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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.

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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])

Knoa Pharma to Present Pipeline Assets at BIO International Convention 2026

On June 22, 2026 Knoa Pharma LLC ("Knoa Pharma"), a public health-focused pharmaceutical company dedicated to supporting patients and improving public health, reported it will present its pipeline assets at the BIO International Convention 2026 in San Diego, Calif., on Tuesday, June 23, at 10:30 a.m. PT in Theatre 1. Knoa Pharma is actively seeking partnerships to advance the development of investigational therapeutics for multiple assets across several disease areas including genitourinary disorders, substance use disorders, and oncology.
The company is discussing two assets, sunobinop and tinostamustine, both of which could present substantial revenue opportunities.*

Tinostamustine is a novel, first-in-class investigational drug combining DNA alkylating activity and HDAC inhibition in a single molecule. It has the potential to be a first-line agent to treat patients with glioblastoma (GBM), a highly aggressive form of brain cancer. In Phase 1 studies as an adjuvant to standard chemoradiation, tinostamustine showed promising activity in difficult-to-treat newly diagnosed patients. The drug has received orphan drug designation from FDA and has the potential to be the first new pharmacologic treatment option for GBM in more than 20 years. In Phase 1/2 clinical trials, tinostamustine has also shown promise in multiple other solid and hematological tumors.

Currently, tinostamustine is also a part of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447), sponsored by the Global Coalition for Adaptive Research. This is a seamless phase 2/3 study conducted under a master protocol enabling multiple therapies or combinations of therapies to be evaluated simultaneously against a shared control arm. With its innovative design and efficient operational infrastructure, data from GBM AGILE can potentially be used as the foundation for new drug applications and registrations to the U.S. FDA and other health authorities.

Sunobinop is a novel, first-in-class nociceptin receptor agonist. The orally active investigational drug is in Phase 1/2 clinical development for multiple indications, including alcohol use disorder (AUD), interstitial cystitis/bladder pain syndrome (IC/BPS), and overactive bladder (OAB). Related to AUD, sunobinop is the only agent intended to address alcohol craving, consumption, and sleep issues; it has the potential to be the first new modality in AUD in almost 20 years. Related to OAB and IC/BPS, sunobinop is a novel, first-in-class agent that targets the sensory nerves in the bladder to affect urination and pain, in addition to reducing nocturia. Both conditions, OAB and IC/BPS, have significant unmet need.

"Our approach is grounded in rigorous R&D and a deep exploration of disease biology to advance innovative therapies for patients facing complex and underserved conditions," said Dr. Julie Ducharme, Chief Scientific Officer, Knoa Pharma. "There are meaningful opportunities to collaborate along the way, and we look forward to partnering with those who share our ambitions."

"At the BIO International Convention, we will showcase our promising pipeline assets that have potential to benefit patients with unmet medical needs," said David Saussy, Head of Licensing and Business Development at Knoa Pharma. "We look forward to and welcome the opportunity to engage with potential partners who share in our commitment to scientific innovation and developing meaningful treatment options."

Companies interested in learning more about Knoa Pharma’s pipeline and partnership opportunities are encouraged to connect with the team during the BIO International Convention 2026. For more information on pipeline products, e-mail [email protected]. View the BIO presentation here.

(Press release, Knoa Pharma, JUN 22, 2026, View Source [SID1234668895])

Ellison Medical Institute and UniQuest enter exclusive license to advance novel prostate cancer therapy toward first-in-human studies

On June 22, 2026 The Ellison Medical Institute (EMI) reported it has entered into an exclusive license with UniQuest, the commercialization company of The University of Queensland (UQ), to advance QED-203, a promising new treatment for advanced and therapy-resistant prostate cancer, toward first-in-human studies.

Developed from research conducted at UQ, QED-203 is a novel small molecule therapeutic designed to address significant unmet needs in metastatic castration-resistant prostate cancer (mCRPC).

Established in 2016, EMI is a Los Angeles-based clinical and research organization advancing cancer research, translational science, and drug development to accelerate the path from scientific discovery to patient impact.

Under the agreement, EMI will lead the continued development of QED-203, applying its integrated capabilities across AI-enabled discovery, translational research, human-relevant preclinical models, and in-house clinical expertise to prepare the program for clinical evaluation. In partnership with UQ, these efforts will reduce risk and accelerate progress toward first-in-human studies in early 2027.

Based on research led by Professor Greg Monteith from UQ’s School of Pharmacy and Pharmaceutical Sciences, QED-203 was developed at the Queensland Emory Drug Discovery Initiative (QEDDI), the small molecule drug discovery group of UniQuest.

The treatment is being developed for metastatic castration-resistant prostate cancer (mCRPC), an advanced form of the disease where patients often have limited treatment options after standard therapies stop working.

QEDDI Head Dr. Brian Dymock said QED-203 was a potential first-in-class therapy targeting TRPV6, a calcium ion channel associated with aggressive prostate cancer.

"Patients with metastatic castration-resistant prostate cancer often face very limited options once existing therapies stop working," Dr. Dymock said. "Our goal has been to develop a novel treatment approach that could ultimately improve clinical outcomes for patients with advanced and therapy-resistant disease."

Dr. Monteith said the deal marked an important milestone and built on more than 15 years of research into the role of calcium signaling in cancer progression.

"It reflects the collaborative work behind a completely new therapeutic approach for patients with advanced disease," Dr. Monteith said.

"We are excited to advance the development of QED-203 to address urgent unmet needs in metastatic prostate cancer and meaningfully benefit patients," said Dr. David Agus, Founding CEO of the Ellison Medical Institute. "EMI is uniquely positioned to push this work forward, with deep expertise in oncology and a translational mission built for programs like this. Together, with UniQuest, we’re bringing expertise and a shared sense of purpose needed to move this work forward for the patients and families who need it most."

UniQuest CEO Dr. Dean Moss said the deal highlighted the strength of QEDDI’s model for translating world-class research at UQ into commercial opportunities with the potential to deliver impact.

"This partnership demonstrates the value of building dedicated drug discovery and translation capability around outstanding university research and pairing it with a development partner equipped to advance promising programs toward the clinic," Dr. Moss said. "QEDDI was established to help transform promising discoveries from UQ into high-quality development candidates, and this partnership with EMI is a strong example of that model in action. Together, we aim to build on this promising science and leverage EMI’s integrated research and development engine to accelerate progress towards the clinic and, in time, to patients."

QED-203 has been supported by the Biomedical Translation Bridge (an initiative of the Medical Research Future Fund delivered by MTPConnect); the Critical Path Institute’s Translational Therapeutics Accelerator; and the National Health and Medical Research Council Development Grant scheme to fund key preclinical studies, manufacturing and safety activities.

(Press release, The Ellison Medical Institute, JUN 22, 2026, View Source [SID1234668894])