Addex Therapeutics SA, of Geneva, said a review published in Alcohol and Alcoholism suggests that positive allosteric modulators (PAMs) of the gamma-aminobutyric acid B (GABAB) receptor could offer a new treatment option for patients with severe alcohol use disorder. Direct, orthosteric GABAB receptor agonists such as baclofen have been shown to attenuate addiction-related behaviors in preclinical studies. However, the therapeutic use of baclofen is limited due to significant side effects, including sedation, drowsiness and sleepiness. Following analysis of a number of studies, the review emphasized that all preclinical behavioral results have shown the efficacy of GABAB PAMs for addiction treatment and offer similar mechanistic and therapeutic effects, while avoiding the tolerance and toxicity issues associated with baclofen. In particular, Addex’s GABAB PAM, ADX7-1441, demonstrated efficacy on several alcohol-related behaviors in rat models. It decreased binge-like drinking, reduced relapse-like drinking and dose-dependently reduced alcohol self-administration as well as decreased motivation to consume alcohol.
Alkido Pharma Inc., of New York, said it executed a letter of intent with Silo Pharma Inc., of Englewood Cliffs, N.J., to grant to Alkido a worldwide, exclusive sublicense for use of peptide therapy, combined with psilocybin, in the therapeutic treatment of neuroinflammatory disease in cancer patients. The letter of intent is in addition to the Jan. 6, 2021, licensing agreement between AIkido and Silo, and those additional assets expand the company's asset base in the area of psilocybin to treat cancer. Terms were not disclosed.
Anixa Biosciences Inc., of San Jose, Calif., said it started animal testing with two of its compounds that have shown potency in in vitro studies. One of the compounds being tested targets an enzyme called an endoribonuclease, and the other compound targets the enzyme known as the main protease, Mpro. Upon demonstration of potency in animals with one of those compounds, Anixa and collaboration partner Ontochem GmbH, of Halle, Germany, will have medicinal chemistry performed to optimize the potency before commencing comprehensive animal studies in anticipation of human clinical trials.
Athersys Inc., of Cleveland, said it entered a cooperation agreement with Healios K.K., of Tokyo, the company’s largest shareholder and one of its commercial partners, and Hardy TS Kagimoto, a member of the company’s board and the chairman and CEO of Healios. The cooperation agreement is intended to reaffirm the mutual commitment to collaborative development of Multistem in Japan.
Avexegen Therapeutics Inc., of San Francisco, said it received a phase II award of $2.94 million under the U.S. NIH’s Small Business Innovation Research Program for the development of an oral neuregulin-4-based therapy for inflammatory bowel disease.
Basilea Pharmaceutica Ltd., of Basil, Switzerland, said it entered an agreement to divest its Chinese R&D subsidiary, Basilea Pharmaceutica China Ltd. (BPC), by selling BPC’s parent company, BPh Investitionen Ltd., to the U.S.-based custom manufacturing organization PHT International Inc. That is expected to increase flexibility in sourcing R&D services in the future. All 72 employees and the facilities will be transferred to PHT. The initial payment is $2.5 million, which will be due upon closing of the transaction, expected in the second quarter of 2021. Basilea is entitled to additional payments of $3.8 million over the course of the next three years, for a total purchase price of $6.3 million.
Beyond Air Inc., of Garden City, N.Y., disclosed a funding agreement with the Cystic Fibrosis Foundation to advance the clinical development of high concentration nitric oxide (NO) for the treatment of NTM pulmonary disease. Under the terms, Beyond Air will receive up to $2.17 million to help fund its ongoing Lungfit GO NTM pilot study, an at-home, 12-week, single-arm, multicenter pilot trial in Australia, which is expected to enroll about 20 CF or non-CF bronchiectasis patients with refractory Mycobacterium avium complex or Mycobacterium abscessus complex lung infections. Beyond Air expects to report interim data around the middle of calendar year 2021, which will be followed by top-line data about six months later.
Cannabics Pharmaceuticals Inc., of Tel Aviv, Israel, reported final results of its in vivo study of RCC-33 for the treatment of colorectal cancer in nude mice, showing a significant and robust inhibitory effect on tumor growth, as evidenced by a 33% reduction in tumor volume in mice exposed to RCC-33 vs. sham control mice (p≤ 0.016).
Cend Therapeutics Inc., of San Diego, and Qilu Pharmaceutical Ltd., of Jinan, China, said they entered a collaboration and license agreement to develop and commercialize Cend’s CEND-1 in greater China. Qilu will gain exclusive rights to CEND-1 in greater China, including Taiwan, Hong Kong and Macau, and will take on development as well as commercialization responsibilities within the territory. In exchange, it will make an up-front license fee of $10 million. Cend also will be eligible to receive up to $225 million in milestones as well as tiered double-digit royalties on product sales in the region. Cend will continue to retain all rights outside of greater China. Cend is advancing CEND-1, a drug designed to modify the tumor microenvironment, in phase II studies in pancreatic cancer.
Clearside Biomedical Inc., of Alpharetta, Ga., presented preclinical data at the virtual Angiogenesis, Exudation, and Degeneration 2021 program hosted by the University of Miami Health System Bascom Palmer Eye Institute, showing that axitinib had intrinsic high potency, pan-VEGF inhibition through receptor blockade vs. focused VEGF-A inhibition seen in currently marketed anti-VEGF treatments. Axitinib is a tyrosine kinase inhibitor (TKI) that has been observed preclinically to be greater than 10 times more potent than other TKIs, and inhibits and regresses angiogenesis, the company said.
Enzolytics Inc., of College Station, Texas, reported results of an in vitro study showing that its ITV-1/IPF peptide treatment demonstrated broad efficacy with low toxicity when tested against human coronavirus 229E strain, and it exhibited comparable efficacy but with a 20-fold lower toxicity than widely used influenza medicine Tamiflu (oseltamivir).
Moderna Inc., of Cambridge, Mass., said it has supplied 45.4 million doses of its COVID-19 vaccine to the U.S. government to date. The CDC reported that about 25.5 million doses have been administered in the U.S. An additional 33.2 million doses have been produced and are filled in vials and in the final stages of production and testing before release. The company said it expects to deliver 100 million doses to the U.S. by the end of March, with an additional 100 million doses to come by the end of May and another 100 million doses by the end of July.
Neuren Pharmaceuticals Ltd., of Melbourne, Australia, said Prader-Willi syndrome has been added to its development pipeline for NNZ-2591 following a study in a preclinical model that showed compelling effects of treatment on key symptoms. All behavioral deficits were eliminated and the important problems of obesity and excessive insulin were also reduced to normal.
Nicox SA, of Sophia Antipolis, France, said its exclusive U.S licensee, Eyevance Pharmaceuticals, a wholly owned subsidiary of Santen Pharmaceutical Co. Ltd., of Osaka, Japan, entered a partnership with Hikma Pharmaceuticals plc, of London, for the co-promotion of Zerviate (cetirizine), indicated for the treatment of ocular itching associated with allergic conjunctivitis. Under the terms, Hikma will be responsible for promoting Zerviate to U.S. health care professionals working outside the eye care specialty, with all sales continuing to be booked by Eyevance, on which Nicox will receive royalties. Eyevance will continue to promote Zerviate to ophthalmology and optometry health care professionals in the U.S.
Novavax Inc., of Gaithersburg, Md., and SK Bioscience, a vaccine business subsidiary of SK Group, of South Korea, said they expanded their collaboration and license agreement. In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373, Novavax’ COVID-19 vaccine, for sale to the Korean government. SK Bioscience will add significant production capacity under that new agreement. Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing phase III trial in the U.K. and is currently conducting a phase III trial in the U.S. and Mexico.
Onward Therapeutics SA, of Lausanne, Switzerland, said it executed a worldwide exclusive license and co-development agreement with Biomunex Pharmaceuticals SAS, of Paris, for a bispecific antibody targeting two immune checkpoints. Under the terms, Biomunex grants the rights for Onward to pursue development, manufacture and commercialization, and the two firms will jointly develop the antibody during the preclinical and early clinical program. Biomunex is responsible for early preclinical development, while Onward will complete the IND-enabling studies, and will be responsible for GMP manufacture, clinical development and commercialization. Onward will pay up-front, development, regulatory and sales milestones, as well as tiered royalties on net sales. It also will make an equity investment in Biomunex and C. Grace Yeh, Onward’s chairman and CEO, will join Biomunex’s board. Specific financial terms were not disclosed.
Recce Pharmaceuticals Ltd., of Sydney, reported results showing that RECCE-327 demonstrated encouraging virucidal activity against the SARS-CoV-2 virus with a positive safety profile. Data showed a reduction in SARS-CoV-2 viral genome numbers at 4,000 parts per million and virus was no longer detectable by viral titration. The RT-PCR detected the three-log drop in viral genome copies (99.9% reduction). Further testing will be required at higher dose levels to establish the IC 50 and cytotoxicity, which will then allow the company to decide whether to pursue R327 as an anti SARS-CoV2 inhibitor candidate. In separate news, Recce said it formalized an agreement with Fiona Stanley Hospital for a phase I/II trial to assess the potential of RECCE-327 spray-on, broad-spectrum antibiotic to treat topical burn wound infections.
Renibus Therapeutics Inc., of Dallas, said data published in Nephrology Dialysis Transplant demonstrated that its investigational treatment for iron deficiency anemia, RBT-3, reduces cisplatin-induced kidney toxicity in an experimental preclinical model. RBT-3 was found to prophylactically reduce cisplatin-mediated nephrotoxicity in mice, and that protection was associated with a significant up-regulation of hepcidin, a protein known to be protective against kidney injury. However, unlike hepcidin, RBT-3 was also found to reduce cisplatin uptake in the kidney and up-regulate the antioxidant regulator Nrf2.
Sensorion SAS, of Montpellier, France, said it added a new gene therapy target, GJB2 coding for the Connexin 26 protein, to its development portfolio. The target is the third candidate to emerge from Sensorion’s R&D collaboration with Institut Pasteur. The GJB2 program will focus on major new markets with an estimated patient population (prevalence) of 300,000 children and adults in Europe and in the U.S. alone. It has the potential to target three pathologies related to GJB2 mutations: age-related hearing loss in adults, progressive forms of hearing loss in children, and pediatric congenital deafness. Sensorion said initially the focus will be on the first two populations.
Shepherd Therapeutics Inc., of Boston, and Oncoheroes Biosciences Inc., also of Boston, said they entered a partnership to collaborate in the discovery, development and commercialization of innovative drug products for rare oncology indications. The companies will use Delve, Shepherd's next-generation, precision-oncology platform that integrates bioinformatics, machine learning and mathematics, to unveil insights into rare cancers, including childhood cancer. The companies' first project will identify additional pediatric and rare adult indications for Oncoheroes' lead asset, volasertib, an inhibitor of Polo-like-kinase 1, an enzyme known to be involved in disease progression in a number of cancers.
Tryp Therapeutics Inc., of La Jolla, Calif., said Albany Molecular Research has begun the process of manufacturing the 200-g non-GMP demonstration batch of psilocybin. That production step is one of a series of steps in the project plan to manufacture batches of Tryp's formulation of cGMP psilocybin to support the company's clinical development and for the company's upcoming clinical trials.