Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
The H3D Foundation and the International Federation of Pharmaceutical Manufacturers and Associations forged a three-year partnership aimed at bolstering drug development for the African continent. The partnership aims to strengthen drug discovery and development in Africa by scaling existing initiatives and identifying new development opportunities for young and mid-career scientists in the region.
The ongoing COVID-19 pandemic has highlighted concerns over the state of disease control in Africa. According to H3D-F, a foundation established to reduce barriers for health innovation and actively support African researchers and centers within the field of drug discovery and related sciences, the continent is “primed for progress but requires an integrated health innovation ecosystem, investment in robust infrastructure, technology platforms, a critical mass of skilled talent, and job creation.”
Africa now claims more than 250 research sites and 73 vaccine clinical trials, but there are still areas of concern. For example, less than 10 universities provide vaccinology courses and only two local universities engage in vaccine-related pre-clinical studies. The collaboration aims to call attention to drug innovation and access in the region – key pillars to achieving the sustainable development goals and universal health coverage.
Elsewhere around the globe:
Genetika+ -- Israel-based Genetika+ closed a $10 million Series A funding round. The company’s novel Brain-in-a-Dish technology allows for a first-of-its-kind in vitro screen, in which a simple blood draw is used to predict the best antidepressant or combination therapy for that patient. The funding is expected to accelerate the company’s next phase, including expanded clinical trials, increase manufacturing capabilities and establish a clinical lab in Boston. The company is accelerating growth through increased hiring for multiple positions over the next 12 months in Boston and Israel to support research and business development activities across the U.S. market.
RDIF – The Russian Direct Investment Fund and AstraZeneca announced preliminary virus neutralizing activity results of combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine (Sputnik Light vaccine based on human adenovirus serotype 26). Data was collected from a study ongoing in the Republic of Azerbaijan. According to the results of the interim analysis, a fourfold or higher increase in neutralizing antibodies to the spike protein (S-protein) of the SARS-CoV-2 was found in 85% of the volunteers. Besides Azerbaijan, clinical trials of a combination of the two vaccines are being carried out as part of a global program in UAE and Russia.
Sapreme – Netherlands-based Sapreme will present in vivo data on improving oligo delivery to the liver in an online poster presentation at the 17th Annual Meeting of the Oligonucleotide Therapeutics Society. These data highlight the capability of its proprietary endosomal escape platform to significantly improve intracellular target engagement both in vitro as well as in vivo. The large majority of therapeutic oligonucleotide formats struggle to achieve sufficient levels of cytoplasmic or nuclear target engagement while maintaining low toxicity due to compounds becoming trapped, and thereby rendered ineffective, by the endosome. Sapreme’s endosomal enhancers strive to overcome this by enabling improvements in potency through efficient endosomal escape and by providing superior tissue- or cell-selective targeting. This is accomplished through use of targeting ligands, including GalNAc for hepatic targeting and antibodies or other ligands for non-hepatic tissues, according to the company.
ASLAN Pharmaceuticals – Singapore’s ASLAN announced positive topline data from its multiple-ascending-dose (MAD) Phase I study of ASLAN004 for the treatment of moderate-to-severe atopic dermatitis. ASLAN004, a potential first-in-class monoclonal antibody that targets the IL-13 receptor, was shown to be well tolerated across all doses. Data from the study conclusively establishes proof of concept, and supports the potential of ASLAN004 as a differentiated, novel treatment for AD.
Astellas Pharma – Japan-based Astellas announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review. Radically unresectable urothelial carcinoma is urothelial cancer that cannot be treated by surgical removal of the urinary bladder or the kidney and the ureter due to tumor growth. The approval is primarily based on the global Phase III EV-301 clinical trial, which included sites in Japan. The trial evaluated enfortumab vedotin versus chemotherapy in adult patients who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. At the time of pre-specified interim analysis, patients who received enfortumab vedotin lived a median of 3.9 months longer than those who received chemotherapy. Median overall survival was 12.9 months compared to 9 months, respectively.
Cyxone AB – Sweden-based Cyxone intends to announce Phase II results of a study of rabeximod, an orally administered immunomodulator originally targeting RA, in COVID-19 patients later this year. Rabeximod is also being developed as a potential new treatment for rheumatoid arthritis, where planning of a Phase IIb study is underway.
BetterLife Pharma, Inc. – Based in Vancouver, BetterLife has applied for patent protection of new compositions of 2-bromo-LSD for its use in the treatment of cluster headaches, neuropathic pain and range of mental health conditions, including depression, anxiety and PTSD, and related disorders. BetterLife is developing one of the new compositions of 2-bromo-LSD (TD-0148A), a second-generation lysergic acid diethylamide derivative molecule that does not cause hallucinations, and therefore not subject to controlled substance regulations.
Eyevensys – Privately-held Eyevensys, based in France, entered into a collaboration with Phillips-Medisize and Minnetronix Medical to develop the next generation of the company’s core technology. Eyevensys has developed a non-viral gene therapy ocular drug delivery platform designed to deliver DNA plasmids encoding therapeutic proteins into the ciliary muscle and sustainably treat major eye diseases. Phillips-Medisize will be responsible for Ocular Device design optimization and the high-volume manufacturing capability to support the commercial launch, and Minnetronix Medical will fulfill the same responsibilities for the Pulse Generator component.
MRM Health – Belgium-based MRM Health received authorization to begin a Phase I/IIa study in Belgium with its novel next-generation optimized consortium therapy, MH002, in patients with mild-to-moderate ulcerative colitis (UC). Developed through MRM Health’s proprietary Microbiome Optimization Technology, MH002 consists of 6 well-characterized commensal strains that are optimized to form a synergistic microecosystem driving differentiated potency, resiliency, and engraftment. MH002 is produced using MRM Health’s breakthrough scalable, robust, and standardized cGMP manufacturing platform, overcoming past microbiome challenges in manufacturing multi-strain consortia of uniform composition. Preclinical studies in inflammatory bowel disease (IBD) models showed that MH002 repairs gut microbiome dysbiosis, heals the dysfunctional intestinal barrier, and restores immune homeostasis with its differentiated mechanism targeting multiple key disease pathways. MH002 has demonstrated excellent safety and superior preclinical efficacy as compared to conventional, non-optimized microbiome therapeutics as well as mesalamine, the current first-line standard of care in UC.
ViroCell Biologics – U.K.-based ViroCell and Great Ormond Street Hospital for Children NHS Foundation Trust announced a new partnership that will address the global viral vector manufacturing bottleneck for clinical trials. ViroCell, an innovation-driven Contract Development and Manufacturing Organization, is addressing the global viral vector supply demand imbalance that constrains the manufacture of novel cell and gene therapies. ViroCell focuses exclusively on the design and GMP manufacture of viral vectors and gene modified cells for clinical trials.
Artios Pharma Limited – Also based in the U.K., Artios Pharma Limited has dosed the first patient in its Phase I/IIa study with its polymerase theta (Polθ) inhibitor, ART4215. The open label, multi-center study will assess the safety, tolerability, pharmacokinetics, and clinical activity of ART4215 administered orally as a monotherapy and in combination with other anticancer medicines in patients with advanced or metastatic solid tumors.
ProBioGen – Germany’s ProBioGen announced the closing of a DirectedLuck Transposase Technology research license agreement with an unnamed global biopharma company. The license covers the evaluation of the DirectedLuck Transposase technology in their cell line development processes.
Iterum Therapeutics – Based in Ireland, Iterum Therapeutics conducted a Type A meeting with the FDA to discuss the resubmission of a New Drug Application for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI). In July, the company received a Complete Response Letter from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI.
Ultromics – England’s Ultromics has entered into a collaboration with Janssen to identify patients with amyloidosis with cardiac involvement from routine echocardiograms. The agreement was facilitated by Johnson & Johnson Innovation. Ultromics will work with the data science and oncology scientists at Janssen to develop an AI tool to promote screening of patients at risk for the potential build-up of amyloid, an abnormal protein, in the heart. Without treatment, the build-up of amyloid proteins in the heart can lead to cardiac dysfunction, making it more difficult for the organ to pump blood around the body and putting the individual at risk of developing heart failure and death.
NuCana plc – Scotland-based NuCana received Fast Track Designation from the FDA for Acelarin (NUC-1031), which is currently being evaluated in a Phase III study for the first-line treatment of patients with advanced biliary tract cancer. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need.
Immutep Limited – Australia-based Immutep received a €2,126,617 research and development (R&D) tax incentive payment in cash from the French Government under its Crédit d’Impôt Recherche scheme (CIR). Immutep qualifies to receive CIR tax incentive through its subsidiary Immutep S.A.S. due to the research and development conducted in its laboratory at Châtenay-Malabry in southwestern Paris. The funds will be used to support the ongoing and planned global clinical development of eftilagimod alpha and the preclinical development of IMP761.
