Molecular Partners presents three posters at AACR 2026, with new preclinical data for first Switch-DARPin T cell engager MP0632 and DLL3 Radio-DARPin MP0712

On April 19, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported the presentation of new preclinical data across three posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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 poster outlines preclinical data supporting proof-of-concept for MP0632, a logic-gated Switch-DARPin CD3 T cell engager with CD2 co-stimulation designed to selectively kill cells co-expressing mesothelin (MSLN) and epithelial cell adhesion molecule (EpCAM). MP0632 leads to regression of established tumors expressing both EpCAM and MSLN, with minimal impact on tumors expressing only one antigen, indicating a favorable therapeutic window. In addition, the Switch-DARPin candidate allowed for safe use of potent costimulation for efficient tumor cell killing with low cytokine release profile. The data support MP0632’s potential as clinical lead candidate for the treatment of ovarian cancer and other MSLN- and EpCAM-positive solid tumors.

"We are excited to present new data on MP0632, our first logic-gated T cell engager candidate leveraging our Switch-DARPin technology. We designed MP0632 to achieve potent yet safe tumor-localized immune activation through incorporation of CD2 costimulation and through unmasking of the CD3 binder upon binding to two co-expressed tumor antigens – MSLN and EpCAM. We are looking forward to advancing MP0632 and building on the strong preclinical data package, which indicates its potential to make a difference to cancer patients," said Martin Steegmaier, Ph.D., CSO of Molecular Partners.

The second poster presents a computational workflow to identify and prioritize tumor-associated antigen pairs for improved tumor-selectivity and safety in support of designing novel Switch-DARPin candidates, such as MP0632. This scalable, data-driven platform provides a strong foundation for the discovery of next-generation multispecific immunotherapies. This workflow could also be leveraged for the identification of complementary tumor antigen pairs to address heterogeneous tumors, which could enable the design of next-generation multispecific Radio-DARPin candidates.

The third poster outlines the molecular characteristics of MP0712, the Company’s first 212Pb-based Radio-DARPin candidate, with high affinity binding to DLL3 and optimized half-life extended properties. MP0712’s properties are hypothesized to facilitate sustained tumor uptake through repeated DLL3 internalization-replenishment despite low cell surface density of the target, thereby supporting the attractive biodistribution profile of MP0712 observed in preclinical studies as well as in first patient imaging data from a Named Patient Access Program in South Africa using MP0712 with 203Pb.

MP0712, co-developed with strategic partner Orano Med, is evaluated in an ongoing Phase 1/2a trial in the US for the treatment of patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers.

Details of the presentations at AACR (Free AACR Whitepaper) 2026:

Logic-gated Switch-DARPin T cell engager with CD2 co-stimulation for improved safety and efficacy in MSLN and EpCAM co-expressing ovarian cancer
Session Category: Immunology
Session Title: T Cell Engagers 1
Session Start: 4/20/2026 9:00 AM PT
Session End: 4/20/2026 12:00 PM PT
Location: Poster Section 10
Poster Board Number: 16
Poster Number: 1624

Logic-gated Switch-DARPin–based immune cell engagers guided by data-driven tumor-antigen profiling: A computational workflow for the development of cancer immunotherapies
Session Category: Bioinformatics / Computational Biology / Systems Biology / Convergent Science
Session Title: Application of Bioinformatics to Cancer Biology 3
Session Start: 4/20/2026 2:00 PM PT
Session End: 4/20/2026 5:00 PM PT
Location: Poster Section 1
Poster Board Number: 16
Poster Number: 2691

Molecular characteristics of MP0712, a clinical stage ²¹²Pb-based Radio-DARPin candidate for targeted anti-DLL3 radiotherapy of small cell lung cancer (SCLC)
Session Category: Experimental and Molecular Therapeutics
Session Title: Targeted Radiopharmaceuticals and Combination Strategies in Cancer Therapy
Session Start: 4/22/2026 9:00 AM PT
Session End: 4/22/2026 12:00 PM PT
Location: Poster Section 17
Poster Board Number: 16
Poster Number: 7197

The posters will be made available on Molecular Partners’ website after the presentations.

(Press release, Molecular Partners, APR 19, 2026, View Source [SID1234664521])

Sutro Biopharma Presents Promising Preclinical Data Across its Pipeline of Next-Generation Single and Dual-Payload ADC Programs at AACR 2026

On April 19, 2026 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported promising preclinical data across its pipeline of next- generation ADCs in five posters and one oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Of note, results from a preclinical study of STRO-004, its DAR8 Topo1 ADC targeting Tissue Factor (TF), were reviewed today in an oral presentation titled "STRO-004, an exatecan-based next-generation tissue factor (TF)-targeted ADC, demonstrates superior efficacy across TF-expressing solid tumors in a comprehensive single-mouse PDX trial."

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!

In the preclinical study, STRO-004 demonstrated robust and consistent antitumor activity across a broad range of TF-expressing solid tumor patient-derived xenograft (PDX) models, with improved efficacy compared to benchmark ADCs. At a single, clinically relevant dose of 5 mg/kg, STRO-004 achieved remarkable disease control and tumor reduction across multiple tumor types. STRO-004’s favorable tolerability, with a highest non-severely toxic dose (HNSTD) of 50 mg/kg, and pharmacokinetic profile are expected to enable increased drug exposure and payload delivery, supporting the Company’s belief that STRO-004 will demonstrate superior depth and durability of response in the clinic. Exploratory biomarker analyses provide preliminary insight into STRO-004’s mechanism of action, suggesting potential for combination studies addressing specific indications in either early or late lines of treatment.

"The STRO-004 preclinical data presented today underscore the potential of our next-generation ADCs to drive meaningful activity across multiple solid tumors," said Jane Chung, Sutro’s Chief Executive Officer. "As STRO-004 advances in the clinic – with initial results from our Phase 1 study expected in mid-2026 – these preclinical data further strengthen our confidence in its potential across indications. More broadly, they underscore the versatility of our platform to generate differentiated ADCs across many targets and payloads, supporting a pipeline designed to address significant unmet need in cancer."

In addition to the oral presentation, Sutro will present multiple posters highlighting advances across its ADC pipeline and discovery platforms, the full details of which are included below.

Select Poster Highlights:

Preclinical data for STRO-006, an integrin β6-targeting ADC (DAR 8 exatecan), demonstrated robust, dose-dependent antitumor activity across multiple solid tumor models at a single, clinically relevant dose of 5 mg/kg, including non-small cell lung cancer (NSCLC) and head and neck cancers. The program also shows a favorable pharmacokinetic and tolerability profile, supporting its potential as a differentiated next-generation ADC with IND submission planned for 2026.
Preclinical data for STRO-227, a PTK7-targeting dual-payload ADC (DAR 10; 8 exatecan + 2 MMAE), demonstrated robust, dose-dependent antitumor activity across multiple solid tumor models, including breast, ovarian and NSCLC, with improved efficacy versus single-payload ADCs. The program also shows favorable pharmacokinetics, stable payload delivery, and tolerability comparable to benchmark ADCs, supporting the potential of its dual-payload design. These findings position STRO-227 as a differentiated ADC with broad applicability across solid tumors. Sutro expects to file an IND for STRO-227, its first wholly-owned dual-payload ADC, in late 2026.

Full Poster Presentation Details:

Poster: "Phase 1 open-label study to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 in adults with refractory/recurrent metastatic solid tumors"
Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
Poster: "STRO-006: An Integrin beta-6–targeting ADC demonstrates favorable safety profile and potent antitumor activity in preclinical solid tumors"
Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
Poster: "Preclinical characterization of STRO-227: A PTK7-targeting dual-payload ADC with topoisomerase 1 and tubulin inhibitors"
Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
Poster: "The HER2-targeting dual-payload antibody-drug conjugate combining a topoisomerase I inhibitor and a microtubule inhibitor demonstrates superior efficacy and overcomes resistance to single-payload ADCs in xenograft models"
Session Date and Time: Monday, April 20, 2026; 9:00 AM-12:00 PM PT
Poster: "Sutro’s Site-Specific Dual-Payload ADCs Combining TOPO1i and DNA Damage Response Inhibitors to Enhance Efficacy, Overcome Resistance, and Improve Safety"
Session Date and Time: Tuesday, April 21, 2026; 9:00 AM-12:00 PM PT

In addition to these presentations, Sutro’s strategic partner, Astellas Pharma, also reviewed preclinical results from its TROP2-targeted iADC program at AACR (Free AACR Whitepaper) today. The oral presentation, titled "ASP2998, a TROP2-targeted immunostimulatory antibody-drug conjugate (iADC) with dual payloads, demonstrates potent efficacy and a favorable safety profile in nonclinical models," highlighted the company’s progress in the development of next-generation iADCs leveraging Sutro’s cell-free protein synthesis platform. ASP2998 is a first-in-class iADC that combines cytotoxic and immune-stimulatory mechanisms to enhance antitumor efficacy. Inclusion of a STING agonist augments the antitumor efficacy, immune activation and durable tumor immunity of ASP2998, supporting its superior activity over toxin-only anti-TROP2 ADCs. Preclinically, ASP2998 demonstrated a favorable safety profile, supporting a promising therapeutic index. ASP2998 entered the clinic earlier this year and is actively dosing patients.

Following the congress, the Company’s presentations will be made available in the Scientific Publications section of Sutro Biopharma’s website at www.sutrobio.com.

(Press release, Sutro Biopharma, APR 19, 2026, View Source [SID1234664520])

Revolution Medicines to Present Updated Phase 1 Clinical Data for Zoldonrasib in Patients with Previously Treated KRAS G12D Non-Small Cell Lung Cancer at the 2026 AACR Annual Meeting

On April 19, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC). Results were highlighted in the official press program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and will be featured in a plenary oral presentation today, April 19, 2026, at 1:30 p.m. PDT.

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!

"Patients with RAS G12D non-small cell lung cancer remain a population with a significant unmet medical need for targeted therapeutic options," said Jonathan Riess M.D., medical director of thoracic oncology at UC Davis Comprehensive Cancer Center and principal investigator for the RMC-9805-001 trial. "The manageable safety profile and evidence of clinical activity in this Phase 1 trial are encouraging and support the continued clinical development of zoldonrasib."

"We believe these updated data further strengthen the profile of zoldonrasib as a potentially important targeted therapy for patients with RAS G12D non-small cell lung cancer where historical treatment options, such as chemotherapy, have offered limited benefit, and are often associated with considerable toxicity," said Alan Sandler, M.D., chief development officer of Revolution Medicines. "The emerging profile supports advancing zoldonrasib across monotherapy and combination settings in lung cancer and other RAS G12D-driven cancers."

Summary of Phase 1 Zoldonrasib Data at AACR (Free AACR Whitepaper) 2026 (Abstract # CT021)

RMC-9805-001 is a multicenter, open-label, dose escalation and dose expansion Phase 1 trial designed to evaluate zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation. The data to be presented at the AACR (Free AACR Whitepaper) Annual Meeting are as of a December 1, 2025 data cutoff, and included 40 patients with KRAS G12D NSCLC treated with zoldonrasib 1200 mg once daily, the recommended Phase 2 dose, and who were evaluable for safety. Efficacy analyses were conducted in a subset of patients with prior immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel treatment who had sufficient follow-up for response assessment (n=27).

Zoldonrasib was generally well tolerated and demonstrated a safety profile consistent with previously reported findings. Treatment-related adverse events (TRAEs) of any grade occurring in at least 15% of patients were nausea (43%), vomiting (33%), diarrhea (30%), and rash (18%). The majority of TRAEs were Grade 1 in severity. Grade 3 TRAEs occurred in 13% of patients and resolved following dose interruption; TRAEs led to treatment discontinuation in 5% of patients. No Grade 4 or Grade 5 TRAEs were observed. Zoldonrasib demonstrated a favorable mean dose intensity of 94%.

Zoldonrasib demonstrated encouraging clinical activity in patients with KRAS G12D NSCLC previously treated with immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel. Among this subset of patients (n=27), the confirmed objective response rate was 52% (confidence interval (CI): 32, 71) and the disease control rate was 93% (CI: 76, 99). Median time to response was 1.4 months and median duration of response was not yet estimable (95% CI: 8.3, not estimable). Median progression-free survival (PFS) was 11.1 months (95% CI: 5.3, not estimable), with an estimated 12-month PFS rate of 48% (95% CI: 27, 66). Overall survival (OS) data were immature at the time of analysis, and median OS was not yet reached with median potential follow-up of 13.1 months (range: 9.1–19.9). Estimated survival rate at 12 months was 73% (95% CI: 52, 86), suggesting encouraging early survival outcomes.

About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. KRAS G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.3

About Zoldonrasib
Zoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. KRAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers, and currently lacks an approved targeted therapy.4 Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the United States.5 Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.

(Press release, Revolution Medicines, APR 19, 2026, View Source [SID1234664519])

Pliant Therapeutics Announces Presentation of Updated Data from the Phase 1 Trial of PLN-101095 in Patients with ICI-Refractory Solid Tumors at the 2026 AACR Annual Meeting

On April 18, 2026 Pliant Therapeutics, Inc. (Nasdaq: PLRX) reported the presentation of updated data from its Phase 1 trial of PLN-101095, in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. The oral presentation was made at the Clinical Trials Mini Symposium of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting.

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!

Timothy A. Yap, MBBS, Ph.D., Medical Oncologist and Physician-Scientist at the University of Texas MD Anderson Cancer Center, presented results from the dose escalation portion of the ongoing Phase 1a/1b trial covering data as of February 27, 2026. Results showed that in the heavily pretreated ICI-secondary refractory patient subgroup, twice daily (BID) treatment with PLN-101095 at the highest doses in combination with the ICI pembrolizumab showed antitumor activity. One confirmed overall complete response, two confirmed overall partial responses, including one patient with a complete response of baseline target lesions, and one unconfirmed partial response were reported in patients with cholangiocarcinoma, non-small cell lung cancer (NSCLC), melanoma and head and neck squamous cell carcinoma, respectively. As of the data cutoff date, the median time on treatment for the three confirmed responders was 19 months, who experienced an average baseline target tumor reduction of 89%.

All responding patients showed large increases (4- to 13-fold vs. baseline) in plasma interferon gamma (IFN-γ) after a 14-day run-in period of monotherapy with PLN-101095. At Week 10, all responders maintained more than a 2-fold increase in IFN-γ. No non-responders showed meaningful increases in IFN- γ. In addition to IFN- γ increases, all responding patients showed elevated plasma PD-L1 levels, known to be induced by increased IFN-γ and a predictor of an improved ICI response. As increases in IFN-γ have the potential to serve as a biomarker of TGF-β inhibition and an early indicator of PLN-101095 anti-tumor activity. Pliant anticipates further study of this biomarker as part of the expansion cohorts in the Phase 1b trial.

PLN-101095 was generally well tolerated across all doses evaluated with few discontinuations (n=2) due to adverse events. Rash was the most common treatment-related adverse event (TRAE), all Grade 1 or 2, and the majority of events occurred within the first 2 days of the initial pembrolizumab dose. One Grade 3 TRAE was observed.

PLN-101095 demonstrated a dose-ordered exposure at Day 14 with doses ≥1000 mg BID achieving sustained IC90 coverage and all participants dosed at ≥1000 mg BID maintaining IC75 coverage over 24 hours. These results support the consistent target engagement of PLN-101095.

Sixteen patients with ten different tumor types, including both primary and secondary refractory patients, were enrolled in five dose cohorts. Patients were treated for 14 days with PLN-101095 monotherapy administered orally at doses of 250 mg twice a day (BID) (n=1), 500 mg BID (n=2), 1000 mg BID (n=6), 1000 mg three times a day (TID) (n=4) or 2000 mg BID (n=3), followed by the addition of pembrolizumab at 200 mg administered intravenously every three weeks until disease progression. Scans were conducted at baseline, Day 14, Week 10, and every 8 weeks thereafter.

Dr. Yap commented "One of the ways that the tumor microenvironment can suppress responses to immune checkpoint inhibitors is through a process that is activated by integrins to upregulate TGF-β. PLN-101095 is designed to inhibit the integrins before they can ever do that, which gives it significant potential to stimulate or reinvigorate the immune response to cancer. These clinical trial data, for the combination of PLN-101095 and pembrolizumab in patients with secondary immune checkpoint inhibitor resistance, show the potential to meet a high unmet therapeutic need."

"These encouraging results show a deepening of baseline tumor reductions in confirmed responders and an increased median time on treatment with PLN-101095 in patients with difficult-to-treat ICI refractory tumors," said Bernard Coulie, M.D., PhD., Chief Executive Officer of Pliant. "We have initiated the Phase 1b trial to expand this novel combination therapy in specific tumor types to address patients in need and deliver value to our investors."

Slides accompanying these data can be found here and under the Investors & Media page of Pliant’s website at www.PliantRx.com.

PLN-101095 Phase 1b Indication Expansion Trial

Pliant has initiated a Phase 1b open-label indication expansion trial enrolling three cohorts of patients with NSCLC, tumors with high tumor mutational burden or clear cell renal cell carcinoma. Patients will be treated for 14 days with PLN-101095 dosed at 1,000 mg twice daily as monotherapy, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

PLN-101095 for the Treatment of Checkpoint Resistant Tumors

PLN-101095 is an oral, small molecule inhibitor of integrins αvβ8 and αvβ1. PLN-101095 is being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. Activated transforming growth factor-β (TGF-β) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has been shown to prevent the activation of TGF-β and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration.

(Press release, Pliant Therapeutics, APR 18, 2026, View Source [SID1234664529])

Moderna to Present Phase 1/2 Data on Its Investigational Cancer Antigen Therapy mRNA-4359 as First-Line Therapy in Combination with Pembrolizumab in Locally Advanced or Metastatic Melanoma at the 2026 AACR Annual Meeting

On April 18, 2026 Moderna, Inc. (NASDAQ:MRNA) reported that the Company will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, CA, on April 17-22, 2026. The presentation reports safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study (NCT05533697), which evaluated mRNA-4359 + pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma.

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!

Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate (ORR) of 83% (95% CI: 52%-98%), with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate (DCR) of 92% (95% CI: 62%-100%). The median time to response was six weeks (range, 5.6-24.0). Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% (95%CI: 47%-100%) among patients with PD-L1+ (TPS≥1%) tumors, and 67% (95%CI: 9%-99%) among patients with PD-L1- (TPS<1%) tumors. Consistent with mRNA-4359’s mechanistic rationale, antigen-specific T-cell responses and novel expanded T-cell receptor (TCR) clonality was observed in all patients (n=7) with evaluable samples. mRNA-4359 + pembrolizumab demonstrated a manageable safety profile, with no new immune-related adverse events (AEs).

"This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient’s journey. While conducted among a small patient population, we are encouraged by the high response rates and mechanistic translational results," said David Berman, M.D., Ph.D., Chief Development Officer of Moderna. "We look forward to further evaluating the potential of mRNA-4359 in patients with melanoma."

"This early data supports the potential activity of the mRNA-4359 + pembrolizumab combination, with promising anti-tumor activity," Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, the abstract’s lead author and presenter. "The consistent activation of antigen-specific T-cell responses provides important early evidence that mRNA technology could be used to help direct the immune system against melanoma in a multi-targeted manner."

This presentation builds on promising early data presented at the 2025 European Society for Medical Oncology Congress, in which mRNA-4359 + pembrolizumab achieved an ORR of 24% and DCR of 60% among 29 evaluable patients with checkpoint inhibitor-resistant/refractory (CPI-R/R) melanoma. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67%.

The U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of CPI refractory unresectable or metastatic melanoma with PD-L1+ (TPS>1%). Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and that fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The details of the presentation are as follows:

Abstract Presentation #CT106: First-Line mRNA-4359 Plus Pembrolizumab (Pembro) in Locally Advanced or Metastatic Melanoma: Results from the Phase 1/2 mRNA-4359-P101 Study

Session Title: Clinical Trials Plenary 3: Cellular Therapies and Complex Immunotherapies

Session Date/Time: Monday, April 20, 10:15AM – 12:15PM PT

Presenter: Dr. Pavlina Spiliopoulou, School of Cancer Sciences, University of Glasgow, UK

About mRNA-4359

mRNA-4359 is an investigational, immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it is designed to elicit antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

(Press release, Moderna Therapeutics, APR 18, 2026, https://feeds.issuerdirect.com/news-release.html?newsid=8054079664924385&symbol=MRNA [SID1234664479])