Aligos Therapeutics Inc., of South San Francisco, said its Belgian subsidiary, Aligos Belgium BV, has been awarded a €1.8 million (US$2.1 million) grant by the Flemish Agency for Innovation and Entrepreneurship to support a nonclinical research project related to combination therapy for hepatitis B at Aligos. The three-year project will include collaborations with the laboratories around the world, and will focus on a clearer understanding of the virus’ life cycle, Aligos said.
Amcure GmbH, of Eggenstein-Leopoldshafen, Germany, and Hinova Pharmaceuticals Inc., of Chengdu, China, signed an exclusive license agreement for the development, manufacturing and commercialization of AMC-303 in oncology in the greater China region. Hinova will develop, manufacture and commercialize AMC-303 with an initial focus on esophageal metastatic squamous cancer. China is projected to be the largest market globally for esophageal squamous cancer treatments, the companies noted. The candidate targets CD44v6, a splice variant of the CD44 family of transmembrane glycoproteins.
Annovis Bio Inc., of Berwyn, Pa., completed the dog cohort of a chronic toxicology study of its lead therapeutic compound, ANVS-401, for the treatment of Alzheimer’s and Parkinson’s disease, reporting no negative side effects. The nine-month dog study was part of a series of animal toxicology studies, funded by a $1.9 million grant from the U.S. NIH that began in the fourth quarter of 2019. The safety data corroborate the positive results from the company’s prior one-month safety studies in mice, rats, dogs and humans and six-month study in rats. ANVS-401 inhibits the translation and, therefore, the levels of several key neurotoxic proteins both in vitro and in vivo, including APP, tau and αSYN, Annovis said.
Astrazeneca plc, of Cambridge, U.K., is partnering with CCT Research Inc., of Scottsdale, Ariz., to advance COVID-19 research. With local health care providers, CCT will facilitate clinical trials for AZD-1222, an investigational vaccine for the prevention of COVID-19. CCT is recruiting eligible study participants ages 18 to 85, not pregnant, in good general health and have not been previously diagnosed with COVID-19. The study is taking place at Bayless Integrated Healthcare's downtown Phoenix location.
Atara Biotherapeutics Inc., of South San Francisco, presented the first preclinical evaluation of ATA-3271, a next-generation, off-the-shelf, allogeneic Epstein-Barr virus CAR T-cell therapy targeting mesothelin designed for the treatment of solid tumors. The data were highlighted during the Society for Immunotherapy of Cancer annual meeting. In vitro functional studies showed potent antitumor activity of ATA-3271 against mesothelin-expressing cell lines, with potency maintained in the presence of high tumor PD-L1 expression.
Curevac NV, of Tubingen, Germany, said its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and within defined specifications for at least three months when stored at a standard refrigerator temperature of +5 C (+41 F) and up to 24 hours as ready-to-use vaccine when stored at room temperature. Storage of sample material, as well as analytical testing of CVnCoV was performed under standard conditions defined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Stability of the liquid drug product of CVnCoV was tested at the anticipated storage concentration and stored at +5 C (+41 F) as well as below -60 C (-76 F) .
Greenwich Lifesciences Inc., of Stafford, Texas, partnered with Baylor College of Medicine in Houston to act as the lead clinical site for the company’s upcoming phase III trial. Mothaffar Rimawi agreed to serve as the global principal investigator, and Kent Osborne and Rimawi are expected to serve as the first members of the company’s clinical advisory board for the development of Greenwich’s GP2 immunotherapy across all indications and HER2-expressing cancers. GP2 is a nine amino acid transmembrane peptide of the HER2/neu protein.
The Institute for Clinical and Economic Review (ICER) released a draft evidence report assessing the comparative clinical effectiveness and value of inclisiran (Novartis AG), bempedoic acid (Nexletol, Esperion Therapeutics Inc.) and bempedoic acid/ezetimibe (Nexlizet, Esperion) for patients with heterozygous familial hypercholesterolemia and for secondary prevention of atherosclerotic cardiovascular disease. The preliminary draft marks the midpoint of ICER's process of assessing these treatments. The draft is open to public comment until Dec. 11.
Jubilant Therapeutics Inc., of Bedminster, N.J., and Onethree Biotech Inc., of New York, said they have completed a study focused on identifying specific biomarkers for new indications in oncology. In determining the mechanism for Jubilant’s dual epigenetic inhibitor targeting melanoma, myelodysplastic syndrome and acute myeloid leukemia, the collaboration generated new data supporting dual inhibition (LSD1 and HDAC6) to drive inhibition. The collaboration also found pinpoint molecular markers that could be used to identify patients who might benefit from the dual inhibition.
Kiadis Pharma NV, of Amsterdam, released new data from its study exploring the combination of two investigational therapies, oncolytic virotherapy and adoptive PM21-NK cell therapy, enhancing the overall killing of lung cancer cells in both 2D and 3D tumor cultures. Results in the 2D cultures show that PM21-NK cells more efficiently kill A549 cells that have been infected with P/V CPI-virus and enhance the overall rate of killing compared to uninfected cell targets. In 3D cultures of A549 tumor spheroids, although PIV5-P/V infection was limited to the outer layer of the spheroid, the addition of PM21-NK cells to PIV5-P/V-infected spheroids resulted in killing of not only the infected surface of the spheroid, but continued to the uninfected cells located at the center of the spheroid.
Morphosys AG, of Planegg, Germany, and Cherry Biolabs GmbH, of Würzburg, Germany, entered a licensing agreement granting Morphosys the rights to apply Cherry’s multispecific hemibody technology to six exclusive targets. The technology offers the potential to generate novel T-cell engaging medicines with higher precision and better safety profiles for the treatment of cancer patients, the companies said. Financial details were not disclosed.
New preclinical data from Nanobiotix SA, of Paris and Cambridge, Mass., showed that its NBTX-R3 nanoparticle with immunoradiation improved survival and generated long-term antitumor memory in an anti-PD-1-resistant murine lung cancer model, the company said. NBTX-R3 is a radioenhancer composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiation therapy. The primary mode of action is designed to generate increased cellular destruction when activated by radiation therapy without increasing damage to healthy tissues.
Noxopharm Ltd., of Sydney, is partnering with Bristol Myers Squibb Co., of New York, to study Noxopharm's sphingosine-1-phosphate inhibitor, Veyonda, in cancer patients who have developed a resistance to BMS’ Opdivo (nivolumab). The study, called Iconic-1, will start recruiting patients early in 2021.
Pluristyx Inc., of Seattle, will support a collaboration between Kiadis Pharma NV, of Amsterdam, and the Advanced Regenerative Manufacturing Institute’s BiofabUSA program as part of its $9.5 million award from ARMI and the U.S. Department of Defense. The funds will support a phase I/IIa study of K-NK-ID101 in COVID-19 and the scale up of GMP manufacturing of the natural killer cells, which Pluristyx will support. Pluristyx will also lead development of cryopreservation processes.
Selva Therapeutics Inc., of San Diego, reported preclinical data in a paper on Biorxiv showing in several host cell models that its cysteine protease inhibitor, SLV-213, inhibited SARS-CoV-2 infection by blocking the human host cell cysteine protease cathepsin L, thus preventing activation of the viral spike protein and blocking viral entry into host cells. SLV-213 was shown to inhibit SARS-CoV-2 infection at nanomolar efficacy in multiple types of human and monkey cells.
Sierra Oncology Inc., of Vancouver, British Columbia, and CRT Pioneer Fund LP have amended their 2016 licensing agreement for the Chk1 inhibitor SRA-737. CRT's potential unearned milestone payments of up to an aggregate of $319.5 million were reduced to an aggregate of $290 million. The milestone payment due to CRT for treating the first patient in the first phase I study was reduced from $7.5 million to $2 million. Sareum Holdings plc, of Cambridge, U.K., continues to be eligible for 27.5% of the economics of the agreement.
Taiho Pharmaceutical Co. Ltd., of Tokyo, licensed the rights to LTI-01 in Japan from Lung Therapeutics Inc., of Austin, Texas. Lung Therapeutics will receive an up-front payment and is eligible for milestone and royalty payments based on product sales. LTI-01 is a recombinant human single-chain urokinase plasminogen activator being developed for loculated pleural effusion.
Triplet Therapeutics Inc., of Cambridge, Mass., exceeded the target enrollment in the Shield HD natural history study of 60 patients with Huntington’s disease. The study is using a range of clinical outcomes and biomarkers, including the composite Unified HD Rating Scale, brain MRI, DNA Damage Response gene expression and neurofilament light chain biomarker in the blood and spinal fluid.
Tufts Center for the Study of Drug Development, of Boston, issued a report on the adoption of decentralized clinical trials. The survey found that 55% of active ongoing clinical trials have transitioned to remote and virtual execution models, but 60% of investigative sites had no prior experience with remote processes and solutions before the pandemic.
UCB SA, of Brussels, Belgium, acquired Handl Therapeutics BV, of Leuven, Belgium, to gain access to Handl's gene therapy programs to treat neurodegenerative diseases through AAV capsid technology. UCB also announced a research collaboration and licensing agreement with Lacerta Therapeutics Inc., of Alachua, Fla., to develop gene therapies for neurodegenerative diseases. Lacerta will lead research, preclinical activities and the early manufacturing process development, while UCB will be responsible for completing IND-enabling studies, manufacturing and clinical development of products that arise from the collaboration. Financial terms weren’t disclosed for either deal.
Vaxart Inc., of South San Francisco, reported results of a hamster challenge study of its oral COVID-19 vaccine. Animals that received two doses of the vaccine had lung viral loads 4-5 logs below the level seen in non-vaccinated animals. The vaccinated animals had no systemic weight loss, compared to an approximately 9% weight loss in non-vaccinated animals. The lungs of non-vaccinated animals were more than two times heavier than vaccinated hamsters. Shares of Vaxart (NASDAQ:VXRT) closed up 70 cents, or 15.3%, to $5.31 on Nov. 12.
Vistagen Therapeutics Inc., of South San Francisco, reported preclinical data on PH-94B, an intranasal neuroactive steroid, which showed the drug doesn't directly activate GABA-A receptors, unlike benzodiazepines that act as direct positive modulators of GABA-A receptors. Vistagen is preparing to run a phase III study of PH-94B in patients with social anxiety disorder.
Wuxi Advanced Therapies Inc., of Philadelphia, a unit of Shanghai-based Wuxi Apptec Co. Ltd., added capabilities to supply R&D and GMP plasmids.
Xencor Inc., of Monrovia, Calif., Morphosys AG, of Planegg, Germany, and Incyte Corp., of Wilmington, Del., are collaborating to test Morphosys' tafasitamab, which is sold in the U.S. as Monjuvi by Incyte, with Xencor's plamotamab and Revlimid (lenalidomide, Bristol Myers Squibb Co.). The companies will start with a phase I/II study in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) as well as multiple phase Ib studies in relapsed or refractory follicular lymphoma and first-line DLBCL. The studies will be sponsored and funded by Xencor. Morphosys and Incyte will provide tafasitamab for the studies.
Xilio Therapeutics Inc., of Waltham, Mass., presented preclinical data on XTX-201, a tumor-selective IL-2, and XTX-101, a tumor-selective anti-CTLA4 antibody, at the Society for Immunotherapy of Cancer meeting. XTX-201 produced tumor-selective activity in mice and didn't have peripheral toxicities in nonhuman primates. XTX-101 demonstrated tumor-selective pharmacodynamics and efficacy in preclinical models.