Adma Biologics Inc., of Ramsey, N.J., said it started a collection of convalescent plasma through its wholly owned subsidiary, Adma Biocenters Georgia Inc., from individuals who have recovered from COVID-19. The company is seeking U.S. citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. Adma is a member of the CoVIg-19 Plasma Alliance, established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19.
Beigene Ltd., of Beijing, said it signed an exclusive distribution agreement for Medison Pharma Ltd., of Petach Tikva, Israel, to commercialize its BTK inhibitor, Brukinsa (zanubrutinib), in Israel. In addition, a new drug application has been submitted in Israel for Brukinsa for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
Beximco Pharmaceuticals Ltd., of Dhaka, Bangladesh, a manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, said it launched remdesivir (under the brand name Bemsivir), an antiviral drug, which has been recently granted emergency use authorization by the FDA for the treatment of COVID-19. The company said it is the first in the world to launch a generic version of remdesivir for the treatment of COVID-19. The launch follows the granting of an emergency use authorization by the Directorate General of Drug Administration, the regulatory authority in Bangladesh, for remdesivir I.V. injection.
I-Mab Biopharma Co. Ltd., of Shanghai, and Genexine Co. Ltd., of Seoul, South Korea, said they expanded their agreement to include development of TJ-107/Hyleukin-7 (efineptakin alfa), a long-acting recombinant human interleukin-7, in glioblastoma multiforme. The companies received regulatory clearance in China for a phase II study in lymphopenic patients with newly diagnosed disease. Under the terms of the expanded collaboration, I-Mab will be mainly responsible for conducting the clinical trial in China, and Genexine will share the development strategies, data and costs for success of the clinical trial. Financial terms are not disclosed.
IMV Inc., of Dartmouth, Nova Scotia, said, based on positive preclinical results demonstrating robust immunogenic and antibody responses, it has selected multiple peptide epitopes to be formulated within its DPX platform to form a vaccine candidate against the novel coronavirus, DPX-COVID-19. In preclinical animal models, the company evaluated all 23 peptides formulated within the DPX platform. The majority of peptide epitopes tested generated targeted antibody responses after the first and second dose, without requiring an adjuvant.
KBP Biosciences Inc., of Princeton, N.J., said safety and pharmacokinetic (PK) results from a PK study of its lead product candidate, KBP-5074, a nonsteroidal mineralocorticoid receptor antagonist (MRA), in patients with severe chronic kidney disease (CKD) has been published online in MedRxiv. The compound is in development to treat uncontrolled hypertension in patients with stage 3B and 4 CKD. The study was conducted in patients with severe CKD with and without hemodialysis. The objective was to evaluate the safety and PK of single oral doses of 0.5 mg KBP-5074 in both groups and evaluate the effect of hemodialysis on PK profile. The overall plasma exposure of KBP-5074 was lower in patients receiving hemodialysis, which did not directly alter the drug concentration. Plasma aldosterone and serum potassium concentrations were generally comparable between the two groups.
Kleo Pharmaceuticals Inc., of New Haven, Conn., and Celularity Inc., of Warren, N.J., a developer of allogeneic natural killer (NK) cell therapies, said they entered a preclinical research collaboration to advance synergistic combinations of each company’s technology platform as potential treatments for COVID-19 and multiple myeloma. Earlier this year, Kleo received IND authorization from the FDA to test its CD38-targeting antibody recruiting molecule (ARM) in combination with autologous NK cells in a clinical study. Celularity also received FDA authorization to evaluate one of its allogeneic NK cell products, CYNK-001, in COVID-19-infected adults. When used in combination with NK cells, ARM molecules behave similarly to chimeric antigen receptors, though their synthetic nature eliminates the need for genetic engineering.
Nanomab Technology Ltd., of London, said it is collaborating with Germany's University Hospital Aachen to initiate a cancer therapy program to develop Nanomab's NM-02 radiopharmaceutical for HER2-positive breast cancer. The partners are targeting a first-in-human administration for the fourth quarter.
Orion Corp., of Espoo, Finland, said it has received €28 million (US$30.8 million) in total milestone payments from Leverkusen, Germany-based Bayer AG tied to the first commercial sales of Nubeqa (darolutamide), an androgen receptor antagonist the companies jointly developed for the treatment of non-metastatic castration-resistant prostate cancer. Orion said the payments, €20 million tied to initial EU sales and €8 million tied to initial Japan sales, had already been included in its financial guidance.
Progenabiome LLC, of Malibu, Calif., said it is starting two FDA-approved clinical trials that include hydroxychloroquine. A phase II study sponsored by the genetic research sequencing lab is testing whether treatment with a combination of hydroxychloroquine, vitamin C, vitamin D and zinc can prevent symptoms of COVID-19. Another phase II trial will treat people with confirmed cases of COVID-19 with the same interventions, plus azithromycin, to measure rate of recovery, among other outcomes. Neither study was listed as recruiting yet.
Sorrento Therapeutics Inc., of San Diego, said it has established terms for an exclusive license to San Diego-based Acea Therapeutics Inc.'s tyrosine kinase inhibitor, abivertinib, across all indications for all territories outside of China. Final terms of the license will be set forth in a definitive agreement to be entered between the parties, Sorrento said. The candidate has already been tested in patients with non-small-cell lung cancer and B-cell malignancies in China. Sorrento said promptly following the execution of the license agreement, it expects to meet with the FDA to discuss available data on the candidate and the path forward to seek approval for oncology indications.
Sutrovax Inc., of Foster City, Calif, changed its name to Vaxcyte Inc. The company expects to submit an investigational new drug application for VAX-24, its lead vaccine candidate that was formerly referred to as SVX-24, to the FDA in the second half of 2021 to evaluate it for the prevention of invasive pneumococcal disease. The company is also working on a prophylactic vaccine to prevent group A strep infections, now called VAX-A1, and a therapeutic vaccine to treat periodontal disease, now called VAX-PG.
Synlogic Inc., of Cambridge, Mass., said it terminated its collaboration to develop synthetic biotic medicines to treat inflammatory bowel disease (IBD) with North Chicago-based Abbvie Inc. Synlogic regains all rights to develop those and new synthetic biotic medicines for all effectors targeting IBD. Synlogic also regains the rights to partner its IBD programs. Synlogic had provided Abbvie with an exclusive option to acquire a Synlogic subsidiary, which would have an exclusive worldwide license to develop and commercialize synthetic biotic medicines to treat IBD. Abbvie had agreed to pay Synlogic an up-front $2 million and up to $16.5 million upon the achievement of certain research milestones.
Takara Bio Inc., of Kusatsu, Japan, and AGC Biologics, a contract development and manufacturing organization based in Søborg, Denmark, will collaborate on a prophylaxis DNA vaccine, with AGC manufacturing the vaccine’s plasmid DNA intermediate. The vaccine will be developed based on Osaka University and Anges Inc.'s expertise of developing plasmid DNA products.
In an open letter, Washington-based Vanda Pharmaceuticals Inc. CEO Mihael H. Polymeropoulos recommended sharing clinical trial data. “The reason for sharing of clinical data includes allowing the scientific community to independently form their own conclusions from their own analyses, develop new insights from the data, and accelerate discoveries in the field by not having to repeat the same experiments,” Polymeropoulos wrote. “In the case of remdesivir and COVID-19, this degree of data sharing is even more urgent given the finite amount of time within which a study can be conducted in the face of a declining number of new cases. There are a number of questions that could be answered by the existing remdesivir [National Institute of Allergy and Infectious Diseases] study that remain unanswered by the complete unavailability of the data. For example: Is there a subgroup of patients that performed better than others? Is this subgroup of a certain characteristic, such as age, sex, race, genetic makeup, time since infection, severity of disease, viral load, medication, underlying condition? And there are many others to be answered.”