BioSpace Global Roundup, April 9
Takeda Pharmaceutical – Takeda received an extension of its current marketing authorization of Alunbrig (brigatinib) to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. The approval is based on results from the Phase III ALTA-1L trial that showed Alunbrig demonstrated superiority compared to crizotinib with significant anti-tumor activity observed in patients with baseline brain metastases. After more than two years of follow-up, Alunbrig reduced the risk of intracranial disease progression or death by 69% in patients with brain metastases at baseline. The safety profile of ALUNBRIG in the ALTA-1L trial was generally consistent with the existing European summary, the company said.
Lundbeck – Lundbeck’s Vyepti (eptinezumab-jjmr), an IV treatment for migraine prevention, is now available in the United States. However, due to COVID-19, the company adjusted its launch activities to largely center on delivering content virtually, digitally and socially, so patients and their healthcare providers are informed about this new treatment option. The efficacy and safety of Vyepti, approved in February, was demonstrated in two Phase III clinical trials (PROMISE 1 in episodic migraine and PROMISE 2 in chronic migraine). Vyepti met its primary endpoint of a decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine.
CARMAT – France’s CARMAT said the French National Authority for Health (HAS) has given definitive approval to initiate a clinical study of the CARMAT artificial heart within the framework of the Forfait Innovation program. The design of the study, which includes 52 patients to be implanted with the CARMAT heart as a bridge to a heart transplant, has been adjusted in accordance with the observations expressed by the HAS in the conditional approval received by CARMAT in February 2020. The primary endpoint of the study is the survival rate at 180 days after implantation without a disabling stroke or a successful cardiac transplantation within 180 days post-implant.
BGI – China’s BGI is collaborating with Etopia on a mobile, inflatable P2 level biosafety laboratory: the “Huo-Yan Air Lab.” The first lab was installed at the Shenzhen National GeneBank on April 3. The Huo-Yan (meaning ‘Fire Eye’) Air Lab can be easily transported and quickly deployed to support the screening and detection capabilities of countries around the world, thereby allowing authorities to control the COVID-19 pandemic at an earlier stage. Huo-Yan is based on BGI’s previous experience constructing a P3 level biosafety laboratory using an inflatable structure during the Ebola outbreak in 2014 in West Africa.
Gedea Biotech – Sweden-based Gedea Biotech received its ISO certificate for the design, development, marketing, distribution and production of antibiotic-free vaginal tablets intended to treat bacterial vaginosis.
Immunova – Sweden’s Immunova announced the company’s lung cancer collaboration with an unnamed global pharmaceutical company has been terminated. Immunova’s own early detection program in lung cancer continues as planned and the company has received the necessary fresh blood samples from the pharma partner for testing and analysis. Immunova’s study is on track and will be finished in Q2 2020 as planned, the company said.
Inventiva – Based in France, Inventiva posted an update to its business activities related to the COVID-19 pandemic. The company has put on hold non-essential pre-clinical activities and implemented a work from home policy for most of its employees, including those engaged in research and development functions. To date, the company said it does not anticipate that the COVID-19 pandemic will significantly impact Inventiva’s Phase IIb NATIVE clinical trial evaluating lanifibranor in the treatment of NASH. Following the completion of patient visits and the analysis of all exit biopsies announced on March 17, 2020, the publication of the trial top-line results remains on track for June 2020, in line with expectations.
SIRION Biotech – Germany-based SIRION announced Beam Therapeutics licensed its LentiBOOST for use in their CAR-T products. Under the terms of this agreement, SIRION agreed to provide Beam with non-exclusive access to its proprietary lentiviral transduction enhancer LentiBOOST for clinical development and commercialization of Beam’s portfolio of CAR-T programs. SIRION will be entitled to undisclosed upfront and milestone payments and is eligible to receive royalties on future product net sales plus license fees tied to commercial success.
Revive Therapeutics – Canada’s Revive has retained Novotech as its clinical research organization in the Asia-Pacific region. Novotech will handle clinical studies for Bucillamine in the treatment of infectious diseases, including the coronavirus disease.
Avacta – England-based Avacta Group entered into a collaboration with Cytiva, formerly known as GE Healthcare Life Sciences. The companies will develop and manufacture an Affimer-based point-of-care rapid test intended for screening of large populations to diagnose the COVID-19 coronavirus infection. Avacta is already generating Affimer reagents that detect the COVID-19 virus and together with Cytiva will develop and manufacture a test capable of diagnosing the infection in minutes using a respiratory sample such as saliva. Cytiva will transfer this diagnostic assay onto its proprietary point-of-care test strip platform and both companies will work together to complete analytical and clinical validation of the test as quickly as possible.