Orum Presents New Preclinical Data at AACR 2026 on ORM-1153, a CD123-Targeting Degrader-Antibody Conjugate, Highlighting Broad Activity in AML and the Potential for Improved Efficacy and Tolerability

On April 17, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported the presentation of new preclinical data for ORM-1153, a CD123-targeting DAC designed to selectively deliver a proprietary GSPT1-degrading payload, in development for the treatment of AML and other CD123-positive hematological malignancies. The data were presented in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026.

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"These data show strong preclinical activity and the potential for a differentiated safety and tolerability profile, supporting the advancement of ORM-1153 as a next-generation CD123-targeting degrader-antibody conjugate for acute myeloid leukemia," said Chad May, Ph.D., Chief Scientific Officer of Orum. "Our approach combines a proprietary CD123-antibody and novel GSPT1-targeted protein degrader with the goal of achieving greater selectivity than conventional cytotoxic antibody-drug conjugates. We believe this strategy can enable more effective and better-tolerated therapies for patients with AML."

The first poster (Abstract Number: 1824) highlights how ORM-1153 was engineered with a proprietary CD123-antibody designed for enhanced internalization and reduced Fc-gamma receptor interactions, together with a linker optimized for plasma stability, an approach intended to improve delivery, reduce off-target and immune cell engagement, and support favorable pharmacologic properties. Consistent with that design, ORM-1153 showed strong preclinical anti-leukemia activity at low doses, along with prolonged accumulation in tumors, undetectable systemic free payload, and favorable repeat-dose non-human primate findings supporting a manageable safety and tolerability profile.

Data from the second poster (Abstract Number: 1710) extend Orum’s previously presented findings by showing activity across primary AML patient samples and in models with relevant tumor mutations, including TP53. Taken together, the findings support the potential for broad activity in AML, including in patients with TP53 mutations.

"These AACR (Free AACR Whitepaper) data are particularly encouraging in the context of AML, where many patients, especially those with TP53 mutations, continue to have limited treatment options and poor outcomes," said Olaf Christensen, M.D., Chief Medical Officer of Orum. "The activity we are seeing across primary patient samples and TP53-relevant models, together with a consistent pharmacologic and tolerability profile, supports the continued advancement of ORM-1153 toward clinical development."

Both posters are available on Orum’s website and will be presented at AACR (Free AACR Whitepaper) on Monday, April 20, from 9 am to 12 pm PDT.

About ORM-1153

ORM-1153 is a CD123-targeting degrader-antibody conjugate developed using Orum’s Dual-Precision TPD² approach. The molecule is built from two proprietary elements, a GSPT1-degrading payload and an anti-CD123 antibody engineered for high internalization efficiency, conjugated with a cleavable β-glucuronide linker. By combining tumor-selective antibody delivery with targeted protein degradation, ORM-1153 is designed to induce cancer cell death through degradation of GSPT1, a protein implicated in cell survival, including in TP53-mutant AML, while minimizing effects on normal tissues.

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, APR 17, 2026, View Source [SID1234664797])

Cogent Biosciences Announces Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting 2026

On April 17, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that preclinical data from the Company’s KRAS and ErbB2 pipeline programs will be presented during poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 taking place in April 17-22 in San Diego, CA.

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"As we prepare for the potential launch of bezuclastinib later this year, we are excited to share updates from two of our pipeline programs this weekend at the 2026 annual AACR (Free AACR Whitepaper) meeting," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "First, we are presenting data on CGT1263, our novel pan-KRAS(ON) inhibitor, which shows best-in-class cellular potency along with evidence that its kinase selectivity advantage over multi-RAS inhibitors could drive clinical differentiation with regards to skin toxicity, a current liability of advanced clinical programs. Separately, we provide an update on CGT4255, our novel, selective ErbB2 inhibitor that was specifically designed for its best-in-class CNS penetrant properties to address a significant unmet need for HER2+ patients with brain metastases. This presentation also includes preclinical data in combination with a HER2 ADC suggesting potential synergistic activity leading to improved duration of therapy as well as re-sensitization of patients following HER2 ADC resistance. With multiple potential blockbuster programs advancing in our pipeline, we believe these new data underscore the long-term potential of Cogent Biosciences."

Poster Details

Title: Characterization of CGT1263, a KRAS (ON/OFF) inhibitor clinical candidate with selectivity for mutant KRAS over HRAS and NRAS
Session Category: Experimental and Molecular Therapeutics
Session Title: Novel Antitumor Agents 1
Session Date and Time: April 19, 2026 – 2:00 PM – 5:00 PM PT (5:00 PM – 8:00 PM ET)
Location: Poster Section 17
Poster Board Number: 13
Poster Number: 410

Mutations in KRAS are among the most prevalent mutations found in cancer, occurring most often in colorectal cancer, non-small cell lung cancer and pancreatic cancer. The preclinical poster highlights Cogent’s internally developed pan-KRAS(ON) inhibitor with >500x selectivity for KRAS over HRAS and NRAS. Plasma exposure following oral administration across species resulted in sustained pERK inhibition and robust antitumor activity. Tumor pERK inhibition was also achieved with limited skin suppression, supporting the potential of a larger therapeutic window for CGT1263 when compared to multi-RAS inhibitors currently in clinical development. This aligns with historical data implicating the RAS-MAPK-ERK pathway as essential for skin development given its role in regulation of keratinocyte proliferation, differentiation, and survival; combined suppression of multiple targets within this pathway is thought to be the driver of frequent rash observed in patients treated with multi-RAS inhibitors. Overall, these findings suggest CGT1263 could provide an advantage for patients, enabling higher dosing designed to elicit a more profound molecular response. Investigational New Drug (IND) enabling studies are ongoing with an IND submission expected later this year.

Title: Preclinical characterization of CGT4255, an EGFR sparing, pan-mutant HER2 clinical development candidate with potential best-in-class brain penetration
Session Category: Experimental and Molecular Therapeutics
Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors
Session Date and Time: April 21, 2026 – 2:00 PM – 5:00 PM PT (5:00 PM – 8:00 PM ET)
Location: Poster Section 18
Poster Board Number: 7
Poster Number: 5869

Cogent’s EGFR-sparing, brain-penetrant ErbB2 inhibitor includes potent coverage of key mutations (YVMA, S310F, V842I, L755S) inadequately addressed by currently approved therapies. Activating mutations in the ErbB2 gene have been identified in multiple cancers and demonstrate a tumorigenic role similar to that of ErbB2 amplification. New data presented describe CGT4255’s >100-fold selectivity over EGFR while robustly engaging HER2 amplification, insertion and mutant lines in addition to reinforcing best-in-class potential CNS performance relative to other agents in development. Additional mechanistic studies presented suggest CGT4255 may have synergistic effects on efficacy and durability when combined with HER2 targeted ADCs. Preclinical evidence demonstrates that concurrent treatment of CGT4255 and T-DXd enhances receptor internalization and cancer cell apoptosis, suggesting the potential for a synergistic combination that could improve patient outcomes. The Phase 1 study of CGT4255 is ongoing.

Posters will be available on the ‘Posters and Publications’ page of Cogent’s website.

(Press release, Cogent Biosciences, APR 17, 2026, View Source [SID1234664468])

Nested Therapeutics Reports Initial Encouraging Clinical Activity and Favorable Tolerability of NST-628, a Brain-Penetrant Pan-RAF/MEK Molecular Glue, at AACR 2026

On April 17, 2026 Nested Therapeutics, a clinical-stage oncology company developing transformative therapies for RAS/MAPK-driven disorders, reported initial clinical results from its ongoing Phase 1 study evaluating NST-628, a brain-penetrant non-degrading pan-RAF/MEK molecular glue, in patients with advanced solid tumors. Data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026 demonstrate encouraging single-agent anti-tumor activity and a favorable tolerability profile in a range of RAF and RAS-mutant tumors, including a 38% response rate and 85% disease control rate at the recommended dose in heavily pretreated NRAS and BRAF Class II/III melanoma, a population that represents approximately 33% of cutaneous melanoma patients, for whom no approved targeted therapies are available.

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"These initial data support our hypothesis that targeting RAF/MEK signaling with a single-agent, fully brain-penetrant pan-RAF/MEK molecular glue can deliver meaningful clinical benefit with a tolerability profile that supports sustained dosing even in comparison to what may be expected from combination regimens," said Darrin Miles, Chief Executive Officer of Nested Therapeutics. "We are particularly encouraged by the durable responses in NRAS and BRAF Class II/III melanoma – large patient populations with historically poorer outcomes and for whom there are no approved targeted therapy options – as well as early signals of clinical activity beyond melanoma, including in KRAS-mutant solid tumors and evidence of brain penetrance. Together, these clinical findings, in addition to robust preclinical evidence and favorable drug properties, support the potential for NST-628 to address significant unmet need across RAS/MAPK-driven cancers and to serve as a foundational therapy in both monotherapy and combination settings."

Key Data Highlights

As of the data cutoff date of February 1, 2026, NST-628 has been administered to 69 patients: 64 patients in dose-escalation and 5 patients in the expansion phase. Key findings are summarized below.

Monotherapy Clinical Activity in evaluable patients (with at least one tumor assessment or who discontinued the study) at Recommended Dose for Expansion (RDE)

NST-628 monotherapy demonstrated a 38% response rate in BRAF Class II/III and NRAS-mutant melanoma (N=13) and 33% response rate overall (N=18); response rates include one unconfirmed partial response
Disease control rate was 85% in the melanoma subgroup and 72% overall
With a median follow-up of 6.4 months, the median duration of response in melanoma was not yet reached
Anti-Tumor Activity Beyond Melanoma

Responses to NST-628 were observed across multiple tumor types and genotypes, including KRAS-mutant ovarian and cervical cancers – highlighted by an ongoing partial response in a KRAS G12V-mutant cervical cancer patient with a treatment duration exceeding one year – as well as NRAS/BRAF Class III-mutant colorectal cancer and BRAF Class II-mutant thymic cancer
A patient with high-grade astrocytoma (BRAF V600E), previously treated with multiple lines of RAF/MEK-targeted therapy, demonstrated 70% tumor shrinkage on NST-628 monotherapy, consistent with NST-628’s preclinical brain penetration profile
Reductions in ctDNA correlated with radiographic response
Safety and Tolerability

Adverse events were consistent with the mechanism of action and predominantly Grade 1-2
Most common treatment-related adverse events included dermatologic, gastrointestinal, CK elevation, constitutional, and ocular events
Grade ≥3 TRAEs were infrequent; most common was CK elevation
No Grade 5 events reported
At the RDE:
Discontinuation rate: 9%
Dose intensity (actual dose delivered vs. intended): 82%
"The anti-tumor activity observed with NST-628 monotherapy is encouraging," said Philip Komarnitsky, MD, PhD, Chief Medical Officer of Nested Therapeutics. "A safety profile that supports continuous dosing at 82% dose intensity with a 9% discontinuation rate, combined with the response rate of 38% and disease control rate of 85% in NRAS and BRAF Class II/III melanoma patients at the recommended dose, is promising for this patient population with no approved targeted therapies. The clinical evidence of activity in malignancies with BRAF class III mutations, an emerging resistance mechanism to RAS inhibitors, and of brain penetrance consistent with preclinical findings is particularly noteworthy. These data support the continued development of NST-628 as monotherapy and its evaluation in rational combinations."

Nested plans to continue enrollment in the ongoing Phase 1 expansion cohort and evaluate NST-628 in additional malignant and non-malignant MAPK-driven diseases and combination settings, including mutant-selective RAS and other inhibitors.

Poster Presentation Details

Title: Preliminary results from a Phase 1a/b dose-escalation and expansion trial of the pan-RAF-MEK molecular glue NST-628 in patients (pts) with advanced or refractory RAF, KRAS, and NRAS-mutant solid tumors

Presenter: Ahmad A. Tarhini, MD, PhD, Moffitt Cancer Center

Presentation Date and Time: Monday, April 20, 2026, 2:00 PM-5:00 PM PT

Session: PO.CT01.01 – Phase 0 and First-in-Human Phase I Clinical Trials

Location: Section 51

About the Phase 1 Study of NST-628, NST-628-001

The ongoing Phase 1 open-label, single-arm, two-part study (NCT06326411) is investigating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of single-agent NST-628 in adult patients with RAS-MAPK pathway mutated/dependent advanced solid tumors, especially diverse KRAS, NRAS, and BRAF alterations, who have exhausted standard treatment options. The study includes two parts: dose escalation (Part A), which enrolled 64 patients across seven dose regimens, followed by dose expansion (Part B) at the recommended dose for expansion. Part B is currently enrolling. For more information, visit clinicaltrials.gov.

About NST-628

NST-628 is a brain-penetrant, non-degrading molecular glue designed to inhibit RAF and MEK signaling by stabilizing RAF-MEK complexes in a catalytically inactive form. This mechanism is intended to prevent pathway reactivation, a common liability of existing RAS/MAPK-targeted therapies, and enable more durable pathway suppression across RAS/MAPK-driven cancers.

(Press release, Nested Therapeutics, APR 17, 2026, View Source [SID1234664484])

Salubris Biotherapeutics Presents Phase 1/2 Dose Escalation and Expansion Cohort Data for JK06, 5T4-Targeted Antibody Drug Conjugate, at the American Association for Cancer Research Annual Meeting

On April 17, 2026 Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, reported expansion cohort data from the Phase 1/2 study of JK06, a 5T4-targeted antibody drug conjugate (ADC), in patients with unresectable locally advanced or metastatic cancer, including non-small cell lung cancer (NSCLC) and breast cancer, which is being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 on April 17-22, 2026 in San Diego, California.

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"JK06 continues to demonstrate encouraging and durable efficacy among heavily pre-treated metastatic solid tumors. Partial responses have now been observed across four different cancers, including NSCLC and breast cancer, at multiple dose levels. These data are complemented by a consistently favorable safety profile, underscoring our belief that JK06 has the potential to be an important new first-in-class ADC that can address the unmet needs of patients with 5T4-expressing cancers," said Sam Murphy, Chief Executive Officer of Salubris Biotherapeutics. "These results provide a robust foundation for further exploration of JK06 in NSCLC and breast cancer and will propel our efforts to interrogate the pan-tumor opportunity. We look forward to progressing this study into the next stages of expansion cohorts, including additional monotherapy cohorts and evaluation of JK06 in multiple combination therapy regimens."

Expansion cohort data presented at AACR (Free AACR Whitepaper) include 112 patients enrolled in Europe with advanced relapsed/refractory solid tumors who were treated with JK06 once every three weeks, including two randomized dose cohorts (3.7 mg/kg, 4.5 mg/kg) in NSCLC and breast cancer and a basket cohort consisting of multiple tumor types known to express 5T4. The data cutoff was March 29, 2026.

Key efficacy findings include:

Among 38 response-evaluable NSCLC patients, 10 attained confirmed PRs (ORR 26%), including three out of seven response-evaluable squamous cell NSCLC patients (ORR 43%), and two of three response-evaluable Epidermal Growth Factor Receptor (EGFR) mutant patients.
Five out of 19 response-evaluable breast cancer patients attained PRs (ORR 26%), including four out of nine hormone receptor-positive (HR+) breast cancer patients (ORR 44%).
Among other tumor types, the first and only response-evaluable gastric cancer patient enrolled attained a partial response (PR, -55%), and one of four response-evaluable cervical cancer patients attained a partial response (PR, -49%).
Among 112 safety-evaluable patients enrolled in expansion cohorts, key safety findings include:

Treatment with JK06 at doses ≤ 5.2 mg/kg was generally well-tolerated with predominantly low grade (Grades 1 and 2) treatment-related adverse events (TRAEs) and manageable toxicities.
All JK06-related AEs of any grade are below 10% frequency overall except for asthenia (11% overall).
Only three total Grade 3 events have been observed to date among the 112 patients (fatigue, gait disturbance, keratitis), and no Grade 4 or 5 events have been observed.
Of the total 153 patients enrolled across all dose levels in dose escalation and expansion, only seven patients have dose-reduced due to a TRAE resulting from JK06.

The Phase 1/2 open-label, dose-escalation and expansion study (NCT06667960) to assess the safety, pharmacokinetics, and preliminary efficacy of JK06 is ongoing.

Details of the AACR (Free AACR Whitepaper) presentation are as follows:

Title: A Phase 1/2 Study of JK06, a 5T4-Targeted Antibody Drug Conjugate (ADC), In Patients with Unresectable Locally Advanced or Metastatic Cancer
Presenter: Omar Saavedra, M.D., Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Abstract #: CT250
Session: Phase II Clinical Trials
Date/Time: April 21, 2026 | 2:00 – 5:00 PM PT

About JK06

JK06 is a first-in-class quadrivalent, biparatopic ADC that selectively targets 5T4 with a monomethyl auristatin E (MMAE) payload. 5T4 is an oncofetal protein that is overexpressed in a wide range of solid tumors, including non-small cell lung cancer (NSCLC), breast, gastric and genitourinary cancers, and is associated with more aggressive tumor progression and reduced survival. JK06 has demonstrated picomolar affinity for 5T4 and enhanced internalization resulting from the biparatopic design. Together with stable, site-specific payload conjugation, JK06 has demonstrated the potential for robust efficacy and a favorable safety profile.

(Press release, Salubris Biotherapeutics, APR 17, 2026, View Source [SID1234664500])

Evaxion’s AI-Immunology™ platform demonstrates 86% vaccine target precision in phase 2 personalized cancer vaccine trial

On April 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported new data demonstrating that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets. The data will be presented at the AACR (Free AACR Whitepaper) Annual Meeting in San Diego, California, on April 22, 2026.

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86% of the vaccine targets included in Evaxion’s personalized cancer vaccine EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods. The high number reflects a broad yet specific immune response, increasing the likelihood of strong anti-tumor effect and positive clinical outcomes.

"We are delighted with the data demonstrating again the unique capabilities of AI-Immunology in identifying and selecting relevant vaccine targets. This is a further validation of the platform as an effective tool for developing potentially transformational treatments of cancer and other diseases," says Bigitte Rønø, CSO of Evaxion.

Encouraging data
In addition to the 86% success rate, the new data set includes two-year analysis showing durable vaccine-specific immune responses following EVX-01 administration. Notably, high de novo responses (86%) were observed, meaning the vaccine gives rise to a high number of novel tumor specific T cells. This potentially increases the vaccine’s tumor killing ability.

Further, a positive correlation between vaccine target AI-prediction scores and the magnitude of the immune responses was demonstrated, underlining the predictive power of AI-Immunology.

The new data stems from the phase 2 trial investigating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma. Each patient enrolled in the trial received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

The trial has already yielded encouraging two-year clinical data, including a 75% Objective Response Rate. Its one-year extension was successfully completed earlier this month with three-year clinical data expected to be presented in the second half of 2026.

AACR presentation details
Abstract title: AI-designed personalized neoantigen vaccine, EVX-01, induces durable de novo T-cell responses in advanced melanoma patients
Poster#: 7741
Session category: Clinical research
Session title: Immune response to therapies
Location: Poster section 42
Date/Time: April 22, 2026, at 9am-12pm CST/16-19 CET
Presenter: Mads Lausen Nielsen, PhD, Project Manager at Evaxion

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

Designed with our AI-Immunology platform, EVX-01 and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

(Press release, Evaxion, APR 17, 2026, View Source [SID1234664516])