On August 4, 2026 Forlong Biotechnology, a clinical-stage biotech company focused on developing transformative cytokine therapies for patients with severe unmet needs, reported approval to initiate a Phase I study of FL115 subcutaneous injection (administered once every three weeks) in patients with advanced solid tumors in Australia. The study has been approved under Australia’s Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme, following review by the Human Research Ethics Committee (HREC).

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FL115, an engineered IL-15/IL-15Rα-Fbody fusion protein, has been evaluated as a monotherapy administered via IV infusion in two Phase I studies in patients with advanced solid tumors. These studies demonstrated a favorable safety profile along with preliminary clinical efficacy, supported by significant and sustained expansion of NK and CD8+ T cells, as well as a strong, transient induction of IFN-γ. Clinical benefit has been observed, with 3 patients remaining on treatment (one patient with stable disease and two patients with confirmed partial response) over 12 months.

Compared with IV infusion, subcutaneous administration of FL115 has been shown in preclinical studies to lower Cmax by more than 20-fold while significantly extending meaningful exposure duration, with bioavailability of 60% or higher and no significant gross skin irritation. Such a profile may enhance clinical efficacy through stronger NK and T cell stimulation, while also improving clinical safety by reducing the release of certain cytokines.

"FL115 monotherapy via IV infusion has demonstrated good safety and tolerability, with early signs of potent anti-tumor activity in Phase I studies in patients with heavily-pretreated solid tumors," said Dong Wei, Ph.D., Chief Executive Officer of Forlong Biotechnology. "We expect the subcutaneous formulation of FL115, dosed once every three weeks, to further improve the safety and efficacy profile, as well as convenience for patients — continuing to establish FL115 as a potential best-in-class IL-15 superagonist and, ultimately, bringing new treatment options to cancer patients in need."

About FL115

FL115 is an engineered IL-15/IL-15Rα-Fbody fusion protein designed to enhance anti-tumor immunity through IL-15-mediated signaling on NK and CD8+ T cells, while minimizing the complexity associated with an Fc domain. FL115 has demonstrated significant anti-tumor activity in vivo, both as a monotherapy and in combination therapy, and can be manufactured through a robust, efficient process with excellent product stability. Clinically, FL115 has shown a favorable safety profile and preliminary clinical responses as a monotherapy, and has best-in-class potential to synergize with current and emerging T cell–targeting immunotherapies through combination approaches that could meaningfully improve treatment outcomes for patients.

FL115 is currently being investigated in combination with Bacillus Calmette-Guérin (BCG) in a Phase II clinical trial evaluating safety and preliminary efficacy in patients with non-muscle invasive bladder cancer (NMIBC), and in combination with an anti-PD-1 monoclonal antibody in a Phase I clinical trial evaluating safety and preliminary efficacy in patients with advanced solid tumors. A Phase I clinical trial of FL115 subcutaneous injection is also being initiated in Australia.

(Press release, Forlong Biotechnology, AUG 4, 2026, View Source [SID1234669680])

On August 4, 2026 enGene Therapeutics Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported that it will host a virtual key opinion leader (KOL) event on Tuesday, August 11, 2026 at 11:00 AM ET featuring Neal Shore, MD, FACS (Carolina Urologic Research Center; Atlantic Urology Clinics). Dr. Shore will join management to provide insights into the evolving NMIBC treatment landscape and the various considerations driving treatment selection.

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The event will provide an overview of:

The future treatment paradigm in NMIBC and how sequencing therapies may evolve
Insights on community urology practices and how treatment considerations and choice drivers vary
Pricing and reimbursement dynamics
A live question and answer session will follow the formal presentations.

To register for the webinar, please click here. The live webinar and subsequent replay of the event can also be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com.

Featured Speaker

Neal Shore, MD, FACS is the Medical Director for START-Carolinas Research (formerly Carolina Urologic Research Center) in Myrtle Beach, SC, USA, and the Global Director of GU Oncology for START Cancer Research. He is actively involved with the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Guidelines Committee for Bladder Cancer and has served on the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, and the Duke Global Health Institute.

Dr. Shore has conducted over 500 clinical trials, primarily in genitourinary oncology, and has authored more than 400 peer-reviewed publications along with numerous book chapters. He is Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and co-Chair of the annual AUA International Prostate Cancer Forum. He has served or continues to serve on the editorial boards of Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP, Everyday Urology, Oncology, and World Journal of Urology. He is the Editor-in-Chief of Reviews in Urology.

Dr. Shore graduated from Duke University and Duke University Medical School. He completed his general surgery and urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Kettering Cancer Center. He is a Fellow of the American College of Surgeons and a Certified Physician Investigator.

(Press release, enGene Therapeutics, AUG 4, 2026, View Source [SID1234669679])

On August 4, 2026 CEL-SCI Corporation (NYSE American: CVM) reported the publication of its study, "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," in the internationally recognized journal Oral Oncology.

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The peer-reviewed publication provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI’s upcoming global Confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection)*. The Oral Oncology published study identifies low and zero tumor PD-L1 expression (TPS <10%) and the absence of lymph node involvement (N0) as prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine administered before surgery.

In this biomarker-selected patient population, patients receiving the Multikine treatment regimen prior to surgery followed by standard of care achieved a 73.4% five-year overall survival (OS) rate compared with 45.8% for patients receiving surgery followed by standard of care alone, corresponding to a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute improvement in five-year survival. The published study also demonstrated a statistically significant improvement in progression-free survival (PFS), with a 49% reduction in the risk of disease progression or death (PFS hazard ratio 0.51; p=0.0197) compared to control in the same patient population.

Importantly, the peer-reviewed publication concludes that these biomarkers can be used prospectively to identify patients most likely to benefit from Multikine and guide future clinical studies in head and neck (squamous cell carcinoma) cancer.

"Publication of these findings in Oral Oncology represents an important peer-reviewed acceptance of the science behind our Multikine development program," said Geert Kersten, CEO of CEL-SCI. "The results not only confirm the remarkable overall and progression free survival benefit observed in the selected population analyzed in our Phase 3 trial, but they also provide strong support for the biomarker selection strategy we are implementing for our Confirmatory Registration Study. It is important to note that when Keytruda was approved by the FDA in the same indication, based on event free survival, it had not established overall survival benefit. As awareness of the Multikine data grows within the global oncology community, we believe Multikine will become increasingly recognized as a differentiated immunotherapy."

The publication in Oral Oncology notes that currently approved checkpoint inhibitor therapies are generally directed toward patients with higher PD-L1 expression, while Multikine’s unique mechanism of action enables it to benefit patients whose tumors express low (TPS <10%), as well as zero (0%) PD-L1. This creates the potential for a treatment approach that specifically targets the underserved low and zero PD-L1 patient population.

CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which will evaluate Multikine in newly diagnosed, previously untreated, locally advanced resectable head and neck oral cancer patients with low and zero (TPS <10%) PD-L1 tumor expression and no lymph node involvement—the same patient population reported on in the newly published study in Oral Oncology. The trial is designed with approximately 97% statistical power to confirm the previously observed overall survival benefit.

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.

(Press release, Cel-Sci, AUG 4, 2026, View Source [SID1234669678])

On August 4, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported study results demonstrating that PRISM2, a multimodal slide-level pathology foundation model developed in collaboration with researchers from Microsoft, can perform clinically important diagnostic tasks using simple prompts and can be leveraged for a variety of downstream applications. The results were published in Nature Medicine.

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PRISM2 outperformed or matched existing slide-level foundation models across a comprehensive set of diagnostic, biomarker and patient outcome prediction tasks. Additionally, when further tuned to specifically predict long-term outcomes, PRISM2 outperformed standalone models, including achieving high performance predicting colorectal cancer recurrence-free survival.

"PRISM2 represents a true leap forward both in terms of scale and multi-modal AI capabilities," said Razik Yousfi, Senior Vice President and General Manager of AI Products at Tempus. "Our Pathology Foundation Models allow us to have a detailed understanding of tissue, unlocking clinical-grade precision and novel research applications capable of predicting patient outcomes and biomarker status. PRISM2 builds on this by aligning whole-slide pathology images with the language of clinical diagnosis through clinical dialogue training. It can seamlessly handle complex diagnostic and prognostic research tasks without requiring specialized fine-tuning, offering a powerful tool to advance precision oncology."

As part of Tempus’ proprietary Pathology Foundation Models, PRISM2 turns routine hematoxylin and eosin (H&E) slides into deep biological insights. By combining large vision models built from pathology images with large language models, it unlocks diagnostic-grade precision in research involving cancer detection, biomarker identification and prognosis prediction.

PRISM2 was trained on a diverse set of 2.3 million whole-slide images and 14 million diagnostic question−answer pairs derived from nearly 700,000 pathology reports, making it the largest multimodal slide-level pathology datasets to date.

To support ongoing research, open science, and other non-commercial and non-clinical use cases, the full PRISM2 model weights are publicly available through Hugging Face at View Source and View Source-survival.

(Press release, Tempus, AUG 4, 2026, View Source [SID1234669677])

On August 4, 2026 SOPHiA GENETICS (NASDAQ: SOPH) reported a new global collaboration to develop, validate, and deploy two companion diagnostics (CDx) supporting precision oncology therapies with AstraZeneca (LSE/STO/NYSE: AZN).

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This multi-year collaboration agreement will advance the development and commercialization of two companion diagnostic programs, bringing SOPHiA GENETICS’s decentralized clinical trial assays and companion diagnostic capabilities to AstraZeneca therapies.

As part of the collaboration, SOPHiA GENETICS will develop its Solid Tumor application into a decentralized companion diagnostic. In addition, the company will develop and validate its Hematological Oncology application to support a companion diagnostic program for patients with blood cancer.

"A breakthrough therapy only matters to the patients we can find in time to treat. We are moving towards a future that no longer depends on geography, where any laboratory can run the same test to the same high standard on day one of a launch. We believe these programs are what that future looks like in practice. Bringing the right therapy to the right patient, in any country and any laboratory, is the work that will define the next generation of precision medicine," said Ross Muken, CEO, SOPHiA GENETICS.

By combining accurate biomarker detection with rapid deployment, SOPHiA GENETICS aims to shorten the distance between a new therapy and the patients who need it. Through its global data-driven platform, insights generated from patient populations can help advance informed clinical decision-making across healthcare systems. This vision of connected, data-driven medicine underpins these programs, with the goal of expanding access to innovative treatments and improving outcomes for patients worldwide.

About SOPHiA GENETICS Companion Diagnostics

SOPHiA GENETICS end-to-end diagnostic capabilities span the drug development and launch continuum:

Clinical Trial Assay (CTA) development, to identify, screen, and enroll the right patients quickly and accurately during a trial.
Companion Diagnostic (CDx) development, validation, and regulatory submission, taking an assay from research use through analytical and clinical validation to approval in the US, EU, Japan, and beyond.
Deployment through the SOPHiA DDMTM Platform and the SOPHiA DDMTM MaxCare Program, enabling laboratories to bring testing in-house and adopt new genomic applications with confidence, reaching larger populations around the globe.
SOPHiA GENETICS’s technology-agnostic, cloud-based platform lets healthcare institutions run the same validated, AI-powered analysis locally, while sharing and benefiting from the collective intelligence of a global network of more than 1,000 connected institutions across over 75 countries. For a pharmaceutical partner preparing a global launch, that means a companion diagnostic that can be available in the local lab on day one of drug approval.

(Press release, AstraZeneca, AUG 4, 2026, View Source [SID1234669676])