually agree to initiate up to two additional programs, and to have AbCellera conduct certain activities for investigational new drug-enabling studies and manufacture clinical supply for any program under the collaboration.

(Press release, Jazz Pharmaceuticals, JUN 17, 2026, View Source [SID1234668785])

Nectin Therapeutics Reports Encouraging Phase 1 Results for NTX1088 in Combination with Keytruda® (pembrolizumab) at ASCO 2026

On June 17, 2026 Nectin Therapeutics, a clinical-stage oncology company developing first-in-class immuno-oncology and antibody-drug conjugate (ADC) therapies, reported the presentation of Phase 1a/1b clinical data of NTX1088 in combination with pembrolizumab (Keytruda), Merck’s (known as MSD outside of the U.S. and Canada) anti-PD1 therapy, during an oral presentation at the 2026 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago.

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The data highlighted NTX1088, a first-in-class monoclonal antibody targeting the poliovirus receptor (PVR; CD155), a key regulator of the DNAM1 axis and an important driver of tumor-mediated immune suppression.

The results were presented from the ongoing Phase 1a/1b, open-label, multicenter, dose-escalation and expansion study, NTX-1088-01 (KEYNOTE E92, NCT05378425), evaluating NTX1088 as both a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.

A total of 91 patients were treated in the study., and NTX1088 was well tolerated, with no dose-limiting toxicities observed. Based on pharmacokinetics and target occupancy, a dose of 1,750 mg was selected as the recommended dose for expansion.

Preliminary efficacy analysis focused on patients receiving active dose levels of NTX1088 (1200 and 1750 mg) in combination with pembrolizumab (200 mg). Among 41 evaluable patients, confirmed partial responses (PRs) were observed across multiple tumor types, including gastric, bladder, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and melanoma.

The study population represented a particularly challenging treatment setting, with a median of four prior lines of therapy and high rates of prior immune checkpoint inhibitors (CPIs) exposure. Additional patients achieved stable disease, and most responding patients were ongoing at data cutoff with a maximum treatment duration of 24 months.

"These Phase 1 results indicate that NTX1088 in combination with pembrolizumab was well tolerated and demonstrated encouraging preliminary anti-tumor activity in a difficult-to-treat, CPI-pretreated population," said Sarina A. Piha-Paul, M.D., lead Principal Investigator of the NTX-1088-01 study at The University of Texas MD Anderson Cancer Center. "Based on these findings, further clinical evaluation in Phase 2 studies, including in less heavily pretreated and biomarker-enriched cohorts, is warranted."

(Press release, Nectin Therapeutics, JUN 17, 2026, View Source [SID1234668784])