Accord Healthcare Ltd., of Harrow, U.K., entered an exclusive distribution agreement with Molteni Farmaceutici SpA, of Giussano, Italy, for the commercialization of Sixmo (buprenorphine) in Europe. The drug is an opioid agonist therapy treatment, delivered through a first-of-its-kind implant, placed under the skin for six months. It was approved in Europe in June 2019. Terms were not disclosed.
Acelrx Pharmaceuticals Inc., of Redwood City, Calif., said the U.S. military's access to Dsuvia (sufentanil) has been expanded with the addition of the drug to the defense department’s formulary. Dsuvia was approved for pain by the FDA in November 2018 for use in adults in certified medically supervised health care settings.
The AIDS Healthcare Foundation sharply criticized drug companies working on COVID-19 vaccines over a near total lack of transparency on the companies’ respective trials. The group cited setbacks with London-based Astrazeneca plc’s vaccine trial that briefly forced its suspension last week as well as claims by Pfizer Inc., of New York, that it could have an answer about whether its vaccine works before the end of October, despite also disclosing that it was expanding its vaccine trial to 44,000 people, up from its previous goal of 30,000.
Arctoris Ltd., of Oxford, U.K., signed a memorandum of understanding with Syntekabio Inc., of Yuseong, South Korea, to collaborate on drug discovery efforts. The first project under the agreement sees the two companies work together to assess small-molecule therapeutics for COVID-19. The pair will screen a series of potential candidate molecules. Other terms were not disclosed.
Biogen Inc., of Cambridge, Mass., disclosed Healthy Climate, Healthy Lives, a $250 million, 20-year initiative to eliminate fossil fuels across its operations and collaborate with institutions with the aim to improve health, especially for the world’s most vulnerable populations. Biogen’s goal is to eliminate its fossil fuel emissions by 2040, as well as be a catalyst for change by advancing the science around how fossil fuels impact human health and taking action to promote climate and health equity, the company said.
Evotec SE, of Hamburg, Germany, and the Bioaster Technological Research Institute signed a partnership to advance research for infectious diseases. Bioaster is a technology and innovation hub located in Lyon, France, that has created a new model to address the latest challenges in the microbiology field, including antimicrobial resistance and vaccine safety and efficacy. The organizations have been working together since the beginning of 2020.
Glycot Therapeutics LLC, of Baltimore, a startup based on intellectual property (IP) developed at the University of Maryland, Baltimore and University of Maryland, College Park, executed a sublicense agreement for its glycoengineering technology with Daiichi Sankyo Co. Ltd., of Tokyo. The agreement grants Daiichi Sankyo worldwide and nonexclusive rights to IP that Glycot currently licenses from the two universities and includes an undisclosed up-front payment, annual fees and adequate royalties of sales to Glycot.
Hifibio Therapeutics Inc., of Cambridge, Mass., disclosed a partnership agreement with ABL Bio Ltd., of Gyeonggi-Do, South Korea, to advance HFB-30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. Hifibio discovered, engineered and developed the product in less than six months. The company submitted an IND Aug. 25.
Keros Therapeutics Inc., of Lexington, Mass., reported preclinical results at the American Society for Bone and Mineral Research virtual meeting showing that KER-012, an activin receptor type II ligand trap, increased trabecular bone by reducing bone catabolism and enhancing anabolism. In adult male mice, administration of KER-012 (20 mg/kg twice weekly for five weeks) increased trabecular bone volume (82%; p<0.001), produced higher trabecular bone volume fraction (78.3%; <0.001) and increased trabecular number (33.5%; p<0.01). Treatment also increased trabecular thickness (28.8%; p<0.01) and reduced trabecular separation (-27.2%; p<0.001). Reductions in bone catabolism were evidenced by reduced trabecular eroded surface (-42.2%; p<0.001) and trabecular osteoclast number (-45.8%; p<0.01). The observed increase in osteoblast/osteoclast ratio (+125%; p<0.01) is potentially indicative of the dual mechanism of increased anabolism and decreased catabolism, the company said.
Lava Therapeutics BV, of Utrecht, the Netherlands, along with Amsterdam UMC and the Monash Biomedicine Discovery Institute in Australia, said Nature Cancer published a paper detailing findings that highlight the potential for a Lava-derived antibody fragment, known as a single domain antibody, to act as a bridge to link together two key immune cell receptors – the CD1d receptor and the T-cell receptor of natural killer T (NKT) cells – in order to enhance the body’s immune response to cancer. Preclinical research through the companies’ collaboration demonstrates that a CD1d-NKT cell-targeting antibody resulted in significant activation of NKT cells and the subsequent killing of CD1d-expressing tumor cells in multiple tumor samples, including multiple myeloma and acute myeloid leukemia.
Marinus Pharmaceuticals Inc., of Radnor, Pa., said it entered a five-year development contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of I.V. ganaxolone for the treatment of refractory status epilepticus, a life-threatening condition in which a significant number of patients do not respond to first- and second-line anticonvulsant drugs. The agreement covers a base period during which BARDA will provide subject matter expertise and $21 million to fund, on a cost-share basis, the company’s planned phase III trial and will fund preclinical studies of ganaxolone in nerve agent exposure animal models. Contingent on favorable clinical and preclinical outcomes in the base period, the contract includes up to about $30 million of additional BARDA funding spanning three options in support of manufacturing, supply chain, clinical, regulatory and toxicology activities. Under the contract, Marinus will be responsible for cost-sharing in the amount of $33 million if all development options are completed.
Molecular Partners AG, of Zurich, Switzerland, said it completed its initial GMP manufacturing runs of its trispecific antiviral DARPin candidate, MP-04290, in development as a potential therapeutic and prophylactic option for COVID-19. A phase I trial is expected to start this fall.
Moleculin Biotech Inc., of Houston, said it contracted with an independent laboratory to test the antiviral activity of its WP-1122 portfolio in a COVID-19 animal model. The testing will involve that laboratory's hamster model and SARS-CoV-2. Based on the estimated start date of the study, final data may be available in December.
Navire Pharma Inc., of San Francisco, an affiliate of Bridgebio Pharma Inc., and the University of Texas MD Anderson Cancer Center reported data showing SHP2 inhibitor IACS-13909 is able to overcome multiple therapeutic-resistance mechanisms in non-small-cell lung cancer, suggesting a possible new approach to treating cancers that have developed resistance to the targeted EGFR inhibitor osimertinib. Data were published in Cancer Research. Navire plans to launch a clinical studies of SHP2 inhibitors by the end of 2020.
Navrogen Inc., of Cheyney, Pa., said it was awarded a U.S. National Cancer Institute (NCI) grant to support its NAV-006 program involving the development of a next-generation rituximab that is refractory to the immunosuppressive effects of the tumor microenvironment. Navrogen has employed its Humoral Immuno Oncology technology to identify the factors reducing rituximab’s therapeutic effects against immunosuppressed tumors. It will use the NCI grant to apply its block-removed immunoglobulin technology (BRITE) to create a next-generation rituximab. Upon successful optimization, it will seek strategic partners to support later stages of development.
Neuraxpharm Group, of Dusseldorf, Germany, said it acquired prescription brand Buccolam (oromucosal midazolam) from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan. Financial terms were not disclosed. The deal is expected to close by the end of 2020.
Orexo AB, of Uppsala, Sweden, said it filed a patent infringement action in the U.S. District Court for the District of New Jersey against Sun Pharmaceutical Industries Ltd., of Mumbai, India, along with Sun Pharma Global FZE, Sun Pharma Global Inc. and Sun Pharmaceutical Industries Inc. The lawsuit was filed in response to an ANDA filed by Sun with the FDA, seeking to market and sell generic versions of Orexo's Zubsolv products, (buprenorphine and naloxone) sublingual tablets, in the U.S. prior to expiration of the patents listed in FDA's Orange Book. Since Orexo timely filed a lawsuit against Sun, it said the FDA is statutorily precluded from approving Sun's ANDA for 30 months, or until a district court decision finds the patents to be invalid or not infringed, whichever occurs first. The 30-month stay period began as of the date Orexo received the notice letter from Sun advising Orexo of the ANDA filing.
Pascal Biosciences Inc., of Seattle, and Sōrse Technology Corp., of Vancouver, British Columbia, entered a collaborative research agreement to advance Pascal’s PAS-393 into clinical testing. The companies will share their respective technologies to test the cannabinoid in human volunteers, enabling testing of cancer patients treated with checkpoint inhibitors. Pascal and Sōrse scientists will optimize a cannabinoid formulation for human subjects and will then test the formulated PAS-393 in volunteers. Sōrse will provide $750,000 in research funding to Pascal throughout the 15-month collaboration and will pay for related research expenditures.
Santhera Pharmaceuticals AG, of Pratteln, Switzerland, said Emory University scientists and partner Reveragen Biopharma Inc., of Rockville, Md., have published new data on the molecular mode of action of vamorolone compared to standard corticosteroids (prednisone and deflazacort). Published in the Proceedings of the National Academy of Sciences, data extend previous publications that characterized the pharmacological properties of vamorolone, a dissociative steroidal drug candidate that decreased muscle inflammation and improved muscle strength in mouse models of Duchenne muscular dystrophy (DMD). Moreover, initial open-label clinical trials with vamorolone showed dose-responsive efficacy in DMD while biomarker measurements indicated reduced safety concerns typically associated with traditional corticosteroid treatments. Vamorolone is currently in advanced clinical development in patients with DMD.
Société des Produits Nestlé SA, of Vevey, Switzerland, said its wholly owned subsidiary, SPN Merger Sub Inc., commenced Sept. 14 a cash tender offer to purchase all of the outstanding shares of Aimmune Therapeutics Inc., of Brisbane, Calif., for a price of $34.50 per share. The deal, disclosed last month, is valued at about $2.6 billion.
Sorrento Therapeutics Inc., of San Diego, said it entered an exclusive license agreement with Mayo Clinic for a potential breakthrough technology platform that is capable of generating stable antibody-drug-nanoparticle albumin-bound immune complexes (ADNICs) targeting many types of human diseases, including various solid and liquid tumors. The ADNIC is described as a next-generation antibody-drug conjugate (ADC) technology that potentially addresses limitations of current ADC technology, such as complex manufacturing processes, which can affect drug half-life, stability and tumor accessibility, and result in high cost of goods. The ADNIC platform is currently generating clinical data at Mayo Clinic through clinical trials with multiple investigational products in a variety of cancers, including ovarian, endometrial and multiple lymphoma subtypes.
Springworks Therapeutics Inc., of Stamford, Conn., said it entered a clinical collaboration and supply agreement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to evaluate Springworks’ investigational gamma-secretase inhibitor, nirogacestat, in combination with Janssen’s bispecific antibody targeting BCMA and CD3, teclistamab, in patients with relapsed or refractory multiple myeloma. Under the terms, Janssen will sponsor and conduct the phase I study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat. Springworks will also form a joint oversight committee with Janssen. Pending discussions with regulators, the study is anticipated to commence by early 2021.
Starpharma Ltd., of Melbourne, Australia, said it completed additional antiviral testing for SPL-7013 against SARS‑CoV-2 in studies conducted at the Scripps Research Institute in the U.S. The latest results confirm that when SPL-7013 is applied at the concentration of the SPL-7013 COVID-19 nasal spray, it has potent virucidal activity, inactivating more than 99.9% of SARS-CoV-2, the virus that causes COVID-19. Starpharma is expediting the development of the SPL-7013 nasal spray and has already completed reformulation, pilot product manufacture, selection of device and packaging components, identification of manufacturer and compiled regulatory documentation in preparation for submission.
Talaris Therapeutics Inc., of Boston, said it is collaborating with Kentucky Organ Donor Affiliates (KODA), an independent, nonprofit organ and tissue procurement organization that facilitates deceased donor transplants throughout Kentucky, southern Indiana and western West Virginia. The collaboration will advance preclinical studies of the potential of Talaris’ allogeneic cell therapy to induce immune tolerance to an organ from a deceased donor. Within the collaboration, KODA, after authorization from the donor’s family, will recover vertebrae from deceased organ donors. Then researchers at Talaris will isolate stem cells from the vertebrae, with the goal of demonstrating the feasibility of producing its FCR-001 candidate from vertebral bone marrow. Those preclinical studies will serve as a first step toward enabling future clinical studies to evaluate whether FCR-001 administered alongside organ transplantation can induce durable immune tolerance to an organ from a deceased donor, the company said.
Tikomed AB, of Viken, Sweden, said preclinical data published in Antioxidants show a single injection of lead candidate ILB has beneficial effects on the metabolic damages caused by severe traumatic brain injury (sTBI) in a rodent model. Data show administration after sTBI dose-dependently improves brain metabolism, inhibits oxidative/nitrosative stress and avoids the depletion of low molecular weight antioxidants. ILB is designed to target multiple cellular pathways responsible for the loss of neuron structure and function in the neurodegenerative disease processes, boosting self-repair and protection mechanisms, enabling neurons to regain lost functions.
Vaxess Technologies Inc., of Cambridge, Mass., said it formed a partnership with Taiwanese company Medigen Vaccine Biologics Corp. (MVC) to develop a combined COVID-19 and quadrivalent seasonal influenza vaccine, delivered via Vaxess’ MIMIX patch system. The vaccine in development uses a stabilized form of the spike protein from the SARS-CoV-2 virus, and the immunogen was co-developed by researchers at the Vaccine Research Center of the National Institute of Allergy and Infectious Diseases, part of the U.S. NIH, and at the University of Texas at Austin. MVC aims to enter phase I trials in September 2020, with an adjuvanted intramuscular injection of the vaccine. In parallel, Vaxess will initiate a U.S. clinical trial using the company’s MIMIX platform technology.