Abbvie Inc., of North Chicago, said the expiration date of the offers to exchange any and all outstanding notes of certain series issued by Allergan Finance LLC, Allergan Inc., Allergan Sales, LLC and Allergan Funding SCS for new notes to be issued by Abbvie has been extended to April 24, 2020.
Aim Immunotech Inc., of Ocala, Fla., said the National Cancer Institute has awarded $14.54 million to Roswell Park Comprehensive Cancer Center to test chemokine modulation incorporating the company's drug, Ampligen (rintatolimod), as an immunomodulator as part of a strategy to turn cold tumors hot. The grant will fund five clinical trials in patients with colorectal, ovarian or melanoma tumors.
Akers Biosciences Inc., of Thorofare, N.J., said a collaboration with Premas Biotech Pvt. Ltd., of Gurgaon, India, has reached a milestone of obtaining clones of all three coronavirus antigens – spike, envelope and membrane – that they have selected for their vaccine candidate. The clone development process has four primary steps, including the design and synthesis of the genes; selection of the right host; the insertion of the gene into the host; and the verification that the clone has the right gene, and all characteristics are correct.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and Dicerna Pharmaceuticals Inc., of Lexington, Mass., formed a development and commercialization collaboration on investigational RNAi therapeutics for the treatment of alpha-1 antitrypsin (A1AT) deficiency-associated liver disease (alpha-1 liver disease). In addition, the companies have completed a cross-license of their respective intellectual property for Alnylam’s lumasiran and Dicerna’s nedosiran investigational programs for the treatment of primary hyperoxaluria (PH). The companies said those agreements will enhance and accelerate Alnylam’s and Dicerna’s ability to bring those orphan product candidates to market. ALN-AAT02 and Dicerna’s DCR-A1AT, investigational RNAi therapeutics, each in phase I/II development, will be explored for the treatment of alpha-1 liver disease. Dicerna assumes responsibility for both ALN-AAT02 and DCR-A1AT at its cost, and may progress one or both of those investigational medicines through clinical development. Dicerna will select which product candidate(s) to advance in development. At the completion of phase III work, Alnylam has the no-cost opportunity to opt-in to commercialize the selected candidate in countries outside the U.S., where it already has a commercialization infrastructure in place. If Alnylam exercises its opt-in right, each party will pay tiered royalties to the other party based on net product sales generated in its territory at rates dependent on which candidate is commercialized. In the event Alnylam waives its commercialization option, Dicerna will keep worldwide rights to commercialize the selected candidate(s) in exchange for milestones and royalties payable to Alnylam, also at a rate dependent on which candidate is ultimately commercialized. In a separate agreement, Alnylam and Dicerna granted each other a nonexclusive cross-license to their respective intellectual property related to their PH treatment investigational programs to ensure that each party has the freedom to develop and commercialize its respective candidate. Shares of Dicerna (NASDAQ:DRNA) gained $1.91, or 10.7%, to close April 6 at $19.81, while Alnylam (NASDAQ:ALNY) gained $6.32 to close at $112.14.
Assembly Biosciences Inc., of South San Francisco, said results from a research study evaluating the turnover rate of covalently closed circular DNA (cccDNA), which plays a pivotal role in the establishment and persistence of hepatitis B virus (HBV) infection, were published in Hepatology, the journal of the American Association for the Study of Liver Diseases. The study was conducted in collaboration with Nanfang Hospital, Southern Medical University in Guangzhou, China and used a molecular genetic approach to monitor the appearance and disappearance of resistance mutations as a biomarker of cccDNA turnover in longitudinal liver biopsies and serum samples obtained from patients from two clinical trials. HBV virion DNA, cccDNA and HBV pgRNA were isolated and sequenced from clinical samples. The genetic makeup of cccDNA pools were shown to turnover in as little as three to four months, consistent with frequent cccDNA replacement in chronically infected patients and suggesting that regimens which fully inhibit cccDNA replenishment may achieve a finite cure through decay of the existing cccDNA pool during treatment. Results also showed a strong correlation observed between cccDNA composition and serum pgRNA in paired liver and serum samples, suggesting that serum HBV pgRNA is a primary surrogate marker of cccDNA when liver biopsies are unavailable. Shares of Assembly (NASDAQ:ASMB) gained $1.85, or 12%, to close April 6 at $16.95.
Evotec SE, of Hamburg, Germany, established a dedicated site for research and development of gene therapy-based projects. Evotec Gene Therapy will start operations with a team of gene therapy experts at an R&D site in Orth/Donau, Austria. The site marks an important step towards Evotec’s long-term vision of becoming a fully modality-agnostic drug discovery and development partnership company, Evotec said. Separately, Evotec and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, established a long-term research alliance with Takeda to support Takeda’s growing number of research-stage gene therapy discovery programs. Evotec will support multiple Takeda efforts targeting conditions aligned with Takeda’s four core therapeutic areas: oncology, rare diseases, neuroscience and gastroenterology.
Glaxosmithkline plc (GSK), of London, and Vir Biotechnology Inc., of San Francisco, signed a binding agreement to enter a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir’s monoclonal antibody platform technology to accelerate existing and identify new antiviral antibodies that could be used as therapeutic or preventative options to help address the COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines. Due to the urgent patient need for COVID-19 solutions, the initial focus of the collaboration will be to accelerate the development of specific antibody candidates identified by the Vir platform, VIR-7831 and VIR-7832, that have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live virus-cellular assays, the companies said. Subject to regulatory review, the companies plan to proceed directly into a phase II trial within the next three to five months. Under the terms, and to gain access to Vir’s technology, GSK will make an equity investment in Vir of $250 million, priced at $37.73, a 10% premium to the closing share price on Friday, March 27. Shares of Vir (NASDAQ:VIR) gained 26.5% April 6 to close at $36.70, up $7.70.
The Harrington Discovery Institute at University Hospitals in Cleveland said it launched an initiative that galvanizes its transatlantic network of academic institutions, foundations and philanthropic partners to accelerate promising, near-term therapies to treat COVID-19 and its complications and battle future pandemic threats. In advancing its portfolio of 120 drugs-in-the-making at 54 academic centers in North America and the U.K., Harrington said it has developed a model that has enabled scientists in academia to accelerate their breakthrough drug discoveries toward trials in patients. Among its actions, the initiative will allocate Harrington operating and grantmaking capital toward near-term COVID-19-related treatment efforts and accelerate programs in its current portfolio that may target coronavirus and its clinical ramifications. That entails advancing treatments that may enter clinical trials right away, the institute said.
Innovation Pharma Inc., of Wakefield, Mass., said it is engaged in discussions with health care provider networks and hospitals in the U.S. and Europe regarding options to rapidly advance brilacidin into human trials to evaluate its potential as a COVID-19 therapeutic. The interest in brilacidin is based on the drug’s antiviral activity against SARS-CoV-2, as supported in preliminary testing conducted in a monkey epithelial cell line, and its established anti-inflammatory and antimicrobial properties, a potential three-in-one treatment combination. In advance of potential clinical testing, the company is investigating procurement of appropriate drug supply (i.e., manufacture of intravenous drug product), and preparing for engagement with regulatory authorities.
Intelgenx Technologies Corp., of Saint Laurent, Quebec, disclosed initiatives aimed at helping the company address, and satisfactorily respond to, the complete response letter that it recently received from the FDA regarding its resubmitted 505(b)(2) NDA for Rizaport Versafilm, as well as maintain Intelgenx’s financial stability in light of the current market environment and the challenges posed by the global COVID-19 pandemic. Revenue expectations for 2020 have been significantly reduced, the company said. The board has decided to launch an aggressive performance improvement program that focusses on generating near-term revenue, reducing staff headcount and implementing other measures to preserve the company’s resources and extend its cash runway. The company also will implement organizational changes to strengthen various parts of Intelgenx’s business, including regulatory affairs and manufacturing operations, and undertake steps to accelerate the launch of Rizaport in Spain and, subsequently, in other European countries.
La Jolla Pharmaceutical Co., of San Diego, said it is providing Giapreza (angiotensin II) for named patient emergency use in patients with septic shock due to COVID-19 at Royal Surrey County Hospital, Guildford, U.K. In December 2017, Giapreza was approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. Giapreza was recently approved by the European Commission but is commercially unavailable in Europe. According to English law, authorized medicines can be made available prior to commercial availability to fulfill special patient needs.
Mateon Therapeutics Inc., of Agoura Hills, Calif., said it delivered testing results to Golden Mountain Partners (GMP) confirming the applicability of OT-101 for treating COVID-19. OT-101 exhibited activity against both COVID-19 and SARS with a safety index of >500, the company said. Mateon also said it submitted an IND to the FDA. The mechanism of action for OT-101 against COVID-19 includes inhibiting cellular binding, inhibiting viral replication and suppressing viral-induced pneumonia.
Medincell SA, of Montpellier, France, said researchers at Monash University in Melbourne, Australia, published a study showing that antiparasitic drug ivermectin can kill coronavirus in a laboratory setting in under 48 hours. A single treatment is able to effect roughly 5,000-fold reduction in virus at 48 hours in cell culture, the company said. Medincell has launched a research initiative on a long-acting injectable formulation of ivermectin for possible use in COVID-19 management.
Oncology Pharma Inc. and Kalos Therapeutics Inc., both of San Francisco, said they amended terms of their collaboration exploring potential COVID-19 treatments by proposing they investigate Kalos’ lead drug, KTH-222 (alone and/or in combination with anti-viral drugs), as part of monitoring viral loads in cancer patients infected with COVID-19 or in undiagnosed but symptomatic patients. In 2019, Kalos signed a letter of intent with Oncology for worldwide license and co-development of KTH-222. The agreement centered on KTH-222 as a monotherapy and/or in combination with antiviral drugs or therapies approved by the FDA and/or the appropriate regulatory agencies.
Oncosec Medical Inc., of Pennington, N.J., said Providence Cancer Institute, part of Providence St. Joseph Health, will evaluate Oncosec’s DNA-encodable vaccine, CORVax12, which is designed to act as a prophylactic vaccine to address COVID-19. CORVax1 combines Tavo (plasmid IL-12) with a DNA-encodable version of the spike, or “S,” glycoprotein, a component of the SARS-CoV-2 virus developed at the NIH. Previous vaccine efforts against coronaviruses, including SARS, focused on the spike glycoprotein, which facilitates interaction with the host cell through binding to the ACE2 receptor.
Onxeo SA, of Paris, said it entered agreements with Acrotech Biopharma LL, a wholly owned subsidiary of Aurobindo Pharma Ltd., of Hyderabad, India, which extend Acrotech’s rights to belinostat to all territories not previously covered under the companies’ prior agreement. Onxeo will receive a one-time payment of $6.6 million from Acrotech. Belinostat is currently marketed in the U.S. under the name Beleodaq for second-line treatment of peripheral T-cell lymphoma.
Protokinetix Inc., of Marietta, Ohio, said preliminary efficacy and safety results of PKX-001 for treating dry eye disease demonstrated a protective effect in a murine model. The effect of 5% PKX-001, delivered once daily via bilateral topical administration, was evaluated in an acute murine model of desiccating stress (DS). PKX-001 reduced the DS-induced corneal permeability to the same level as the positive control. PKX-001 safety upon ocular administration was evaluated in two animal models
Results of studies from Qu Biologics Inc., of Vancouver, British Columbia, show site-specific immunomodulators (SSIs) activate and mobilize cells of the innate immune system to enhance and reinforce immune and barrier function of target organs to treat or prevent disease. Qu said it demonstrated that innate immune system cells can be trained to be on alert and recruited to specific organs that either have disease present or are imminently threatened by disease. Qu’s SSIs have been used to treat lung cancer and ulcerative colitis and is in two phase II trials for Crohn’s disease. Proof-of-concept studies have been completed for treating chronic obstructive pulmonary disease and asthma using its lung-targeting SSI.
Redhill Biopharma Ltd., of Tel Aviv, Israel, and Raleigh, N.C., said it received authorization from the Italian National Institute for Infectious Diseases and Central Italian Ethics Committee for an expanded access program allowing immediate compassionate use of opaganib (Yeliva, ABC-294640), in Italy for patients with confirmed COVID-19 infection with life-threatening clinical manifestations. About 160 patients will be treated in three major hospitals in northern Italy, one of the pandemic’s epicenters. Opaganib is an oral sphingosine kinase-2 selective inhibitor with anticancer, antiviral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. Preclinical data show both antiviral and anti-inflammatory activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage, the company said.
Samsung Biologics Co. Ltd., of Songdo, South Korea, formed a strategic partnership with Daejeon, South Korea-based Pharmabcine Inc. for the development and manufacturing of PMC-402, a fully human agonistic IgG targeting TIE2, for oncology and neovascular disorders. According to Pharmabcine, PMC-402 is expected to enhance the delivery of immune cells and cancer therapeutics to treat tumor cells via active normalization of leaky blood vessels. The partners plan to test the candidate's safety and to initiate a phase I trial by 2021.
Shenogen Pharma Group Ltd., of Beijing, formed an exclusive collaboration and licensing agreement with Shanghai Bioardis Co. Ltd., of Shanghai, and Bioardis LLC, of San Diego, for the development and commercialization of Bioardis' fibroblast growth factor receptor 4 (FGFR4) kinase inhibitor, BIO-1262, either as a monotherapy or combination therapy in mainland China, Hong Kong, Macau and Taiwan. Bioardis will retain all rights to the licensed product in the rest of the world. The candidate, also known as SNG-203, is being evaluated as a potential new treatment for hepatocellular carcinoma and other solid tumors positive for FGFR4 and klotho beta expression
Sosei Heptares, part of Sosei Group Corp., of Tokyo, and software company Discngine entered a deal for the former to use Discngine’s 3decision software as part of a structural GPCR chemogenomics platform. Sosei Heptares will use 3decision to merge the public Protein Data Bank structures with internal unpublished GPCR structures used for structure-based drug discovery. The knowledge will directly benefit the internal Structure-Based Drug Design projects and help to further reinforce Sosei Heptares’ strong expertise in GPCR structural cheminformatics, Sosei Heptares said.
Xbiotech Inc., of Austin, Texas, and the San Antonio, Texas-based nonprofit blood and tissue supply organization Biobridge Global have agreed to work together to participate in an FDA program encouraging the development of a potential COVID-19 treatment based on convalescent plasma. Xbiotech has developed a clinical test that Qualtex Laboratories, a subsidiary of Biobridge, will use to identify natural antibodies present in the blood of convalescent donors.