On June 10, 2026 Orionis Biosciences, a privately held, clinical-stage life sciences company pioneering proximity-induced therapeutic modalities, reported a multi-year collaboration with Novartis to discover and design molecular glue drugs for challenging therapeutic targets across multiple disease areas. The collaboration expands the existing relationship between the companies and reflects a shared commitment to unlock the full value of induced proximity approaches in drug development.

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Under the terms of the agreement, Novartis and Orionis will use Orionis’s Allo-Glue platform, together with its AI-driven discovery engine, to accelerate target and ligase profiling and molecular glue optimization. These integrated capabilities enable the systematic discovery of small molecule glues that modulate therapeutic targets through induced proximity mechanisms. Orionis will receive an upfront payment of USD 40 million and is eligible to receive research, development, and commercial milestone payments of up to USD 1.4 billion, in addition to tiered royalties on net sales of collaboration products.

"We are proud to renew and expand our collaboration with Novartis," said Niko Kley, Chief Executive Officer of Orionis Biosciences. "Having such a partner continue to engage deeply with us is a strong validation of the value of our molecular glue platform and the progress we have achieved toward rational and scalable discovery of this emerging drug class."

"Our recent advances in AI and robotic automation have accelerated all aspects of molecular glue discovery, from systematic prioritization of productive target–ligase pairs to glue candidate discovery and optimization," said Riccardo Sabatini, Chief Data Scientist at Orionis Biosciences. "This is exactly the kind of platform maturity that makes collaborations like this possible."

"We are excited to deepen our collaboration with Orionis and to explore the full potential of molecular glue modalities across multiple therapeutic areas," said John Tallarico, Head of Discovery Sciences at Novartis. "The Orionis platform offers an opportunity to rapidly uncover and design molecular glue mechanisms, enabling us to expand the horizon of targetable biology for future therapies."

(Press release, Orionis Biosciences, JUN 10, 2026, View Source [SID1234666549])

On June 10, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI), an oncology company integrating novel delivery technology with standard-of-care therapies and an investigational immunotherapeutic to transform outcomes for patients with solid tumors, reported it will host a virtual key opinion leader (KOL) event on Wednesday, June 24, 2026 at 8:00 AM ET. The event will feature the findings of a newly published real-world outcomes study demonstrating that Pressure-Enabled Drug Delivery (PEDD) delivered a 48% improvement in drug delivery to target tumors while reducing complications associated with off-target administration when compared with conventional embolization approaches — results with meaningful implications for the estimated 900,000 patients diagnosed annually worldwide with primary liver tumors or liver metastases.

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Alexander S. Misono, MD, MBA, RPVI, Chief of Interventional Radiology at Hoag Hospital (Newport Beach, CA), will join TriSalus management to discuss the current treatment landscape for hepatocellular carcinoma (HCC) and liver metastases, how the new real-world evidence shapes patient selection and treatment strategy, and share clinical experience and case examples using the TriNav Infusion System. A live Q&A session will follow the formal presentations, providing direct engagement with management and Dr. Misono.

Event: Virtual KOL Webinar

Date: Wednesday, June 24, 2026

Time: 8:00 AM ET

Speaker: Alexander S. Misono, MD, MBA, RPVI — Chief of Interventional Radiology, Hoag Hospital

Register: View Source

"The publication of this real-world evidence marks an important milestone in demonstrating the clinical and economic value of PEDD technology for patients undergoing liver embolization. We look forward to a rich discussion with Dr. Misono on how these findings can help interventional oncologists optimize treatment decisions and improve outcomes for their patients."

— Mary Szela, President & CEO, TriSalus Life Sciences

The TriNav Infusion System is one of three FDA-cleared devices in the TriSalus platform that utilize the PEDD approach to deliver therapeutics directly to liver and pancreatic tumors. The technology is designed to modulate pressure and flow to maximize drug delivery to the tumor while reducing undesired delivery to healthy tissue.

(Press release, TriSalus Life Sciences, JUN 10, 2026, View Source [SID1234666548])

On June 10, 2026 Predicta Biosciences, a company building ultra-sensitive molecular and immune diagnostic platforms, and CIMA LAB Diagnostics from the Clínica Universidad de Navarra, a leading European University Medical Center, reported a partnership to offer a combined service that integrates CIMA LAB’s flow cytometry capabilities with the GenoPredicta assay. The offering will be available to academic institutions and biopharma across Spain and the European Union.

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Led by Dr. Bruno Paiva, the CIMA LAB Diagnostics Flow Cytometry Unit has recognized expertise in the diagnosis and monitoring of hematologic malignancies. Flow cytometry is an essential technique for differential diagnosis, prognostic classification, and monitoring minimal residual disease (MRD) across multiple blood cancers.

"This partnership with CIMA LAB Diagnostics will accelerate and expand the availability of our GenoPredicta platform for EU partners," said Brian McKernan, CEO of Predicta Biosciences. "Dr. Paiva has been an outstanding collaborator, and we are excited about what this relationship with CIMA LAB Diagnostics will bring to the future of blood cancer diagnostics."

"We are honored and very excited to partner with Predicta Biosciences. The GenoPredicta assay is the optimal solution for a missing element in our quest for innovation and improved diagnosis and monitoring of patients with blood cancer. With this partnership, not only can we detect and quantify rare tumor clones, but also characterize their genome at the single-cell level. This is a novel and extremely powerful tool for precision medicine across different types of blood cancer," said Dr. Bruno Paiva.

Dr. Paiva will present an update on the GenoPredicta platform at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (June 11–14, Stockholm, Sweden, and virtual): PF787, "Whole Genome Sequencing of Multiple Myeloma Cells with a Novel Clinical Assay Uncovers Diversity of Genetic Alterations Underlying Immunotherapy Resistance."

(Press release, Predicta Biosciences, JUN 10, 2026, View Source [SID1234666547])

On June 10, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the Taiwan’s Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adult patients with essential thrombocythemia (ET). BESREMi is the first new therapy approved for ET in nearly 30 years.

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The approval represents the first global regulatory approval of BESREMi in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi is well-positioned to address a significant global market opportunity, including in the United States, where the U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.

ET is a chronic MPN characterized by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi franchise.

"This first global approval of BESREMi in ET represents an important strategic milestone for PharmaEssentia and further strengthens the Company’s leadership position in myeloproliferative neoplasms," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. "We believe ET represents a major long-term growth opportunity for BESREMi and has the potential to significantly expand the reach of the Company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi franchise as we continue preparations for a potential U.S. approval and commercial launch in ET later this year."

Dr. Lin continued, "Data generated across the Phase 3 SURPASS-ET study and the Phase 2b EXCEED-ET trial demonstrated the potential of ropeginterferon alfa-2b to achieve durable hematologic and molecular responses in ET patients, supporting the potential for durable hematologic and molecular responses consistent with disease-modifying activity in ET. We believe the differentiated profile and dosing schedule of BESREMi position BESREMi as a differentiated treatment option for a broad range of ET patients."

The TFDA approval was supported by data from the global Phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients resistant or intolerant to hydroxyurea. Specifically, in the global Phase 3 trial SURPASS-ET, BESREMi demonstrated a superior durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001). Across clinical studies, BESREMi demonstrated clinically meaningful hematologic responses, molecular responses, and a manageable safety profile.

In addition to the ongoing FDA review of the ET sBLA, ropeginterferon alfa-2b has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for the treatment of ET, further supporting increasing adoption of interferon-based treatment approaches in ET and other MPNs.

PharmaEssentia is the inventor and owner of BESREMi (ropeginterferon alfa-2b-njft) and maintains intellectual property rights for the product across all indications.

(Press release, PharmaEssentia, JUN 10, 2026, View Source [SID1234666546])

On June 10, 2026 Sumitomo Pharma America, Inc. (SMPA) reported that it has enrolled the required number of participants in its pivotal Phase 2 monotherapy trial for enzomenib, an investigational, oral selective menin inhibitor for the treatment of relapsed/refractory acute leukemia with KMT2A rearrangement, to allow for interim analysis. Achieving this milestone will enable SMPA to obtain results of the interim analysis by the end of calendar year 2026. These results will be promptly disclosed, with detailed data to be presented at an upcoming medical congress. If the primary endpoint is met, SMPA would then proceed with preparation for regulatory submission with the aim of obtaining approval in the US and Japan during FY2027.

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"Acute leukemias, especially at the relapsed/refractory stage, are profoundly difficult to treat, and are associated with very poor outcomes," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "Achieving this enrollment milestone is an important step in our efforts to bring a new, differentiated therapeutic option to acute leukemia patients and their families. My sincere thanks to the patients who are taking part in this study to further our scientific understanding of leukemia treatment."

In addition to this study, SMPA continues to enroll patients in its pivotal Phase 2 monotherapy study of enzomenib in patients with relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation.

About Leukemia

Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells, in the bone marrow. Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.1 Approximately 30% of patients with AML have NPM1 mutations,2 and 5%-10% of patients with AML have KMT2A rearrangements.3

About Enzomenib (DSP-5336)

Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.4,5 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.4,6 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements and NPM1 mutation.7,8 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

(Press release, Sumitomo Dainippon Pharma, JUN 10, 2026, View Source [SID1234666545])