BioSpace Global Roundup, June 6

Global Connection

Avacta Group – U.K.-based Avacta Group, plans to submit an Investigational New Drug application early in 2020 to test the TMAC linker in a Phase I study in patients with selected solid tumors. In an acceleration of the TMAC program, Avacta is now in a position to test this critical TMAC linker in humans, a major de-risking milestone for the program, early in 2020 and well ahead of its original plans. Avacta’s tumor microenvironment activated drug conjugates (TMAC) are a ground-breaking new form of cancer immunotherapy, co-invented with Tufts University Medical School, combining Affimers with chemotherapies in a single drug, using a linker that is designed to only release the chemotherapy in the tumor microenvironment. This allows extremely potent chemotherapies, too potent to be given to patients systemically, to be combined with Affimer immune-checkpoint therapies.

Nouscom – Based in Switzerland, immuno-oncology company Nouscom said the FDA accepted its IND for the first clinical trial of its lead candidate, NOUS-209. The company will conduct a phase 1 clinical trial of NOUS-209, a therapeutic vaccine for gastric, colorectal, and gastroesophageal junction Microsatellite Instable (MSI) cancers (tumors characterized by a defective DNA mismatch repair system) in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab. The trial will be enrolling up to 30 patients across several US clinical centers and is expected to begin during the third quarter of 2019. Initial clinical data are expected in early 2020. Based on preclinical data, NOUS-209 is expected to induce potent and broad CD8+ and CD4+ responses in humans. In addition to safety and efficacy, the study will evaluate vaccine-induced immune responses, as well as preliminary signs of anti-tumor activity in enrolled patients.

Immunovia -- Optimization work for the commercial version of IMMray PanCan-d, designed for early detection of pancreatic cancer (PDAC), has been successful and significantly improved the performance of the test, Sweden-based Immunovia said. The test now shows accuracies higher than 90 percent and even up to 98 percent in differentiating PDAC of stage I through IV versus the large symptomatic risk groups, such as patients with non-specific but concerning symptoms, including type II diabetics, results which have never been reported before in the pancreatic cancer field.

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Biocartis – Belgium-based BioCartis entered into a Master Development and Commercialization Agreement with Kite, a subsidiary of Gilead Sciences. The agreement is aimed at the development of molecular-based assays on BioCartis’ molecular diagnostics Idylla platform that are supportive to Kite’s therapies. The collaboration with Kite is BioCartis’ second assay development partnership in the immunotherapy domain, a fast-growing market and one of the key strategic focus areas of the Idylla assay menu. BioCartis believes the speed and ease-of-use of the Idylla platform could enable regular and rapid monitoring of patients under such cancer cell therapies in a near-patient setting, which is expected to help optimize patient management. Financial details on the agreement with Kite are not disclosed.

ERS Genomics – Ireland-based ERS Genomics Limited and Denmark-based Bioneer A/S announced the signing of a license agreement providing Bioneer access to CRISPR/Cas9 genome editing technology intellectual property. Bioneer will use CRISPR/Cas9 technology to generate a range of innovative human cell-based disease models. Under the terms of the license, Bioneer is able to generate and commercialize CRISPR-edited cell-based models, broadening its core capabilities and expanding on Bioneer's expertise in biomedical research support. Financial details of the agreement were not disclosed.

Tridek One – France-based Tridek One, a biotech specializing in the treatment of immune disorders, secured funding of €3 million to advance its pipeline. Funding was led by Advent France Biotechnology and Advent Life Sciences. The company will use the funds to accelerate the company's preparations for clinical trials of the first CD31 agonist.

Yukin Therapeutics – Also based in France, Yukin Therapeutics completed a €3.3 million financing round for the development and optimization of its proprietary therapeutic molecules for cancer treatment. Advent France Biotechnology, a major player in life sciences investments, led this round with Medicxi, a life sciences-focused investment firm based in London. Yukin Therapeutics develops kinase inhibitors. The company specifically targets the NIK protein (NF-κB inducing kinase), a recognized therapeutic target involved in the aggressiveness of cancer cells. The NIK kinase inhibition by the pharmacological approach of Yukin Therapeutics has strong potential to result in the effective treatment of several types of cancer, including skin and pancreatic cancers. Yukin Therapeutics obtained proof of concept in animals, demonstrating the efficacy of its first-in-class NIK kinase inhibitors. These studies demonstrate a significant reduction in tumor volume in animals treated with NIK kinase inhibitor compounds and show synergy with the administration of antibodies specific to the PD1 molecule, a standard of care in immuno-oncology. The company now wants to accelerate the development of its therapeutic molecules in order to identify its first drug candidate ahead of launching a clinical trial by 2022.

Biotage AB – Stockholm-based Biotage forged an alliance with Shandong Yingsheng Biotechnology Co., Ltd. to develop Clinical Mass Spectrometry Applications in China. Biotage will provide systems and consumables within its Analytical Chemistry portfolio to be sold by Yingsheng under its own brand and together with Yingsheng’s other products and technical solutions.

Themis Bioscience – Austria-based Themis Bioscience snagged $21 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support its Phase III-ready Chikungunya vaccine (MV-CHIK). This is the second partnering agreement between Themis and CEPI. The funding will underwrite a collaborative effort to accelerate regulatory approval of Themis’ Chikungunya vaccine and ensure that at-risk populations have access to the vaccine. The pivotal multi-center Phase III trial will be launched in Europe, the United States and the Americas and will also test a single-shot regimen.

Origenis GmbH – Privately-held German biopharmaceutical company Origenis GmbH forged an agreement with Memorial Sloan Kettering Cancer Center to target glioblastoma. In this collaboration, Origenis and MSK will work together to identify and optimize a novel series of small molecules to inhibit GBM, among the most fatal of cancers. Under the research and collaboration agreement, Origenis will use its proprietary AI platform for drug discovery and development. The platform features Cippix, a unique tool for evolutionary learning with data extracted from patents, alongside proprietary biology and chemical knowledge, and the alignment of novel compounds to targets with real-life chemical synthesis routes using MolMind.

Sigrid Therapeutics AB – Sweden-based Sigrid Therapeutics completed treatment of 25 percent of patients in the STAR trial of its first-in-class medical device, SiPore15, and is well on track to finalize results by the end of the year. STAR aims to demonstrate that the specially engineered mesoporous silica particle (MSP) can achieve a significant reduction in key cardio-metabolic risk factors - blood sugar, blood lipids and body fat composition – in both pre-diabetics and newly diagnosed type 2 diabetics. The company said that treatment compliance is good and the safety profile continues to look positive.

Owlstone Medical – U.K.-based Owlstone formed an alliance with the International Association of Heat and Frost Insulators and Allied Workers to identify and verify breath-based biomarkers for the early detection of malignant mesothelioma. The partnership aims to address the need for early detection by using Breath Biopsy to examine the chemicals found on the breath of individuals with documented historical exposure to asbestos and radiologically and histologically confirmed Breath samples will be collected using Owlstone Medical’s ReCIVA Breath Sampler and will be analyzed by their state-of-the-art Breath Biopsy laboratory in Cambridge.

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