Ranok Therapeutics Announces the Publication of Positive Phase 1a Clinical Results for KRAS G12D Inhibitor RNK08954 in Cancer Discovery

On May 11, 2026 Ranok Therapeutics, a clinical-stage biotechnology company developing innovative therapies, reported the publication of preliminary clinical results from its Phase 1a study of RNK08954 in the peer-reviewed journal Cancer Discovery. RNK08954 is a proprietary, highly selective, oral small-molecule inhibitor targeting KRAS G12D mutation in patients with advanced solid tumors.

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The study evaluated the safety, tolerability, and clinical activity of RNK08954 in patients harboring KRAS G12D mutation across multiple sites in China. The study enrolled patients with advanced solid tumors, primarily focusing on safety and the determination of the Recommended Dose for Expansion. A total of 36 patients were evaluable for clinical activity. The overall objective response rate (ORR) was 28%, with a disease control rate (DCR) of 86%. Notably, patients with non-small cell lung cancer (NSCLC) achieved an ORR of 58.33% and a DCR of 100%. RNK08954 was generally well tolerated, with treatment-related adverse events consisting predominantly of Grade 1-2 gastrointestinal adverse events and decreased appetite. No dose-limiting toxicities were observed during the dose-escalation phase. [1]

"I am grateful that the editors of Cancer Discovery selected our study for publication," said Professor Song Zhengbo, Director of Phase I Clinical Trial Unit at Zhejiang Cancer Hospital, and the study’s Principal Investigator. "RNK08954 represents a critical step in advancing KRAS G12D-targeted therapy from concept to clinical validation. These findings not only accelerate the clinical translation of precision oncology but also lay a solid data foundation for subsequent pivotal clinical studies."

"The publication of these data underscores the potential for RNK08954 to provide a meaningful option for KRAS G12D-mutant cancers," commented Dr. Iman Elhariry, Chief Medical Officer at Ranok Therapeutics and co-author of the article. "Seeing a 58.33% objective response rate in the NSCLC cohort is particularly encouraging as it validates our approach of targeting the Switch II pocket with high selectivity. Based on these strong signals of clinical activity and the clean safety profile, we have already initiated our Phase 1b expansion study to further explore the drug’s potential as a monotherapy and in combination regimens across NSCLC, pancreatic and other indications."

Dr. Weiwen, Founder and CEO of Ranok Therapeutics, added: "The significant progress in KRAS inhibitors has been made possible by over a decade of accumulated knowledge in structural biology and medicinal chemistry. These clinical research achievements will inspire our team to further explore the clinical potential of RNK08954, fully unlocking its value for patients who currently lack effective targeted therapies."

About RNK08954 and KRAS G12D

KRAS G12D is one of the most prevalent oncogenic drivers in solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). For decades, this mutation was considered "undruggable". RNK08954 is designed to bind directly to the Switch II pocket of the KRAS G12D protein in its active and inactive states, effectively blocking downstream signaling pathways that drive tumor growth.

(Press release, Ranok Therapeutics, MAY 11, 2026, View Source [SID1234665456])

Eikon Therapeutics Reports First Quarter 2026 Financial Results and Provides Clinical Updates

On May 11, 2026 Eikon Therapeutics, Inc. (Nasdaq: EIKN) ("Eikon"), a late-stage clinical biopharmaceutical company dedicated to developing innovative medicines to address serious unmet medical needs, reported first quarter 2026 financial results and provided updates on its lead clinical programs.

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"We made meaningful progress in the first quarter advancing our oncology programs and expanding the clinical evidence supporting their potential," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics. "We are particularly encouraged by the breadth of data emerging across our pipeline, which will be featured at the ASCO (Free ASCO Whitepaper) annual meeting, and we believe these programs are well positioned to address important unmet needs in oncology. With a strong balance sheet, we remain focused on disciplined execution as we advance toward additional clinical milestones this year."

Clinical Updates
Eikon continues to advance its lead programs and reports the following updates through the end of the first quarter of 2026:

EIK1001 is a systemically administered dual-agonist of Toll-like receptors 7 and 8 designed to stimulate both innate and adaptive immune responses. Phase 1 studies have previously shown that EIK1001 exhibits single-agent activity in patients with advanced malignancy. This mechanism may complement the antitumor immune response engendered by PD-(L)1 blockade. The program continues to advance across multiple clinical trials in melanoma and non-small cell lung cancer ("NSCLC"). Three abstracts have been accepted for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") annual meeting, including an updated data set from a now fully enrolled Phase 2 trial evaluating EIK1001 in combination with pembrolizumab and chemotherapy for NSCLC. The updated data set includes a full interim data readout of the non-squamous cohort and a partial interim data readout of the squamous cohort. In addition, we expect to make a Trial-in-Progress presentation to highlight an ongoing Phase 2/3 trial of EIK1001 in combination with pembrolizumab for advanced melanoma, as well as the initiation of a Phase 2/3 trial in combination with pembrolizumab and chemotherapy for stage 4 NSCLC.

EIK1003 is a next-generation, highly selective PARP1 inhibitor that has been observed to leave PARP2 signaling intact. PARP2 inhibition may be a key driver of the hematological toxicity associated with first generation, non-selective PARP inhibitors. The program is advancing through an ongoing Phase 1/2 trial in patients with breast, ovarian, prostate, or pancreatic cancer. An abstract has been accepted for presentation at the ASCO (Free ASCO Whitepaper) annual meeting, including updated data from Cohort 1A evaluating EIK1003 as a monotherapy and Cohort 1C evaluating EIK1003 in combination with paclitaxel in patients with platinum-resistant ovarian cancer, or breast cancer patients who are either Her-2 negative, ER+, and hormonal therapy-experienced, or ER- and chemotherapy-experienced. The dose escalation portion of the trial has been completed for Cohorts 1A, 1B (in prostate cancer patients in combination with the novel hormonal agent, abiraterone, and prednisone), and 1C, with backfill nearing completion. Separately, the first patient has been dosed in a Phase 2 dose optimization trial. In addition, global site selection has been initiated for Cohort 1D, which will evaluate EIK1003 in combination with paclitaxel and platinum-based chemotherapeutic agents in patients with breast or ovarian cancer.

EIK1005 is a WRN helicase inhibitor with demonstrated in vitro activity in MSI-high cancer cells. EIK1005 was optimized using Eikon’s technology platform, which includes its imaging instruments that permit single molecule tracking in living cells. The program has advanced into clinical development, with a Phase 1/2 trial underway in patients with advanced solid tumors, which began dosing in February 2026. Two abstracts have been accepted for presentation or publication at the ASCO (Free ASCO Whitepaper) annual meeting, including data on pharmacokinetics and pharmacodynamics in healthy volunteers and resulting dose modeling, as well as a Trial-in-Progress presentation for the ongoing Phase 1/2 trial.

First Quarter 2026 Financial Results

Cash Position: As of March 31, 2026, Eikon had cash, cash equivalents, and marketable securities of $596.0 million. Eikon expects its current cash, cash equivalents, and marketable securities, to fund operations into the second half of 2027.

Research and Development ("R&D") expenses: R&D expenses were $70.0 million for the first quarter of 2026 compared to $56.6 million for the first quarter of 2025, an increase of $13.5 million, or 24%. The increase was primarily due to accelerating clinical trial activity and a $5.0 million milestone payment to Impact Therapeutics (Shanghai) Inc. in the first quarter of 2026 for advancement of EIK1003 into Phase 2 development.

General and Administrative ("G&A") expenses: G&A expenses were $17.3 million for the first quarter of 2026 compared to $14.8 million for the first quarter of 2025, an increase of $2.5 million, or 17%. The increase was primarily due to higher depreciation expense following the occupation of Eikon’s Millbrae headquarters in April 2025 and higher professional fees, insurance expenses, and recruitment fees.

Net Loss: Net loss attributable to common stockholders was $83.0 million for the first quarter of 2026, as compared to $74.5 million for the prior-year period.

(Press release, Eikon Therapeutics, MAY 11, 2026, View Source [SID1234665472])

Erasca Reports First Quarter 2026 Business Updates and Financial Results

On May 11, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the fiscal quarter ended March 31, 2026.

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"We continue to execute well across our RAS-targeting franchise, advancing ERAS-0015 clinical development ahead of schedule," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "The best-in-class potential of ERAS-0015 is striking, highlighted by robust responses in patients with KRAS G12X lung or pancreatic cancer, along with favorable safety and tolerability results primarily consisting of low-grade adverse events in our recently reported data. Notably, we believe ERAS-0015 has the potential to become a backbone of combination therapy based in part on the initial panitumumab combination data we shared last month. We continue to advance monotherapy expansion and combination dose escalation cohorts, with data from both anticipated in the first half of 2027."

Dr. Lim continued, "In parallel, our pan-KRAS inhibitor ERAS-4001 is progressing through Phase 1 dose escalation, with preliminary safety, tolerability, pharmacokinetics, and early efficacy data expected in the second half of 2026. We are encouraged by the differentiated potential of our RAS-targeting franchise to meaningfully transform the treatment landscape for RAS-driven cancers and look forward to sharing further updates in the coming months."

Research and Development (R&D) Highlights


Entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Merck: In May 2026, Erasca announced that it had entered into a CTCSA with Merck (known as MSD outside of the United States and Canada) under which ERAS-0015 will be combined with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). Pursuant to the CTCSA, Merck will supply pembrolizumab at no cost, and Erasca will be the trial sponsor.

Robust Preliminary Dose Escalation Monotherapy Data for ERAS-0015: In April 2026, Erasca announced positive preliminary dose escalation data for ERAS-0015 monotherapy including robust response rates in KRAS G12X non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The safety and tolerability results were generally favorable, with mostly low-grade adverse events (AEs), limited dose reductions due to treatment-related adverse events (TRAEs), and no discontinuations due to TRAEs. Pharmacokinetic (PK) data showed dose-dependent exposure with no observed plateau, supporting the selection of 24 mg and 32 mg QD (once daily) as recommended doses for expansion. In addition, encouraging early combination data support the potential of ERAS-0015 in combination with panitumumab. (U.S. monotherapy trial AURORAS-1 data cutoff (DCO) 4Apr2026; China monotherapy trial JYP0015M101 DCO 27Feb2026; U.S. panitumumab combination trial DCO 31Mar2026.)

Initiated Monotherapy Expansion and Combination Dose Escalation: In April 2026, Erasca announced that dose escalation of ERAS-0015 in combination with anti-EGFR monoclonal antibody panitumumab was initiated in the first quarter of 2026 and that the monotherapy expansion cohorts for ERAS-0015 were initiated in the second quarter of 2026. Both of these milestones were completed ahead of the original second half of 2026 guidance.

Entered into a CTCSA with Tango Therapeutics (Tango): In March 2026, Erasca announced that it had entered into a CTCSA with Tango under which ERAS-0015 will be combined with vopimetostat (Tango’s PRMT5 inhibitor). Pursuant to the CTCSA, Erasca will supply ERAS-0015 at no cost, and Tango will be the trial sponsor.

U.S. Composition of Matter Patent Issued for ERAS-4001: In February 2026, Erasca announced that the U.S. Patent and Trademark Office issued patent No. 12,552,813, which protects the composition of matter and related compositions for potentially first-in-class pan-KRAS inhibitor ERAS-4001 until June 2043, absent any patent term adjustments or extensions.

Corporate Highlights


Expanded License Agreement Territory for ERAS-0015:In March 2026, Erasca announced the expansion of its existing licensing agreement with Joyo Pharmatech Co., Ltd. (Joyo) to include China, Hong Kong, and Macau, providing Erasca with worldwide rights to its potential best-in-class pan-RAS molecular glue ERAS-0015.

Completed Upsized Financing: In January 2026, Erasca completed a successful upsized public offering, raising approximately $258.8 million in gross proceeds. The transaction, supported by high-quality new and existing healthcare-focused investors, significantly strengthened Erasca’s balance sheet.

Key Upcoming Milestones


AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RAS-mutant solid tumors
o
Monotherapy expansion data expected in the first half of 2027
o
Combination dose escalation data planned for the first half of 2027

BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRAS-mutant solid tumors
o
Preliminary safety, tolerability, PK, and initial efficacy Phase 1 monotherapy data expected in the second half of 2026
o
Initiation of monotherapy expansion cohorts and combination dose escalation cohorts planned for 2027

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $408.5 million as of March 31, 2026, compared to $341.8 million as of December 31, 2025. Erasca expects its cash, cash equivalents, and marketable securities to fund operations into the second half of 2028.

Research and Development (R&D) Expenses: R&D expenses were $27.3 million for the quarter ended March 31, 2026, compared to $26.0 million for the quarter ended March 31, 2025. The increase was primarily driven by increases in personnel costs, including stock-based compensation expense, and expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by decreases in outsourced services, consulting fees, and facilities-related expenses and depreciation. Erasca also recorded $150.0 million of in-process R&D expense during the quarter ended March 31, 2026 for the exercise of the option to expand its territory to worldwide under Erasca’s ERAS-0015 license agreement.

General and Administrative (G&A) Expenses: G&A expenses were $10.6 million for the quarter ended March 31, 2026, compared to $9.7 million for the quarter ended March 31, 2025. The increase was primarily driven by personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $183.4 million, or $(0.60) per basic and diluted share, for the quarter ended March 31, 2026, compared to $31.0 million, or $(0.11) per basic and diluted share, for the quarter ended March 31, 2025.

(Press release, Erasca, MAY 11, 2026, View Source [SID1234665433])

Leads Biolabs R&D Symposium: Platform Synergy and Multi-Mechanism Integration Reshape the Immuno-Oncology Landscape

On May 11, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs"; Stock Code: 9887.HK) reported its R&D Symposium in Shanghai. Under the theme "Leads Innovation, Future Forward", the event comprehensively presented the Company’s strategic elevation from "multi-platform synergy" to "multi-mechanism integration". Leads Biolabs highlighted its innovation ecosystem propelled by four proprietary technology platforms—IO 2.0, TCE, ADC, and the world-first TDC—alongside milestone advancements in core clinical pipelines, a preclinical pipeline matrix with global first-in-class potential, and forward-looking development roadmaps.

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Dr. Xiaoqiang Kang, Founder, Chairman, and CEO of Leads Biolabs, said: "Focusing on the prevailing unmet clinical needs and core challenges in immuno-oncology (IO), Leads Biolabs has established a differentiated layout by deeply integrating three frontier technologies: IO 2.0, TCE, and ADC. We have constructed a clinical pipeline matrix characterized by multi-mechanism fusion. By adhering to a phased development strategy encompassing single-agent validation, platform iteration, and combination expansion, we aim to systematically surmount clinical barriers such as ‘cold tumors’, immune resistance, and poor response. The year 2027 is poised to witness the launch of the Company’s first commercial product, marking its official transition into the inaugural year of commercialization. Propelled by our robust technology platforms, we aim to advance 20+ novel molecules into clinical trials, progress 4 to 8 assets into late-stage development, and achieve commercialization for 3 products by 2030. These milestones will drive us steadily toward our ultimate vision: ‘Transforming cancer into a manageable chronic disease’."

Clinical Breakthroughs & Value Realization: From Clinical-Stage Biotech to Integrated Biopharma

Since its inception, Leads Biolabs has remained committed to an "asymmetric competition" strategy, taking unaddressed clinical gaps left by PD-(L)1 inhibitors as its strategic cornerstone. By proactively anchoring its research in IO 2.0, the Company has pioneered the synergistic mechanism of "immune checkpoint inhibition plus co-stimulatory signal activation". This approach has successfully propelled LBL-024—a potential global first-in-class (FIC) PD-L1/4-1BB bispecific antibody—to the BLA (Biologics License Application) submission stage.

LBL-024: A Potential IO 2.0 Pan-Tumor Backbone Therapy with Survival Benefit. Utilizing the unique 2:2 molecular structure design of the X-body platform, LBL-024 releases PD-L1-mediated immunosuppression while conditionally activating the 4-1BB co-stimulatory pathway, achieving the synergistic effect of "releasing the brakes and stepping on the accelerator". Clinical studies have confirmed that LBL-024 not only overcomes the global technical challenge of the 4-1BB target, where no drugs have been marketed due to uncontrollable hepatotoxicity, but also demonstrates breakthrough efficacy across multiple cancer types and "cold tumors":

Safety: With over 600 patients enrolled, liver enzyme abnormalities in LBL-024 monotherapy or combination with chemotherapy occurred only in the early stages. No cumulative hepatotoxicity was observed with long-term treatment, and the overall safety profile is similar to that of PD-(L)1 monoclonal antibodies. Dose escalation up to 25.0 mg/kg did not reach the maximum tolerated dose (MTD), and no dose-limiting toxicities (DLTs) were observed.
Pan-cancer Efficacy: LBL-024 has demonstrated global first- or best-in-class potential in registrational or Phase II clinical studies for extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and biliary tract cancer (BTC).
Cold Tumor Efficacy: LBL-024 is poised to become the first approved drug for EP-NEC, a typical cold tumor. In first-line SCLC combined with chemotherapy, the objective response rate (ORR) reached 88.1%, significantly superior to the approximately 60% of standard of care (SoC). It is also effective in PD-L1 low-expression NSCLC, achieving an efficacy breakthrough in populations difficult to cover with PD-1 monoclonal antibodies.
Durable Response: In late-line EP-NEC, the median overall survival (mOS) reached 11.9 months, doubling that of existing regimens. A clear survival benefit trend was also observed in first-line patients, offering the potential for long-term functional cure.
LBL-024 adopts a clear and progressive development strategy: advancing from late-line to first-line, from monotherapy to combination therapy, and from orphan diseases to major indications. Currently, LBL-024 covers 13 solid tumor indications, with one pivotal registrational study and eight proof-of-concept (PoC) studies underway.

LBL-024 is set to reach a series of intensive milestones in the second half of 2026. Regarding data readouts, data from a large patient cohort for first-line NSCLC will be presented at the World Conference on Lung Cancer (WCLC) in September. In October, the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting will feature the pivotal single-arm registrational clinical trial data for late-line EP-NEC, alongside the latest clinical results for first-line EP-NEC, SCLC, and BTC. On the commercialization front, LBL-024 has garnered Breakthrough Therapy Designation (BTD) from the CDE, as well as Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. FDA, and ODD from the European Union. The Company expects to submit the BLA for LBL-024 to the CDE in Q3 2026. The approval of LBL-024 will signify a pivotal milestone in the Company’s transition from a clinical-stage Biotech to an integrated Biopharma.

Platform-Driven, Innovation from the Source: An In-house R&D System Integrating High-Efficiency Multi-functional Platforms and Technical Capabilities

The future of oncology treatment lies in synergy, with combinations such as IO + ADC and TCE + ADC emerging as essential expansion pathways under this prevailing trend. Leads Biolabs is dedicated to expanding the reach of immunotherapy through the deep integration of its platforms. Currently, the Company has established four core technology platforms:

X-body (4-1BB Engager) Platform (IO 2.0): This platform utilizes advanced antibody engineering to create differentiated bispecific antibodies with a 2:2 molecular architecture, successfully addressing the hepatotoxicity and narrow therapeutic window typically associated with 4-1BB agonists.
LeadsBody (CD3 T-cell Engager) Platform (TCE): Designed to enhance efficacy and overcome treatment resistance, the next-generation LeadsBody platform has been clinically validated in hematologic malignancies by the potential best-in-class (BIC) LBL-034 (GPRC5D/CD3 bispecific antibody). For solid tumors, the platform is advancing in three strategic directions: multi-TAA (Tumor-Associated Antigen) targeting, co-stimulatory trispecific TCE, and TCE-ADC.
TOPiKinectics Platform in the ADC Field: The differentiated TOPiKinectics platform possesses full-chain, in-house design capabilities, including payload release within the tumor microenvironment (TME). It enables targeted tumor killing while minimizing off-target toxicity, thereby resolving industry pain points such as the narrow therapeutic window and frequent resistance associated with traditional ADC treatments. Furthermore, it offers advantages such as synergistic anti-tumor effects between ADC and IO.

World-First TDC Platform ImBiTDC (TCE-ADC): Leveraging proprietary antibody platforms and the TOPiKinectics platform, this technology deeply integrates TCE modules targeting tumor-specific antigens with ADC technology. This pioneers a completely new therapeutic track designed to address challenges such as overlapping toxicities and patient compliance issues associated with separate administration in traditional combination regimens. The TDC platform offers two key advantages: broad-spectrum efficacy and optimized safety. Unconstrained by the single mechanisms of either ADC or TCE, it is adaptable to diverse tumor scenarios with varying T-cell infiltration levels, T-cell functional states, and antigen expression abundance. It can efficiently kill high-antigen, high-payload-sensitive tumors, while also covering low-antigen, immunosuppressive patient populations through bystander effects and T-cell redirection. This significantly expands the eligible patient population and substantially reduces the risk of CRS, enhancing efficacy while simultaneously improving safety.

Through the progressive synergy of its technology platforms and the deep integration of multiple mechanisms, Leads Biolabs is constructing an innovative R&D ecosystem characterized by the cross-empowerment of multiple targets, molecule types, and technological routes. This ecosystem aims to lead the next generation of immuno-oncology, ensuring more cancer patients benefit from the continuous evolution of immunotherapy.

(Press release, Nanjing Leads Biolabs, MAY 11, 2026, View Source [SID1234665457])

Pheast Therapeutics Presents Preclinical Data on PHST677, a Novel Bispecific ADC Targeting CDH1 and Nectin-4 at PEGS Boston Summit 2026

On May 11, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing macrophage-directed immunotherapies for cancer, reported the identification of CDH1 (E-cadherin) as a novel immune-activating target for antibody-drug conjugates (ADCs), and the first presentation of preclinical data on PHST677, the company’s CDH1-targeting bispecific ADC, at the PEGS Boston Summit 2026.

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"Today’s presentation marks an important milestone for Pheast, representing the first public disclosure of CDH1 as a novel immune-regulatory ADC target," said Roy Maute, Ph.D., Co-founder and Chief Executive Officer of Pheast Therapeutics. "PHST677, designed to combine immune activation with targeted cytotoxicity, demonstrates how our discovery platform and deep engineering capabilities can unlock targets previously inaccessible to traditional ADC approaches. The data presented also reflects our continued expansion into ADCs and the broadening of our pipeline beyond monoclonal antibodies, highlighting the versality of our platform to generate differentiated therapies across multiple modalities."

CDH1, a cell surface protein previously known for its role in cell-cell adhesion was identified by Pheast’s proprietary functional genomic screening platform as a negative regulator of macrophage phagocytosis. This newly defined role positions CDH1 as a novel immuno-oncology target and reveals significant upregulation across multiple solid tumor types.

An anti-CDH1 monoclonal antibody demonstrated robust single-agent efficacy in preclinical tumor models, providing initial validation of CDH1 as a therapeutic target. Pheast developed PHST677, a bispecific ADC designed to combine CDH1-mediated macrophage-driven tumor clearance with tumor-selective targeting via Nectin-4. Importantly, the cytotoxic payload enables direct killing of tumor cells, complementing immune-mediated clearance.

"What differentiates PHST677 is that the CDH1 arm actively engages the immune system at the tumor site, rather than acting solely as a targeting mechanism," said John S. Burg, Ph.D., Senior Director of Protein Sciences at Pheast Therapeutics. "By combining the CDH1 blockade with Nectin-4-directed payload delivery, we’re pairing direct tumor-killing activity with macrophage activation. Together, these orthogonal mechanisms represent a truly differentiated approach to ADC design."

CDH1 and Nectin-4 are co-expressed across multiple solid tumors, including breast, bladder, colorectal, lung, and gastric cancers. The bispecific design restricts payload delivery to cells expressing both targets, improving selectivity and reducing on-target, off-tumor toxicity. Preclinical studies demonstrated selective internalization and efficacy in breast and bladder cancer xenograft models, supporting the therapeutic potential of PHST677.

Pheast’s pipeline now spans two distinct macrophage checkpoint targets across two modalities. The company’s lead program, PHST001, an anti-CD24 monoclonal antibody, is currently in Phase 1 clinical trials for advanced solid tumors and has received FDA Fast Track Designation for ovarian cancer. The advancement of PHST677 expands Pheast’s footprint into ADCs and reinforces the continued productivity of its discovery platform.

PEGS Boston Summit Presentation Details:

Presentation Title: "Coupling Tumor-Specific Payload Delivery with a Novel Target for Immune Engagement"

Presenter: John Burg, Ph.D., Senior Director of Protein Sciences, Pheast Therapeutics

Session Date & Time: Monday, May 11, 2026 at 11:30 AM ET

About CDH1

CDH1 (E-cadherin) is a cell surface protein that mediates cell-cell adhesion in epithelial tissues and is significantly upregulated in multiple human cancers. Through functional genomic screening, Pheast identified CDH1 as a novel negative regulator of macrophage phagocytosis. CDH1 acts as a "don’t eat me" signal that enables tumor cells to evade innate immune clearance. With no previously published role in immune regulation, CDH1 offers a potentially first-in-class macrophage checkpoint mechanism distinct from known macrophage checkpoints such as the CD47–SIRPα and CD24–Siglec-10 axes. Blocking CDH1 increases tumor cell susceptibility to macrophage-mediated phagocytosis and weakens the cell-cell interactions that would otherwise limit access by immune cells and therapeutic agents. CDH1 is co-expressed with Nectin-4 across multiple solid tumor types, making it a compelling target for combination therapeutic strategies.

(Press release, Pheast Therapeutics, MAY 11, 2026, View Source [SID1234665473])