Affinity Biosciences Pty. Ltd., of Melbourne, Australia, said its neutralizing antibodies could be useful for developing a rapid therapy vaccine or protecting those in high-risk situations such as health care workers or others in direct contact with COVID-19 patients. The company said it requested proposals to manufacture the antibody for clinical trials from Australian and overseas contract manufacturing organizations and added that it is in discussions with regulatory consultants to establish an expedited path for manufacturing, trials and approval of the antibody therapy.
American Gene Technologies Inc., of Rockville, Md., said a paper co-authored by scientists from the company and the U.S. National Institute of Allergy and Infectious Diseases describes the evolution of the AGT103-T manufacturing process as researchers developed the large-scale production of modified HIV-specific, CD4 T cells that resist infection and depletion by HIV. Experimentation confirmed that process and characterized those cells. AGT103-T shows the potential for clinical impact on HIV disease, the company said.
Appili Therapeutics Inc., of Halifax, Nova Scotia, said it initiated site screening of long-term care facilities in Ontario for its phase II study evaluating favipiravir, an oral, broad-spectrum antiviral, as a post-exposure outbreak control measure against COVID-19. Residents at screened sites will be eligible for enrollment and randomization into the trial upon confirmation of a COVID-19 outbreak. The trial is expected to enroll about 760 participants in at least 16 facilities. Favipiravir was originally developed and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza outbreak.
Betterlife Pharma Inc., of Vancouver, British Columbia, said that 91.3% of shareholders from Altum Pharmaceuticals Inc., of Vancouver, British Columbia, voted in favor of merging with Betterlife. Betterlife now awaits ratification of the merger by the Canadian Securities Exchange. Altum, also of Vancouver, British Columbia, has a pipeline of three products, including AP-003, an interferon a2b inhalation formulation. Recent studies in China and the U.K. provided data suggesting the therapeutic efficacy of interferon-based treatments for COVID-19, according to Betterlife.
Cannabis Global Inc., of Los Angeles, said it is ready to begin its mouse study in August to determine if administration of tetrahydrocannabivarin (THC-V) promotes appetite suppression and/or weight loss. The study will consist of 35 mice, randomly divided into five groups: a control group receiving no THC-V, a group receiving the human equivalent of 10 mg of botanically derived THC-V daily prior to feeding, a group receiving the human equivalent of 40 mg of botanically THC-V daily prior to feeding, a group receiving the human equivalent of 1 mg of sustained-release THC-V nanoparticle preparation daily prior to feeding and a group receiving the human equivalent of 2 mg of sustained release THC-V nanoparticle preparation daily prior to feeding. All groups will be maintained on high-fat diets throughout the study. Body weights will be taken and recorded twice weekly during the six-week THC-V dosing period.
Cerevel Therapeutics Inc., of Boston, and Arya Sciences Acquisition Corp II, a special purpose acquisition company incorporated in the Cayman Islands, entered a definitive business combination agreement. Arya II will redomicile as a Delaware corporation, be renamed Cerevel Therapeutics Holdings Inc. and its common stock is expected to be listed on Nasdaq under the ticker symbol CERE. The combined company is expected to receive net proceeds of approximately $445 million at closing. The boards of both Arya II and Cerevel have approved the proposed transaction. Completion of the transaction, expected by the fourth quarter of 2020, is subject to approval of Arya II’s shareholders.
FSD Pharma Inc., of Toronto, said it notified Health Canada that it plans to forfeit licenses and suspend all activities of its medical cannabis subsidiary, FV Pharma, within 30 days. The firm will focus efforts on pharmaceutical R&D, including work on a cannabinoid CB2 receptor modulator FSD-201 (ultramicronized PEA) for use in COVID-19 patients. FSD plans to submit an IND to the FDA to test FSD-201 in down-regulating the overexpressed pro-inflammatory cytokine immune response to SARS-CoV-2 virus infection.
Gen1e Lifesciences Inc., of Palo Alto, Calif., a Y Combinator and Startx company focused on accelerating cures for diseases of inflammation and aging, and Vituity are partnering to speed up development of COVID-19 treatments and improve patient outcomes. As part of the new partnership, Gen1e will leverage Vituity’s health care expertise to optimize the design and efficiency of clinical trials for COVID-19 pneumonia and acute respiratory distress syndrome treatments. In addition, Vituity will invest in Gen1e to rapidly advance its drug development platform to ensure those treatments can be rapidly produced and distributed to patients.
Inovio Inc., of Plymouth Meeting, Pa., said its COVID-19 DNA vaccine, INO-4800, was effective in protecting nonhuman primates (NHPs, specifically rhesus macaques) from live virus challenge 13 weeks after the last vaccination. The protective results were mediated by memory T- and B-cell immune responses from INO-4800 vaccination, Inovio said. The results, submitted to a peer-reviewed journal and published on the non-peer reviewed online preprint site Biorxiv, demonstrate that INO-4800 reduced viral load in both the lower lungs and nasal passages in NHPs that received two doses of INO-4800 (1 mg) four weeks apart and then were challenged with live virus 13 weeks after the second dose (study week 17).
Johnson & Johnson, of New Brunswick, N.J., said its lead vaccine candidate protected against infection with COVID-19 in preclinical studies. The data, published in Nature, show the company’s adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by neutralizing antibodies, successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in nonhuman primates. Based on the strength of the data, a phase I/IIa first-in-human trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the U.S. and Belgium.
Neurotrope Inc., of New York, said its wholly owned subsidiary, Neurotrope Bioscience Inc., signed a services agreement with Worldwide Clinical Trials Inc., of Morrisville, N.C., to support site recruitment and activation for the company's ongoing phase II study of bryostatin-1 in the treatment of moderately severe Alzheimer's disease (AD). The study is being conducted in collaboration with the U.S. NIH under a $2.7 million grant to Neurotrope. The trial is expected to enroll about 100 AD patients and will evaluate bryostatin-1 in the absence of Namenda (memantine, Allergan plc) for a six-month period, which will include two 11-week dosing cycles.
PDL Biopharma Inc., of Incline Village, Nev., signed a definitive agreement for the sale of 100% of the outstanding stock in its wholly owned subsidiaries, Noden Pharma DAC and Noden USA, to Stanley Capital. The total value of the transaction will result in payments to PDL of up to $48.25 million in cash. After taking into account the expected adjustments for transaction expenses, indebtedness and working capital, payments to PDL are expected to be about $12 million at closing. The deal provides for $33 million more to be paid to PDL in 12 equal quarterly installments from January 2021 to October 2023. Also included is the potential for two more contingent payments totaling $3.25 million.
Pharvaris GmbH, of Zug, Switzerland, published data describing a novel class of small-molecule bradykinin B2-receptor antagonists. Preclinical data appear in a recent open-access article in Frontiers in Pharmacology demonstrating potency, mechanism and properties consistent with oral bioavailability. The chemical class provided a significant stepping-stone for the discovery of PHA-121, described as a highly selective, potent and orally bioavailable B2-receptor antagonist, the company noted.
Teva Pharmaceutical Industries Ltd., of Tel Aviv, Israel, which holds (through its Japanese affiliates) with Takeda Pharmaceutical Co. Ltd., of Tokyo, a joint business venture (BV) in the Japanese market, disclosed a new strategy for its local commercial operations. Nearly five years since its inception, and following an in-depth review of market opportunities, the BV's new strategy will focus on commercializing a selection of complex generics, specialty assets and other pipeline opportunities, the company said. The shift will include a divestment of the majority of the BV's generic and operational assets to Nichi-Iko Pharmaceutical Co. Ltd., of Toyama, Japan. The transaction is expected to close by early 2021.