Marengo Reports Late-Breaking Initial Phase 2 Clinical Results from Invikafusp Alfa Plus TRODELVY® and Unveils Partnered Novel IPN01203/STAR0501 STAR Program in Phase 1 at AACR 2026

On April 17, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported multiple presentations that highlight clear progress for key assets at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 17-22, 2026 in San Diego, CA.

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Findings to be shared include late-breaking interim Phase 2a clinical results from Marengo’s ongoing STARt-002 Phase 1b/2a trial of invikafusp alfa plus TRODELVY as part of a collaboration with Gilead Sciences and the first public disclosure of its second precision T cell activator from the STAR program, IPN01203/STAR0501, being advanced in partnership with Ipsen in the prestigious New Drugs on the Horizon session.

"Combining invikafusp alfa with ADC-mediated immunogenic tumor killing is a scientifically compelling approach, and it is exciting to see this translate into meaningful clinical responses in patients with metastatic breast cancer," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "The observation of confirmed complete responses in heavily pretreated breast cancer patients that did not respond to any prior therapy further reinforces our confidence in this novel combination. As enrollment progresses rapidly, we look forward to reporting additional data that both validate our platform and potentially offer a critical new treatment option in a disease with high unmet need."

The initial Phase 2a data build on results presented at the 2025 San Antonio Breast Cancer Symposium, demonstrating encouraging clinical activity with invikafusp alfa plus TRODELVY (sacituzumab govitecan-hziy) in heavily pretreated metastatic breast cancer patients, including confirmed complete responses, across both metastatic triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer.

To date, invikafusp alfa with TRODELVY has shown a safety profile consistent with the known profiles of the individual agents. Pharmacodynamic analyses further confirmed that invikafusp alfa maintains its mechanism of action in a combination regimen, driving robust and selective expansion of Vβ6/Vβ10 T cells. The STARt-002 Phase 1b/2a trial is actively enrolling patients at select cancer centers across North America, with enrollment expected to be completed later this year.

"In a heavily pretreated metastatic breast cancer population, the observation of confirmed complete responses is notable and warrants attention," said Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research. "While these are early data, the activity observed across both TNBC and HR+/HER2− subtypes, along with a safety profile consistent with the individual agents, supports further clinical evaluation of this combination."

In parallel, Marengo will highlight the continued advancement of the STAR platform through its collaboration with Ipsen. The next clinical candidate, IPN01203/STAR0501, has been selected for an oral presentation during the New Drugs on the Horizon session.

"Together with Marengo, we are advancing a novel precision T cell activation approach with the potential to transform treatment paradigms in solid tumors," said David Jenkins, Senior Vice President, Head of Research and External Innovation at Ipsen. "The rapid progression of this program into the clinic underscores the strength of our collaboration and the quality of scientific execution, and we look forward to exploring its clinical potential."

"We are excited to see the second STAR program advance into the clinic with Ipsen and to share these important data with the scientific community," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "This milestone reflects both the strength of our platform and the productivity of our collaboration as we work together to bring novel immunotherapies to patients with solid tumors."

Additional presentation details are as follows:

Presentation: Initial clinical and translational results and selection of recommended phase 2 dose (RP2D) from START-002: A Phase 1b/2 study of invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in metastatic triple-negative or HR+/HER2- breast cancer
Abstract Number: LBA045 / 5

Session: First-in-Human Phase I Clinical Trials

Date/Time: Monday April 20, 9:00 AM – 12:00 PM PT

Presentation: Development of IPN01203, a dual T cell agonist activating Vβ6/Vβ10 TCR-expressing T cells
Abstract Number: ND12

Session: New Drugs on the Horizon: Part 3

Date/Time: Monday, April 20, 10:15 AM – 11:45 AM PT

(Press release, Marengo Therapeutics, APR 17, 2026, View Source [SID1234664486])

Ensem Therapeutics Highlights Novel, Potent, and Selective Oral pan-KRAS and WRN Inhibitors with Best-in-Class Potential

On April 17, 2026 Ensem Therapeutics, Inc. (ENSEM), a clinical-stage, oncology-focused biopharmaceutical company, reported presentations of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 17–22 in San Diego, CA. The data support the differentiated preclinical profiles of ETX-929, a pan-KRAS inhibitor for the treatment of KRAS-altered solid tumors, and ETX-880, a covalent WRN inhibitor for the treatment of microsatellite instability-high (MSI-H) solid tumors.

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"These AACR (Free AACR Whitepaper) presentations underscore the breadth and depth of ENSEM’s oncology pipeline, fueled by our proprietary Kinetic Ensemble platform," said Shengfang Jin, PhD, Co-Founder, President, and Chief Executive Officer of ENSEM. "With ETX-929 and ETX-880, we are advancing potential best-in-class small molecule inhibitors against two of the most compelling targets in oncology today—KRAS and WRN. These programs, alongside our clinical-stage PI3Kα program ETX-636, demonstrate the power of our platform to systematically tackle high-value, difficult-to-drug targets with differentiated molecules."

AACR Presentation Details

Details of the presentations are as follows:

ETX-929 (Pan-KRAS Inhibitor)

Title: ETX-929, a potential best-In-class, oral, highly potent and selective dual ON / OFF state Pan-KRAS small molecule inhibitor for the treatment of KRAS mutant and wild-type amplified cancers
Poster ID: 418
Session: Novel Antitumor Agents 1
Date/Time: 4/19/2026 2PM – 5PM PT
Location: Poster Section 17, Poster Board Number: 21
ETX-880 (Covalent WRN Inhibitor)

Title: ETX-880, a potential best-in-class, oral, highly potent and selective covalent inhibitor of Werner helicase for the treatment of microsatellite instability-high (MSI-H) cancers
Poster ID: 423
Session: Novel Antitumor Agents 1
Date/Time: 4/19/2026 2PM – 5PM PT
Location: Poster Section 17, Poster Board Number: 26
About ETX-929

ETX-929 is a potent and selective oral pan-KRAS inhibitor designed leveraging ENSEM’s proprietary Kinetic Ensemble platform. ETX-929 inhibits multiple KRAS-mutant variants, including KRASG12D, KRASG12V, KRASG12C, and other clinically relevant mutations, in both the active (GTP-bound/ON) and inactive (GDP-bound/OFF) states. KRAS is the most frequently mutated oncogene in human cancers, driving approximately 25% of all solid tumors, including pancreatic, colorectal, and non-small cell lung cancers. Despite recent advances in allele-specific KRAS inhibitors, there remains a significant unmet need for pan-KRAS therapeutics that can address the full spectrum of KRAS-driven cancers. ETX-929 has demonstrated potent anti-tumor activity in preclinical models and has completed IND-enabling studies with anticipated IND clearance in Q2 2026.

About ETX-880

ETX-880 is a covalent, potent, oral inhibitor of Werner syndrome ATP-dependent helicase (WRN) designed leveraging ENSEM’s Kinetic Ensemble platform. WRN helicase has emerged as a compelling synthetic lethal target in microsatellite instability-high (MSI-H) cancers. MSI-H tumors arise from defects in the DNA mismatch repair pathway and are found across multiple tumor types, including colorectal, endometrial, gastric, and ovarian cancers. While immune checkpoint inhibitors have demonstrated clinical benefit in MSI-H cancers, 40–70% of patients either do not respond or eventually develop resistance, underscoring the need for novel therapeutic approaches. ETX-880’s covalent binding mechanism is designed to deliver deep and sustained WRN inhibition, and the compound has demonstrated selective anti-proliferative activity against MSI-H cancers in preclinical studies. ETX-880 is currently at the IND-enabling stage.

(Press release, ENSEM Therapeutics, APR 17, 2026, View Source [SID1234664502])

Enveric Biosciences Announces Closing of Up To $13.9 Million Private Placement Priced At-The-Market Under Nasdaq Rules

On April 17, 2026 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, reported the closing of its previously announced private placement priced at-the-market under Nasdaq rules for the purchase and sale of 2,222,223 shares of its common stock (or pre-funded warrants in lieu thereof), Series I warrants to purchase up to an aggregate of 2,222,223 shares of common stock and short-term Series J warrants to purchase up to an aggregate of 2,222,223 shares of common stock, at a purchase price of $2.25 per share (or pre-funded warrant in lieu thereof) and accompanying warrants. The warrants have an exercise price of $2.00 per share and are exercisable immediately upon issuance. The Series I warrants will expire five years after the effective date of the Resale Registration Statement (as defined below) and the short-term Series J warrants will expire eighteen months after the effective date of the Resale Registration Statement.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $5 million before deducting placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series I warrants and the short-term Series J warrants, if fully exercised on a cash basis, will be approximately $8.9 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The Company intends to use the net proceeds from the offering for product development, working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Securities Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering (the "Resale Registration Statement").

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

(Press release, Enveric Biosciences, APR 17, 2026, View Source [SID1234664518])

INNATE PHARMA TO PRESENT MATISSE PHASE 2 INTERIM RESULTS
OF IPH5201 IN CLINICAL TRIALS PLENARY SESSION AT AACR 2026

On April 17, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company"), reported that interim results from the MATISSE Phase 2 study evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in resectable non-small cell lung cancer (NSCLC) will be presented in one of the Clinical Trials Plenary Sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22, 2026 in San Diego, California.

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The MATISSE study (NCT05742607) is a single arm Phase 2 clinical trial evaluating perioperative IPH5201, an anti-CD39 blocking antibody, in combination with perioperative durvalumab (anti-PD-L1) in addition to neoadjuvant platinum-based chemotherapy in previously untreated patients with resectable NSCLC. The trial is designed to assess whether dual inhibition of the CD39 and PD-L1 pathways, together with chemotherapy, can enhance anti-tumor immune responses and improve clinical outcomes in early-stage lung cancer.

These results follow a pre-planned interim analysis on 40 patients. The combination of IPH5201 with durvalumab and chemotherapy demonstrated higher pathological complete response (pCR) rates compared with the benchmark set by durvalumab plus chemotherapy alone. Notably, pCR was 35.7% and 50% in patients with tumors expressing PD-L1 ≥1% and PD-L1 ≥50%, respectively. Based on these results, the study continues to recruit patients with tumors expressing PD-L1≥1%.

"Patients with resectable NSCLC remain at significant risk of recurrence, underscoring the need for novel perioperative treatment strategies. Disrupting the adenosine pathway through CD39 inhibition with IPH5201, in combination with PD-1 blockade and chemotherapy, could enhance anti-tumor immune responses—particularly in patients with PD-L1 positive tumors, where we observed up to 50% pCR rate in the MATISSE trial. This signal will be further investigated as we complete enrollment of the study in the PD-L1-positive population," commented Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma.

The presentation will be available in the publication section of Innate Pharma’s website.

Abstract details
Dual CD39 and PD-L1 inhibition: Interim results from the Phase 2 MATISSE trial of IPH5201 plus durvalumab and platinum-based chemotherapy in patients with resectable NSCLC
Abstract Code: CT231
Session: CTPL04 – Advances in Immunotherapy
Session Date/Time: Tuesday, April 21, 2026, 10:45 – 11:00 AM PDT
Presenter: Pr. Fabrice Barlesi, CEO of Institut Gustave Roussy

About IPH5201
IPH5201 is a first-in-class monoclonal antibody targeting CD39, a key immunosuppressive enzyme in the adenosine pathway. CD39 is expressed on tumor-infiltrating immune and stromal cells and contributes to immunosuppression by degrading extracellular adenosine triphosphate (ATP) into adenosine monophosphate (AMP), which is then further degraded into adenosine by CD73. By blocking CD39, IPH5201 promotes the accumulation of immunostimulatory ATP and reduces the production of immunosuppressive adenosine, thereby enhancing anti-tumor immune responses.
IPH5201 is being co-developed in collaboration with AstraZeneca and is currently being evaluated in the Phase 2 MATISSE trial (NCT05742607), a multicenter study investigating perioperative treatment with IPH5201 in combination with durvalumab (anti-PD-L1) and platinum-based chemotherapy in patients with resectable non-small cell lung cancer (NSCLC).
The MATISSE trial is designed to assess anti-tumor activity, including pathological complete response, and safety, with the goal of determining whether dual inhibition of the CD39 and PD-L1 pathways, in combination with chemotherapy, can enhance anti-tumor immunity and improve clinical outcomes in early-stage NSCLC.

(Press release, Innate Pharma, APR 17, 2026, View Source [SID1234664471])

Ultima Genomics releases groundbreaking TRACERx MRD data showing ppmSeq performance and unveils clinical progress of whole genome sequencing at inaugural global MRD Symposium at AACR 2026

On April 17, 2026 Ultima Genomics, a developer of an innovative, ultra-high throughput sequencing architecture reported key milestones for its ppmSeq technology with a growing body of evidence from data presented across six abstracts, including an oral session and a plenary session at the 2026 AACR (Free AACR Whitepaper) Annual Meeting in San Diego, taking place April 17–22, 2026. Highlighting the program will be initial TRACERx MRD data showcasing the performance of ppmSeq relative to ultrasensitive bespoke panels. Data from collaborators, including LabCorp and DELFI Diagnostics, will also be presented at the conference. Collectively, these add to the growing body of evidence establishing ppmSeq as a new standard for ultrasensitive MRD, providing low single-digit parts-per-million sensitivity, with a simple, scalable, and distributable whole genome workflow that can be deployed globally.

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"We built ppmSeq to find tumor-derived molecules in a sea of normal DNA, without the need to produce a customized assay for every patient," said Gilad Almogy, Founder and CEO of Ultima Genomics. "The data presented at AACR (Free AACR Whitepaper) this week demonstrate these capabilities and point toward a future where whole-genome MRD is the standard of care for patients globally."

Ultima showcases low single-digit parts-per-million accuracy across tumor types to be shown at AACR (Free AACR Whitepaper) 2026

Today, Ultima is showcasing low single-digit parts-per-million levels of accuracy across tumor types, which include samples from the TRACERx (TRAcking Cancer Evolution through therapy (Rx)) cancer program, one of the largest tumor evolution studies funded by Cancer Research UK to generate deep sequencing multi-region and multi-time-point genetic data from over 3,200 tumor samples from over 800 lung cancer patients.

Led by Professor Charles Swanton (UCL / Cancer Research UK / The Francis Crick Institute), an early validation pilot of ppmSeq across 50 plasma samples — using tumor-specific variants identified from prior whole genome sequencing — achieved high analytical sensitivity for ctDNA detection at low single-digit parts-per-million, without the complexity of bespoke panel approaches. Results will be presented at a plenary and a late-breaking oral session during the conference.

"TRACERx has always followed the science of cancer evolution wherever it leads," said Charles Swanton, Deputy Clinical Director at The Francis Crick Institute. "Improving the sensitivity of ctDNA detection is central to the wider ambition for MRD monitoring, and expanding studies across a broader patient population will give us the statistical power and clinical context to determine how whole genome MRD monitoring can be deployed at NHS scale and beyond."

"The ability to perform personalized, tumor-guided ctDNA detection at parts-per-million sensitivity — without bespoke panel design and production — fundamentally changes what is achievable in lung cancer MRD monitoring," said Dan A. Landau, MD, PhD, a core member at the New York Genome Center, and Professor of Medicine & Professor of Physiology and Biophysics at Weill Cornell Medicine.

Additional work will assess prognostic performance at scale, and with the created dataset, explore tumor-agnostic MRD approaches that require no prior knowledge of a patient’s tumor mutational profile. Follow-up data will be presented later in 2026.

Other collaborators, including Labcorp and DELFI Diagnostics, to present data addressing clinical implementation of ppmSeq and enablement of new applications at AACR (Free AACR Whitepaper) 2026

In addition to the TRACERx data, important collaborators will showcase the clinical implementation and real-world deployment of ppmSeq whole genome sequencing, including:

Labcorp: Analytical performance of an ultrasensitive whole genome sequencing assay for molecular residual disease detection – Poster No. 5307/2

Labcorp will present data from an independent analytical study of an assay developed in coordination with ppmSeq technology, including the performance across multiple solid tumor types in pre-surgical, treatment-naive plasma samples. This analysis of 120 non-cancerous donor samples showed specificity exceeding 99.9%, underscoring the ability of ppmSeq whole genome sequencing to accurately differentiate between cancerous and non-cancerous samples, minimizing false positives. Additional analysis across three commercially available cancer cell lines spanning 13 concentration levels from 0.5 to 500 parts per million showed a 95% limit of detection below 3 ppm, demonstrating the assay’s capacity to detect ultra-low levels of circulating tumor DNA (ctDNA). Collectively, these results represent a significant milestone in the transition from research-grade performance to clinical-grade reliability.

"The whole genome approach enabled by ppmSeq changes the operational efficiency for tumor-informed MRD testing in a reference laboratory setting," said Taylor Jensen, Ph.D., Vice President and Head of Oncology Science at Labcorp. "Eliminating the need for individualized design and physical production of a panel while maintaining low single-digit parts-per-million analytical sensitivity is the kind of advancement that makes broad clinical deployment feasible, and the analytical data we are presenting at AACR (Free AACR Whitepaper) support a compelling case for WGS-based MRD as a scalable solution."

DELFI: Enhanced cfDNA fragmentation-based treatment monitoring on the Ultima Genomics platform – Abstract No. 3863/24

This study examined the performance of DELFI-TF, a cfDNA fragmentation-based tool for monitoring cancer treatment response, across Ultima vs Illumina platforms. Fragmentation profiles were consistent across platforms, and Ultima-based DELFI-TF values strongly tracked tumor burden and longitudinal treatment response. Notably, combining DELFI-TF with Ultima’s ppmSeq enabled distinction of tumor- from normal-derived DNA fragments, opening a path toward improved ctDNA detection sensitivity.

Labcorp: Utility of TAPS+: a positive-readout methylation sequencing approach for high-fidelity epigenetic profiling – Poster No. 3213/23

This study evaluated the TAPS+ workflow from Watchmaker Genomics on a 24-sample cohort of invasive breast carcinoma patients and healthy donors. TAPS+ demonstrated higher library yields, shorter turnaround times, and enabled the identification of more potentially relevant differentially methylated regions, in addition to a higher rate of DNA methylation observed in fully methylated control samples (88.8% vs. 76.8%). Importantly, TAPS+ libraries sequenced on the Ultima Genomics UG 100 platform showed equivalent methylation patterns, conversion efficiency, and transcription sites (TSS) profiles to those generated on an alternative sequencing platform, validating cross-platform reproducibility. Together, these results position TAPS+ with Ultima WGS as a robust, platform-agnostic epigenetic profiling method suitable for clinical assay development and early cancer detection.

Ultima announces inaugural global MRD Symposium focused on the current and future state of minimal residual disease detection technologies and utility in clinical practice

Prior to AACR (Free AACR Whitepaper), Ultima Genomics will co-host its inaugural global MRD symposium alongside Dan Landau and Charles Swanton. This exclusive event will bring together leaders in oncology research to discuss clinical adoption of MRD globally, and novel sequencing approaches that provide ultra-sensitive detection, and will feature a short series of selected presentations from key experts in the pharmaceutical, translational, and research fields.

Registration and details are available at: www.ultimagenomics.com/mrd-symposium

Summary of selected presentations at AACR (Free AACR Whitepaper):

Session

Presenters

Location/Time

Presentation Title

Discovery Science Plenary

Dan Landau

Weill Cornell Medicine

PLENARY

Sat. April 18

The Next Frontier in Minimal Residual Disease: Solid Tumors

Late-Breaking Poster Session: Clinical Research (LBPO.CL02)

Jonathan Wan
Francis Crick Institute

Section 52 LB116/3

Mon. April 20

Error-corrected plasma whole-genome sequencing for personalised and tumour-agnostic minimal residual disease detection in NSCLC

Poster – Liquid Biopsies: Circulating Nucleic Acids 4 (PO.CL01.10)

Andrew Georgiadis Labcorp

Section 45 5307/2

Tues. April 21

Analytical performance of an ultrasensitive whole genome sequencing assay for molecular residual disease detection

Mini Symposium – AACR (Free AACR Whitepaper) Project GENIE Use Cases (MS.MD01.01)

Elizabeth E. Martin
Broad Institute of MIT and Harvard

Room 14 Mezzanine Level Mon. April 20

Leveraging Ultima Genomics ppmSeq WGS-cfDNA to accurately detect clonal evolution over sequential blood biopsies

Poster – Liquid Biopsies: Circulating Nucleic Acids 3 (PO.CL01.09)

Laurel K. Millberg
DELFI Diagnostics

Section 45 3863/24

Mon. April 20

Enhanced cfDNA fragmentation-based treatment monitoring on the Ultima Genomics platform

Poster – Epigenetic Changes as Molecular Markers of Cancer (PO.MCB06.03)

Kimberly A. Holden Labcorp

Section 20 3213/23

Mon. April 20

Utility of TAPS+: a positive-readout methylation sequencing approach for high-fidelity epigenetic profiling

Poster – Network Biology and Precision Medicine (PO.BCS01.14)

Orly Alter

University of Utah and Prism AI Therapeutics, Inc

Section 3 6884/28

Wed. April 22

Quantum mechanics-based multi-tensor AI/ML correctly predicts glioblastoma patients’ overall survival, gene targets, and treatment response from whole genomes

(Press release, Ultima Genomics, APR 17, 2026, View Source [SID1234664487])