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VolitionRx Announces Data Showing the Prognostic Value of its Nu.Q® Cancer Test

On July 7, 2026 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the release of a new clinical study demonstrating the significant prognostic value of its Nu.Q Cancer Assay in newly diagnosed lung cancer patients, which could help clinicians identify patients’ likely outcomes and personalize treatment selection accordingly. The clinical paper entitled "Prognostic value of circulating H3K27Me3-nucleosomes in newly diagnosed lung cancer patients: Real-world evidence1" has been written in conjunction with researchers and clinicians at the Hospices Civils de Lyon (HCL), France’s second largest university hospital system, and is currently under peer review.

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Dr Andrew Retter, Medical Consultant, Volition said:

"Nu.Q Cancer represents a significant advancement in lung cancer patient management, offering clinicians an additional tool to enhance precision in treatment selection and monitoring and is a test we envisage will be used routinely in the clinic once approved.

"We have worked closely with the Lyon team over several years to develop the strong scientific and clinical evidence to support the use of Nu.Q in the management of cancer patients. These results indicate that measuring methylated nucleosome biomarker levels with the Nu.Q test, at Non Small Cell Lung Cancer diagnosis, can provide valuable information about survival, progression-free survival and, crucially, enhance the identification of patients who may benefit from curative care1-4.

"The integration of epigenetic biomarkers, such as circulating H3K27Me3-nucleosome, into personalized medicine frameworks holds great promise for refining patient stratification and treatment selection.

The test is simple to complete and easy to implement, the new information helps to empower bedside clinicians and their patients to make better informed decisions on treatments and planning future care together."

Frederic Wuilque, Vice President, Global Products, added:

"The first step in introducing the Nu.Q Cancer test into routine clinical practice, the clinical certification at HCL, has been completed.
"With the active support of HCL, we are working towards the submission of our reimbursement dossier in the coming months, under the framework of the "Innovative Procedures Outside the Nomenclature" (RIHN-référentiel des actes innovants hors nomenclature). Once the dossier is classified as admissible, we understand that determination of eligibility for reimbursement coverage is mandated to take no more than five months.
"We are delighted to showcase more evidence to demonstrate the clinical utility of our Nu.Q Cancer test and would like to thank our long term collaborator, Hospices Civils de Lyon, for their continued support. We continue to move through the steps on the path to the first use of Nu.Q in clinical practice, an exciting prospect which is core to Volition’s mission, using our tests to help save lives."

Mr. Gael Forterre, Chief Commercial Officer, Volition concluded:

"From a commercial perspective, France is just the beginning: the Volition team is actively discussing Nu.Q Cancer, not only with hospital networks in other countries but also potentially licensing the technology to third party collaborators. For this direct sales model we anticipate approximately €50 per test as revenue to Volition.
"Reimbursement will be a major milestone for Volition in the commercialization and licensing of Nu.Q in the human cancer field. Once achieved, we anticipate the introduction into routine clinical use in France."

About the Study

A large, real-world evidence study which demonstrated that plasma levels of Nu.Q Cancer assay H3K27Me3 were associated with cancer stage, and highly elevated levels were observed in patients with a poor outcome.
Overall survival (OS) analysis revealed that patients with a H3K27Me3-nucleosome level below the optimal cut-off had a significantly better mean survival compared to those with higher concentrations, particularly for patients who are ctDNA-negative and therefore lacking detectable actionable mutations.
Interestingly, a Cox Proportional Hazards (CPH) prognostic model, integrating baseline H3K27Me3-nucleosome concentrations with commonly collected clinical covariates (cancer stage, ctDNA molecular profile and age) enabled stratification of patients at diagnosis into low and high risk mortality groups, facilitating prediction of patient-level survival probabilities in a timeline of up to 30 months.

(Press release, VolitionRX, JUL 7, 2026, View Source [SID1234669092])

OTR Therapeutics Enters Strategic Collaboration with LG Chem to Accelerate Development of Novel Oncology Therapies

On July 7, 2026 OTR Therapeutics, a clinical-stage biotechnology company dedicated to transforming early-stage innovations into globally impactful therapies, reported that it has entered into a strategic collaboration agreement with LG Chem, a leading global company that specializes in life sciences as one of its core businesses. The strategic alliance is structured to accelerate joint efforts to identify, evaluate and develop novel oncology assets from China.

The collaboration brings together OTR’s proprietary R&D platform and deep connection with China’s life science ecosystem, along with LG Chem’s global development expertise and commercial infrastructure. Together, the companies will establish a partnership for discovering, evaluating, and advancing innovative oncology assets from China to patients worldwide.

Under this strategic framework, OTR will identify and conduct initial technical assessment of promising oncology programs aligned with LG Chem’s strategic priorities through its regional scientific network and business development capabilities, followed by joint evaluation and licensing by both companies. OTR will lead preclinical and early clinical development by leveraging China’s speed, scientific excellence, and capital-efficient R&D environment, while LG Chem will take a leading role in ex-China clinical development, regulatory strategy, and commercialization.

Under the terms of each program-specific agreement, OTR will receive upfront payments and be entitled to global development and regulatory milestone payments. In addition, OTR has the option to participate in global development and obtain a share of global rights of programs entering late-stage clinical development. Through this long-term partnership the companies aim to accelerate the translation of innovative science into globally competitive medicines while creating a sustainable pipeline of differentiated oncology therapies for patients with significant unmet medical needs.

Dr. Son Ji-woong, President of LG Chem Life Sciences Company, stated:

"This collaboration with OTR strengthens our ability to systematically identify and evaluate promising assets emerging from China, which is becoming an emerging center of biopharmaceutical innovation. By securing high-potential assets at an early stage and advancing them jointly with our partner through future development opportunities, we aim to enhance our global competitiveness and improve patient access to innovative treatments."

Dr. Zhui Chen, Founder and Chief Executive Officer of OTR Therapeutics, commented:

"We are very delighted to collaborate with LG Chem to unlock the immense innovation potential residing within the Chinese biopharma ecosystem. By combining our agile R&D and business development capability with LG Chem’s robust clinical and commercial infrastructure, we are creating an accelerated pathway to transform early-stage breakthroughs into highly differentiated, clinically impactful therapies for patients worldwide."

(Press release, OTR Therapeutics, JUL 7, 2026, View Source [SID1234669091])

Propanc Biopharma Signs MOU with Avance Clinical Pty Ltd

On July 7, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported it has signed a Memorandum of Understanding (MOU) with Avance Clinical Pty Ltd. The MOU sets out the shared intent of Propanc and Avance to work together to support the clinical delivery of Propanc’s Phase 1b, First-In-Human (FIH) clinical trial for PRP, Propanc’s lead investigational candidate for advanced solid tumors. Importantly, both parties intend to approach the collaboration in a spirit of openness, scientific rigor, and shared problem-solving, with the goal of advancing PRP efficiently from FIH into Proof-of-Concept and, as data supports, later-phase development.

Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across North America, Asia Pacific, New Zealand and Europe. With more than 30 years of experience leading early phase clinical trials, they leverage the unique advantages of the Australian market, including rapid ethics approval, and up to 43.5% off with the Australian R&D tax rebate, to provide biotech companies with an accelerated pathway to clinical success. With Propanc’s headquarters and wholly owned operating subsidiary, Propanc Pty Ltd, based in Melbourne, Australia, since 2007, it is ready to capitalize on these advantages in partnership with Avance Clinical.

"We are delighted to enter this Memorandum of Understanding with Avance Clinical as we prepare to initiate the First-in-Human Phase 1 clinical study of PRP, Propanc’s lead oncology candidate. It represents an important milestone in our journey from preclinical development to clinical evaluation. Avance Clinical’s proven expertise in the conduct of early-phase oncology studies, combined with its strong reputation for quality and regulatory excellence, makes them an ideal partner for this critical stage of development," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "The planned Phase 1b FIH study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary clinical activity of PRP in patients with advanced cancer. We believe that PRP’s unique mechanism of action, low toxicity and good tolerability has the potential to address a significant unmet medical need and offers a novel therapeutic approach for patients with limited treatment options. We look forward to working closely with the Avance Clinical team to efficiently advance this important program and generate the clinical data necessary to support the continued development of PRP. This collaboration reflects our shared commitment to scientific excellence, patient safety, and the pursuit of innovative cancer therapies that may improve outcomes for patients worldwide."

"As Propanc advances PRP into its Phase 1b trial in patients with advanced solid tumors, we are delighted to support the design and delivery of this important study. At Avance Clinical, we bring extensive experience in early‑phase oncology, including adaptive dose‑escalation strategies, PK/PD‑rich designs, and integrated safety and preliminary efficacy assessments, with a particular focus on aligning dose‑finding approaches with evolving FDA Project Optimus expectations," said Dr. Gabriel Kremmidiotis, PhD, Avance Clinical’s Chief Scientific Officer. "We are excited to partner with Propanc to guide PRP through its early clinical evaluation in cancer patients and, as data emerges, to support a disciplined, data‑driven transition into later‑phase proof‑of‑concept studies. In collaboration with Propanc, we aim to build a data-driven foundation for PRP’s development that balances innovation with disciplined risk management and keeps patient safety and scientific excellence at the center of decision-making."

(Press release, Propanc, JUL 7, 2026, View Source [SID1234669090])

Theriva™ Biologics Announces Regulatory Authorization to Proceed with a VIRAGE2 Phase 2a Clinical Trial to Evaluate More Frequent Dosing of VCN-01 (zabilugene almadenorepvec) in First-Line Patients with Metastatic Pancreatic Ductal Adenocarcinoma

On July 7, 2026 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the Company to initiate the VIRAGE2 clinical trial, entitled "A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer" (EUCT: 2026-525566-21-00).

The VIRAGE2 trial builds on the results of the 112-patient VIRAGE Phase 2b clinical trial evaluating VCN_01 in treatment naïve metastatic pancreatic ductal adenocarcinoma (PDAC) patients receiving gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy. In the VIRAGE trial, patients who received 2 doses of VCN-01 administered 3 months apart had significantly improved overall survival, progression free survival, and duration of response compared to patients treated with only one dose of VCN-01 or with SoC chemotherapy alone. As previously reported, both the EMA and the FDA recognized the improved survival in the group treated with 2 doses of VCN-01, and raised the possibility of more frequent repeated dosing of VCN-01 in combination with SoC chemotherapy to potentially improve clinical outcomes. The VIRAGE2 trial is designed to evaluate the feasibility of administering at least 3 doses of VCN-01 given 2 months apart in combination with SoC chemotherapy (see About VIRAGE2). Results from this trial will inform the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial.

"We are excited to start this important exploratory clinical trial to refine the VCN-01 dosing regimen," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "From the first VIRAGE trial we learned that repeated dosing of VCN-01 can lead to improved clinical outcomes in first-line metastatic PDAC patients receiving gemcitabine/nab-paclitaxel SoC chemotherapy. We expect more frequent repeated dosing of VCN-01 to enable more potent degradation of the tumor stroma and elicit earlier induction of an antitumor immune response. The primary objective of VIRAGE2 is to determine whether more frequent repeated dosing of VCN-01 is well tolerated by patients and does not adversely impact VCN-01 levels in the body. If feasible, more frequent repeated dosing of VCN-01 could significantly improve the potential clinical benefits achievable in future clinical trials of VCN-01 combined with a range of treatments, including chemotherapy, immunotherapy, antibody-drug conjugates, and/or KRAS inhibitors."

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney, and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms. In many instances, progressive abdominal pain is the first symptom. Therefore, in most cases, pancreatic cancer is diagnosed in its late stages (locally advanced non-metastatic or metastatic stage of the disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VIRAGE2

VIRAGE2 is a Phase 2a, single-arm, open-label, clinical trial in 6 evaluable patients with histologically confirmed, newly diagnosed metastatic PDAC enrolled at a single site in Spain. Patients are intended to receive at least three "macrocycles" of VCN-01 (zabilugene almadenorepvec) and gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy, followed by SoC gemcitabine/nab-paclitaxel cycles until disease progression. In each VCN-01 macrocycle, intravenous VCN-01 is administered on day 1 followed by gemcitabine/nab-paclitaxel SoC chemotherapy on days 8, 15, 22, 36, 43 and 50. Macrocycles are repeated on days 57 and 113. The primary objective of the VIRAGE2 trial is to evaluate whether administration of at least 3 doses of VCN-01, with 2 months between doses, is well tolerated by patients without adversely impacting VCN-01 pharmacodynamics. Primary endpoints for the trial are the adverse event profile and levels of VCN-01 viral genomes in blood. Secondary endpoints include objective response rate, duration of response, progression free survival, overall survival, and circulating levels of anti-VCN-01 neutralizing antibodies. Exploratory endpoints include estimates of potential VCN-01 shedding by measuring VCN-01 viral genomes in sputum and stool. The study is designed with 80% power to detect a difference in VCN-01 viral genome levels between the second and first VCN-01 doses with a 2-sided alpha of 0.05. The study is not formally powered for evaluation of clinical efficacy endpoints and is intended to support evaluation of the potential efficacy of the more frequent repeated dosing regimen in subsequent clinical trials (EUCT: 2026-525566-21-00).

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in Company- and investigator-sponsored clinical trials in different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). VCN-01 has also been made available for compassionate use in retinoblastoma patients, and 2 patients have been treated in this program. More information on VCN-01 clinical trials is available at Clinicaltrials.gov.

(Press release, Theriva Biologics, JUL 7, 2026, View Source [SID1234669089])

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

On July 7, 2026 FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, reported the closing of an upsized Series D-2 extension financing of $67.4 million, bringing the total Series D-2 amount raised to $110 million. The financing was co-led by SR One, Medicxi, and SymBiosis and supported by a syndicate of new investors, including TaiAx, LG Technology Ventures, Primer Ventures and Axil, and all existing investors, including OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung and 3B Capital. Proceeds from the financing will be used to support the ongoing late-stage development of plixorafenib, including delivering on the topline data from the recurrent or progressive BRAF V600E primary CNS tumor basket of the FORTE study around the end of 2026, a subsequent regulatory submission, and continued development in additional distinct monotherapy indications including rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions.

"We are pleased with the progress at Fore this year, which allowed us to expand our investor base with new, quality healthcare investors and are grateful for the continued support from all our existing investors, which reflects their confidence in the potential for plixorafenib to disrupt the BRAF market," said William Hinshaw, Chief Executive Officer of Fore. "With target enrollment now complete in the primary CNS tumor basket, we look forward to reporting topline data from this basket around the end of 2026. With the recent Breakthrough Therapy Designation granted to plixorafenib, we continue to progress towards a planned regulatory submission in 2027 for BRAF V600E CNS tumors and bringing this novel mechanism and differentiated profile to patients who are in need of improved therapeutic options."

Plixorafenib Updates

Fore Bio also announced several positive program updates for its ongoing FORTE study demonstrating continued timely execution as well as notable patient-friendly improvements to the protocol:

Target enrollment of approximately 50 patients has been reached in the BRAF V600E CNS tumor basket of the FORTE study, and topline data from the study is now anticipated around the end of 2026. This basket previously met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned based on responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety. The company anticipates that the primary analysis of data from this basket, if positive, would enable the submission of a New Drug Application to the U.S. Food and Drug Administration under the Accelerated Approval pathway.

Based upon the protocol-specified decision rule and available safety and PK data, clearance from the IDMC has been received to enroll patients as young as 8 years of age, compared to a prior age range starting at 10 years old, to align more closely with the observed BRAF-altered patient population including children and young adults in which low-grade gliomas (LGG) and other primary CNS tumors more commonly occur.

Fore Bio has implemented an improvement to the dosing regimen in the FORTE study to administer plixorafenib with food, on the basis of a recent food effect study. On the basis of this data, and the supportive data from clinical studies showing robust exposures and anti-tumor activity with plixorafenib alone, cobicistat, an approved CYP3A inhibitor designed to serve as a PK booster, will no longer be administered with plixorafenib.

Mr. Hinshaw concluded, "With several key clinical and regulatory catalysts on the horizon, we believe plixorafenib has the potential to meaningfully improve upon the current treatment paradigm, representing a significant opportunity across several BRAF-altered CNS tumor types including high and low grade glial and glioneuronal brain and spinal cord tumors, glioblastomas, and others, in addition to the distinct patient populations currently being evaluated in the FORTE study."

The company is currently evaluating plixorafenib in two additional monotherapy baskets in the FORTE study, in rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions, respectively. The company anticipates advancing through multiple clinical and regulatory milestones across the plixorafenib development program throughout 2026 and into 2027.

About the Global Phase 2 FORTE Basket Study

The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600E primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. Plixorafenib received Breakthrough Therapy Designation by the U.S. Food and Drug Administration in April 2026. In a previously conducted Phase 1/2 study in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

(Press release, Fore Biotherapeutics, JUL 7, 2026, View Source [SID1234669088])