Akron Biotechnology Inc., of Boca Raton, Fla., said it signed an agreement with Synairgen plc, of Southampton, U.K., for the provision of its inhaled interferon-beta (IFN-beta) therapeutic candidate for the treatment of COVID-19 patients. The company reported positive results from its phase II trial of SNG-001 in 101 hospitalized COVID-19 patients in July, indicating that its inhaled IFN-beta could provide a valuable treatment option. Akron will support the future clinical and commercial development of SNG-001 through the provision of its IFN-beta in Synairgen’s formulation.
Aridis Pharmaceuticals Inc., of San Jose, Calif., said it is developing a fully human immunoglobulin 1 monoclonal antibody, AR-711, discovered from convalescent COVID-19 patients, that has successfully eliminated all detectable SARS-CoV-2 virus in infected animals at substantially lower doses than parenterally administered COVID-19 monoclonal antibodies. AR-711, engineered to be long-acting in blood for up to six to 12 months, is directed against the conserved receptor-binding domain region of the original SARS-CoV2 virus and its newly emerging variants, including the currently prevalent strain G614.
Beyond Air Inc., of Garden City, N.Y., reported additional preclinical data that further suggest endogenous high concentration of gaseous nitric oxide (gNO)(>10,000 ppm) administered directly to solid tumors may trigger a systemic antitumor immune response. Those data were included in a presentation at the AACR Conference on Tumor Immunology and Immunotherapy. In the studies, colon and breast tumor-bearing mice (CT26 and 4T1 models, respectively) received a single treatment with high concentration gNO intratumorally. The CT26 study mice received either 20,000 or 50,000 ppm gNO for five minutes and the 4T1 study mice received 50,000 ppm gNO for 10 minutes. Naïve mice, inoculated with the same cancer cells, served as an internal control for each study, with the 4T1 study having an additional control arm of mice treated with nitrogen gas. Up to 21 days after gNO administration to the primary tumor, all mice were inoculated with a challenge tumor and growth of that tumor was tracked. At day 45 in the CT26 study, challenge tumor uptake was observed in 100% of naïve mice, 27% of 20,000 ppm gNO mice, and 0% of 50,000 ppm gNO mice, suggesting dose-dependence. With respect to CT26-related mortality at day 45, 25% of naïve mice, 73% of 20,000 ppm gNO mice and 100% of 50,000 ppm gNO mice were alive. In the 4T1 study, while tumor take was observed in all mice, tumor take was delayed in the gNO-treated mice compared to both control groups.
Brainstorm Cell Therapeutics Inc., of New York, a developer of adult stem cell therapies for neurodegenerative diseases, said it is presenting preclinical acute respiratory distress syndrome (ARDS) outcomes for MSC-NTF (Nurown) exosomes at the virtual New York Stem Cell Foundation Conference. Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of Nurown-derived exosomes resulted in a statistically significant improvement in multiple lung parameters, including functional lung recovery, reduction in pro-inflammatory cytokines and attenuation of lung damage.
Catalyst Pharmaceuticals Inc., of Coral Gables, Fla., said it filed a lawsuit in the U.S. District Court for New Jersey against Plainsboro, N.J.-based Jacobus Pharmaceuticals Inc., and a lawsuit in the U.S. District Court for the Western District of Pennsylvania against Pantherrx Rare LLC, of Pittsburgh, for infringement of U.S. Patent No. 10,793,893 exclusively licensed to Catalyst and covers certain methods for treating disease using amifampridine drug products, including its Firdapse product, in patients who are slow metabolizers of amifampridine. The lawsuit arises from Jacobus’ and Pantherrx’s sales and marketing of Ruzurgi (amifampridine, 10 mg) and alleges that this product infringes the ‘893 patent when administered in accordance with its product labeling.
Cocrystal Pharma Inc., of Bothell, Wash., said toxicity data for its influenza A preclinical lead molecule, CC-42344, which is currently being evaluated in IND-enabling studies for the treatment of both seasonal and pandemic influenza strain A, has strong synergistic effects when combined with approved influenza antiviral drugs, including Tamiflu (oseltamivir) and Xofluza (baloxavir). Recent data show that CC-42344 retained single-digit nanomolar potency (EC50 = 0.5 nM) against a Xofluza-resistant influenza A strain (H1N1, I38T). Additionally, it reported a favorable safety profile from the ongoing IND-enabling studies including seven-day rat and dog toxicology studies, genotoxicity and safety pharmacology.
Cognition Therapeutics Inc., of Pittsburgh, said its scientists have published data in the Journal of Neurochemistry relating to the evidence that individuals with the A673T mutation (Icelandic mutation) in the protein Aβ are four times less likely to develop Alzheimer’s disease than are noncarriers, making this the strongest protective mutation discovered to date for this disease. Cognition’s research demonstrates that these mutant Aβ oligomers bind with a fourfold lower affinity to synapses in the brain than do normal oligomers. When bound to synapses, Aβ oligomers cause the brain cell dysfunction and memory failure characteristic of Alzheimer’s disease. That suggests that the reduction in oligomer binding is the main reason Icelandic mutation carriers are four times less likely to develop Alzheimer’s disease.
Connectyx Technologies Holdings Group, of Boca Raton, Fla., said it entered an exclusive evaluation and commercialization option license agreement with the National Cancer Institute (NCI), part of the U.S. NIH, for use of a novel monoclonal antibody in an antibody-drug conjugate to treat brain cancer. While the field of use covers treating adult and pediatric glioblastomas, the company is targeting pediatric glioblastoma, an orphan disease, as the first indication for the product.
Endo International plc, of Dublin, said it will acquire all outstanding shares of Biospecifics Technologies Corp., of Lynbrook, N.Y., a commercial-stage biopharmaceutical company, for $88.50 in cash per share, an estimated enterprise value of approximately $540 million, with a net of approximately $120 million in cash. Endo struck a strategic relationship with Biospecifics in 2004. Biospecifics receives a royalty stream from Endo related to Endo's collagenase-based therapies, which includes Xiaflex, marketed by Endo, for treating Dupuytren's contracture and Peyronie's disease, and Qwo, the first FDA-approved injectable treatment for cellulite, which is expected to be launched by Endo Aesthetics in 2021.
Evotec SE, of Hamburg, Germany, said its Seattle-based subsidiary, Just-Evotec Biologics Inc., received a grant from the Bill & Melinda Gates Foundation to enable the development and production of monoclonal antibody candidates for preventing severe COVID-19 in vulnerable populations in low and middle income countries. Just-Evotec will perform an in silico analysis of several lead candidate sequences of anti-SARS-CoV-2 candidates provided to the foundation by several academic medical centers around the world. Just-Evotec also will perform cell line development for two lead molecules.
Genesis Therapeutics Inc., of South San Francisco, said it entered a multitarget collaboration agreement with Genentech Inc., a unit of the Roche Group. The collaboration leverages Genesis’ graph machine learning and drug discovery ability to identify candidates for therapeutic targets in multiple disease areas. Genesis will receive an up-front payment and is eligible to receive preclinical, clinical and regulatory milestone payments, as well as future royalties on Genentech’s sales of approved drugs resulting from the collaboration.
Immunogen Inc., of Waltham, Mass., and Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd., a wholly owned subsidiary of Huadong Medicine Co. Ltd., of China, entered an exclusive collaboration to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau and Taiwan. Immunogen will retain all rights to mirvetuximab in the rest of the world. Immunogen will receive $40 million up front and is eligible to receive additional milestone payments of up to $265 million. Immunogen is also eligible to receive low double-digit to high teen royalties as a percentage of mirvetuximab commercial sales by Huadong in Taiwan. Mirvetuximab soravtansine is an antibody-drug conjugate comprising a folate receptor alpha-binding antibody, cleavable linker and the maytansinoid DM4, a tubulin-targeting agent to kill targeted cancer cells.
Kamada Ltd., of Rehovot, Israel, said it signed an agreement with the Israeli Ministry of Health to supply its anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin product to treat COVID-19 patients in Israel. Kamada said it will manufacture the product from convalescent plasma collected and supplied by the Israeli National Blood Services and additional Israeli medical institutions. The initial order, planned to be supplied in early 2021, is for treating approximately 500 hospitalized patients. The initial supply is expected to generate approximately $3.4 million in revenue for Kamada during the first quarter of 2021, the company said.
Kazia Therapeutics Ltd., of Sydney, Australia, said it executed a definitive agreement with the Global Coalition for Adaptive Research to commence Kazia's participation in the coalition’s AGILE pivotal study in glioblastoma. The study will open a new arm with Kazia's investigational new drug, paxalisib (formerly GDC-0084), and will now move into an operational phase with recruitment of patients to the paxalisib arm expected to begin in the first quarter of 2021. Kazia said it will pay an initial fee of $5 million to the coalition, with further milestone payments payable in the course of the study.
NGM Biopharmaceuticals Inc., of South San Francisco, said it expanded its oncology portfolio with its first immuno-oncology development candidate, NGM-707, a dual antagonist antibody that inhibits immunoglobulin-like transcript 2 and immunoglobulin-like transcript 4. NGM-707 joins NGM-120, an antagonistic antibody that binds glial cell-derived neurotrophic factor receptor alpha-like and inhibits growth differentiation factor 15 signaling, in NGM’s oncology portfolio. NGM-120 is in an ongoing phase Ia/Ib trial in patients with cancer and cancer anorexia/cachexia syndrome.
Oncomyx Therapeutics Inc., of Phoenix, presented preclinical data at the AACR Virtual Special Conference: Tumor Immunology and Immunotherapy. The findings are the first to demonstrate preclinical therapeutic activity of armed myxoma virus alone and in combination with immune checkpoint inhibitors of the company’s armed myxoma virotherapy in development to improve cancer treatment. Myxoma is a large dsDNA pox virus suitable for intratumoral or intravenous oncolytic virotherapy and is engineerable to carry multiple transgenic payloads with robust transgene production and function, the company said.
Orgenesis Inc., of Germantown, Md., completed the acquisition of Koligo Therapeutics Inc., of New Albany, Ind. Also, the company said it has acquired substantially all of the assets of Tissue Genesis LLC, of Houston. The takeover of Tissue Genesis was initially undertaken via Koligo, and became part of the Koligo acquisition. Orgenesis will now own the entire inventory of Tissue’s Icellator devices, related kits and reagents, and a broad patent portfolio to protect the technology, Orgenesis said.
Samsung Biologics Co. Ltd., of Incheon, South Korea, signed a partnership agreement with Bioeleven Co. Ltd., of Seoul, South Korea, to develop and manufacture BN-101A, a third-generation immunotherapy to treat cancer. Samsung will provide development services from cell line development, process development, to nonclinical and clinical material manufacturing as well as IND filing support. Terms were not disclosed.
Sanofi SA, of Paris, said Sanofi Pasteur, its vaccines global business unit, and Translate Bio Inc., of Lexington, Mass., disclosed preclinical results for MRT-5500, an mRNA-based vaccine candidate against COVID-19. Evaluation demonstrated a favorable immune response profile, and the data support the selection of the compound for clinical development. A phase I/II experiment is expected to begin in the fourth quarter of 2020.
Sesen Bio Inc., of Cambridge, Mass., selected Cardinal Health Inc., of Dublin, Ohio, as its exclusive provider for third-party logistics and specialty pharmaceutical distribution services related to the commercial distribution of vicineum in the U.S. Vicineum, also known as VB4-845, is currently in the follow-up stage of a phase III registration trial for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer. In December 2019, the company initiated the BLA submission for vicineum, a locally administered fusion protein.
Som Biotech SL, of Barcelona, said in silico and in vitro results of eravacycline for the treatment of SARS-CoV-2 showed the dual COVID-19 replicase polyprotein 1a/1ab inhibitor establishes a covalent bond with Cys145 in the catalytic domain of the SARS-CoV-2 3CL protease, a viral protein essential for coronavirus infection and replication in host cells. In vitro experiments confirmed inhibition of the protease with an IC50 in the low micromolar range. Eravacycline also inhibited infection of SARS-CoV-2 in VeroE6 cells and showed no toxicity when applied alone, and it inhibited the 3CL proteases of related coronaviruses, such as SARS-CoV and MERS-CoV, suggesting it could be repositioned to treat beta-coronavirus infections. The data are scheduled for a virtual poster presentation at IDWeek 2020.
Sunshine Biopharma Inc., of Montreal, said it agreed to work with the University of Georgia to advance development of its lead anti-coronavirus compound, SBFM-PL4. The protease inhibitor will be assessed in a series of in vitro tests to evaluate its inhibitory activity against the SARS-CoV-2 papain-like protease, one of two coronavirus-encoded proteases essential for viral replication. Following initial in vitro studies, SBFM-PL4 will be moved to the cell culture testing stage and assessment in coronavirus-infected mice.
The non-profit Transcelerate Biopharma Inc., of Philadelphia, said it launched several initiatives to improve pharmaceutical R&D. To respond to the COVID-19 pandemic, a module was created in its Datacelerate platform to enable patient-level data sharing of both the investigational product and control arms of COVID-19 trials, along with supporting documentation. Access to the COVID-19-related trial data is available to Transcelerate member companies, qualifying non-member biopharmas and select government biomedical research agencies. Also in response to the pandemic, Transcelerate approved the Modernizing Clinical Trial Conduct initiative, whose data and experience will be used to inform future development strategies for industry and policy initiatives for regulators. Transcelerate’s Real World Data initiative aims to support collaboration among global regulatory agencies to define tools, methodologies, use cases and appropriate levels of evidence to support regulatory decision-making using real world data. Finally, with a growing number of pharmacovigilance agreements between companies requiring an exchange of safety information, the Pharmacovigilance Agreements Optimization initiative seeks to produce a customizable resource for contract partners that can inform and/or streamline process development, contract drafting and negotiations around these documents.