Astrazeneca plc, of London, completed the divestment of commercial rights to Atacand (candesartan cilexetil) and Atacand Plus (a fixed-dose combination of candesartan cilexetil and hydrochlorothiazide) in more than 70 countries to Cheplapharm Arzneimittel GmbH, of Mesekenhagen, Germany. Astrazeneca received a payment of $250 million from Cheplapharm, and will get $150 million more during the first half of 2021. Atacand and Atacand Plus generated product sales of $148 million and profit before tax of $89 million in the countries covered by the agreement.
Azurrx Biopharma Inc., of Delray Beach, Fla., signed an exclusive worldwide licensing agreement with First Wave Bio Inc., of Boston, for the use of the patented and proprietary oral and rectal formulations of niclosamide for the treatment of immune checkpoint inhibitor-associated colitis and COVID-19 gastrointestinal infections. Niclosamide is a small-molecule drug that was approved by the FDA in 1982 for the treatment of intestinal tapeworm infections and is on the World Health Organization’s list of essential medicines. Under the terms, Azurrx gains worldwide rights to develop, manufacture and commercialize immediate-release oral and enema formulations of niclosamide. First Wave will receive an up-front payment of $10.25 million in cash payable as $9 million at closing and $1.25 million by June 30, 2021, and $3 million of convertible junior preferred stock.
Biocure Technology Inc., of Vancouver, British Columbia, signed through a subsidiary a memo of understanding with Symbasis GmbH, of Lohmar, Germany. The firms expressed a common interest in developing a CAR T therapy for chronic lymphocyte leukemia. The purpose of the memo is to establish a joint venture in Germany under the name Oncocart for clinical trials, production and marketing in Europe, (potentially, including other regions of the world) of ROR1-based products.
Entheon Biomedical Corp., of Vancouver, British Columbia, disclosed a business arrangement with, and a strategic investment in, Heading Health LLC, a psychiatric clinic platform focused on the administration of psychedelic-assisted therapy to treat mental health disorders. Entheon has participated in a series A preferred stock financing, investing $200,000 for a 5% stake in Heading. Under the terms, Entheon has the option to increase its overall holdings to up to 10% of Heading in a subsequent round of financing.
Epivax Therapeutics Inc. (EVT), of Providence, R.I., provided an update on the advancement of the peptide-based COVID-19 vaccine, EPV-CoV-19. A T-cell epitope-based vaccine designed by Epivax Inc.’s scientists in February 2020 and licensed to EVT in August 2020, the product has completed IND-enabling preclinical validation studies and is making steady progress toward a clinical trial, anticipated in early 2021, the firm said. The vaccine consists of peptides containing T-cell epitopes derived from the antigenic SARS-CoV-2 spike, membrane and envelope surface proteins.
Generation Bio Co., of Cambridge, Mass., disclosed data from a study achieving tolerability and targeted factor VIII expression levels in hemophilia A mice with a single dose of closed-ended DNA (ceDNA) delivered via the company’s cell-targeted lipid nanoparticle (ctLNP) system. In this study, conducted with a ceDNA development construct, a dose response was observed across three cohorts, with the highest dose of 2 mg/kg yielding a mean human factor VIII expression of 23% of normal. The company also disclosed data from studies conducted with a ceDNA research construct delivered via ctLNP demonstrating about 2-to-1 species translation from mice to nonhuman primates.
Hoth Therapeutics Inc., of New York, said it entered a nonexclusive commercial evaluation license agreement with the U.S. Army Medical Research and Development Command for a new molecular entity (NME) developed by the Walter Reed Army Institute of Research with a novel antibacterial mechanism of action that targets multiple bacterial pathogens. While the NME (to be developed under the identifier HT-006) has the potential to treat many different types of bacterial infections, Hoth will initially target treatment of serious bacterial infections of the lung, such as hospital-acquired pneumonia and ventilator-associated pneumonia. As such, Hoth intends to pursue streamlined development opportunities under the FDA’s program for "antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases." That streamlined program allows for the use of nonclinical animal studies to reduce clinical studies required for approval.
Inovio Inc., of Plymouth Meeting, Pa., and Advaccine Biopharmaceuticals Suzhou Co. Ltd., of Suzhou, China, said they entered a collaboration and license agreement for COVID-19 DNA vaccine candidate INO-4800. Advaccine will have the exclusive right to develop, manufacture and commercialize INO-4800 within greater China, inclusive of mainland China, Hong Kong, Macao and Taiwan. Advaccine will license its plasmid manufacturing process for use with INO-4800 and other Inovio pipeline product candidates to Inovio with the right to sublicense to Inovio's manufacturing partners. Additionally, Advaccine will provide its clinical data to Inovio in support of Inovio’s global INO-4800 regulatory filings, and Inovio will provide its INO-4800 clinical data for Advaccine to incorporate into its marketing applications in greater China. Under the terms, Advaccine will make an up-front payment of $3 million as well as pay an aggregate of $108 million upon the achievement of specified development and sales-based milestones for INO-4800 in greater China. Inovio will be entitled to receive a royalty equal to a high single-digit percentage of annual net sales in each region within greater China.
Lantern Pharma Inc., of Dallas, said it will launch the development of its antibody-drug conjugate (ADC) program through an evaluation and potential development agreement with Califia Pharma Inc., of San Diego, along with other key internal development and computational initiatives. Lantern will potentially leverage the patent-protected linker library, conjugation processes and payloads, including its own DNA damage causing compounds, LP-100 and LP-184, for development as ADC-based therapies for a range of solid tumors and blood cancers. In addition, Lantern intends to utilize its AI platform, known as RADR, to help determine the cancer types, targets and cancer biomarker signatures believed most likely to respond to and benefit from that ADC approach.
Moderna Inc., of Cambridge, Mass., provided a supply update for its COVID-19 vaccine, increasing its base-case global production estimate from 500 million to 600 million doses for 2021. The company said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021. It expects 100 million doses to be available in the U.S. by the end of the first quarter, with 200 million doses available by the end of the second quarter. Additional vaccine doses have also been supplied to the Canadian government following authorization by Health Canada on Dec. 23.
Novus Therapeutics Inc., of Irvine, Calif., said it changed its name to Eledon Pharmaceuticals Inc. (NASDAQ:ELDN) to reflect its new focus on transplantation and autoimmune diseases.
Oncorus Inc., of Cambridge, Mass., said it signed a 15-year lease to build a state-of-the-art, 88,000-square-foot GMP viral immunotherapy clinical manufacturing facility in Andover, Mass.
Taysha Gene Therapies Inc., of Dallas, said it signed a multiyear collaboration with Allstripes (formerly RDMD), a health care technology company working in the rare disease space, in which Taysha will use Allstripes’ platform to inform its understanding of SURF1-associated Leigh syndrome natural history and burden of disease, as well as patients’ diagnostic journeys. The collaboration will focus on advancing the development of TSHA-104, an AAV9-based gene therapy product candidate. An IND for TSHA-104 in SURF1-associated Leigh syndrome is expected to be submitted to the FDA in 2021.
Wize Pharma Inc., of Hod Hasharon, Israel, said it completed its transactions with Bonus Biogroup Ltd., a Haifa, Israel-based company applying technology to supply tissue-engineered viable bone grafts. Wize and Bonus entered a strategic transaction in January 2020, in which Bonus had issued to Wize new ordinary shares of Bonus and placed additional Bonus shares in escrow together with funds invested by Wize. Those shares and funds were to be released pending, among other things, an uplisting of Bonus to Nasdaq. According to the addendum, Wize agreed to amend certain provisions in the original transaction, including waiving the Nasdaq milestone. In consideration, Wize received about 3 million additional Bonus shares that, together with the 5.7 million Bonus shares released to Wize from escrow, are worth approximately $1.3 million.