AB Science SA, of Paris, published preclinical data on its tyrosine kinase inhibitor, masitinib, for the treatment of pancreatic cancer in Cells. Treatment of pancreatic ductal adenocarcinoma tissue resulted in activation of various markers of mast cell activity compared with adjacent normal tissue. Mast cells were strongly associated with angiogenesis in pancreatic cancer tissue. The researchers identified two tissue biomarkers that may be predictive of response to masitinib: density of mast cells positive for tryptase and area of mast cells positive for tryptase.
Aridis Pharmaceuticals Inc., of Los Gatos, Calif., has developed an inhaled monoclonal antibody cocktail that includes AR-711, designed to target the original coronavirus that causes COVID-19, and AR-713 that is designed to neutralize newly emerging variants, including those from South Africa, Brazil and Japan. The company plans to start a phase I/II/III study of the cocktail in the second half of 2021.
Bioatla Inc., of San Diego, published data in the Proceedings of the National Academy of Sciences, on the design and functionality of its CTLA4 antibody candidates that use the company's conditionally active biologic technology. The antibodies are only active in the acidic tumor microenvironment, while binding is reversible in healthy tissue.
Biocardia Inc., of San Carlos, Calif., granted a one-year license to its Helix catheter biotherapeutic delivery product candidates for certain cell types for cardiac indications to an undisclosed Japanese pharmaceutical company. The pharma also has an option to negotiate for a nonexclusive worldwide license. Biocardia will receive $500,000 up front, a portion of which is creditable for biotherapeutic delivery products and support services.
Bio-Techne Corp., of Minneapolis, issued a nonexclusive license to its TcBuster nonviral transposon-based gene delivery system to Luminary Therapeutics Inc., also of Minneapolis. Luminary plans to use TcBuster in LMY-920, its BAFF-CAR-T product, which will be ready for an IND filing with the FDA later this year. Financial terms of the deal weren't disclosed.
Celldex Therapeutics Inc., of Hampton, N.J., said it plans to expand development of CDX-0159, its humanized monoclonal antibody that binds the KIT receptor, into prurigo nodularis (PN). In early clinical trials, CDX-0159 demonstrated profound and durable reductions of plasma tryptase, indicative of systemic mast cell suppression/ablation, and Celldex is evaluating the drug in two ongoing phase Ib trials in chronic spontaneous urticaria and chronic inducible urticaria. By exploring the potential of CDX-0159 to suppress chronic itch and neuroinflammation in PN, Celldex said it believes it may have the opportunity to expand future development to include other chronic pruritic skin conditions and other medically significant conditions driven by itch and neuroinflammation.
Day One Biopharmaceuticals Inc., of South San Francisco, licensed rights to MEK 1/2 inhibitors pimasertib and MSC-2015103B from Merck KGaA, Darmstadt, Germany. Day One plans to combine pimasertib with its pan-RAF kinase inhibitor, DAY-101. Merck will receive an undisclosed up-front payment and is eligible for regulatory, approval and sales-based milestone payments as well as royalties on net sales of pimasertib and MSC-2015103B.
Dublin-based ERS Genomics Ltd. and G+FLAS Life Sciences Inc., of Seoul, South Korea, signed a nonexclusive license agreement granting G+FLAS access to ERS’ CRISPR/Cas9 patent portfolio. G+FLAS produces research tools and reagents under ISO 13485 and ISO 9001 and applies CRISPR PLUS technology to the development of drugs and production of CRISPR genome edited plants in a non-GMO way.
Florica Therapeutics Inc., of San Francisco, said it was awarded a National Science Foundation Small Business Innovation Research grant for $255,678 to study hypothalamus stem cell exosomes for treating COVID-19. The phase I grant is for developing drugs to modulate the immune response for preventing escalation of COVID-19 to acute respiratory distress syndrome. The hypothalamus is crucial to secretion of cortisol and other immune-modulators that dampen the immune response following immune activation, according to Florica.
Mymd Pharmaceuticals Inc., of Baltimore, said new data from a study conducted by the Eurofins Discovery Phenotypic Center of Excellence indicate the potential of MYMD-1 to limit fibrotic biology associated with idiopathic pulmonary fibrosis (IPF). MYMD-1 is a platform based on a clinical-stage small molecule that regulates the immunometabolic system to control TNF-α and other pro-inflammatory cytokines. MYMD-1 is being developed to treat autoimmune diseases, including those currently treated with non-selective TNF-α blocking drugs, and aging and longevity. The company said it plans to test combinations of MYMD-1 with approved fibrosis drugs to determine how the agents interact to impact IPF’s disease biology.
New data from Nabriva Therapeutics plc, of King of Prussia, Pa., and Dublin, documents high rates of macrolide-resistant Streptococcus pneumoniae throughout the U.S. and demonstrated that macrolide resistance in S. pneumoniae is greater than 25% in most regions of the country and 39.5% overall. The retrospective cohort study assessed 3,626 patients with a positive S. pneumoniae blood or respiratory culture evaluated between October 2018 and September 2019 at 329 hospitals across nine U.S. census geographic regions. Macrolide resistance was observed in 47.3% of S. pneumoniae obtained from respiratory cultures and 29.6% from blood cultures. While the overall rate of macrolide resistance was 39.5%, macrolide resistance in respiratory isolates was ≥25% in all regions of the U.S. In addition, higher rates of macrolide resistance were seen among ambulatory patients (45.3%) as compared with inpatients (37.8%). Nabriva is developing anti-infective agents.
In a new study, Nicox SA, of Sophia Antipolis, France, demonstrated preclinical intraocular pressure (IOP)-lowering results on a new class of non-prostaglandin analogue (PGA), nitric oxide (NO)-donating compounds. Increased IOP is a principal risk factor of open-angle glaucoma. The NO-mediated IOP-lowering effect in the new class of compounds is enhanced by concomitant action of phosphodiesterase type-5 inhibition within the same molecule, the company said. The study focuses on NCX-1741, an analogue of Nicox’s development candidate, NCX-1728, comparing its IOP lowering effect to that of travoprost in a nonhuman primate model of ocular hypertension. NCX-1741 reduced IOP to a similar extent to travoprost, with faster onset of activity, the company said.
Oncolytics Biotech Inc., of San Diego, disclosed the publication of an electronic poster at the CAR-TCR Summit Europe 2021 with data from a preclinical study evaluating pelareorep and CAR T-cell combination therapy in solid tumors. Newly published results show that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells. Pelareorep is a non-pathogenic isolate of the unmodified reovirus.
Oncosec Medical Inc., of Pennington, N.J., disclosed the approval of $2.5 million in tax credit certificates from the New Jersey Economic Development Authority. The certificates enable eligible technology and biotechnology companies based in New Jersey to sell unused net operating losses and R&D tax credits for cash proceeds.
Shepherd Therapeutics Inc., of Boston, disclosed a collaboration with the National Center for Advancing Translational Sciences (NCATS), part of the U.S. NIH. The pact will leverage NCATS and Shepherd's technology and scientific capabilities, including Shepherd's Delve computational platform, to identify drugs and drug combinations from NCATS' annotated compound libraries that may have the potential to significantly improve treatment options and outcomes for patients with adenoid cystic carcinoma, a rare head and neck cancer, the company said.
Sirion Biotech GmbH, of Munich, signed a license and collaboration agreement with Sanofi SA, of Paris, to develop improved tissue-selective adeno-associated virus (AAV) vectors to realize effective gene therapy treatments for disorders affecting major human organs. Sanofi, with Sirion and Dirk Grimm, at Heidelberg University Hospital, will combine their technology platforms to create a next generation of AAV vectors, Sirion said. Terms were not disclosed.
Soleno Therapeutics Inc., of Redwood City, Calif., said it signed a collaboration agreement with Vanderbilt University to discover and develop novel KATP channel activators with the potential to treat rare diseases. Terms of the collaboration were not disclosed. Activating ATP-dependent potassium (or KATP) channels has been shown to be beneficial in the treatment of various rare diseases, such as hyperinsulinemic hypoglycemia, according to Soleno, which is developing DCCR, an activator of KATP channels that has demonstrated benefit in a phase III study for the treatment of Prader-Willi syndrome.
Sunrock Biopharma SL, of Barcelona, Spain, and Genscript Probio, the CDMO segment of Genscript Probio Corp., of Nanjing, China, agreed to collaborate on efforts ranging from preclinical discovery to large-scale GMP manufacturing for Sunrock’s CCR9 therapeutic antibody candidates. CCR9, expressed in highly aggressive cancer, is associated with increased metastatic potential and tumor-chemoresistance. Sunrock aims to start clinical trials in June 2022.
Scynexis Inc., of Jersey City, N.J., said it partnered with Amplity Health, a contract commercialization organization, in connection with its anticipated U.S. launch of Brexafemme (ibrexafungerp), an oral antifungal for vulvovaginal candidiasis under FDA review, with a PDUFA date of June 1, 2021. Under the terms of the five-year agreement, Scynexis will use Amplity’s commercial expertise and resources for sales force, remote engagement, training, market access and select operations services. Amplity is deferring a portion of its direct service costs in the first two years (2021 and 2022) up to a cap, which Scynexis will repay over three years starting in 2023. Amplity has the potential to earn a performance-based success fee in the 2023-2025 time frame by exceeding certain revenue targets. Scynexis maintains full ownership of Brexafemme, control of all strategic aspects of the launch and has the right to terminate the agreement, including upon a change of control.
UCB SA, of Brussels, and Microsoft said they inked a multiyear collaboration to Microsoft's computational services, cloud and artificial intelligence with UCB's drug discovery and development capabilities. The companies said the collaboration builds on the work they have already started, focusing on COVID-19 and will work to accelerate development of therapies for severe diseases in immunology and neurology. Terms were not disclosed.
Virpax Pharmaceuticals Inc., of West Chester, Pa., said that, according to the Cooperative Research and Development Agreement between Virpax and the National Center for Advancing Translational Sciences, part of the U.S. NIH, NCATS has begun the IND-enabling studies of Envelta to support Virpax's future application for clearance from the FDA to initiate its first-in-human trials. Envelta is an intranasal enkephalin drug formulation based on nanotechnology to enable the delivery of the drug product to the brain. In animal models, it has demonstrated analgesic potential without developing opioid tolerance, withdrawal, respiratory depression, euphoria or addiction associated with the use of opioids.
Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, presented preclinical data at the ASENT 2021 annual meeting of the American Society for Experimental Neurotherapeutics showing that combining sub-efficacious doses of Kv7 potassium channel modulator XEN-1101 and other anti-seizure medications provided robust efficacy in animal models, which was not an apparent drug-drug interaction effect. In addition, the combination dosing was well-tolerated in the dose ranges explored. Xenon said the work suggests XEN-1101 may be well-suited for use as a monotherapy or applied in a rational polypharmacy setting to treat seizures.