Abbvie Inc., of North Chicago, said the expiration date of the offers to exchange any and all outstanding notes of certain series issued regarding its acquisition of Allergan plc, of Dublin, has been extended from March 27 to April 10.
AC Immune SA, of Lausanne, Switzerland, said it will receive a second milestone payment of CHF10 million (US$10.18 million) from Eli Lilly and Co., of Indianapolis, based on development progress in the small-molecule Morphomer tau aggregation inhibitor program. Their multiyear collaboration agreement was established in December 2018 and focuses on the broad development of Morphomer tau aggregation inhibitors for Alzheimer’s disease (AD) and other neurodegenerative diseases. ACI-3024, an oral small-molecule tau Morphomer for treatment of AD and other neurodegenerative disorders, has been advanced from preclinical into phase I development. Under the updated collaboration terms, AC Immune will now also be eligible for a new CHF60 million potential milestone after initiation of tau Morphomer phase II testing. The company could also earn up to $1.7 billion more in development, regulatory and commercial milestones, as well as tiered low double-digit royalties on product sales.
Allovir Inc., of Cambridge, Mass., said it has expanded its research and development collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2. In addition, the investigational virus-specific T-cell therapy may also address other coronavirus (CoV) strains, including SARS-CoV, MERS-CoV and also the endemic CoVs that commonly afflict immunocompromised patients. The company aims to develop a therapy for CoVs that can be used as a standalone treatment or incorporated into the company’s multi-respiratory virus investigational therapy, ALVR-106, which is designed to address other community-acquired respiratory viruses.
Amneal Pharmaceuticals Inc., of Bridgewater, N.J., said it is responding to the national COVID-19 health emergency by building on its existing supply of hydroxychloroquine sulfate. Amneal is ramping up production of the drug at several of its manufacturing sites and expects to produce about 20 million tablets between now and mid-April. Those tablets will be made available nationwide through Amneal’s existing retail and wholesale customers, as well as through direct sales to larger institutions in need.
Bellus Health Inc., of Laval, Quebec, signed an asset purchase and sale agreement to acquire all of the remaining BLU-5937 and related P2X3 antagonists intellectual property assets from Admare Bioinnovations’ Neomed Institute. The deal gives Bellus complete ownership of the rights to BLU-5937 and related P2X3 antagonists, eliminating any future financial obligations. The parties have agreed to terminate, effective as of the closing date, the 2017 license agreement pursuant to which the company has exclusive rights to develop and commercialize the BLU-5937 assets. The company will issue to Admare and Astrazeneca AB, a wholly owned subsidiary of London-based Astrazeneca plc, about 4.7 million common shares from treasury, representing 7.3% of the company’s fully diluted equity. Astrazeneca assigned the BLU-5937 assets to Admare in 2012.
Cel-Sci Corp., of Vienna, Va., signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop LEAPS (Ligand Epitope Antigen Presentation System) COVID-19 immunotherapy. The company’s immunotherapy candidate aims to treat patients at highest risk of dying from COVID-19. The collaboration will commence with preclinical studies based on the experiments previously conducted with LEAPS immunotherapy in collaboration with the National Institutes for Allergies and Infectious Diseases against another respiratory virus, H1N1, involved in the 2009 H1N1 flu pandemic.
CNS Pharmaceuticals AG Inc., of Houston, signed an agreement with WPD Pharmaceuticals sp. z o.o., of Warsaw, Poland, for the development of several preclinical drug candidates, including WP-1122, which is being tested on a range of viruses including the coronavirus SARS-CoV-2. WPD previously licensed rights to a portfolio of drug candidates, including WP-1122, from Moleculin Biotech Inc., of Houston. WP-1122 is a prodrug of 2-DG (2-deoxy-D-glucose) that, based on recently developed preclinical data, appears to overcome 2-DG's lack of drug-like properties and is able to significantly increase tissue/organ concentration, CNS said.
Codexis Inc., of Redwood City, Calif., said it inked a collaboration and licensing agreement with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, for the research and development of gene therapies for certain disease indications, including the treatment of lysosomal storage disorders and blood factor deficiencies. Under the terms, Codexis will generate gene sequences encoding protein variants tailored to enhance efficacy as a result of increased activity, stability and cellular uptake using its Codeevolver protein engineering platform. Takeda will combine those improved transgenes with its gene therapy capabilities to generate candidates for the treatment of rare genetic disorders. In addition to three initial programs, Takeda may initiate up to four additional programs for separate target indications. Subject to the terms of the agreement, Codexis is eligible to receive an up-front payment, reimbursement for research and development fees, development and commercial milestone payments, and low- to mid-single digit percentage royalties on sales of any commercial product developed through such initial programs and any other programs that Takeda may elect under the agreement.
Due to the pandemic, Eli Lilly and Co., of Indianapolis, said it is delaying most of its new clinical trial starts and pausing enrollment in most of its ongoing studies while continuing those for patients who are already enrolled. Lilly said it repurposed its laboratories to conduct diagnostic testing for patients while it researches potential therapeutics. The goal, the company said, is to ease the burden on participating health care facilities and help it focus on COVID-19 R&D.
E-therapeutics plc, of Oxford, U.K., whose platform is designed to carry out in silico phenotypic screening to find active compounds for protecting human cells in influenza, is actively looking for partners to help it test the compounds. The company said it needs established partners with relevant assays for SARS-CoV-2. It also needs help with additional experimental work, such as proteomic studies, to enhance the project with additional data. Potential partners, the company added, can be industrial, governmental or academic.
Etherna Immunotherapies NV, of Niel, Belgium, said a consortium has been formed with North American and European partners to develop a novel mRNA vaccine against SARS-CoV-2 and preclinical development has started. Chinese partners may be added in the consortium in due course. Administered intranasally, the proposed vaccine is intended primarily for high-risk populations such as health care workers and families of confirmed cases. It is also designed to be protective against future variations of the virus by targeting conserved epitopes from the whole CoV-2 genome. Patient enrollment in clinical trials is expected in early 2021.
Medexus Pharmaceuticals Inc., of Chicago, Toronto, and Montreal, said COVID-19 will result in “meaningful delays” for its pediatric trial of Ixinity. The company said it does not know the extent of the delay but it should not materially affect the company’s revenue forecasts. The delay will, most likely, the company added, enhance its near-term revenue flow. Seattle-based Aptevo Therapeutics Inc. sold Ixinity for more than $100 million to Medexus in February. In January, Aptevo started dosing patients in a phase IV trial to evaluate the safety and efficacy of Ixinity, an intravenous recombinant factor IX therapeutic, for a potentially broader label in previously treated patients under 12 with hemophilia B.
Merck & Co. Inc., of Kenilworth, N.J., said it does not endorse TRC Capital Investment Corp.’s unsolicited mini-tender offer, dated March 26, to purchase up to 1.5 million shares of Merck common stock at $73.35 per share. The offer price is approximately 4.4% below the closing price of the Merck common stock on March 13 ($76.75), the last trading day before the date of the offer, but approximately 2.8% above the closing price of the Merck common stock on March 20. Merck said it recommends that its shareholders reject the offer and not tender their shares, saying that the offer puts investors at risk because they may unknowingly sell their shares at a discount.
Neoimmunetech Inc., of Rockville, Md., entered an exclusive license agreement with Ubix Therapeutics Inc., of Seoul, South Korea, to develop up to three drug candidates using Ubix’s platform, which enables target protein degradation. Neoimmunetech now has exclusive worldwide rights to research, develop and commercialize drug candidates in exchange for development and sales milestones, plus royalties. Preclinical development will be conducted at its institute in South Korea.
Novan Inc., of Morrisville, N.C., said it plans to explore the use of its Nitricil technology to advance a potential topical oral or nasal candidate for COVID-19, targeting the reduction of viral shedding and transmission based on nitric oxide’s ability to inhibit viral replication of viruses within the Coronaviridae family. The company said it initiated a work order to complete in vitro assessment of the technology, berdazimer sodium (NVN-1000), against species within the Coronaviridae family, including SARS-CoV-2, and is exploring the potential for federal grants to support those efforts.
Pharnext SA, of Paris, said it identified 97 frequently prescribed drugs as potential candidates to be repositioned for treating COVID-19 through the use of its Pleotherapy platform. Most of the drugs identified are not known to have antiviral activities, the company said, and four of the drugs identified are already undergoing clinical trials for COVID-19, including chloroquine. Pharnext is evaluating various options to validate its initial findings as well as to further advance the work toward a treatment for COVID-19 through various collaborations.
Resverlogix Corp., of Calgary, Alberta, said it is seeking to collaborate with organizations currently testing therapies for SARS-CoV-2, the virus responsible for COVID-19, in preclinical or clinical models. Apabetalone is designed to prevent specialized proteins –bromodomain and extraterminal domain proteins – from activating the expression of disease-associated and other genes, potentially disrupting SARS-CoV-2 reproduction while also limiting the entry of the virus into human cells.
Schrodinger Inc., of New York, said it expanded its collaboration with Astrazeneca plc, of Cambridge, U.K., focused on refining a biologics modeling solution with the aim of speeding up the development of antibody and protein-based therapeutic candidates. The multiyear agreement extends an existing collaboration in which Astrazeneca is deploying Schrödinger’s computational platform to advance small-molecule drug discovery efforts. The new collaboration is aimed at enhancing Schrödinger’s Free Energy Perturbation, or FEP+, technology for the optimization of key properties of biologics, such as affinity and selectivity, with particular focus on binding affinity. Financial terms were not disclosed.
Soligenix Inc., of Princeton, N.J., said it is expanding its ongoing collaboration with the University of Hawaiʻi at Mānoa to assess potential coronavirus vaccines (including against COVID-19). Ongoing collaborations have demonstrated the feasibility of developing heat stable subunit filovirus vaccines, including Ebola virus disease caused by either Zaire or Sudan ebolavirus variants, as well as Marburg virus disease, with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit). Soligenix and its collaborators are expanding the technology platform to assess compatibility with coronaviruses, including SARS-CoV-2, the cause of COVID-19.
Sorrento Therapeutics Inc., of San Diego, and Smartpharm Therapeutics Inc., of Boston, said they are collaborating to develop a next-generation, gene-encoded antibody vaccine for COVID-19. The collaboration will utilize monoclonal antibodies against SARS-CoV-2 virus discovered and/or generated by Sorrento that will be encoded into a gene for delivery utilizing Smartpharm’s nonviral nanoparticle platform. As part of the deal, the companies said they expect to develop a gene-encoded antibody or antibodies that can be administered as a prophylaxis against SARS-CoV-2 infection. Plans may include candidate development as well as filing of an IND application in the next few months.
Syncona Ltd., of London, a life sciences investor with a portfolio of firms, said its firms have made or are considering appropriate plans for delays to clinical trials due to the COVID-19 pandemic. Though Syncona said it is hard to forecast the precise impact, “we would expect delays to a number of our clinical-stage programs of at least three months.”
Tetra Bio-Pharma Inc., of Ottawa, said in a company update that its Serenity and Reborn activities will be slowed by COVID-19 pandemic. The company’s phase III Serenity study is testing vaporizer delivery of the cannabinoid drug Caumz, formerly referred to as PPP-001, in advanced cancer pain patients. Reborn is a phase II program testing Caumz vs. fentanyl in breakthrough pain in cancer patients. The company said it began procedures to increase the number of clinical sites. Tetra also communicated with all of its drug suppliers, including those that produce THC, CBD, HU308 and PPP-001, and said current assessment is that the COVID-19 crisis will not significantly affect supply of the clinical research medications.
The Montreal Heart Institute said its research center has launched a COVID-19 clinical study in Canada to determine whether short-term treatment would reduce the risk of pulmonary complications and related deaths. The clinical study, named COLCORONA, coordinated by the Montreal Health Innovations Coordinating Center, is funded by the government of Quebec. COLCORONA is designed to evaluate the inflammatory storm present in adults suffering from severe COVID-19 complications. The researchers hypothesized that the treatment could reduce the complications associated with COVID-19. The clinical study will involve the recruitment of approximately 6,000 participants followed for 30 days. Initial results will be available a few days after study completion. Participants’ eligibility criteria include being tested positive for COVID-19, being age 40 or over, being willing to take the medication or placebo daily for 30 days and being available for follow-up by phone or video conference.
Zealand Pharma A/S, of Copenhagen, said Boehringer Ingelheim GmbH, of Ingelheim, Germany, returned an analogue of amylin in development for treating obesity and type 2 diabetes. Zealand, which now regains worldwide rights to that program, said it will evaluate its development path within the company’s pipeline. The partnership with Boehringer will continue with development of a second program, a GLP-1/glucagon asset, that it plans to advance into phase II development.
Ziphius Therapeutics NV, of Oostkamp, Belgium, said it prioritized resources to intensify the development of ZIP-1642, a vaccine against the novel coronavirus. Ziphius is interacting with researchers at Ghent University in Belgium, who recently succeeded to produce an mRNA vaccine against Zika virus. That mRNA platform could also be applicable for the development of a COVID-19 vaccine.