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Hexagon Bio Announces Formation of Clinical Advisory Board of Renowned Breast Cancer Experts to Support Development of HEX-360, a Next-Generation HER2-Targeting ADC

On June 22, 2026 Hexagon Bio, a biopharmaceutical company pioneering the discovery of novel small molecule payloads for antibody-drug conjugates (ADCs), reported the formation of a clinical advisory board (CAB) consisting of leading experts in the treatment and investigation of new therapies for breast cancer.

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CAB Members:

Hope Rugo, M.D., Division Chief of Breast Medical Oncology and a Professor of Medical Oncology and Therapeutics Research at City of Hope, Los Angeles, California, USA
Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research at Sarah Cannon Research Institute, Nashville, Tennessee, USA
Javier Cortes, M.D., Ph.D., Co-founder and Scientific Director of IOB Institute of Oncology, Madrid, Spain

Hexagon Bio’s CAB members will provide strategic guidance as the company advances its lead development candidate, HEX-360, toward first-in-human study. HEX-360 is a HER2-targeting ADC that features a novel translation inhibitor payload discovered by Hexagon Bio.

Current ADCs primarily deliver chemotherapeutic payloads for cancer cell killing, which often are associated with poor tolerability and patients’ development of resistance mechanisms. Conversely, HEX-360’s payload is designed to suppress oncogenic protein production, offering the potential for enhanced tolerability and the ability to overcome resistance mechanisms. In preclinical studies, HEX-360 has demonstrated a differentiated profile compared to topoisomerase inhibitor- and tubulin inhibitor-based ADCs.

"We are excited to welcome our distinguished Clinical Advisory Board members, and look forward to their expert input and guidance as we rapidly advance HEX-360 toward planned clinic entry next year," said Maureen Hillenmeyer, Ph.D., Chief Executive Officer at Hexagon Bio. "By targeting translation, a key vulnerability in oncogene-driven tumors, HEX-360 has a mechanistically distinct ADC payload and the potential to be a much-needed therapeutic option for patients who have progressed on or cannot tolerate current treatments for HER2-positive cancers."

"ADCs represent a significant advance in cancer care. But, unfortunately, most patients with advanced breast cancer treated with today’s approved ADCs will eventually relapse primarily due to the development of payload resistance. The development of novel payload mechanisms to overcome these resistance mechanisms is critical to improving patient outcomes," said Hope Rugo, M.D., Chief of Breast Medical Oncology at City of Hope. "I look forward to working with the Hexagon Bio team and my fellow Clinical Advisory Board members as HEX-360 transitions to a clinical-stage candidate for the treatment of breast cancer."

HEX-360 is currently in IND-enabling studies with anticipated initiation of clinical investigation in 1H of 2027.

HEX-360 Preclinical Data Presented at AACR (Free AACR Whitepaper) Annual Meeting 2026

Hexagon Bio recently reported preclinical efficacy and safety data for HEX-360 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlighting the potential of its novel payload to address critical gaps in the current ADC landscape.

Transition inhibitor payload results:

Demonstrates potency at low (≤ 10 nM) concentrations in the majority (>90%) of nearly 200 cell lines tested, including cell lines resistant to topoisomerase and tubulin inhibitors
Has low vulnerability to key mechanisms of payload resistance (e.g., drug efflux)
Has good properties (e.g., permeability, lipophilicity), enabling bystander tumor-cell killing similar to topoisomerase inhibitors

HEX-360 results:

Shows equivalent or superior efficacy to a comparator analogous to ENHERTU administered at matched payload exposure in cell line- and patient-derived xenograft models
Achieves deep and durable response in models resistant to topoisomerase inhibitors
Has favorable PK properties in preclinical species, supporting Q3W dosing in humans
Demonstrates good tolerability in both rat and non-human primates, without the hallmark toxicities observed with topoisomerase inhibitor-based ADCs

(Press release, Hexagon Bio, JUN 22, 2026, View Source [SID1234668901])

Elevar Therapeutics Announces First Patients Dosed in Phase 2 Study of Lirafugratinib Among Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

On June 22, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the first patients were dosed in its global Phase 2 study of lirafugratinib in non-cholangiocarcinoma (CCA) solid tumors with FGFR2 fusion or rearrangement.

"Elevar believes lirafugratinib has much potential as a strong anti-tumor therapy across a wider range of FGFR2 fusion or rearrangement driven tumors. We are committed to do our best to obtain meaningful study results to present to the FDA," said Dong-Gun Kim, chief executive officer of Elevar. "We are pleased that the first patients have been dosed and we look forward to completing enrollment."

The trial, known as ReFocus202 (Protocol ID ELE-4008-202; NCT07359820), is an open-label, single-arm study evaluating the efficacy and safety among a broad scope of tumors containing an FGFR2 fusion or rearrangement. The primary endpoint is objective response rate.

The first patient was dosed at Samsung Medical Center in Seoul, South Korea, and a second patient at Moffitt Cancer Center in Tampa, Florida. The multi-site study is set to take place in the U.S., Korea, the UK, Spain, and France.

"Patients with advanced solid tumors harboring FGFR2 fusions or rearrangements often have limited treatment options, particularly beyond cholangiocarcinoma," said Dr. Richard Kim, ReFocus202 principal investigator and service chief of medical gastrointestinal oncology at Moffitt Cancer Center. "This study gives us an important opportunity to better understand whether selective FGFR2 inhibition with lirafugratinib can benefit a broader group of patients whose tumors are driven by FGFR2 alterations. I am pleased that our team was able to enroll the first patient in the U.S. and contribute to this important effort."

Lirafugratinib received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) for CCA. Priority review of its new drug application for the treatment of patients with CCA with FGFR2 fusion/rearrangement who have received prior therapy is ongoing by the FDA, which set a Prescription Drug User Fee Act date of Sep 27, 2026.

ReFocus202 aims to confirm the tumor-agnostic potential of lirafugratinib in patients with FGFR2 fusion/rearrangement.

In the Phase 1/2 ReFocus study, data from 42 non-CCA solid tumor patients with FGFR2 fusion/rearrangement (13 tumor types) showed meaningful antitumor activity of lirafugratinib. Elevar plans to leverage that dataset, along with data generated under ReFocus202, to conduct an interim analysis across at least seven tumor types with at least five patients per tumor type.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib

Lirafugratinib (RLY-4008) is a potent, selective, and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JUN 22, 2026, View Source [SID1234668900])

bioAffinity Technologies Reports Positive Preclinical Findings Showing Proprietary Gene Silencing Technology Is Selectively Cytotoxic to Squamous Skin Cancer Cells Without Harming Healthy Cells

On June 22, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics and targeted therapeutics, reported it will present preclinical findings for a novel therapeutic approach that uses small interfering RNAs (siRNAs) that kill squamous and basal skin cancer cells in vitro while leaving non-cancerous skin cells unharmed.

The newly released findings support the Company’s efforts to develop topical treatments for squamous cell and basal cell carcinoma, two of the most common forms of skin cancer. An estimated 5.4 million cases of these skin cancers are diagnosed every year in the U.S., according to the American Cancer Society. Although surgery is the standard treatment, many patients require additional intervention because of incomplete resection, in which all of the cancerous tissue is not removed, or the risk of recurrence. To date, there is no commercial topical siRNA therapy specifically indicated for basal cell or squamous cell carcinoma.

David J. Elzi, PhD, bioAffinity Technologies Vice President of Product Development, will present the Company’s research at the 2026 RNA Therapeutics (RNATx) Symposium. RNATx brings together researchers, biotech/pharma, clinicians and industry focused on RNA therapeutics, oligonucleotides, mRNA, siRNA, gene editing and translational medicine.

"Basal cell and cutaneous squamous cell carcinomas are among the most common cancers we treat," said surgical oncologist Rosa Cuenca, MD, who is not affiliated with bioAffinity Technologies. "Unfortunately, surgical removal is not always the end of the story. A topical therapeutic that selectively targets malignant cells while preserving healthy skin could potentially expand our treatment options, particularly for patients with recurrent lesions or cosmetically sensitive tumors."

The research builds on earlier findings showing that siRNA silencing of two specific cell surface receptors, CD320 and LRP2, impaired cell viability across multiple cancer cell lines in vitro – including lung, breast, prostate, brain, and skin cancer – while sparing healthy primary cells. That discovery is the subject of U.S. Patent No. 12,305,171, "Compositions and Methods for Treating Cancer," issued in 2025.

"Our in vitro findings indicate that silencing specific cell surface receptors was selectively cytotoxic to or impaired the proliferation of squamous skin cancer cells while leaving normal skin cells unaffected," Dr. Elzi said. "The selectivity observed in these preclinical studies suggests the potential for further development of noninvasive, targeted topical approaches for common cutaneous cancers, subject to further research and regulatory review."

"Our preclinical results represent an encouraging step toward developing less-invasive treatments for some of the most common cancers affecting patients today," said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. "This research reinforces our innovative approach to cancer treatments and expands our mission to improve cancer outcomes by developing technologies designed to detect and treat cancer earlier and more precisely."

In the in vitro study, researchers synthesized siRNAs targeting specific cell receptors and transfected them into squamous and basal skin cancer cell lines and non-cancerous skin cells. Non-cancerous skin cells were unaffected by silencing the receptors, while squamous and basal skin cancer cell proliferation was significantly impaired. Microscopic analysis corroborated these findings, demonstrating cancer cell cytotoxicity following treatment without observable harm to healthy cells. These results were obtained in controlled laboratory conditions and may not be predictive of results in human clinical trials. The Company’s preclinical findings have not been tested in humans, and no Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA).

About the Research

The poster, "siRNAs targeting CD320 and LRP2 are selectively cytotoxic to squamous skin cancer cells while leaving normal skin cells unharmed," will be presented at RNATx 2026 June 24-26 hosted by the RNA Therapeutics Institute at UMass Chan Medical School in Worcester, MA.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, JUN 22, 2026, View Source [SID1234668899])

One Biosciences Receives BOOST Funding From Paris-Saclay Cancer Cluster to Advance the First Single-Cell Assay Approach for ADC Therapies

On June 22, 2026 One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, reported financial support via a Paris-Saclay Cancer Cluster (PSCC) BOOST grant to develop the first single-cell assay for antibody-drug conjugates (ADC) therapies in oncology.

The rapid growth of ADCs is driving demand for more sophisticated biomarker strategies. By capturing tumor complexity at cellular resolution, single-cell profiling has the potential to enhance patient selection and support the development of next-generation ADCs. Ultimately, it will help match the right patients to the right therapies, maximizing therapeutic benefit.

The PSCC BOOST-funded project seeks to bring a new level of precision to ADC development. It will be conducted in collaboration with Adcytherix, a clinical-stage biotech company developing differentiated ADCs for cancers with high unmet medical need.

The collaboration will combine Adcytherix’s expertise in ADC development with One Biosciences’ AI-powered single-cell profiling technology to analyze tumor samples and explore cellular and molecular signatures associated with treatment response. The long-term objective is to support more precise patient selection and lay the foundation for future companion diagnostic development.

"This grant is an important milestone for One Biosciences and for the broader adoption of single-cell technologies in oncology drug development," said Hedi Ben Brahim, CEO of One Biosciences. "This project enables us to deploy our single-cell platform in the context of an innovative ADC development program with the aim of better understanding treatment response and thereby supporting the development of more precise therapeutic strategies."

Supported by a PSCC BOOST grant, this project aims to position France at the forefront of precision oncology innovation while accelerating the emergence of clinical-grade single-cell companion diagnostics for cancer drug development.

One Biosciences is already accelerated by PSCC and works with many partners within the cluster. This project will further reinforce the company’s ties with the oncology community.

(Press release, One Biosciences, JUN 22, 2026, View Source [SID1234668898])

Pfizer Announces Topline Phase 3 Results for Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

On June 22, 2026 Pfizer Inc. (NYSE: PFE) reported topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) who had received one or more lines of prior therapy.

In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of overall survival (OS) compared to docetaxel.
The safety profile of sigvotatug vedotin was manageable and consistent with prior studies.
Encouragingly, in patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and progression-free survival (PFS) for sigvotatug vedotin over docetaxel.
In the exploratory analysis, no clear IB6 expression-response relationship was observed.
Detailed results from SigVie-002 will be submitted for presentation at a future medical congress.

"Patients with previously treated advanced NSCLC are a historically difficult-to-treat population, and there is clearly more work to be done to improve the outcomes for this population," said Jeff Legos, Chief Oncology Officer, Pfizer. "Although the overall study results did not demonstrate superiority over docetaxel, it is encouraging that second-line patients treated with sigvotatug vedotin achieved strong efficacy outcomes compared to an established standard of care, alongside a manageable safety profile. This observed clinical benefit, along with our Phase 1 combination data in the first-line setting, reinforces our confidence in the potential of the sigvotatug vedotin program, including an ongoing Phase 3 trial in combination with pembrolizumab in first-line advanced NSCLC."

"It is important not to underestimate the activity of docetaxel as a comparator in this setting. Patients enrolled in this trial were heavily pre-treated, with most having previously received both platinum-based chemotherapy and immunotherapy, yet docetaxel continues to provide meaningful clinical benefit. Although the study did not meet its overall survival endpoint, in second-line patients the data suggest a clinically meaningful survival benefit for sigvotatug vedotin over docetaxel, supporting continued scientific evaluation of sigvotatug vedotin in earlier lines in combination with immunotherapy," said Solange Peters, M.D., PhD, Chair of Medical Oncology & Thoracic Cancers Clinic, Lausanne University Hospital, Switzerland. "The ability of sigvotatug vedotin to induce immunogenic cell death provides a strong rationale for combination approaches with immunotherapy, particularly in earlier treatment settings where immune competence is better preserved. In this context, the promising phase 1 efficacy signals observed in treatment-naïve patients with high PD-L1 expression warrant further evaluation and may represent a more effective clinical application of this strategy."

In NSCLC, IB6 is expressed on approximately 90% of tumors. IB6 is associated with poor prognosis. Sigvotatug vedotin is a novel ADC designed for high target selectivity of IB6 and rapid internalization, which may help limit binding to other integrins more likely to be expressed in normal tissues and potentially reduce off-target toxicity.

Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors, including:

An ongoing Phase 3 study evaluating sigvotatug vedotin + pembrolizumab in 1L NSCLC with PD-L1 tumor proportion score (TPS) ≥50%; and
Exploration of sigvotatug vedotin in novel combinations, including with PF’4404, the novel bispecific antibody targeting PD-1 and VEGF, in early-stage lung cancers and other IB6-expressing tumors.
Since the acquisition of Seagen, Pfizer has continued to advance a broad ADC portfolio spanning marketed medicines and pipeline programs. Pfizer is progressing multiple differentiated ADC candidates, including fetrastobart vedotin, a PD-L1–directed ADC currently in Phase 3 in NSCLC, additional IB6-targeted ADCs with alternate payloads, and early-stage candidates exploring novel targets and payloads, including topoisomerase I (Topo1) inhibitors and novel auristatin-based payloads. This breadth reinforces the strength of Pfizer’s Oncology pipeline, including the potential for novel combinations with its investigational PD-1xVEGF bispecific antibody (PF-08634404), supporting the company’s goal of delivering 8 potential Oncology breakthroughs by 2030.

About the SigVie-002 Trial

SigVie-002 (NCT06012435) is an ongoing, open-label randomized, Phase 3, global study evaluating sigvotatug vedotin compared with docetaxel in adult participants with previously treated locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC). Patients were randomized to receive sigvotatug vedotin administered intravenously on Days 1 and 15 of each 28-day cycle or docetaxel administered intravenously on Day 1 of each 21-day cycle.

The primary endpoint of this trial is overall survival (OS). The study enrolled 703 participants. Descriptive, secondary endpoints include progression-free survival (PFS), confirmed objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 as assessed by blinded independent central review (BICR).

For more information, visit ClinicalTrials.gov and reference NCT06012435.

(Press release, Pfizer, JUN 22, 2026, View Source [SID1234668897])