Advaxis Inc., of Princeton, N.J., and Personalis Inc., of Menlo Park, Calif., said they are collaborating to leverage Personalis’ Immunoid Next platform in Advaxis’ ongoing phase I/II ADXS-503 (HOT Lung) program evaluating ADXS-503 alone and in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with non-small-cell lung cancer. The ADXS-503 construct targets 11 public or shared hotspot neoantigens in KRAS, EGFR and TP53 as well as 11 proprietary tumor-associated antigen targets. Under the terms of the expanded agreement, Personalis will conduct comprehensive tumor immunogenomic profiling to enable the identification of predictive composite biomarkers and/or signatures of response, as well as the broad evaluation of potential mechanisms of therapy resistance. The new agreement builds upon the prior two-year collaboration between the companies for the genomic analysis of clinical tumor samples to manufacture ADXS-NEO drug construct, Advaxis’ personalized, neoantigen-directed immunotherapy to treat a variety of late-stage cancers.
Aptorum Group Ltd., of Hong Kong, reported further positive data from its current IND-enabling studies for ALS-4, a small-molecule candidate indicated for the treatment of infections caused by Staphylococcus aureus, including methicillin-resistant Staphylococcus aureus, based on a novel antivirulence nonbactericidal approach. Subject to completion of the current studies, Aptorum is planning to submit an IND for ALS-4 in the second half of this year and start a phase I trial. ALS-4 inhibits dehydrosqualene desaturase of S. aureus, an enzyme that is critically involved in the biosynthesis of staphyloxanthin, believed to be primarily responsible for the bacteria's defense mechanism against the attack from reactive oxygen species deployed by phagocytic cells and neutrophils.
Biodesix Inc., of Boulder, Colo., said the next phase of the biomarker development program with Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York, has begun. The companies completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor Bavencio (avelumab, EMD Serono Inc./Pfizer Inc.). The focus will now be directed on transferring the test into Biodesix’s CLIA lab in Boulder, Colo., for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the Biodesix Diagnostic Cortex artificial intelligence platform.
Briacell Therapeutics Corp., of Berkeley, Calif., said Saveri Bhattacharya, an oncologist at the Sidney Kimmel Cancer Center in Philadelphia, has been selected to receive support from Kenilworth, N.J.-based Merck & Co. Inc.’s investigator studies program for a phase I/IIa study of Briacell’s lead clinical candidate, Bria-IMT, in combination with Keytruda (pembrolizumab).
Clene Nanomedicine Inc., of Salt Lake City, said data published in Scientific Reports describe the preclinical efficacy of CNM-Au8, a suspension of clean-surfaced, faceted gold nanocrystals, to support remyelinating activity, functional myelin generation and improved motor function in animal models of multiple sclerosis. In response to CNM-Au8, co-cultured central nervous system cells exhibited elevated levels of the redox coenzyme nicotine adenine dinucleotide (NAD+), elevated total intracellular ATP levels, and elevated extracellular lactate levels, along with up-regulation of myelin-synthesis related genes, collectively resulting in functional myelin generation. Oral delivery of CNM-Au8 improved motor functions of cuprizone-treated mice in both open field and kinematic gait studies.
CNS Pharmaceuticals Inc., of Houston, and Vancouver, British Columbia’s WPD Pharmaceuticals Inc. are collaborating on a phase I trial for treating brain cancer with CNS’ chemotherapy candidate, berubicin. The study, to be conducted at Children’s Memorial Health Institute in Warsaw, Poland, is an investigation of an anthracycline, berubicin, and topoisomerase II inhibitor for treating pediatric brain tumors. In a $2 million deal last November, CNS granted berubicin-related patent rights to WPD in Eastern Europe and Central Asia.
Dianomi Therapeutics Inc., of Madison, Wis., licensed a second suite of intellectual property from the Wisconsin Alumni Research Foundation to expand use of Dianomi’s mineral-coated microparticle technology into nucleic acid therapy. The newly acquired intellectual property covers compositions and methods for delivering nucleic acid-based therapies for use across nucleic acid fields, including DNA, mRNA and RNAi applications. Dianomi's first product is an interleukin-1 receptor antagonist for treating osteoarthritis.
ERS Genomics Ltd., of Dublin, granted Vienna’s Aelian Biotechnology GmbH access to ERS’ CRISPR/Cas9 patent portfolio to support Aelian’s genomic screening platform. The deal allows Aelian to offer its technology worldwide to pharmaceutical and biotech companies. Aelian combines CRISPR/Cas9 screening with single-cell sequencing to identify and study disease targets and drug mechanisms of action. The platform is applicable across a range of cell types, including primary cells, and offers access to a span of phenotypes.
Genprex Inc., of Austin, Texas, said it signed an exclusive license agreement with the University of Pittsburgh for a diabetes gene therapy that might have potential in both type 1 and type 2 diabetes. The treatment is designed to work by reprogramming beta cells in the pancreas to restore their function, using an endoscope and an adeno-associated virus vector to deliver Pdx1 and MafA genes to the pancreas. The proteins those genes express transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system. The gene therapy has been tested in vivo in mice and in nonhuman primates. Genprex said it plans to pursue potential partnerships for the development of the therapy globally and in the U.S.
Immune Therapeutics Inc., of Orlando, Fla., has not received a definitive response from FINRA regarding the 1,000-to-1 reverse stock split and name change request it made in November. Since the filing, Immune’s management said, the company has responded to FINRA’s requests for further information multiple times. Immune is developing T-cell activation therapies to treat cancer, autoimmune disease and inflammatory disease.
Kalvista Pharmaceuticals Inc., of Cambridge, Mass., said the option agreement between the company and Merck & Co. Inc., of Kenilworth, N.J., related to intravitreal diabetic macular edema (DME) candidate KVD-001 and future oral DME molecules has expired. Kalvista said it respects the Merck decision but noted the efficacy signal observed supports the relevance of that target and that there is a clear market opportunity for KVD-001 and oral plasma kallikrein inhibitors in patients with DME. With the option expiration, Kalvista has no obligations to Merck, and retains full ownership of all of its DME intellectual property in addition to its oral hereditary angioedema portfolio.
Kannalife Inc., of Doylestown, Pa., completed its phase I study funded by a grant from the NIH. The study was performed by Kannalife and the Lewis Katz School of Medicine at Temple University to assess KLS-13019, the company’s patented cannabidiol-like molecule as a potential treatment of neuropathic pain and drug dependence. The preclinical grant study was performed in an animal model to evaluate the potential use of KLS-13019 as a potent, non-opioid alternative in the prevention and reversal of chemotherapy-induced peripheral neuropathy.
Luye Pharma Group, of Hong Kong, signed an exclusive distribution and marketing service agreement with a subsidiary of Cipla Ltd., of Mumbai, India, for Seroquel (quetiapine fumarate, immediate-release) and Seroquel XR (extended-release formulation) in South Africa, Namibia and Botswana. The drugs are atypical antipsychotic medicines with antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also approved in some markets for major depressive disorder and generalized anxiety disorder. Terms were not disclosed.
M8 Pharmaceuticals Inc., of Berwin, Pa., and Daewoong Pharmaceutical Co. Ltd., of Hwaseong, South Korea, signed an exclusive licensing agreement whereby M8 will have the rights to commercialize and promote Fexuprazan in the Mexican market. The new drug is described a potassium-competitive acid blocker, in the class regarded as the next-generation treatments to replace proton pump inhibitors, often used for gastroesophageal reflux disease. Terms were not disclosed.
Olaris Inc., of Waltham, Mass., received a grant from The Michael J. Fox Foundation for Parkinson’s Research. With the funding, Olaris will work to identify biomarkers that can detect Parkinson’s disease at its earliest onset. The company will apply its metabolite profiling platform and customized machine learning algorithms. The amount of the grant was not disclosed.
Revive Therapeutics Ltd., of Toronto, signed a supply and collaboration agreement with Red Light Holland Financing Inc., of Amsterdam, an arm’s-length party. Pursuant to the agreement, Red Light will sell to Revive a consistent strain of truffles for the sole purpose of Revive undertaking research and development on the suitability and implementation of its novel cannabinoid delivery technology with respect to the truffles and its extracts. Red Light has also agreed to, upon request, provide Revive with any information, studies, papers and other information it may have pertaining to the truffles which may be deemed to be beneficial to Revive for undertaking the research and development.
Synergy Pharmaceuticals Inc., of New South Wales, Australia, performed a study that investigated a new approach to breaking down the herpes viral envelope by employing specific T cells generated through an amino-acid formula. The treatment consisted of five immunotherapeutic core compounds (5CC) comprising rhodiola, tribulus, astragalus, lysine and a proprietary mix of amino acids. The 5CCs are effective inhibitors of herpes viral DNA synthesis and interferon-induced cellular antiviral response and were found to neutralize antiviral reproduction by blocking cell-to-cell infection, the company said. The study was able to validate that for some participants there was a noted progression from a positive antibody serology to a negative one. This was the first time evidence has documented a cure for the herpes simplex virus, Synergy said.
Vistagen Therapeutics Inc., of South San Francisco, disclosed positive preclinical data of AV-101, an oral NMDAR N-methyl-D-aspartate receptor antagonist prodrug, administered in combination with probenecid. The new data suggest that there is a substantially increased brain concentration of AV-101 and its active metabolite, 7-chlorokynurenic acid, when given with probenecid. The surprising effects were first revealed in the company's recent preclinical study, although they are consistent with well-documented clinical studies of probenecid increasing the therapeutic levels of several unrelated classes of approved drugs, Vistagen said.