BioSpace Global Roundup, June 13

Global Connection

Avacta Group – U.K.-based Avacta Group pinpointed its clinical development candidate for first-time-in-human clinical trials of the Affimer platform. This milestone means that Avacta remains on track to submit an IND/CTA application for an Affimer PD-L1 inhibitor by the end of 2020. Avacta has selected a specific Affimer molecule (AVA004) as its clinical candidate because of its excellent in vitro and in vivo pharmacological properties, the company said. Affimer has been shown to have equivalent tumor growth inhibition to three approved monoclonal antibody inhibitors of PD-L1, Tecentriq, Imfinzi and Bavencio, in several in vivo animal efficacy models, the company noted. The planned phase I study will be in patients with advanced PD-L1 positive solid tumors. This study will explore both intravenous and subcutaneous routes of administration to provide proof-of-concept with primary endpoints of safety, tolerability and appropriate pharmacokinetics/pharmacodynamics, and with a secondary efficacy endpoint.

Sphere Fluidics – Based in Cambridge, U.K., closed a $4.8 million financing round that will be used to expand the company’s operations in the United State and the United Kingdom. The funding will be used as working capital for the Company’s Cyto-Mine Single Cell Analysis System, expansion of the U.K. facility and enable the doubling of personnel through the opening of a new U.S. sales office and demo lab in California. The funding round was led by Greenwood Way Capital whose members, which included several international family offices, invested a total of $4.3 million, alongside 24Haymarket Limited and other individual investors. Sphere Fluidics’ Cyto-Mine is an automated platform which integrates single-cell screening, sorting, dispensing, imaging and clone verification. It can process up to 40 million cells per day and assesses and isolates those that produce a specific antibody or biologic to help streamline workflows and improve throughput in biologics discovery and cell line development.

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RedHill Biopharma Ltd. – Israel-based RedHill secured a U.S. patent that covers the company’s asset for Crohn’s disease, RH-104, as well as and RHB-204 for Mycobacterium avium complex (MAC) disease, the most common cause of pulmonary nontuberculous mycobacteria (NTM) infections. The patent is expected to be valid until at least 2029.

SAGA – Sweden-based SAGA Diagnostics AB raised €3.7 Million, about $4.1 million, to advance the company’s ultrasensitive cancer liquid biopsies. Hadean Ventures, a Nordic-focused European life science fund manager, led the round and is joined by a number of existing shareholders including Fårö Capital and the Gunnar Nilsson Cancer Foundation. SAGA’s technologies quantify aberrations in DNA, RNA, and circulating tumor DNA and are uniquely capable of achieving limits of detection down to 0.001% mutant allele fraction. A spin-out from innovative research at Lund University, the company already has commercial agreements with a number of pharmaceutical partners and biomedical laboratories for the use of its proprietary technologies, central lab testing services and reagent kits.

Inventiva – Small molecule-focused French biotech Inventiva ended patient recruitment for its IIa trial evaluating odiparcil for the treatment of mucopolysaccharidosis type VI (MPS VI). The clinical trial includes 20 patients and the headline results of the double-blind placebo-controlled arms, which include the fifteen ERT-treated patients, are expected by the end of the year, the company said.

Advicenne – Another French biotech, Advicenne specializes in the development of adult and pediatric therapeutic products for the treatment of orphan diseases. The company announced the successful listing of its shares on the Euronext Brussels regulated market. As of today, the ordinary shares of Advicenne are listed on Euronext Paris, its primary listing venue, and on Euronext Brussels under the ticker ADVIC. Advicenne now benefits from a cross-listing on the two largest Euronext markets for companies in the life sciences sector with the aim of further increasing the visibility of its shares in Belgium and across Europe. The listing on Euronext Brussels is also in line with the clinical developments of the company as Advicenne is conducting a Phase II/III clinical study in Belgium for ADV7103, its lead product, in the treatment of cystinuria, a rare nephrological disease.

Immunicum – Sweden’s Immunicum AB posted positive topline results for its Phase I/II clinical trial examining the safety and tolerability of Immunicum’s lead candidate, ilixadencel, in combination with tyrosine kinase inhibitors (TKIs) in six patients with Gastrointestinal Stromal Tumors (GIST), a rare and difficult-to-treat disease indication. The trial showed that ilixadencel had a favorable safety profile, confirming similar data from past studies, in combination with several TKIs. In addition, analysis of the secondary clinical trial endpoints provided initial signals of clinical benefit in two patients that showed partial response to the treatment. Immunicum plans to publish the full data in a peer-reviewed journal.

Sensorion – France-based Sensorion received €20 million from two new investors, Invus Public Equities and Sofinnova Crossover. The proceeds will be used to fund the Phase II clinical programs for SENS-111 and SENS-401, the initiation of the company’s new gene therapy preclinical programs and the company’s overhead costs until the second half of 2020. The company said it expects the efficacy results of SENS-111 in the second half of 2019. The Phase II of SENS-401 for sudden hearing loss is underway and interim readout results should be available by the end of the year, the company added.

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