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Enara Bio Presents First-in-Class DARKFOX-Targeting Bispecific T Cell Engager ENA101 in Oral Presentation at AACR 2026, Showcasing Breakthrough Potential in Solid Tumor Immunotherapy

On April 20, 2026 Enara Bio, a pioneer in Dark Antigen discovery and bispecific T cell engager (TCE) innovation, reported the presentation of new preclinical data for ENA101, its first‑in‑class bispecific T cell engager (TCE), delivered today in an oral session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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ENA101 targets DARKFOX, a novel, cancer‑specific Dark Antigen encoded by a previously undiscovered alternative open reading frame (alt‑ORF) within FOXM1. DARKFOX was discovered and validated using Enara’s proprietary EDAPT platform and represents a new class of highly tumor‑specific targets derived from the dark proteome.

"ENA101 exemplifies the power of uncovering antigens within the dark proteome to overcome long-standing challenges in solid tumor immunotherapy," said Dr. Joe Dukes, Chief Scientific Officer of Enara Bio. "The data presented today at AACR (Free AACR Whitepaper) demonstrate that DARKFOX is a compelling cancer specific target and that ENA101 exhibits the potency, specificity and druglike profile required to advance a best-in-class T cell engager toward the clinic."

The oral presentation, titled "ENA101: A First‑in‑Class Bispecific T Cell Engager Targeting a DARKFOX Peptide Presented by Solid Tumors," was delivered by Dr. Joe Dukes in the Advances in Therapeutic Antibodies session
(Abstract #4052). The presentation highlighted the discovery of DARKFOX, the engineering of ENA101, and the comprehensive preclinical dataset supporting its advancement into clinical development.

Enara Bio is currently advancing ENA101 through IND-enabling studies to support IND filing in 2H’2026.

The abstract is available in Proceedings of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

About ENA101
ENA101 is a first‑in‑class bispecific T cell engager developed using Enara Bio’s proprietary EnTiCE platform. It incorporates a high‑affinity TCR‑mimic binder targeting the DARKFOX‑A3 peptide, a clinically validated anti‑CD3 arm, and an Fc‑based architecture for half‑life extension, to enable potent, selective and durable anti‑tumor immune responses.

(Press release, Enara Bio, APR 20, 2026, View Source [SID1234664592])

Perspective Therapeutics Presents Updated Interim Data of [212Pb]VMT-α-NET in Its Ongoing Phase 1/2a Clinical Trial at the 2026 AACR Annual Meeting

On April 20, 2026 Perspective Therapeutics, Inc. ("Perspective" or the "Company) (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported updated interim results from its ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs) as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. [212Pb]VMT-α-NET is potentially the first-in-class 212Pb-radiopharmaceutical therapy targeting SSTR2.

Interim results with a data cut-off date of March 4, 2026 formed the basis of the AACR (Free AACR Whitepaper) update. The presentation includes safety data from 64 patients across three dose cohorts who have received at least one treatment of [212Pb]VMT-α-NET, and efficacy analysis from two patients in Cohort 1 (2.5 mCi) and 23 patients in Cohort 2 (5.0 mCi). Efficacy analysis with earlier data cut-off dates for the same patients were previously presented at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2026 (ASCO-GI 2026) and the European Society for Medical Oncology Congress 2025 (ESMO 2025) in October 2025.

"Updated analyses continue to support the compelling overall clinical profile of [212Pb]VMT-α-NET as a treatment for GEP-NETs at the Cohort 2 dose level of 5 mCi per dose or up to 20 mCi cumulatively," said Markus Puhlmann, Chief Medical Officer of Perspective. "We are particularly encouraged by continued learning on the time to onset of best response, durability of response, as well as emerging long-term safety of [212Pb]VMT-α-NET. Meanwhile, we are enhancing our robust clinical package and adding optionality with additional dose cohorts, as well as looking beyond GEP-NETs."

As of the data cut-off date of March 4, 2026:

Safety findings based on 64 patients who received at least one treatment:

The 64 patients in this safety analysis comprised two patients in Cohort 1 (2.5 mCi), 46 patients in Cohort 2 (5.0 mCi), and 16 patients in Cohort 3 (6.0 mCi).
There were no reports of dose limiting toxicities (DLTs), treatment-related discontinuations, serious renal complications, dysphagia, or clinically significant treatment-related myelosuppression.
Grade 3 or higher treatment-emergent adverse events were reported in 23 patients (36%). One of these patients, who was enrolled in Cohort 3, experienced a transient lymphocyte count decrease on the cusp of Grades 3 and 4. This event was subsequently determined by the site to be a Grade 3 event. This event was transient and resolved without medical intervention. The patient completed the full course of [212Pb]VMT-α-NET treatment of four treatments without interruption and remains on study. No further Grade 4 events have occurred in this patient or in other patients in the study. There were no Grade 5 events.
No additional patients experienced serious adverse events (SAEs) since the most recent data update at ASCO (Free ASCO Whitepaper)-GI 2026, with none of the five SAEs deemed related to the study medication.

Anti-tumor activity based on both patients in Cohort 1 and 23 patients in Cohort 2:

Updated efficacy analysis in the same 25 patients from ASCO (Free ASCO Whitepaper)-GI 2026 and ESMO (Free ESMO Whitepaper) 2025 was presented with an additional ~12 weeks and ~25 weeks of follow-up, respectively.
18 of the 25 patients (72%) were without progression and remained alive, including both patients in Cohort 1.
Ten (43%) patients in Cohort 2 were observed to have response according to investigator-assessed RECIST v1.1. Nine of those responses were previously reported at ASCO (Free ASCO Whitepaper)-GI 2026, including one initial response reported at ASCO (Free ASCO Whitepaper)-GI 2026 that has since been confirmed. Since then, one more patient experienced an initial response in their most recent tumor assessment. As the patient remains on study, the patient is expected to receive a subsequent tumor assessment.
Eight (50%) of the 16 patients in Cohort 2 whose tumors all express SSTR2 were observed to have response according to investigator-assessed RECIST v1.1.
Nine patients were observed to have deepening of best response since initial tumor assessments on these patients were reported at ESMO (Free ESMO Whitepaper) in October 2025.
About [212Pb]VMT-α-NET

Perspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing somatostatin receptor type 2 (SSTR2). The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies (RPT).

(Press release, Perspective Therapeutics, APR 20, 2026, View Source [SID1234664591])

Monte Rosa Therapeutics Presents Preclinical Data at American Association for Cancer Research (AACR) Annual Meeting 2026 on the Potential of its Cyclin E1 (CCNE1)-directed Molecular Glue Degrader to Treat CCNE1-amplified Solid Tumors

On April 20, 2026 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported the company will present preclinical data highlighting the potential of its highly selective, first-in-class cyclin E1 (CCNE1)-directed MGD, MRT-55811, to treat CCNE1-amplified solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17-22 in San Diego, CA.

"CCNE1 MGDs represent a first-in-class opportunity to directly target a frequently amplified driver oncogene in several solid tumor cancer populations with high unmet medical need. In CCNE1-amplified in vivo models of ovarian, gastric, and breast cancer, MRT-55811 demonstrated compelling monotherapy anti-tumor activity," said Sharon Townson, Ph.D., Chief Scientific Officer of Monte Rosa Therapeutics. "MRT-55811 also exhibited superior selectivity when compared to clinical-stage CDK2 inhibitors, suggesting that our CCNE1-directed MGDs could avoid the dose-limiting toxicities reported for these less selective agents. We believe that our oral CCNE1 degrader has the potential to provide clinical benefit across multiple cancer types where CCNE1 is amplified. These data also reinforce the power of our QuEEN discovery engine, as cyclin E1 represents yet another previously undruggable target we’ve successfully targeted. We anticipate submitting an IND for this program later this year."

The presentation, "Selective targeting of CCNE1 using molecular glue degraders for the treatment of CCNE1 amplified cancers" (Abstract Presentation Number 6778), will be presented by Ralph Tiedt, Ph.D., Vice President, Biology, Monte Rosa Therapeutics, at the Minisymposium, "Targeted Protein Degradation and Non-canonical Oncogenic Signaling," on April 21, 2026, from 2:30 p.m. to 4:30 p.m. PT.

Summary of results:

MRT-55811 exhibited potent degradation and high selectivity for CCNE1, with no detectable degradation of closely related cyclins or cyclin-dependent kinases (CDKs), and favorable drug-like properties.
MRT-55811 induced deep cyclin E1 degradation and downstream pathway suppression, as well as co-degradation of CDK2 within the cyclin E1/CDK2 holoenzyme complex in CCNE1-amplified cell lines.
MRT-55811 demonstrated superior selectivity compared with clinical-stage CDK2 inhibitors, which exhibited significant off-target activity, as evidenced by kinome profiling and genetic modeling.
In CCNE1-amplified cancer cell lines, MRT-55811 selectively inhibited cellular proliferation, while sparing cell lines without amplification.
In vivo, MRT-55811 monotherapy resulted in tumor regression and pathway suppression in multiple CCNE1-amplified models.
MRT-55811 downmodulated retinoblastoma (RB) protein phosphorylation and E2F-driven gene expression, demonstrating on-target effects in tumors grown in vivo.

About CCNE1 MGDs
Cyclin E1 (CCNE1) is a well-recognized human oncogene and critical driver of cell cycle progression and cell proliferation and was historically considered an undruggable target. It acts as the regulatory subunit of the CCNE1-CDK2 holoenzyme, which coordinates G1-S cell cycle progression and drives cell proliferation through RB phosphorylation and repression. CCNE1 is frequently amplified or overexpressed across multiple cancer types, including ovarian, endometrial, gastric, breast, and others. Leveraging a cryptic pocket, Monte Rosa’s CCNE1-directed MGDs selectively degrade the cyclin E1/CDK2 holoenzyme complex, while sparing other proteins such as other closely related cyclins or CDKs. As a result of this exquisite selectivity, CCNE1-directed MGDs represent an opportunity to directly and selectively target a frequently amplified driver oncogene across multiple cancers.

(Press release, Monte Rosa Therapeutics, APR 20, 2026, View Source [SID1234664587])

Radiopharm Theranostics Presents Initial Findings from Phase 1 First-in-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026

On April 20, 2026 Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California.

"These first-in-human results represent an important early milestone for our HER2-targeted radiopharmaceutical program," said Dr. Dimitris Voliotis, Chief Medical Officer of Radiopharm Theranostics. "In a heavily pre-treated patient population with significant unmet need, 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile at the lowest dose level. Importantly, the observed dosimetry supports continued dose escalation, which was recently approved by the Data Safety and Monitoring Committee (DSMC) to advance to the third cohort at 130 mCi dosing. We look forward to further evaluating the therapeutic potential of this novel approach and expect to see signs of antitumor activity at higher, more therapeutic dose levels."

The AACR (Free AACR Whitepaper) poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi.

Key Findings from the AACR (Free AACR Whitepaper) Abstract and Poster

Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions
177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events
No dose-limiting toxicities or treatment discontinuations due to adverse events were observed
Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation
Poster Presentation Details

Title: A First-in-Class HER2-Targeted Radiopharmaceutical Therapy: Initial Findings from the Phase 0/1 HEAT Trial of 177Lu-RAD202 in HER2+ Advanced Solid Tumors
Abstract Number: CT046
Presenter: Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics
Session: Poster Session
Dates: April 20, 2026 at 9:00 AM PT
The complete poster can be found on the Company’s website here.

On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance 177Lu-RAD202 to the third cohort at a dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors1. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation.

About the HEAT Trial

177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density.

The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors.

Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose
Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose
About RAD202:

RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution.

(Press release, Radiopharm Theranostics, APR 20, 2026, View Source [SID1234664586])

BriaCell Presents Positive Phase 3 Quality of Life and Phase 2 Biomarker Data at the 2026 AACR Meeting

On April 20, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that it is presenting positive data in three clinical posters at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17–22 at the San Diego Convention Center in San Diego, California. The presentations will include one poster featuring data from BriaCell’s ongoing pivotal Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (ClinicalTrials.gov identifier: NCT06072612), and two posters highlighting further analyses of Phase 2 data. Abstracts will be published in the online Proceedings of the AACR (Free AACR Whitepaper).

"Standards of care in cancer are evolving rapidly as innovative immunotherapy approaches emerge with potentially better safety profiles than chemotherapy. Clinical data, including BriaCell’s, highlight that maintaining quality of life is an important treatment goal alongside efficacy and safety," stated lead author, Saranya Chumsri, MD, Principal Investigator of BriaCell Phase 3 study of Bria-IMT+CPI, and Professor of Oncology, Mayo Clinic.

"At BriaCell, we are focused on bringing novel therapeutics to cancer patients with unmet medical needs with the ultimate goal of improving patients’ lives," noted William V. Williams, MD, BriaCell’s President & CEO. "Our new quality of life data from the Phase 3 Bria-IMT + CPI study in patients with metastatic breast cancer who failed prior therapies show very positive trends, bringing us one step closer to transforming care for these patients."

Session Title: Phase II and Phase III Clinical Trials
Session: 4/20/2026 2:00-5:00 PM PST
Location: Poster Section 52
Poster Board Number: 1
Poster Number: CT137
Title: QOL Outcomes in Bria-ABC Late-Stage Metastatic Phase 3 Trial
Summary: Heavily pretreated metastatic breast cancer patients in the pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor maintained overall health status and key functional measures with a favorable safety profile. These findings are encouraging because they suggest meaningful preservation of quality of life for late-stage metastatic breast cancer patients with limited treatment options.

QOL largely preserved in a heavily pretreated population with prior antibody-drug conjugate (ADC), check point inhibitor (CPI), and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor exposure
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Survey showed:
1) Global health status stable through early and mid-treatment
2) Emotional and cognitive functioning maintained; symptom burden stable
Safety profile and time-to-deterioration analyses support durable tolerability in a late-line setting
BriaCell clinical data supports feasibility of decentralized treatment approaches, including potential home self-administration strategies
Session Category: Clinical Research
Session: 4/19/2026 2:00-5:00 PM PST
Location: Poster Section 42
Poster Board Number: 5
Poster Number: 1065
Title: Mitosis in Circulating Tumor Cells Correlates with Highly Aggressive Disease in Metastatic Breast Cancer

Summary: Circulating tumor cells (CTCs) are a well-established non-invasive blood-based biomarker that can help stratify prognosis in patients with metastatic breast cancer (MBC), particularly in aggressive disease subtypes. Early pilot studies had identified a distinct subset of CTCs undergoing mitosis (dividing cells), whose presence appeared to correlate with worse survival outcomes. However, their prognostic significance and potential interaction with different treatment regimens have not been clinically evaluated. In this multi-institutional prospective study, patients with mitotic CTCs were found to have poorer outcomes than those with non-mitotic CTCs or no CTCs, but appeared to have overall survival benefit when treated with targeted therapy. Overall, these findings support mitotic CTCs as a novel potential prognostic biomarker in metastatic breast cancer.

Session Category: Clinical Research
Session Title: Biomarkers Predictive of Therapeutic Benefit 1
Session: 4/19/2026 2:00-5:00 PM PST
Location: Poster Section 40
Poster Board Number: 19
Poster Number: 1025
Title: Monitoring PD-L1 in tumor macrophage fusion cells in blood identifies high PD-L1 checkpoint inhibitor responses in metastatic breast cancer

Summary: Tissue biopsy PD-L1 combined positive score (CPS≥10) has been identified as a positive prognostic marker in metastatic breast cancer. However, a significant percentage of MBC patients with CPS <10 seem to benefit from immune check point inhibitor (ICI) therapy. Circulating tumor-macrophage fusion cells (TMFCs) express PD-L1 and changes in TMFC PD-L1 expression during ICI treatment may explain this outcome. This Phase 2 prospective study found no correlation between tumor PD-L1 CPS and clinical response while demonstrating that patients with PD-L1 positive TMFCs in their blood had significantly improved progression free survival. Monitoring PD-L1 in TMFCs may serve as a real-time biomarker to better indicate ICI response and further studies into the role of TMFC PD-L1 in predicting therapeutic response are ongoing.

Following the presentation, copies of the posters will be made available at View Source

(Press release, BriaCell Therapeutics, APR 20, 2026, View Source [SID1234664585])