New data on regeneration, aging and cancer from Agex Therapeutics Inc., of Alameda, Calif., revealed alterations in certain genes that may prevent regeneration from occurring in adults. The data, from the report “Differential Expression of α, β, and γ Protocadherin Isoforms During Differentiation, Aging, and Cancer,” also provide evidence the family of genes may be involved in a wide array of human cancers. The report was published in Biorxiv, from the Cold Spring Harbor Laboratory.
Altimmune Inc., of Gaithersburg, Md., and Basel, Switzerland, said it expanded its manufacturing collaboration with Lonza Group Ltd., which will commission a dedicated manufacturing suite for clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19, at its facility near Houston. In preclinical studies, it was shown to neutralize antibodies and T-cell responses along with mucosal immunity in the respiratory tract.
Aveo Oncology Inc., of Boston, and New York-based Bristol Myers Squibb Co. will collaborate in a clinical trial and a supply agreement to evaluate Fotivda (tivozanib) in combination with anti-PD-1 therapy Opdivo (nivolumab) in the pivotal phase III TiNivo-2 trial in patients with advanced relapsed or refractory renal cell carcinoma (RCC) following prior immunotherapy exposure. Fotivda is an oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor approved for treating adults with relapsed or refractory advanced RCC following two or more prior systemic therapies. The randomized, open-label, controlled study is expected to enroll approximately 326 patients with advanced RCC who have progressed following immunotherapy treatment.
The EMA has begun its review of Cambridge, Mass.-based Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) a gene therapy for beta thalassemia. The review follows a case of acute myeloid leukemia in a patient treated with a related investigational medicine, BB-1111. This medicine uses the same viral vector as Zynteglo.
BPS Bioscience Inc., of San Diego, said it expanded its coronavirus portfolio to study COVID-19 variants. The company said it developed a line of spike pseudotyped lentiviruses produced by using the viral spike protein as an envelope glycoprotein. The spike pseudotyped lentiviruses can be used to measure the activity of neutralizing antibody against SARS-CoV-2, the company added. BPS said its pseudoviruses includes the original wild-type (Wuhan) sequence, the B.1.1.7 (U.K.), B.1.351 (South African) and P.1 (Brazil) variants, as well as versions including only the highly conserved D614G mutation or the three mutations (K417T, E484K, N501Y) in the receptor binding domain of the Brazilian variant.
Cell Source Inc., of New York, said its fully mismatched mouse Veto Cell-based bone marrow transplant protocol durably prevents onset of the pathological parameters of sickle cell disease, including complete conversion to normal, donor-derived red blood cells. The protocol could overcome the lack of suitable donors, treatment toxicities and graft-related challenges, the company added. The study data were published in BMT Journal.
Contrafect Corp., of Yonkers, N.Y, said it was awarded a cost-share contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) and will receive $9.8 million in initial funding and up to an additional $77 million. Initial funding will be used to support Contrafect’s ongoing pivotal phase III DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen Trial) superiority study of exebacase in patients with S. aureus bacteremia, including right-sided endocarditis. BARDA may provide the company additional funding upon achieving key milestones to continue advancement of exebacase through FDA approval and completion of post-approval commitments.
Evolve Biosystems Inc., of Davis, Calif., said its product, activated B. infantis EVC-001, will be used in one of the largest international clinical studies on preventing type 1 diabetes in genetically predisposed children. The randomized, controlled, double-blind, multicenter trial will be conducted across eight research centers in five European countries. The Leona M. and Harry B. Helmsley Charitable Trust is funding the study and the continuation of the established newborn screening with more than $30 million.
Hepatx Corp., of Palo Alto, Calif., Namocell Inc., of Mountain View, Calif., and Takara Bio Inc., of Kusatsu, Japan, completed the second phase of their collaboration on single cell analysis of hepatocyte-like cells differentiated from adipose tissue-derived stromal cells using Namocell's single cell dispensers and Takara Bio's SMART-seq kits to characterize Hepatx's cell therapies for liver disease. The results demonstrated a 95% success rate in single cell isolation and library construction.
The Institute for Clinical and Economic Review released it evidence report assessing the comparative clinical effectiveness and value of Lupkynis (voclosporin) from Victoria, British Columbia-based Aurinia Pharmaceuticals Inc., and Benlysta (belimumab), from Glaxosmithkline plc, of London, for the treatment of lupus nephritis. Despite substantial uncertainty that remains about longer-term use and outcomes with both treatments, their estimated net price in the market is aligned with their anticipated clinical benefits for patients, the institute said.
Immunitybio Inc., of Culver City, Calif., said it is developing an hAd5 ACE2 Decoy therapeutic vaccine to neutralize the SARS-CoV-2 virus, including the E484K and N501Y mutations. Results reported at the recent Conference on Retroviruses and Opportunistic Infections and published on preprint server Biorxiv highlighted development of a recombinant protein construct designed to act as a “decoy” human angiotensin converting enzyme 2 (ACE2) receptor that would compete with ACE2 on cells of the respiratory tract to bind the receptor binding domain (RBD) of the SARS-CoV-2 spike protein. Findings showed the ACE2 Decoy not only maintains its high affinity for S RBD expressing the E484K and N501Y mutations, but shows enhanced affinity for S RBD expressing the N501Y or L452R mutations and the highest affinity for S RBD expressing both the E484K and N501Y mutations. The candidate warrants continued development, beginning with testing in challenge studies, the company said.
The clinical and scientific team of Intrommune Therapeutics Inc., of New York, participated in the virtual 2021 annual meeting of the American Academy of Allergy, Asthma & Immunology. Findings included data from an investigational study1 of peanut allergic toddlers with sublingual immunotherapy (SLIT), which is the daily placement under the tongue of liquid drops containing peanut protein. After a period of gradually increasing doses, children were treated with 4 mg per day of liquid peanut protein for a total of three years. Treated subjects increased the threshold of peanut protein they could safely consume by more than 30-fold (median of 4,443 mg protein tolerated after treatment). There was no need for epinephrine use with SLIT in this study. The results suggest that targeting the oral mucosa with SLIT is at least on par with previous studies of daily ingestion of powder peanut protein.
NLS Pharmaceutics Ltd., of Stans, Switzerland, signed a licensing deal with Novartis AG, of Basel, Switzerland, whereby the former has obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex (mazindol) submitted to the FDA in February 1972. The agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all postmarketing clinical studies and periodic safety reports from 1973 forward. The drug is approved for the management of exogenous obesity as a short-term adjunct in a regimen of weight reduction based on caloric restriction in certain patients.
Persephone Biosciences Inc., of San Diego, started the 10,000-person, non-interventional Voices study to determine specific gut microbiota and the metabolic processes that are involved in optimal immune response and function to COVID-19 vaccinations.
Translate Bio Inc., of Lexington, Mass., said it will receive a $25 million payment from Sanofi SA, of Paris, triggered by the start of a phase I/II trial testing mRNA vaccine candidate MRT-5500 in COVID-19.