Akers Biosciences Inc., of Thorofare, N.J., said Premas Biotech Pvt Ltd., of Haryana, India, its partner in development of a vaccine candidate targeting the COVID-19 pandemic, has completed its vaccine prototype. Premas obtained transmission electron microscopic images of the recombinant virus-like particle (VLP) assembled in yeast during the past week. Premas, which is primarily responsible for the development of the vaccine candidate through proof of concept, is collating data at this time and, collectively with Akers, moving forward with conversations with regulatory authorities in India and continuing to develop a regulatory strategy in the U.S. A manufacturing protocol has also been established and large-scale production studies have been initiated for the vaccine candidate, the companies said.
Almac Discovery, of Belfast, U.K., a member of the Almac Group, said it has established an out-licensing partnership with an undisclosed biotechnology company in order to advance the development and commercialization of one of its portfolio projects, ALM-301, a potent, subtype selective Akt kinase inhibitor with good pharmacokinetic properties across multiple species, and an excellent selectivity profile. It has demonstrated robust efficacy in preclinical prostate, breast and other cancer xenograft models, both as a single agent and in combination with standard chemotherapeutic agents, where synergy has been observed. The molecule is currently in late-stage preclinical development, and the partner will complete that before progressing into the clinical development phase.
Bayer AG, of Leverkusen, Germany, and Archerdx Inc., of Boulder, Colo., said they have established a global collaboration for the development and commercialization of a next-generation sequencing (NGS)-based companion diagnostic (CDx) for Vitrakvi (larotrectinib), indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation. The objective of the collaboration is to broaden patient access to comprehensive genomic testing inclusive of neurotrophic receptor tyrosine kinase 1 (NTRK1), NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer which can lead to meaningful treatment options. The companies are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3 for Vitrakvi and plan to seek approval in different markets.
Biopharmx Corp., of Campbell, Calif., said its stockholders approved all proposals related to the proposed merger with Timber Pharmaceuticals LLC, of Woodcliff Lake, N.J. The merger is expected to close on or about May 18.
The Biotechnology Innovation Organization (BIO) said Michelle McMurry-Heath is slated to become the organization’s next president and CEO on June 1, succeeding Jim Greenwood, who has led the organization since 2005. McMurry-Heath has served in numerous senior leadership roles at Johnson & Johnson (J&J) since 2014. Most recently, as vice president of external innovation and global leader for regulatory science, she led a team of 900 employees charting the evidence generation and regulatory strategy across J&J’s medical device companies, specializing in using cutting-edge tools and innovative methods to bring new breakthroughs to patients. Prior to her work at J&J, she served on the Obama administration’s Science Transition Team before being appointed to a scientific leadership role at the FDA Center for Devices and Radiological Health from 2010 to 2014.
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said it acquired Toronto-based Northern Biologics Inc., a wholly owned subsidiary of Northern LP. which focuses on therapeutic antibodies targeting the tumor microenvironment. With the transaction, Boehringer Ingelheim said it is now positioned at the forefront of the stromal biology space, an emerging area in cancer immunology. Northern Biologics will continue to drive certain preclinical efforts on one of the programs, while Boehringer Ingelheim will be responsible for clinical, regulatory and commercial development of the acquired programs. The first program, in late preclinical development, is an antibody inhibitor of periostin, a secreted matricellular protein overexpressed in the immunosuppressive stroma microenvironment of many solid tumor types. The deal includes an up-front payment, milestones and other consideration payments.
Cellink AB, of Gothenburg, Sweden, renewed its agreement with Cambridge, U.K.-based Astrazeneca plc to provide bioprinters and bioinks to explore new disease targets in Astrazeneca’s main therapeutic areas, which include oncology, respiratory, and cardiovascular, renal and metabolic diseases. Cellink provides pre-bioprinting preparation of cells through post-bioprinting analysis. Cellink said it will continue to provide a team to assist Astrazeneca scientists in Gaithersburg, Md.
Cue Biopharma Inc., of Cambridge, Mass., and the University of Oxford will collaborate to determine molecular mechanisms underlying the activity of Cue’s IL-2 biologics. The two will research immune synapse interactions for selecting specific activation of tumor-antigen-specific T cells in cancer and autoimmune diseases.
Curevac AG, of Tubingen, Germany, reported preclinical results for the low dose of its lead vaccine candidate against SARS-CoV-2, the virus causing COVID-19. Data showed a fast induction of a balanced immune response with high levels of virus neutralizing titers (VNTs) and T-cell responses. VNTs are a major criterion supporting that the vaccine candidate has the potential to induce a strong immunologic response to neutralize SARS-CoV-2. Curevac said the results underline the strength of its mRNA technology platform and are in line with previously generated data in rabies, flu and respiratory syncytial virus.
Dtx Pharma Inc., of San Diego, said it received a funding award from the Alzheimer's Association and the Rainwater Charitable Foundation of $400,000 to advance drug discovery research targeting tau-mediated disorders such as Alzheimer's disease, progressive supranuclear palsy and frontotemporal dementia. The company said that award, along with prior and pending grants, will enable it to expand the application of its lipid conjugate technology for the delivery of oligonucleotides as potential treatment for neurodegenerative diseases. The newly funded program will support the generation and testing of siRNAs designed to reduce the activity of the MSUT2 (mammalian suppressor of tau) gene, recently characterized as a critical mediator of tau-induced damage by Brian Kraemer, of the University of Washington and VA Puget Sound in Seattle.
Histogen Inc., of San Diego, said data published in the Journal of Medicine and Surgical Sciences showed HST-004, its naturally derived material for spinal disc repair, reversed inflammation and protease activity in a spinal disc study and stimulated aggrecan secretion in the thrombin-induced rabbit ex vivo model. In vivo studies in the rabbit degenerative disc model showed that, in as little as four weeks post-treatment with HST-004, disc height increased as compared to the control. MRI analysis demonstrated regeneration of the disc tissue (Pfirrmann grading analysis p<0.05).
Luye Pharma Group, of Shanghai, entered an exclusive promotion agreement with Moksha8 Brasil Distribuidora e Representação de Medicamentos Ltda. and Moksha8 Farmacéutica S. de R.L. de C.V., of Mexico City, granting exclusive promotion rights to Moksha8 in Brazil and Mexico, for the two CNS drugs Seroquel and Seroquel XR. Seroquel (quetiapine fumarate, immediate release) and Seroquel XR (extended-release formulation) are atypical antipsychotic medicines with antidepressant properties. Seroquel is for treating schizophrenia and bipolar disorder. Seroquel XR is for treating major depressive disorder and generalized anxiety disorder.
Medicago Inc., of Quebec City, said its vaccine candidate for COVID-19 induced a positive antibody response only 10 days after a single dose in mice. Once results from a second boost dose are available, the company said it plans to submit a CTA to Health Canada and an IND to the FDA for human trials. Though the precise dosage for the vaccine in humans is not yet determined, Medicago estimates its current facilities in Quebec and North Carolina could produce up to 20 million and 100 million annual doses, respectively, of pharmaceutical-grade COVID-19 vaccines.
Orgenesis Inc., of Germantown, Md., said it launched its cell-based vaccine platform targeting SARS-CoV-2, the virus that causes COVID-19, as well as other viral diseases such as Zika, West Nile virus, yellow fever, dengue fever, MERS, HCV and cytomegalovirus infection. The platform uses irradiated permissive cells (human or nonhuman, infected with a high titer virus or transfected with viral antigens), which activate endogenous dendritic cells. Those cells activate CD4+T cells and cytotoxic CD8+ T cells. CD4+ cells activate humoral immune response via B cells, which generate neutralizing antibodies, while CD8+ cell mount cytotoxic immune response against virus-infected cells. The company said it has plans for animal testing.
Pluristem Therapeutics Inc., of Haifa, Israel, said eight of 18 patients with COVID-19 treated with PLX cells under a compassionate-use program in Israel and a single-patient expanded access program in the U.S. completed 28-day follow-up. The patients were on invasive mechanical ventilation in intensive care units and diagnosed with acute respiratory distress syndrome at the time of treatment. At 28 days, their survival rate was 87.5%, including 75% who no longer required mechanical ventilation and 62.5% who were discharged alive from the hospital. Pluristem plans to use 28 days as the time line for the primary endpoint of a U.S. phase II study expected to initiate enrollment within days. On May 14 the company’s shares (NASDAQ:PSTI) gained 87 cents, or about 9.5%, to close at $10.06.
Predictive Oncology Inc., of Minneapolis, said it is developing a COVID-19 vaccine. The company, which has acquired Soluble Therapeutics Inc. and subsequently licensed a nanoparticle vaccine platform, said its vaccine technology is based on a self-assembling nanoparticle called NSP10. The NSP10 Nanoparticle is designed to have special surface properties that allow for the rapid design and display of viral receptor stems for virtually any virus, making it extremely versatile, the company said.
Recursion Pharmaceuticals Inc., of Salt Lake City, entered a global licensing agreement with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for the rights to TAK-733, an MEK inhibitor, and to develop it for treating a hereditary cancer syndrome and related areas of oncology. Recursion obtains exclusive worldwide rights to develop and commercialize TAK-733. No terms were released.
Clinical biomarker data from Cambridge, Mass.-based Solid Biosciences Inc.’s SGT-001 microdystrophin gene therapy clinical trial for treating Duchenne muscular dystrophy show that a dose of 2E14 vg/kg administration results in dose-dependent, muscle wide microdystrophin expression in muscle biopsies collected 90 days post-SGT-001 administration. The data also showed SGT-001-driven microdystrophin expression results in stabilization of dystrophin associated proteins and also results in restored enzymatically active neuronal nitric oxide synthase at the sarcolemma.
New data from Uniqure NV, of Lexington, Mass., and Amsterdam, of AMT-150 in spinocerebellar ataxia type 3 show a continuation of strong proof-of-concept in mice and other preclinical models, as well as encouraging new data in nonhuman primates. AMT-150 is a one-time, intrathecally-administered AAV gene therapy. Also, new data related to AAV biology show that a single administration of AAV5-hFIX in newborn mice led to stable hFIX expression up to 18 months after dosing, the company said. Results were presented at the American Society of Gene and Cell Therapy annual meeting.
Viralclear Pharmaceuticals, a subsidiary of Biosig Technologies Inc., of Westport, Conn., said an article, titled “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro,” was published by F1000 Research, an online peer-reviewed life sciences journal. It highlights preclinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch. The results are helping the company plan for initial clinical trials of merimepodib, it noted. A first proposed COVID-19 trial is expected to be conducted in hospitalized patients who require supplemental oxygen and receive remdesivir as part of their standard of care. Patients will be randomized to either placebo or merimepodib.
Yumab GmbH, of Braunschweig, Germany, said it identified fully human monoclonal antibodies with neutralizing activity against patient-derived SARS-CoV2. That milestone was achieved in collaboration with CORAT, a consortium of academic and industrial partners aligned to combat COVID-19. Yumab's universal human antibody platform generated hundreds of virus-specific antibody candidates and the company built antibody libraries from recovered COVID-19 donors for identification of additional therapeutic candidates. Antibody drug candidates with full neutralization capacity of a patient-derived SARS-CoV2 strain were confirmed by Helmholtz Center for Infection Research.