based in Paris ipsen received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. Onivyde, in combination with fluorouracil and leucovorin, was previously approved for the treatment of patients with metastatic adenocarcinoma of the pancreas following disease progression following gemcitabine-based therapy.
The designation marks the second Onivyde achieved in the past six months. In June, the FDA granted Onivyde designation for patients with previously untreated, unresectable, locally advanced and metastatic ductal adenocarcinoma of the pancreas.
Ipsen is conducting an ongoing Phase III study evaluating Onivyde as monotherapy for patients in the SCLC study who have progressed on or after platinum-based first-line therapy.
Howard Mayer, head of research and development at Ipsen, called the Fast Track designation for Onivyde “an extension of Ipsen’s focus and contribution” to the oncology landscape.
“With this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients,” Mayer said in a statement.
Lung cancer is the second most common cancer in the United States. In 2020, the American Cancer Society estimates that there will be approximately 228,280 new cases of lung cancer in the country. SCLC comprises 10% to 15% of all lung cancers and is a very aggressive cancer with about 70% of people having metastatic disease when diagnosed.
Elsewhere in the world:
RevoluGen – UK-based RevoluGen has announced new results from its enhanced Fire Monkey/Fire Flower version 8 (FMv8) protocol. The results show that the protocol provides a 30Gb+ yield of long DNA reads from raw data from a E coli bacterial sample on a single Oxford Nanopore Technologies (ONT) MinION flow cell. The increased yield offers significant potential cost and performance benefits across all sequencing platforms, the company said. The FMv8 protocol introduces a needle suction-based cell resuspension step prior to cell lysis that stimulates DNA repair. The spin column is optimized to provide homogeneous high molecular weight DNA extracted and purified from bacterial and mammalian samples. In front of E coli, the FMv8 protocol enables the ONT MinION to deliver optimal sequencing throughput with an impressive N50 of 36.7Kb, the company added.
GENFIT– France’s GENFIT announced the completion of the partial repurchase of GENFIT’s 6,081,081 convertible bonds maturing in October 2022. The company said it had achieved satisfactory results. Once the buyback is complete, the company will announce the final results.
Abivax – Also based in France, Abivax completed recruitment for its Phase IIb induction study for ABX464 for the treatment of patients with moderate to severe ulcerative colitis. Top-line results of the Phase IIb UC induction study are expected to be available in the second quarter of 2021. The Phase IIb induction study in patients with moderate to severe UC, the first patient enrolled in August 2019. In addition, Abivax initiated an accompanying open -label long-term maintenance study in which patients who completed the induction study were eligible to continue treatment to further investigate the long-term safety and efficacy profile of ABX464. Previously, in September 2018, the company announced positive results from its previous Phase IIa induction study in UC.
HZI – Germany’s Helmholtz Center for Infection Research (HZI) has received two awards worth up to $15 million from CARB-X for the development of non-traditional approaches to antibiotic-resistant pathogens. The goal is to develop a first-class treatment for Staphylococcus aureus infections and thereby prevent the worsening of pneumonia. The drug is a small-molecule inhibitor of the S. aureus α-hemolysin, a virulence factor responsible for the pathogenicity of the bacterium and its ability to cause infection and disease. The drug is said to disarm the pathogen’s main toxin that causes damage to lung tissue and immune cells. In addition, HZI wants to develop a new treatment for difficult-to-treat Pseudomonas aeruginosa infections in patients with cystic fibrosis. The new “pathoblocker” treatment aims to disarm pathogens and suppress the disease-causing properties of P. aeruginosa bacteria, instead of killing the bacteria as an antibiotic would like to do. By rendering the pathogens harmless rather than killing them, the selection pressure on the pathogens is alleviated and resistance is likely to develop more slowly.
ERS Genomics Ireland’s ERS Genomics Limited and Germany’s Vivlion GmbH have announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio to enhance Vivlion’s gene editing reagents and screening services. Vivlion has an exclusive license to Goethe University Frankfurt’s proprietary 3Cs technology for the production of next-generation 3Cs CRISPR/Cas gRNA libraries. The ERS Genomics license now enables Vivlion to offer both R&D reagents and screening services to its customers worldwide. Financial details of the agreement were not disclosed.
Noema Pharma – Swiss startup Noema Pharma has raised $59 million in a Series A funding round, as well as four neurological product candidates from Roche. The product candidates will be developed for neurological indications with severe unmet need, such as tuberous sclerosis complex (TSC) attacks, trigeminal neuralgia, Tourette syndrome and other rare neurological disorders.
TSK Laboratory – The Netherlands-based TSK developed a new needle that could save 4% to 8% of vaccine doses, which could prevent parts of the preventive COVID-19 drugs from being wasted. A conventional needle has an average dead space of 45 microliters, the amount of vaccine or drug wasted per injection. TSK Laboratory developed an inventive and patented needle in 2014 that reduces this average dead space to 14 microliters. TSK said its Low Dead Space technology prevents wastage of liquid vaccine when it is removed from the container, ultimately extending the number of doses available.
Horizon Discovery Group – UK-based Horizon Discovery Group has licensed Chinese Sanyou Biopharmaceuticals Co. for its cGMP compliant CHOSOURCE platform. Sanyou will use Horizon’s gene-edited Glutamine Synthetase (GS) knockout Chinese Hamster Ovary (CHO) K1 cell line for the development of preclinical antibody drug projects and to support the clinical development and commercialization of its customers’ human biotherapeutic products, as well as the platform through its contract research services.
eTheRNA – Belgium-based eTheRNA immunotherapies NV has signed a strategic agreement with China Grand Pharmaceutical & Healthcare Holdings Ltd. to establish a new joint venture, Nanjing AuroRNA Biotech Co., Ltd. in mainland China. The new company will deploy eTheRNA’s proprietary mRNA technology for pharmaceutical research and development and manufacturing in the Greater China region. This follows an undisclosed equity investment by China Grand Pharma in eTheRNA’s Series B financing round earlier in 2020. The formation of AuroRNA Biotech with China Grand Pharma gives eTheRNA access to the Greater China market for select cancer mRNA and vaccine programs. infectious diseases, proprietary mRNA formulation technologies and GMP manufacturing process technology. eTheRNA’s global programs will benefit from China Grand Pharma’s development, clinical and marketing input.
4D biomaterials – Innovate UK has awarded 4D Biomaterials, a spin-out of the University of Birmingham Enterprise and Warwick Innovations, for the development of a new commercialization of a new class of liquid resins that can be custom printed into bioresorbable 3D tissue scaffolds for accelerated and improved wound healing after major surgery.
tubulis – Germany’s Tubulis has entered into a strategic partnership with WuXi STA and WuXi Biologics to produce Tubulis’ next-generation antibody-drug conjugates (ADCs) and advance toward studies that enable the IND. Tubulis has developed a two-platform approach to generate uniquely matched and disease-specific ADCs that combine selective antibodies with effective payloads. Tubulis recently completed a €10.7 million Series A to expand the therapeutic potential of ADCs and enhance its uniquely versatile and adaptable ADC technology portfolio. The company uses two proprietary technologies to address the limitations of currently approved ADCs, including stability and payload induced toxicity.