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In Brief This Week: Autolus Therapeutics, Vuno, Ambrx Biopharma, Point Biopharma, Zymeworks

NEW YORK –  Autolus Therapeutics said this week that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its gene therapy product, obecabatagene autoleucel (obe-cel), a CAR T-cell therapy the firm is studying in a Phase II clinical trial in patients with relapsed or refractory B-acute lymphocytic leukemia. Obe-cel has previously been given priority medicines designation by the European Medicines Agency and Innovative Licensing and Access Pathway designation by the UK's Medicines and Healthcare Products Regulatory Agency.

Korean medical artificial intelligence company Vuno said last week that it will collaborate with the Mayo Clinic to develop machine learning and artificial intelligence technologies to identify predictive and prognostic biomarkers in hopes of improving diagnosis and treatment of cancer. 

Ambrx Biopharma and Quantum Leap Healthcare Collaborative said this week that Ambrx's antibody-drug conjugate ARX788 has been incorporated into the ongoing I-SPY2.2 trial in a new treatment arm for HER2-positive breast cancer patients. I-SPY2.2 is a continuation of the ongoing I-SPY2 adaptive Phase II trial, sponsored by Quantum Leap, and evaluates emerging targeting agents for biomarker-defined breast cancer patients. Ambrx's ARX788 will be evaluated both alone and together with Regeneron's checkpoint inhibitor Libtayo (cemiplimab) as neoadjuvant treatment for HER2-positive early-stage breast cancer. Quantum Leap plans to begin accruing patients to the new arm of the trial in the coming month.  

Point Biopharma said this week that it has dosed its first patient in the European Union as part of the Phase III SPLASH trial evaluating 177Lu-PNT2002 for chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). The trial, launched in June 2021, is evaluating 177Lu-PNT2002, a radioligand designed to target prostate-specific membrane antigen (PSMA) on the surface of cancer cells. To be eligible for the SPLASH trial, patients' tumors must have confirmed PSMA expression as determined by one of two PET imaging agents, 68Ga-PSMA-11 or 18F-DCFPyL. 

Zymeworks said this week that it has completed enrollment for its Phase II HERIZON-BTC-01 pivotal clinical trial evaluating zanidatamab monotherapy in patients with previously treated advanced or metastatic HER2-amplified biliary tract cancers, including gallbladder cancer and cholangiocarcinoma. The trial enrolled patients in two cohorts: the primary efficacy cohort, which included patients with tumor tissue showing HER2 immunohistochemistry 2+ or 3+ staining; and cohort 2 with patients showing HER2 IHC 0 or 1+ staining. The company expects to announce results from the trial by early 2023.

Caris Life Sciences has opened a new liquid biopsy laboratory in Phoenix, Arizona, expanding the company's molecular profiling capabilities, which include tumor profiling and blood-based cancer diagnostics. The $45 million investment in the new laboratory will enable the firm to continue to develop and launch its blood-based diagnostic assay, Caris Assure. It will also create hundreds of new bioscience job opportunities in Phoenix.

According to Caris, the lab is one of the largest high-throughput sequencing facilities in the world and will provide profiling on blood specimens for up to 1,500 patients per day. It brings the company's total lab facility footprint in the state to approximately 160,000 square feet.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.