On February 11, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial.

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The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues.

Dr Chris Burns, CEO of Amplia, commented: "These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enrol the ongoing study as efficiently as possible. We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities."

The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.

(Press release, Amplia Therapeutics, FEB 11, 2026, View Source [SID1234662577])

On February 11, 2026 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company with a diversified portfolio of cell therapy and small molecule product candidates, reported its post-transaction strategy to advance its newly acquired CAR-T assets while maintaining a capital-efficient operation model.

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Following the recent closing of its strategic transaction, Tempest plans to prioritize development of its clinical-stage dual-targeting CD19/BCMA CAR-T program, TPST-2003, while expanding the portfolio into next-generation modalities, including TPST-4003, a newly disclosed in vivo CAR-T program designed to deliver the same dual-targeting CD19/BCMA construct without the need for ex vivo cell manufacturing.

"Our strategy is to leverage partner-funded and externally supported development where possible to generate high-value clinical data before committing significant internal capital," said Dr. Matt Angel, President and Chief Executive Officer of Tempest. "This approach allows us to advance multiple programs in parallel, expand the long-term optionality of our CAR-T portfolio and preserve flexibility as we evaluate the most compelling path forward."

Strategic Priorities:

Advance TPST-2003 through upcoming clinical milestones
Tempest plans to continue development of TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, with near-term clinical data expected from an ongoing Phase 1 clinical trial in China. The company anticipates initiation of a registrational Phase 2b in China by the end of 2026, with interim data expected in 2027. Development activities in China are funded by a strategic partner, providing access to pivotal data while preserving internal capital.
Expand the portfolio with in vivo CAR-T development (TPST-4003)
TPST-4003 represents Tempest’s first in vivo CAR-T program and is designed to extend the TPST-2003 biology into a potentially more scalable and patient-friendly modality. The company expects to advance the program through preclinical development and evaluate potential clinical entry through a strategic partner-funded Investigator Initiated Trial in the near-term.
Position amezalpat for pivotal development through business development
Amezalpat remains Phase 3-ready in first-line hepatocellular carcinoma ("HCC"), supported by global regulatory alignment and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development.
Advance TPST-1495 through externally funded clinical development
Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis ("FAP"), with first patient enrollment expected in Q1 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement with limited internal capital deployment.
Advance a diversified next-generation CAR-T pipeline
Tempest plans to progress additional dual-targeting CAR-T programs that broaden the platform across modalities and indications, including:
TPST-3003: an allogeneic dual-targeting CD19/BCMA CAR-T
TPST-2206: a dual-targeting CD70/CD70 CAR-T
TPST-3206: an allogeneic dual-targeting CD70/CD70 CAR-T

(Press release, Tempest Therapeutics, FEB 11, 2026, View Source [SID1234662606])

On February 11, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Francesca Barone, M.D., Ph.D., Candel’s Chief Scientific Officer, will present data and participate in multiple sessions at the 7th Annual Glioblastoma Drug Development Summit, taking place February 17-19, 2026 in Boston, Massachusetts.

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Dr. Barone will share insights from Candel’s HSV-based platform and the linoserpaturev (CAN-3110) program in recurrent high-grade glioma (rHGG) through workshop presentations and panel discussions focused on advancing biomarker-driven clinical development in glioblastoma.

Details are as follows:

Workshop Panel

Title: Harnessing Omics Data & Molecular Subtyping to Inform Patient Stratification in Clinical & Translational Strategies in Glioblastoma Drug Development
Date/Time: Tuesday, Feb. 17, 2026, 8:00 a.m. ET

Conference Presentation

Title: Integration of Biomarkers & Imaging to Define Patient Response in a Phase I/II Clinical Trial
Date/Time: Wednesday, Feb. 18, 2026, 9:30 a.m. ET

Panel Discussion

Title: Driving the Use of Biomarker-Based Enrollment in GBM Trials to Accelerate Clinical Success & Improve Patient Outcomes
Date/Time: Wednesday, Feb. 18, 2026, 12:00 p.m. ET

About linoserpaturev (CAN-3110)

CAN-3110 is a first-in-class, replication-competent, next-generation oncolytic herpes simplex virus-1 (HSV-1) immunotherapy candidate designed for dual activity for oncolysis and immune activation in a single therapeutic. In October 2023, the Company announced that Nature published results from the ongoing clinical trial where linoserpaturev was reported to be generally well tolerated with no dose-limiting toxicity. In the clinical trial, the investigators observed improved median overall survival compared to historical controls after a single linoserpaturev injection in this therapy-resistant condition.1 The Company and academic collaborators are currently supported by the Break Through Cancer foundation to evaluate the effects of repeated linoserpaturev injections in patients with recurrent glioblastoma in an expansion cohort from the phase 1b clinical trial. In October 2025, Science Translational Medicine presented findings from the comprehensive analysis of 97 serial tumor biopsies collected from two patients treated with repeated administrations of linoserpaturev in arm C. Linoserpaturev previously received Fast Track Designation and Orphan Drug Designation for the treatment of recurrent HGG from the U.S. Food and Drug Administration (FDA).

(Press release, Candel Therapeutics, FEB 11, 2026, View Source [SID1234662607])

On February 11, 2026 SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, reported that the first patient has been dosed in the second of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with Pancreatic Ductal Adenocarcinoma.

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"Dosing the first patient in our FAPI-PRO trial is a major step forward in the evaluation of FAPI as an oncological diagnostic tool," said Philipp Czernin, Chief Business Officer, SOFIE Biosciences. "We undergo this trial encouraged by the results of our Phase 2 and independent academic investigator-initiated studies supporting [18F]FAPI-74’s potential role in staging accuracy, which is especially needed for pancreatic cancer."

"The potential sensitivity of [18F]FAPI-74 PET makes its availability to stage patients with newly diagnosed pancreatic ductal adenocarcinoma attractive to patients and clinicians alike. The whole team, including surgeons and oncologists, are enthusiastic about using [18F]FAPI-74 PET to help select the best initial treatments," said Dr. Gary Ulaner, James & Pamela Muzzy Endowed Chair in Molecular Imaging and Therapy, Hoag Family Cancer Institute, and Professor of Radiology and Cancer Biology, University of Southern California.

The FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer) trial is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in adults with Pancreatic Ductal Adenocarcinoma. The study is planned for 18 sites with an estimated enrollment of 200 subjects over a 24-month period.

The primary study endpoints are sensitivity and specificity for detection of distant metastatic disease (M1). For additional trial details, visit the study page on ClinicalTrials.gov NCT07217717).

The partner Phase 3 study, FAPI-GO (FAPI in Gastroesophageal Oncology), which began November 2025, is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in adults with gastroesophageal cancers. The first patient in FAPI-GO was dosed on December 26, 2025. For additional trial details, visit the study page on ClinicalTrials.gov (NCT07217704).

ABOUT [18F]FAPI-74

[18F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer in the FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety, and a biodistribution profile amenable to detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners.

(Press release, Sofie Biosciences, FEB 11, 2026, View Source [SID1234662608])

On February 11, 2026 Niowave Inc., a U.S.-based global leader in medical radioisotope production, reported a new long-term supply agreement with Novartis to deliver Actinium-225 (Ac-225). The agreement provides Novartis with a scalable supply of this critical isotope to support its growing portfolio of radioligand therapies (RLT). RLTs use a targeting component with a radioisotope to selectively target and destroy cancer cells. Financial terms of the agreement are not being disclosed.

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The long-term agreement supports Novartis’s growing portfolio of RLT programs for difficult-to-treat cancers. In turn, Niowave expects to expand production capacity, and to support that growth, intends to begin construction of a new manufacturing facility in Lansing, Michigan, in early 2026.

"Our new agreement with Novartis underscores Niowave’s leading position as a trusted global supplier of medical radioisotopes," said Mike Zamiara, Chief Executive Officer of Niowave. "Niowave’s ability to provide dependable, scalable supply of Actinium-225 will contribute to the advancement of Novartis’s targeted cancer therapies and has the potential to meaningfully transform cancer care on a global scale."

Actinium-225 is among the most promising isotopes in oncology. Its alpha particles deliver highly potent energy, enabling the precise destruction of cancer cells while minimizing damage to surrounding healthy tissue. Despite its significant potential, global supply of Ac-225 remains limited. Niowave’s proprietary superconducting linear accelerator technology and advanced radiochemistry capabilities enable the company to provide sustainable production to address this critical supply challenge.

This new supply agreement highlights both the transformative promise of radiopharmaceuticals and the importance of securing a reliable isotope supply.

Solomon Partners and PMCF acted as advisors to Niowave.

(Press release, Novartis, FEB 11, 2026, View Source [SID1234662609])