1stOncology™: Cancer Intelligence Service – Page 165 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Incyte and Edison Scientific Announce Strategic Collaboration to Employ the Kosmos AI Platform for Research and Development

On May 19, 2026 Incyte (Nasdaq:INCY) and Edison Scientific reported a strategic collaboration to employ Kosmos, Edison’s AI scientist, for Incyte’s discovery and development work.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Kosmos will be embedded across the Incyte discovery and development lifecycle, enabling continuous learning from translational and clinical data, real-time synthesis of evidence and predictive models of therapeutic performance.

The initial deployment will be focused on high-impact use cases in target discovery and validation and translational biology, centered on embedding Edison’s AI capabilities within Incyte’s research workflows to support more efficient exploration of experimental, clinical and biomarker data with the potential to expand across Incyte’s broader R&D organization. The companies will work together to measure impact on decision quality and long-term pipeline productivity as the system evolves.

"Our vision is for our data to become a learning system that enhances every decision," said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development at Incyte. "This partnership aims to maximize our data’s value by integrating AI to guide experimental design and improve the quality and consistency of scientific and development decisions. Our goal is not just faster development, but better outcomes across our programs."

"By using systems that learn from our experimental and clinical data, we can enhance result interpretation, creating a feedback loop that boosts both speed and quality in future programs," added Patrick Mayes, Ph.D., Executive Vice President and Chief Scientific Officer at Incyte.

At the core of the collaboration is a new model for biopharma: one in which a company’s data is not just stored and analyzed, but becomes a compounding asset, used to train AI systems that improve over time and systematically enhance experimental and clinical outcomes.

"Most AI efforts in pharma treat data as something to analyze," said Sam Rodriques, Ph.D., Chief Executive Officer of Edison Scientific. "What we are building treats data as something to learn from continuously. The result is a system that compounds—where every experiment, every clinical readout and every decision improves the underlying models. That is how companies, like Incyte, will turn their data into a sustainable advantage over their competitors."

(Press release, Incyte, MAY 19, 2026, View Source [SID1234665885])

Sensome Announces Positive First-in-Human Study Results for In Situ Tumor Detection Technology for Lung Cancer

On May 19, 2026 Sensome, the pioneer of microsensing technology for real-time, intra-operative tissue analysis, reported positive results from its first-in-human INSPECT study evaluating its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy. The study showed that Sensome’s tumor detection technology safely and accurately identified and differentiated between cancerous tissue and healthy tissue. The study was presented today by Amir Hanna, MD, Interventional Pulmonologist and Principal Investigator of the INSPECT study for Marie-Lannelongue Hospital, France at the annual meeting of the American Thoracic Society (ATS) in Orlando, Florida.

Lead author Dr. Hanna commented, "In this early study, the smart stylet accurately identified lesions or cancer amid the complex conditions of in situ lung tissue. With the learning curves of the technology’s algorithm suggesting the potential to exceed 90% overall performance,1 these results show clear promise for real-time decision support during lung biopsy. By confirming relevant sampling sites and tool-in-lesion, this technology holds promise to significantly boost biopsy diagnostic yield and shorten the path to lung cancer diagnosis and treatment."

Lung cancer is the most common and deadly cancer in the world, killing almost two million people globally each year. Detection of lung cancer in its early stages dramatically improves the five-year survival rate of patients when compared to late-stage detection. However, lung cancer is challenging to diagnose today with conventional methods, with an up to 58% failure rate in obtaining a successful biopsy,2 which causes repeat procedures and treatment delays of up to six months.3

Sensome’s technology is intended to confirm placement of a biopsy tool within a tumor during bronchoscopic biopsy of endobronchial and peripheral tumors without reliance on additional imaging modalities, which are not able to identify cancerous tissue. The novel tool-in-lesion system is designed to guide the bronchoscopist in precisely locating optimal biopsy sites, with the goal of reducing delays in the diagnosis and treatment of lung cancer.

INSPECT Study Results

The INSPECT study is a first-in-human, multi-center, single-arm study of 27 patients across Australia and France. In each case, the smart stylet was placed inside the biopsy needle and tissue readings were taken immediately prior to biopsy of each patient, with histopathology confirming accuracy of the measurement. Results were validated using cross-validation.

In the study, not only was the smart stylet able to differentiate between cancer and healthy tissue, but it also differentiated cancer from other non-cancerous tissue, such as necrotic tissue. With a dataset of only 27 patients, the Sensome technology demonstrated 80.9% accuracy in differentiating healthy from abnormal lung tissue—achieving sensitivity of 88.5% and specificity of 71.4%—and 78.7% accuracy when differentiating cancer from all other types of tissues—achieving sensitivity of 78.3% and specificity of 79.2%.1

"Lung cancer screening programs have commenced around the world, resulting in an explosion of demand for lung cancer biopsies. It is important that we have the tools that will enable us to respond to this new flood of patients with timely and accurate diagnosis," said Associate Professor David Fielding, Director of Thoracic Medicine at Royal Brisbane and Women’s Hospital in Australia and Principal Investigator of the INSPECT study. "The results from the INSPECT study suggest that Sensome’s smart stylet has the potential to provide this, especially as it integrates well into our existing workflow."

"We have developed a tool designed to assist clinicians in the moment of action, to ensure they are performing a biopsy of the cancerous tumor and not healthy or other non-cancerous tissue; a biopsy of non-cancerous tissue is not useful in arriving at a diagnosis. Our goal is to eliminate the trial and error associated with mistakenly performing biopsy on tissue that delays cancer diagnosis and treatment," said Sensome CEO Franz Bozsak. "Our technology works just like a conventional stylet used in biopsy today, except we have made it ‘smart’ with the integration of our sensor into the device, which provides biological intelligence. We are very encouraged by the positive results seen in this feasibility study and expect to see even greater accuracy from our technology in the future as its algorithms learn and improve from the additional patient data we will gather."

(Press release, Sensome, MAY 19, 2026, View Source [SID1234665884])

Amplia Therapeutics Launches First Stage of Registration-Enabling Trial of Narmafotinib

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

"To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enroll patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665883])

Cullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia

On May 19, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

"FDA Orphan Drug Designation for CLN-049 emphasizes both the urgent need for new therapies for people living with relapsed or refractory acute myeloid leukemia – including patients with TP53-mutated AML who currently face a particularly poor prognosis – and the potential of this FLT3-directed T cell engager to expand treatment options across the broadest population of AML patients," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Coupled with promising results from our ongoing Phase 1 program, this designation by the FDA reinforces a shared goal to rapidly advance novel therapies for patients living with AML."

About Orphan Drug Designation

The U.S. FDA’s Orphan Drug Designation provides orphan status to drugs and biologics intended to prevent, diagnose, or treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies sponsors for certain development incentives, including tax credits for qualified clinical trials, exemption from certain FDA user fees, and the potential for seven years of market exclusivity in the United States following marketing approval.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, enabling targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.3 Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.4 Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.5

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.8 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, MAY 19, 2026, View Source [SID1234665882])

ITM to Announce Dosimetry Data from the Phase 3 COMPETE Trial at SNMMI 2026 and Host Satellite Symposium

On May 19, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that dosimetry data from its Phase 3 COMPETE trial will be provided in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, held from May 30 – June 2, 2026 in Los Angeles, California. ITM will also host a satellite symposium on the evolution of SSTR-targeted radiopharmaceutical therapy.

Poster Presentation Details
Title: Accurate single-time-point dosimetry of [177Lu]Lu-edotreotide using non-linear mixed-effects modeling: results from the COMPETE Phase 3 trial
Display Date and Location: May 31 – June 2 at the SNMMI Science Pavilion

Satellite Symposium Details
Title: ITM Dinner Symposium – The Evolution of SSTR‑Targeted Therapy – from Agonists to Antagonists and Emerging Radionuclides
Objective: Discuss the evolution of SSTR‑targeted radiopharmaceutical therapy; spanning early approaches, current ¹⁷⁷Lu agonist therapies to next‑generation ligand biology and emerging radionuclides – linking today’s clinical practice with future therapeutic directions
Speaker: Dr. Julia Fricke, MD, Clinic for Radiology and Nuclear Medicine at the University Hospital Basel, Switzerland
Date: May 31, 2026, 6:30 PM – 7:30 PM PT
Location: Petree Hall C, LA Convention Center, Los Angeles, CA

During the conference, ITM will exhibit its innovative isotope portfolio, including Lutetium-177, Actinium-225 and Terbium-161. Attendees will have the opportunity to learn more about the company’s innovative radiopharmaceutical pipeline and its capabilities in the manufacturing and supply of radioisotopes at booth #1523.

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 (NCT04919226), 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, MAY 19, 2026, View Source [SID1234665881])