Alopexx Oncology LLC, of Concord, Mass., said it inked an exclusive license agreement with Beijing Shenogen Pharma Group, of Beijing, to develop and commercialize DI-Leu16-IL2 (anti-CD20-IL2 immunocytokine) in China and other parts of Asia. Alopexx is set to receive an up-front payment and development and commercial milestones, amounts undisclosed, along with sales royalties. The antibody-cytokine fusion protein, or immunocytokine, is in development to treat B-cell lymphoma.
Arcturus Therapeutics Holdings Inc., of San Diego, said it is partnering with Duke-NUS Medical School, a collaboration between Duke University and the National University of Singapore, to develop a vaccine to treat the coronavirus COVID-19 for Singapore. The alliance will employ the company’s STARR technology, which combines self-replicating RNA with LUNAR – a nanoparticle nonviral delivery system – to produce proteins inside the human body, together with a platform developed at Duke-NUS allowing rapid screening of vaccines for effectiveness and safety. The STARR technology is expected to produce a vaccine response at lower doses than traditional mRNA vaccines, potentially enabling treatment of more people with a single GMP-manufactured production batch. Financial terms were not disclosed.
Cellect Biotechnology Ltd., of Tel Aviv, Israel, said it concluded, subject to definitive agreements, a commercial binding letter of intent (LOI) with Canndoc Ltd., of Herzliya, Israel, covering rights to use Canndoc products to reduce opioid usage, including accumulated data and ongoing trials. Canndoc, a pharma-grade medical cannabis producer and wholly owned subsidiary of Israeli medical device company Intercure Ltd., also agreed to supply Cellect over five years a minimum of six tons of GMP pharma-grade cannabis products valued at $18 million. Cellect retained an option to extend the agreement for an additional five years. In exchange, Cellect agreed to issue Canndoc approximately 1 million American depositary receipts (ADRs) representing 19% of Cellect's share capital on a partially diluted basis. In addition to the commercial LOI, the companies inked a nonbinding LOI for a merger that calls for Cellect to acquire Canndoc’s outstanding shares from Intercure in exchange for additional Cellect ADRs totaling approximately 95% (93% on a fully diluted basis) of the merged company. The companies aim to close the proposed deal in the second quarter of 2020, subject to definitive agreement, board approval and customary closing conditions, including approval of the Israeli Medical Cannabis Agency and Cellect's shareholders. They also agreed to cooperate in fulfilling the requirements for Cellect to continue to trade on Nasdaq, with Intercure committing to invest at least $3 million in cash in any public offering that Cellect may undertake, at a price equal or exceeding $4.50 per ADR. On March 4, Cellect’s ADRs (NASDAQ:APOP) gained 94 cents to close at $3.03.
Generex Biotechnology Corp., of Miramar, Fla., said it signed a contract covering the use of computational tools developed by Epivax Inc., of Providence, R.I., to predict epitopes that can be used to generate peptide vaccines against the nCOV-2019 coronavirus using Ii-Key technology from Nugenerex Immuno-Oncology (formerly Antigen Express Inc.), a wholly owned Generex subsidiary. Using epitopes predicted by Epivax, which identified “hot spots” in the amino acid sequences of the nCOV-2019 coronavirus proteins, Generex plans to manufacture a series of synthetic amino acid peptides that mimic those epitopes and send them to China, where they’ll be tested for reactivity against blood samples collected from individuals who recovered from COVID-19. The program aims to select the best Ii-Key hybrid peptides to create a commercially viable vaccine to proceed to human testing.
Insmed Inc., of Bridgewater, N.J., said discussion of the clinical management of common respiratory adverse events associated with Arikayce (amikacin liposome inhalation suspension), based on a survey of patients with refractory Mycobacterium avium complex lung disease, were published in Open Forum Infectious Disease. The patient-directed study, conducted at Emory University and Louisiana State University Health Science Center Clinics, suggested the application of techniques communicated by treating physicians and practiced by patients were generally effective in improving common respiratory events such as dysphonia, increased sputum production, increased cough and dyspnea. Symptom management techniques included intake of soothing fluids, gargling with warm water and mouth rinsing following nebulizer treatment. Additionally, changing the time of Arikayce administration to evening, optimizing airway clearance and managing bronchodilator use generally yielded positive effects.
Mallinckrodt plc, of Staines-upon-Thames, U.K., had a complaint filed against it by the U.S. Department of Justice in the U.S. District Court for the District of Massachusetts. The complaint claims that the company's Mallinckrodt ARD LLC unit, formerly known as Mallinckrodt ARD Inc. and previously Questcor Pharmaceuticals Inc., violated the False Claims Act by underpaying Medicaid rebates on Acthar Gel. The government claims that Acthar Gel was marketed before 1990, but the company avoided paying inflationary rebates by basing the rebates on the price in 2013 because the company had raised the price of Acthar Gel by more than $20,000 per unit prior to 2013. In separate news, Mallinckrodt published results of a retrospective analysis of 92 patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) or dermatomyositis/polymyositis (DM/PM) treated with Acthar Gel in Open Access Rheumatology: Research and Reviews. The most frequent reasons patients started treatment with Acthar Gel were inadequate response to prior therapies, acute exacerbation or flare of disease and need for an alternative therapy. Of the 57 patients with data on physician impression change, 78.1% of patients with RA, 94.7% of patients with SLE and 66.7% of patients with DM/PM had a rating of improved. The mean time to best impression of change was 3.4 months for RA, 4.3 months for SLE and 3.4 months for DM/PM.
Merck & Co. Inc., of Kenilworth, N.J., and the Walter and Eliza Hall Institute of Medical Research published research on the discovery of a novel class of antimalarial agents in Cell Host & Microbe. The class of drugs inhibits both plasmepsins IX and X, two proteases in the malarial parasite, Plasmodium falciparum. The most potent drug in the class, WM-382, cured mice of P. berghei, which causes malaria in rodents, and prevented blood infection in the liver. The drug was also effective against P. falciparum asexual infection in humanized mice and prevented transmission to mosquitoes.
Morphosys AG, of Planegg, Germany, and Incyte Corp., of Wilmington, Del. said their deal to develop and commercialize Morphosys' tafasitamab received antitrust clearance.
Nascent Biotech Inc., of San Diego, plans to test pritumumab, its monoclonal antibody targeting vimentin, as a treatment for COVID-19. Cell surface vimentin has been previously hypothesized as a potential target for the treatment of coronavirus infections.
Respirerx Pharmaceuticals Inc., of Glen Rock, N.J., paid $2,500 for a six-month option to license GABA(A) receptor allosteric neuromodulator intellectual property from the UWM Research Foundation Inc., which is affiliated with the University of Wisconsin-Milwaukee. A condition of the option requires the company to secure a contractual commitment of at least $1 million of aggregate financing.
Synedgen Inc., of Claremont, Calif., was awarded a combined $1 million from the Defense Health Agency (DHA) Small Business Innovation Research Program and additional research funds from the DHA. The funds will be used to commercialize Synedgen's Synepure Wound Cleanser and Catasyn Advanced Technology Wound Hydrogel and to run a clinical trial comparing them to the current standard of care in patients with partial thickness (second-degree) burns.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, started development of TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune globulin product to treat high-risk individuals with COVID-19. The drug will be made from plasma of patients who have successfully recovered from the disease. The company is also testing currently-marketed and pipeline products in its portfolio as potential treatments for COVID-19. In separate news, Takeda completed its sale of a portfolio of products to Stada Arzneimittel AG, of Bad Vilbel, Germany, for $660 million.
Voluntis SA, of Paris, and Bristol-Myers Squibb Co., of New York, are collaborating to develop digital therapeutic solutions for cancer patients. The project involves creating a mobile app that will support management of patients' symptoms and allow for remote monitoring by health care providers. Financial terms of the deal weren't disclosed.