Alcresta Therapeutics Inc., of Newton, Mass., said a paper published in the Journal of Pediatric Gastroenterology and Nutrition provides guidance on the medical management of pancreatitis in children based on existing medical literature. The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Pancreas Committee recommended use of Relizorb in patients who are on enteral feeding due to chronic pancreatitis who demonstrate poor weight gain or malabsorption as a result of their inability to produce enough of the enzyme lipase to break down fats. Relizorb is designed to mimic the function of pancreatic lipase.
Allarity Therapeutics A/S, of Horsholm, Denmark, said it has ongoing and planned in vitro studies testing the antiviral activity of PARP inhibitor stenoparib against coronavirus variant B.1.1.7 (the U.K. variant) and variant B1.351 (the South African variant). Previous preclinical results showed the drug inhibits SARS-CoV-2 as a single agent and in combination with remdesivir (Gilead Sciences Inc.). Allarity aims to advance stenoparib into human trials as a potential therapy for COVID-19 and is working to secure funding to advance such trials. At the same time, the company said it also plans to test stenoparib against other emerging coronavirus strains.
Cybrexa Therapeutics Inc., of New Haven, Conn., said it entered a Cooperative Research and Development Agreement with the U.S. National Cancer Institute (NCI), part of the NIH. Under terms, Cybrexa and the NCI will collaborate on preclinical and potential clinical development of Cybrexa’s lead therapeutic candidate, CBX-12 (alphalex-exatecan), a peptide-drug conjugate. If preclinical studies support clinical development, they will move to demonstrate the drug’s safety and efficacy in patients with a variety of solid tumors.
Cyprium Therapeutics Inc., of New York, a Fortress Biotech Inc. partner company, and Sentynl Therapeutics Inc., a Solana Beach, Calif.-based specialty pharma firm owned by Zydus Group, said they executed an asset purchase agreement to commit development funding for and acquire Cyprium’s rights to CUTX-101, its copper histidinate product candidate for the treatment of Menkes disease. Under the terms, Cyprium is eligible to receive up to $20 million in up-front development and regulatory cash milestones through NDA approval, as well as potential sales milestones. Royalties on CUTX-101 net sales ranging from the mid-single digits up to the mid-20s are also payable. Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval. Continued development of CUTX-101 will be overseen by a joint steering committee consisting of representatives from Cyprium and Sentynl.
Daiichi Sankyo Co. Ltd., of Tokyo, and lymphoma-focused research network LYSA-LYSARC-CALYM said they entered a strategic research collaboration to study valemetostat (DS-3201), Daiichi Sankyo’s potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a phase II study in patients with five subtypes of relapsed/refractory B-cell lymphoma, expected to start this year. Terms were not disclosed.
Fresh preclinical data from Decibel Therapeutics Inc., of Boston, showed that DB-OTO in nonhuman primates produced successful distribution and expression across the cochlear length. The candidate uses dual AAV vectors and a cell-selective promoter to express functional otoferlin in hair cells of the inner ear, allowing the ear to transmit sound to the brain and enable hearing. In the studies, DB-OTO and the surgical administration were generally well-tolerated. The company suggested hair cell selective expression of otoferlin may enable greater efficacy and durability and minimize potential toxicity. Decibel also said the preclinical studies showed that DB-OTO restored normal hearing sensitivity in animal models of otoferlin deficiency. Decibel is developing DB-OTO with Regeneron Pharmaceuticals Inc. and said it expects to submit an IND or CTA in 2022.
Enamine Ltd., of Kyiv, Ukraine, and Addex Therapeutics Ltd., of Geneva, have extended their research collaboration in CNS drug discovery. Enamine provides Addex with medicinal chemistry, pharmacology and ADME/PK to support Addex’s small-molecule CNS drug discovery programs. Addex specializes in allosteric modulation-based drug discovery and development.
Generex Biotechnology Corp., of Miramar, Fla., said it completed a mouse immunogenicity study for its li-Key COVID-19 vaccine development program with transgenic mice genetically engineered with the DR4 human leukocyte antigen allele, a gene from the human immune system. The results, the company said, demonstrated that the Ii-Key vaccine in combination with the adjuvant produced antibodies directed against the Ii-Key-SARS-CoV-2 epitopes as measured by ELISA assay. T cells from the mice reacted strongly to stimulation by the Ii-Key vaccine in ex vivo studies of the mouse spleen cells containing T and B cells, dendritic cells and macrophages, which have different immune functions, the company added.
Graviton Bioscience Corp., of New York, and Beijing Tide Pharmaceutical Co. Ltd., of Beijing, signed an exclusive license agreement granting development and commercialization rights for TDI-01, a targeted inhibitor of Rho/Rho containing protein kinase 2, to Graviton in all territories, excluding China. Graviton will make an up-front payment and additional amounts for development, regulatory and sales milestone payments for all programs, as well as royalties on net sales and an option for a revenue-sharing arrangement for certain developed products. The aggregate amount of up-front, development, regulatory and sales milestone payments is up to $517.5 million.
Insilico Medicine Inc., of Hong Kong, said it designed a preclinical candidate – ITI-1284 – for a broad disease indication. The small-molecule inhibitor of a biological target demonstrated in vitro and in vivo efficacy in preclinical studies for idiopathic pulmonary fibrosis and a good safety profile in the 14-day repeated mouse dose range finding study. Insilico develops software leveraging generative models, reinforcement learning and other machine learning techniques to generate new molecular structures with specific properties.
Mydecin Innovations Group, of Denver, said it entered an exclusive partnership with Applied Pharmaceutical Innovation at the University of Alberta. Mydecine said the partnership allows it to legally cultivate, extract, import, export and commercialize full cGMP pharmaceutical grade natural and synthetic compounds to reciprocal licensed facilities globally. The company is building a pipeline of nature-sourced psychedelic-assisted therapeutics, compounds, therapy protocols and delivery systems for treating mental health issues.
Pan-Biome Pharmaceuticals Inc., of Vancouver, British Columbia, said one of its drugs produced strong effects in modulating gut microbiota in a mouse model study of inflammatory bowel disease. In a study run by the Gut4Health Microbiome Core at British Columbia’s Children’s Hospital Research Institute, the compound induced a distinct shift in microbiota composition, by increasing “good” bacteria while suppressing bacteria associated with the development of obesity and type 2 diabetes, the firm said.
Poxel SA, of Lyon, France, completed its arbitration with Darmstadt, Germany-based Merck KGaA. The arbitral tribunal dismissed the majority of Merck Serono’s claims, confirming a significant part of Poxel’s position on the matter. As part of the final settlement, Poxel will pay about €1.8 million (US$2.1 million). In 2019, Poxel was notified of the initiation of arbitration proceedings by Merck to settle a difference in interpretation of the assignment and licensing agreement related to Poxel’s revenue base to be subject to compensation under the partnership agreement with Roivant Sciences Ltd., of Basel, Switzerland.
Qiagen N.V., of Hilden, Germany, and Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., extended their partnership with a new master collaboration agreement to develop liquid biopsy-based companion diagnostic products based on next-generation sequencing (NGS) technology to complement Inovio's therapies. The initial project in this expanded collaboration focuses on the co-development of a diagnostic test that identifies women who are most likely to benefit from clinical use of VGX-3100, Inovio's immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus.
Recce Pharmaceuticals Ltd., of Sydney, Australia, commenced the application process to dual list its stock on the Frankfurt Stock Exchange.