On April 21, 2026 Remix Therapeutics (Remix), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported the final results of the Phase 1 dose-escalation cohort of the Phase 1/2 ARIA study evaluating MYB mRNA degrader, REM-422, in patients with recurrent or metastatic (R/M) adenoid cystic carcinoma (ACC), have been accepted for an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place on May 29 – June 2, 2026 in Chicago and online.

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 presentation will be delivered by Renata Ferrarotto, MD, from The University of Texas MD Anderson Cancer Center and will highlight results from the Phase 1 portion of the study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of REM-42 in patients with R/M ACC, a disease driven by MYB dysregulation, for which there are no approved systemic therapies.

Oral Presentation Details:

Title: Clinical Activity of REM-422, a MYB mRNA Degrader, in Recurrent/Metastatic Adenoid Cystic Carcinoma: Final Results from the Phase 1/2 Dose-Escalation Cohort
Session Type/Title: Clinical Science Symposium – Small Glands, Big Challenges: Novel Therapeutics in Salivary Gland Cancer
Presenter: Renata Ferrarotto, MD, Professor in the Department of Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center
Abstract Number: 6009
Date and Time: June 1, 2026, 8:00 AM – 9:30 AM CDT

About REM-422

REM-422 is a first-in-class, potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

About the ARIA (A study of REM-422 In Adenoid cystic carcinoma) Clinical Trial
This Phase 1/2, open-label, non-randomized, multicenter study (NCT06118086) is investigating REM-422 in patients with recurrent, metastatic or unresectable Adenoid Cystic Carcinoma (ACC). The study includes a Dose Escalation Phase and a Dose Expansion Phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent, metastatic, or unresectable ACC. The purpose of Dose Expansion is to further evaluate the safety and anti-tumor activity of the REM-422 RP2D in biomarker positive patients.

About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) is a solid tumor that most commonly arises in the salivary glands characterized by frequent recurrent, perineural invasion and dysregulation of the MYB oncogene. Depending on the location of the tumor, symptoms may include numbness of the face, difficulties swallowing, changes in vision, or difficulty breathing, among others. Many therapeutic approaches, such as chemotherapy, kinase inhibitors, and immunotherapy have been studied in ACC with modest or disappointing results, and there remain no approved treatment options.

(Press release, Remix Therapeutics, APR 21, 2026, View Source [SID1234664661])

On April 21, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION, a tumor-activated oncology delivery platform, reported two presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. These presentations include the first in vivo efficacy and exposure pharmacology for the pre|CISION dual payload technology program and updated pharmacology and preclinical exposure data analyses highlighting the favorable delivery profile of AVA6103 (FAP-EXd), its second clinical candidate, which has recently entered Phase 1 development. Updates to the ongoing Phase 1 clinical trial are also being presented.

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!

Christina Coughlin, CEO of Avacta, commented:

"The data being presented at AACR (Free AACR Whitepaper) underline the potential of our pre|CISION technology and AVA6103 to make a considerable difference to cancer patients. These observations could significantly increase the probability of success with AVA6103, given both the ability of FAP-Exd to deliver more payload selectively to the tumor in the preclinical setting, and the success of Enhertu in the clinic. The FOCUS-01 Phase 1 clinical trial of AVA6103, now underway in the US, is designed to demonstrate the benefits of pre|CISION in unlocking the full potential of exatecan while minimizing systemic toxicity.

Furthermore, we have shown how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel medicines. The dual delivery mechanism of pre|CISION shows its potential to dramatically increase the therapeutic window and reduce systemic toxicities, offering improved outcomes for patients with cancer."

Details of the Two Presentations:

AVA6103 (FAP-EXd) Preclinical and Clinical Trial in Progress Highlights (Rink, C. et al.)

This presentation includes updated preclinical data from the Company’s second clinical candidate, AVA6103, a novel FAP-activated pre|CISION peptide-drug conjugate (PDC) delivering the topoisomerase I inhibitor (TOP1i) exatecan directly to the tumor-stroma interface, as well as details of the ongoing FOCUS-01 Phase 1 trial of this agent.

The data demonstrate that AVA6103 has robust activity in multiple patient-derived xenograft (PDX) models with FAP levels ranging from very low to high, suggesting excellent antitumor effects even at the lowest levels of FAP expression in stromal cells only. This presentation also includes a data analysis comparing pre|CISION FAP-cleavable payload delivery with that of the leading marketed ADC Enhertu (an AstraZeneca/Daiichi Sankyo product).

The data analysis used a synthetic comparator arm that was generated using AI to recreate a published AstraZeneca data set[1] and compare to experimental data generated with AVA6103 in a similar experimental design using a FAP-high animal model with two drugs using similar payloads (exatecan and deruxtecan). It demonstrated three key differences in the pharmacokinetics (PK) of the payload: more rapid tumor penetration and payload release with AVA6103, tumor Cmax of more than one log higher with AVA6103, and Tumor Selectivity Index (TSI: AUCtumor / AUCplasma) three times higher with AVA6103.

AVA6103 has recently entered the clinic, with the first patient receiving treatment in the FOCUS-01 study in March. FOCUS-01 (NCT07454642) is a multicenter, open-label Phase 1 clinical trial of AVA6103 in adults with selected advanced cancers, and the initial clinical data readout from the study is anticipated later this year. Based on favorable preclinical activity and biomarker readouts from the strategic collaboration with Tempus, two indications have been added to the trial: colorectal cancer (CRC) and hormone receptor-positive breast cancer (HR+ BC)

Abstract Number and Title: Abstract #5846, AVA6103 is a FAP-enabled pre|CISION peptide-drug conjugate delivering sustained release of exatecan in the tumor microenvironment with potent antitumor activity.
Poster number and Location: 5846, Section 17, Board 15
Session: Tumor Microenvironment, Multi-specifics, and Immunomodulation

The pre|CISION dual payload technology (AVA6207) update (Juskaite, V. et al.)

This presentation includes the description of how pre|CISION delivers a therapeutically relevant combination of payloads specifically to the tumor microenvironment while reducing systemic dose-limiting toxicities, broadening its utility in the delivery of novel combinations of medicines.

The AVA6207 dual payload is designed to simultaneously release a TOP1i and a DNA Damage Repair (DDR) inhibitor by FAP cleavage, resulting in synthetic lethality in two genetic models of TOP1i resistance: tumor cells harboring either (1) ATM-deficiency or (2) loss of SLFN11. These studies demonstrate the ability of AVA6207 to overcome key mechanisms of TOP1i resistance and mediate synergistic tumor cell killing.

The first in vivo data with this novel combination mechanism are presented, with tumor and plasma pharmacokinetic studies demonstrating the robust tumor-selective release of both payloads with a highly potent TSI. In addition to the robust exposure data, antitumor efficacy is demonstrated in a patient-derived xenograft (PDX) model of HER2+ gastric cancer with low FAP expression with optimal activity of AVA6207 over the HER2-targeted TOP1i ADC (Enhertu)

Abstract Number and Title: Abstract #5656, Characterization and translational development of novel pre|CISION technology compounds delivering complementary dual payloads to the tumor microenvironment following FAP cleavage

Session: Antibody-Drug Conjugates and Linker Engineering 4
Section: Experimental and Molecular Therapeutics

(Press release, Avacta Life Sciences, APR 21, 2026, View Source [SID1234664660])

On April 21, 2026 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, reported new preclinical data for Selective SMARCA2 inhibitor FHD-909 showing complete and durable tumor regression together with anti-tumor immune memory following combination treatment with an anti-PD-1 antibody in preclinical syngeneic mouse models. The company also reported new preclinical data for its Selective CBP and Selective EP300 degrader programs, demonstrating favorable efficacy and safety profiles across a range of difficult-to-treat cancers, in addition to progress with its Selective ARID1B degrader program. These data were unveiled in multiple oral and poster presentations at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) 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!

"These exciting new preclinical data highlight FHD-909’s potential in combination with an anti-PD-1 antibody in SMARCA4-mutated cancers," said Adrian Gottschalk, President and Chief Executive Officer of Foghorn. "Additionally, our selective CBP degrader continues to show promise in ER+ breast cancer models and our selective EP300 degrader outperforms its clinical benchmark in preclinical multiple myeloma models. We also shared that we have achieved robust degradation with our cereblon-based selective ARID1B degraders, designed for potential oral bioavailability. We are pleased with the continued progress across our innovative pipeline which has the potential to provide meaningful benefit to patients."

Oral Presentation Highlights

Title: Leveraging paralog relationships for targeting chromatin modulators in cancer: ARID1B and SMARCA2 (FHD-909)

We are advancing a first-in-class selective enzymatic inhibitor of SMARCA2 in collaboration with Lilly, FHD-909, as well as first-in-class selective ARID1B degraders for ARID1A-mutant cancers. Updates include:

FHD-909:

Complete regression in pre-clinical syngeneic efficacy models of FHD-909 in combination with an anti-PD1 antibody, with tumors failing to regrow after dosing halted
Tumor rejection upon rechallenge, where attempts to implant fresh tumor on the opposite flank of previously treated animals with FHD-909 plus an anti-PD1 antibody were not successful, suggesting an immune memory effect
ARID1B:

Robust degradation achieved with cereblon-based selective ARID1B degraders with potential for oral bioavailability
Title: Targeting chromatin regulatory proteins in hematologic malignancies

Targeting EP300 represents a well-validated example of lineage dependence in hematologic malignancies. In preclinical multiple myeloma studies, selective EP300 degraders show:

Tumor regression, including a model with acquired resistance to pomalidomide with superior efficacy to clinical benchmark dual CBP/EP300 inhibitor inobrodib
A profound impact on multiple transcription factors important for the survival of multiple myeloma cells
Synergistic impact on cancer cells in the context of combinations with several standards of care
Poster Presentation Highlights

Title: Preclinical characterization of FHT-171, a first-in-class degrader targeting CREB-binding protein (CBP) in CBP-dependent solid tumors

FHT-171 is a selective CBP degrader with potential to treat CBP-dependent solid tumors showing:

Strong anti-tumor activity as a monotherapy in PDX models of heavily pretreated ER+ breast cancer
Favorable tolerability profile in preclinical in vivo studies
High selectivity and potent CBP degradation with clear on-target transcriptional effects by SAR, proteomics, and mechanistic analyses
Mechanistic understanding of the utility of CBP degraders in ER+ breast cancer
Title: Preclinical evaluation of selective and potent EP300 degraders demonstrates robust antitumor activity and favorable tolerability in hematologic malignancies

Foghorn’s Selective EP300 degraders demonstrate promise for the treatment of hematological malignancies with preclinical data showing:

Superior anti-tumor activity, including complete responses, compared to clinical benchmark dual CBP/EP300 inhibitor inobrodib
Superior safety, by body weight loss and platelet counts, over dual degradation
Tumor regression in a multiple myeloma xenograft model of acquired pomalidomide resistance
Selective EP300 degradation as a novel and promising therapeutic strategy to treat multiple myeloma
Title: Identification of first-in-class selective ARID1B degraders

Selective ARID1B degraders represent a first-in-class approach to target prevalent ARID1A-mutant cancers by exploiting a synthetic lethal dependency. Preclinical data of this previously intractable target show:

Successful identification of the first selective ARID1B binders
Robust degradation via VHL and CRBN-based mechanisms
Clear on-mechanism activity with downstream transcriptional modulation
The presentations and the posters will be accessible under the Science section of the Company’s website.

(Press release, Foghorn Therapeutics, APR 21, 2026, View Source [SID1234664659])

On April 21, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC")," reported the completion of enrollment in its Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT06699836) evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

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 open-label, randomized, two-arm, multi-center study is evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients who have progressed following prior standard therapies. With enrollment now complete, CytoDyn will advance the study through treatment and follow-up, with resulting data expected to inform the program’s development strategy and potential next steps.

"Completing enrollment in this Phase 2 study marks an important milestone for CytoDyn and for the continued development of leronlimab in oncology," said Dr. Jacob Lalezari, Chief Executive Officer of CytoDyn. "We are grateful to the patients, investigators, and clinical sites whose commitment made completion of enrollment possible and look forward to evaluating the study results."

"CLOVER is designed to prospectively assess the activity of leronlimab in combination with an established regimen in a difficult to treat and highly refractory patient population with microsatellite stable (MSS) metastatic colorectal cancer, " said Pashtoon M. Kasi, M.D., M.S., Principal Investigator of the study and Medical Director of GI Oncology, City of Hope Orange County, Irvine, California. "With enrollment now complete, the study is well positioned to generate meaningful insights in this patient population with a high unmet need."

The CLOVER study builds on emerging clinical and translational findings from CytoDyn’s ongoing Phase 2 mCRC program, including data being presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. Preliminary results demonstrated early signals of clinical and biomarker activity with leronlimab in combination with TAS-102 and bevacizumab, including rapid reductions in circulating tumor DNA and modulation of immune-related markers. These findings support further evaluation of CCR5 inhibition as a strategy to enhance anti-tumor activity in metastatic colorectal cancer.

Leronlimab is a monoclonal antibody targeting CCR5, a receptor involved in immune cell trafficking and tumor biology. By blocking CCR5, leronlimab may help modulate the tumor microenvironment and enhance the activity of existing therapies in difficult-to-treat cancers.

CytoDyn plans to share topline data from the study as they become available.

About the Phase 2 mCRC Study (NCT06699836)
This Phase 2 clinical study is an open-label, randomized, two-arm, multi-center study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as CLOVER – CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen.

Approximately 60 patients were enrolled and randomized 1:1 to receive either 350 mg or 700 mg of leronlimab in combination with standard-of-care therapy. Eligible participants are adults with histologically confirmed mCRC who have progressed following prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, where appropriate, anti-EGFR therapy.

The primary endpoint of the study is objective response rate (ORR), as defined by RECIST v1.1 criteria. Secondary endpoints include safety and tolerability, duration of response, and overall survival. Patients will be followed for up to 12 months.

(Press release, CytoDyn, APR 21, 2026, View Source [SID1234664658])

On April 21, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported that an abstract highlighting clinical data from the ongoing Phase 1a/b study of RGT-61159, an oral MYB splicing modulator, in patients with adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) has been accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2, 2026 in Chicago, IL.

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!

Poster presentation details:

Title: A Phase 1a/b Study of RGT-61159, An Oral MYB Splicing Modulator, in
Patients with Advanced Adenoid Cystic Carcinoma and Colorectal Cancer.
Abstract #: 3089
Session Title: Poster Session – Developmental Therapeutics—Molecularly Targeted
Agents and Tumor Biology
Poster Board: 226
Date and Time: May 30, 2026, 1:30 – 4:30 p.m. CDT

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of the oncogenic MYB protein and potential cell death of the cancer cells that overexpress the MYB protein. MYB acts as a master regulator of cell proliferation, self-renewal, and differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemia (AML), T-cell acute lymphoblastic leukemia (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer. Rgenta is evaluating RGT-61159 in an ongoing multi-center, open-label Phase 1a/b clinical trial in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is designed to evaluate safety, tolerability, pharmacokinetics, target engagement, and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

(Press release, Rgenta Therapeutics, APR 21, 2026, View Source [SID1234664657])