Biopharma companies from across the globe provide updates on their business and pipelines.
Innate Pharma – France’s Innate Pharma dosed its first patient in a Phase II study of its anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia. The primary endpoint of the study is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome.
Secarna Pharmaceuticals – Germany’s Secarna Pharmaceuticals entered into a cooperation with the First Affiliated Hospital at Guangzhou Sun Yat-sen University for the development of a treatment or prophylactic for SARS-CoV-2 viral infections. Under this agreement, Secarna will employ its proprietary LNAplus platform to develop antisense oligonucleotides (ASOs) which specifically suppress the expression of a certain host factor that is essential for the viral infection cycle. The feasibility of Secarna’s concept was successfully demonstrated in a 2019 Ebola study.
Innate Pharma – France-based Innate Pharma dosed the first patient in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of its anti-C5aR antibody, avdoralimab (IPH5401), in COVID-19 patients with severe pneumonia. The primary objective of this investigator-sponsored trial, named FORCE, is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome. The Phase II trial is supported by an exploratory translational study, EXPLORE COVID-19, which suggests that patients who progress towards severe COVID-19 disease exhibit an activation of the C5a/C5aR pathway.
Immunovia – In its first quarterly report for 2020, Sweden’s Immunovia said it has made significant strides toward the launch of IMMray PanCan-d. Following the end of Q1 2020, the company provided an update on the measures the company has taken and continues to take in order to support patients, employees and public health initiatives in response to the COVID-19 pandemic.
Adaptimmune – The European Medicine Agency’s Committee for Orphan Medicinal Products (COMP) adopted a positive opinion for Orphan Drug Designation for ADP-A2M4, the company’s investigational treatment of soft tissue sarcomas. Adaptimmune’s SPEARHEAD-1 trial with ADP-A2M4 for people with synovial sarcoma and myxoid/round cell liposarcoma (MRCLS) is actively enrolling at approximately 25 clinical sites in Canada, France, Spain, the United Kingdom, and the U.S. The SPEARHEAD-1 trial is intended to support the registration of ADP‑A2M4 for the treatment of advanced synovial sarcoma and MRCLS. Earlier this year, the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4 for the treatment of soft tissue sarcomas and Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of synovial sarcoma.
NanoMab Technology – Privately-held NanoMab, based in China, established a U.K. subsidiary office and moved its center of operations as it prepares to start clinical trials for its camelid antibody therapeutics and imaging agents in the fourth quarter of 2020.
PharmaMar -- Spain’s PharmaMar received clearance from the Spanish Medicines and Healthcare Products Agency to begin a clinical trial in hospitalized COVID-19 patients with Aplidin (plitidepsin). Plitidepsin acts by blocking the protein eEF1A, present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this inhibition, the expectation is that reproduction of the virus inside the cell is prevented, making this propagation to the rest of the cells unviable.
Hansa Biopharma – Following the completion of the first quarter of 2020, Hansa Biopharma pointed to some highlights including an ongoing review for imlifidase in Europe by the EMA. An opinion from the agency is expected in the second quarter of this year. The company is also progressing in its discussions with the FDA on the design of a trial in kidney transplantation. Submission of the study protocol is expected in the second quarter and recruitment of the first patient is targeted for the fourth quarter of this year.
RemeGen – China’s RemeGen announced the FDA cleared an Investigational New Drug Application to launch a Phase II clinical trial of RC48 (disitamab vedotin), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the treatment of HER2 positive metastatic or unresectable urothelial cancer (UC). RemeGen previously presented topline data from its China-based Phase II clinical trial for RC48 at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed significant anti-tumor activities in a number of HER2-positive UC cancer patients, making it the first potential targeted, biologic therapy for HER2+mUC in a disease state with no new treatments in nearly 20 years.
Horizon Discovery Group – U.K.-based Horizon Discovery Group has added two new sample formats to its cell-based OncoSpan reference standards for use in the development and validation of workflows for cancer diagnostic assays. Horizon’s OncoSpan range now includes formalin-fixed, paraffin-embedded (FFPE) and cell-free DNA (cfDNA) formats for mimicking solid tumors and liquid biopsy samples, respectively, in addition to its well-established genomic DNA (gDNA) format. Its cfDNA format offers one of the largest number of variants and genes, over 380 and 152 respectively, of any characterized reference standard to help standardize liquid biopsy testing, the company said in its announcement. These cell-line derived reference standards closely mimic patient samples and offer an unlimited and reproducible resource to help ensure consistency during the establishment and validation of diagnostic assays.
Genespire – Italy-based Genespire closed a €16M Series A financing from Sofinnova Partners, a European life sciences venture capital firm based in Paris. The funds will be used to advance Genespire’s leading-edge platform technologies towards the development of novel gene therapies in two main areas, primary immunodeficiencies and metabolic genetic diseases.
PanThera – U.K.-based start-up Panthera is undertaking Phase II, III and IV vaccine trials on behalf of its pharma and CRO clients across its network of sites in the U.K. Panthera will continue to undertake trials for conditions treated in primary care including cardiovascular disease, osteoarthritis, osteoporosis, diabetes, allergies and migraine.
