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BlossomHill Therapeutics to Present Preliminary Results From Phase 1 Dose Escalation/Backfill Cohorts in Phase 1/2 SOLARA Trial of OMNI-EGFR Inhibitor, BH-30643, in Advanced EGFR-mutant NSCLC at the 2026 ASCO Annual Meeting

On May 21, 2026 BlossomHill Therapeutics, Inc., a privately-held, clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported an upcoming presentation of the preliminary, Phase 1 dose escalation/backfill data from the company’s ongoing Phase 1/2 SOLARA clinical trial of BH-30643 in epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer (NSCLC). The data will be presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Tuesday, June 2, 2026.

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BH-30643 is a non-covalent, macrocyclic, brain active, mutant-selective OMNI-EGFR inhibitor designed to address a broad spectrum of EGFR mutations, including classical mutations, on-target resistance mutations such as C797S (with or without T790M), atypical mutations and exon 20 insertion mutations.

"BH-30643 represents a potentially important advancement in the evolution of targeted therapies for treating EGFR mutant NSCLC," said Xiuning Le, M.D., Ph.D., Associate Professor in Medical Oncology at the MD Anderson Cancer Center. "Using a novel macrocyclic approach, BH-30643 has the potential to impact multiple clinically relevant EGFR mutation classes while minimizing inhibition of wild-type EGFR. The response data we are presenting at ASCO (Free ASCO Whitepaper) are encouraging – in a heavily pretreated Phase 1 dose escalation/backfill population, in patients with brain metastases, and even in the difficult-to-treat C797S/T790M population. These findings suggest BH-30643’s potential to address a significant unmet need for patients, especially those whose disease has progressed on prior EGFR TKIs."

"These Phase 1 dose escalation/backfill data demonstrated encouraging clinical activity for BH-30643, with a favorable tolerability profile in the setting of high PK exposures, and with responses observed across a broad range of EGFR genotypes," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "Importantly, we are seeing confirmed responses in patients harboring C797S resistance mutations, a population where current treatment options remain limited and outcomes are poor. We believe these findings support the potential for BH-30643 to address significant unmet need. Phase 1 dose expansion is ongoing to determine the recommended Phase 2 dose and support further clinical development, with an initial focus on patients with C797S-positive resistance."

Key presentation highlights to include:

Preliminary results (March 2, 2026, data cut, with efficacy follow-up through April 29, 2026) from the Phase 1 dose escalation/backfill in Phase 1/2 SOLARA trial in patients with heavily pretreated and heterogeneous EGFR-mutant NSCLC. The Phase 1 dose escalation/backfill portion enrolled 82 patients (median of 3 prior lines of therapy, 66% with history of brain metastases, and 71% ECOG=1) across dose cohorts ranging from 20 mg to 160 mg total daily dose of BH-30643.
High plasma exposures were observed that exceeded target EC90 at candidate doses.
BH-30643 demonstrated a favorable tolerability profile with primarily low-grade EGFR wildtype toxicity as well as asymptomatic Gilbert’s-like bilirubin elevation; Grade ≥2 EGFR-wildtype treatment related adverse events (TRAEs) were reported in 27% of patients. No clinically significant cardiac effects were seen.
Responses and prolonged stable disease were observed across diverse EGFR genotypes in a heavily pretreated Phase 1 cohort, suggesting effective targeting of on-target resistance.
32 patients with C797S mutations were response evaluable across escalation and expansion cohorts; favorable overall response rate (ORR, confirmed or unconfirmed and ongoing) were seen both without prior chemo (50%) and with prior chemo (39%).
Responses were observed with or without concurrent T790M and with or without prior history of brain metastases
Robust C797S and T790M ctDNA clearance was observed in the context of diverse EGFR driver mutations including exon 19 del or indel, L858R, G719X, and exon20ins

Presentation Details
Abstract Title: First-in-human trial of BH-30643, a novel macrocyclic, non-covalent, mutant-selective OMNI-EGFR inhibitor, in EGFR-mutant (EGFRm) NSCLC
Abstract Number: 3014
Session Type/Title: Rapid Oral Abstract Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: June 2, 2026, at 9:45 AM – 11:15 AM CDT / 10:45 AM-12:15 PM EDT

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, mutant-selective, OMNI-EGFR inhibitor. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical activating mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR.

BH-30643 is currently being evaluated in the Phase 1/2 SOLARA clinical trial in adults with locally advanced or metastatic NSCLC harboring EGFR or HER2 mutations. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

(Press release, BlossomHill Therapeutics, MAY 21, 2026, View Source [SID1234665993])

HiberCell to Present Preliminary Results from the Phase 1b Trial of GCN2 Activator HC-7366 when Combined with WELIREG® (belzutifan) for the Treatment of Late-Line Clear Cell Renal Cell Carcinoma (ccRCC) at the Upcoming 2026 ASCO Annual Meeting

On May 21, 2026 HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics targeting the integrated stress response (ISR) to address cancer relapse, metastasis, and resistance, reported that preliminary results from its ongoing Phase 1b study (NCT06234605) of HC-7366 in combination with WELIREG (belzutifan), Merck’s (known as MSD outside of the United States and Canada) oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, will be presented in two poster presentations at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The study is evaluating HC-7366, an activator of the ISR kinase GCN2, in patients with advanced clear cell renal cell carcinoma (ccRCC) whose disease progressed after prior PD-1/PD-L1 checkpoint inhibitor and VEGF-tyrosine kinase inhibitor (VEGF-TKI) therapy.

"These preliminary results from the Phase 1b study are encouraging," said Robert Motzer, M.D., lead principal investigator for the study. "In a patient population with limited treatment options following checkpoint inhibitor and VEGF-TKI therapy, the combination of HC-7366 and belzutifan demonstrated a manageable safety profile and early signals of disease control that warrant further investigation."

"The data from our dose escalation and expansion cohorts suggest that HC-7366 in combination with belzutifan is generally well tolerated, with preliminary efficacy findings that are consistent with our preclinical hypotheses," said Nandita Bose, Ph.D., Chief Development Officer of HiberCell. "While these are early results, the observed response rates and pharmacodynamic evidence of pathway engagement provide a reasonable basis for continuing evaluation in our Expansion 2 cohort."

Abstract 4534 – A phase 1b, open-label, safety, tolerability, and efficacy study of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic renal cell carcinoma.

The study enrolled patients with advanced ccRCC previously treated with ≥1 anti-PD-1/PD-L1 and ≥1 VEGF-TKI. As of the later data cutoff date for the poster presentation, April 23, 2026, 69 patients received study treatment: 16 monotherapy and 53 as part of dose escalation/Expansion 1 of HC-7366 in combination with belzutifan (7 at 20 mg, 22 at 40 mg, 24 at 60 mg with 120 mg belzutifan). Expansion 2 in ~20 patients is fully enrolled and follow-up is ongoing.

The median number of prior therapies was 3 (range 1-5) in monotherapy and 2 (range 1-4) in combination. Most TEAEs were Grade 1-2. Grade 3 events were mainly hematological (anemia) and gastrointestinal (nausea and diarrhea), with one DLT (Grade 3 nausea, 40 mg combination).

In efficacy-evaluable patients, the 40 mg combination (median follow-up of 13.3 months) demonstrated a best overall response rate (BORR) of 37%, including a confirmed ORR (cORR) of 26%, disease control rate (DCR) of 89%, and primary progressive disease (PD) rate of 11%. The 60 mg combination (median follow-up of 10.9 months) had a BORR and cORR of 37%, DCR of 84%, and primary PD rate of 16%. In monotherapy, BORR of 15% and DCR of 62% were observed. Early efficacy signals at 40–60 mg align with the preclinical projected optimal efficacious dose range.

Overall, HC-7366, alone or in combination with belzutifan, was generally well tolerated. Preliminary efficacy analyses indicate favorable disease control, characterized by a high DCR and low primary PD for the combination.

Abstract 4535 – Combining HC-7366 with belzutifan in patients with renal cell carcinoma to alter tumor and microenvironment: Pharmacokinetic and pharmacodynamic (PK/PD) analysis of a phase 1b study.

Findings from a robust translational program, including pharmacokinetic and pharmacodynamic analyses from paired tumor biopsies and systemic biomarker assessments, demonstrated clear evidence of HC-7366 pathway engagement and a differential pharmacodynamic biomarker profile distinguishing monotherapy from the combination. Notably, several favorable changes countering ccRCC biology were observed, including sustained inhibition of the HIF-2 target EPO, reduction of HIF-1α, cell cycle inhibition, and modulation of pro- and anti-tumor adipokines. Modulation of angiogenic and immune-related pathways further supports the scientific rationale for evaluating HC-7366/belzutifan in combination with immune checkpoint inhibitors and/or VEGF-TKIs.

WELIREG is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About HC-7366

HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with various standard-of-care agents in preclinical models of both solid and liquid tumors. HC-7366 is currently under clinical development in Phase 1b studies in ccRCC and acute myeloid leukemia (AML).

(Press release, HiberCell, MAY 21, 2026, View Source [SID1234665992])

Rgenta Therapeutics Presents Positive Preliminary Data from Ongoing Phase 1a/b Clinical Trial of RGT-61159 in Patients with Adenoid Cystic Carcinoma and Colorectal Cancer at the 2026 ASCO Meeting

On May 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 positive preliminary data from its ongoing Phase 1a/b clinical trial of RGT-61159, an oral small molecule targeting MYB, in patients with advanced, relapsed or refractory adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting being held this week in Chicago. The early data supports promising and durable anti-tumor activity in advanced ACC, demonstrated MYB target engagement and an attractive, well-tolerated safety profile at RP2Ds for once-daily oral administration of RGT-61159.

"While still early, these data are encouraging and supportive of the potential of RGT-61159 as a promising anti-tumor agent with a favorable safety profile in a particularly aggressive form of cancer, ACC," said Dr. Ho, M.D., Chief of Head and Neck Medical Oncology at Memorial Sloan Kettering Cancer Center. "Further, these data demonstrate that RGT-61159 knockdown of MYB protein, an oncogene that drives cancer progression, is a promising approach for treating cancers that over-express MYB. I look forward to the final results from this study and seeing the continued maturity of efficacy, safety and durability data."

Simon Xi, Ph.D., co-founder and chief executive officer of Rgenta added, "These are the first clinical data generated for RGT-61159 and we are pleased with the early results showing an impressive disease control rate and anti-tumor activity in ACC that deepens over time. In addition, RGT-61159 has demonstrated a favorable, well-tolerated safety profile. We look forward to initially advancing RGT-61159 into further development in ACC, an indication with a high unmet need, and plan to expand into other MYB-driven cancers in the future."

Rgenta’s Phase 1a/b clinical trial of RGT-61159 is a multi-center, open-label dose escalation and expansion study in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is evaluating 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).

Preliminary data from the initial patients in the trial showed clinically meaningful disease control of 84.6% in 39 evaluable patients, with 3 patients achieving partial response according to RECIST criteria (2 confirmed). Responses continued to deepen with longer treatment duration. Patients with partial responses have remained on study for a mean of 8.2 months, while all ongoing patients across the trial have a mean on-study duration of 7.3 months. RGT-61159 was well tolerated with the most common adverse events being fatigue, anemia, diarrhea and nausea.

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 oncogenic MYB protein production, which has the potential to inhibit proliferation or induce cell death of cancer cells that overexpress MYB protein. MYB acts as a master regulator of cell proliferation differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer.

About Adenoid Cystic Carcinoma (ACC)
It is estimated that approximately 200,000 people are living with ACC throughout the world including 11,000 in the US. While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. There is thus an unmet medical need for new therapeutic targets and treatment strategies for patients with this fatal cancer.

About Colorectal Cancer (CRC)
CRC is the third most prevalent cancer and the second leading cause of cancer-related mortality worldwide. According to the World Health Organization, in 2022, more than 1.9 million cases of CRC were diagnosed. Despite the improved early detection of CRC and the recent success of targeted therapeutics, approximately 15%-30% of patients present with metastases and 20%-50% of patients with initially localized disease will develop metastases. Patients with relapsed or refractory CRC who have exhausted all the available standard of care therapy options, have a very poor prognosis. MYB is significantly overexpressed in 80-85% of CRC and has been frequently found to be a predictive biomarker of tumor aggressiveness and poor prognosis. Developing novel therapies to treat patients with metastatic CRC remains a major unmet medical need.

(Press release, Rgenta Therapeutics, MAY 21, 2026, View Source [SID1234665991])

Ficerafusp Alfa Plus Pembrolizumab Demonstrated Differentiated Three-Year Overall Survival and Deep Responses Driven by TGF-β Inhibition in 1L R/M HPV-Negative HNSCC

On May 21, 2026 Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, reported extended follow-up data out to three years from the Phase 1/1b study of ficerafusp alfa in combination with pembrolizumab in first-line (1L) recurrent/metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). The data, which included the 750mg weekly (QW), 1500mg QW, and 2000mg every-other-week (Q2W) expansion cohorts, demonstrated deep, durable responses observed to be driven by TGF-β inhibition. The data will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

Ficerafusp alfa is a bifunctional epidermal growth factor receptor (EGFR)-directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap designed to enable increased tumor penetration to drive deep and durable responses and potentially improve survival outcomes. Bicara is currently evaluating ficerafusp alfa at 1500mg QW in combination with pembrolizumab in the Phase 3 portion of the ongoing FORTIFI-HN01 pivotal study. Additionally, the company plans to initiate a study evaluating a 12-week loading dose followed by a 2250mg every-three-weeks maintenance dose regimen in the third quarter of 2026 to support long-term administration.

"Ficerafusp alfa continued to deliver deep, durable responses with up to three years of follow-up in 1L R/M HPV-negative HNSCC, reinforcing its best-in-class potential in this setting. At our pivotal study dose of 1500mg QW, an estimated one in three patients was alive at three years – approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients," said Bill Schelman, M.D., Ph.D., Chief Medical Officer of Bicara Therapeutics. "TGF-β inhibition was observed to be the mechanistic foundation of this clinical benefit: driving tumor penetration, enabling immune cell infiltration, and translating depth of response into durable, long-term survival – a clinical profile no other EGFR-directed therapy in head and neck cancer has demonstrated."

Up to three years of follow-up reinforces ficerafusp alfa’s best-in-class potential in 1L R/M HPV-negative HNSCC

Across all dose cohorts of ficerafusp alfa in combination with pembrolizumab, the data demonstrated deep, durable responses and a generally well-tolerated safety profile. All three dose cohorts also demonstrated clinically meaningful duration of response (DOR), progression-free survival (PFS) and overall survival (OS), representing substantial improvements over standard of care treatment.

Notably, complete response (CR) rates have continued to mature across all three cohorts since prior data presentation – increasing to 13% at 750mg QW, 25% at 1500mg QW, and 30% at 2000mg Q2W as of the March 31, 2026 data snapshot.

Additionally, deep responses of at least 80% tumor shrinkage were observed at doses of ficerafusp alfa that resulted in greater TGF-β inhibition and tumor penetration, with more than three-fourths of responders in the 1500mg QW and 2000mg Q2W cohorts achieving deep responses.

Three-year follow-up from the 1500mg QW dose cohort, as of the March 31, 2026 data snapshot, showed an estimated OS rate of 31%, approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients.1

Table 1. Key Efficacy Results Across Ficerafusp Alfa Dose Cohorts in Combination with Pembrolizumab in 1L R/M HPV-Negative HNSCC

750mg QW
(n=30) 1500mg QW
(n=28) 2000mg Q2W
(n=27)
Confirmed overall response rate 57% 54% 48%
CR rate 13% 25% 30%
Deep (≥80%) responses 47% 80% 77%
Median time to response 1.6 months 1.4 months 1.6 months
Median DOR NR (>16.6 months) 21.7 months NR (>12.8 months)
Median PFS 6.9 months 9.9 months 12.7 months
Median OS NM (>19.4 months) 21.3 months NM (>12.7 months; >23.6 months in patients with > 2-year follow-up)*
Data snapshot as of March 31, 2026. NR = not reached; NM = not mature
*Data maturation reflects a bimodal enrollment distribution: in the initial 15 efficacy evaluable patients (median follow-up: 27 months) median OS is not mature but has surpassed 23.6 months. The remaining 12 efficacy evaluable patients had a median follow-up of 11.7 months.

TGF-β inhibition drove depth and durability of response

Biomarker analyses across all three dose cohorts demonstrated sustained TGF-β inhibition and immune activation with ficerafusp alfa, reinforcing the mechanistic link between intra-tumoral TGF-β inhibition, immune activation, and the deep, durable responses.

Deep responses translated to improved durability and long-term outcomes for patients

Ficerafusp alfa’s depth of response, as demonstrated by CR rates and proportion of deep responders, has been well-established and is clinically differentiating. The updated data further reinforced depth of response as a driver of long-term outcomes in patients with 1L R/M HPV-negative HNSCC. Across a pooled cohort analysis, two-thirds of responders achieved deep responses of greater than 80% tumor shrinkage and experienced more durable disease control, with meaningfully longer DOR, PFS, and OS compared to patients with partial responses of less than 80% tumor shrinkage.

Across the pooled analysis comparing deep responders to partial responders of less than 80% tumor shrinkage, deep responders demonstrated:

A median DOR of 31.6 months;
A median PFS of 36.9 months, with a 65% reduction in the risk of disease progression or death; and
A median OS that has not been reached, with a 63% reduction in the risk of death.
This updated dataset provides compelling evidence for depth of response as a clinical surrogate for differentiated long-term outcomes with ficerafusp alfa treatment.

ASCO 2026 Poster Presentations
Annual Meeting | Chicago, IL | May 30 – June 3, 2026

Poster 1 (Wong et al.): Sustained Depth and Durability of Response with TGF-β Trapping in 1L R/M HPV-Negative HNSCC
Sustained depth and durability of response with TGF-β trapping in recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC): Long-term results from two expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab
Authors: Wong DJ, et al. | Abstract #6040 | Poster Board: 497 | May 30, 2026, 1:30-4:30 p.m. CDT

Poster 2 (Kaczmar et al.): Impact of Depth of Response on Long-Term Clinical Outcomes
The impact of depth of response on long-term clinical outcomes: Exploratory analyses from multiple expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab in first-line recurrent/metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC)
Authors: Kaczmar J, et al. | Abstract #6058| Poster Board: 515 | May 30, 2026, 1:30-4:30 p.m. CDT

Poster 3 (Ferrarotto et al.): FORTIFI-HN01 Trial in Progress
A multicenter, randomized, double-blind, phase 2/3 study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab for first-line treatment of PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma: FORTIFI-HN01
Authors: Ferrarotto R, et al. | Abstract #TPS6129| Poster Board: 584A | May 30, 2026, 1:30-4:30 p.m. CDT

1. Based on a retrospective analysis of Supplementary Figure 1C, Vasiliadou, Ifigenia, et al. International Journal of Cancer 155.5 (2024): 883-893. No head-to-head studies have been conducted, and cross-trial comparisons differences in molecule composition, trial design, and patient population and characteristics.

Conference Call Information
Bicara will host a live conference call and webcast on Friday, May 22, 2026 at 8:30 a.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event.

About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients’ quality of life.

About Ficerafusp Alfa
Ficerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC.

(Press release, Bicara Therapeutics, MAY 21, 2026, View Source [SID1234665990])

Asher Biotherapeutics Announces Two Presentations at the ASCO 2026 Annual Meeting Highlighting Clinical Progress Across Its CD8-Targeted Cytokine Pipeline

On May 21, 2026 Asher Biotherapeutics (Asher Bio), a clinical-stage biotechnology company developing precisely-targeted immunotherapies for cancer, reported two upcoming presentations at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 29 – June 2, 2026 in Chicago.

The presentations will include updated clinical data from the phase 1A/B study of AB248, Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, alone and in combination with pembrolizumab in patients with advanced solid tumor malignancies, as well as a trials-in-progress report from the ongoing phase 1 study of AB821, Asher Bio’s CD8-targeted interleukin-21(IL-21) immunotherapy candidate, in patients with locally advanced or metastatic melanoma and other solid tumor malignancies.

"AB248 and AB821 were each designed to address historical limitations of cytokine therapy by selectively activating CD8+ T cells while avoiding the broader immune activation associated with conventional cytokines," said Ivana Djuretic, Ph.D., chief executive officer and co-founder of Asher Bio. "Together, these programs are designed to selectively deliver complementary IL-2 and IL-21 biology to CD8+ T cells, with the goal of providing the proliferative and functional signals needed to drive potent antitumor immunity. Updated data to be presented at ASCO (Free ASCO Whitepaper) continue to support the differentiated profile of AB248, with robust and selective CD8+ T-cell expansion, encouraging antitumor activity in a heavily pretreated melanoma population and a tolerability profile that supports further evaluation. In addition, the evaluation and trial design for AB821 highlight the broader potential of our CD8-targeted cytokine platform, including the potential to use these drugs in combination with each other."

AB248 (Etakafusp alfa)

As of the most recent data cutoff, AB248 demonstrates robust and dose-dependent pharmacologic activity, including preferential CD8+ T cell expansion of approximately 20-fold at higher dose levels. Importantly, this magnitude of CD8+ T cell expansion was achieved without vascular leak or a capillary leak-driven toxicity pattern, a key distinction from high-dose systemic IL-2, where capillary leak syndrome is a recognized dose-limiting toxicity. Across the phase 1A/B study, the most common treatment-emergent adverse events were predominantly grade 1 or 2 and self-limited.

Additionally, AB248 demonstrates anti-tumor activity in patients with immune checkpoint inhibitor-refractory melanoma. In the monotherapy arm, deep and durable responses were observed in two out of 11 patients with cutaneous melanoma treated at higher dose levels (0.3 – 0.5 mg/kg), representing an 18% objective response rate (ORR). In the combination arm with pembrolizumab, seven of 30 patients with IO doublet-refractory melanoma treated with 0.15 – 0.3 mg/kg AB248 achieved an objective response, including 30% of patients treated at 0.3 mg/kg. Activity was observed across melanoma subtypes, including cutaneous melanoma and more difficult-to-treat forms of the disease, such as mucosal and acral melanoma. A maximum tolerated dose (MTD) was not reached with step-up dosing, supporting further evaluation of dose optimization, including the potential to evaluate higher doses.

"These data are particularly encouraging given that patients enrolled in the melanoma cohorts had received extensive prior immunotherapy, including prior checkpoint inhibitor doublets," said Harriet Kluger, M.D., Harvey and Kate Cushing Professor of Medicine (Oncology) and of Dermatology at Yale School of Medicine and chief of the Skin and Kidney Cancer Program at Smilow Cancer Hospital at Yale New Haven. "The observation of responses across cutaneous, mucosal and acral melanoma supports continued development of AB248 in combination with anti-PD-1 therapy, including additional dose optimization and expansion."

AB821

Asher Bio will also present the trial design from the ongoing phase 1 study of AB821, an investigational CD8-targeted IL-21 immunotherapy candidate designed to selectively deliver IL-21 activity to CD8+ T cells. The ongoing study is evaluating AB821 as monotherapy in patients with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Preliminary findings from approximately 10 patients enrolled to date suggest promising pharmacokinetic, pharmacodynamic, tolerability and clinical activity. Emerging results are consistent with preclinical data, including evidence of cis-targeting and pharmacodynamic effects on CD8+ T cells. An amendment evaluating AB821 in combination with AB248 is in development.

"Together, these presentations highlight an important step in advancing our CD8-targeted cytokine portfolio from platform biology into clinical translation," said Edward Garmey, M.D., interim chief medical officer of Asher Bio. "The AB248 data continue to inform dose optimization and combination strategies for CD8-targeted IL-2, while the initial AB821 findings provide an early clinical view of CD8-targeted IL-21. Looking ahead, we are particularly interested in exploring how these complementary cytokine signals may be used individually and potentially together to deepen and extend antitumor responses while maintaining tolerability."

ASCO 2026 Presentation Details

Title: Phase 1A/B study of AB248, a CD8+ selective IL-2 mutein fusion protein, alone or in combination with pembrolizumab, in patients with advanced solid tumor malignancies
Abstract Number: 2616
Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board: 406
Date and Time: Saturday, May 30, 2026, 1:30 – 4:30 p.m. CDT

Title: Phase 1 clinical trial investigating the safety, pharmacokinetics, pharmacodynamics and antitumor activity of AB821 in adult patients with locally advanced or metastatic melanoma and other solid tumor malignancies
Abstract Number: TPS2687
Poster Session: Developmental Therapeutics – Immunotherapy
Poster Board: 466a
Date and Time: Saturday, May 30, 2026, 1:30 – 4:30 p.m. CDT

For more information on these and other abstracts, please visit the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting website.

About AB248
AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T cells, which are the immune cells that drive antitumor efficacy, while avoiding natural killer cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T cells, which are immunosuppressive. Asher Bio is evaluating AB248 in a phase 1A/B clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of AB248 alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. AB248 is also being evaluated in combination with IMDELLTRA (tarlatamab), Amgen’s DLL3-targeting Bispecific T-cell Engager (BiTE) therapy, in an Amgen-sponsored phase 1b trial in patients with extensive-stage small cell lung cancer (ES-SCLC). Please refer to ClinicalTrials.gov, NCT05653882 and NCT07037758, for additional details related to these clinical trials.

About AB821
AB821 is a CD8-targeted IL-21 immunotherapy candidate designed to selectively activate CD8+ T cells, the immune cell type driving antitumor response. AB821 is a fusion protein combining a CD8+ T-cell targeting antibody with a modified IL-21 cytokine designed to prevent binding to other cell types that may drive toxicity or act as a pharmacological sink. In preclinical studies, AB821 enhanced CD8+ T-cell cytotoxicity and memory formation, with potential to reinvigorate exhausted immune responses and generate new antitumor activity, both as monotherapy and in combination with checkpoint inhibitors. AB821 is being evaluated in an ongoing phase 1 clinical trial in patients with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors.

(Press release, Asher Biotherapeutics, MAY 21, 2026, View Source [SID1234665989])