Acelrx Pharmaceuticals Inc., of Redwood City, Calif., said that Dsuvia (sufentanil sublingual tablet) achieved Milestone C approval, a decision that clears the path for the product to be included in military sets, kits and outfits (SKOs). Separately, the company said it expects to close the acquisition of Tetraphase Pharmaceuticals Inc., of Watertown, Mass., following the special meeting of its stockholders, which is scheduled for June 8.
Affibody AB, of Solna, Sweden, said its partner Daewoong Pharmaceutical Co. Ltd., a South Korea-based pharmaceutical company, has exercised an option to develop and commercialize an innovative half-life extended biotherapeutics product. Affibody will receive a license conversion fee and milestone payments as well as royalties. Further financial details were not disclosed.
Amra Medical, of Linkoping, Sweden, said it expanded its collaboration with New York-based Pfizer Inc. to further investigate body fat distribution and muscle composition in a range of disease and overall metabolic health. In 2015, Amra and Pfizer launched a pilot collaboration to perform body composition profiling from magnetic resonance images in individuals who were part of the U.K. Biobank registry to better understand the relationship between body composition and risk for obesity-related diseases.
Astrazeneca plc, of Cambridge, U.K., and the University of Oxford have entered an agreement for the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. It aims to advance the ChAdOx1 nCoV-19 vaccine, being developed by the Jenner Institute and Oxford Vaccine Group at the University of Oxford. Under the arrangement, Astrazeneca will be responsible for development and worldwide manufacturing and distribution of the vaccine, which entered phase I trials last week.
Atreca Inc., of South San Francisco, Beigene Ltd., of Beijing, and IGM Biosciences Inc., of Mountain View, Calif., said they plan to collaborate to help address the COVID-19 pandemic. The companies will leverage their combined technology and expertise to discover, develop and manufacture IgM and IgA antibodies targeting SARS-CoV-2. They will start work immediately and will work out financial details of the arrangement and other terms in the future. The alliance will utilize Atreca’s discovery platform to generate the sequences of antibodies made by particular B cells found in blood obtained from acutely infected COVID-19 patients. IGM’s technology platform will then be leveraged to develop and manufacture engineered IgM and IgA therapeutic antibodies from the identified sequences. Beigene has agreed to provide global clinical development support. If research, manufacturing and regulatory activities proceed well, the companies said they believe an antibody may be ready to begin clinical testing in the first half of next year.
Bavarian Nordic A/S, of Copenhagen, said the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, has placed a new order under the contract, awarded in 2017, for the manufacturing and supply of Jynneos (smallpox and monkeypox vaccine, live, non-replicating), at a total value of $202 million. The new order is in addition to the existing option to manufacture about 13 million freeze-dried doses worth $299 million the company expects to start manufacturing in 2022. The contract expansion covers two years of performance and includes the manufacturing of additional bulk vaccine and the supply of up to 1.4 million doses of liquid frozen Jynneos. The vaccine was approved by the FDA in September 2019.
Bioage Labs Inc., of Richmond, Calif., said it entered an exclusive worldwide license agreement with Tokyo-based Taisho Pharmaceutical Co. Ltd. to develop and commercialize its clinical-stage hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor, BGE-117 (named TS-143 by Taisho), to ameliorate multiple diseases of aging. Under the terms of the agreement, Bioage will make an up-front payment to Taisho, which is entitled to receive development and commercial milestone payments plus royalties based on annual net sales. Bioage will be responsible for all development, manufacturing and commercialization of BGE-117 worldwide, while Taisho has an option right for co-commercialization in Japan and several countries in southeast Asia. The company said it believes that BGE-117 can potentially treat multiple diseases of aging through the activation of HIF-1 target genes that are involved in numerous biological processes, including tissue regeneration, erythropoiesis, glycolysis, glucose uptake, vascular remodeling and angiogenesis. Inhibition of HIF-PH increases HIF pathway activation and has the potential to increase resilience, repair and regeneration across multiple body systems.
Bioinvent International AB, of Lund, Sweden, said it signed a manufacturing agreement with a cell therapy company based in Massachusetts. The agreement, for an undisclosed amount, includes process development and conjugation of two antibodies in the company's development labs, with work expected to start in May.
Biostem Technologies Inc., of Pompano Beach, Fla., said it embarked on a new initiative for its two distinct businesses. Biostem Technologies will identify, develop and market regenerative biologics, formally spearheaded by Biostem Life Sciences. Those include an all-new biologic therapeutic pipeline focused on acute respiratory distress syndrome and osteoarthritis. It will also assume the sales and distribution of the Rheo and Vendaje brands. Biostem Life Sciences will transition to a GMP level, contract development and manufacturing organization.
Cytodyn Inc., of Vancouver, Washington, reported updates on 49 COVID-19 patients who have received leronlimab (PRO-140), a CCR5 antagonist with the potential for multiple therapeutic indications, under the FDA emergency investigational new drug program. All treated patients (11) were in intensive care units in a New York hospital because of acute respiratory failure, eight of whom were intubated. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, the company said it believes they were able to save the lives of four patients. All patient blood samples were evaluated, and results from the effect of leronlimab were demonstrated in almost all of those patients. Another NY hospital patient was taken off oxygen and discharged from hospital after leronlimab treatment. Of 17 severe condition (but not critical) patients, in a southern California hospital, 11 patients demonstrated improvement in respiratory parameters (eight of them were discharged from hospital, two patients remain relatively stable, two have shown deterioration in respiratory parameters and information is pending for two recently treated patients), the company said.
Fujifilm Diosynth Biotechnologies, of Hillerod, Denmark, said it will reserve manufacturing capacity for a future COVID-19 therapy for the COVID-19 Therapeutics Accelerator, an initiative launched by the Bill & Melinda Gates Foundation, Wellcome Trust and Mastercard to speed up the response to the global pandemic. The company will work with a selected pharmaceutical partner in supporting the fast manufacture and dedicated supply for patients with COVID-19 in lower-income countries. Under the agreement, production volumes are secured for 2021 with options for several years thereafter.
Geovax Labs Inc., of Atlanta, said that Beijing- and Philadelphia-based Sino Biological Inc. will be its exclusive supplier of SARS-Cov-2 (COVID-19) bioreagents such as recombinant proteins, antibodies and detection kits for use in COVID-19 vaccine development. It will also obtain exclusive rights to research-use-only reagents developed jointly by the companies. Financial terms were not disclosed.
Inovio Pharmaceuticals Inc., of Plymouth Meeting, Pa., said it is expanding its partnership with Richter-Helm Biologics GmbH & Co. KG to support large-scale manufacturing of Inovio's COVID-19 DNA vaccine INO-4800, which is in a phase I study in the U.S. The agreement is partly funded by a $1.3 million grant from the Coalition for Epidemic Preparedness Innovations, bringing the coalition’s total support for INO-4800 development to $17.2 million.
Just-Evotec Biologics Inc, of Seattle, and Ology Bioservices Inc., of Alachua, Fla., will collaborate to evaluate and characterize antibodies to fight SARS-CoV-2. Just-Evotec will screen a panel of anti-SARS-CoV-2 antibodies from convalescing COVID-19 patients and provided by Ology. Just-Evotec will help filter the antibodies into a smaller set with predicted desirable characteristics for manufacturing and long-term storage. Once the final antibody panel has been selected and produced at a small scale by Ology, material will be sent to Just-Evotec for evaluation of biophysical properties and potential post-translational modifications.
PDS Biotechnology Corp., of Princeton, N.J., said its Cooperative Research and Development Agreement with the National Cancer Institute (NCI) has been expanded to include preclinical studies of PDS-0103, a product created from the company’s T-cell activating platform and incorporating novel mucin-1 (MUC1) epitopes developed by the NCI. PDS-0103 targets ovarian, breast, colorectal and lung cancers, where overexpression of MUC1 is associated with a high degree of unmet need, the company said.
Promis Neurosciences Inc., of Cambridge, Mass., and Toronto, said it generated intrabodies highly selective for misfolded forms of TAR DNA-binding protein 43 (TDP-43) implicated in amyotrophic lateral sclerosis, frontotemporal dementia and several other neurologic disorders. Early data support the use of those intrabodies within gene therapy vectors based on their selectivity and ability to promote degradation of toxic species of TDP-43 while preserving normal forms of the protein, the company said.
Siga Technologies Inc., of New York, said it exercised options under its 2018 Biomedical Advanced Research and Development Authority (BARDA) contract worth about $101.3 million for procuring oral Tpoxx to treat smallpox (tecovirimat). Deliveries of oral Tpoxx to maintain national preparedness under those option exercises are expected to start in the second quarter of 2020 and be completed by April 2021, the company said. Siga’s full 19C BARDA contract has up to $414 million of procurement-related options remaining for future exercise.
Research results from Sprint Bioscience AB, of Stockholm, Sweden, show that SB0-2024 activates the immune system in tumors in malignant melanoma and colorectal cancer. Sprint said it demonstrates that inhibition of the Vps34 protein and the autophagy of tumor cells can be an important part of future immunological treatments. SB0-2024 blocks the autophagy of tumor cells by inhibiting the protein Vps34. When autophagy is blocked, the tumor cells become visible to the immune system again, the company said.
Stabilitech Biopharma Ltd., of Burgess, U.K., is seeking an investment of £6 million (US$7.56 million) to fund clinical development and manufacturing of its oral coronavirus vaccine, OraPro-COVID-19. The DNA-based vaccine is delivered via an adenovirus, which induces expression of the spike protein of the novel coronavirus.
Trio Pharmaceuticals Inc., of San Diego, and Ajinomoto Bio-Pharma Services, of San Francisco, are collaborating to test the use of Ajinomoto's Ajicap site-specific conjugation technology with Trio's Triobody drug conjugate technology, which delivers drug payloads and also induces immunosuppression. Financial terms of the deal weren't disclosed.
Union Therapeutics A/S, of Copenhagen, Denmark, is collaborating with Institut Pasteur Korea to test an optimized salt form of niclosamide as a treatment of COVID-19. In vitro studies showed the drug was 25 times more potent than chloroquine and more than 40 times more potent remdesivir (Gilead Sciences Inc.).
Vaxart Inc., of South San Francisco, reported preclinical data for its COVID-19 vaccine candidates, several of which induced immune responses after a single dose. The company plans to start a phase I study in the second half of 2020.
Viralclear Pharmaceuticals Inc., a subsidiary of Westport, Conn.-based Biosig Technologies Inc., submitted an article highlighting preclinical data on the use of merimepodib with remdesivir (Gilead Sciences Inc.) as a treatment for COVID-19 to an online peer-reviewed life sciences journal. The combination reduced replication of SARS-CoV-2 replication to undetectable levels in vitro. Viralclear plans to start clinical development of merimepodib in the second quarter of 2020.
Wuxi Biologics Co. Ltd., of Shanghai, is collaborating with Aravive Inc., of Houston, to develop antibodies targeting CCN2. Wuxi will be responsible for discovery and manufacturing. Aravive will do the preclinical and clinical development. Financial terms of the deal weren't disclosed.
Xortx Therapeutics Inc., of Calgary, Alberta, contracted with Lonza Pharma & Biotech, a unit of Lonza Group AG, of Basel, Switzerland, to manufacture oxypurinol, the active ingredient for XRx-101 and Xrx-008. Xortx is discussing the development of XRx-101 for COVID-19 and Xrx-008 for autosomal dominant kidney disease with regulatory agencies and plans to begin clinical development in May.