NEW YORK – Hologic said this week it has completed the acquisition of Somatex Medical Technologies for $64 million. The Berlin-based firm develops and manufactures minimally invasive devices used in the field of tumor diagnostics, biopsy, and interventional specialties, and the deal supports Marlborough, Massachusetts-based Hologic's goal of providing a comprehensive breast healthcare portfolio. Somatex's products will enable Hologic to strengthen and expand its breast marker product line, which has consistently grown, the firm said, adding that the acquisition also enhances its sales presence in Europe by expanding its direct channel in Germany, as well as its network of regional and international distributors.
The US Food and Drug Administration this week granted fast track designation to Ambrx's ARX788, a HER2-targeting antibody drug conjugate being developed as a treatment for advanced or metastatic HER2-positive breast cancer patients previously treated with at least one other anti-HER2-based regimen. ARX788 comprises two cytotoxic payloads attached to a trastuzumab (Genentech's Herceptin) antibody. The FDA decided to expedite the development of ARX788 based on results from Phase I studies evaluating the drug’s safety, tolerability, pharmacokinetics, and preliminary efficacy.
Genentech said this week that its anti-TIGIT therapy, tiragolumab, in combination with atezolizumab (Genentech's Tecentriq) was granted breakthrough therapy designation by the US Food and Drug Administration. The designation was based on data from the Phase II CITYSCAPE study evaluating tiragolumab plus atezolizumab in patients with PD-L1-positive metastatic non-small cell lung cancer. That study showed an improved overall response rate and progression-free survival for NSCLC patients taking the combination regimen versus atezolizumab alone.
Certis Oncology Solutions this week said that it has made its orthotopic patient-derived xenograft (O-PDX) services available to the commercial pharmaceutical industry to aid in developing and testing cancer therapies. Certis' O-PDX modeling approach to drug efficacy testing comprises surgically engrafting pieces of patients' tumors into immunocompromised mice, which the company says offers superior concordance with human subjects versus the subcutaneous and cell derived PDX models routinely used in drug development. Certis also announced this week that Debbie Snyder-Stanton has joined the company as vice president of pharmaceutical business development.
Exact Sciences said this week that it has completed its $2.15 billion acquisition of Thrive Earlier Detection. The deal was originally announced in October.
Myriad Genetics said this week that the Myriad myChoice Diagnostic System, which is used to identify ovarian cancer patients who are likely to benefit from niraparib (GlaxoSmithKline's Zejula), is now reimbursed by the Japanese government. Japan's Ministry of Health, Labor, and Welfare approved the companion diagnostic for niraparib in September, and the test is now being reimbursed by the government. Myriad has a deal with SRL, a subsidiary of HU Group Holdings, to commercialize myChoice in Japan.
The US Food and Drug Administration this week granted fast track designation to Merus' HER3-targeting agent zenocutuzumab, which the company is developing as a treatment for metastatic solid tumors harboring NRG1 gene fusions after progression on standard of care. Merus will evaluate zenocutuzumab as a monotherapy in a Phase I/II clinical trial, dubbed eNRGy, for which patients with NRG1-positive non-small cell lung cancer, pancreatic cancer, and other solid tumors are currently being enrolled and stratified into three cohorts based on tumor type.