Advaxis Inc., of Princeton, N.J., said it received the first milestone payment related to its licensing agreement for ADXS31-164 (now OST-HER2) to OS Therapies LLC, of Middletown, Del., to treat osteosarcoma. Under terms of the amended and restated agreement, OS Therapies, in collaboration with the Children’s Oncology Group, assumed responsibility to conduct and fund a study assessing OST-HER2 in recurrent, completely resected osteosarcoma and secured funding to support the research, triggering the milestone payment. Advaxis is entitled to additional clinical, regulatory and sales-based milestone payments and royalties on product sales.
Aptinyx Inc., of Evanston, Ill., said publication of a review article in Medicine in Drug Discovery featured data on its N-methyl-D-aspartate (NMDA) receptor modulator, NYX-2925, across multiple preclinical models. The review described the role of central brain changes that occur in response to chronic pain, potentially leading to a maladaptive state that creates a lifelong pain sensation despite the absence of painful sensory stimuli. In the article, preclinical data from preclinical pain models showed the analgesic effects exhibited by NYX-2925 on modulation of NMDA receptor activity, implicated in chronic pain states.
Brickbio Inc., of Boston, said it created a class of bispecific antibodies that can be labeled and conjugated at two distinct sites, allowing the company to continue to the second phase of a therapeutic partnership with one of its large pharma partners. Additional details were not disclosed.
Capricor Therapeutics Inc., of Los Angeles, said a publication developed in collaboration with researchers at Cedars-Sinai Medical Center showed the utility of pathway-enhancing culture conditions and small-molecule inhibitors to retain markers of cell therapy potency. The paper, published in Nanomedicine: Nanotechnology, Biology and Medicine, showed that manipulation of cell culture conditions with GSK3 inhibitors leads to up-regulation of beta-catenin and down-regulation of CD90, leading to a more consistent and potent cell line. Activation of canonical Wnt signaling was correlated with increased enrichment of therapeutically relevant microRNAs, including miR-22 and miR-146a, both implicated in cell potency. The data link the potency of cell therapy to the contents of the exosomes, especially miR-22 and miR-146a, according to the researchers.
Cocrystal Pharma Inc., of Bothell, Wash., said it completed its research obligations under an exclusive global license and collaboration agreement with Merck & Co. Inc., of Kenilworth, N.J., with Merck assuming sole responsibility for additional development of the influenza A/B dual polymerase inhibitors, discovered using Cocrystal’s structure-based technologies.
Conserv Bioscience Ltd., of London, and Lawrence Livermore National Laboratory have agreed to collaborate on the development of a broad-spectrum coronavirus vaccine. The pact brings together Conserv's expertise in identifying antigens and Lawrence Livermore’s nanolipoprotein particle technology delivery system. The vaccine has been designed to provide broad-spectrum protection against coronavirus pathogens of human and animal origin, including but not limited to MERS, SARS and SARS-CoV-2, the company said.
Cure Genetics Co. Ltd., of Suzhou, China, disclosed a collaboration with Boehringer Ingelheim GmbH, of Ingelheim, Germany, to develop adeno-associated virus vectors leveraging Cure’s VELP platform to develop next-generation gene therapies. The aim is to provide potential new AAV serotypes for patients. Terms were not disclosed.
The Silikotac Program consortium, consisting of Elsalys Biotech SA, of Lyon, France, Novadiscovery Sas, also of Lyon, and two expert academic teams from Hôpital St Louis (Paris) and Hôpital Henri Mondor (Paris), has been awarded €3.35 million (US$4 million) in nondilutive funding by Bpifrance to support development of inolimomab in graft-vs.-host disease. The ambition of the Silikotac program is to create the first French industrial and scientific immunotherapy chain group focused on the disease. The financing is part of the PSPC (Projet de recherche et développement Structurant pour la Compétitivité) program fund from Bpifrance, a financing initiative from the French government to support new and emerging industries within France.
Entheon Biomedical Corp., of Vancouver, British Columbia, partnered with Divergence Neuro Technologies Inc., of Toronto, to research and develop N, N-dimethyltryptamine (DMT) biomarkers and a predictive model of biomarker responses to drug dosage and delivery of DMT-based psychedelic therapeutic products. The drugs will be targeted to treat a number of addiction and substance use disorders. Terms were not disclosed.
Everest Medicines Ltd., of Shanghai, said that under an amended license agreement with Spero Therapeutics Inc., of Cambridge, Mass., the relevant patents for SPR-206 will be assigned to Everest in greater China, South Korea and certain Southeast Asian countries. The companies disclosed in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR-206 in the territory. The compound, a polymyxin derivative, is in development for multidrug-resistant gram-negative bacterial infections.
Faron Pharmaceuticals Oy, of Turku, Finland, said the U.S. Department of Defense has selected the Hibiscus study to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security Act. The phase II/III trial will assess Traumakine, Faron’s intravenous IFN beta-1a therapy, for the treatment of hospitalized COVID-19 patients in the U.S. The funding support for Hibiscus requires final contracting between Faron and the department designated military unit and is under preparation. Faron has already established a working relationship with the 59th Medical Wing and U.S. Army Institute of Surgical Research to explore the use of Traumakine for organ protection in combat wounds leading to multi-organ failure from ischemia and reperfusion.
Gritstone Oncology Inc., of Emeryville, Calif., is advancing development of a second-generation vaccine against SARS-CoV-2, with potential for prolonged protection and potency against spike mutants. Gritstone and the U.S. NIH signed a clinical trial agreement to initiate clinical testing. A phase I study is in development. The Bill & Melinda Gates Foundation is supporting the preclinical evaluation of the vaccine.
Immunitybio Inc., of Culver City, Calif., reported findings from a follow-up molecular dynamics (MD) simulation study of the SARS-CoV-2 spike receptor binding domain (RBD) and its binding to its receptor on human cells, angiotensin-converting enzyme 2 (ACE2). In the first study, “Millisecond-scale molecular dynamics simulation of spike RBD structure reveals evolutionary adaption of SARS-CoV-2 to stably bind ACE2” using exceptionally long-duration millisecond scale MD simulation, Immunitybio scientists revealed the evolutionary adaptation of spike RBD for binding to ACE2, and the regions of RBD that strongly bind ACE2. Those findings provide targets for potential new therapeutics or vaccines. In the new study, MD simulation was applied to the new strains of SARS-CoV-2, including the predominating variant in South Africa 501Y.V2 and the U.K. variant B.1.1.7. The simulations were focused on the mutations found at the interface of the spike RBD and ACE2, E484K, K417N and N501Y, because those mutations are highly likely to affect binding and thus transmissibility. IE484K and N501Y were found to increase affinity of RBD binding to ACE2.
Innovent Biologics Inc., of Suzhou, China, disclosed an agreement with Etana Biotechnologies Hong Kong Ltd., of Hong Kong, through PT Etana Biotechnologies Indonesia, to out-license Byvasda (bevacizumab biosimilar) development and commercialization rights in Indonesia to Etana. The latter is committed to launch Byvasda in the local market. In return, Innovent will receive milestone payments for development and commercialization as well as double-digit royalties on net sales.
Intravacc BV, a CDMO in Bilthoven, the Netherlands, said the polyvalent inactivated coxsackievirus B (CVB) vaccine it developed and manufactured for Provention Bio Inc., of Red Bank, N.J., has entered a phase I study. The vaccine is designed to prevent acute CVB infection and potentially delay or prevent type 1 diabetes and celiac disease. CVB is also the leading cause of viral myocarditis, a common condition that can cause fatal arrythmia and lead to a serious chronic myocarditis that often needs heart transplantation.
Invixa Inc., of Davis, California, said it entered an exclusive licensing deal with the University of California, Davis giving Invixa intellectual property rights to commercialize inhaled statins for treating COVID-19 and other viral-based respiratory diseases. Financial details were not disclosed. The company said it is finalizing preclinical testing and that it believes inhalation, rather than taking a pill, is the best way to effectively treat SARS-CoV-2.
Royalty Pharma plc, of New York, will acquire royalty interest in seltorexant from Minerva Neurosciences Inc., of Waltham, Mass., for an up-front $60 million payment and up to $95 million in additional milestone payments. Seltorexant is in a phase III study for treating major depressive disorder with insomnia symptoms by Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson. Minerva is entitled to a mid-single-digit royalty on seltorexant’s worldwide net sales.
Neucyte Inc., of San Carlos, California, said it entered a research collaboration agreement with the Seaver Autism Center for Research and Treatment at the Icahn School of Medicine at Mount Sinai. The multiyear, milestone-based collaboration will focus on using Neucyte's human induced pluripotent stem cell-based in vitro CNS disease modeling and assay development technology platform for early preclinical research around autism-associated mutations. The goal of the research is functional characterization of novel genes for better understanding of their role in autism and eventually for more effective therapeutic development.
Miragen Therapeutics Inc., of Boulder, Colo., has changed its name to Viridian Therapeutics Inc. Beginning Jan. 20, Viridian will trade on Nasdaq under the ticker VRDN. Viridian is developing multiple product candidates to treat patients who suffer from thyroid eye disease, an orphan disease that can cause bulging eyes, or proptosis, as well as double vision and potential blindness. The company’s lead product, VRDN-001, is a clinical-stage anti-IGF-1R monoclonal antibody.
Neurogene Inc., of New York, and the University of Edinburgh will collaborate to develop multiple platform approaches to creating gene therapies. Neurogene will provide financial support in exchange for the right to license any applicable intellectual property at agreed-upon economic terms. Neurogene will be responsible for late-stage preclinical and all clinical development of any products the collaboration generates.
Neurophth Therapeutics Inc., of Wuhan, China, and Aavnergene Inc. will collaborate to provide Neurophth worldwide rights to mutually select adeno-associated virus (AAV) capsids for the development of next-generation ophthalmic gene therapy. Neurophth will make an initial cash payment to Aavnergene to test about 100 AAV capsids. Within six to 12 months upon receiving the AAV capsids, Neurophth is responsible for completing the preclinical studies. After that, the companies will jointly evaluate the capsids and select the appropriate ones for further development. Once the capsids are selected, Neurophth will pay Aavnergene additional cash and/or potentially purchase Aavnergene’s common stock, based on Neurophth's achievement of specified development, regulatory and commercial milestones. In addition, Neurophth will pay Aavnergene royalties for the sales of any resulting commercialized gene therapy.
Oncosec Medical Inc., of Pennington, N.J., said it granted Sirtex Medical Inc., of San Diego, the option to nonexclusively co-promote Oncosec's lead candidate, Tavo (tavokinogene telseplasmid), in anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. Sirtex will pay Oncosec $5 million for a nonexclusive option to co-promote Tavo in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with anti-PD-1 checkpoint refractory metastatic melanoma in the U.S. If exercised, the option requires Sirtex to pay an additional $20 million in cash and purchase $5 million in the company’s common stock. The option must be exercised by Sirtex within 90 days of Oncosec filing a BLA and carries an eight-year co-promote term. Oncosec said it reserves the right to grant others co-promotion rights, as well as the right to buy back the co-promotion rights for a certain amount determined by the remaining number of years left in the term but not to exceed $45 million.
Orchard Therapeutics plc, of London, said it will extend the company’s commercial reach in the Middle East and Turkey through exclusive agreements with Genpharm Services and Gen, two regional specialty pharmaceutical companies with experience in rare genetic disease. Genpharm and Gen will facilitate access to treatment with Libmeldy in European-based qualified treatment centers for eligible patients living in the Middle East and Turkey. Libmeldy was approved in the EU in December 2020 as the first gene therapy for treating early onset metachromatic leukodystrophy, an inherited, neurodegenerative disorder. Libmeldy, or OTL-200, is an autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase-A gene.
Oxford Biotherapeutics Ltd. (OBT), of Oxford, U.K., and Wuxi Biologics Inc., of Shanghai, said the former has selected a second bispecific program that will combine an anti-PD-L1 antibody with OBT’s immuno-oncology candidate, OX-003. OBT will research and develop OX-003/PD-L1, which employs Wuxi Biologics’ bispecific antibody platform, Wuxibody.
Propanc Biopharma Inc., of Melbourne, Australia, said it received expressions of interest to evaluate proenzyme therapy as a method to prevent recurrence and metastasis of solid tumors in pancreatic and ovarian cancers. The letters of interest were confirmed by Natalia Luque Caro and Fernando Gálvez Montosa, medical oncologists specializing in pancreatic and ovarian cancers, respectively, from the University Hospital of Jaén, in Granada, Spain. The evaluation will most likely be conducted as separate phase IIa proof-of-concept multicenter studies for each target indication.
Secarna Pharmaceuticals GmbH & Co. KG, of Munich, Germany, said partner Lipigon Pharmaceuticals AB, of Martinsried, Germany, selected a candidate, Lipisense, to treat elevated levels of plasma lipid triglycerides. An antisense oligonucleotide, Lipisense is in development for patients with severe hypertriglyceridemia as well as the rare disease familial chylomicronemia syndrome.
Syntekabio Inc., of Yuseong, South Korea, said it signed multiple co-development agreements with Hanmi Science, part of Hanmi Pharmaceutical Co. Ltd., of Seoul, South Korea, to develop COVID-19 treatments utilizing drug repositioning technologies. After signing an memorandum of understanding with Hanmi Science in September 2020 to develop COVID-19 drug candidates using drug repurposing, Syntekabio has been discussing specific cooperation plans. Through the contract, Syntekabio will also collaborate with Hanmi Science to drive clinical development for its COVID-19 treatments (zafirlukast-sulfinpyrazone combination therapy) and subsequent drug repositioning research, including clinical development and regulatory affairs. Terms were not disclosed.
Tenax Therapeutics Inc., of Morrisville, N.C., said it acquired privately held PH Precision Med, a company developing tyrosine kinase inhibitor imatinib for treating pulmonary arterial hypertension. In connection with the acquisition, Tenax will issue to PHPM’s stockholders in a private placement an aggregate of about 12.1 million unregistered shares of common stock and securities convertible into common stock.
Tennor Therapeutics Ltd., of Suzhou, China, said it entered a research collaboration with Janssen Pharmaceuticals Inc., part of New Brunswick, N.J.-based Johnson & Johnson, in which the parties will use a multitargeting drug conjugation platform developed by Tennor to discover therapies for the treatment of nontuberculous mycobacteria diseases. The agreement was facilitated by Johnson & Johnson Innovation LLC. Terms were not disclosed.
Twist Bioscience Corp., of South San Francisco, said it signed two licensing agreements, one with Serotiny, in which it will discover CARs for CAR T-cell therapies, and one in which it will work with Applied Stemcell to use its Targatt CHO Cell Technology. Both agreements support and expand Twist Biopharma’s capabilities for the discovery of novel antibody therapeutics, the company said. Financial terms were not disclosed.
Vigeneron GmbH, of Munich, Germany, said it signed a research collaboration to utilize its engineered adeno-associated virus (vgAAV) vectors with Daiichi Sankyo Co. Ltd., of Tokyo, for delivering a therapeutic protein to address an undisclosed target in a highly prevalent ophthalmic disease. Vigeneron’s vgAAVs are designed to enable the efficient transduction of target cells via intravitreal injection that allows efficient lateral spreading and minimizes the risk of collateral damage caused by conventional subretinal injection. Under the agreement, Daiichi Sankyo and Vigeneron will jointly conduct the first stage of research, and Daiichi Sankyo will have the option to negotiate a follow-on collaboration agreement for an undisclosed therapeutic target in the highly prevalent eye disease. Financial terms were not disclosed.