Global Roundup: EU Approves ViiV's HIV-1 Drug and More

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The European Union (EU) authorized ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) in conjunction with Janssen’s Edurant (rilpivirine tablets) for the treatment of HIV-1 infection in adults who are virologically suppressed. Vocabria is intended for adults who are virologically suppressed on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. The approval of ViiV’s treatment is the first time HIV-1 patients in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.

Marketing Authorization was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies. In July, ViiV Healthcare, which is based in London, resubmitted the New Drug Application (NDA) for once-monthly dosing of cabotegravir and rilpivirine to the U.S. Food and Drug Administration (FDA), and further regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide, the company said.

Elsewhere around the world:

Avacta Group – U.K.-based Avacta Group entered into a license agreement with Astrea Bioseparations that allows that company to use Avacta’s Affimer platform in affinity purification applications. Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. It is a division of Gamma Biosciences. The agreement includes a £500,000 upfront payment to Avacta which gives Astrea the rights to generate and develop Affimer reagents in-house for affinity separation. It also provides Astrea with an option to convert the agreement into an exclusive license if certain commercial performance criteria are met over the next three years and subject to the payment of an additional undisclosed option exercise fee.

Additionally, Avacta announced it submitted a Clinical Trial Application in the UK for a Phase 1, first-in-human, open label, dose-escalation and expansion study of its lead pre|CISION prodrug, AVA6000, in patients with locally advanced or metastatic selected solid tumors.

Shanghai Haini Pharmaceutical -- China’s Shanghai Haini Pharmaceutical Co., and France’s Allecra Therapeutics signed an exclusive licensing agreement under which Shanghai Haini will manufacture, develop and commercialize cefepime/enmetazobactam within Greater China, including Mainland China with Hong Kong and Macau, and Taiwan. Cefepime/enmetazobactam has shown superiority over standard of care in patients with complicated urinary tract infections (cUTIs) in a randomized, controlled, double-blind, global Phase III trial. Shanghai Haini will be responsible for manufacturing, development and commercialization of cefepime/enmetazobactam, including commercial manufacturing, and all associated costs, within the licensed territory.

BioMedion AG – Germany-based BioMedion acquired the Compliance Division of arivis AG, a provider of regulatory software and biomedical 3D and big image data software solutions. The acquisition includes the cloud-based arivis5D content platform that offers a holistic, integrated, and computerized approach for users in the pharmaceutical, medical device, food, and crop sciences industry. With the integration of both parties’ technologies, BioMedion will provide a new operating system for regulated applications operating effectively on one platform in controlled environments. Following the acquisition, the arivis5D content platform will be rebranded to neuronOS. neuronOS will reinforce the company’s GxP quality, compliance, and archiving solutions by adding new technology to handle all types of digital content, including instrument data and digital forms.

GeneMe – Based in Poland, GeneMe completed a €5.2 million seed funding round. The proceeds will be used to refine the company’s development of its molecular NAAT COVID-19 tests: FRANKD, SAVD, and ICED. FRANKD is CE IVD-approved and FDA EUA-applied. The latest round of seed funding also empowers GeneMe to consolidate emergency triage services by acquiring a minority stake in the medical-box startup Medicalls, the company said. Funding efforts were led by Robin Tombs, co-Founder of Yoti and previously of Gamesys, and other angel investors.

RDIF -- The Russian Direct Investment Fund, AstraZeneca and R-Pharm signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine and one of the components of the AZD1222 vaccine, developed by AstraZeneca and the University of Oxford. The parties also agreed to develop scientific and business relations and explore the possibilities for joint use of the Sputnik V vaccine and the AZD1222 vaccine in order to create more effective and long-term immunization against potential new coronavirus infections.

BioNTech – Germany’s BioNTech and partner Pfizer secured authorization from the European Medicines Agency for its COVID-19 vaccine. The positive recommendation represents the first for both a COVID-19 and mRNA vaccine in the European Union. The COVID-19 vaccine of BioNTech and Pfizer has been authorized in the UK, USA, Canada, Israel, Bahrein, Saudi Arabia, Mexico, Chile, Ecuador, and Switzerland so far.

Ilya Pharma – Sweden’s Ilya Pharma announced it extended its research collaboration in immunophysiology with Uppsala University. The company said the new knowledge to be generated from the extended collaboration will help further de-risk and accelerate development of Ilya’s pipeline of advanced therapies based on modified lactic acid bacteria expressing human chemokines beyond acute skin wounds to diabetic wounds and inflammatory bowel disease.

MaaT Pharma – France’s MaaT Pharma announced that it will move forward with its Phase Ib study of a treatment for acute myeloid leukemia following a positive finding from an Independent Data and Safety Monitoring Board. Maat is developing a capsule formulation of Maat033, its lead biotherapeutic for this indication. The DSMB reviewed safety data from the first patient cohort treated with the first dose of MaaT033 and confirmed the absence of safety issues during the trial and recommended that the trial continue without modifications.

Ultimovacs ASA – Norway-based Ultimovacs initated its Phase II FOCUS study evaluating its proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy, Keytruda. The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020.

Peijia Medical – China’s Peijia Medical partnered with France’s HighLife SAS on the development of a unique transeptal mitral valve replacement (TMVR) system to treat patients suffering from mitral regurgitation. Peijia received an exclusive license regarding certain proprietary TMVR products currently in development by HighLife. The TMVR technology developed by HighLife uses a transeptal approach to treat patients with MR, and is currently evaluated in international clinical studies in more than 20 sites on three continents. 

AMO Pharma – London’s AMO initiated the REACH-CDM study to assess the efficacy and safety of AMO-02, the company's dual action investigational mRNA modulating/GSK3ß kinase inhibitor, in the treatment of congenital myotonic dystrophy (CDM1).

MODAG – Germany’s MODAG initiated a first-in-patient Phase Ib study for anle138b in patients with mild to moderate Parkinson´s Disease (PD). Anle138b is a disease-modifying treatment option for synucleinopathies, such as Multiple System Atrophy (MSA) and PD. The study’s primary endpoints include safety, tolerability and pharmacokinetics of anle138b in Parkinson’s patients in order to establish the optimal dosing scheme for future long-term efficacy trials.

Recce Pharmaceuticals – Australia-based Recce Pharmaceuticals announced results from its international SARS-CoV-2 in-vivo studies, demonstrating positive activity of RECCE 327 (R327) and RECCE 529 (R529) against the SARS-CoV-2 virus in Syrian golden hamsters. The results, in both R327 and R529, demonstrated a positive reduction in COVID-19 viral load compared to the placebo group.

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