Arcturus Therapeutics Inc., of San Diego, said it plans to initiate a clinical trial for its COVID-19 vaccine, also known as LUNAR-COV19, a very low dose, potential single-shot, self-replicating mRNA vaccine that is devoid of any viral material or co-adjuvants. Under the guidance of the Singapore Health Sciences Authority, the trial plans to enroll up to 76 healthy volunteer adults, including elderly individuals, with follow-up over several months to evaluate extent and duration of immune response.
Axon Neuroscience SE, of Bratislava, Slovakia, said it is developing a promising vaccine candidate against COVID-19. It contains only selected epitopes capable of inducing desirable T-cell and B-cell mediated immune responses to prevent interaction of the virus Spike (S) glycoprotein with its target human cells, thus preventing the virus from entering the cells and spreading. The approach is designed to prevent the unwanted serious side effects observed in previous studies of conventional vaccines against SARS-CoV.
Biosig Technologies Inc., of Westport, Conn., said its Viralclear subsidiary published data in Biorxiv showing broad-spectrum antiviral drug Vicromax suppresses SARS-CoV-2 replications. Vicromax was shown to decrease viral production of COVID-19 coronavirus by more than 98%. The drug is in preclinical testing, and the company said it aims to pursue development through FDA-approved clinical trials in the second quarter of 2020.
Celularity Inc., of Warren, N.J., said it expanded its existing license agreement with Lung Biotechnology PBC, a subsidiary of United Therapeutics Corp., of Silver Spring, Md., to include the treatment of COVID-19 and acute respiratory distress syndrome (ARDS). The announcement builds on recent work by Celularity for the use of CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease COVID-19, and extends that application of the technology to ARDS. Under the amended agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a joint steering committee to oversee development and commercialization activities. Financial terms were not disclosed.
Circassia Pharmaceuticals plc, of Oxford, U.K., said its board has concluded that it is in the best interests of the company to terminate the development and commercialization agreement with Astrazeneca UK Ltd., a subsidiary of Astrazeneca plc, of Cambridge, U.K., for the U.S. commercial rights to Tudorza and Duaklir and transfer the assets to Astrazeneca together with certain ancillary rights and assets. The transaction will be satisfied by way of a set-off against the loan amount owed to Astrazeneca that totals approximately $149.9 million. Astrazeneca will retain its 18.9% shareholding in the company. On completion of the transaction, Circassia proposes to change its name to Circassia Group plc, subject to the passing of a special resolution at the general meeting.
Epitopoietic Research Corp. (ERC Worldwide), of Isnes, Belgium, said it has a development program for its therapeutic and prophylactic vaccine against SARS-CoV-2 based on ERC’s Gliovac/ERC-1671 glioblastoma vaccine platform currently in an FDA-approved clinical trial in the U.S. The vaccine is being created from human cell lines infected with SARS-CoV-2 virus. ERC’s product will not be composed of static antigens or viral particles; instead, it will contain virions, viral proteins at different stages of viral replication, as well as whole human cells and cellular fragments, composing all elements of viral replication. The composition is designed to elicit a powerful immune response to the whole universe of antigens involved in the viral infection, the company said. To prevent infection with SARS-Cov-2 virus, the vaccine will be given in one double shot. A booster vaccine would be given at three months if adequate IgG immunity was not achieved in noninfected patients.
Excelra Ltd., of Hyderabad, India, released the COVID-19 Drug Repurposing Database, an open-access compilation of previously approved small molecules and biologics with known preclinical, pharmacokinetic, pharmacodynamic and toxicity profiles that can rapidly enter either phase II or phase III trials on a fast track basis for COVID-19. In addition, the database includes information on promising drug candidates that are in various clinical, preclinical and experimental stages of drug discovery and development for COVID-19.
F-Star Ltd., of Cambridge, U.K., disclosed the publication of preclinical data on the antitumor activity of FS-120, a potentially first-in-class dual-agonist tetravalent bispecific antibody targeting CD137 and OX40, in Cancer Immunology Research. FS-120 was shown to delay tumor growth by improving the activation and proliferation of peripheral T cells. Those data also reinforce the superiority of dual agonist targeting over alternative TNFR-targeting agonists and support the clinical development of the candidate to treat patients with cancer.
Hoth Therapeutics Inc., of New York, started the next phase of its study of VNLG-152 retinamides (retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases, at Weill Cornell Medicine. Hoth continues to examine the efficacy of RAMBAs in blocking acne pathogenic gene expression and carcinogenesis in mice. Solubility and formulation had been established for the drug for use in both human keratinocytes and mouse studies. A human keratinocyte in vitro acne study has been optimized, which uses molecules released by Propionibacterium acnes to induce an inflammatory response in those cells.
Researchers from the not-for-profit Intermountain Healthcare and University of Utah Health in Salt Lake City have launched two clinical trials to test the effectiveness and safety of two drugs – hydroxychloroquine (HCQ) and azithromycin – to treat patients with COVID-19. Personnel from the two health systems plan to enroll nearly 2,300 patients who are COVID-19-positive or suspected of being positive for the virus. In the first trial, patients hospitalized with suspected or confirmed COVID-19 will be given either HCQ or azithromycin to determine whether either drug affects the severity of COVID-19 and saves lives, the entities said. Researchers plan to enroll 300 patients in the clinical trial from across all Intermountain hospitals and university hospitals treating COVID-19 patients.
Lipocine Inc., of Salt Lake City, said the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office. Previously the PTAB granted Lipocine's priority motion in the interference case with Clarus Therapeutics Inc., of Northbrook, Ill. Lipocine said it was “extremely pleased with the federal circuit’s affirmation of the judgement of the PTAB canceling all the claims” of the Clarus patent.
Lupus Therapeutics, the clinical trial affiliate of the Lupus Research Alliance, said it is beginning a study assessing hydroxychloroquine and/or other lupus therapies in preventing or reducing COVID-19 symptoms in lupus patients. The study will be designed and conducted with Lupus Therapeutics’ Lupus Clinical Investigators Network, which comprises 57 academic medical centers in the U.S. and Canada. The study is a follow-up to anecdotal data from several academic centers within the network.
New York-based Pfizer Inc. and Biontech Inc., of Mainz, Germany, agreed to develop a COVID-19 vaccine and scale manufacturing capacity. Biontech will contribute multiple mRNA vaccine candidates as part of its BNT-162 COVID-19 vaccine program. Biontech will receive an up-front $185 million payment, including an equity investment of approximately $113 million, and is eligible to receive future milestone payments of up to $563 million for a potential total consideration of $748 million. Also, Pfizer confirmed a lead compound and analogues are potent inhibitors of the SARS-CoV-2 3C-like protease, based on initial screening assay results. Pfizer also said its preliminary data suggest the lead protease inhibitor shows antiviral activity against SARS-CoV-2. Pfizer said it will perform preclinical confirmatory studies, including further antiviral profiling and assessment of the suitability of the lead molecule for I.V. administration clinically. The company also said it is investing in materials to accelerate the start of a potential clinical study of the lead molecule to the third quarter of 2020, three or more months in advance of earlier estimates, subject to positive completion of the preclinical confirmatory studies.
Pharvaris GmbH, of Zug, Switzerland, said it established a proof-of-concept model for hereditary angioedema (HAE) in nonhuman primates. In the model, PHA-121 inhibited bradykinin-induced changes in blood pressure at all doses tested (0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg and 10 mg/kg given orally) with a faster onset of action than icatibant. The duration of the effect was dose dependent. The objective of the study was to investigate the ability of PHA-121 to attenuate blood pressure changes induced by bradykinin injection. Freely moving monkeys were challenged with bradykinin, resulting in a transient drop in blood pressure. Bradykinin is an endogenous peptide known to mediate signs and symptoms of HAE. The model was validated utilizing icatibant, a marketed injectable B2 receptor antagonist, providing back-translation from human clinical experience with icatibant.
Relief Therapeutics Holding AG, of Geneva, said aviptadil has entered FDA clinical trials at Thomas Jefferson University Hospital in Philadelphia for the treatment of acute respiratory distress syndrome in COVID-19. The multicenter trial will enroll patients who are already on mechanical ventilation in the hopes that aviptadil can decrease mortality and help to improve the ability of the patient’s lung to transfer oxygen to the body. The trial is being run by partner Neurorx Inc., of Radnor, Pa.
Sangamo Therapeutics Inc., of Brisbane, Calif., said it closed its sale of stock to Cambridge, Mass.-based Biogen Inc., and the global licensing agreement with Biogen to develop and commercialize gene regulation therapies for Alzheimer’s, Parkinson’s neuromuscular and other neurological diseases is now effective. Under the terms, Sangamo received $225 million from the purchase by Biogen of newly issued Sangamo stock and will receive an up-front license fee of $125 million no later than May 8. Sangamo also is eligible to earn up to $2.37 billion in milestones.
TFF Pharmaceuticals Inc., of Austin, Texas, said it entered a research collaboration with the University of Georgia’s Center for Vaccines and Immunology (CVI), along with the University of Texas at Austin (UT Austin), to evaluate the immunogenicity and efficacy of universal influenza vaccines following Thin Film Freezing. Under the terms, TFF, along with UT Austin and the University of Georgia’s CVI will investigate TFF-formulated CVI recombinant universal influenza vaccines. UT Austin will formulate hemagglutinin and neuraminidase proteins, with and without adjuvant, using TFF’s Thin Film Freezing technology. The University of Georgia’s CVI will then evaluate the ability of those TFF-formulated compounds to elicit broadly reactive immune responses and potentially provide longer-lasting protection against a wider variety of influenza viruses, in a preclinical challenge model.
Theravance Biopharma Inc., of Dublin, said it is advancing TD-0903, a lung-selective nebulized JAK inhibitor into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury in patients hospitalized due to COVID-19, with the ultimate goal of preventing progression to acute respiratory distress syndrome. If the initial CTA submission for the study in healthy volunteers is approved and the study successful, Theravance said it intends to study TD-0903 in COVID-19 patients in the near future.
Tiziana Life Sciences plc, of New York and London, said it has developed investigational new technology to treat COVID-19 infections, which consists of direct delivery of anti-IL-6 receptor monoclonal antibodies into the lungs using a handheld inhaler or nebulizer. Development of that technology is a step toward expediting development of TZLS-501, a fully-human anti-IL-6R monoclonal antibody for COVID-19. The company said it believes the technology could also be applicable for use with other FDA-approved antibodies and drugs.
Vanda Pharmaceuticals Inc., of Washington, and the University of Illinois at Chicago said they entered a research partnership focused on the investigation of small molecules with the potential to treat COVID-19. The collaboration will include the use of a high-throughput screening assay to identify small molecules that may prevent cathepsin-L cleavage of SARS-CoV-2 (COVID-19) glycoproteins that are required for viral processing in the host cell. SARS-CoV-2 and other viruses depend on cathepsin L for processing in target cells. The viral glycoproteins need to be primed by protease cleavage, activating them for fusion with the host cell membrane. Previous research has demonstrated the potential of small molecules to inhibit the cathepsin L cleavage of viral peptides with minimal inhibition of physiological substrate cleavage, the company said.