Abzena, Angiex Collaborate for Phase I Trial of Solid Cancer Tumor Therapy

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A transmembrane 4 L six family member 1 (TM4SF1)-directed antibody-drug conjugate (ADC) called AGX101 is now being given to patients in a Phase I clinical trial, as announced by Abzena in a press release on Aug. 8, 2024 (1,2). Abzena, a contract development and manufacturing organization (CDMO), is partnering with Angiex, a developer of nuclear-delivered antibody-drug conjugate (ND-ADC) therapies for solid cancers, to conduct the trial (1).

As defined by the two companies, the AGX101 monotherapy targets two different tumor components, its vasculature and cancer cells, and operates via three mechanisms: eliminating tumor blood vessels, killing tumor cells that may be capable of invasion and/or metastasis, and, finally, instructing the immune system to attack the cancer (1).

In preparation for the Phase I trial being run by Angiex, Abzena said it provided linker-payload design and synthesis, bioconjugation, process development, and current good manufacturing practice (CGMP) manufacturing (1). The Phase I study is open-label, with dose escalation and expansion components that are intended to evaluate the safety, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity of AGX101.

“We are very excited to have dosed our first patient in our first-in-human study of our novel TM4SF1 ADC, AGX101,” Paul Jaminet, Angiex co-founder and CEO, said in the press release. “Throughout the development of AGX101, Abzena has worked closely with us to achieve successful GMP manufacturing and quality control. We could not have reached this milestone without Abzena’s expertise, cooperation, and support. Both companies have extensive expertise in their respective fields and an aligned mission, and we look forward to continuing our partnership to ensure that AGX101 is available to meet the needs of clinical cancer patients. We are delighted that Abzena shares our vision that no one should die of cancer.”

“The Abzena team is incredibly proud to have helped Angiex achieve this significant milestone,” Abzena CEO Matt Stober added in the release. “Our unique ability to support Angiex with a fully integrated approach allowed us to de-risk and rapidly progress AGX101 into the clinic for patient dosing. We will continue supporting Angiex with our extensive ADC expertise and integrated capabilities to accelerate the development timeline of AGX101, and ultimately get this life-changing treatment to cancer patients faster.”

According to the two companies, the dose escalation portion of the study can assess doses up to 10 mg/kg in the solid tumor patient population, while the dose expansion portion can evaluate treatment at the recommended Phase II dose in multiple indications (1).

The press release did not indicate a timeline for the Phase I study, or when further trials might be scheduled.

References

1. Abzena. Abzena Supplies Clinical Trial Material for Angiex’s Phase I Study of AGX101, a First-in-Class TM4SF1-directed ADC. Press Release. Aug. 8, 2024.
2. Chen, G.; She, X.; Yin, Y.; et al. Targeting TM4SF1 Exhibits Therapeutic Potential Via Inhibition of Cancer Stem Cells. Signal Transduction Targeted Ther. 2022, 7, 350. DOI: 10.1038/s41392-022-01177-7