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])

On February 13, 2026 Precision Biologics, Inc. CEO Philip M. Arlen, MD reported a Keynote presentation describing in vitro and in vivo efficacy of its novel tumor-specific antibody-drug-conjugate PB-223 ADC (PB-vcMMAE-5). Recent tumor killing data showing specific non-toxic anti-tumor activity in several human cancer types expressing truncated core 2 O-glycans will be reported in "PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors", at the 6th Ace Drug Discovery Summit, The Insurance Hall, London, UK, February 18-19, 2026.

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"The exquisite sensitivity and specificity of our recently developed mAb enables maximum anti-tumor response to our PB-223 ADC with minimal toxicity in the preclinical animal studies. The target is found on a broad variety of human solid tumors but not on healthy tissue, suggesting a strong rationale to move this drug into clinical trials."

"We’re excited to discuss PB-223 ADC with the scientific community, to share compelling preclinical data with several human tumor types, showing animal xenograph human tumor models resulting in complete tumor eradication with minimal toxicity observed in blood and tissue analysis," he went on to say. Although some preliminary data was shown on posters at SITC (Free SITC Whitepaper) (Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) and AACR (Free AACR Whitepaper)-Ovarian (American Association for Cancer Research, Ovarian Cancer) meetings, this is the first public talk presenting and explaining the full data in person.

Here are details of the presentation:

Title:

"PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors"

Date/Time:

Thursday, February 19, 12:00pm – 12:30pm – Day 2 – Presentation no. 15

Place:

6th ACE Drug Discovery Summit, The Insurance Hall, 20-21 Aldermanbury, London, UK

Keynote Speaker:

Philip Arlen, President & CEO, Precision Biologics, Inc.

(Press release, Precision Biologics, FEB 13, 2026, View Source [SID1234662676])

On February 13, 2026 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, reported the closing of its underwritten public offering of $460 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants. Nektar sold 7,637,931 shares of common stock in the offering, which includes 1,034,482 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering, and 293,103 pre-funded warrants. The shares of common stock were sold at a public offering price of $58.00 per share and the pre-funded warrants to purchase shares of common stock were sold at a public offering price of $57.9999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price of each pre-funded warrant. The gross proceeds to Nektar from the offering were approximately $460 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Jefferies, TD Cowen, and Piper Sandler acted as joint bookrunning managers for the offering. Oppenheimer & Co. and H.C. Wainwright & Co. acted as lead managers and B. Riley Securities acted as manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3ASR (No. 333-291466) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on November 12, 2025 and automatically became effective upon filing. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; or Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

(Press release, Nektar Therapeutics, FEB 13, 2026, View Source [SID1234662675])