Mirai Bio Presents Data Showing Rapid Advancement of Novel CD8+ T-Cell Targeted LNPs to Functional NHP Proof-of-Concept at ASGCT 2026

On May 12, 2026 Mirai Bio, the innovation delivery partner for companies developing next generation nucleic acid medicines, reported new preclinical data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting 2026 demonstrating the rapid advancement of its CD8-targeted lipid nanoparticle (LNP) platform from novel particle design to functional non-human primate (NHP) proof-of-concept in only 10 months. T cells are a high-value delivery frontier because of their central role in immune biology and relevance across autoimmune diseases, oncology, and other immune-mediated conditions. The two poster presentations show how Mirai’s integrated platform addresses the core requirements for in vivo T-cell targeting, including T-cell specificity, reduced liver-directed delivery, scalable production, tolerability, and functional activity in relevant models, creating a cargo-ready foundation for partner programs.

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!

"Nucleic acid medicine programs can only move as fast as their delivery systems allow," said Jagesh V. Shah, Ph.D., SVP, Head of Platform at Mirai Bio. "These data show that Mirai can help partners move from delivery concept to functional NHP proof-of-concept with the speed and translational relevance needed to make confident development decisions. For in vivo T-cell programs, that means generating the proof points that matter, including functional activity, tolerability, and a clear path toward the clinic."

In the first poster, Mirai described the discovery and evaluation of novel ionizable lipids and long-circulating LNP compositions designed to support extrahepatic, targeted mRNA delivery to T cells. Using a modular lipid discovery platform, Mirai generated structurally diverse ionizable lipid libraries and screened LNPs with dual mRNA cargoes to assess both liver expression and tissue distribution. Lead particles were reformulated into long-circulating compositions that reduced hepatic expression and supported extrahepatic delivery in mice. These optimized base particles were then converted into CD8-targeted LNPs, which showed selective CD8+ T-cell expression with minimal CD4+ T-cell or B-cell transfection and, when loaded with CD20 CAR mRNA, produced dose-dependent CAR expression and B-cell depletion in CD34+ humanized mice, connecting particle design to functional immune-cell activity.

In the second poster, Mirai extended the CD8-targeted LNP platform into NHP-scale production and functional in vivo evaluation. Mirai generated CD8-targeted LNPs encapsulating mRNA encoding a second-generation human and cynomolgus cross-reactive anti-CD20 CAR and administered the particles systemically in NHPs. A single dose generated CAR-expressing endogenous CD8+ T cells and drove rapid depletion of circulating CD20+ B cells out to seven days post-dose, with reduced CD20+ cells also observed in the spleen at 72 hours. The data also showed a tolerability profile supportive of continued translational development, with cytokine and clinical chemistry findings that were monitored and controlled across studies and no major clinical observations in NHPs through the end of study.

The data were presented at the ASGCT (Free ASGCT Whitepaper) Annual Meeting 2026 in two poster presentations:

Abstract 2008: "Mirai Bio’s CD8-targeted lipid nanoparticle delivery platform enables in vivo generation of CD20 CAR T cells and B cell depletion" was presented by Brian Duke, Ph.D., Principal Scientist, Translational Science at Mirai Bio, on May 12 from 5:00 p.m. to 6:30 p.m. ET.
Abstract 1073: "Novel ionizable lipids and long-circulating LNP compositions designed for extrahepatic delivery to enable targeted mRNA delivery to T cells," was presented by Chelsea Martinez, Ph.D., Senior Scientist I at Mirai Bio, on May 13 from 5:00 p.m. to 6:30 p.m. ET

(Press release, Mirai Bio, MAY 12, 2026, View Source [SID1234665577])

Incyte Announces More Than 20 Abstracts Accepted for Presentation at the European Hematology Association (EHA) 2026 Congress

On May 12, 2026 Incyte (Nasdaq:INCY) reported that data from key programs in its Hematology and Oncology franchises will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, to be held June 11 – 14, 2026, in Stockholm, Sweden.

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!

"The breadth of the data that will be showcased at the 2026 EHA (Free EHA Whitepaper) Congress highlights the continued advancement of our Hematology and Oncology pipeline and our focus on delivering differentiated medicines for patients with cancer and hematologic diseases," said Pablo J. Cagnoni, M.D., President and Global Head of Research and Development, Incyte. "These presentations include findings from the frontMIND study, which support the U.S. and EU regulatory applications for tafasitamab (Monjuvi/Minjuvi) in patients with first-line diffuse large B-cell lymphoma (DLBCL). Additionally, data presentations for INCA033989, which support our Phase 3 trials, demonstrate the steady advancement of this molecularly targeted therapy that has the potential to revolutionize treatment for patients with myeloproliferative neoplasms (MPNs)."

Details on key data presentations at EHA (Free EHA Whitepaper) include:

Plenary Abstract Session

Tafasitamab

Tafasitamab Plus Lenalidomide and R-CHOP for Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL): Results From the Phase 3 frontMIND Study
(Plenary Abstract Session. June 13, 6:00 – 7:30 a.m. ET [12:00-1:30 p.m. CEST]. Abstract #S101.)

Oral Presentations

INCA033989 (mutCALR)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Robust Spleen, Anemia, and Molecular Responses in Patients with Myelofibrosis
(Session: Myeloproliferative neoplasms – Clinical. June 13, 11:15 a.m. – 12:30 p.m. ET [5:15-6:30 p.m. CEST]. Abstract #S216.)

Poster Presentations

INCA033989 (mutCALR)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, Produces Clonal Molecular Responses that Correlate with Clinical Responses in Patients with MF
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF884)

Mutant Calreticulin-Specific Monoclonal Antibody, INCA033989, is Well Tolerated and Achieves Rapid and Sustained Hematologic and Molecular Responses in Patients with Essential Thrombocythemia (ET)
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1983)

INCA035784 (mutCALR)

Preclinical Evaluation of INCA035784, a Novel T-Cell–Redirecting Antibody for the Treatment of MutCALR-Driven Myeloproliferative Neoplasms (MPNs)
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF858)

INCA160058 (JAK2V617F)

INCB160058 Selectively Targets JAK2V617F-driven Hematopoiesis in Diverse and Drug-Resistant Models of Myeloproliferative Neoplasms (MPNs)
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 -7:45 p.m. CEST], Abstract #PF872)

Axatilimab

Assessments of Bone Health Among Patients with Chronic Graft-Versus-Host Disease Receiving Axatilimab in the AGAVE-201 Trial
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1151)

Axatilimab in Combination with Ruxolitinib in Patients with Newly Diagnosed Chronic Graft-Versus-Host Disease: Updated Safety Analysis of a Randomized, Phase 2 Study
​(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2243)

Ponatinib

Efficacy and Safety of Ponatinib in Pediatric Patients With BCR::ABL–Positive Chronic Phase Chronic Myeloid Leukemia (CP-CML): Preliminary Results From the INCB84344-102 Study
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF628)

Ruxolitinib

Longitudinal Analysis of Iron Deficiency Markers in Patients with Polycythemia Vera Enrolled in the Prospective Observational REVEAL Study
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF910)

Risk factors for Progressive Kidney Impairment Among Patients with Polycythemia Vera (PV) are Recapitulated and Treatable in Mouse Models of PV
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 CEST], Abstract #PF914)

AI-Quantified Bone Marrow Fibrosis and Megakaryocyte Features Correlate With Driver VAF and Outcomes in the MOST MPN Study
​(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1961)

Identification of Biomarkers to Predict Disease Progression Via Molecular Analysis of Patients (pts) with Low-Risk Myelofibrosis (MF) Enrolled in the MOST Study
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS1970)

Tafasitamab

Phase 3 inMIND trial of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) in Relapsed/Refractory (R/R) Follicular Lymphoma (FL): Analyses of Biomarkers Predictive of Patient (pt) Response
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF1075)

Phase 3 inMIND Study Of Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Clinical Characteristics and Outcomes of Patients Receiving Second-Line Treatment
(Poster Session 1- June 12, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PF948)

Phase 3 inMIND Study of Tafasitamab (Tafa) plus Lenalidomide (Len) and Rituximab (R) for Relapsed or Refractory Follicular Lymphoma (R/R FL): Outcomes in Patients With or Without High-risk Factors
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2048)

Effectiveness and Safety of Chimeric Antigen Receptor T-Cell (CAR-T) Therapy After Tafasitamab (Tafa) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL): A Real-World Study
(Poster Session 2- June 13, 12:45 – 1:45 p.m. ET [6:45 – 7:45 p.m. CEST], Abstract #PS2089)

More information regarding the EHA (Free EHA Whitepaper) 2026 Congress can be found at: View Source

About Jakafi (ruxolitinib)
Jakafi (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab)
Monjuvi (tafasitamab-cxix)/Minjuvi (tafasitamab) 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 is approved by the U.S. FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

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.

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).

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.

Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

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.

About Niktimvo (axatilimab-csfr)
Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Iclusig (ponatinib) tablets
Iclusig (ponatinib), targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved tyrosine kinase inhibitors.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

(Press release, Incyte, MAY 12, 2026, View Source [SID1234665576])

TriSalus Life Sciences Reports First Quarter 2026 Results Demonstrating Commercial and Clinical Progress for Facilitating Long-Term Growth

On May 12, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported financial results for the quarter ended March 31, 2026, and provided an operational update.

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!

"The first quarter marked an important strategic inflection point for TriSalus as we significantly strengthened our commercial infrastructure, expanded the clinical evidence supporting PEDD, and continued advancing our next-generation platform opportunities," said Mary Szela, President and Chief Executive Officer of TriSalus. "We are increasingly demonstrating that PEDD is not simply a device, but a differentiated therapeutic delivery platform capable of improving procedural outcomes, reducing healthcare utilization, and expanding treatment possibilities across multiple indications.

During and subsequent to the quarter, we added meaningful new clinical evidence supporting PEDD across liver embolization therapy for liver cancer, and other new embolization applications, including one of the largest real-world analyses ever conducted in interventional oncology. At the same time, we substantially completed the commercial expansion initiatives designed to support our next phase of growth and broader market penetration.

Our updated revenue outlook reflects the lower Q1 revenue from the commercial expansion and the delayed FDA clearance timing for TriNav Advance, our next-generation device which extends PEDD capability to small distal vessels via microcatheter. We continue to believe the long-term growth opportunity for the PEDD platform remains substantial."

Highlights for First Quarter 2026 and Recent Weeks

Reported publication of Real World PEDD Study of more than 16,800 patients (603 PEDD patients matched against 16,210 non-PEDD patients) published in Journal of Comparative Effectiveness Research, which found PEDD technology was associated with fewer post-procedure complications, reduced hospitalizations, and approximately $7,700 in per-patient charge avoidance despite PEDD patients having greater baseline clinical complexity.
Presented new clinical and preclinical data at the 2026 Society of Interventional Radiology Annual Scientific Meeting including a preclinical study showing enhanced hepatic tumor penetration during embolic sphere delivery, a clinical analysis of embolization in neuroendocrine tumor liver metastases before and after PEDD, and a clinical assessment of safety and efficacy in uterine artery embolization, further expanding the body of evidence supporting PEDD across multiple applications.
Reported publication of preclinical research in Frontiers in Oncology demonstrating enhanced delivery and immune activation with nelitolimod delivered with PEDD in liver tumor models.
Completed a public offering during the quarter, further strengthening the balance sheet with $46 million in gross proceeds and supporting the Company’s planned commercial expansion initiatives designed to support long-term growth and broader market opportunity.
Appointed veteran healthcare investor Michael P. Stansky to the Board of Directors in February 2026.
Announced the appointment of Richard Marshall, M.D., as Chief Medical Officer effective June 29, 2026.
Financial Results for Q1 2026

Revenue from the sale of the TriNav system, was $8.9 million for the three months ended March 31, 2026, a decrease of 2.9% compared to the same period in 2025. The decrease in revenue was primarily due to the Company’s commercial expansion.
Gross margins were 86.2% for the three months ended March 31, 2026, compared to 83.7% for the same period in 2025. The year-over-year increase in gross margin was primarily due to lower average cost per TriNav unit.
Operating losses were $8.4 million for the three months ended March 31, 2026, compared to losses of $7.3 million for the same period in 2025. The increase in operating losses was primarily driven by higher sales and marketing expenses related to our commercial expansion and an increase in non-cash stock-based compensation expense, partially offset by improved gross margins.
Net income available to common stockholders was $1.5 million for three months ended March 31, 2026, compared to a net loss of $11.1 million for the same period in 2025. The current period includes $11.3 million of non-cash gains related to changes in the fair value of various derivatives for the three months ended March 31, 2026, compared to losses of $1.7 million for the same period in 2025. The basic and diluted earnings (loss) per share for three months ended March 31, 2026, was $0.03, compared to $(0.39) for the same period in 2025.
The non-GAAP measure of adjusted EBITDA is shown in the table below as the Company believes it is an important measure of performance. Adjusted EBITDA losses were $5.8 million for the three months ended March 31, 2026, compared to losses of $5.5 million for the same period in 2025. The increase in adjusted EBITDA losses were primarily driven by higher stock-based compensation and increased operating expenses.
On March 31, 2026, cash and cash equivalents totaled $56.6 million. The Company raised $46.0 million in gross proceeds in the first quarter from an equity offering. The Company believes that these proceeds provide sufficient cash runway to fully fund commercial expansion and pipeline development.
Conference Call & Webcast

The Company will host a conference call and webcast today at 4:30 PM eastern time to discuss its financial results for the quarter ended March 31, 2026. Parties interested in participating by phone should register using the online form on our investor relations website. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin. The event will also be webcast live on the investor relations section of TriSalus’ website. A replay will also be available on the website following the event.

(Press release, TriSalus Life Sciences, MAY 12, 2026, View Source [SID1234665575])

SkylineDx to Showcase New Cutaneous Squamous Cell Carcinoma Findings at 83rd Society for Investigative Dermatology Annual Meeting

On May 12, 2026 SkylineDx, an innovative company specializing in molecular diagnostics for dermatology, reported data from two oral and one e-poster presentation, focusing on CSCC, at the 83rd Society for Investigative Dermatology Annual Meeting, taking place May 13-16, in Chicago. The presentations will showcase findings from a comprehensive genomic and transcriptomic characterization of CSCC, including driver mutations and genetic alterations in HLA class I genes, and a new gene expression signature associated with metastatic risk.

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!

CSCC is the second most common form of skin cancer worldwide1, and while most tumors are not life-threatening, 2-5% of patients develop metastases². A major unmet clinical need is to identify this subset of patients who will eventually develop metastatic disease. Achieving this has been challenging because CSCC is not included in most cancer registries and was left out of large-scale consortia projects. Within the framework of an international collaboration of top research institutions, the Erasmus Medical Center, Rotterdam, the University of California, San Francisco, and SkylineDx sought to characterize the genomic and transcriptomic drivers of CSCC metastasis to inform future development in clinical settings.

Oral Presentations:

"Comprehensive genomic characterization of cutaneous squamous cell carcinoma"

To better understand what causes some CSCCs to progress to metastatic disease, four national databases in the Netherlands were integrated to assemble a cohort of clinically annotated tumors linked to outcome. RNA-sequencing was performed on 366 tumors, and whole-exome sequencing was performed on 147 tumors. Findings provide a new, more detailed molecular picture of CSCC and identify which biomarkers can be associated with poor prognosis – providing better insights into tumor biology.

"Genetic alterations of HLA class I genes in cutaneous squamous cell carcinoma"

CSCCs exhibit high mutation burden and are highly immunogenic; however, mutations affecting antigen presentation have not been systematically characterized. To address this knowledge gap, the role of germline HLA diversity in cancer susceptibility was first examined. Next, it was investigated whether HLA genes are also subject to somatic selection during CSCC tumorigenesis. The findings suggest that a reduced baseline capacity for antigen presentation, inherited by germline HLA alleles, and/or the acquired loss of antigen presentation, through somatic alterations, promote keratinocyte carcinogenesis.

E-Poster:

"Gene expression predicts metastatic risk in low-risk cutaneous squamous cell carcinoma."

SCCore GEP, a novel gene expression signature for CSCC, addresses the need for improved metastatic risk stratification, as more than one-third of metastases occur in patients initially classified as "low risk" (T1, T2a), which represents 90% of patients. This SCCore GEP gene expression signature may enable more precise risk stratification by revealing biological risk factors that extend beyond traditional clinical and pathological features as represented by the staging systems.

"The Cancer Genome Atlas and other large-scale sequencing consortia overlooked CSCC, despite it being one of the most common forms of cancer Worldwide. Our study is the largest omics characterization of CSCC to date, which will serve as a major resource to the research community," said Hunter Shain, Associate Professor, Department of Dermatology and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco. "Already, we have discovered promising biomarkers that complement and/or outperform established staging systems. I look forward to seeing how else this rich dataset will foster discovery in this historically neglected area of cancer research."

"CSCC patients stand to benefit from an improved risk stratification that can identify those at highest risk of poor outcomes, such as metastasis3," said SkylineDx CEO Dharminder Chahal. "Building on our experience in melanoma, we are striving to develop molecular diagnostic solutions for CSCC that enhance currently available risk stratification measures such as staging systems and nomograms based on clinicopathological factors, to ultimately improve patient outcomes."

(Press release, SkylineDx, MAY 12, 2026, View Source [SID1234665574])

Compugen to Participate in 2026 Stifel Virtual Targeted Oncology Forum

On May 12, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI/ML, reported that management will present at the 2026 Stifel Virtual Targeted Oncology Forum. The presentation will take place on Tuesday, May 19, 2026, at 10:00-10:25 AM ET.

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!

A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, MAY 12, 2026, View Source [SID1234665573])