On February 15, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the U.S. FDA has cleared the IND application to initiate a Phase II clinical trial of its core asset, CS2009, in patients with advanced solid tumors.

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "We are pleased to receive FDA clearance to proceed with the global Phase II clinical trial of CS2009. This milestone follows a productive interaction with the agency, during which they reviewed our comprehensive Phase I data—including safety and antitumor activity data collected during dose escalation and expansion—and provided alignment on key elements of the Phase II study design, including dose optimization and expansion strategies. We are now actively advancing CS2009 clinical program globally and look forward to sharing further updates as the study progresses."

About CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

CS2009, an innovative trispecific antibody designed and developed by CStone, with the potential to be first- or best-in-class. It combines three clinically validated targets—PD-1, VEGFA, and CTLA-4—and exerts multidimensional anti-tumor effects through synergistic actions. Specifically, anti-PD-1 activity reverses T cell exhaustion, anti-CTLA-4 activity promotes T cell activation and proliferation, while anti-VEGFA activity blocks tumor angiogenesis and improves the tumor micro-environment (TME). In the TME, anti-PD-1 and anti-CTLA-4 activities are significantly enhanced by crosslinking with VEGFA. Meanwhile, CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive tumor-infiltrating T cells while minimizing interference with CTLA-4 regulation in peripheral T cells.

The ongoing global, multicenter Phase II clinical trial of CS2009 features a multi-cohort, parallel expansion design to evaluate the efficacy, safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of CS2009 as monotherapy and combination regimens. The study comprises 15 monotherapy and combination therapy cohorts across 9 solid tumor indications, including NSCLC, CRC, TNBC, ES-SCLC, PROC, cervical cancer (CC), hepatocellular carcinoma (HCC), gastric or gastroesophageal junction cancer (GC/GEJC), and esophageal squamous cell carcinoma (ESCC). The trial is actively enrolling patients in Australia and China and has received IND clearance in the U.S.

(Press release, CStone Pharmaceauticals, FEB 15, 2026, View Source [SID1234662683])

On February 15, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the release of an abstract on the Co-PSMA (NCT06907641)1 IIT, accepted for oral presentation at the upcoming EAU Congress 2026, Europe’s largest urological conference, to be held from 13 to 16 March 2026 in London, UK2. The abstract outlines key findings from the study.

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Co-PSMA ("Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy") was led by Prof Louise Emmett at St Vincent’s Hospital Sydney. This Phase II IIT evaluated the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 prostate cancer patients with BCR who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT within 3 weeks (at 1 h and 24 h post-injection, same-day and next-day imaging, respectively), on the same digital PET camera. A standard of truth (SOT) was used to determine accuracy of the PET findings and included biopsy, response to targeted treatment without androgen deprivation therapy [ADT] or corroborative imaging. The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number.

64Cu-SAR-bisPSMA PET/CT identified a statistically significant greater number of lesions per participant than 68Ga-PSMA-11 PET/CT, with a higher true positive rate also favouring 64Cu-SAR-bisPSMA. The mean per-patient lesion for 64Cu-SAR-bisPSMA was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 64Cu-SAR-bisPSMA next-day imaging detected 63 lesions. On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on the 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable SOT, the true positive rate was 75% for 64Cu-SAR-bisPSMA (21/28) compared to 39% (11/28) for 68Ga-PSMA-11.

These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, with limited ability to detect cancer, especially in patients with low PSA levels3,4,5.

Further data outlining results from the Co-PSMA IIT will be announced in mid-March following their oral presentation at the EAU 2026.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The data from the Co-PSMA trial are nothing short of exceptional. We already knew of the significant benefits of the optimised bisPSMA molecule from the early days around 7 years ago, when it was purposely developed to overcome the many shortfalls of the current single-targeting SOC PSMA imaging agents. This innovative benchtop research of the dual-targeting bisPSMA agent quickly progressed to multiple clinical trials, including COBRA6, PROPELLER7 and SECuRE8, which enabled us to secure three Fast Track Designations from the United States (US) Food and Drug Administration (FDA) and advance to two registrational trials, AMPLIFY9 and CLARIFY10, both of which are nearing completion of recruitment.

"Importantly, in the COBRA trial, we also looked at the performance of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer following definitive therapy, but with participant selection criteria having no limitation on upper PSA levels (median 0.9 ng/mL, range 0.25 to 17.6). The Co-PSMA data we are seeing to date reinforces the COBRA trial findings where more lesions and patients with a positive scan were identified using 64Cu-SAR-bisPSMA compared to SOC PSMA PET products, including 68Ga-PSMA-11 and 18F-DCFPyL6. A subset of participants in the COBRA trial had a follow-up SOC PSMA PET. While 90% of these participants had a positive scan on the initial 64Cu-SAR-bisPSMA next-day imaging, only 60% were positive on SOC PSMA PET, despite median scan time from the first 64Cu-SAR-bisPSMA imaging to the follow-up scan being 73.5 days. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA on next-day imaging was >2.6 times higher than that detected by SOC PET agents (52.6 vs 20 lesions)6.

"What we are learning today from the head-to-head Co-PSMA study is a valuable insight into how 64Cu-SAR-bisPSMA directly compares against 68Ga-PSMA-11, further bolstering the data seen to date. Similar to COBRA, Co-PSMA demonstrated that our product was able to identify more than 2.5 times total number of lesions on the next-day imaging in comparison to the SOC. Furthermore, 4 out of every 5 participants had a positive scan for prostate cancer using 64Cu-SAR-bisPSMA, compared to only 2 in 5 participants using 68Ga-PSMA-11, therefore making 64Cu-SAR-bisPSMA far more reliable than 68Ga-PSMA-11 in detecting the presence of cancer in these patients. These findings, coupled with the much higher true positive rate of 64Cu-SAR-bisPSMA (75% vs. 39% for 68Ga-PSMA-11), will enable clinicians to treat prostate cancer more effectively and with a greater level of confidence based on the accurate detection of disease. These results speak for themselves, clearly illustrating that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence. Moreover, this sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management: almost half of the Co-PSMA and COBRA study participants had a change of their planned disease management as a result of the 64Cu-SAR-bisPSMA findings6, which could be absolutely game-changing for clinicians and their patients. This is the difference between allowing prostate cancer lesions to grow or having a clear diagnosis and an active and highly targeted treatment plan. Earlier intervention in BCR can prevent cancer growth and spread, avoid side effects from systemic therapies and considerably improve patient outcomes.

"The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. Unfortunately, this blockbuster market is dominated by 68Ga-PSMA-11 and 18F-DCFPyL, both of which have low sensitivity4,5. The development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no significant differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. Time and time again we are seeing significant clinical and logistical benefits offered by 64Cu-SAR-bisPSMA through our trials. We strongly believe this product could not only become the new SOC in PSMA PET but also grow the market opportunity further by substantially improving the diagnosis of prostate cancer in many stages of the disease, from its early phases pre-definitive therapy, through to better identification of lesions in the BCR setting, including in patients with oligometastatic disease.

"While the AMPLIFY and CLARIFY trials are key to getting 64Cu-SAR-bisPSMA towards commercialisation, Co-PSMA provides further evidence of its benefits to clinicians and prostate cancer patients. This makes the paradigm shift towards improved diagnostics a no-brainer due to our relentless focus on rigorous clinical development and commitment to strong science to change the lives of people living with cancer. The acceptance of the Co-PSMA data by a world-leading urology conference as an oral presentation is a testament to the strength and quality of the data, generated by Prof Emmett, a global key opinion leader in the field."

Prof Louise Emmett (St Vincent’s Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "While approved PSMA PET agents are highly specific, their low sensitivity at low PSA levels means that many patients with early rising PSA show no detectable disease, making treatment planning challenging. More sensitive diagnostics that remain highly specific are needed for effective early intervention in BCR. Our research demonstrates that 64Cu-SAR-bisPSMA PET/CT offers a significant advancement in the detection of recurrent prostate cancer. Compared to 68Ga-PSMA-11, the 24-hour 64Cu-SAR-bisPSMA images identified the site of disease recurrence in a higher proportion of patients, directly informing tailored treatment decisions for men in BCR. These findings highlight the potential for 64Cu-SAR-bisPSMA to improve patient outcomes."

(Press release, Clarity Pharmaceuticals, FEB 15, 2026, View Source [SID1234662682])

On February 13, 2026 Akiram Therapeutics reported that the preclinical study underpinning the clinical development of lead candidate AKIR001, published in The Journal of Nuclear Medicine (JNM), has been selected as best basic investigation and overall featured article for the February issue.

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AKIR001 is developed by Akiram Therapeutics, a Swedish biotech company developing targeted radiopharmaceutical therapies for cancer. The candidate targets CD44v6 and is currently under evaluation in a first-in-human Phase 1 clinical trial.

The article presents the preclinical validation of AKIR001. The data demonstrate selective tumor uptake, favorable dosimetry, and clear antitumor effects in relevant models, strengthening the scientific foundation for the ongoing study in patients with CD44v6-positive tumors.

"We are pleased to see the study recognized both as best basic investigation and as overall featured article in JNM," says Marika Nestor, CEO of Akiram Therapeutics. "It is a strong recognition of the preclinical work behind AKIR001 and adds further weight as the program advances in clinical development."

About the Phase 1 clinical trial
The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.

The trial is registered at ClinicalTrials.gov:
View Source

(Press release, Akiram Therapeutics, FEB 13, 2026, View Source [SID1234662681])

On February 13, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a collaboration with Median Technologies (EPA: ALMDT) to bring Median’s proprietary eyonis LCS to the Tempus Pixel platform. This collaboration empowers clinical workflows with a powerful tool to support informed diagnostic and disease management decisions.

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According to a study by the American Cancer Society, only about 20% of eligible individuals in the U.S. were screened for lung cancer in 2024. Closing the gap and achieving full participation among eligible individuals could prevent an estimated 62,110 lung cancer deaths over five years. eyonis LCS is an AI-based CADe/CADx software as a medical device (SaMD) for lung cancer screening. It enables clinicians to not only detect lung nodules but also characterize and risk stratify them from the same CT image without additional steps in the workflow. eyonis LCS received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this month.

Through this collaboration, Tempus will integrate eyonis LCS into Tempus Pixel1, an FDA-cleared, CE-marked AI-enabled solution that provides advanced analysis, tools, and automated reporting from radiology images to help providers accurately track and quantify lesions. The integration of eyonis LCS will enable non-invasive characterization of CT identified lung nodules at the time of nodule detection with its proprietary nodule malignancy score, a feature that will allow clinical teams to stratify and prioritize patients in lung cancer screening programs.

"Activating our distribution collaboration with Tempus AI is a decisive step in bringing eyonis LCS to patients at national scale," said Fredrik Brag, CEO and Founder of Median Technologies. "Tempus’ strong leadership in AI-enabled precision medicine, deeply integrated data-technology ecosystem, and strong market presence make them an exceptional partner to drive rapid and high-impact adoption of eyonis LCS across the United States."

"We believe AI reaches its full potential when it helps clinicians identify disease earlier and more accurately," said Razik Yousfi, Tempus SVP & GM, AI Products. "By expanding our Pixel platform with sophisticated lung cancer screening AI tools, we are enabling radiologists to manage complex caseloads while prioritizing early-stage detection. Our collaboration with Median Technologies is about more than technology; it’s about improving the standard of care and preventing avoidable deaths through better screening access."

Tempus has significantly expanded its diagnostic capabilities by developing and deploying a suite of advanced algorithms across radiology and pathology, helping clinicians deliver more precise, personalized care. In 2022, Tempus acquired Arterys, incorporating its AI-driven imaging tools—ranging from lung CTs and chest X-rays to cardiac MRIs—into the Tempus ecosystem. This was followed by the acquisition of Paige, which contributed a proprietary dataset of almost 7 million clinically annotated, de-identified pathology slides to further accelerate Tempus’ efforts.

(Press release, Tempus, FEB 13, 2026, View Source [SID1234662678])

On February 13, 2026 China Medical University Hospital (CMUH) reported that, in collaboration with Ever Supreme Bio Technology, it has successfully developed the world’s first EXO 001 targeted exosome platform, a breakthrough technology that enables direct in vivo programming of T cells to generate multi-target nanobody-based CAR-T cells.

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In multiple solid tumor animal models, EXO 001 demonstrated significant therapeutic efficacy, including complete tumor eradication in select cases, offering a fundamentally new treatment strategy for patients with advanced solid malignancies.

In Vivo Immune Programming Overcomes the Limitations of Conventional CAR-T Therapy

According to CMUH Superintendent Dr. Der-Yang Cho, both autologous and allogeneic CAR-T therapies currently rely on complex and time-consuming ex vivo cell manufacturing processes. For patients with rapidly progressing solid tumors, these approaches are often too slow to meet clinical needs and remain constrained by immune rejection, manufacturing failure, and high costs.

The core innovation of EXO 001 lies in repositioning exosomes as carriers for in vivo immune programming, representing an advanced evolution of the CAR001 platform currently under clinical evaluation.

Following intravenous administration, EXO 001 circulates through key immune organs such as the spleen, where it precisely delivers Nb-CAR.BiTE genes to CD3-positive T cells. This enables direct genetic programming within the patient’s body, converting native T cells into multi-target CAR-T cells capable of infiltrating solid tumors, killing cancer cells, and dismantling the immunosuppressive tumor microenvironment.

This design enables immune cells to be "trained in vivo and deployed immediately," combining the immune compatibility of autologous CAR-T therapy with the off-the-shelf availability and scalability typically associated with allogeneic approaches—an essential factor in EXO 001’s effectiveness against solid tumors.

Compelling Animal Data

Compelling Preclinical Results: Tumor Clearance and Extended Survival

Dr. Cho noted that in mouse models of colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer, intravenous administration of EXO 001 successfully generated CAR-T cells in vivo. These cells effectively penetrated the tumor microenvironment, significantly inhibited tumor growth, and extended survival by two- to three-fold. In some animals, tumors were completely eliminated with long-term, recurrence-free outcomes.

By using exosomes as a gene and drug delivery vehicle, EXO 001 achieves higher biocompatibility and safety compared with viral vectors or synthetic lipid materials. This approach reduces immunogenicity, minimizes the risk of cytokine storm and anti-drug antibody formation, and lowers overall immune-related risks.

A Platform with Clear Clinical and Industrial Advantages

Wen-Liang Huang, General Manager of Ever Supreme Bio Technology, emphasized that EXO 001 offers not only academic innovation but also strong translational and commercialization potential, including:

Single-cell-line sourcing with stable quality
Exosomes derived from a single engineered cell line minimize donor variability and support standardized production and quality control.

Scalable manufacturing aligned with international standards
Production can be carried out in fully closed, automated systems compliant with U.S. FDA regulations for cell-based therapies.

Off-the-shelf readiness
Eliminates the need for patient- or donor-specific ex vivo cell cultivation, enabling timely intervention for rapidly progressing solid tumors.

Cost advantages and improved accessibility
Significantly reduces overall production costs compared with traditional autologous CAR-T manufacturing.

Platform extensibility
Beyond solid tumors, the platform can be adapted to carry different CAR genes, nucleic acids, or small-molecule drugs, supporting multiple therapeutic indications.

Potential for long-term anti-tumor immunity
Animal studies indicate the induction of CAR-T cells with immune memory characteristics, suggesting more durable anti-cancer effects.
Global Momentum in In Vivo CAR-T Development

In recent years, in vivo CAR-T has emerged as a key focus for global pharmaceutical leaders. Companies such as Gilead Sciences (Kite), AstraZeneca, Bristol Myers Squibb, and AbbVie have actively invested in viral vectors, lipid nanoparticles, and nanocarrier-based immune programming technologies to overcome the limitations of conventional CAR-T therapy in solid tumors.

Within this global landscape, the EXO 001 targeted exosome platform—developed jointly by CMUH and Ever Supreme Bio Technology—stands out for its use of high-biocompatibility, naturally derived exosomes, offering a differentiated and internationally competitive approach.

Next Steps Toward Clinical Translation

This research has been accepted for publication in the internationally recognized journal Advanced Science (January 2026), has secured patents in the United States and other countries, and has completed technology transfer. Manufacturing development and clinical trial preparation are currently underway, with first-in-human trials anticipated as early as next year, targeting patients with colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer.

The EXO 001 platform represents a new horizon for solid tumor immunotherapy and a promising step forward for patients with advanced cancer.

(Press release, Ever Supreme Bio Technology, FEB 13, 2026, View Source [SID1234662677])