BioSpace Global Roundup: Ipsen Wins Fast Track Designation for Cancer Drug and More


Paris-based Ipsen secured 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 after disease progression following gemcitabine-based therapy.

The designation marks the second Onivyde secured in the past six months. In June, the FDA awarded the designation to Onivyde for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma.

Ipsen is conducting an ongoing Phase III study assessing Onivyde as a monotherapy for SCLC study patients who have progressed on or after a first-line platinum-based regimen.

Howard Mayer, Ipsen’s head of research and development, 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 there to be about 228,280 new cases of lung cancer in the country. SCLC comprises 10% to 15% of all lung cancers and is a very aggressive form of cancer with about 70% of people having metastatic disease when they are diagnosed.

Elsewhere around the globe:

RevoluGen – U.K.-based RevoluGen announced new results from its improved Fire Monkey/Fire Flower version 8 (FMv8) protocol. Results show the protocol demonstrated a 30Gb+ yield of long DNA reads raw data of an E. Coli bacterial sample on a single Oxford Nanopore Technologies (ONT) MinION flow cell. The increased yield offers significant potential cost and performance advantages across all sequencing platforms, the company said. The FMv8 protocol introduces a needle-aspirate-based, cell-resuspension step prior to cell lysis that boosts DNA recovery. The spin-column has been optimized to deliver homogenous High Molecular Weight DNA extracted and purified from bacterial and mammalian samples. For E. Coli, the FMv8 protocol allows the ONT MinION to deliver optimal sequencing throughput at an impressive N50 of 36.7Kb, the company added.

GENFIT– France’s GENFIT announced the conclusion of the partial buyback of GENFIT’s 6,081,081 convertible bonds maturing in October 2022. The company said it 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 as a 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 Q2 2021. The Phase IIb induction study in patients with moderate-to-severe UC, enrolled the first patient in August 2019. In addition, Abivax initiated a companion long-term open-label maintenance study in which patients who have completed the induction study were eligible to continue the treatment to further investigate the long-term safety and efficacy profile of ABX464. Previously, the company announced positive results of the previous Phase IIa induction study in UC in September 2018.

HZI – Germany’s Helmholtz Centre for Infection Research (HZI) secured two awards worth up to $15 million from CARB-X to develop non-traditional approaches against antibiotic-resistant pathogens. The goal is to develop a first-in-class treatment for Staphylococcus aureus infections and thereby prevent exacerbation of pneumonia. The drug is a small-molecule inhibitor of the S. aureus α-hemolysin, a virulence factor responsible for the bacterium’s pathogenicity and ability to cause infection and disease. The drug would disarm the pathogen’s most important toxin that causes damage to lung tissue and immune cells. Additionally, HZI is looking to develop a new treatment for difficult-to-treat Pseudomonas aeruginosa infections in cystic fibrosis patients. 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 aim to do. By rendering the pathogens harmless instead of killing them, selection pressure on the pathogens is relieved and resistance is likely to develop more slowly.

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, 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 holds an exclusive license to Goethe University of Frankfurt’s proprietary 3Cs technology for the production of next generation 3Cs CRISPR/Cas gRNA libraries. The license from ERS Genomics 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 secured $59 million in a Series A funding round, as well as four neurological product candidates from Roche. The product candidates will be developed in neurological indications with severe unmet need, such as seizures in tuberous sclerosis complex (TSC), trigeminal neuralgia, Tourette syndrome and other rare neurological disorders.

TSK Laboratory – Netherlands-based TSK developed a new needle that could save 4% to 8% of vaccine doses, which could prevent wasted parts of the COVID-19 preventative medicines. A conventional needle has an average dead space of 45 microliters, which is the amount of vaccine or medicine being wasted per injection. TSK Laboratory developed an inventive and patented needle in 2014 in which this average dead space is reduced to 14 microliters. TSK said its Low Dead Space technology prevents waste of liquid vaccine when it is being extracted from the container, which will ultimately stretch the number of available doses.

Horizon Discovery Group – U.K.-based Horizon Discovery Group granted a license to China’s 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 pre-clinical antibody drug projects and to support the clinical development and commercialization of its customers’ human biotherapeutic products as well as offering the platform through its contract research services.

eTheRNA – Belgium-based eTheRNA immunotherapies NV entered into a strategic agreement with China Grand Pharmaceutical & Healthcare Holdings Ltd. to establish a new joint venture company, Nanjing AuroRNA Biotech Co., Ltd. in Mainland China. The new company will deploy eTheRNA’s proprietary mRNA technology for pharmaceutical research and development and production 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 provides eTheRNA access to the Greater China market for selected mRNA cancer and infectious disease vaccine programs, its 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 awarded 4D Biomaterials, a spinout by University of Birmingham Enterprise and Warwick Innovations, to develop new commercialization of a new class of liquid resins that can be custom-printed into bioresorbable 3D tissue scaffolds providing accelerated and improved wound healing following major surgery.

Tubulis – Germany’s Tubulis formed a strategic collaboration with WuXi STA and WuXi Biologics to manufacture and advance Tubulis’ next generation antibody-drug conjugates (ADCs) towards IND-enabling studies. Tubulis has developed a dual 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 to advance its uniquely versatile and customizable ADC technology portfolio. The company utilizes two proprietary technologies to tackle limitations of currently approved ADCs, which include stability and payload-driven toxicity.

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