Aim Immunotech Inc., of Ocala, Fla., told its stockholders the company is re-examining the antiviral properties of Ampligen (rintatolimod) to determine if it could become a vaccine to protect against the Wuhan coronavirus (COVID-19). The company said it obtained genomic RNA sequences of the new virus and compared them to the SARS virus' RNA sequences. The RNA sequences of the SARS virus in key areas of viral replication are almost identical for the Wuhan coronavirus, the company said, adding that, in NIH studies of SARS-infected mice, Ampligen conferred “significant antiviral/survival effect.” Ampligen is in clinical trials for treating renal cell carcinoma, malignant melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple-negative metastatic breast cancer.
Audentes Therapeutics Inc., of San Francisco, an Astellas company, said it plans to invest $109 million to build a new 135,000-square-foot gene therapy manufacturing facility in Sanford, N.C. The initial phase of the capital investment is planned to occur over about 18 months, and the plant is expected to be operational in 2021.
Aytu Bioscience Inc., of Englewood, Colo., completed its acquisition of San Diego’s Innovus Pharmaceuticals Inc. Aytu retired Innovus’ outstanding common stock and certain Innovus warrants for about 3.8 million shares of Aytu common stock and approximately 2 million shares of preferred stock. It also forgave $1.35 million of debt previously owed to Aytu. Aytu also assumed $3.2 million of Innovus’ unsecured debt. Additional consideration for up to $16 million in milestone payments in the form of contingent value rights were issued to Innovus shareholders at the acquisition’s close.
The settlement struck between Brickell Biotech Inc., of Boulder, Colo., and Bodor Laboratories Inc. allows Brickell to continue developing sofpironium bromide to treat hyperhidrosis, a condition in which a person sweats more than the body requires to regulate its temperature. The parties agreed to dismiss the related litigation and arbitration with prejudice. As part of the settlement and amended license agreement, Brickell agreed to make an up-front payment to Bodor of $1 million in cash and pay up to $1 million in cash and $1.5 million in common stock upon achieving specified milestones. Additionally, Brickell agreed to pay Bodor a low single-digit royalty related to a newly filed provisional patent application and modified the percentage of certain sublicensing income that Bodor may receive in the future.
DNX Biopharmaceuticals Inc., of San Diego, said it entered a strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson. Under terms of the agreement, the Lung Cancer Initiative has taken an exclusive license to research, develop and commercialize molecules from within the DNX portfolio. Financial terms were not disclosed. Founded in 2014, DNX is developing non-immunogenic, long-acting biologic therapies for the treatment of patients with life-long diseases linked to inflammation, autoinflammation and oncology.
Eyepoint Pharmaceuticals Inc., of Watertown, Mass., and Vision Center Network of America LLC entered a purchase agreement for Dexycu (dexamethasone intraocular suspension) 9%, allowing Vision Center’s physicians to use Dexycu to treat ocular inflammation associated with cataract surgery. Vision Center has nine surgery centers in New York and New Jersey that perform an estimated 60,000 cataract procedures annually.
IBM Watson Health unveiled its cloud-based IBM Study Advance, a tool with an interface to provide access to commercial and claims data from de-identified patient profiles covering 89 million lives from multiple employer-sponsored U.S. health care beneficiaries, as well as tools to assess the impact of inclusion and exclusion criteria on the eligible patient population. IBM also launched Study Advance's collaborative workspace, which is designed to allow near real-time collaboration with study design team members who can manage and assign teams to specific sections of the protocol. The workspace is also designed to provide access to standard protocol templates and version control capabilities with traceability back to changes, aiming to reduce the average time required to author a clinical trial protocol.
Shareholders of Raleigh, N.C.-based Innovate Biopharmaceuticals Inc. approved all proposals connected with the pending merger with RDD Pharma Ltd., of New York and Tel Aviv, Israel, to create 9 Meters Biopharma Inc., a GI-focused platform company. Innovate is developing therapeutics for autoimmune and inflammatory diseases. Its lead candidate, larazotide acetate, renormalizes the dysfunctional intestinal barrier by decreasing intestinal permeability and reducing antigen trafficking, such as gliadin fragments in celiac disease, and bacterial toxins and immunogenic antigens in NASH.
Innovation Pharmaceuticals Inc., of Wakefield, Mass., said it is exploring its lead defensin mimetic candidate, brilacidin, as a treatment for the COVID-19 coronavirus.
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) awarded Lytica Therapeutics Inc., of Cambridge, Mass., up to $5.3 million to develop antibacterial peptides with broad activity against multidrug-resistant bacteria. The company could receive up to $11.6 million in additional funding if the project achieves certain development milestones, for a potential total of $16.9 million. CARB-X is a consortium led by Boston University and funded by a global partnership.
M8 Pharmaceuticals Inc., of Berwin, Pa., and Vectans Pharma, of Saint-Cloud, France, signed an exclusive licensing agreement giving M8 the rights to register and commercialize Loramyc (miconazole) for Mexico and Brazil. Loramyc is an antifungal agent, administered as a mucoadhesive buccal tablet to treat oropharyngeal candidiasis in immunocompromised patients, particularly those with head and neck cancers who have undergone radiotherapy, and those infected by HIV. Vectans received its first Loramyc marketing authorization in France in October 2006. Loramyc is registered in 26 European countries, in South Korea, Japan and the U.S.
Neuropore Therapies Inc., of San Diego, received a $500,000 grant from the ALS Association to support the preclinical evaluation and development of Neuropore’s leading Toll-like receptor 2 (TLR2) antagonist, NPT1220-312, to treat amyotrophic lateral sclerosis. NPT1220-312 is designed to protect neurons from damaging inflammation generated by TLR2 receptors. Pending positive outcomes in ongoing studies, the goal is to submit an IND to FDA by first half of 2021.
Phosplatin Therapeutics LLC, of New York, disclosed its publication in Oncoimmunology of in vitro and in vivo data demonstrating that PT-112 is a bona fide immunogenic cell death (ICD) inducer, and as a result can initiate anticancer immunity, as a monotherapy and in combination with immune checkpoint inhibition. PT-112 causes the release of so-called damage associated molecular patterns, a signature of ICD, by dying cancer cells. In addition, PT-112 synergizes with immune checkpoint blockers in the context of superior immune infiltration. Those findings are in line with preliminary clinical evidence on the use of PT-112 in patients with solid tumors, either as a monotherapy or in combination with anti-PD-L1 immune checkpoint blockade, the company said.
Revive Therapeutics Ltd., of Toronto, provided an update on the company’s clinical development plan for cannabidiol (CBD) in the treatment of autoimmune hepatitis (AIH). Revive is in the process of preparing its IND for submission to the FDA for CBD in the treatment of AIH, and plans to submit the IND within 90 days, with the objective to proceed with a proposed phase I/IIa study to determine the recommended dose of CBD for future clinical studies of AIH, to assess its safety, efficacy and clinical benefit, as well as to support an NDA.
Saniona AB, of Copenhagen, started a new company to identify and develop migraine treatments based on Saniona’s ion channel competence and central nervous system technology platform. Headache authority Jes Olesen is a co-founder of newco Cephagenix and is providing private financing for the company. Cephagenix has the aim of identifying and developing new effective migraine treatments. Following completion of year one of the collaboration, Saniona will own 33.3% of the new company and Olesen the remaining 67.7%. Olesen will provide private financing including DKK1.2 million (US$173,633) to cover funding of all Saniona activities for Cephagenix during its first year.
Sanofi SA, of Paris, said it will leverage previous development work for a severe acute respiratory syndrome (SARS) vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the U.S. Biomedical Advanced Research and Development Authority, expanding the company's longstanding partnership with the authority. In late 2002, the SARS coronavirus emerged and then largely disappeared by 2004. Sanofi plans to further investigate an advanced preclinical SARS vaccine candidate that could protect against COVID-19.
Servier SAS, of Paris, and Oncodesign SA, of Dijon, France, reached milestone in their strategic partnership on research and development of potential drug candidates for Parkinson’s disease (PD). Over the life of their partnership, Servier could reward Oncodesign with up to €320 million (US$360 million) in milestone payments, excluding royalties. For the latest achievement, Oncodesign receives a first success payment in the program of €1 million. In addition, Oncodesign stands to receive €3 million in annual funding during the research phase of the project. Next steps, which are subject to further milestone payments, will validate the Nanocyclix platform to have the potential to deliver small-molecule drugs as therapeutics against PD.
Stealth Biotherapeutics Inc., of Boston, disclosed positive results from its retrospective natural history study, clinical protocol SPIBA-001, evaluating the efficacy of subcutaneous injections of elamipretide relative to a natural history control comprising 19 propensity score-matched subjects with Barth syndrome. Subjects receiving elamipretide for up to one year during the Tazpower trial and open-label extension showed a mean improvement of greater than 80 meters on their six-minute walk test, the primary efficacy endpoint, compared to less than one meter for subjects in the natural history group evaluated over the same time period (p=0.0005). Patients also showed statistically significant improvements in several key secondary endpoints, including muscle strength and sit-to-stand evaluations. Additional analysis of those data will be presented at an upcoming medical meeting.
Vaxil Bio Ltd., of Ness Ziona, Israel, updated work on possible identification of vaccine candidate targeting coronavirus COVID-19. During the next quarter, Vaxil plans to initiate non-GMP manufacturing. The non-GMP product will be made available for preclinical testing by those who express interest and qualify. In addition, Vaxil said it will explore partnerships and other possibilities to test the vaccine.
Vifor Pharma Group, of St. Gallen, Switzerland, agreed to purchase an FDA priority review voucher from an undisclosed party. The voucher entitles the holder to obtain priority review for an NDA or BLA, the company noted. Terms were not disclosed.
Wuxi Biologics Co. Ltd., of Shanghai, said Wuxi Vaccines, its joint venture with Shanghai Hile Biotechnology Co. Ltd., also of Shanghai, signed a strategic partnership and a 20-year vaccine manufacturing contract valued at about $3 billion, pursuant to which Wuxi will build a dedicated facility and supply commercial vaccine products for the global market. Specifically, Wuxi will build an integrated vaccine manufacturing facility including drug substance manufacturing, drug product manufacturing, and manufacturing science and technology labs, as well as quality control labs. The facility will be dedicated to the manufacture of one of its partner's vaccine products for the global market. The new facility is expected to be operational in 2022.