4Teen4 Pharmaceuticals GmbH, of Berlin, said preclinical data showed its therapeutic antibody, procizumab, restored heart function in life-threatening cardiac depression induced by sepsis by inhibiting the cardiac depressant factor DPP3. In the randomized, controlled study, procizumab immediately and significantly improved heart function by increasing cardiac output, stroke volume and left ventricular shortening fraction, the company said. Inactivating DPP3 fully restored cardiac contraction and improved survival. Procizumab is a humanized monoclonal antibody in preclinical development specifically binding circulating DPP3.
7 Hills Pharma Inc., of Houston, said it was awarded a two-year, $2 million Small Business Innovation Research grant from the U.S. NIH’s National Cancer Institute. The funding will support phase I trials of 7HP-349, an oral small-molecule immunostimulant designed to improve effectiveness of immunotherapies such as immuno-oncology drugs and infectious disease vaccines. 7HP-349 is part of 7 Hill’s platform of small-molecule integrin activators promoting cell adhesion to boost immune system activation.
Cantabio Pharmaceuticals Inc., of Palo Alto, Calif., said the Michael J. Fox Foundation for Parkinson’s Research awarded the company a grant to support its ongoing DJ-1-focused biomarker research program aiming at allowing early diagnosis and tracking the progress of Parkinson’s disease (PD). The project targets DJ-1, a protein genetically linked to early-onset of familial PD that acts as a vital defensive protein, protecting cells from damage caused by biochemical stress such as oxidative and glyoxal stress and protein aggregation.
The Russian Direct Investment Fund (RDIF) and Dr. Reddy's Laboratories Ltd., of Hyderabad, India, said they agreed to cooperate on trials and distribution of Sputnik V COVID-19 vaccine in India. Upon regulatory approval in India, RDIF agreed to supply 100 million doses of the vaccine, a COVID-19 Spike glycoprotein modulator, to Dr. Reddy's.
Enzolytics Inc., of Plano, Texas, said it executed a nonbinding letter of intent to merge with Bioclonetics Immunotherapeutics Inc., of Dallas. Bioclonetics is in the final stage of development of a parent monoclonal antibody (MAb) that is non-toxic and has shown in initial in vitro testing to be effective against more than 95% of all strains and viral subtypes of HIV-1 against which it has been tested, the company said. The Bioclonetics recombinant MAbs will be combined with the Enzolytics' compound ITV-1, which is a suspension of inactivated pepsin fragment (IPF) that studies have shown is effective in treating HIV. IPF is the active drug substance of ITV-1 and is a purified extract of porcine pepsin.
Greenlight Biosciences Inc., of Boston, said it received a $3.3 million grant from the Bill & Melinda Gates Foundation to develop new mRNA-based gene therapies for sickle cell disease and other global health needs. Greenlight also said it plans to develop a gene editing platform to address a variety of diseases affecting underserved patient populations, such as treating HIV in developing countries.
Havn Life Sciences Inc., of Vancouver, British Columbia, said it can now list its common shares on the Frankfurt Stock Exchange under the trading symbol 5NP. The company's shares are cross-listed on the Canadian Securities Exchange and the Frankfurt exchange. Havn focuses on standardized, quality-controlled extraction of psychoactive compounds from plants and fungi, and developing natural health care products from non-regulated compounds.
Histogen Inc., of San Diego, said it was awarded a $2 million grant by the Peer Reviewed Orthopedic Research Program of the U.S. Department of Defense to help fund a phase I/II trial of human extracellular matrix candidate HST-003 for regeneration of cartilage in the knee. The trial is designed to evaluate HST-003 in combination with a microfracture procedure in 15 civilian and military patients with recent focal cartilage defects in the knee caused by injury. In addition to safety parameters, endpoints will include traditional scores for pain and joint function from The Knee Injury and Osteoarthritis Outcome Scores and The International Knee Documentation Committee, as well as an MRI to quantify cartilage regeneration.
Hookipa Pharma Inc., of New York, said data published in OncoImmunology showed systemic administration of HB-201, an arenavirus vector-based immunotherapy for human papillomavirus 16 (HPV16)-positive cancers, resulted in dose-dependent induction of a robust, systemic cytotoxic T-cell response directed against HPV16 proteins, as well as tumor infiltration of HPV16-specific cytotoxic T cells. It also showed significantly delayed tumor growth or complete tumor clearance accompanied with prolonged survival. Mice that have cleared tumors post-HB-201 administration developed long-term protection, as demonstrated by the rejection of re-administered tumors. Furthermore, the combination of HB-201 with a checkpoint inhibitor increased the antitumor efficacy, with more than 77% of treated mice clearing established tumors.
Inflammasome Therapeutics Inc., of Newton, Mass., said it was awarded a $1 million grant to develop a long-term bioerodible birth control implant. The grant, funded by the Bill & Melinda Gates Foundation, covers the development of test devices and preclinical studies. The implant will be designed to be injected under the skin and provide a constant and consistent low plasma level of the hormone levonorgestrel for a period of 1.5 to two years.
Inmune Bio Inc., of La Jolla, Calif., said it received a $2.9 million Small Business Innovation Research grant from the U.S. NIH, of which (subject to the terms of the grant) the company will receive $739,739 this year, $1.2 million next year with the balance to be received in 2022. The grant will support a phase II study of XPro-1595, a selective inhibitor of soluble TNF, in patients with treatment-resistant depression.
Janone Inc., of Las Vegas, in an update regarding its initiatives to pursue a strategic alternative process for its legacy businesses first announced in June 2020, said it has received interest from third parties with respect to the sale of its legacy recycling business and is currently reviewing those opportunities. The company is focused on advancing clinical candidate JAN-101 to treat peripheral artery disease, as well as pursuing the drug’s potential to treat vascular complications related to COVID-19.
Nanoviricides Inc., of Shelton, Conn., said it nominated a clinical drug candidate for the treatment of COVID-19. Identified as NV-CoV-1-R, the drug is made up of a nanoviricide found to possess broad-spectrum anti-coronavirus activity (NV-CoV-1), with remdesivir (Gilead Sciences Inc.) encapsulated inside the core of NV-CoV-1. Nanoviricides said the combined attack enabled by NV-CoV-1-R on the virus could prove to be a cure for the infection and the disease, provided that the necessary dosage level can be attained without undue adverse effects. The company is now working on performing required safety pharmacology studies and completing an IND application for NV-CoV-1-R.
Octimet Oncology NV, of Geel, Belgium, said it licensed the greater China rights for lead compound OMO-1 and a second preclinical asset exclusively to Shanghai Allist Pharmaceuticals Co. Ltd., of Shanghai. OMO-1 is an oral, selective small-molecule MET kinase inhibitor that has demonstrated single-agent and combination activity in a range of preclinical cancer models. Allist will drive the clinical development of the compound in China, initially focusing on expanding the combination data with Allist's third-generation EGFR tyrosine kinase inhibitor, furmonertinib (AST-2818). Financial terms of the deal were not disclosed.
Oncbiomune d/b/a Theralink Technologies Inc., of Golden, Colo., said it formed a translational research collaboration with Biomed Valley Discoveries Inc., of Kansas City, Mo., to provide laser capture microdissection and reverse phase protein array services for Biomed’s ERK 1/2 inhibitor, ulixertinib (BVD-523), including phosphoproteomic profiling in ulixertinib-treated preclinical models and interrogation of putative compensatory feedback mechanisms after drug target inhibition. Financial terms were not disclosed.
Pfizer Inc., of New York, reported preclinical data from a study in human cells showing antiviral drug candidate PF-00835231 may be at least as potent as the drug remdesivir (Gilead Sciences Inc.) in blocking the reproduction of the virus that causes COVID-19. In preliminary research conducted by NYU Grossman School of Medicine and Pfizer, PF-00835231 was shown to block the action of the viral enzyme 3CLpro (Mpro). That protease cuts up precursors into working proteins necessary for the reproduction of the SARS-CoV-2 virus. In one set of cell culture experiments, PF-00835231 was statistically more potent in blocking the replication of the pandemic virus (it took 3.3 times more remdesivir than PF-00835231 to fully suppress replication). In a second model (a 3D reconstruction of the human airway), researchers found that both treatments were equally effective at blocking viral replication. Data were posted online on the pre-print server bioRxiv.
Poseida Therapeutics Inc., of San Diego, presented data at the CAR-TCR Digital Week 2020 meeting relating to its manufacturing process designed to optimize its CAR T product candidates. Utilizing its Piggybac DNA Modification System, Poseida said its nonviral manufacturing process can produce highly purified CAR T treatment candidates comprising a high percentage of stem cell memory T, or TSCM, cells. Those high-TSCM product candidates may improve therapeutic response and tolerability profile as compared to existing CAR T therapies using viral-based manufacturing methods. The company was able to demonstrate increased transposition frequency by using Nanoplasmid technology licensed from Nature Technology Corp., which, when compared to a standard plasmid, yields more CAR-positive cells at the start of the process. In turn, that reduces manufacturing timelines, has resulted in a higher proliferative capacity in patients, and has the potential to create more efficacious CAR T products with less toxicity, Poseida said.
Revive Therapeutics Ltd., of Toronto, said its expanded access protocol (EAP) for compassionate use of bucillamine to treat COVID-19 in the U.S. received IRB approval. Revive expects to begin enrolling patients in September 2020 in the compassionate use program, a multicenter, open-label study in hospitalized individuals with severe coronavirus infection that is designed to complement the company’s U.S. phase III COVID-19 study. The EAP for compassionate use provides physicians with access to bucillamine, a xanthine oxidase inhibitor, under Revive’s existing IND application for COVID-19.
Revolution Medicines Inc., of Redwood City, Calif., reported data showing that its KRAS G12D inhibitors induced decreases in tumor volume in a xenograft model of human pancreatic cancer carrying an oncogenic KRAS G12D mutation. The antitumor activity was observed across multiple dose levels, which were well-tolerated. The findings on the K-Ras GTPase inhibitor program, currently in lead optimization, were reported at the 2nd annual RAS-Targeted Drug Development Conference.
Seqirus Inc., of Summit, N.J., said real-world evidence on its cell-based quadrivalent influenza vaccine (QIVc), published in Vaccine, suggested the product was more effective than standard, egg-based quadrivalent vaccine (QIVe-SD) in preventing influenza-related hospitalization and emergency room (ER) visits, all-cause hospitalizations and hospitalizations/ER visits related to serious respiratory events. Study participants included commercially insured U.S. individuals 4 to 64 years of age during the 2017-18 influenza season. In a secondary economic analysis, the study found that QIVc was associated with lower all-cause health care resource utilization compared with QIVe-SD.
Springworks Therapeutics Inc., of Stamford, Conn., said it is providing support for a phase II study sponsored by the Children’s Oncology Group evaluating nirogacestat, its gamma secretase inhibitor candidate, to treat children and adolescents with progressive, surgically unresectable desmoid tumors. Springworks also said investigators at the University of Minnesota and the Dana-Farber Cancer Institute reported in Pediatric Cancer & Blood that four pediatric and young adult desmoid tumor patients who received nirogacestat under the company’s expanded access program showed a clinical response. After a median of 13.5 months on treatment, three experienced a durable benefit (one complete response, one partial response and one stable disease) and one had an initial partial response followed by disease progression.
Synaffix BV, of Amsterdam, said trastuzumab-based antibody-drug conjugates (ADCs) prepared using its Syntecan E linker-payload showed an efficacy profile equivalent to trastuzumab deruxtecan (Enhertu, Astrazeneca plc/Daiichi Sankyo Co. Ltd.)-based ADCs in a mouse BT-474 xenograft study. Following a single dose, both HER2-targeting ADCs, which have the same drug-to-antibody ratio and were administered at the same dose, achieved complete tumor regression. Syntecan E is an exatecan-based linker-payload that contains the company’s Hydraspace polar spacer technology, a conventional dipeptide cleavable linker, and was conjugated in that study to the native antibody glycan using the company’s Glycoconnect technology. A poster of the data is slated for presentation on Sept. 17 at the World ADC Digital conference.
Tiziana Life Sciences plc, of London, said it plans to spin out its Stemprinter asset into an independently listed public company named Accustem Sciences Ltd. and to provide the entity with $1.3 million in cash. Stemprinter is a genomic signature-based assay for the prognosis of early and late recurrence of ER+/HER2 breast cancer in early stage breast cancer patients. Accustem expects to begin the process of seeking CE Mark approval for the technology in November 2020, with anticipated commercialization in the EU in the second quarter of 2021, followed by filings with the FDA. Tiziana plans to meet with shareholders on Oct. 2 to vote on the planned action. To effect the transaction, the company said it will distribute a 1-to-1 share dividend to shareholders of record at 7 a.m. London time on Oct. 30. By year-end 2020, Accustem Sciences intends to list on the London Stock Exchange, with a potential dual listing in 2021 on Nasdaq.
Transcenta Biomedical (Shanghai) Co. Ltd., of Suzhou, China, said it scaled up its continuous perfusion process to 200 liters and completed GMP production of a bispecific antibody for a phase I study. The company has disclosed four bispecific assets, including TST-001, a claudin 18 inhibitor in a phase I study in the U.S. and China in metastatic solid tumors.
Yufan Biotechnologies Co. Ltd., of Xi'an, China, said it agreed to a three-year partnership with Abound Bio Inc., of Pittsburgh, Pa., covering the incorporation of antibodies to cancer targets into an enhanced HPK1-inhibited CAR T-cell platform. The agreement covers 10 cancer targets, with shared inventorship and development rights. Financial terms were not disclosed.