Acepodia Inc., of San Francisco and Taipei, Taiwan, and JW Therapeutics Co. Ltd., of Shanghai, plan to develop and commercialize ACE-1702 and ACE-1655, cell therapy candidates for treating solid tumors and hematologic malignancies, in mainland China, Hong Kong and Macau. Acepodia will receive up-front and milestone payments plus royalties on sales.
Arch Biopartners Inc., of Toronto, said it signed an unnamed global contract research organization to initiate and conduct a phase II trial for Metablok (LSALT peptide) to treat COVID-19 patients. The study will be a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept trial of LSALT peptide for preventing acute respiratory distress syndrome and acute kidney injury in 60 patients infected with SARS-CoV-2.
Astrazeneca plc, of Cambridge, U.K., said it selected Iqvia to help develop a COVID-19 vaccine. The collaboration is part of the U.S. government Operation Warp Speed. The collaboration is designed to accelerate clinical studies of AZD-1222, formerly ChAdOx1, which is on an accelerated path and supported with $1.2 billion through the federal program. Already part of a phase I/II trial with the University of Oxford, it is set to enter a phase II/III. Astrazeneca signed an $87 million partnership with Emergent Biosolutions Inc., of Gaithersburg, Md., in June and agreed to supply the European Union with 400 million doses with deliveries starting by the end of 2020.
Avita Therapeutics Inc., of Valencia, Calif., said the U.S. Biomedical Advanced Research and Development Authority (BARDA), a part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), will procure the Recell System as part of the HHS mission to build preparedness for public health emergencies. BARDA has agreed to the purchase, storage and delivery of Recell Systems utilizing a vendor-managed inventory plan valued at $7.6 million. Further, BARDA has expanded its awarded contract to provide supplemental funding of $1.6 million to support emergency deployment of Recell for use in mass casualty or other emergency situations. Delivery of Recell Systems under the plan is expected to commence later this calendar year. Recell allows in-theater preparation of a spray-on suspension consisting of cells derived from a small, thin biopsy of a patient's own skin.
Cellink AB, of Gothenburg, Sweden, and Kugelmeiers Ltd., of Erlenbach, Switzerland, forged a distribution partnership to market Cellink Spheroid Kits, which packages Kugelmeiers Sphericalplate 5D for forming standardized spheroids with Cellink’s bioinks. The kits will be distributed globally, except in Japan and Switzerland, through Cellink’s existing marketing and distribution network. When coupled with 3D bioprinting, spheroids can be used for tissue engineering.
Daiichi Sankyo Europe GmbH, of Munich, Germany, released results from five analyses of 12-month data of ETNA-VTE in patients with venous thromboembolism (VTE), a non-interventional, post-authorization safety study evaluating edoxaban (Lixiana). In routine clinical practice in 4,595 (mean age 64) VTE patients, overall rates of bleeding and VTE recurrence were considered low by study investigators' assessment in a range of VTE subpopulations, the company said. A global subanalysis suggested that at 12 months, rates of recurrent VTE were not associated with increasing age, while major bleeding and all-cause mortality increased with age, the company added.
Fate Therapeutics Inc., of San Diego, said it entered an exclusive license agreement with Baylor College of Medicine covering alloimmune defense receptors, a potentially first-in-class approach that renders off-the-shelf allogeneic cell products resistant to host immune rejection. Preclinical studies published in Nature Biotechnology demonstrated that allogeneic cells engineered with a novel alloimmune defense receptor (ADR) are protected from both T- and NK-cell-mediated rejection, and provide proof of concept that ADR-expressing allogeneic cell therapies can durably persist in immunocompetent recipients.
Gilead Sciences Inc., of Foster City, Calif., and Arcus Biosciences Inc., of Hayward, Calif., closed their option and co-development and co-commercialization partnership agreement signed on May 27, triggering a payment of $175 million by Gilead to Arcus. Gilead also made an equity investment in Arcus of about $200 million by purchasing shares at $33.54 each. Gilead now owns nearly 8.2 million shares of Arcus common stock, representing approximately 13% of Arcus’s outstanding shares.
Immunomedics Inc., of Morris Plains, N.J., said it expanded its collaboration with Roche Holding AG, of Basel, Switzerland, to evaluate Trodelvy (sacituzumab govitecan-hziy), Immunomedics’ anti-Trop-2 antibody-drug conjugate, in combination with Tecentriq (atezolizumab), Roche’s PD-L1 checkpoint inhibitor (CPI), in patients with metastatic urothelial cancer (mUC) and metastatic non-small-cell lung cancer (mNSCLC). Roche will conduct two open-label, multicenter, randomized phase Ib/II studies. The study will randomize CPI-naïve mUC patients who failed platinum-containing chemotherapy to receive Tecentriq plus Trodelvy or Tecentriq alone. The second study will enroll CPI-experienced mNSCLC patients after failure with platinum-based regimen to receive either Tecentriq and Trodelvy or docetaxel alone.
Invivoscribe Inc., of San Diego, launched a fully integrated drug development engine. The company in-licensed technology involving a preclinical molecule and associated small molecules from Domainex Ltd., of Saffron Walden, U.K. Invivoscribe will develop and commercialize molecules generated by Domainex as oral immunotherapy agents to treat hematological malignancies, including acute myeloid leukemia. The deal includes an up-front payment and subsequent milestone payments based on various phases of drug development, regulatory submission and commercialization, including royalties on the resulting commercial products.
Lamassu Pharma LLC, of Durham, N.C., received a $1.5 million Small Business Innovation Research grant from the NIH, which the company plans to use for the development of RABI-767, a small-molecule lipase inhibitor, as a treatment for acute pancreatitis.
Merus NV, of Utrecht, the Netherlands and Caris Life Sciences, of Irving, Texas, are collaborating to detect neuregulin 1 fusions in cancer patients. Caris will perform whole exome sequencing of DNA and whole transcriptome sequencing of RNA for potential enrollment of patients in Merus’ phase I/II eNRGy study of zenocutuzumab, a bispecific antibody targeting the neuregulin/HER3 tumor-signaling pathway.
Orgenesis Inc., of Germantown, Md., and Educell Ltd., of Trzin, Slovenia, plan to conduct one or more collaborative cell-based research projects. Orgenesis will contribute its cell and gene therapy platform to develop CAR T and whole cell-based vaccine immunotherapies.
Pascal Biosciences Inc., of Seattle, discovered cannabinoids that block replication of SARS-CoV-2, the novel coronavirus that causes COVID-19. The best cannabinoid had potency similar to remdesivir (Gilead Sciences Inc.) in a cell-based assay. Pascal plans to do more testing on the compounds and hopes to start a clinical trial within a year.
PDS Biotechnology Corp., of Florham Park, N.J., said its collaborator, J. Woodward of the University of Kentucky School of Medicine, was awarded a grant from the National Institute of Allergy and Infectious Diseases’ Collaborative Influenza Vaccine Innovation Centers to support development of its influenza vaccine, PDS-0202.
Revivemed Inc., of Cambridge, Mass., said it is pursuing an evaluation study with New York-based Bristol Myers Squibb Co. designed to leverage Revivemed’s artificial intelligence platform to better understand mechanisms of response and resistance to immunotherapies in patients with cancer.
Sanofi SA, of Paris, and the University of Texas MD Anderson Cancer Center established a five-year collaboration to test Sanofi’s targeted drugs and immunotherapies for patients with cancer using MD Anderson’s clinical trial infrastructure. The first projects are expected to start in the summer of 2020.
Vitro Diagnostics Inc., of Golden, Colo., reported results of the treatment of a critically ill COVID-19 patient treated with Allorx stem cells. After treatment, the patient experienced resolution of multiple organ failure, recovery from coma and restoration of neurological, pulmonary, liver and renal function and was removed from assisted respiration and dialysis.
Xbiotech Inc., of Austin, Texas, published preclinical data on its antibody that blocks interleukin-1 (IL-1) alpha in Circulation. In a stroke model, animals treated with the anti-IL-1 alpha antibody had a 36% reduction in brain damage and retained significantly better neurological function, as measured by activity tests, compared to the non-treated controls.