On June 26, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on cancer diagnostics and targeted therapeutics, reported it will present findings related to the discovery of a potential broad-spectrum cancer therapy that is the subject of the Company’s recently issued U.S. Patent No. 12,305,171 and the notification of patent grant from the China National Intellectual Property Administration (Press release, BioAffinity Technologies, JUN 26, 2025, View Source [SID1234654150]).

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The presentation at the 2025 RNA Therapeutics Conference, titled "Silencing CD320 and LRP2 by siRNAs selectively kills cancer cells: mechanistic enigmas," highlights a novel therapeutic approach that uses small interfering RNAs (siRNAs) to selectively kill cancer cells by targeting two specific cell surface receptors, CD320 and LRP2. The data demonstrates that dual suppression of these proteins is highly effective in killing cancer cells while sparing normal cells, offering promising potential for the development of new RNA-based therapies. Research is underway to develop a topical treatment for cutaneous malignancies and neoplasms of the skin.

RNA-based cancer therapeutics represent one of the fastest-growing segments within oncology, driven by the urgent need for more targeted and effective treatments. bioAffinity’s approach, utilizing siRNAs to selectively silence cell surface proteins, holds substantial commercial promise due to its broad-spectrum effectiveness demonstrated across multiple tumor types including lung, breast, prostate, brain, and skin cancers. The potential to develop targeted therapies that could significantly enhance patient outcomes positions the Company favorably within this rapidly expanding market.

David Elzi, PhD, Vice President of Product Development, will present the research on behalf of fellow authors, William Bauta, PhD, Chief Science Officer, and Staff Scientist Reggie Jacob, MS.

"Our studies show that silencing the cell surface receptors CD320 and LRP2 using siRNAs selectively kills or halts the growth of cancer cells while leaving normal cells unaffected," Dr. Elzi said. "This effect was observed across multiple cancer types, regardless of mutation status."

"We’re proud to share this research with the scientific, academic and industry leaders who attend the leading conference on RNA innovation," bioAffinity President and CEO Maria Zannes said. "This work reflects our commitment to developing novel, highly selective treatments in the battle against cancer."

The RNA Therapeutics Institute at the University of Massachusetts (UMass) T.H. Chan Medical School in Worcester, MA, leverages RNA biology and clinical research to develop new therapeutics for multiple diseases based on the fundamental mechanisms of cellular RNAs.

On June 25, 2025 Hamlet BioPharma, the pharmaceutical company, specializing in the development of drugs for cancer and infections, reported the successful first in-person meeting with the U.S. Food and Drug Administration (FDA) (Press release, HAMLET Pharma, JUN 25, 2025, View Source [SID1234654118]). The meeting was held on June 24, 2025. The ‘take home message’ from the discussion was a clear pathway to the Phase III trial leading to market approval.

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The Hamlet team summarized the scientific and clinical background and presented data from Hamlet’s successful and recently completed Phase II study (Dec 2024). The impressive data to date in the Alpha1H program was well received by the FDA and the fruitful discussion included the clinical team in Prague and Target Health’s regulatory expertise and leadership.

The discussion proceeded to cover FDA’s helpful feedback on a new Phase III trial design for NMIBC patients, which will support the registration of Alpha1H. Hamlet BioPharma will now incorporate FDA’s input into its Phase III protocol. The company remains on track to initiate the Phase III trial, subject to final protocol agreement and regulatory clearance. The meeting marked a key milestone in the regulatory pathway and provided an opportunity to align with the FDA on key aspects of the trial design.

`’Congratulations to the Hamlet team,” says Adam Harris, MM, RAC, from Target Health, who was regulatory lead for the meeting with the FDA.

"We appreciate the FDA’s engagement and valuable feedback as we continue the late-stage development of Alpha 1H and the treatment of Bladder Cancer," comments Catharina Svanborg, CEO, Hamlet Biopharma. "This meeting brings us one step closer to delivering a new treatment option for patients facing bladder cancer."

On June 25, 2025 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting Smart Allostery platform-identified regulatory sites on proteins referred to as "natural hotspots," reported the presentation of preclinical data from the Company’s interferon regulatory factor 5 (IRF5) program in an oral and poster presentation at the 25th Annual Meeting of the Federation of Clinical Immunology Societies (FOCIS 2025) (Press release, HotSpot Therapeutics, JUN 25, 2025, View Source [SID1234654119]).

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IRF5 is a transcription factor involved in a diverse range of biological activities in which it functions as a master regulator of innate immunity. Genome-wide association studies have established compelling evidence as to the involvement of IRF5 in multiple inflammatory and immune system disorders, including systemic lupus erythematosus, Sjögren’s, rheumatoid arthritis, systemic sclerosis, and myositis. Historical efforts to modulate IRF5 using traditional small molecule approaches have been unsuccessful because IRF5 lacks a traditional active site. Leveraging the Company’s proprietary Smart Allostery platform, HotSpot has discovered potent and selective small molecule IRF5 inhibitors that effectively drug the target.

"Our Smart Allostery platform has yielded highly potent and selective small molecule inhibitors of IRF5, with preclinical in vivo data demonstrating dose-dependent reductions in key biological markers of IRF5 inhibition, as well as efficacy in arthritis disease models," said Geraldine Harriman, Ph.D., Chief Scientific Officer of HotSpot Therapeutics. "With robust genetic and biologic validation implicating IRF5’s role in a range of autoimmune diseases, we look forward to continuing to advance this program with the goal of offering novel, oral treatment options for patients."

The presentation described preclinical data for HotSpot’s Smart Allostery platform-enabled IRF5 program:

HotSpot’s Smart Allostery platform enabled the discovery of potent and selective small molecule inhibitors of IRF5.
HotSpot’s IRF5 inhibitors demonstrated complete, dose-dependent inhibition of IRF5 phosphorylation and nuclear translocation.
HotSpot IRF5 inhibitors demonstrated a reduction in interferon response genes, antigen-specific antibodies, and joint swelling in two in vivo mouse models of arthritis.

On June 25, 2025 Blue Earth Therapeutics reported radiation dosimetry results for its radiohybrid lutetium labelled, PSMA targeted, investigational radioligand therapy at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting (Press release, Blue Earth Therapeutics, JUN 25, 2025, View Source [SID1234654120]). The Phase 1 clinical trial results were presented by Professor James Nagarajah of Radboud University Medical Centre, the Netherlands. Data were evaluated from 34 cycles of treatment across 13 metastatic castrate resistant prostate cancer patients in the radiation dosimetry portion of a Phase 1/2 clinical trial (NCT05413850) of Lutetium (177Lu) rhPSMA-10.1 Injection.

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The abstract can be found here: View Source;sid=46736&abid=146032

The data presented analysed tumour, kidney, salivary gland, and other healthy organ-absorbed radiation doses, and calculated tumour-to-kidney (T:K) and tumour-to salivary gland (T:S) ratios. These data used a tumour dosimetry methodology in which PET or SPECT scans identified lesions for evaluation that is in line with those reported in the literature for other radioligand therapies.

Mean tumour-absorbed dose was 8.87 Gy/GBq
Mean kidney-absorbed dose was 0.30 Gy/GBq
Mean salivary gland-absorbed dose was 0.13 Gy/GBq
The tumour:kidney ratio was 32.09
The tumour:salivary gland ratio was 73.19
An additional "anatomy-based" dosimetry evaluation was also performed, which used tumour volumes defined only on CT scan by a blinded radiologist, thereby capturing all regions of the tumour irrespective of uptake of the drug. In this analysis, the T:K and T:S ratios were 9 and 19, respectively.

David Gauden DPhil, CEO of Blue Earth Therapeutics, said, "Numerous studies across various cancer types have shown the therapeutic value of delivering high radiation doses to tumours. At the same time, due to the risk of normal organ toxicity, one cannot simply administer unlimited amounts of radioactivity to patients. The solution is to develop therapeutic agents that improve the tumour:normal organ ratios so that the proportion of injected radioactivity reaching the tumors is scaled up to maximise efficacy. The Phase 1 dosimetry data being presented here at SNMMI is an important validation of the concept that improved agents are possible. We look forward to the clinical efficacy results from the ongoing Phase 2 portion of the trial. In this phase, we may begin to see benefits driven by the unique properties of the rhPSMA molecule. Additionally, the novel dosing regimen, which is designed to deliver higher cumulative doses of radioactivity with front-loading in the early treatment cycles, could provide further therapeutic advantage."

About metastatic prostate cancer
In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate–Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate–Specific Membrane Antigen–targeted receptor ligand. It is attached to two labelling moieties which may be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

On June 25, 2025 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer (Press release, BioThera Solutions, JUN 25, 2025, View Source;for-the-treatment-of-platinum-resistant-ovarian-cancer-302490679.html [SID1234654121]). The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator’s choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.

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At the Rapid Oral Abstract Session of the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, early clinical data of BAT8006 demonstrated promising results in platinum-resistant ovarian cancer. Among 133 enrolled patients (regardless of FRα expression levels or prior lines of therapy) in the dose-escalation and expansion study, the therapy achieved a median progression-free survival (PFS) of 7.63 months, with an objective response rate (ORR) of 40.7% and disease control rate (DCR) of 80.5%. Importantly, no cases of interstitial lung disease or ocular toxicity were observed. These findings indicate that BAT8006 exhibits significant clinical efficacy and a favorable safety profile, highlighting its strong clinical potential for platinum-resistant ovarian cancer.

Platinum-resistant ovarian cancer remains a significant clinical challenge with poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate (ADC) is approved globally, and its indication is restricted to patients with FRα expression ≥75% (only 25%-30% of the platinum-resistant population). This approved therapy demonstrates limited median progression-free survival (mPFS) and is associated with ocular toxicity.

As one of the first FRα ADCs in China entering a pivotal phase 3 clinical trial, BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients (regardless of FRα expression levels). These promising data suggest BAT8006 may offer a novel therapeutic option for this difficult-to-treat population.