BioSpace Global Roundup: Ayala Moves Forward with Desmoid Tumor Asset in Phase II/III Study

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Israel’s Ayala Pharmaceuticals is on track to accelerate the development of its treatment for desmoid tumors. Following an end-of-Phase I meeting with the U.S. Food and Drug Administration, Ayala is aiming to move AL102 into a pivotal Phase II/III study.

AL102 is a potent, selective, oral gamma secretase inhibitor. The clinical trial is expected to begin in the first half of 2021 and can be used as a registrational study, the company said. The Phase II/III study, dubbed RINGSIDE, will evaluate the efficacy, safety and tolerability of AL102 in adult and adolescent patients with desmoid tumors. Part 1 of the study will be open-label and will enroll up to 36 patients with progressive desmoid tumors in three study arms across three doses of AL102. Part 2 of the study will start immediately after dose selection from part 1 and will be a double-blind placebo-controlled study enrolling up to 156 patients with progressive disease. An interim data readout could be available in 2022.

“This exciting news of entering into a potentially registration-enabling pivotal trial, earlier than expected, represents an important step for Ayala as we are able to accelerate the development of AL102 for the treatment of desmoid tumors based on positive and encouraging feedback from the FDA following our end-of-Phase 1 meeting,” Roni Mamluk, chief executive officer of Ayala said in a statement.

Elsewhere around the globe:

NeonMind Biosciences – Vancouver’s NeonMind is now trading on the Canadian Securities Exchange (the “Exchange”) under the ticker symbol “NEON.” NeonMind, a psychedelic drug development company, completed its oversubscribed initial public offering on Dec. 30, 2020, for gross proceeds of $4,600,000. NeonMind’s initial focus is obesity. NeonMind is exploring the use of psilocybin (a complex organic compound found in psychedelic mushrooms) as a potential treatment for weight loss through a preclinical trial. The company expects to complete an application for a Phase II trial in the spring of 2021.

Ilya Pharma – Based in Sweden, Ilya Pharma announced positive results from the Phase I study of its lead wound gene therapy candidate ILP100. The company expects to rapidly move the asset into Phase II studies. ILP100 is the first drug candidate based on genetically engineered Lactobacillus to be approved to enter human trials, the company said. The ILP-technology is based on deploying chemokines, which until now have been regarded as being too instable and having too short a half-life in tissue to be effective in major wounds. However, with ILP100, the lactic acid bacteria functions as small bioreactors on site in the wound, continuously introducing the CXCL12 into the wound tissue for a transient time. Success with this trial also de-risks the use of ILP-drug candidates in other medical indications, including the company’s inflammatory bowel disease program.

EMA – The European Medicines Agency approved a new intramuscular (IM) injection route of administration for Biogen’s Plegridy (peginterferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis (MS). A subcutaneous (SC) formula was previously approved. The approval for IM administration is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. Bioequivalence between the two dosing regimens was confirmed and data show that participants receiving Plegridy through IM administration experienced fewer injection site reactions in comparison to participants receiving SC administration.

Abivax – France’s Abivax published a paper on the “Specific and selective induction of miR-124 in immune cells by ABX464: a transformative therapy for inflammatory diseases” in the journal Drug Discovery Today. ABX464 is the first-in-class small molecule that has shown to induce and upregulate a specific microRNA, miR-124, in human immune cells leading to a robust and long-lasting anti-inflammatory effect in UC patients. The review summarizes the multiple effects of ABX464 in dampening inflammatory processes through the downregulation of several critical pro-inflammatory cytokines and cells, like TNFa, IL-6, MCP-1, IL-17 and Th17+ cells, emphasizing the potential of Abivax’s lead drug candidate as an efficient and long-term effective therapy for the treatment of inflammatory diseases.

Inventiva – Also based in France, Inventiva announced the details of the Phase III clinical trial with its lead drug candidate lanifibranor in NASH following the end-of-phase II meeting with the FDA and the receipt of the Scientific Advice letter from the European Medicines Agency. The Phase III will seek accelerated approval in the U.S. and conditional approval in Europe for lanifibranor based on a pre-specified histology analysis in approximately 900 patients after 72 weeks establishing a positive benefit-risk ratio. The trial will also use a primary composite endpoint combining NASH resolution and fibrosis improvement and established adequacy of long-term use after 72 weeks. The trial preparations are progressing according to schedule and Inventiva plans to initiate the trial in the first half of 2021.

Novasep – Another French company, Novasep this week signed an agreement with Sartorius Stedim Biotech regarding the proposed sale of Novasep’s chromatography equipment division. This proposed transaction covers operations located on different Novasep sites employing approximately 100 people, the majority of whom work at the Pompey site in eastern France and some in the U.S., China and India. Novasep’s chromatography equipment division comprises resin-based batch and intensified chromatography systems, and primarily focuses on high-pressure, multi-use applications for smaller molecules, such as oligonucleotides, peptides and insulin. Since 2018, Novasep and Sartorius have been collaborating in the joint development of an optimized system for a membrane-based, low-pressure chromatography that processes larger molecules more productively and that will be launched soon.

RDIF -- The Russian Direct Investment Fund signed an agreement with the government of Serbia to supply 2 million doses of Sputnik V. Vaccination against coronavirus with Sputnik V started in Serbia today. First batch. Serbia follows other countries in authorizing the Russian vaccine, including Argentina and Belarus. Sputnik V has 91.4% efficacy rate, RDIF said, citing results of Phase III clinical trials in Russia obtained 21 days after administering the first dose to volunteers.

Intravacc – Netherlands-based Intravacc and Cristal Therapeutics forged a strategic collaboration to develop novel vaccine programs against human diseases with the initial candidate targeting COVID-19. Under the terms of the agreement, Cristal Therapeutics and Intravacc will collaborate with an initial focus on generating a CriVac vaccine candidate based on the receptor-binding domain of the SARS-CoV-2 spike protein. In addition, Cristal Therapeutics will provide its powerful copper-free click chemistry reagent, CliCr, for evaluation with Intravacc’s proprietary outer membrane vesicles (OMV) technology. OMV vaccines allow for the native conformation of immunity-stimulating antigens. After completion of the evaluation period Intravacc and Cristal will jointly explore next steps to further advance the program.

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