Arcus Biosciences Inc., of Hayward, Calif., and Taiho Pharmaceutical Co. Ltd., of Tokyo, said the latter exercised its option to exclusively license zimberelimab, an anti-PD-1 monoclonal antibody, from Arcus for commercialization in Japan and certain other territories in Asia (excluding China). It marks Taiho’s second exercise of an Arcus program and follows a 2018 decision to license AB-928, a dual A2a/A2b adenosine receptor antagonist in the clinic. Financial terms of the deal were not disclosed.
Dialectic Therapeutics Inc., of Dallas, said it received a $3 million seed award for product development research from the Cancer Prevention & Research Institute of Texas. Dialectic will use the funding to further the development of its lead product candidate, DT-2216, a compound built using its APTaD (antiapoptotic protein targeted degradation) technology. In preclinical studies, DT-2216 selectively induces cancer cells to degrade B-cell lymphoma extra large, or BCL-XL, stimulating the cells to commit suicide or become more susceptible to chemotherapy. The product is currently in the IND-enabling phase for use as a single agent or as part of a combination therapy in hematologic cancers.
Novavax Inc., of Gaithersburg, Md., updated its efforts to develop a novel vaccine to protect against coronavirus disease COVID-19. Novavax has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing, which is expected to begin by the end of spring 2020. The candidate was created using the firm’s recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax expects to utilize its Matrix-M adjuvant with its COVID-19 vaccine candidate to enhance immune responses. In separate news, the company said research published in Vaccines describes the immunogenic potential of Nanoflu, the firm’s recombinant seasonal influenza vaccine candidate adjuvanted with Matrix-M, highlighting the potential for Nanoflu to offer broadly protective immunity and improved vaccine efficacy. Top-line data from the company’s ongoing phase III trial are expected late this quarter. Shares of Novavax (NASDAQ:NVAX) gained $1.27, or 16%, to close Feb. 26 at $9.22.
Promis Neurosciences Inc., of Cambridge, Mass., along with Toronto Memory Program, a Canadian memory clinic, said it started a pilot longitudinal study to assess the level of blood-based biomarkers in early Alzheimer’s disease (AD) with the support of Parexel, a clinical research organization. Promis will leverage Parexel’s data management and CNS expertise for the study, which it will use as the historical control arm for its anticipated phase I study of PMN-310, an antibody that selectively targets the toxic oligomeric species of amyloid beta. Promis said the dataset will help it detect a treatment signal as early as phase I, potentially allowing for rapid proof of concept at a fraction of the expense associated with traditional clinical trials. The dataset will be made available as a communal resource for AD researchers.
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it acquired Pvp Biologics Inc., of San Diego, following the conclusion of a phase I proof-of-mechanism study testing TAK-062 (Kuma-062), a super glutenase compound, for the treatment of uncontrolled celiac disease. The two firms entered a development and option agreement in early 2017, under which Pvp was responsible for conducting research and development through phase I in exchange for funding by Takeda related to a predefined development plan. Takeda has now exercised its option to acquire Pvp for a prenegotiated up-front payment as well as development and regulatory milestones totaling up to $330 million. Data from the phase I study showed the ability of TAK-062 to degrade ingested gluten in healthy volunteers, and Takeda plans to submit the results for presentation at an upcoming medical congress. The addition of TAK-062 adds to Takeda’s pipeline targeting celiac disease. The company previously reported phase IIa data for another drug, TAK-101, demonstrating T-cell response suppression, suggesting that it may induce tolerance to gluten in patients with celiac disease by immune uptake of proprietary nanoparticles loaded with gliadin proteins, a disease-specific antigen.
Tonix Pharmaceuticals Inc., of New York, said it entered a collaboration with Southern Research to support the development of a vaccine, TNX-1800 (live modified horsepox virus vaccine for percutaneous administration), to protect against the new coronavirus disease, COVID-19, based on Tonix’s horsepox vaccine platform. Tonix is developing TNX-801 (live horsepox virus vaccine for percutaneous administration) as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a monkeypox preventing vaccine. The new research collaboration will develop and test a potential horsepox vaccine that expresses protein from the virus that causes COVID-19 to protect against the disease. Under the terms, Southern Research will test one or more vaccine constructs in the Tonix horsepox vector that express one or more proteins or protein fragments from the virus that causes COVID-19, starting with TNX-1800.