On May 7, 2025 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys") and Sona Nanotech Inc. (CSE: SONA) (OTC: SNANF) ("Sona") reported that they have entered into a Research Agreement ("Agreement") to collaborate on the development of new cancer therapeutics based on BioVaxys’ DPX Immune Educating Platform ("DPX") in combination with Sona’s Targeted Hyperthermia Therapy ("THT"), a photothermal cancer therapy that uses highly targeted infrared light to treat solid tumors (Press release, BioVaxys Technology, MAY 7, 2025, View Source [SID1234652672]). The heat for THT is delivered to tumors using infrared light that is absorbed by Sona’s proprietary biocompatible Gold Nanorod ("GNR") technology which elicits a strong immune response.

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Carman Giacomantonio, MD, Chief Medical Officer ("CMO") for Sona Nanotech Inc., commented, "Looking beyond our approaching first-in-human Early Feasibility Study clinical trial for our THT cancer therapy, Sona continues to conduct research to build our pipeline of programs to fully exploit the potential of our GNR technology platform. To that end, we’re pleased to enter this research collaboration with BioVaxys whose DPX technology provides a unique delivery system that better presents antigens to the immune system. We believe that DPX, with its immune stimulating properties and antigen presentation capabilities, could be an ideal carrier for the neo-antigens that Sona’s THT enables, thereby accelerating THT’s efficacy and so we look forward to working with the BioVaxys team to quickly assess the potential for technology synergies."

"We are very pleased to have the opportunity to evaluate synergies between our DPX platform and Sona’s THT and GNR technologies, as our collaboration is ideal for advancing the highly promising applications of our respective technologies," says Kenneth Kovan, President and Chief Operating Officer at BioVaxys. "With Sona’s exciting study data and the clinical trial data we have with DPX it’s conceivable that our collaboration could lead to a new and even better treatment for immunotherapy-resistant solid tumors."

The collaboration between BioVaxys and Sona will evaluate the immune stimulatory properties of DPX (without an antigen cargo) administered together with THT, as a characteristic of DPX is that it helps prime the innate immune system which in turn can activate and strengthen the adaptive immune response. The collaboration will also evaluate the combination use of THT together with a DPX formulation as a carrier for novel neoantigens expressed on the surface of tumor cells following immunotherapy, such as with THT. Neoantigens are unique proteins that are not present in healthy tissues that arise from changes in cancer cells and play a crucial role in stimulating anti-tumor immune response. Immunotherapy such as THT can trigger these tumor cell changes and the expression of neoantigens, so packaging a tumor neoantigen in DPX for presentation to the immune system is anticipated to accelerate THT’s efficacy.

The research studies based on the BioVaxys and Sona technologies will be conducted at Dalhousie University, Halifax, Nova Scotia, under the direction of Sona’s CMO, Carman Giacomantonio, MD MSc FRCSC, Division of General and Gastrointestinal Surgery, Department of Pathology, Dalhousie University, and Barry Kennedy, PhD, of the Giacomantonio Immuno-Oncology Research Group at Dalhousie University (the "Principal Investigators").

Each company will contribute their respective technologies for the study with the research costs covered by the Giacomantonio Immuno-Oncology Research Group. Any novel candidate therapeutic developed in this program will be co-owned and co-prosecuted by BioVaxys and Sona, with the parties planning to enter into a commercialization agreement for a vaccine clinical candidate prior to the initiation of any Phase 1 study.

Sona’s current focus for advanced biomedical applications using its biocompatible GNR platform technology with its THT therapy aims to shrink cancerous tumors for certain solid cancers and in so doing trigger a systematic immune response to eliminate both treated and distant, untreated metastases. Sona’s GNRs are uniquely manufactured without the use of CTAB (cetyltrimethylammonium bromide), eliminating the toxicity risks associated with the use of other GNR technologies in medical applications.

In a preclinical study presented at the 19th International Canadian Melanoma Conference in Vancouver this past February, Sona’s research team confirmed that its GNR-based THT causes cancer-specific cell death that activates a strong immune response by the body’s immune system. Of critical importance is evidence that the immunity generated by Sona’s THT is observed in cancers that are known to be resistant to modern immunotherapies. Using an industry standard, immunotherapy resistant, CT-26 colon cancer model, Sona’s THT -activated systemic immunity that, when followed by previously ineffective PD-1 inhibition, demonstrated a 100% response rate in these previously resistant tumors. These findings were published in Frontiers in Immunology and repeated in industry standard preclinical breast cancer and melanoma models.

BioVaxys’ DPX technology is a patented delivery platform that can incorporate a range of bioactive molecules, such as mRNA/polynucleotides, peptides/proteins, virus-like particles, and small molecules, to produce targeted, long-lasting immune responses enabled by various formulated components. The DPX platform, which is non-aqueous and non-systemic, facilitates antigen delivery to regional lymph nodes and has been demonstrated to induce robust and durable T cell and B cell responses in pre-clinical and clinical studies for both cancer and infectious disease. The DPX platform has been proven in multiple Phase 1 and Phase 2 clinical studies across a range of different antigens in oncology and infectious disease applications, and has demonstrated excellent safety and tolerability.

A study conducted by Hakimeh Ebrahimi-Nik, DVM, PhD, of The Ohio State University Comprehensive Cancer Center and Pelotonia Institute for Immuno-Oncology, and presented December by BioVaxys at the Personalized Cancer Vaccine Summit in Boston, compared the immune-stimulating properties of the most commonly used vaccine adjuvants that are frequently given together with cancer immunotherapies to boost their efficacy, against DPX antigen formulations as well as DPX administered just on its own. The DPX formulations were shown to be more effective than any of the popular adjuvants, as effective as the gold standard—bone marrow-derived dendritic cells—and DPX on its own appeared to have meaningful immune stimulating properties.

On May 7, 2025 Hanx Biopharmaceuticals Ltd. (HanxBio), a clinical-stage biotechnology company pioneering next-generation immunotherapies, reported its expanding oncology and autoimmune disease pipeline with five research poster presentations at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago (April 25–30) (Press release, HanX Biopharmaceuticals, MAY 7, 2025, View Source [SID1234652671]). The presentations spotlighted novel bispecific antibodies and a CSF-1R inhibitor, underscoring the company’s leadership in innovative cancer treatment strategies.

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Key Highlights from HanxBio’s AACR (Free AACR Whitepaper) Presentations

1. HX044: A first-in-class (FIC) CTLA-4xSIRPα is a bispecific antibody fusion protein designed to enhance safety and amplify anti-tumor immunity. HX044 targets PD-1-resistant solid tumors (e.g., non-small cell lung cancer, melanoma, renal cell carcinoma). Currently in Phase I trials, it represents a breakthrough in overcoming resistance to existing immunotherapies.

2. HX035: A preclinical OX40-targeting bispecific antibody engineered to address inflammatory and autoimmune diseases. By binding two distinct OX40 epitopes, HX035 aims to achieve best-in-class (BIC) precision in modulating immune responses.

3. HX016-7 & HX016-9: Two preclinical bispecific antibodies targeting PD-L1xVEGF and PD-1xVEGF, respectively. These dual-target therapies aim to disrupt both tumor immune evasion and blood vessel growth (angiogenesis), offering a novel approach to treating solid tumors.

4. HX301 (Narazaciclib): A CSF-1R inhibitor co-developed with Traws Pharma, Inc., now in Phase II trials for glioblastoma. HX301 is being evaluated in combination with temozolomide (TMZ), a standard chemotherapy, to enhance anti-tumor efficacy.

Dr. Henry Li, CEO and CSO of HanxBio, attended and presented posters at the AACR (Free AACR Whitepaper) Annual Conference and he emphasized the company’s progress: "Our AACR (Free AACR Whitepaper) presentations reflect HanxBio’s commitment to redefining cancer and autoimmune disease treatment through cutting-edge bispecific antibody platforms. With HX044 advancing in clinical trials and a robust preclinical pipeline, we are poised to deliver transformative therapies that address critical unmet needs for patients globally." He added, "By targeting multiple pathways simultaneously or by exploring coordinated binding (cis-bindings)—we aim to overcome enhanced activity and safety, thus improving outcomes for hard-to-treat cancers."

On May 7, 2025 SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company pioneering TCR T cell therapy for infectious diseases and associated cancers, reported late-breaking clinical data from its Phase 1 trial evaluating SCG101, autologous HBV-specific TCR-T cell therapy, in patients with advanced HBV-related hepatocellular carcinoma (HCC) (Press release, SCG Cell Therapy, MAY 7, 2025, View Source [SID1234652670]). These data were presented at the European Association for the Study of the Liver (EASL) Congress 2025.

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The results demonstrated that SCG101 led to sustained clearance of serum hepatitis B surface antigen (HBsAg) and HBV-DNA in heavily pre-treated patients with HBV-related HCC. Notably, 94% of patients had received prior nucleoside analogue (NA) antiviral therapy, and 72% presented with liver cirrhosis at baseline. Following a single-dose SCG101 infusion, all treated patients experienced a rapid decline in serum HBsAg, with 94% (16/17) achieving a 1.0–4.6 log₁₀ reduction within 28 days and persisting < 100 lU/mL for up to 1 year. Notably, 4 patients (23.5%) achieved HBsAg loss.

In addition to its antiviral effects, SCG101 demonstrated encouraging antitumor activity. All patients had received at least 2 prior lines of systemic cancer treatment, including immune checkpoint inhibitors. Despite this heavily pre-treated population, 8 out of 17 patients (47%) showed measurable tumour regression. At the time of data cutoff, median overall survival (OS) had not yet been reached.

SCG101 was generally well tolerated, with a good safety profile. Transient alanine aminotransferase (ALT) elevation, consistent with the cytolytic mechanism of SCG101, was observed in 94% of patients and resolved within 14 days. Other common treatment-related adverse events (TRAEs) included cytokine release syndrome (CRS), neutropenia, and thrombocytopenia—all of which were manageable and reversible.

Prof. Dr. Shunda Du, Chief of Liver Surgery Department, Peking Union Medical College Hospital, said: "The dual antiviral and antitumor effects observed with SCG101 are highly promising, especially in this heavily pre-treated patient population. The sustained HBsAg clearance and tumour response suggest that SCG101 may offer a novel immunotherapeutic option for patients with HBV-related HCC, addressing an area of significant unmet clinical need".

HBV remains a major global health burden, affecting over 250 million people worldwide. It is a leading cause of liver cancer, responsible for 50%–80% of hepatocellular carcinoma cases globally.1 Chronic HBV infection leads to the integration of HBV DNA into the host genome, resulting in persistent HBsAg expression, chromosomal instability, and activation of oncogenes, thereby contributing to the development of hepatocellular carcinoma.2

SCG101 is designed to selectively target and eliminate HBV-infected hepatocytes and HCC cells by recognizing specific epitope of HBV surface antigen (HBsAg) presented via the major histocompatibility complex (MHC). By triggering both cytolytic and non-cytolytic mechanisms, SCG101 effectively eliminates HBV-infected hepatocytes as well as premalignant and HBV-HCC cells with HBV-DNA integration.

"These positive data mark an important step forward in the development of SCG101 and validate our approach of harnessing precision T cell therapy to target chronic HBV infection and HBV-related liver cancer," said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "SCG101 is the first TCR-T cell therapy to demonstrate both virologic clearance and tumour regression in HBV-related HCC patients. We are encouraged by the data, and we look forward to advancing SCG101 through further clinical development to bring this potentially curative therapy to patients in need."

About SCG101

SCG101 is an investigational autologous T cell receptor (TCR) T cell therapy designed to selectively target specific epitope of the hepatitis B surface antigen (HBsAg). Powered by SCG’s proprietary GianT TCR screening platform, which enables the discovery of natural, high-affinity, high-avidity TCRs against intracellular antigens presented via the major histocompatibility complex (MHC). SCG101 delivers precise immune-mediated clearance of infected and malignant cells demonstrating significant tumour inhibition and the eradication of HBV covalently closed circular DNA (cccDNA) in preclinical and clinical studies.

About Hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. In 2020, it was estimated that over 905,000 new cases of liver cancer were diagnosed, and more than 830,100 deaths occurred globally, making it one of the leading causes of cancer-related mortality.3 Chronic hepatitis B virus (HBV) infection is responsible for at least 50% of HCC cases worldwide.1 HCC is typically diagnosed at an advanced stage, contributing to a poor prognosis with a five-year survival rate of less than 15%.

On May 7, 2025 PAQ Therapeutics, a biotechnology company developing best- and first-in-class KRAS degraders for patients with lethal cancers lacking effective treatment options, reported the completion of its $39 million Series B funding (Press release, PAQ Therapeutics, MAY 7, 2025, View Source [SID1234652669]). The Series B round was co-led by Bayland Capital and MRL Ventures Fund (MRLV), with participation from Johnson & Johnson Innovation – JJDC, Inc. (JJDC), LAV Fund, BioTrack Capital, and existing investor Sherpa Health Partners.

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The capital raised will fund PAQ’s next stage of clinical development for the company’s lead asset PT0253, a potent and selective degrader of KRAS G12D, a known driver for a range of solid tumors. PT0253 has demonstrated best-in-class potential based on preclinical comparison to existing agents currently in clinical development targeting the same KRAS mutant. In Q1 2025, the first patient was dosed in a Phase 1 study to assess its safety and tolerability.

"The successful completion of our Series B funding and rapid enrollment of our Phase 1 trial in the US for PT0253 mark significant steps forward in our clinical development efforts," said Nan Ji, PhD, PAQ’s co-founder, President, and CEO. "The strong support from our investors validates the potential of our innovative approach. We now turn our focus to executing a robust clinical development plan while continuing to develop a differentiated pipeline of KRAS degraders."

The funds will also support the advancement of the company’s second asset through IND-enabling studies.

"PAQ represents a compelling opportunity to develop transformative therapies for oncology populations with high unmet need," said Olga Danilchanka, Partner, MRLV, the therapeutics-focused corporate venture arm of Merck & Co. "Their innovative efforts advancing the targeted protein degradation modality aligns with our commitment to backing scientifically rigorous teams that tackle pressing medical challenges. We’re confident in PAQ’s ability to unlock the full potential of KRAS degraders and are proud to support their journey toward achieving clinical impact."

"The team at PAQ is at the forefront of an innovative approach to treat some of the most underserved patient populations in oncology," said Yuexing Su, Founding Partner, Bayland Capital. "We were attracted to PAQ based on its scientific approach, preclinical data, and experienced leadership team. We believe there is tremendous potential for KRAS degraders and are excited to be part of PAQ’s next stage of growth."

PAQ Therapeutics was founded in 2020 and completed a $30M Series A financing in 2021. Over the last three years, the PAQ team gained proprietary understanding of KRAS biology, which guided medicinal chemistry to identify KRAS degraders. These programs have the potential to address key limitations of clinical-stage KRAS inhibitors, offering more effective and durable treatments.

On May 7, 2025 Accuray Incorporated (NASDAQ: ARAY) reported that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company’s CyberKnife System in the treatment of prostate cancer at multiple stages of the cancer journey (Press release, Accuray, MAY 7, 2025, View Source [SID1234652668]). The studies, shared at the annual congress held in Vienna, Austria, indicate the system’s accuracy and precision enable treatment of high-risk disease, as well as recurrent prostate cancer following prostatectomy, with stereotactic body radiation therapy (SBRT), expanding access to a non-invasive, short course of care to more men.

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"At this year’s ESTRO meeting important analyses of real-world evidence (RWE) underscored the benefits of our unique robotic and helical platforms, reaffirming their use as patients’ primary care option or along with other modalities such as surgery, chemotherapy or immunotherapy. Stand out studies focused on the company’s CyberKnife System for the treatment of prostate cancer, building on a robust body of clinical data supporting its use and confirming the durability and quality of life after 10 years post-treatment. We’re grateful to the clinicians who continue to evaluate our technologies and advance personalized and precise care of patients through the work that they do," said Suzanne Winter, president and CEO of Accuray.

During the meeting, Accuray hosted a symposium titled, "Integrating Advanced Techniques in Genitourinary Radiotherapy: Harmonizing Precision, Personalization, and Efficacy," attended by 350 healthcare professionals. The event featured global thought leaders who spoke on advancements in the treatment of genitourinary indications – prostate, kidney, and bladder cancers – with radiotherapy. Patient care in these areas is dynamic and evolving rapidly, with SBRT now recognized as a safe and effective alternative to conventional treatments for localized prostate cancer and evidence continuing to build for the use of SBRT in salvage prostate treatments.

CyberKnife Platform: Empowering Advances in Prostate Cancer Patient Care
A retrospective analysis titled, "Long-term outcomes and treatment efficacy in high-risk prostate cancer patients treated with stereotactic extreme hypofractionated radiotherapy," reports on 262 men over the age of 70 or with severe comorbidities who were diagnosed with either non-metastatic high-risk or very high-risk prostate cancer and received SBRT delivered with the CyberKnife System in five sessions. With a median follow-up of 39 months, investigators found that treatment with the system offers a promising option with favorable outcomes and low rates of acute and late urogenital (UG) and gastrointestinal (GI) toxicities.

"Early results from a trial on stereotactic salvage radiotherapy for macroscopic prostate bed recurrence after prostatectomy: STARR (NCT05455736)" is a prospective study evaluating the use of stereotactic salvage radiotherapy (SSRT) delivered with the CyberKnife System in five sessions. Androgen deprivation therapy was prohibited during SSRT. An early analysis of 51 patients with a median follow up of 16 months found that the CyberKnife System provides an effective and convenient option with mild toxicity for the treatment of recurrent cancer in the prostate bed following prostatectomy. The study investigators concluded, "Only mild toxicity was reported, underlining the safety of the treatment. Moreover, SSRT may be considered a convenient approach considering the shorter treatment duration if compared to standard approach."